Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
Increased heart rate (could feel heartbeat in her teeth); Itching on the roof of mouth; Itching on the top of head; Case reference number US-BN-2024-002771 is a spontaneous case initially received from other health care professional via Bavarian Nordic (reference number: BN_2024_03074) on 11-Nov-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of Vivotif vaccine (batch number: unknown) at unknown dose, route or site of administration, for unknown indication. On unspecified date, for unknown amount of time from a first dose of Vitotif vaccine, the patient experienced adverse events of itching on the roof of mouth, itching on the top of head, and increased heart rate (could feel heartbeat in teeth). At the time of the initial report, it was unknown if the patient recovered from the events of 'heart rate increased', 'oral pruritus', and 'itchy scalp'. The reporter did not provide a seriousness and causality assessment for events of 'heart rate increased', 'oral pruritus', and 'itchy scalp'. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of itching on the roof of mouth, itching on the top of head, and increased heart rate an unknown amount of time after the patient took the first dose of Vivotif vaccine for unknown indication. Heart rate increased and oral pruritus are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst pruritus is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details 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 experienced non-serious events of itching on the roof of mouth, itching on the top of head, and increased heart rate an unknown amount of time after the patient took the first dose of Vivotif vaccine for unknown indication. Heart rate increased and oral pruritus are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst pruritus is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details 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