Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain, Vaccination site reaction
Clinical narrative: Patient has uveitis or inflammation of eye only in left eye; not being able to calm my eyes down from the flare caused by the vaccine; My fear is getting the second shot; Had a few heart palpitations which comes and goes; Pain that went down her sides as if the pain was right underneath her chest cavity that radiated up to her neck and shoulder; And not herself; A COVID arm; Pain that went down her sides as if the pain was right underneath her chest cavity that radiated up to her neck and shoulder; There is still some soreness and tenderness under the armpit; Sore arm; Was very very tired and not herself; She felt bad for two days; Her autoimmune disorder flared up/full blown autoimmune response; This spontaneous case was reported by a nurse and describes the occurrence of AUTOIMMUNE DISORDER (Her autoimmune disorder flared up/full blown autoimmune response) and UVEITIS (Patient has uveitis or inflammation of eye only in left eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety and Breathing difficult. Concomitant products included CORTISONE ACETATE (CORTISOL [CORTISONE ACETATE]) for Anxiety and Breathing difficult, VITAMINS NOS for an unknown indication.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced AUTOIMMUNE DISORDER (Her autoimmune disorder flared up/full blown autoimmune response) (seriousness criterion medically significant). On an unknown date, the patient experienced UVEITIS (Patient has uveitis or inflammation of eye only in left eye) (seriousness criterion medically significant), EYE MOVEMENT DISORDER (not being able to calm my eyes down from the flare caused by the vaccine), FEAR OF INJECTION (My fear is getting the second shot), PALPITATIONS (Had a few heart palpitations which comes and goes), NECK PAIN (Pain that went down her sides as if the pain was right underneath her chest cavity that radiated up to her neck and shoulder), FEELING ABNORMAL (And not herself), VACCINATION SITE REACTION (A COVID arm), ARTHRALGIA (Pain that went down her sides as if the pain was right underneath her chest cavity that radiated up to her neck and shoulder), AXILLARY PAIN (There is still some soreness and tenderness under the armpit), VACCINATION SITE PAIN (Sore arm), FATIGUE (Was very very tired and not herself) and VACCINATION COMPLICATION (She felt bad for two days). The patient was treated with DIFLUPREDNATE (DUREZOL) for Adverse event, at a dose of UNK UNK, bid. At the time of the report, AUTOIMMUNE DISORDER (Her autoimmune disorder flared up/full blown autoimmune response), UVEITIS (Patient has uveitis or inflammation of eye only in left eye), PALPITATIONS (Had a few heart palpitations which comes and goes), NECK PAIN (Pain that went down her sides as if the pain was right underneath her chest cavity that radiated up to her neck and shoulder), ARTHRALGIA (Pain that went down her sides as if the pain was right underneath her chest cavity that radiated up to her neck and shoulder), AXILLARY PAIN (There is still some soreness and tenderness under the armpit) and FATIGUE (Was very very tired and not herself) had not resolved, EYE MOVEMENT DISORDER (not being able to calm my eyes down from the flare caused by the vaccine), FEAR OF INJECTION (My fear is getting the second shot), FEELING ABNORMAL (And not herself), VACCINATION SITE PAIN (Sore arm) and VACCINATION COMPLICATION (She felt bad for two days) outcome was unknown and VACCINATION SITE REACTION (A COVID arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that if treating with eye drops also if disease get uncontrolled she may have lost her eyesight and there is a possibility that every flare she will have to go on oral steroids. She doesn't want to do that because of IBD. The symptoms are still there and patient expecting symptoms get resolve in mid October or last November. Before taking vaccination patient experienced anxiety and shortness of breath. Patient is frequently visiting her ophthalmologist for the side effects and going to see ophthalmologist again.  Company Comment: This case concerns a 41-year-old, female patient with no relevant medical history, who experienced the expected event of Autoimmune Disorder and Uveitis. The event Autoimmune Disorder occurred 6 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and the event uveitis occurred after an unknown number of days after the first dose of the vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of  mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow- up received on 17-Sep-2021. Added events; Sender's Comments: This case concerns a 41-year-old, female patient with no relevant medical history, who experienced the expected event of Autoimmune Disorder and Uveitis. The event Autoimmune Disorder occurred 6 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and the event uveitis occurred after an unknown number of days after the first dose of the vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of  mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.