Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Autoimmune disorder, Blood test
Clinical narrative: I have an autoimmune disease, it exacerbated that I think; Haven't been able to sleep well in the last week,; I feel energized and exhausted at the same time; I feel worn out /I feel energized and exhausted at the same time; Weak; and was having trouble walking; Body ache; Extreme joint pain; Headache/I still have pain in my head on top and the back of head; I had chest pain; A lot pressure in my head; A lot of vertigo; Very shaky/I feel like I have a shock in my body; Dizziness; Anxiety/Anxiety attack; Panic attack; I immediately had nausea; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (I have an autoimmune disease, it exacerbated that I think) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Autoimmune disorder NOS. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (I have an autoimmune disease, it exacerbated that I think) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizziness), ANXIETY (Anxiety/Anxiety attack), PANIC ATTACK (Panic attack) and NAUSEA (I immediately had nausea). On 03-May-2021, the patient experienced CHEST PAIN (I had chest pain), HEAD DISCOMFORT (A lot pressure in my head), VERTIGO (A lot of vertigo), TREMOR (Very shaky/I feel like I have a shock in my body), GAIT DISTURBANCE (and was having trouble walking), HEADACHE (Headache/I still have pain in my head on top and the back of head), MYALGIA (Body ache) and ARTHRALGIA (Extreme joint pain). On 03-Jun-2021, the patient experienced ASTHENIA (Weak). On 05-Jun-2021, the patient experienced INSOMNIA (Haven't been able to sleep well in the last week,), ENERGY INCREASED (I feel energized and exhausted at the same time) and FATIGUE (I feel worn out /I feel energized and exhausted at the same time). The patient was hospitalized from 03-May-2021 to 04-May-2021 due to AUTOIMMUNE DISORDER. The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Vertigo, at a dose of 1 dosage form; ACRIVASTINE (BENADRYL OTC) at a dose of 1 dosage form; IBUPROFEN at a dose of 200 mg three times a day and PARACETAMOL (TYLENOL 8 HOUR) at a dose of 1 dosage form. At the time of the report, AUTOIMMUNE DISORDER (I have an autoimmune disease, it exacerbated that I think), DIZZINESS (Dizziness), ANXIETY (Anxiety/Anxiety attack), PANIC ATTACK (Panic attack), CHEST PAIN (I had chest pain), HEAD DISCOMFORT (A lot pressure in my head), VERTIGO (A lot of vertigo), TREMOR (Very shaky/I feel like I have a shock in my body), ASTHENIA (Weak), GAIT DISTURBANCE (and was having trouble walking), INSOMNIA (Haven't been able to sleep well in the last week,), ENERGY INCREASED (I feel energized and exhausted at the same time), HEADACHE (Headache/I still have pain in my head on top and the back of head), NAUSEA (I immediately had nausea), MYALGIA (Body ache), ARTHRALGIA (Extreme joint pain) and FATIGUE (I feel worn out /I feel energized and exhausted at the same time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Blood test: normal No findings. On 03-May-2021, Electrocardiogram: no blood clots normal. On 03-May-2021, Ultrasound chest: no blood clots normal.         Patient does not have DVT. She is allergic to many allergens so the Emergency Room did not prescribe her any medications.Treatment information mentioned IV fluids NOS.  Additional information mentioned, the patient had a few similar events occur after the second dose as well. She went to the emergency room to get treated. Post that, still had some events and has scheduled a doctors appointment.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209781 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.