Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Discomfort, Fatigue, Incorrect route of product administration
Clinical narrative: flu like symptoms; fatigued/extremely fatigued and it lasted for about 3 months/ very fatigued; moderate to severe arthritic pain/ arthralgia/joint pain; Severe Muscle pain/lot of pain throughout her body,; Inappropriate route of vaccination; Experiencing autoimmune - like symptoms; malaise; a lot of pain throughout her body; It was very uncomfortable; This spontaneous case was reported by a nurse and describes the occurrence of AUTOIMMUNE DISORDER (Experiencing autoimmune - like symptoms), MALAISE (malaise), PAIN (a lot of pain throughout her body), DISCOMFORT (It was very uncomfortable) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k202a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Oral surgery on 02-Jun-2021. Concurrent medical conditions included GERD since 01-Jan-2010, Supraventricular tachycardia since 01-Jan-2005, Migraine since 01-Jan-2005 and Serotonin deficiency since 01-Jan-2005. Concomitant products included FAMOTIDINE from 01-Jan-2010 to an unknown date for GERD, RIZATRIPTAN from 01-Jan-2005 to an unknown date for Migraine, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Jan-2005 to an unknown date for Prevention, DULOXETINE HYDROCHLORIDE (CYMBALTA) from 01-Jan-2005 to an unknown date for Serotonin deficiency, METOPROLOL from 01-Jan-2005 to an unknown date for Supraventricular tachycardia, CELECOXIB (COXID) for an unknown indication.   On 14-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). In February 2021, the patient experienced AUTOIMMUNE DISORDER (Experiencing autoimmune - like symptoms), MALAISE (malaise), PAIN (a lot of pain throughout her body) and DISCOMFORT (It was very uncomfortable). On 19-Feb-2021, the patient experienced FATIGUE (fatigued/extremely fatigued and it lasted for about 3 months/ very fatigued), ARTHRALGIA (moderate to severe arthritic pain/ arthralgia/joint pain) and MYALGIA (Severe Muscle pain/lot of pain throughout her body,). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with AMOXICILLIN from 02-Jun-2021 to 23-Jun-2021 for Tooth cavity, at a dose of UNK dosage form. On 11-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. On 22-Jun-2021, ARTHRALGIA (moderate to severe arthritic pain/ arthralgia/joint pain) and MYALGIA (Severe Muscle pain/lot of pain throughout her body,) had resolved. On 23-Jun-2021, MALAISE (malaise), PAIN (a lot of pain throughout her body) and FATIGUE (fatigued/extremely fatigued and it lasted for about 3 months/ very fatigued) had resolved. At the time of the report, AUTOIMMUNE DISORDER (Experiencing autoimmune - like symptoms) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown and DISCOMFORT (It was very uncomfortable) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   DIAGNOSTIC RESULTS: On an unknown date, Blood test: negative  On an unknown date, Inflammatory marker test: low  On an unknown date, X-ray:  Negative for inflammation..    The patient started to experience the events two weeks after the second dose. The patient states  that her symptoms  lasted for about 3 months. She went to rheumatologist and blood work was negative for inflammation but she still had the symptoms. The patient had oral surgery 02-Jun-2021 and had to be on antibiotics for three weeks and then stopped antibiotics.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information received and new events were updated. On 24-Jul-2021: Follow-up was received and New medical history, lab test, concomitant drug, treatment drug and events(myalgia and flu like symptoms) were added. The outcome of the events changed from not recovered to recovered.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events