Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004007 | PO / MO |
The patient felt abdominal pain and diarrhea; The patient felt abdominal pain and diarrhea; The Vivotif vaccine was stored nine days out of refrigerator, maximum temperature reached 70 Fahrenheit and patient took three doses of this vaccine; The Vivotif vaccine was stored nine days out of refrigerator, maximum temperature reached 70 Fahrenheit and patient took three doses of this vaccine; Case reference number US-BN-2024-001885 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0955) on 07-May-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication was not provided. On an unspecified date, the Vivotif vaccine was stored nine days out of the refrigerator, maximum temperature reached 70 Fahrenheit (explicitly coded as 'product storage error'). On 30-Apr-2024, the patient took first dose of Vivotif (batch number: 3004007), at unknown dose, orally, for unknown indication (explicitly coded as 'Product administration error'). On 02-May-2024, two days after first dose of Vivotif, the patient took second dose of Vivotif (batch number: 3004007), at unknown dose, orally (explicitly coded as 'Product administration error'). On 04-May-2024, two days after second dose of Vivotif, the patient took third dose of Vivotif (batch number: 3004007), at unknown dose, orally (explicitly coded as 'Product administration error'). On an unspecified date, the patient felt abdominal pain and diarrhea. As reported, the patient didn't get any treatment for the symptoms and had no laboratory results. At the time of initial report, it was unknown if the patient recovered from events of abdominal pain and diarrhea. The reporter assessed the events of abdominal pain and diarrhea as non-serious and possibly related to the product of Vivotif. No further information was provided.; Reporter's Comments: A patient of unspecified gender or age took the first, second and the third dose of Vivotif for unknown indication, after the Vivotif vaccine was stored nine days out of the refrigerator, maximum temperature reached 70 Fahrenheit, which is considered as product administration error and product storage error. On an unspecified date, the patient felt abdominal pain and diarrhoea. Diarrhoea and abdominal pain are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst product storage error and product administration error. The patient's medical history and concomitant medication was not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. Product storage error and product administration error have 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 patient of unspecified gender or age took the first, second and the third dose of Vivotif for unknown indication, after the Vivotif vaccine was stored nine days out of the refrigerator, maximum temperature reached 70 Fahrenheit, which is considered as product administration error and product storage error. On an unspecified date, the patient felt abdominal pain and diarrhoea. Diarrhoea and abdominal pain are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst product storage error and product administration error. The patient's medical history and concomitant medication was not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None