Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Bigger bubble; The patient fevered for a day; The patient had redness, swelling and itching at the site of intradermal administration; The patient had redness, swelling and itching at the site of intradermal administration; The patient had redness, swelling and itching at the site of intradermal administration; The second dose of Jynneos administrated intradermally; Case reference number US-BN-2024-000646 is a spontaneous case report initially received from a nurse (reference number: USBAV24-0531) on 18-Mar-2024 and concerns an adult male patient.  The patient's medical history and concomitant medication details were not provided.  On 18-Mar-2024, the patient received the first dose of Jynneos (batch number: unknown), administered *subcutaneously* at a dose of 0.5 mL, at unknown site of administration, for unknown indication.  On unspecified date, unknown amount of time after the first dose of Jynneos, the patient developed a bigger bubble, appearing as larger volume and stated as reaction appropriate according to the reporter's staff.  *On unspecified date, unknown amount of time after the first dose of Jynneos, the patient received second dose of Jynneos (batch number: unknown), at unknown dose, administered intradermally, at unknown site of administration (explicitly coded as 'intradermal injection').*  *On unspecified date, unknown amount of time after the second dose of Jynneos,as reported the patient had greater local and systemic response to second dose than the patient's first dose of Jynneos. The patient fevered and had redness, swelling, and itching at the site of intradermal administration.  *On unspecified date, reported as after for a day the patient recovered from fevered.*  *On unspecified date, reported as within week, the patient recovered from events of local and systemic response, redness, swelling, and itching at the site of intradermal administration.*  At the time of initial report, it was unknown if the patient recovered from event of bigger bubble.  The reporter did not provide seriousness assessment for the events of bigger bubble, *local and systemic response, fevered, redness, swelling, and itching at the site of intradermal administration. The reporter did not provide causality assessment for events of local and systemic response, fevered, redness, swelling, and itching at the site of intradermal administration* while the causality for the event of bigger bubble was assessed as possible, stated as an appropriate reaction.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from nurse on 10-Apr-2024: New information included: route of administration for first dose of Jynneos, dosing information for second dose of Jynneos, adverse events after second dose and outcome of the events.  Non-significant case correction received from the reporter on 16-Apr-2024 included: confirmation that no further information was available.; Reporter's Comments: An adult male patient received the first dose of Jynneos, administered subcutaneously at a dose of 0.5 mL, for unknown indication. Reportedly, on unspecified date, an unknown amount of time after the first dose of Jynneos, the patient developed a bigger bubble. Unknown amount of time after the first dose of Jynneos, the patient received second dose of Jynneos, at unknown dose, administered intradermally, at unknown site of administration which is considered as intradermal injection. Unknown time after the second dose of Jynneos the patient experienced fever and had redness, swelling, and itching at the site of intradermal administration. Injection site urticaria is unlisted and unexpected for Jynneos according to the insert. Pyrexia, injection site erythema, injection site swelling and injection site pruritus are all listed and expected according to summary. Intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of pyrexia, injection site erythema, injection site swelling and injection site pruritus was resolved while the outcome of injection site urticaria was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of injection site urticaria has been considered as related to Jynneos. Considering the known product safety profile for events pyrexia, injection site erythema, injection site swelling and injection site pruritus and since contributory role of suspect product cannot be excluded, the abovementioned events are assessed as related. Injection is considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient received the first dose of Jynneos, administered subcutaneously at a dose of 0.5 mL, for unknown indication. Reportedly, on unspecified date, an unknown amount of time after the first dose of Jynneos, the patient developed a bigger bubble. Unknown amount of time after the first dose of Jynneos, the patient received second dose of Jynneos, at unknown dose, administered intradermally, at unknown site of administration which is considered as intradermal injection. Unknown time after the second dose of Jynneos the patient experienced fever and had redness, swelling, and itching at the site of intradermal administration. Injection site urticaria is unlisted and unexpected for Jynneos according to the insert. Pyrexia, injection site erythema, injection site swelling and injection site pruritus are all listed and expected according to insert. Intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of pyrexia, injection site erythema, injection site swelling and injection site pruritus was resolved while the outcome of injection site urticaria was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of injection site urticaria has been considered as related to Jynneos. Considering the known product safety profile for events pyrexia, injection site erythema, injection site swelling and injection site pruritus and since contributory role of suspect product cannot be excluded, the abovementioned events are assessed as related. Injection is considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.