Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Tinnitus
Clinical narrative: motion sickness; ears ringing; having chills; severe dizziness / Extreme dizziness; She could not stand,; legs felt like rubber.; Couldn't drive; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness / Extreme dizziness), TINNITUS (ears ringing), DYSSTASIA (She could not stand,), MUSCULAR WEAKNESS (legs felt like rubber.) and MOTION SICKNESS (motion sickness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: TDAP (Few weeks before getting second of the Moderna COVID-19 vaccine.) on 26-Feb-2021. Concurrent medical conditions included Drug allergy (Tetracycline.), Drug allergy (Imitrex.), Drug allergy (Xanax.), Drug allergy (Fentanyl Patch.), Shingles (Shingles pain.) since 2008 and Migraine (Since Patient was in her 20's). Concomitant products included AMITRIPTYLINE and VERAPAMIL for Migraine, GABAPENTIN for Shingles, ACETYLSALICYLIC ACID, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (FIORINAL CODEINA), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE, PANTOPRAZOLE, MIRTAZAPINE (REMERON) and PROPANOL for an unknown indication.   On 19-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-1900, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't drive). On 19-Mar-2021, the patient experienced DIZZINESS (severe dizziness / Extreme dizziness). 19-Mar-2021, the patient experienced DYSSTASIA (She could not stand,) and MUSCULAR WEAKNESS (legs felt like rubber.). On 19-Mar-2021 at 3:00 AM, the patient experienced CHILLS (having chills). On 21-Mar-2021, the patient experienced TINNITUS (ears ringing). On an unknown date, the patient experienced MOTION SICKNESS (motion sickness). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 1 dosage form once a day. At the time of the report, DIZZINESS (severe dizziness / Extreme dizziness) had not resolved and TINNITUS (ears ringing), DYSSTASIA (She could not stand,), MUSCULAR WEAKNESS (legs felt like rubber.), MOTION SICKNESS (motion sickness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't drive) and CHILLS (having chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the event was considered as not applicable.   This case was linked to MOD-2021-253197 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up information received contains significant information. Updated Reporter Information, Vaccination Time, Patient Demographic Details, Other Medical History, Concomitant Medications, Treatment Medications and an  Event is added On 28-May-2021: Follow up information received contains significant information. Added a Concomitant Medication and Treatment information. Added events Dizziness, Legs rubbered, Could not stand up, Could not drive. On 11-Jul-2021: Follow up information received on 11 Jul. 2021 contains no significant information