Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Hyperhidrosis, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: Autoimmune disorder; Abnormal sensation in eye; Dry throat; Head discomfort; Hyperhidrosis; Laboratory test abnormal; Paraesthesia; Sensation of foreign body; Skin burning sensation; Lymphadenopathy; Arthralgia; Chills; Headache; Pyrexia; Nausea; This case was received via VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disorder) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa allergy) and Seafood allergy (Shrimp allergy).    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disorder) (seriousness criterion medically significant), ABNORMAL SENSATION IN EYE (Abnormal sensation in eye), DRY THROAT (Dry throat), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), LABORATORY TEST ABNORMAL (Laboratory test abnormal), PARAESTHESIA (Paraesthesia), SENSATION OF FOREIGN BODY (Sensation of foreign body), SKIN BURNING SENSATION (Skin burning sensation), LYMPHADENOPATHY (Lymphadenopathy), ARTHRALGIA (Arthralgia), CHILLS (Chills), HEADACHE (Headache), PYREXIA (Pyrexia) and NAUSEA (Nausea). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disorder), ABNORMAL SENSATION IN EYE (Abnormal sensation in eye), DRY THROAT (Dry throat), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), LABORATORY TEST ABNORMAL (Laboratory test abnormal), PARAESTHESIA (Paraesthesia), SENSATION OF FOREIGN BODY (Sensation of foreign body), SKIN BURNING SENSATION (Skin burning sensation), LYMPHADENOPATHY (Lymphadenopathy), ARTHRALGIA (Arthralgia), CHILLS (Chills), HEADACHE (Headache), PYREXIA (Pyrexia) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Autoimmune disorder: positive (Positive) Autoimmune disorder positive. On 01-Feb-2021, Body temperature: 102 (High) 102 Fever. On 17-Feb-2021, Blood test: abnormal (abnormal) Allergy to shrimp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced 102 Fever, Sweats, Chills, all joints on fire and in pain, headache, nausea, swollen lymph nodes in neck. Patient felt better after several days then she has eaten shrimp on 13-FEB-2021 and again on 17-FEB-2021 after which patient had a reaction to the shrimp.  Patient visited a doctor and a complete blood work analysis was done that revealed allergy to shrimp and a high titer which could be an autoimmune disorder.  Patient had determined that she has reaction when something has MSG or Maltodextrin. Patient's throat was dry, a feeling of lump in the throat,  eyes seemed a little dry,  the headache has not gone away.  Patient also experienced pressure on the top of her head and forehead, tingling and on fire in hands wrists, forearms, shins and ankles. Patient has an appointment with a Rheumatologist on March 30.  No concomitant medication were reported. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.