Age: 46.0
Sex: M
Vaccine: PNC20
Symptoms: Condition aggravated, Diabetes mellitus inadequate control, Poor quality product administered, Product storage error
Clinical narrative: Diabetes II uncontrolled; Diabetes II uncontrolled; Prevnar 20 that got too cold/ After this excursion there was a patient that was administered the vaccine/ Received after it was exposed to -8.09 degrees Fahrenheit for 15 minutes; Prevnar 20 that got too cold/ After this excursion there was a patient that was administered the vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 46-year-old male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 25Sep2023 as dose number unknown, 0.50 ml single (Lot number: GW7965, Expiration Date: 30Nov2024) at the age of 46 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetic retinopathy", start date: 01Jul2023 (ongoing); "Hypertension", start date: 19Dec2022 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: influenza vaccine, administration date: 29Aug2023, when the patient was 46-year-old, for immunisation. The following information was reported: DIABETES MELLITUS INADEQUATE CONTROL (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Diabetes II uncontrolled"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 25Sep2023, outcome "unknown", described as "Prevnar 20 that got too cold/ After this excursion there was a patient that was administered the vaccine"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 25Sep2023, outcome "unknown", described as "Prevnar 20 that got too cold/ After this excursion there was a patient that was administered the vaccine/ Received after it was exposed to -8.09 degrees Fahrenheit for 15 minutes". Additional information: Nurse is calling about their Prevnar 20 that got too cold, reaching a minimum temperature of -8.09 degree F for 15 minutes. It had initially been stored at 41.83 degree F, but needed to be moved to a secondary unit temporarily. After this excursion there was a patient that was administered the vaccine. She does not does not have patient's age and gender. This occurred yesterday. As of 26Sep2023, it was reported that the event "received after it was exposed to -8.09 degrees Fahrenheit for 15 minutes" was assessed as serious, medically significant.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.  Follow-up (26Sep2023): This is a spontaneous follow-up report received from a contactable Nurse. Updated information included: new event (Diabetes II uncontrolled), patient details (age, gender, Other relevant med history was updated), product details (lot and expiry updated) and course details.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the event diabetes mellitus inadequate control with PREVNAR 20 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.