Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.; No adverse event; Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Two patients received Moderna Covid-19  bivalent vaccine that underwent a temperature excursion/patients received the vaccine before the clinic knew that there had been a temperature excursion.).    No concomitant medications were reported.  It was reported that Proposed desired Use by Date was 05-Dec-2022. Two unbroken cartons of Bivalent vaccine was stored in frozen condition at the time of excursion. The vial had reached 11.5 degrees Fahrenheit for 1 hour 18 minutes. There was a little bit of frost on the brim or neck of all of the vaccine vials. Now the vials were quarantined in the freezer and labeled not for patient use. No other adverse events reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681490, US-MODERNATX, INC.-MOD-2022-681478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681490:Monovalent case US-MODERNATX, INC.-MOD-2022-681478:patient 1 (Bivalent case)