Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Condition aggravated, Dizziness, Ear swelling
Clinical narrative: could barely lift my head; felt so incredibly incapacitated; unable to move without feeling like I would fall over; closing my eyes made it worse; sick the entire day; hearing in right ear was impacted; Swelling behand ear; Dizziness/severe dizziness; Blurry vision; Unable to wake up; Nausea; Vomiting/unable to move without vomiting/trying to look or focus on anything was impossible without vomiting; Severe vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe vertigo), DIZZINESS (Dizziness/severe dizziness), VISION BLURRED (Blurry vision), SOMNOLENCE (Unable to wake up) and EAR SWELLING (Swelling behand ear) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease since 09-May-2003, Drug allergy (Allergic to Tetracycline and penicillin) and Therapeutic skin care topical. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, VITAMIN D NOS, VITAMIN B [VITAMIN B NOS], ASCORBIC ACID, SODIUM ASCORBATE (VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE]), PROBIOTICS NOS and MAGNESIUM for an unknown indication.   On 11-Apr-2021, the patient received second 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) 1 dosage form. On 06-Mar-2021, the patient experienced VERTIGO (Severe vertigo). On 16-Mar-2021, the patient experienced DIZZINESS (Dizziness/severe dizziness), VISION BLURRED (Blurry vision), SOMNOLENCE (Unable to wake up), NAUSEA (Nausea) and VOMITING (Vomiting/unable to move without vomiting/trying to look or focus on anything was impossible without vomiting). On 17-Mar-2021, the patient experienced EAR SWELLING (Swelling behand ear). On an unknown date, the patient experienced MUSCULAR WEAKNESS (could barely lift my head), ASTHENIA (felt so incredibly incapacitated), BALANCE DISORDER (unable to move without feeling like I would fall over), CONDITION AGGRAVATED (closing my eyes made it worse), MALAISE (sick the entire day) and HYPOACUSIS (hearing in right ear was impacted). At the time of the report, VERTIGO (Severe vertigo), DIZZINESS (Dizziness/severe dizziness), VISION BLURRED (Blurry vision), SOMNOLENCE (Unable to wake up), EAR SWELLING (Swelling behand ear), MUSCULAR WEAKNESS (could barely lift my head), ASTHENIA (felt so incredibly incapacitated) and HYPOACUSIS (hearing in right ear was impacted) had resolved and BALANCE DISORDER (unable to move without feeling like I would fall over), CONDITION AGGRAVATED (closing my eyes made it worse), MALAISE (sick the entire day), NAUSEA (Nausea) and VOMITING (Vomiting/unable to move without vomiting/trying to look or focus on anything was impossible without vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant medication not reported.  Treatment medication includes prednisone,a nti-nausea and steroid medication   This case was linked to MOD-2021-127152 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Completed ADR form received on 13 May 2021 and updated patient medical history and updated event outcome.