Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023; Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023).    No concomitant medication were reported.  It was reported that Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023. They were to be used within 24 hours but administered to 24 patients on unknown dates. Vaccine administration dates and patient information were unknown.  Excursion Timeframe, on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023 Max 8.5 C for 24 hours, on 23-Feb-2023 Max 8.5 C min 7.4 C for 17 hours and 56 minutes. No treatment information was provided by the reporter. This case was reported for patient 1 out of 24.   This case was linked to US-MODERNATX, INC.-MOD-2023-713486, US-MODERNATX, INC.-MOD-2023-713488, US-MODERNATX, INC.-MOD-2023-713490, US-MODERNATX, INC.-MOD-2023-713494, US-MODERNATX, INC.-MOD-2023-713495, US-MODERNATX, INC.-MOD-2023-713498, US-MODERNATX, INC.-MOD-2023-713499, US-MODERNATX, INC.-MOD-2023-713500, US-MODERNATX, INC.-MOD-2023-713502, US-MODERNATX, INC.-MOD-2023-713504, US-MODERNATX, INC.-MOD-2023-713505, US-MODERNATX, INC.-MOD-2023-713471, US-MODERNATX, INC.-MOD-2023-713476, US-MODERNATX, INC.-MOD-2023-713478, US-MODERNATX, INC.-MOD-2023-713479, US-MODERNATX, INC.-MOD-2023-713480, US-MODERNATX, INC.-MOD-2023-713481, US-MODERNATX, INC.-MOD-2023-713484, US-MODERNATX, INC.-MOD-2023-713485, US-MODERNATX, INC.-MOD-2023-713487, US-MODERNATX, INC.-MOD-2023-713489, US-MODERNATX, INC.-MOD-2023-713492, US-MODERNATX, INC.-MOD-2023-713493 Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713502:Patient 10 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713505:Patient 12 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713488:Patient 3 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713490:Patient 4 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713500:Patient 9 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713504:Patient 11 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713495:Patient 6 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713498:Patient 7 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713486:Patient 2 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713494:Patient 5 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713499:Patient 8 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713487:Patient 21 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713471:Patient 13 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713476:Patient 14 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713478:Patient 15 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713481:Patient 18 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713485:Patient 20 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713489:Patient 22 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713493:Patient 24 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713492:Patient 23 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713480:Patient 17 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713484:Patient 19 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713479:Patient 16 out of 24 Patients