Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration, Injection site discolouration, Pain in extremity, Renal function test abnormal
Clinical narrative: Sharp stabbing pains above the left elbow/stabs; Slight anemia that had been detected in September was slightly worse; BUN was 27 and creatinine 1.18, higher values than ever before/Jynneos affecting the renal function; Mark on the skin after the first dose of Jynneos; Jynneos was administered intradermally; Second dose of Jynneos was administered 29 days after the first dose; Second dose of Jynneos was administered intramuscularly; Case reference number US-BN-2023-000691 is a spontaneous case report initially received from a consumer via Bavarian Nordic (reference number: BN_2023_01168) on 15-Apr-2023 and concerns a *78-year-old* male patient.  The patient's concurrent medical history included anemia.   The patient's concomitant medication details were not provided.   *On 22-Sep-2022, the patient had creatinine 0.97 (units not provided) and blood urea nitrogen (BUN) 15 (units not provided).*   On 17-Nov-2022, the patient was vaccinated with the first dose of Jynneos (batch number not provided) administered intradermally (explicitly coded as 'intradermal injection') in the left forearm, at an unknown dose for an unknown indication.   On an unspecified date, unspecified amount of time after first Jynneos dose, the patient had a mark on the skin.  On an unspecified date, reported as several days afterwards *and also as about one week after the first dose of Jynneos *, the patient started having sharp, stabbing pains/*stabs* above the left elbow. *As reported, no formal diagnosis was available.*  On 25-Nov-2022, the sharp, stabbing pains persisted and the patient wondered if he was having a heart attack, went to an emergency room (ER) but it was not a heart attack. On the same day, blood work showed that the slight anemia that had been detected in September was slightly worse, BUN was 27 (units not provided) and creatinine 1.18 (units not provided), higher values than ever before.   *On an unspecified date, reported as a couple of days since sharp, stabbing pains/stabs above the left elbow onset, the patient recovered from the event sharp, stabbing pains/stabs above the left elbow.*  On 16-Dec-2022, 29 days after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number not provided) *administered intramuscularly (explicitly coded as 'inappropriate route of vaccination') in the left forearm also reported as left upper arm (to be clarified)* at an unknown dose (explicitly coded as 'inappropriate schedule of vaccine administered'). *As reported, the patient had no stabs after the second Jynneos shot and there were no deviations or issues during administration of Jynneos vaccine that the patient knew of.*  On 08-Feb-2023, blood work showed higher values.  On 04-Apr-2023, blood work was stabilized, reported as 28 and 1.37 (unit and test name not provided).   *At the time of the follow up report, 'mark on the skin' was ongoing as it was reported the patient could see it and outcome of the events 'anaemia' and 'renal function test abnormal' remained unknown.*  The reporter assessed the event of sharp, stabbing pains above the left elbow/*stabs* *as serious as it made the patient wonder if the patient was having a heart attack* but did not provide seriousness assessment of the events 'anaemia', 'renal function test abnormal', and *'injection site discoloration'*. The reporter assessed the event sharp, stabbing pains above the left elbow/*stabs* as *certainly related to Jynneos vaccine*, and causality of the events 'renal function test abnormal', *'injection site discoloration'* and 'anemia' was not provided.   All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from the consumer on 24-Apr-2023: New information included patient's age, confirmation of no medication association to the event of 'pain in extremity', additional lab data, duration of the event 'pain in extremity', new non-serious AE mark on the skin after the first dose of Jynneos, route and site of administration of the second dose which led to coding of an additional non-event, seriousness and causality assessment for the event of 'pain in extremity'.; Reporter's Comments: A 78-year-old male patient developed serious event sharp, stabbing pains above the left elbow (medical significance) several days after the vaccination with the first dose of Jynneos intradermally in the left forearm, and unspecified amount of time after first Jynneos dose, the patient had a mark on the skin. As the pain in extremity persisted, the patient went to the emergency room eight days after vaccination with the first dose of Jynneos and the blood work showed slight anemia getting worse, and blood urea was 27 and creatinine was 1.18, reported as higher values than ever before. The patient asked if incidences of Jynneos affecting the renal function are found. 29 days after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos, administered intramuscularly, which is considered as inappropriate route of vaccination and inappropriate schedule of vaccine administered. It was reported that month and a half after the second dose of Jynneos blood work showed higher values and stabilized two months later. Anaemia and renal function test abnormal are unlisted for Jynneos per the CCDS and the PI. Pain in extremity and injection site discolouration are listed per the CCDS and unlisted per the PI. Intradermal injection, inappropriate route of vaccination and inappropriate schedule of vaccine administered are listed per convention. The patient's medical history, blood tests details (units, ranges, names), and concomitant medications were not provided. Considering lack of information and suggestive temporal relationship, anaemia, pain in extremity, injection site discolouration and renal function test abnormal have been conservatively assessed as related to Jynneos. Intradermal injection, inappropriate route of vaccination and inappropriate schedule of vaccine administered are not related to Jynneos. The case is serious due to medical significance.; Sender's Comments: A 78-year-old male patient developed serious event sharp, stabbing pains above the left elbow (medical significance) several days after the vaccination with the first dose of Jynneos intradermally in the left forearm, and unspecified amount of time after first Jynneos dose, the patient had a mark on the skin. As the pain in extremity persisted, the patient went to the emergency room eight days after vaccination with the first dose of Jynneos and the blood work showed slight anemia getting worse, and blood urea was 27 and creatinine was 1.18, reported as higher values than ever before. The patient asked if incidences of Jynneos affecting the renal function are found. 29 days after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos, administered intramuscularly, which is considered as inappropriate route of vaccination and inappropriate schedule of vaccine administered. It was reported that month and a half after the second dose of Jynneos blood work showed higher values and stabilized two months later. Anaemia and renal function test abnormal are unlisted for Jynneos per the CCDS and the PI. Pain in extremity and injection site discolouration are listed per the CCDS and unlisted per the PI. Intradermal injection, inappropriate route of vaccination and inappropriate schedule of vaccine administered are listed per convention. The patient's medical history, blood tests details (units, ranges, names), and concomitant medications were not provided. Considering lack of information and suggestive temporal relationship, anaemia, pain in extremity, injection site discolouration and renal function test abnormal have been conservatively assessed as related to Jynneos. Intradermal injection, inappropriate route of vaccination and inappropriate schedule of vaccine administered are not related to Jynneos. The case is serious due to medical significance.