Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Feeling abnormal, Headache, Illness, Intentional product use issue
Clinical narrative: chills; had symptoms and did not receive second dose; ear infection in one ear and felt ears would clog up; felt symptoms of a sinus infection; became very sick after first dose; severe migraine; brain fog; ears blocked; fever; body ache; Nausea; Headache; Arm Pain; light headedness; dizziness; Weakness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), DIZZINESS (light headedness; dizziness), ASTHENIA (Weakness), ILLNESS (became very sick after first dose) and MIGRAINE (severe migraine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus, COPD and Hypothyroidism. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), DIZZINESS (light headedness; dizziness), ASTHENIA (Weakness), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (body ache). On 06-Mar-2021, the patient experienced ILLNESS (became very sick after first dose), MIGRAINE (severe migraine), FEELING ABNORMAL (brain fog), EAR DISCOMFORT (ears blocked) and PYREXIA (fever). On 12-Mar-2021, the patient experienced SINUSITIS (felt symptoms of a sinus infection). On 27-Mar-2021, the patient experienced EAR INFECTION (ear infection in one ear and felt ears would clog up). On 07-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (had symptoms and did not receive second dose). On an unknown date, the patient experienced CHILLS (chills). On 08-Mar-2021, PAIN IN EXTREMITY (Arm Pain), DIZZINESS (light headedness; dizziness), ASTHENIA (Weakness), NAUSEA (Nausea) and MYALGIA (body ache) had resolved. On 07-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (had symptoms and did not receive second dose) had resolved. At the time of the report, ILLNESS (became very sick after first dose), MIGRAINE (severe migraine), FEELING ABNORMAL (brain fog), EAR DISCOMFORT (ears blocked), SINUSITIS (felt symptoms of a sinus infection), EAR INFECTION (ear infection in one ear and felt ears would clog up), CHILLS (chills) and PYREXIA (fever) had resolved and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood glucose fluctuation: low (Low) low.     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 reports current medications as thyroid medication, over the counter eye drops, insulin pump, and insulin four times daily.  27-Mar-2021 Patient went to her physician and was given an antibiotic for an ear infection on one side. It was not disclosed which ear was infected. Patient states her physician did mention her symptoms could be due to vaccine side effects.  Treatment medications are listed as Aleve and an antibiotic. At time of follow-up report, the only ongoing symptom was a constant headache. 07-Apr-2021 Patient was supposed to receive her second dose of vaccine. Patient had symptoms and did not receive her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up report received. Medical history, medications, adverse events, and treatments were updated per new report information.