chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos vaccine was administered intramuscularly instead of prescribed subcutaneous route; Case reference number US-BN-2022-001869 is a spontaneous case report initially received on 12-Aug-2022 from a health care professional via Bavarian Nordic and concerns a male patient of unknown age.  The patients' relevant medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) administered intramuscularly (explicitly coded as 'Inappropriate route of vaccination') at an unreported dose, or anatomical site for unknown indication.   At the time of this report, it was unknown if the patient experienced any adverse events.   Additional information received from MedCommunications on 13-Aug-2022 included additional reference.; Reporter's Comments: A male patient of unknown age was vaccinated with Jynneos vaccine, administered intramuscularly which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with Jynneos vaccine, administered intramuscularly which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: It was painful and swollen; It was painful and swollen; Case reference number US-BN-2022-001906 is a spontaneous case report initially received on 16-Aug-2022 from a consumer (patient's mother) via agency (reference number: USBAV22-1034) and concerns a 19-year old female patient.  The patient's medical history and concomitant medication details were not provided.  On 09-Aug-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 and route of administration, in the left arm, for monkeypox prophylaxis.  On an unspecified date, an unknown amount of time after the vaccination, the patient developed pain and swelling at the injection site. No redness detected. It was reported that the patient had vaccine one week back an it is swollen and very painful.  At the time of this report, outcome of the events was unknown.  The reporter assessed the events of 'injection site pain' and 'injection site swelling' as non-serious. Causality assessment was not provided.  Additional information received from Bavarian Nordic on 17-Aug-2022 included the local BN case ID.; Reporter's Comments: A 19-year old female patient developed non-serious events pain and swelling at the injection site an unknown amount of time after the vaccination with Jynneos. It was reported that the patient had vaccine one week back and it is swollen and very painful. Injection site pain and injection site swelling are listed per the agency 1and the agency 2. The patient's concomitant medications and medical history were not reported. Considering suggestive temporal relationship, both events have been considered as related to Jynneos.; Sender's Comments: A 19-year old female patient developed non-serious events pain and swelling at the injection site an unknown amount of time after the vaccination with Jynneos. It was reported that the patient had vaccine one week back and it is swollen and very painful. Injection site pain and injection site swelling are listed per the agency 1 and the agency 2. The patient's concomitant medications and medical history were not reported. Considering suggestive temporal relationship, both events have been considered as related to Jynneos.
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Lymphadenitis
Clinical narrative: Lymph node inflammation in that arm where the patient was vaccinated; The patient had severe swelling and itching; The patient had inflammation at the site where got the vaccine; Case reference number US-BN-2022-001959 is a spontaneous case report initially received from a consumer via Agency (reference number: USBAV22-1049) on 17-Aug-2022 and concerns a 32-year-old male patient.  The patient's medical history and concomitant medication details were not reported.  On 08-Aug-2022, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route or site of administration, for unknown indication  On the same day, the patient developed injection site inflammation and lymph node inflammation with severe swelling and itching, it was painful to the touch and very tender. As reported, it was close to the injection site, the size of a small lime and went down in the last two days.  At the time of this report, the outcome of the events 'injection site inflammation', 'lymph node inflammation', 'localised itching' and 'swollen lymph nodes' was unknown.  The reporter did not provide a seriousness or causality assessment.  Additional information received from Bavarian Nordic on 17-Aug-2022 included the local BN case ID.; Reporter's Comments: A 32-year-old male patient developed non-serious events lymph node inflammation, itching and injection site inflammation on the same day when the first dose of Jynneos was administered. Lymph node inflammation is unlisted per the CCDS v1 and the PI, while injection site inflammation and pruritus are listed per the CCDS v1 and unlisted per the PI. Reportedly, the patient developed injection site inflammation and lymph node inflammation in the arm where he got a vaccine with severe swelling, itching and pain. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, events have been considered as related to Jynneos.; Sender's Comments: A 32-year-old male patient developed non-serious events lymph node inflammation, itching and injection site inflammation on the same day when the first dose of Jynneos was administered. Lymph node inflammation is unlisted per the CCDS v1 and the PI, while injection site inflammation and pruritus are listed per the CCDS v1 and unlisted per the PI. Reportedly, the patient developed injection site inflammation and lymph node inflammation in the arm where he got a vaccine with severe swelling, itching and pain. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, events have been considered as related to Jynneos.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos vaccine was given intradermally to the patient; Case reference number US-BN-2022-001976 is a spontaneous case report initially received on 18-Aug-2022 from a healthcare professional via agency (reference number: USBAV22-1075) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On 18-Aug-2022, the patient received the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at an unknown dose or site of administration for the unknown indication, intradermally (explicitly coded as ' Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse events due to Jynneos.  Additional information received on 19-Aug-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A patient of unknown age and gender received the first dose of Jynneos for the unknown indication, intradermally, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender received the first dose of Jynneos for the unknown indication, intradermally, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Underdose
