chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos vaccine administered intramuscularly; Case reference number US-BN-2022-003208 is a spontaneous case report initially received on 15-Sep-2022 from a nurse via Bavarian Nordic 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, route or site of administration, for monkeypox prophylaxis.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown), at an unknown dose or site of administration, administered intramuscularly (explicitly coded as 'incorrect route of product administration'). After the vaccination, the patient was observed for approximately 20 minutes and no adverse event occurred.  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received from Company on 15-Sep-2022 included Company ID and indication for Jynneos, and is blended in the case narrative.  This case is linked with the case US-BN-2022-003207 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: Patient had the Jynneos vaccine too early, 22 days after the first dose, the second dose was administered.; Second dose of Jynneos administered at dose of 0.1 milliliter intradermally.; Case reference number US-BN-2022-003274 is a spontaneous case report initially received on 23-Sep-2022 from other health professional via Company (reference number: USBAV22-1513) and concerns an adult male.  The patient's medical history and concomitant medication details were not reported.  On 19-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00012), at a dose reported as 0.5ml, subcutaneously, for monkeypox prophylaxis.  On 10-Sep-2022, 22 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00012), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.  This case is linked with US-BN-2022-003278 and US-BN-2022-003280 due to the same reporter.; Reporter's Comments: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection 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: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection 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: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: Patient had the Jynneos vaccine too early, 18 days after the first dose, the second dose was administered.; Second dose of Jynneos administered at dose of 0.1 milliliter intradermally.; Case reference number US-BN-2022-003278 is a spontaneous case report initially received on 23-Sep-2022 from other health professional via Company (reference number: USBAV22-1517) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not reported.  On 12-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00012), at a dose reported as 0.5ml, subcutaneously, for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00012), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.  This case is linked with US-BN-2022-003274 and US-BN-2022-003280 due to the same reporter.; Reporter's Comments: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 18 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection 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: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 18 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection 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: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: Patient had the Jynneos vaccine too early, 18 days after the first dose, the second dose was administered.; Second dose of Jynneos administered at dose of 0.1 milliliter intradermally.; Case reference number US-BN-2022-003280 is a spontaneous case report initially received on 23-Sep-2022 from other health professional via Company (reference number: USBAV22-1519) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not reported.  On 12-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00016), at a dose reported as 0.5ml, subcutaneously, for monkeypox prophylaxis.  On 30-Aug-2022, 22 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00016), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.  This case is linked with US-BN-2022-003274 and US-BN-2022-003278 due to the same reporter.; Reporter's Comments: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection 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: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: First dose of Jynneos was administered intradermally; Case reference number US-BN-2022-003325 is a spontaneous case report initially received from a nurse via Company (reference number: USBAV22-1514) on 23-Sep-2022 and concerns a patient of unknown demographics.   The patient's medical history included keloids.  The patient's concomitant medication details were not provided.  On an unspecified day, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.  This case is linked to cases US-BN-2022-003326, US-BN-2022-003327 and US-BN-2022-003328 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis, which is considered as intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection is considered as listed per company convention. The patient's medical history included keloids and concomitant medication details were not provided. Intradermal injection 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 patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis, which is considered as intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection is considered as listed per company convention. The patient's medical history included keloids and concomitant medication details were not provided. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: First dose of Jynneos was administered intradermally; Case reference number US-BN-2022-003326 is a spontaneous case report initially received from a nurse via Company (reference number: USBAV22-1514) on 23-Sep-2022 and concerns a patient of unknown demographics.   