Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pruritus
Clinical narrative: a round spot in the injection site area; injection site itchiness, redness; right side neck pain, side of the face; pain on the side of her face; soreness on her shoulder; headache; Pain in right upper back; Ringing ear; Feels stocked up on her ears; Vaccination site pruritus; redness and soreness; redness and soreness; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Feels stocked up on her ears), NECK PAIN (right side neck pain, side of the face), FACIAL PAIN (pain on the side of her face), INJECTION SITE DISCOLOURATION (a round spot in the injection site area) and TINNITUS (Ringing ear) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.    The patient's past medical history included Surgery (Shoulder surgery) in 2021. Concurrent medical conditions included Tetanus, Allergy to antibiotic (Bactrim-hives), Sulfonamide allergy (Sulphur drugs.), Iodine allergy, Mitral valve disease NOS (Leaky mitral valve) since November 2012, Polyp NOS (polyp on esophagus) since 1994, Polycystic ovarian syndrome since 1975, Acid reflux (esophageal) since 2014, Idiopathic peripheral autonomic neuropathy (Idiopathic peripheral neuropathy in both feet) since August 2019, Peripheral neuropathic pain (Chronic neuropathic pain in back and right leg) since August 2019 and Degenerative disc disease (Disc degenerative in back and neck) since 2001. Concomitant products included MELATONIN for Acid reflux (esophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, ATORVASTATIN CALCIUM (LIPITOR) from 10-Oct-2020 to an unknown date for Cholesterol, MACROGOL 3350 (MIRALAX) for Constipation, ESTRADIOL (YUVAFEM) for Hormone replacement therapy, METOPROLOL SUCCINATE, IRBESARTAN, AMLODIPINE and AMLODIPINE BESILATE (NORVASC) for Hypertension, DICLOFENAC SODIUM for Pain, GABAPENTIN for Peripheral neuropathy, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), ACETYLSALICYLIC ACID (BABY ASPIRIN) from 12-Apr-2020 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and CETIRIZINE HYDROCHLORIDE (CETRIZINE) (unknown route) 10 mg once a day. On 07-Jan-2021, the patient experienced EAR INFECTION (Feels stocked up on her ears), VACCINATION SITE PRURITUS (Vaccination site pruritus), INJECTION SITE ERYTHEMA (redness and soreness) and INJECTION SITE PAIN (redness and soreness). On 11-Jan-2021, the patient experienced TINNITUS (Ringing ear). On 12-Jan-2021, the patient experienced BACK PAIN (Pain in right upper back). On 13-Jan-2021, the patient experienced NECK PAIN (right side neck pain, side of the face), FACIAL PAIN (pain on the side of her face), HEADACHE (headache) and ARTHRALGIA (soreness on her shoulder). On 15-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (a round spot in the injection site area) and INJECTION SITE PRURITUS (injection site itchiness, redness). On 08-Jan-2021, EAR INFECTION (Feels stocked up on her ears), VACCINATION SITE PRURITUS (Vaccination site pruritus) and INJECTION SITE PAIN (redness and soreness) had resolved. On 14-Jan-2021, NECK PAIN (right side neck pain, side of the face), FACIAL PAIN (pain on the side of her face), HEADACHE (headache) and ARTHRALGIA (soreness on her shoulder) had resolved. At the time of the report, INJECTION SITE DISCOLOURATION (a round spot in the injection site area), TINNITUS (Ringing ear), BACK PAIN (Pain in right upper back), INJECTION SITE PRURITUS (injection site itchiness, redness) and INJECTION SITE ERYTHEMA (redness and soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2012, Echocardiogram: unknown (Inconclusive) Mild. In August 2019, Electromyogram: unknown (Inconclusive) Idiopathic peripheral neuropathy Chronic neuropathic pain in back and right leg. On 03-Nov-2019, Endoscopy: unknown (Inconclusive) Checked periodically by gastroenterologist, Doctor said common.. On 27-Jan-2021, Laparoscopy: unknown (Inconclusive) PCOS diagnosed via  laparoscopy. On 27-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment: Used a heating pad   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 7-6-2021. Patient demographics added, medical history added, lab data added, concomitant medication added, event added