Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Eye pain, Gingival bleeding, Migraine, Pain in jaw
Clinical narrative: her cheek bone hurt/she has the same symptoms after receiving the first booster dose; When asked if she had tested positive for Covid 19, caller explained that she had not, but she thinks she might have had Covid19 since she experienced gum bleeding, nose running, she was freezing cold and came down with a cold/Feeling cold/ Rhin; teeth hurt/she has the same symptoms after receiving the first booster dose; pain remains her of a migraine; the pain will then go to the ear/she has the same symptoms after receiving the first booster dose; her eyeball would hurt when she touched it/ Eyes hurt/she has the same symptoms after receiving the first booster dose; she experienced gum bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (the pain will then go to the ear/she has the same symptoms after receiving the first booster dose), EYE PAIN (her eyeball would hurt when she touched it/ Eyes hurt/she has the same symptoms after receiving the first booster dose), GINGIVAL BLEEDING (she experienced gum bleeding), PAIN IN JAW (her cheek bone hurt/she has the same symptoms after receiving the first booster dose) and SUSPECTED COVID-19 (When asked if she had tested positive for Covid 19, caller explained that she had not, but she thinks she might have had Covid19 since she experienced gum bleeding, nose running, she was freezing cold and came down with a cold/Feeling cold/ Rhin) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 012A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma and Rhinitis (Non-allergic rhinitis). Concomitant products included ZINC for Rhinitis prophylaxis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced GINGIVAL BLEEDING (she experienced gum bleeding). On an unknown date, the patient experienced EAR PAIN (the pain will then go to the ear/she has the same symptoms after receiving the first booster dose), EYE PAIN (her eyeball would hurt when she touched it/ Eyes hurt/she has the same symptoms after receiving the first booster dose), PAIN IN JAW (her cheek bone hurt/she has the same symptoms after receiving the first booster dose), SUSPECTED COVID-19 (When asked if she had tested positive for Covid 19, caller explained that she had not, but she thinks she might have had Covid19 since she experienced gum bleeding, nose running, she was freezing cold and came down with a cold/Feeling cold/ Rhin), TOOTHACHE (teeth hurt/she has the same symptoms after receiving the first booster dose) and MIGRAINE (pain remains her of a migraine). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergic rhinitis, at an unspecified dose and frequency and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, at an unspecified dose and frequency. In January 2022, EAR PAIN (the pain will then go to the ear/she has the same symptoms after receiving the first booster dose), EYE PAIN (her eyeball would hurt when she touched it/ Eyes hurt/she has the same symptoms after receiving the first booster dose), GINGIVAL BLEEDING (she experienced gum bleeding), PAIN IN JAW (her cheek bone hurt/she has the same symptoms after receiving the first booster dose), SUSPECTED COVID-19 (When asked if she had tested positive for Covid 19, caller explained that she had not, but she thinks she might have had Covid19 since she experienced gum bleeding, nose running, she was freezing cold and came down with a cold/Feeling cold/ Rhin) and TOOTHACHE (teeth hurt/she has the same symptoms after receiving the first booster dose) had resolved. At the time of the report, MIGRAINE (pain remains her of a migraine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies. Patient never tested or diagnosed with COVID. Concomitant medications also included 2 different types of eye drops for her Glaucoma and nasal spray for her non-allergic rhinitis. Patient was not actively experiencing the symptoms and these stopped in January 2022. No treatment details were reported.  Company Comment: This is a Spontaneous case concerning an 80-year-old female patient, with reported medical history of Glaucoma and non-allergic rhinitis, who experienced the non-serious unexpected AESI of Suspected COVID-19. The event occurred approximately 2 weeks after the administration of the 3rd of the mRNA-1273 vaccine. Very limited information is available regarding clinical course and diagnostic work-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.   This case was linked to MOD-2022-546741 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning an 80-year-old female patient, with reported medical history of Glaucoma and non-allergic rhinitis, who experienced the non-serious unexpected AESI of Suspected COVID-19. The event occurred approximately 2 weeks after the administration of the 3rd of the mRNA-1273 vaccine. Very limited information is available regarding clinical course and diagnostic work-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.