Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Loss of personal independence in daily activities, Muscular weakness, SARS-CoV-2 test
Clinical narrative: She got pretty sick, like flu-type deal; Arm was weaker; Patient was tested positive for COVID-19; Pain down my arm from where the injection was / it's where I got the vaccine/Arm was hurting/Pain clear down to my elbow; It's bad enough that it's really affecting our daily life.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain down my arm from where the injection was / it's where I got the vaccine/Arm was hurting/Pain clear down to my elbow) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 023C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no medical history and allergies.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It's bad enough that it's really affecting our daily life.) and VACCINATION SITE PAIN (Pain down my arm from where the injection was / it's where I got the vaccine/Arm was hurting/Pain clear down to my elbow) (seriousness criterion disability). On 03-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient was tested positive for COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (She got pretty sick, like flu-type deal) and MUSCULAR WEAKNESS (Arm was weaker). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (She got pretty sick, like flu-type deal), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It's bad enough that it's really affecting our daily life.), MUSCULAR WEAKNESS (Arm was weaker) and VACCINATION SITE PAIN (Pain down my arm from where the injection was / it's where I got the vaccine/Arm was hurting/Pain clear down to my elbow) had not resolved and COVID-19 (Patient was tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  Patient reported that a couple of weeks after patient realized the arm was hurting and it hurt for 9 months. The more patient uses it, the more it hurts. At night it throbs, and nothing helps. Patient states it was not the shoulder, but it was where patient got the vaccine, and it trickles down a little bit. Patient swims a lot and when patient swims that day the hurt intensifies, and patient was not sure if it was the muscles. At night when patient tries to fall asleep, it just throbs. The patient visited doctor, and doctor told that all the studies had ended. The patient declined to take steroids. The patient states that this was pretty serious because it was almost a year of patient life. Patient never experienced a similar event in the past.  The patient reports trying ice but nothing had helped.  Company comment: This is a spontaneous case concerning a 46-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19 and serious (disability) Vaccination site pain. The event COVID-19 occurred 14 days after the third dose of mRNA-1273 vaccine administration while the event Vaccination site pain occurred unknown days after the third dose of mRNA-1273 vaccination. Patient reported that a couple of weeks after patient realized the arm was hurting and it hurt for 9 months, which has affected her activities of daily living. The pain in the arm radiated down to the elbow and intensifies upon movement. Patient consulted a doctor but declined to take steroids. Patient tried to apply ice on the site but pain did not resolve. No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19 and serious (disability) Vaccination site pain. The event COVID-19 occurred 14 days after the third dose of mRNA-1273 vaccine administration while the event Vaccination site pain occurred unknown days after the third dose of mRNA-1273 vaccination. Patient reported that a couple of weeks after patient realized the arm was hurting and it hurt for 9 months, which has affected her activities of daily living. The pain in the arm radiated down to the elbow and intensifies upon movement. Patient consulted a doctor but declined to take steroids. Patient tried to apply ice on the site but pain did not resolve. No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.