Sex: M
Vaccine: SMALLMNK
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: The patient received second dose of Jynneos vaccine into the back fatty part of upper arm, which got a bit sore for a week; The patient received first dose of Jynneos vaccine into the muscle (intramuscularly); Case reference number US-BN-2025-000003 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-0007) on 02-Jan-2025 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown) at an unknown dose, intramuscularly, administered into the muscle, for unknown indication (explicitly coded as 'inappropriate route of vaccination').  On an unspecified date, unknown amount of time after first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown) at an unknown dose, and route, administered into back fatty part of upper arm which got a bit sore for a week.  At the time of the initial report, it was unknown if the patient recovered from the event 'pain in arm'.   The reporter did not provide a seriousness and causality assessment for the event 'pain in arm'.  No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos, intramuscularly, administered into the muscle, for unknown indication, which is considered as inappropriate route of vaccination. On an unspecified date, unknown amount of time after first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos, administered into back fatty part of upper arm which got a bit sore for a week. Pain in extremity is listed per CCDS v7 and unexpected per agency for Jynneos, whilst incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Jynneos. Incorrect route of product administration is considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos, intramuscularly, administered into the muscle, for unknown indication, which is considered as inappropriate route of vaccination. On an unspecified date, unknown amount of time after first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos, administered into back fatty part of upper arm which got a bit sore for a week. Pain in extremity is listed per CCDS v7 and unexpected per agency for Jynneos, whilst incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Jynneos. Incorrect route of product administration is considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.