Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | 96867 | SC / LA |
Pain; Tingling and numbness in left arm hand; Tingling and numbness in left arm hand; Headache; Nausea; Exhaustion; Patient received second dose of Jynneos intramuscularly; Case reference number US-BN-2024-002565 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-2540) on 27-Sep-2024 and concerns a 32-year-old male patient. The patient's medical history and concomitant medication details were not provided. *On 30-Aug-2024, the patient was vaccinated with the first dose of Jynneos (batch number: 96867), 0.5 milliliter, subcutaneously in the left tricep* for prevention of smallpox and monkeypox disease. On 27-Sep-2024, *four weeks after the first dose*, the patient was vaccinated with the second dose of Jynneos (*batch number: 96867*), at a dose of 0.5 milliliter, intramuscularly in the *left tricep. As reported vaccine administrator was not familiar with Jynneos though it was an intramuscular shot*. (explicitly coded as 'inappropriate route of vaccination'). *On an unspecified date, reported as on the day of and for one day after the dose, the patient experienced headache, nausea, pain, tingling and numbness in left arm hand, and exhaustion*. *At the time of the follow up report, it was unknown if the patient recovered from the events headache, nausea, pain, tingling, numbness and exhaustion*. *The reporter did not provide seriousness and causality assessment for the events headache, nausea, pain, tingling, numbness and exhaustion*. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a consumer on 27-Oct-2024: New information included added Jynneos dosage information, events (headache, nausea, pain, tingling and numbness in left arm hand, exhaustion and confirmation on the contributing factor. Non-significant case correction identified on 04-Nov-2024 included: new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240927-54ad16 to US-BAVARIAN NORDIC A/S-US-BN-2024-002565, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 32-year-old male patient was vaccinated with the second dose of Jynneos (four weeks after the first dose) for prevention of smallpox and monkeypox disease, intramuscularly in the left tricep, which is considered as inappropriate route of vaccination. On the day of vaccination and for one day after the dose, the patient experienced headache, nausea, pain, tingling and numbness in left arm hand, and exhaustion. Pain, hypoaesthesia and paraesthesia are unlisted and unexpected while headache, nausea and fatigue are unlisted and unexpected according to CCDS v7 and USPI. Incorrect route of product administration is considered as listed per company convention. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Pain, hypoaesthesia, paraesthesia, headache, nausea and fatigue are all assessed as related due to plausible temporal relationship, known product safety profile (for headache, nausea and fatigue), lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 32-year-old male patient was vaccinated with the second dose of Jynneos (four weeks after the first dose) for prevention of smallpox and monkeypox disease, intramuscularly in the left tricep, which is considered as inappropriate route of vaccination. On the day of vaccination and for one day after the dose, the patient experienced headache, nausea, pain, tingling and numbness in left arm hand, and exhaustion. Pain, hypoaesthesia and paraesthesia are unlisted and unexpected while headache, nausea and fatigue are unlisted and unexpected according to CCDS v7 and USPI. Incorrect route of product administration is considered as listed per company convention. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Pain, hypoaesthesia, paraesthesia, headache, nausea and fatigue are all assessed as related due to plausible temporal relationship, known product safety profile (for headache, nausea and fatigue), lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.