Sex: U
Vaccine: SMALLMNK
Symptoms: Erythema, Incorrect route of product administration, Product administration error, Skin mass, Swelling
Clinical narrative: Two big red bumps on patient's arm; They made two Jynneos vaccination attempts as for the second dose; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-003588 is a spontaneous case report initially received on 03-Oct-2022 from a consumer via communication (reference number: USBAV22-1606) and concerns a patient of unknown gender born in 1999.  The patient's medical history and concomitant medication details were not provided.  On 02-Sep-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at an unknown dose, intradermally, at an unknown site of administration, for an unknown indication (explicitly coded as 'Intradermal injection').  On 02-Oct-2022, 30 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown), at an unknown dose and site of administration, intradermally for an unknown indication. The patient received this dose after the second attempt as it didn't bubble up after the first attempt, as reported. After the second attempt 'it was all good' (explicitly coded as 'product administration error' and 'Intradermal injection').  On an unspecified date, the patient developed two big red bumps on arm.  The outcome of the event of two big red bumps was unknown. No treatment was given for the event.  The reporter assessed the event as non-serious and related to Jynneos vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown gender born in 1999 was vaccinated with the first dose of Jynneos vaccine, at an unknown dose, intradermally, at an unknown site of administration, for an unknown indication, which is considered as intradermal injection. Reportedly, the patient was vaccinated with the second dose of Jynneos vaccine, at an unknown dose and site of administration, intradermally for an unknown indication. The patient received this dose after the second attempt as it didn't bubble up after the first attempt, as reported. After the second attempt 'it was all good', which is considered as product administration error and intradermal injection. On an unspecified date, the patient developed a non-serious event of two big red bumps on arm. Skin mass is listed for Jynneos according to the RA and unlisted per RA. Product administration error and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event was unknown, as reported. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the event, the event of skin mass has been considered as related to Jynneos. Product administration error and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown gender born in 1999 was vaccinated with the first dose of Jynneos vaccine, at an unknown dose, intradermally, at an unknown site of administration, for an unknown indication, which is considered as intradermal injection. Reportedly, the patient was vaccinated with the second dose of Jynneos vaccine, at an unknown dose and site of administration, intradermally for an unknown indication. The patient received this dose after the second attempt as it didn't bubble up after the first attempt, as reported. After the second attempt 'it was all good', which is considered as product administration error and intradermal injection. On an unspecified date, the patient developed a non-serious event of two big red bumps on arm. Skin mass is listed for Jynneos according to the RA and unlisted per RA. Product administration error and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event was unknown, as reported. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the event, the event of skin mass has been considered as related to Jynneos. Product administration error and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.