Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Rotator cuff syndrome, Swelling face
Clinical narrative: shoulder impingement & bursitis; face swollen like moon face from steroids; shoulder impingement; left arm was extremely painful for 10 days; having trouble with her left eye; passed out; felt sick/not feeling well today; felt weak/couldn't get up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 1986.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (felt sick/not feeling well today) and ASTHENIA (felt weak/couldn't get up). On 31-Mar-2022, the patient experienced OCULAR DISCOMFORT (having trouble with her left eye). On an unknown date, the patient experienced BURSITIS (shoulder impingement & bursitis), SWELLING FACE (face swollen like moon face from steroids), ROTATOR CUFF SYNDROME (shoulder impingement) and INJECTION SITE PAIN (left arm was extremely painful for 10 days). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MALAISE (felt sick/not feeling well today), BURSITIS (shoulder impingement & bursitis), SWELLING FACE (face swollen like moon face from steroids), OCULAR DISCOMFORT (having trouble with her left eye), ROTATOR CUFF SYNDROME (shoulder impingement), ASTHENIA (felt weak/couldn't get up) and INJECTION SITE PAIN (left arm was extremely painful for 10 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received her 2nd dose Moderna vaccine on 09 Aug 2021. Following her first dose she had bad pain in her left arm followed by pain and redness in left eye. On the night of the 2nd dose, on her way to the bathroom , she felt sick & passed out.  When she came to she could not get up and felt weak and her husband called the rescue squad. Recently she had a shot for her left shoulder which she hurt by lifting something heavy. She saw an orthopedic surgeon and was told she had shoulder impingement & bursitis.  She did not know the name of the shot but it contained a Steroid and 3 other active ingredients. That shot was given in her left shoulder. She said her left arm  was extremely painful for 10 days.  Next morning her face was swollen like moon face from steroids. She said that she was not feeling well today and  was having trouble with her left eye. She wonders if the shot she received & the Moderna Covid-19 Vaccine have ingredients in common and asks for a list of the ingredients of the Moderna Covid-19 Vaccine.  Concomitant medications was not provided.   This case was linked to MOD-2022-530569 (Patient Link).  Company comment: This spontaneous case concerns a 69-year-old female patient, with medical history of rheumatoid arthritis, who experienced the serious (medically significant) unexpected event of loss of consciousness and non-serious unexpected events of malaise and asthenia on the night after receiving the second dose of mRNA 1273 COVID-19 vaccine. On unknown date, patient hurt her left shoulder after lifting something heavy and was diagnosed to have shoulder impingement and bursitis. She was given unspecified shot of steroid and 3 other ingredients which caused pain in the injection site. Patient also had swollen face which she attributes to the steroid. Seven months after the vaccine patient had ocular discomfort. The patient's history of rheumatoid arthritis remains as confounder to events shoulder impingement and bursitis while the shoulder injury is a confounder to events shoulder impingement, bursitis and the steroid shot is a confounder to events swollen face and injection site pain. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with medical history of rheumatoid arthritis, who experienced the serious (medically significant) unexpected event of loss of consciousness and non-serious unexpected events of malaise and asthenia on the night after receiving the second dose of mRNA 1273 COVID-19 vaccine. On unknown date, patient hurt her left shoulder after lifting something heavy and was diagnosed to have shoulder impingement and bursitis. She was given unspecified shot of steroid and 3 other ingredients which caused pain in the injection site. Patient also had swollen face which she attributes to the steroid. Seven months after the vaccine patient had ocular discomfort. The patient's history of rheumatoid arthritis remains as confounder to events shoulder impingement and bursitis while the shoulder injury is a confounder to events shoulder impingement, bursitis and the steroid shot is a confounder to events swollen face and injection site pain. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.