Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Rash erythematous, Tinnitus, Vaccination site erythema, Vaccination site rash
Clinical narrative: within a minute of each other the nurse gave 2 full doses of vaccine; hard time breathing; lightheadedness; tinnitus, ringing in ears; Incorrect dose administered; Injection site mass; Rash erythematous; redness on left arm; Headache; Injection site reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (within a minute of each other the nurse gave 2 full doses of vaccine), DYSPNOEA (hard time breathing), DIZZINESS (lightheadedness), TINNITUS (tinnitus, ringing in ears) and INCORRECT DOSE ADMINISTERED (Incorrect dose administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MELATONIN for an unknown indication.   On 14-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021 at 12:31 PM, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (within a minute of each other the nurse gave 2 full doses of vaccine), DYSPNOEA (hard time breathing), DIZZINESS (lightheadedness), TINNITUS (tinnitus, ringing in ears) and VACCINATION SITE ERYTHEMA (redness on left arm). 14-Feb-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Incorrect dose administered), INJECTION SITE MASS (Injection site mass), RASH ERYTHEMATOUS (Rash erythematous), HEADACHE (Headache) and VACCINATION SITE RASH (Injection site reaction). On 14-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (within a minute of each other the nurse gave 2 full doses of vaccine) and INCORRECT DOSE ADMINISTERED (Incorrect dose administered) had resolved. At the time of the report, DYSPNOEA (hard time breathing) and VACCINATION SITE ERYTHEMA (redness on left arm) outcome was unknown and DIZZINESS (lightheadedness), TINNITUS (tinnitus, ringing in ears), INJECTION SITE MASS (Injection site mass), RASH ERYTHEMATOUS (Rash erythematous), HEADACHE (Headache) and VACCINATION SITE RASH (Injection site reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included ibuprofen.  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.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Accepted VAERS as Follow-up. Updated new events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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.