Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Intraocular pressure test, Irritability, Mouth ulceration, Poor quality sleep, Rash
Clinical narrative: OPEN SORES IN MOUTH; Sleep unwell; Sleeping difficult; A occasional sensation of numbness; Eye achy; Rash at the injection site; Right side of face and eye were achy; Ear ache; Annoyance; Rash on his arm/Total body rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (A occasional sensation of numbness), EYE PAIN (Eye achy), FACIAL PAIN (Right side of face and eye were achy), EAR PAIN (Ear ache) and INSOMNIA (Sleeping difficult) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus disorder NOS, Drug allergy (Allergy to Sulfa caused open sores in mouth) since 1985 and Allergy to antibiotic (Allergy to Amoxicillin caused total body rash) since 2000.   On 02-Feb-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced FACIAL PAIN (Right side of face and eye were achy), EAR PAIN (Ear ache), IRRITABILITY (Annoyance) and RASH (Rash on his arm/Total body rash). On 10-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site). On 12-Feb-2021, the patient experienced HYPOAESTHESIA (A occasional sensation of numbness), EYE PAIN (Eye achy) and INSOMNIA (Sleeping difficult). On an unknown date, the patient experienced MOUTH ULCERATION (OPEN SORES IN MOUTH) and POOR QUALITY SLEEP (Sleep unwell). On 15-Apr-2021, HYPOAESTHESIA (A occasional sensation of numbness), EYE PAIN (Eye achy), FACIAL PAIN (Right side of face and eye were achy) and INSOMNIA (Sleeping difficult) had resolved. At the time of the report, EAR PAIN (Ear ache), IRRITABILITY (Annoyance), MOUTH ULCERATION (OPEN SORES IN MOUTH), POOR QUALITY SLEEP (Sleep unwell) and RASH (Rash on his arm/Total body rash) outcome was unknown and VACCINATION SITE RASH (Rash at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Intraocular pressure test: normal (normal) Normal, pressure checked on right eye.         The reaction consisted of mainly right side face/cheek pain and with some right eye and ear pain.  And at times, a occasional sensation of numbness. This made sleeping somewhat difficult because the patient couldn't lay the right side of the face on the pillow. After 11 weeks the patient now able to sleep on the right side. No Concomitant medications were provided The patient had 10 day course of antibiotics for sinuses   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021 contains significant information: Added patient's demographic, medical history (Allergy: Sulfa, Amoxicillin), lab data (eye pressure), 2nd dose vaccine information (start date, lot number, route and site of administration), new adverse events (Sensation of numbness, Sleeping difficult, Rash at the injection site).For Eye achness, numbness and facial pain event outcome was changed to recoverd /resovled from unknown On 14-Jul-2021: Follow up information received on 14 Jul 2021 contains significant information; events added