Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Wrong product administered
Clinical narrative: Achy; Tired; Nauseated; Monovalent Moderna Covid-19 vaccine were administered as booster doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated) and WRONG PRODUCT ADMINISTERED (Monovalent Moderna Covid-19 vaccine were administered as booster doses) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 010A21A, 045A21A and 076C21A) for COVID-19 prophylaxis.     Patient was never been diagnosed with/tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Influenza (Lot number: 346349, Intramuscular in left deltoid and 1 dose.) on 10-Oct-2022. Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Hyperlipidemia, Hypertension, Atrial fibrillation and Hypothyroidism. Concomitant products included WARFARIN for Anticoagulant therapy, METOPROLOL for Atrial fibrillation, ATORVASTATIN CALCIUM (ATORVASTIN) for Hyperlipidemia, ENALAPRIL and DILTIAZEM for Hypertension, LEVOTHYROXINE for Hypothyroidism.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 04-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent Moderna Covid-19 vaccine were administered as booster doses). On 05-Nov-2022, the patient experienced PAIN (Achy), FATIGUE (Tired) and NAUSEA (Nauseated). On 08-Nov-2022, PAIN (Achy), FATIGUE (Tired) and NAUSEA (Nauseated) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent Moderna Covid-19 vaccine were administered as booster doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Achy), FATIGUE (Tired) and NAUSEA (Nauseated) to be related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent Moderna Covid-19 vaccine were administered as booster doses).    It was reported that, patient inadvertently received Moderna Monovalent vaccine rather than bivalent dose as booster dose. Patient requested bivalent vaccine, but technician accidently removed wrong vial from the fridge. A technician had removed the vial from a fridge that contained bivalent and monovalent vaccines. The monovalent vaccine was administered in error.   Later, on late saturday night into sunday morning (05-Nov-2022 to 06-Nov-2022), the patient started experiencing aches, tiredness, and nausea. Patient stated that, she did not experience any of these adverse effects after any of the previous doses.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Follow-up information received included new events, concomitant medications, patient demography (gender, age at the time of event onset, race and ethnicity), medical history, and historical vaccine were added. Suspect vaccine details and i-narrative supplement updated.