Sex: M
Vaccine: SMALLMNK
Symptoms: Anxiety, Expired product administered, Injection, Product administration error, Product storage error
Clinical narrative: Intradermal injection; Expired product administered; Feeling anxious; Case reference number US-BN-2022-004589 is a spontaneous case initially received on 07-Nov-2022 from health care professional via Communication (reference numbers: USBAV22-1879, USBAV22-1885, USBAV22-1906) and concerns a 39-year-old male patient.  The patient's relevant medical history and concomitant medications were not provided.  On 07-Nov-2022, the patient was vaccinated with a dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number FDP00016), dose 0.1 mL, intradermally (explicitly coded as 'Intradermal injection'), at an unknown location, for monkeypox prophylaxis.   On 07-Nov-2022, on the day of vaccination with Jynneos, the pharmacist reporter stated they had Jynneos dose that had thawed and had to be used until 24-Oct-2022. They realized it was administered in error (explicitly coded as 'expired product administered').    On 08-Nov-2022, one day after vaccination with Jynneos, the reporter asked if the dose should be repeated immediately if originally administered after beyond use date would apply the same way to an immunocompromised patient. Pharmacist stated the patient was anxious about it.  At the time of this report, the outcome of event 'feeling anxious' was unknown.  The reporter did not provide the seriousness assessment of the event. Causality assessment was not provided.  Additional information received from on 07-Nov-2022 included local case ID.  Additional information received from on 08-Nov-2022 included two follow ups of the case.; Reporter's Comments: A 39-year-old male patient was vaccinated with a dose (0.1 mL) of Jynneos, intradermally (considered as intradermal injection), at an unknown location, for monkeypox prophylaxis and on the same day, the pharmacist reporter stated they had Jynneos dose that had thawed and had to be used until 24-Oct-2022 (approximately two weeks before the patient was vaccinated). They realized it was administered in error which is considered as expired product administered. One day after vaccination with Jynneos, the reporter asked if the dose should be repeated immediately if originally administered after beyond use date would apply the same way to an immunocompromised patient. Pharmacist stated the patient was anxious about it. Anxiety is unlisted and unexpected according to guidelines for Jynneos while injection and expired product administered are both considered listed per company conventions. The outcome was unknown. The patient's relevant medical history and concomitant medications were not provided. Anxiety is assessed as related due to plausible temporal relationship, current circumstances and since contributory role of the suspect product cannot be fully excluded at this point. Injection and expired product administered are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 39-year-old male patient was vaccinated with a dose (0.1 mL) of Jynneos, intradermally (considered as intradermal injection), at an unknown location, for monkeypox prophylaxis and on the same day, the pharmacist reporter stated they had Jynneos dose that had thawed and had to be used until 24-Oct-2022 (approximately two weeks before the patient was vaccinated). They realized it was administered in error which is considered as expired product administered. One day after vaccination with Jynneos, the reporter asked if the dose should be repeated immediately if originally administered after beyond use date would apply the same way to an immunocompromised patient. Pharmacist stated the patient was anxious about it. Anxiety is unlisted and unexpected according to guidelines for Jynneos while injection and expired product administered are both considered listed per company conventions. The outcome was unknown. The patient's relevant medical history and concomitant medications were not provided. Anxiety is assessed as related due to plausible temporal relationship, current circumstances and since contributory role of the suspect product cannot be fully excluded at this point. Injection and expired product administered are both assessed as not related to suspect product but to human factor. The case is non-serious.