Clinical narrative: The patient was vaccinated with Jynneos vaccine intradermally; The patient was vaccinated with a 0.1 milliliter dose of Jynneos vaccine; Case reference number US-BN-2022-001978 is a spontaneous case report initially received on 19-Aug-2022 from a healthcare professional via agency (reference number: USBAV22-1090), and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On 17-Aug-2022, the patient received Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00013) at a dose of 0.1 milliliters, at an unknown anatomical site of administration, intradermally for monkeypox prophylaxis (explicitly coded as 'Inappropriate route of vaccination', 'Vaccine underdose').  At the time of this report, it was unknown whether the patient experienced any adverse events due to Jynneos.  Additional information received on 19-Aug-2022 from Bavarian Nordic included local BN case ID.  This case is linked with US-BN-2022-001979 (same reporter).; Reporter's Comments: A patient of unknown age and gender received a dose of Jynneos at a dose of 0.1 milliliters intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and vaccine underdose. No associated adverse events have been reported. Both inappropriate route of vaccination and vaccine underdose are listed per company convention. The patient's medical history and concomitant medication details were not reported. Both inappropriate route of vaccination and vaccine underdose are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender received a dose of Jynneos at a dose of 0.1 milliliters intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and vaccine underdose. No associated adverse events have been reported. Both inappropriate route of vaccination and vaccine underdose are listed per company convention. The patient's medical history and concomitant medication details were not reported. Both inappropriate route of vaccination and vaccine underdose are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Underdose
Clinical narrative: Patient received Jynneos and the punctured vial was left at room temperature; Case reference number US-BN-2022-002002 is a spontaneous case report initially received on 22-Aug-2022 from other health care professional from via agency (reference number: USBAV22-1114) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose or route of administration, for unknown indication.   It was reported that the punctured vial was left for two hours at room temperature and that only one patient received a dose before excursion (explicitly coded as 'underdose').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 22-Aug-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine, at an unknown dose or route of administration, for unknown indication however it was reported that the punctured vial was left for two hours at room temperature and that only one patient received a dose before excursion which is considered as underdose. Underodose is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine, at an unknown dose or route of administration, for unknown indication however it was reported that the punctured vial was left for two hours at room temperature and that only one patient received a dose before excursion which is considered as underdose. Underodose is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Vaccination site erythema
Clinical narrative: The spot where the vaccine is given is red; Case reference number US-BN-2022-002008 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV22-1106) on 22-Aug-2022 and concerns a male patient of unknown age.    The patient's medical history and concomitant medication details were not provided.   On 18-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) at an unknown dose, route or site of administration for unknown indication.    On an unspecified date, unknown amount of time after the first dose, the patient's spot where the vaccine was given became red.  At the time of this report, the outcome of the event 'injection site redness' was unknown.  The reporter assessed the event as non-serious and possibly related to Jynneos vaccine.  Additional information received from Bavarian Nordic on 23-Aug-2022 included local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos, at an unknown dose, route or site of administration for unknown indication. Unknown time after the first dose, the patient's spot where the vaccine was given became red. Injection site erythema is listed and expected according to RA and RA for Jynneos. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Injection site erythema is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos, at an unknown dose, route or site of administration for unknown indication. Unknown time after the first dose, the patient's spot where the vaccine was given became red. Injection site erythema is listed and expected according to RA and RA for Jynneos. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Injection site erythema is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Underdose
Clinical narrative: Jynneos given intradermally; Jynneos given to a patient at a dose of 0.1 mL; Case reference number US-BN-2022-002025 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communication (reference number: USBAV22-1135) and concerns a patient of unknown demographics.   The patient's medical history and concomitant medication details were not reported.  On 23-Aug-2022, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), intradermally (ID) (explicitly coded as 'inappropriate route of vaccination') at a dose of 0.1 mL (explicitly coded as 'vaccine underdose'), at unknown site, for unknown indication.   It was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 23-Aug-2022 included the local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, intradermally (ID), which is considered as inappropriate route of vaccination at a dose of 0.1 mL, which is considered as underdose, at unknown site, for unknown indication. No associated adverse events have been reported with the reported medication error. The events of incorrect route of product administration and underdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Incorrect route of product administration and underdose 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 demographics was vaccinated with a dose of Jynneos, intradermally (ID), which is considered as inappropriate route of vaccination at a dose of 0.1 mL, which is considered as underdose, at unknown site, for unknown indication. No associated adverse events have been reported with the reported medication error. The events of incorrect route of product administration and underdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Incorrect route of product administration and underdose have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos vaccine administered intradermally; Case reference number US-BN-2022-002033 is a spontaneous case report initially received on 23-Aug-2022 from a consumer via agency (reference number: USBAV22-1138) and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 15-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, administered intradermally and at unknown site, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 24-Aug-2022 included local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine administered intradermally and at unknown site, for an unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine administered intradermally and at unknown site, for an unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received Jynneos intradermally; Case reference number US-BN-2022-002052 is a spontaneous case report initially received on 24-Aug-2022 from a consumer via Bavarian Nordic and concerns a male patient of unknown age.  