Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | — |
Body ache; Sore throat; After two doses of Vivotif, patient was not feeling well; Headache; Case reference number US-BN-2024-001869 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0919) on 03-May-2024 and concerns female patient of unspecified age (teenager). The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient was vaccinated with first and second dose of Vivotif vaccine (batch number: Unknown), at unknown dose, route, or site of administration for unknown indication. On unspecified date, unknown amount of time after administration of Vivotif vaccine patient was not feeling well and patient experienced headache, body ache and sore throat. At the time of initial report, it was unknown if the patient recovered from the events 'feeling unwell', 'headache', 'ache' and 'sore throat'. The reporter assessed the events as non-serious. Causality assessment was reported as not related to Vivotif vaccine. No further information provided.; Reporter's Comments: A female patient of unspecified age (teenager) was not feeling well and experienced non-serious events of headache, body ache and sore throat on unspecified date, unknown amount of time after the patient was vaccinated with first and the second dose of Vivotif vaccine for unknown indication. Malaise and headache are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst pain and oropharyngeal pain are unlisted and unexpected. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age (teenager) was not feeling well and experienced non-serious events of headache, body ache and sore throat on unspecified date, unknown amount of time after the patient was vaccinated with first and the second dose of Vivotif vaccine for unknown indication. Malaise and headache are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst pain and oropharyngeal pain are unlisted and unexpected. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
Comments: None