Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: No adverse event; Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022; Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 060F22A and AS7164B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (April or May 2022 (Treatment received: Paxlovid)) in 2022. Concomitant products included INFLUENZA VACCINE for Flu vaccination, MONTELUKAST SODIUM (SINGULAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .5 milliliter. On 10-Oct-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022).    No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  On 17-MAR-2021 patient has received First Moderna dose of 0.5 mL with lot no. 047A21A. On 14-APR-2021 patient has received Second Moderna dose of 0.5 mL with lot no. 040B21A. On 16-NOV-2021 patient has received First Moderna Booster dose with lot no. 051F21a.  No treatment information was reported with respect to 4th and 5th Bivalent Booster dose.   This case was linked to MOD-2022-656967 (Patient Link).