The patient's medical history included keloids.  The patient's concomitant medication details were not provided.  On an unspecified day, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 04-Oct-2022 included the local BN case ID.  This case is linked to cases US-BN-2022-003325, US-BN-2022-003327 and US-BN-2022-003328 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: First dose of Jynneos was administered intradermally; Case reference number US-BN-2022-003327 is a spontaneous case report initially received from a nurse via Company (reference number: USBAV22-1514) on 23-Sep-2022 and concerns a patient of unknown demographics.   The patient's medical history included keloids.  The patient's concomitant medication details were not provided.  On an unspecified day, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 04-Oct-2022 included the local BN case ID.  This case is linked to cases US-BN-2022-003325, US-BN-2022-003326 and US-BN-2022-003328 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Lack of administration site rotation, No adverse event
Clinical narrative: Intradermal injection; Dose repeated; 1'' from original administration site; Dose repeated; 1'' from original administration site; Case reference number US-BN-2022-003337 is a spontaneous case initially received on 14-Sep-2022 from health care professional via Communication (reference number: USBAV22-1395) and concerns a 24-year-old male patient.  The patient's relevant medical history and concomitant medications were not not provided.  On 06-Sep-2022, the patient was vaccinated with a first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number FDP00005), at an unknown dose, intradermally (explicitly coded as 'intradermal injection'), in left arm, for an unknown indication.   As reported, no wheal formed with initial administration and the dose was repeated with the same lot 1 inch from original administration site (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Lack of administration site rotation').   At the time of this report, it was unknown if patient experienced any adverse event.  No further information received.  Additional information received on 15-Sep-2022 included local case ID.  Additional information received on 19-Sep-2022 included report of this case.; Reporter's Comments: A 24-year-old male patient was vaccinated with first dose of Jynneos vaccine intradermally. As reported, that initial attempt did not result in a wheel and the dose was repeted with the same lot 1 inch from original administration site (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Lack of administration site rotation'). No associated adverse events have been reported. Intradermal injection, lack of administration site rotation and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.; Sender's Comments: A 24-year-old male patient was vaccinated with first dose of Jynneos vaccine intradermally. As reported, that initial attempt did not result in a wheel and the dose was repeted with the same lot 1 inch from original administration site (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Lack of administration site rotation'). No associated adverse events have been reported. Intradermal injection, lack of administration site rotation and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos vaccine administered intramuscularly; Case reference number US-BN-2022-003510 is a spontaneous case report initially received on 23-Sep-2022 from a nurse via Communication (reference number: USBAV22-1515) 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 unknown dose, administered intramuscularly at unknown site, for monkeypox prophylaxis (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 23-Sep-2022 from Communication included Jynneos indication and a dose number.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine at unknown dose, administered intramuscularly at unknown site, for monkeypox prophylaxis, which is considered as inappropriate route of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. 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 patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine at unknown dose, administered intramuscularly at unknown site, for monkeypox prophylaxis, which is considered as inappropriate route of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. 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: Expired product administered, Incorrect route of product administration
Clinical narrative: Jynneos vaccine is administrated intradermally instead subcutaneously; An expired dose of Jynneos is administered to a patient; Case reference number US-BN-2022-003696 is a spontaneous case report initially received from a nurse via  Communication (reference number: USBAV22-1578) on 29-Sep-2022 and concerns a 42-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 29-Sep-2022, the patient was vaccinated with first dose number of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016), at a dose of 0.1 mL, intradermally (ID) (explicitly coded as 'Intradermal injection'), at an unknown site of administration, for monkeypox prophylaxis.   On the same day, immediately after vaccination the reporter realized that they administered an expired dose (explicitly coded as 'Expired vaccine administered').  At the time of this report, no adverse events were reported.  Additional information received from Bavarian Nordic on 29-Sep-2022 included an updated narrative where is stated that the vial had already been punctured on Monday (26-Sep-2022) and the vial was given today (29-Sep-2022) intradermally.  