Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: Gastritis; Tinnitus was worse/ ringing is daily; Severe heartburn; Feeling of fullness; Still feeling off; nausea; Temporary vision loss; Migraine aura/migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Temporary vision loss), MIGRAINE (Migraine aura/migraine headache), GASTRITIS (Gastritis), TINNITUS (Tinnitus was worse/ ringing is daily) and DYSPEPSIA (Severe heartburn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine headache (Family history of cardiovascular disease). Family history included Family history of cardiovascular disorder since an unknown date. Concurrent medical conditions included COPD (The patient experienced trouble in deep breathing after vaccine.) since 2011, Gastritis (Patient experienced severe bout of gastritis a few weeks after the vaccine.) since 2010, TMJ syndrome (Patient had TMJ since his 30's.), Tinnitus (Patient had Tinnitus since his 30's.), Allergy (Allergy to mushrooms), High cholesterol and Vegan. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BLINDNESS TRANSIENT (Temporary vision loss) and MIGRAINE (Migraine aura/migraine headache). On 30-Mar-2021, the patient experienced NAUSEA (nausea). In April 2021, the patient experienced VACCINATION COMPLICATION (Still feeling off). On an unknown date, the patient experienced GASTRITIS (Gastritis), TINNITUS (Tinnitus was worse/ ringing is daily), DYSPEPSIA (Severe heartburn) and ABDOMINAL DISTENSION (Feeling of fullness). On 29-Mar-2021, BLINDNESS TRANSIENT (Temporary vision loss) and MIGRAINE (Migraine aura/migraine headache) had resolved. On 30-Mar-2021, NAUSEA (nausea) had resolved. At the time of the report, GASTRITIS (Gastritis), TINNITUS (Tinnitus was worse/ ringing is daily), DYSPEPSIA (Severe heartburn), VACCINATION COMPLICATION (Still feeling off) and ABDOMINAL DISTENSION (Feeling of fullness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: blood pressure (normal) Blood Pressure. In 2021, Electrocardiogram: ekg (normal) EKG. In 2021, Full blood count: full blood work (normal) Full blood work. In 2021, Heart rate: heart rate (normal) Heart rate.         No treatment information was provided.  Action taken with the drug in response to events was not applicable.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Case is confounded by multiple comorbidities.   The patient had woke up with half of the vision gone on the next after receiving the second dose of moderna vaccine. The patient had history of migraines. The patient was known that migraine was beginning which resolved in few minutes. And after 30 minutes, another aura began which is also resolved in few minutes. Migrains began in an hour, or so, then resolved by the end of the day.  Patient had breathing issues that is continuing from the first dose. Approximately 3 weeks after the second dose, Patient's tinnitus was worse, had ringing in the ear daily, constant and in a higher level. Gastritis was also worse after the second dose with pain doubing, severe heartburn, nausea and feeling of fullness.   This case was linked to MOD21-047977 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: A follow-up email was received from patient with no new information. The patient stated she would send in follow-up forms. On 03-Jun-2021: Follow-up was received on 03-JUN-2021 has significant information. Patient medical history were added. New events ( Breathing difficulty, tinnitus aggravated, heartburn, feeling of fullness, gastritis aggravated) were added. Information about the first dose and its events were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Case is confounded by multiple comorbidities.