Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient felt completely down for the day after taking Vivotif; The patient was not able to continue with Vivotif administration; Stomach cramps and pain in the belly; Diarrhea (ten to 15 times); Vomiting (ten to 15 times); Headache; Fatigue, Completely drained out; Case reference number US-BN-2024-000628 is a spontaneous case report initially received from other health care professional via Med Communications (reference number: USBAV24-0502) on 12-Mar-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medications were not provided. On 10-Mar-2024, the patient took first dose of Vivotif (batch number: unknown), orally, at unknown dose, for typhoid immunization indication. On 11-Mar-2024, one day after taking Vivotif vaccine, the patient experienced pain in the belly, stomach cramps, diarrhea (ten to 15 times), vomiting (ten to 15 times), headache, fatigue. As reported, the patient was completely down for the day after taking Vivotif and completely drained out. As reported, the patient was not able to continue with Vivotif administration (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, the patient was recovering from pain in the belly, stomach cramps, diarrhea, vomiting, headache, fatigue and completely down. As reported, the patient felt much better on the following day. The reporter assessed the events of pain in the belly, stomach cramps, diarrhea, vomiting, headache, fatigue and completely down as non-serious and possibly related to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of pain in the belly, stomach cramps, diarrhea (ten to 15 times), vomiting (ten to 15 times), headache, fatigue, was completely down for the day and was completely drained out on the day 1 after the patient took first dose of Vivotif for typhoid immunization indication. Reportedly, the patient was not able to continue with Vivotif administration, which is considered as incomplete course of vaccination. Abdominal pain upper, diarrhoea, vomiting, headache and fatigue are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst depressed mood is unlisted and unexpected. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. The patient was recovering from the events. Considering plausible temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the events have been considered as related to Vivotif. Incomplete course of vaccination 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 female patient of unspecified age experienced non-serious events of pain in the belly, stomach cramps, diarrhea (ten to 15 times), vomiting (ten to 15 times), headache, fatigue, was completely down for the day and was completely drained out on the day 1 after the patient took first dose of Vivotif for typhoid immunization indication. Reportedly, the patient was not able to continue with Vivotif administration, which is considered as incomplete course of vaccination. Abdominal pain upper, diarrhoea, vomiting, headache and fatigue are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst depressed mood is unlisted and unexpected. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. The patient was recovering from the events. Considering plausible temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the events have been considered as related to Vivotif. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.