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; Anorrexia, after the second dose of Vivotif; Fatigue, after the first dose of Vivotif; Fatigue, after the second dose of Vivotif; Nausea, after the first dose of Vivotif; Nausea, after the second dose of Vivotif; Loose stools, after the first dose of Vivotif; Loose stools, after the second dose of Vivotif; Case reference number US-BN-2024-000043 is a spontaneous case report initially received from a physician via Med Communications (reference number: USBAV24-0053) on 09-Jan-2024 and concerns a 64-years-old male patient. The patient's *current condition included hypercholererolemia, hypogonadism, rheumatoid arthritis, and seasonal allergy.* The patient's concomitant medication included *Pravachol (pravastatin sodium) and ezetimibe (brand name: unknown), testosterone cypionate (brand name: unknown), prednisone (brand name: unknown), and Wal zyr (cetirizine hydrochloride).* As reported, the Vivotif mistakenly was left at room temperature for three weeks (maximum temperature of 68 Fahrenheit degrees), and the patient took the first and second doses (explicitly coded as 'product storage error'). *As reported, the 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, *expiration date: Mar-2024*), at a dose of *2.0-10.0x10^9 Colony-forming unit (CFU)*, orally, 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* fatigue. On an unspecified date, also reported 01-May-2024 (to be confirmed)*, an unknown amount of time after the first dose of Vivotif the patient experienced mild *loose stools, nausea.* *On an unspecified date, after 48 hours the patient recovered from the events of fatigue.* *On an unspecified date, also reported 01-Jul-2024 (to be confirmed), after 48 hours the patient recovered from the events of nausea, and loose stools.* On 08-Jan-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003851, *expiration date: Mar-2024*), at a dose of *2.0-10.0x10^9 CFU*, orally, (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* fatigue. On an unspecified date *also reported as 05-Jan-2024 (to be confirmed)*, an unknown amount of time after the second dose of Vivotif the patient experienced mild *loose stools, anorexia* and *mild* fatigue. *On an unspecified date, after 48 hours the patient recovered from the event of fatigue.* *On an unspecified date, also reported 07-Jan-2024 (to be confirmed)*, after 48 hours the patient recovered from the events of nausea, loose stools, and anorexia.* The reporter assessed the events of all instances of nausea, loose stools, fatigue, and anorexia as non-serious and possibly related to Vivotif. This case is linked with US-BN-2024-000042, 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 (USBAV24-0056). 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, concomitant products, Vivotif dosage information, intensity for the event fatigue, event gastrointestinal symptom was recoded to nausea, stoole loose, anorexia, outcome, start dates and stop dates for events, 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 64-year-old male 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 fatigue, loose stools and nausea. 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 fatigue, loose stools, anorexia and nausea. Diarrhoea and nausea are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue and decreased appetite are 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 condition included hypercholererolemia, hypogonadism, rheumatoid arthritis, and seasonal allergy, and concomitant medication included Pravachol and ezetimibe, testosterone cypionate, prednisone, and Wal zyr. The patient recovered. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, all 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 64-year-old male 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 fatigue, loose stools and nausea. 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 fatigue, loose stools, anorexia and nausea. Diarrhoea and nausea are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue and decreased appetite are 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 condition included hypercholererolemia, hypogonadism, rheumatoid arthritis, and seasonal allergy, and concomitant medication included Pravachol and ezetimibe, testosterone cypionate, prednisone, and Wal zyr. The patient recovered. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, all 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.
Hypercholesterolemia; Hypogonadism; Rheumatoid arthritis; Seasonal allergy
PRAVACHOL; EZETIMIBE; TESTOSTERONE CYPIONATE; PREDNISONE; WAL ZYR