The patient's medical history was not provided.  The patient's concomitant medication included Dupixent (dupilumab).  On 20-Aug-2022, reported also as four days ago, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live nonreplicating; batch number: unknown), at a dose 0.5 mL, administered intradermally, for pre-exposure immunization for monkeypox (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 25-Aug-2022 included confirmation of the country of occurrence.  Additional information received from Communications on 25-Aug-2022 included additional information about the vaccine, about the reporter, reference number.  Additional information received from Communications on 01-Sep-2022 included the patient's gender and an additional reference number.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos at a dose 0.5 mL, administered intradermally, for pre-exposure immunization for monkeypox, which is considered as inappropriate route of vaccination. No associated adverse events have been reported with the reported medication error. Incorrect route of product administration is considered as listed per company convention. The patient's medical history was not provided, and concomitant medication included Dupixent. Incorrect route of product administration 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 male patient of unknown age was vaccinated with the first dose of Jynneos at a dose 0.5 mL, administered intradermally, for pre-exposure immunization for monkeypox, which is considered as inappropriate route of vaccination. No associated adverse events have been reported with the reported medication error. Incorrect route of product administration is considered as listed per company convention. The patient's medical history was not provided, and concomitant medication included Dupixent. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: The patient was worried if he was protected; The patient had received Jynneos just under the skin; Case reference number US-BN-2022-002148 is a spontaneous case report initially received on 26-Aug-2022 from a consumer via Bavarian Nordic and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 26-Aug-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, administered 'just under the skin', as reported (explicitly coded as 'inappropriate route of vaccination'), for unknown indication. On the same day, the patient was worried if that was enough to be protected.  It was also reported that the patient experienced no side effects.  At the time of this report, the outcome of the event 'worry' was unknown.   The reporter did not provide seriousness and causality assessment for the reported event.  Additional information received from Bavarian Nordic on 29-Aug-2022 included the local BN case ID.; Reporter's Comments: A male patient of unknown age was worried if the the vaccination would be enough to be protected, on the same day when he was vaccinated with the first dose of Jynneos, at an unknown dose, administered just under the skin which is considered as inappropriate route of vaccination. Anxiety is unlisted and unexpected according to RA v1 and RA for Jynneos while incorrect route of product administration is considered listed per company convention. Reportedly, the patient experienced no side effects while medical history and concomitant medication details were not provided. Anxiety is assessed as not related to suspect product but to suspect product but to patient's specific thoughts and behavior regarding the vaccine protective effect. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was worried if the the vaccination would be enough to be protected, on the same day when he was vaccinated with the first dose of Jynneos, at an unknown dose, administered just under the skin which is considered as inappropriate route of vaccination. Anxiety is unlisted and unexpected according to RA v1 and RA for Jynneos while incorrect route of product administration is considered listed per company convention. Reportedly, the patient experienced no side effects while medical history and concomitant medication details were not provided. Anxiety is assessed as not related to suspect product but to suspect product but to patient's specific thoughts and behavior regarding the vaccine protective effect. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Jynneos was administered on day 18 instead on day 28; Case reference number US-BN-2022-002180 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional via Communication (reference number: USBAV22-1237) and concerns a male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local BN number.  The case is linked with US-BN-2022-002181, US-BN-2022-002182, US-BN-2022-002183, US-BN-2022-002184 due to the same reporter.; Reporter's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Jynneos was administered on day 18 instead on day 28; Case reference number US-BN-2022-002182 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional via Communication (reference number: USBAV22-1237) and concerns a male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local BN number.  The case is linked with US-BN-2022-002180, US-BN-2022-002181, US-BN-2022-002183, US-BN-2022-002184 due to the same reporter.; Reporter's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Jynneos was administered on day 18 instead on day 28; Case reference number US-BN-2022-002182 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional via Communication (reference number: USBAV22-1237) and concerns a patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local BN number.  The case is linked with US-BN-2022-002180, US-BN-2022-002181, US-BN-2022-002182, US-BN-2022-002184 due to the same reporter.; Reporter's Comments: A mala patient, was vaccinated with second dose of Jynneos vaccine, 18 days after the first dose, at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event due to Jynneos vaccine. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A mala patient, was vaccinated with second dose of Jynneos vaccine, 18 days after the first dose, at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event due to Jynneos vaccine. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Jynneos was administered on day 18 instead on day 28; Case reference number US-BN-2022-002182 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional (reference number: USBAV22-1237) and concerns a male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local number.  The case is linked with US-BN-2022-002180, US-BN-2022-002181, US-BN-2022-002182, US-BN-2022-002183 due to the same reporter.; Reporter's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient born in 1956, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Adverse drug reaction
