Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004063 | PO / MO |
The patient did not take the third dose due to side effects; patient told nurse that they were lactose intolerant and shouldn't have been given Vivotif; patient told nurse that they were lactose intolerant and shouldn't have been given Vivotif; Vomiting; Diarrhea; The patient experienced severe nausea due to lactose intolerance after second dose of Vivotif; The patient experienced abdominal cramping due to lactose intolerance after second dose of Vivotif; The patient experienced stomach pain due to lactose intolerance after second dose of Vivotif vaccine; The patient experienced bloating due to lactose intolerance after second dose of Vivotif vaccine; Case reference number US-BN-2024-002661 is a spontaneous case initially received from a nurse via Communication (reference number: USBAV24-2751) on 17-Oct-2024 and concerns a 33-year-old female patient. The patient's medical history *was not provided* *The patient concomitant medication included Lactaid (tilactase). * The patient's current condition included lactose intolerance. On *14-Oct-2024*, the patient took the first dose of Vivotif (batch number: 3004063; *Expiration date:28-Feb-2024*) one capsule, orally for indication pre-travel immunization. *On 14-Oct-2024, the patient experienced severe nausea, stomach pain, bloating and abdominal cramping.* On the same day, due to lactose intolerance the patient had severe reaction (also reported as major reaction) that included vomiting and diarrhea, reported as eight hours. Patient told nurse that they were lactose intolerant and shouldn't have been given Vivotif (explicitly coded as 'contraindicated product administered' and 'labelled drug-disease interaction error'). As reported, the patient will return to passport health to receive Typhim instead of completing Vivotif Series. *On 15-Oct-2024, one day after the patient took Vivotif, the patient experienced diarrhoea.* On *16-Oct-2024, two days from the first dose*, the patient took the second dose of Vivotif vaccine (batch number: 3004063; *Expiration date: 28-Feb-2024*) one capsule, orally. *The patient didn't take the third dose due to side effects (explicitly coded as 'Incomplete course of vaccination'). *On the same day, the patient experienced vomiting. * At the time of the follow-up report, the patient was recovering from the events of 'stomach pain', 'abdominal cramps', 'abdominal bloating', vomiting, diarrhea and 'nausea'. *The reporter assessed the events of 'stomach pain', 'abdominal cramps', 'abdominal bloating', vomiting, diarrhea, and 'nausea' as serious due to criteria of medically significant and certainly related to the product of Vivotfi.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a nurse on 15-Nov-2024: New information included: patient information, drug administration information and details about additional doses., confirmation for no deviation during administration, and provided events for a severe reaction. Follow-up information received from a nurse on 06-Dec-2024: New information included: drug administration information and details about additional doses, seriousness, causality and severity assessment for the events above, start dates of the events, outcome, concomitant medication information. Non-significant case correction performed for information received from VAERS on 06-Jan-2025 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241017-ac157e to US-BAVARIAN NORDIC A/S-US-BN-2024-002661, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 33-year-old female patient experienced non-serious event of nausea, stomach pain, bloating and abdominal cramping on the day 0 after the patient took the first dose of Vivotif for indication pre-travel immunization. On the same day, the patient experienced severe reaction (also reported as major reaction) due to lactose intolerance, that included vomiting and diarrhea. The patient had lactose intolerance, which is considered contraindicated product administered and labelled drug-disease interaction error, as according to CCDS v8 of Vivotif, patients with problems of galactose intolerance, lactase deficiency, glucose-galactose malabsorption, etc. should not be administered the vaccine which contains lactose. One day after the patient took Vivotif, the patient experienced diarrhoea. Two days from the first dose, the patient took the second dose of Vivotif vaccine, which is considered as inappropriate schedule of product administration. The patient didn't take the third dose due to side effects, which is considered as incomplete course of vaccination. On the same day, the patient experienced vomiting. Vomiting, nausea, diarrhoea and abdominal pain are listed and expected for Vivotif per CCDS v8 and USPI, whilst abdominal distension is listed per CCDS v8 and unexpected per USPI. Abdominal pain upper is considered as listed and expected per CCDS v8 and USPI. Contraindicated product administered, labelled drug-disease interaction error and incomplete course of vaccination are all listed per company convention. The patient's medical history was not provided, concomitant medication included Lactaid, and current condition included lactose intolerance. The patient was recovering from the events. Due to plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered related to Vivotif, based on the reported information. Contraindicated product administered, labelled drug-disease interaction error and incomplete course of vaccination are not related to Vivotif, but to human error. The case is considered as serious due to medical significance.; Sender's Comments: A 33-year-old female patient experienced non-serious event of nausea, stomach pain, bloating and abdominal cramping on the day 0 after the patient took the first dose of Vivotif for indication pre-travel immunization. On the same day, the patient experienced severe reaction (also reported as major reaction) due to lactose intolerance, that included vomiting and diarrhea. The patient had lactose intolerance, which is considered contraindicated product administered and labelled drug-disease interaction error, as according to CCDS v8 of Vivotif, patients with problems of galactose intolerance, lactase deficiency, glucose-galactose malabsorption, etc. should not be administered the vaccine which contains lactose. One day after the patient took Vivotif, the patient experienced diarrhoea. Two days from the first dose, the patient took the second dose of Vivotif vaccine, which is considered as inappropriate schedule of product administration. The patient didn't take the third dose due to side effects, which is considered as incomplete course of vaccination. On the same day, the patient experienced vomiting. Vomiting, nausea, diarrhoea and abdominal pain are listed and expected for Vivotif per CCDS v8 and USPI, whilst abdominal distension is listed per CCDS v8 and unexpected per USPI. Abdominal pain upper is considered as listed and expected per CCDS v8 and USPI. Contraindicated product administered, labelled drug-disease interaction error and incomplete course of vaccination are all listed per company convention. The patient's medical history was not provided, concomitant medication included Lactaid, and current condition included lactose intolerance. The patient was recovering from the events. Due to plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered related to Vivotif, based on the reported information. Contraindicated product administered, labelled drug-disease interaction error and incomplete course of vaccination are not related to Vivotif, but to human error. The case is considered as serious due to medical significance.
Lactose intolerance
LACTAID