Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
Arthritis in hands; Chills; Joint pain; Muscle ache; Fever of 101 (units not specified); several episodes of diarrhoea; The patient stopped taking the Vivotif vaccine; Case reference number US-BN-2024-002813 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2024_03098) on 24-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. The patient's current condition included measles. On an unspecified date, reported as Tuesday, the patient received co-suspect unspecified vaccine (brand name: Unknown; batch number: unknown) at an unknown dose, route, or site of administration for an unknown indication. On an unspecified dates, the patient took the first and second dose of Vivotif (batch number: unknown) at an unknown dose, orally for immunization, as reported, the patient got oral typhoid to get better immunity of intestines. On an unspecified date, reported as last night, unknown amount of time after vaccination, the patient got fever of 101 (units not specified). On an unspecified date, unknown amount of time after vaccination, the patient experienced chills, some arthritis in hands, and joint pain, muscle ache and several episodes of diarrhoea. As reported, the patient stopped taking the Vivotif vaccine and did not know if should continue (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient was recovered from the events of fever, hand arthritis, joint pain, muscle ache, chills, and diarrhoea. The reporter assessed the events of fever, hand arthritis, joint pain, muscle ache, chills, and diarrhoea as non-serious and while the causality assessment between the events was not reported. Additional information received from Bavarian Nordic on 25-Nov-2024: included reference number. Additional information received from the consumer via Med Communications (reference USBAV24-3109) on 25-Nov-2024: added additional events and seriousness criteria, confirmation that the patient stopped taking Vivoitf, patient's gender and confirmation for country of occurrence.; Reporter's Comments: A female patient of unknown age got fever of 101 (units not specified) and experienced chills, some arthritis in hands, joint pain, muscle ache and several episodes of diarrhoea, unknown time after taking the first and second dose of Vivotif, at an unknown dose, orally for immunization. Reportedly, the patient stopped taking the Vivotif vaccine and did not know if should continue which is considered as incomplete course of vaccination. According to CCDS v8 and USPI arthritis is unlisted and unexpected, chills, myalgia and arthralgia are listed however unexpected while pyrexia and diarrhoea are listed and expected. Incomplete course of vaccination is considered listed according to company convention. The outcome was unknown. The patient's medical history and concomitant medication were not provided while current condition included measles. Arthritis, chills, myalgia, arthralgia, pyrexia and diarrhoea are all assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age got fever of 101 (units not specified) and experienced chills, some arthritis in hands, joint pain, muscle ache and several episodes of diarrhoea, unknown time after taking the first and second dose of Vivotif, at an unknown dose, orally for immunization. Reportedly, the patient stopped taking the Vivotif vaccine and did not know if should continue which is considered as incomplete course of vaccination. According to CCDS v8 and USPI arthritis is unlisted and unexpected, chills, myalgia and arthralgia are listed however unexpected while pyrexia and diarrhoea are listed and expected. Incomplete course of vaccination is considered listed according to company convention. The outcome was unknown. The patient's medical history and concomitant medication were not provided while current condition included measles. Arthritis, chills, myalgia, arthralgia, pyrexia and diarrhoea are all assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.
Measles
Test Name: Body temperature; Result Unstructured Data: Test Result:101 ;/; Comments: /