Clinical narrative: Reaction to Jynneos vaccine; Case reference number US-BN-2022-002230 is a spontaneous case report initially received on 01-Sep-2022 from a consumer via Bavarian Nordic and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date, the patients were vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) at an unreported dose, route or anatomical site for unknown indication.   On an unspecified date, the patient experienced a reaction.  The outcome of the event was unknown.  The reporter did not provide seriousness or causality assessment.  At time of this report, no further information was provided.  Additional information received from reporter on 02-Sep-2022 included confirmation of country of occurrence.; Reporter's Comments: A patient of unknown age experienced a reaction, unknown time after vaccination with Jynneos vaccine, at an unreported dose, route or anatomical site for unknown indication. Adverse reaction (unspecified) is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. With limited information provided, causal relationship is conservatively assessed as related at this point. The case is non-serious.; Sender's Comments: A patient of unknown age experienced a reaction, unknown time after vaccination with Jynneos vaccine, at an unreported dose, route or anatomical site for unknown indication. Adverse reaction (unspecified) is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. With limited information provided, causal relationship is conservatively assessed as related at this point. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Overdose
Clinical narrative: The patient received the first dose of Jynneos intradermally and by a mistake double dose; The patient received the first dose of Jynneos intradermally and by a mistake double dose; Case reference number US-BN-2022-002234 is a spontaneous case report initially received on 02-Sep-2022 from a consumer via Communication (reference number: USBAV22-1270) and concerns a male patient of unknown age.  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), administered intradermally and by mistake a double dose, as reported, at an unknown site, for monkeypox prophylaxis (explicitly coded as 'inappropriate route of vaccination' and 'overdose').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 05-Sep-2022 included local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, administered intradermally and by mistake a double dose, at an unknown site, for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and overdose. Incorrect route of product administration and overdose are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality for incorrect route of product administration and overdose is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, administered intradermally and by mistake a double dose, at an unknown site, for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and overdose. Incorrect route of product administration and overdose are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality for incorrect route of product administration and overdose is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was drawn up into the syringe one hour before it was administrated to the patient.; Jynneos vaccine was drawn up into the syringe one hour before it was administrated to the patient.; Case reference number US-BN-2022-002245 is a spontaneous case report initially received on 01-Sep-2022 from a pharmacist via Communications (reference number: USBAV22-1249), and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient received the Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown)  that was drawn up into the syringe one hour before the administration, at an unknown dose, route, or site of administration, for smallpox/ monkeypox (explicitly coded as ' Product storage error', 'Product administration error ').  At the time of this report, it was unknown which dose this was, or whether the patient experienced any adverse events due to Jynneos.  Additional information received on 05-Sep-2022 from Bavarian Nordic included local BN case ID.  This case is linked with US-BN-2022-002246 and US-BN-2022-002247 concerning the same reporter; Reporter's Comments: On an unspecified date, a patient of unknown age and gender received the Jynneos vaccine that was drawn up into the syringe one hour before the administration, for smallpox/monkeypox, which is considered as product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, a patient of unknown age and gender received the Jynneos vaccine that was drawn up into the syringe one hour before the administration, for smallpox/monkeypox, which is considered as product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was drawn up into the syringe 20 minutes before it was administrated to the patient.; Jynneos vaccine was drawn up into the syringe 20 minutes before it was administrated to the patient.; Case reference number US-BN-2022-002246 is a spontaneous case report initially received on 01-Sep-2022 from a pharmacist (reference number: USBAV22-1249), and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient received the Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) that was drawn up into the syringe 20 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/ monkeypox (explicitly coded as ' Product storage error', 'Product administration error ').  At the time of this report, it was unknown which dose this was, or whether the patient experienced any adverse events due to Jynneos.  Additional information received on 05-Sep-2022 from Bavarian Nordic included local case ID.  This case is linked with US-BN-2022-002245 and US-BN-2022-002247 concerning the same reporter; Reporter's Comments: A patient of unknown age and gender received the Jynneos vaccine that was drawn up into the syringe 20 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/ monkeypox, which is considered as product storage error and product administration error. No associated adverse events have been reported with the reported medication error. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error 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 age and gender received the Jynneos vaccine that was drawn up into the syringe 20 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/ monkeypox, which is considered as product storage error and product administration error. No associated adverse events have been reported with the reported medication error. Product storage error and product administration error are considered as listed per company. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.