Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Some fatigue off and on; Sensation in my left ear; Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness; Took temperature 102.5 F; Big rash about size of apple below injection site; Feeling severely cold; I had a terrible bad day yesterday; Mild pain at injection site for two days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling severely cold), FEELING ABNORMAL (I had a terrible bad day yesterday), EAR DISCOMFORT (Sensation in my left ear), DIZZINESS (Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness) and PYREXIA (Took temperature 102.5 F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLINDAMYCIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATENOLOL, MIDODRINE and TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced FEELING COLD (Feeling severely cold), FEELING ABNORMAL (I had a terrible bad day yesterday), PYREXIA (Took temperature 102.5 F) and VACCINATION SITE RASH (Big rash about size of apple below injection site). On 18-Mar-2021, the patient experienced EAR DISCOMFORT (Sensation in my left ear) and DIZZINESS (Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness). On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild pain at injection site for two days) and FATIGUE (Some fatigue off and on). The patient was treated with MECLIZINE [MECLOZINE] on 22-Mar-2021 at a dose of 1 dosage form. On 07-Mar-2021, FEELING ABNORMAL (I had a terrible bad day yesterday) had resolved. At the time of the report, FEELING COLD (Feeling severely cold), EAR DISCOMFORT (Sensation in my left ear), DIZZINESS (Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness), PYREXIA (Took temperature 102.5 F), VACCINATION SITE RASH (Big rash about size of apple below injection site), VACCINATION SITE PAIN (Mild pain at injection site for two days) and FATIGUE (Some fatigue off and on) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Added events mild pain at injection site, fatigue, sensation in my left ear , got real dizzy, could hardly get out of bed because I was so dizzy and could not focus my eyes and severe dizziness, all having outcome unknown.