Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Immune-mediated adverse reaction, Inappropriate schedule of product administration, Memory impairment
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of MENINGITIS ASEPTIC (developed possible aseptic meningoencephalitis) and IMMUNE-MEDIATED ADVERSE REACTION (doctor thought  that I could have hyperimmune react) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Back surgery in June 2015. Concurrent medical conditions included Depression since 2010, Chronic back pain (s/p (status post) back surgery) since 25-Jun-2015, Egg allergy (when patient was in elementary/middle school), Food allergy (spinach - severe abd pain) since 2019, Drug allergy (Reglan), Drug allergy (Fentanyl) and Acid reflux (esophageal) since 2018. Concomitant products included LANSOPRAZOLE (PREVACID) for Acid reflux (esophageal), PARACETAMOL (TYLENOL) for Back pain. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced MENINGITIS ASEPTIC (developed possible aseptic meningoencephalitis) (seriousness criterion medically significant). On 03-Jul-2021, the patient experienced MEMORY IMPAIRMENT (memory deficits), DISTURBANCE IN ATTENTION (concentration problems), MOUTH ULCERATION (mouth ulcers), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), CONSTIPATION (constipation), MUSCLE TWITCHING (muscle twitchings lower legs), BURNING SENSATION (bilateral feet burning), PERIPHERAL COLDNESS (bilateral feet coldness), DEHYDRATION (severe dehydration), VACCINATION COMPLICATION (hyperimmune reaction), VACCINATION SITE INDURATION (left arm induration), MYALGIA (myalgias), HEADACHE (pulsatile headaches) and PYREXIA (fever). On an unknown date, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (doctor thought  that I could have hyperimmune react) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose administration). At the time of the report, MENINGITIS ASEPTIC (developed possible aseptic meningoencephalitis), MEMORY IMPAIRMENT (memory deficits), DISTURBANCE IN ATTENTION (concentration problems), MOUTH ULCERATION (mouth ulcers), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), CONSTIPATION (constipation), MUSCLE TWITCHING (muscle twitchings lower legs), BURNING SENSATION (bilateral feet burning), PERIPHERAL COLDNESS (bilateral feet coldness), DEHYDRATION (severe dehydration), VACCINATION COMPLICATION (hyperimmune reaction), VACCINATION SITE INDURATION (left arm induration), MYALGIA (myalgias), HEADACHE (pulsatile headaches) and PYREXIA (fever) had not resolved, IMMUNE-MEDIATED ADVERSE REACTION (doctor thought  that I could have hyperimmune react) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose administration) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, Body temperature: 99.7 degrees f (High) fever 99.7 degrees F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. 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. This case was linked to MOD-2021-111340, MOD-2021-111340 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received does not contain any new information; 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.