Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Therapeutic response unexpected; Waking up early; Palpitations; Injection site reaction; Muscle/body aches; Fever; Chills (shivering and feeling cold); Local reactions: Pain, Redness, Itching; Local reactions: Pain, Redness, Itching; Local reactions: Pain, Redness, Itching; Case reference number AU-BN-2025-000563 initially downloaded from Department of Health and Aged Care, Reguatory Administration (RA) is a spontaneous case received from consumer via Health Authority (TGA ID: 764130) on 07-Jul-2025 and concerns a 29-year-old female patient. The patient's relevant medical history and concomitant medication details were not provided. *The patient's current condition included chronic fatigue and excessive sleepiness which reportedly seemed to improve after vaccination. * On *14-Dec-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, route or site of administration for unknown indication. On an unspecified date, an unknown of time after the vaccination with Jynneos, the patient developed palpitations, injection site reaction *which were reported to be minor, common and expected, muscle/body aches, fever, therapeutic response unexpected, local reaction of pain, redness, itching, chills (shivering and feeling cold), waking up early and functioning well on significantly less sleep.* *The event management of palpitations was conducted through the self. * At the time of the *follow up* report, the patient *did not recover from events palpitations, injection site reaction, 'myalgia', fever, 'injection site pain', 'injection site redness' and 'injection site itching'. It was unknown if the patient recovered from events therapeutic response unexpected, 'chills', and 'awakening early'.* *The report assessed the events of palpitations, injection site reaction, 'myalgia', fever, 'injection site pain', 'injection site redness', 'injection site itching', 'chills', therapeutic response unexpected and 'awakening early' as non-serious and possibly related to the product of Jynneos.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up downloaded from RA received from consumer via Health authority (TGA ID: AU-TGA-0000764130) on 02-Jul-2025: New information causality, seriousness, event verbatim, onset date, end date, outcome, additional events, Jynneos dosing information, medical history and reporter details.; Reporter's Comments: A 29-year-old female patient experienced non-serious events of palpitations, injection site reaction, myalgia, pyrexia, injection site pain, injection site redness, injection site itching, terminal insomnia, chills and therapeutic response unexpected on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Palpitations, injection site reaction, myalgia, injection site pain, injection site redness, injection site itching, chills and pyrexia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst therapeutic response unexpected and terminal insomnia are unlisted and unexpected. The patient's relevant medical history and concomitant medication details were not provided. The patient's current condition included chronic fatigue and excessive sleepiness which reportedly seemed to improve after vaccination. The patient did not recover from the events of palpitations, injection site reaction, myalgia, fever, injection site pain, injection site redness and injection site itching. Considering implied temporal relationship, lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. This case is considered as non-serious.; Sender's Comments: A 29-year-old female patient experienced non-serious events of palpitations, injection site reaction, myalgia, pyrexia, injection site pain, injection site redness, injection site itching, terminal insomnia, chills and therapeutic response unexpected on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Palpitations, injection site reaction, myalgia, injection site pain, injection site redness, injection site itching, chills and pyrexia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst therapeutic response unexpected and terminal insomnia are unlisted and unexpected. The patient's relevant medical history and concomitant medication details were not provided. The patient's current condition included chronic fatigue and excessive sleepiness which reportedly seemed to improve after vaccination. The patient did not recover from the events of palpitations, injection site reaction, myalgia, fever, injection site pain, injection site redness and injection site itching. Considering implied temporal relationship, lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. This case is considered as non-serious.
Medical History/Concurrent Conditions: Chronic fatigue (Have had chronic fatigue/excessive sleepiness for prior 7 years. Seemed to improve after vaccination); Sleepiness (Have had chronic fatigue/excessive sleepiness for prior 7 years. Seemed to improve after vaccination)