Additional information received from Bavarian Nordic on 29-Sep-2022 included local BN case ID.; Reporter's Comments: A 42-year-old male patient was vaccinated with first dose number of Jynneos vaccine, at a dose of 0.1 mL, intradermally (ID), which is considered as intradermal injection, at an unknown site of administration, for monkeypox prophylaxis. Reportedly, immediately after vaccination the reporter realized that they administered an expired dose, which is considered as expired vaccine administered. At the time of this report, no adverse events were reported. Intradermal injection and expired product administered are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered 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 42-year-old male patient was vaccinated with first dose number of Jynneos vaccine, at a dose of 0.1 mL, intradermally (ID), which is considered as intradermal injection, at an unknown site of administration, for monkeypox prophylaxis. Reportedly, immediately after vaccination the reporter realized that they administered an expired dose, which is considered as expired vaccine administered. At the time of this report, no adverse events were reported. Intradermal injection and expired product administered are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Product administration error
Clinical narrative: The patient was vaccinated with the dose which was past the expiration date; The patient was vaccinated with the dose which was past the expiration date; Case reference number US-BN-2022-003736 is a spontaneous case received from other health professional on 30-Sep-2022 via Communication (reference number: USBAV22-1584) and concerns a patient of unknown demographics.   The patient's relevant medical history and concomitant medications were not provided.  On 30-Sep-2022, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; lot number: FDP00004; expiration date: 27-Sep-2022), at an unknown dose, route or anatomical site and for an unknown indication (explicitly coded as 'expired product administered' and 'product administration error'). As reported on 27-Sep-2022, product reached eight weeks in the fridge.  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 03-Oct-2022 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose, route, or anatomical site and for an unknown indication on 30-Sep-2022. As reported on 27-Sep-2022, product reached eight weeks in the fridge, which is considered as expired product administered and product administration error. At the time of this report, it was unknown if the patient experienced any adverse event. Expired product administered and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered 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 demographics was vaccinated with a dose of Jynneos, at an unknown dose, route, or anatomical site and for an unknown indication on 30-Sep-2022. As reported on 27-Sep-2022, product reached eight weeks in the fridge, which is considered as expired product administered and product administration error. At the time of this report, it was unknown if the patient experienced any adverse event. Expired product administered and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered 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.
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: Jynneos administered intradermally; Case reference number US-BN-2022-003796 is a spontaneous case report initially received on 14-Sep-2022 from other health care professional via Communications (reference number: USBAV22-1398) and concerns a 50-year-old male patient.  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 (Smallpox and monkeypox vaccine, live, nonreplicating, batch number not provided), at an unknown dose, site or route of administration, for unknown indication.  On 09-Sep-2022, an unknown amount of time the first dose, the patient was vaccinated with the second dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number FDP00016) at an unknown dose, intradermally for unknown indication (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos vaccination.  Additional information was received from Bavarian Nordic on 15-Sep-2022 and included the local BN case ID.  Additional information was downloaded from VAERS portal on 26-Sep-2022, and the information included route and site of Jynneos administration.; Reporter's Comments: A 50-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date, at an unknown dose, route or site of vaccination. Reportedly, no wheal was formed following vaccination. On 09-Sep-22 the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine was administered intradermally, and this was coded as intradermal injection. The event is considered listed as per the Company conventions. The patient's medical history and concomitant medications were not provided. It was unknown if the patient experienced any adverse events following vaccination. The case is non-serious. Intradermal injection is assessed as not related to the suspect vaccine but related to a human factor.; Sender's Comments: A 50-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date, at an unknown dose, route or site of vaccination. Reportedly, no wheal was formed following vaccination. On 09-Sep-22 the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine was administered intradermally, and this was coded as intradermal injection. The event is considered listed as per the Company conventions. The patient's medical history and concomitant medications were not provided. It was unknown if the patient experienced any adverse events following vaccination. The case is non-serious. Intradermal injection is assessed as not related to the suspect vaccine but related to a human factor.
