Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: The patient received Jynneos vaccine, which was sitting in a frozen temperature for about an hour, lowest temperature was 26.1 Fahrenheit; The patient received Jynneos vaccine, which was sitting in a frozen temperature for about an hour, lowest temperature was 26.1 Fahrenheit; The patient received Jynneos vaccine intramuscularly; Case reference number US-BN-2024-002694 is a spontaneous case initially received from a health care professional via agency (reference number: USBAV24-2836) on 28-Oct-2024 and concerns a male patient of unknown age.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, as reported Jynneos vaccines, were sitting in a frozen temperature for about an hour, lowest temperature was 26.1 Fahrenheit (explicitly coded as 'product storage error').  On 28-Oct-2024, the patient was vaccinated with a dose of Jynneos (batch number: FDP00020 and expiration date: 31-Oct-2024), at an unknown dose or site of administration, intramuscularly for indication reported as vaccination (explicitly coded as 'inappropriate route of vaccination' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.   No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with a dose of Jynneos which was sitting in a frozen temperature for about an hour, lowest temperature was 26.1 Fahrenheit (considered as product storage error), at an unknown dose or site of administration, intramuscularly for indication reported as vaccination which is considered as inappropriate route of vaccination and product administration error. Incorrect route of product administration, product storage error and product administration error are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with a dose of Jynneos which was sitting in a frozen temperature for about an hour, lowest temperature was 26.1 Fahrenheit (considered as product storage error), at an unknown dose or site of administration, intramuscularly for indication reported as vaccination which is considered as inappropriate route of vaccination and product administration error. Incorrect route of product administration, product storage error and product administration error are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.