Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022; There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022), PRODUCT TEMPERATURE EXCURSION ISSUE (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     It was unknown whether patient ever been diagnosed or tested positive for COVID-19. Patient allergies information include NKA and NKDA.  Concurrent medical conditions included Arthritis (No recent changes in condition status), Hypertension (No recent changes in condition status) and Bone spur (Bone Spurs, No recent changes in condition status). Concomitant products included LISINOPRIL for Hypertension.    On 19-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022), PRODUCT TEMPERATURE EXCURSION ISSUE (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022) had resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (There was more than one excursion/ All of the doses were administered after the excursions since 20Oct2022).    It was reported that patient received moderna vaccine and was observed for 30 mins after injection w/ no adverse reactions. At the present time, advised patient to RTC or PCP should any reaction occur. It was unknown whether patient experienced similar event in the past and there were no any potential causes.  It was reported that the There was more than one excursion on 20 Oct 2022, 21 Oct 2022, 24 Oct 2022, 25 Oct 2022, 27 Oct 2022, 28 Oct 2022, 29 Oct 2022, 30 Oct 2022, 31 Oct 2022, 1 Nov 2022, 2 Nov 2022, 3 Nov 2022, 4 Nov 2022, 5 Nov 2022, 6 Nov 2022, 7 Nov 2022, 8 Nov 2022, 9 Nov 2022, 10 Nov 2022, 11 Nov 2022, 12 Nov 2022, 13 Nov 2022, and 14 Nov 2022. All of the doses were administered after the excursions since 20 Oct 2022.   Treatment drug information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Follow-up received included updated reporter details, patient details, medial history, vaccination details and narrative information.