Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Contusion, Dysphonia, Inappropriate schedule of product administration, Injection site macule
Clinical narrative: Patient received second dose of Jynneos 29 days after the first dose; Dysphonia, described as hoarse voice; Vaccination site macule, described as red dot like a mark from the first Jynneos vaccine and from the second Jynneos dose; Mark disappeared but left a little bruise, left a little blueish; Case reference number US-BN-2023-000271 is a spontaneous case initially received on 29-Nov-2022 from health care professional via Communication (reference number: USBAV23-0256) and concerns a 25-year-old male patient.  The patient's medical history was not provided.  The patient's concomitant medications were not provided.  *The patient's past vaccinations included Covid-19 vaccine (brand name unknown) primary immunization series.*  On 12-Jan-2023, the patient was vaccinated with the first dose of Jynneos (batch number: FDP00018), at an unknown dose and route of administration, in the inside of the right arm for monkeypox prophylaxis and with co-suspect *BNT162b2* (tozinameran), a booster dose at unknown dose, route and site of administration *for Covid-19 immunisation*. As reported, the patient was not even considered a risk group for the monkeypox vaccine.  On unspecified date, an unknown amount of time after vaccination with Jynneos, the patient had a *vaccination site macule, described as* red dot, like a mark from the first vaccine (verbatim as reported).   On 10-Feb-2023, 29 days after the first Jynneos dose, reported as on Friday, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00018), at the unknown dose and route of administration, in the inside of the right arm (explicitly coded as 'inappropriate schedule of vaccine administered').   On an unspecified date, an unknown amount of time after vaccination with Jynneos, reported as four weeks after the first Jynneos dose, the patient experienced *dysphonia, described as* hoarse voice and had *vaccination site macule, described as* a second red dot, like a mark. *As reported, therapeutic measures were not taken as a result of dysphonia and vaccination site macule.*  On an unspecified date, the second red dot, like a mark disappeared but left a little bruise, *left a little blueish (verbatim as reported)*.  On an unspecified date, the patient's hoarseness was getting worse. As reported, the patient had no fever and did not feel sick. As also reported the patient was about to start a biologic.  *At the time of follow up report, the events 'hoarse voice' and 'injection site macule' remained ongoing and event 'bruise' was ongoing*.  The reporter assessed all reported events as non-serious and assessed all reported events as related to Jynneos vaccination.  Additional information received from Company on 14-Feb-2023 included local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information, initially downloaded Vaccine Adverse Event Reporting System (VAERS) on 06-Mar-2023, received from a nurse via Health Authority VAERS (VAERS ID: 2583921-1). New information included new reporter, event term 'red dot, like a mark' updated to 'vaccination site macule, described as red dot like a mark from the first Jynneos vaccine and from the second Jynneos dose' and recoded to 'injection site macule', event 'hoarse voice' updated to 'dysphonia, described as hoarse voice', primary immunization with Covid-19 vaccine added, outcome of the event 'bruise' updated from unknown to ongoing, and Pfizer COVID-19 Vaccine Booster updated to BNT162b2 and its indication added.; Reporter's Comments: A 25-year-old male patient experienced vaccination site macule (described as red dot) like a mark, unknown time after he was vaccinated with the first dose of Jynneos vaccine, at an unknown dose and route of administration, in the inside of the right arm for monkeypox prophylaxis and with co-suspect BNT162b2 (tozinameran), a booster dose at unknown dose, route and site of administration for Covid-19 immunisation. The patient was vaccinated with the second dose of Jynneos on the day 29 after the first dose, at the unknown dose and route of administration, at right arm, which is considered as inappropriate schedule of vaccine administered. On unspecified date, an unknown amount of time after the second dose of Jynneos, the patient experienced dysphonia, described as hoarse voice and vaccination site macule, described as a second red dot (like a mark). As reported, the patient still had a red dot, like a mark from the first dose of Jynneos. The second red dot, like a mark disappeared but left a little bruise. Dysphonia and injection site macule are both unlisted while contusion is listed for Jynneos according to the Specialist v4 however unlisted per company. Inappropriate schedule of vaccine administered is considered as listed per company convention. The outcome for the events was not resolved. The patient's medical history and concomitant medication details were not provided while past vaccinations included Covid-19 vaccine. Since the contributory role of the suspect vaccine cannot be excluded with certainty, dysphonia, injection site macule and contusion are all considered as related to Jynnoes. Causality assessment is confounded with co-suspect BNT162b2 (tozinameran) booster vaccine. Inappropriate schedule of vaccine administered has 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 25-year-old male patient experienced vaccination site macule (described as red dot) like a mark, unknown time after he was vaccinated with the first dose of Jynneos vaccine, at an unknown dose and route of administration, in the inside of the right arm for monkeypox prophylaxis and with co-suspect BNT162b2 (tozinameran), a booster dose at unknown dose, route and site of administration for Covid-19 immunisation. The patient was vaccinated with the second dose of Jynneos on the day 29 after the first dose, at the unknown dose and route of administration, at right arm, which is considered as inappropriate schedule of vaccine administered. On unspecified date, an unknown amount of time after the second dose of Jynneos, the patient experienced dysphonia, described as hoarse voice and vaccination site macule, described as a second red dot (like a mark). As reported, the patient still had a red dot, like a mark from the first dose of Jynneos. The second red dot, like a mark disappeared but left a little bruise. Dysphonia and injection site macule are both unlisted while contusion is listed for Jynneos according to the Specialist v4 however unlisted per company. Inappropriate schedule of vaccine administered is considered as listed per company convention. The outcome for the events was not resolved. The patient's medical history and concomitant medication details were not provided while past vaccinations included Covid-19 vaccine. Since the contributory role of the suspect vaccine cannot be excluded with certainty, dysphonia, injection site macule and contusion are all considered as related to Jynnoes. Causality assessment is confounded with co-suspect BNT162b2 (tozinameran) booster vaccine. Inappropriate schedule of vaccine administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.