Sex: U
Vaccine: SMALLMNK
Symptoms: Occupational exposure to product
Clinical narrative: Nurse had a topical exposure to the vaccine, the content reached her skin for a couple of minutes; Case reference number US-BN-2022-003828 is a spontaneous case received from other health professional on 04-Oct-2022 via  Communication (reference number: USBAV22-1621) and concerns a patient of unknown demographic.  The patient's relevant medical history and medication details were not provided.  On an unspecified date, nurse had topical exposure to the vaccine (explicitly coded as Occupational exposure via skin contact with product). The content reached her skin for a couple of minutes, with no open areas of the skin. The patient washed hands for ten minutes. There are no more details if this was related to the product issue.   At the time of this report, it was unknown if the patient experienced any adverse event.  As reported, it was deemed it not to be a PQC after all since there is no identified product quality defect.  Additional information received on 05-Oct-2022 form Bavarian Nordic included confirmation that this is not PQC report.  Additional information received on 05-Oct-2022 form Bavarian Nordic included local BN case ID.; Reporter's Comments: A patient of unknown demographics was about to be vaccinated with Jynneos vaccine, and as reported, nurse had topical exposure to the vaccine, which is considered as occupational exposure via skin contact with product. The content reached her skin for a couple of minutes, with no open areas of the skin. At the time of this report, it was unknown if the patient experienced any adverse event. Occupational exposure to product is considered as listed per company convention. The patient's relevant medical history and medication details were not provided. Occupational exposure to product 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 patient of unknown demographics was about to be vaccinated with Jynneos vaccine, and as reported, nurse had topical exposure to the vaccine, which is considered as occupational exposure via skin contact with product. The content reached her skin for a couple of minutes, with no open areas of the skin. At the time of this report, it was unknown if the patient experienced any adverse event. Occupational exposure to product is considered as listed per company convention. The patient's relevant medical history and medication details were not provided. Occupational exposure to product has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003913 is a spontaneous case report initially received on 05-Oct-2022 from nurse via  Communications (reference number: USBAV22-1628) and concerns *a patient of unknown demographics (first out of ten)*.  The patient's medical history and concomitant medication details were not provided.  On 03-Oct-2022 and 04-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  *At the time of this report, it was unknown if the patient experienced any adverse events. *  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a pharmacist on 05-Oct-2022 from a nurse via Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved making the case valid.  Additional information received on 05-Oct-2022 from Bavarian Nordic included local BN case ID.  The case is linked to the cases US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. 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 demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. 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.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos vaccine administered intradermally; Case reference number US-BN-2022-003939 is a spontaneous case report initially received on 07-Oct-2022 from a nurse via Communication (reference number: USBAV22-1658) 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 Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose and site of administration, intradermally for unknown indication (explicitly coded as 'intradermal injection').  At the time of this report, it was unknown which dose was this supposed to be or if patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-003940 (same reporter).  No further information received.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos at unknown dose and site of administration, for unknown indication, intradermally (which is considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown which dose was this supposed to be or if patient experienced any adverse event due to Jynneos. 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 Jynneos at unknown dose and site of administration, for unknown indication, intradermally (which is considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown which dose was this supposed to be or if patient experienced any adverse event due to Jynneos. 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: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Another intradermal vaccination from that same vial; Case reference number US-BN-2022-003940 is a spontaneous case report initially received on 07-Oct-2022 from a nurse via Communications (reference number: USBAV22-1658) 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 Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose and site of administration, administered intradermally, for unknown indication. The patient was vaccinated with the vial that was already used a week before (explicitly coded as 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-003939 (same reporter).  Additional information received from Bavarian Nordic on 10-Oct-2022 included the local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos, at unknown dose and site of administration, for unknown indication, administered intradermally (considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. 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 Jynneos, at unknown dose and site of administration, for unknown indication, administered intradermally (considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. 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: U
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003956 is a spontaneous case report initially received on 05-Oct-2022 (reference number: USBAV22-1628) and concerns a patient of unknown demographics (second out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. 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 demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. 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.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003958 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: USBAV22-1628) and concerns a patient of unknown demographics (third out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. 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 demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. 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.