Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3003851 | PO / MO |
The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahrenheit) for three weeks; The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahrenheit) for three weeks; The patient experienced fatigue after the first dose of Vivotif; The patient experienced fatigue after the second dose of Vivotif; Nausea after the first dose of Vivotif; Nausea after the second dose of Vivotif; Case reference number US-BN-2024-000042 is a spontaneous case report initially received from a physician via Med Communications (reference number: USBAV24-0054) on 09-Jan-2024 and concerns a 66-years-old female patient. *The patient's current conditions included depression, hypercholerolemia , and hypertension*. *The patient's concomitant medications included Wellbutrin XL (bupropion hydrochloride), escitalopram (brand name: unknown), ezetimibe (brand name: unknown) and losartan (brand name: unknown)*. As reported, the Vivotif mistakenly was left at room temperature for three weeks (maximum temperature reached 68 Fahrenheit degrees), and the patient took the first and second doses (explicitly coded as 'product storage error'). *As reported Prescriber did not instruct to refrigerate. The pharmacy did not provide verbal instruction to refrigerate, holiday travel plans to grandchildren warranted delaying the start and added to organizational disruption of routines, written instructions were buried in the pamphlet of fine print.* On 06-Jan-2024, the patient took the first dose of Vivotif (batch number: 3003851, *expiry date: Mar-2024*), at an unknown dose, orally, *as reported one capsule*, for typhoid fever (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the first dose of Vivotif the patient experienced mild *nausea* and fatigue. *On an unspecified date, after 48 hours the patient recovered from the events of nausea and fatigue.* On 08-Jan-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003851, *expiry date: Mar-2024*), at an unknown dose, orally, *as reported one capsule* (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the second dose of Vivotif the patient experienced mild *nausea* and fatigue. *On an unspecified date, after 48 hours the patient recovered from the events of nausea and fatigue.* The reporter assessed the events of *nausea* and fatigue as non-serious and possibly related to Vivotif. This case is linked with US-BN-2024-000043, concerning the same reporter. Additional information received from Emergent BioSolutions on 09-Jan-2024 and included additional information about the reporter, information on how long the vaccine was at room temperature, additional events, and additional reference (EMG2024-042). Additional information received from Med Communications on 10-Jan-2024 and included additional reference (USBAV24-0057). All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from the reporter on 13-Feb-2024: New information included patient's details, current conditions, concomitant products, Vivotif dosage information, intensity for the event fatigue, event gastrointestinal symptom was recoded to nausea, outcome, and event duration for the events fatigue, nausea, and confirmation on contributing factors that led to the event. Additional information received from the reporter on 20-Feb-2024: New information included confirmation on the start date of Vivotif for the first two doses.; Reporter's Comments: A 66-year-old female patient took the first and the second dose of Vivotif for Typhoid fever, after Vivotif was mistakenly left at room temperature for three weeks, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. On the day 2 after the first dose of Vivotif, the patient took the second dose of affected Vivotif, which is considered as product administration error. Also, as reported on an unspecified date, an unknown amount of time after the second dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue is listed per CCDS v8 and unexpected per USPI. Product storage error and product administration error are considered as listed per company convention. The patient's current conditions included depression, hypercholerolemia , and hypertension, and concomitant medications included Wellbutrin XL, escitalopram, ezetimibe and losartan. The patient recovered from the events. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of nausea and fatigue 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 66-year-old female patient took the first and the second dose of Vivotif for Typhoid fever, after Vivotif was mistakenly left at room temperature for three weeks, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. On the day 2 after the first dose of Vivotif, the patient took the second dose of affected Vivotif, which is considered as product administration error. Also, as reported on an unspecified date, an unknown amount of time after the second dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue is listed per CCDS v8 and unexpected per USPI. Product storage error and product administration error are considered as listed per company convention. The patient's current conditions included depression, hypercholerolemia , and hypertension, and concomitant medications included Wellbutrin XL, escitalopram, ezetimibe and losartan. The patient recovered from the events. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of nausea and fatigue 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.
Medical History/Concurrent Conditions: Depression; Hyperchloremia; Hypertension
WELLBUTRIN XL; ESCITALOPRAM; EZETIMIBE; LOSARTAN