| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2829365 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took the first and the second dose of Vivotif correctly and then took a five to six days...
The patient took the first and the second dose of Vivotif correctly and then took a five to six days vacation and has not finished the other two doses; Case reference number US-BN-2024-002194 is a spontaneous case initially received from other health care professional via Med Communications (reference number USBAV24-1665) on 15-Jul-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, reported as correctly, the patient took the first and the second dose of Vivotif (batch number: unknown), the dose was unknown, orally for unknown indication. As reported, then patient took a five to six days of vacation and has not finished the other two doses (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age took the first and the second dose of Vivotif for unknown indication. As reported, then patient took a five to six days of vacation and has not finished the other two doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age took the first and the second dose of Vivotif for unknown indication. As reported, then patient took a five to six days of vacation and has not finished the other two doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829366 | SD | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Headache, Malaise, Pain, Pyrexia, Vomiting
Headache, Malaise, Pain, Pyrexia, Vomiting
|
Body pain; Vomited once; The patient had three doses of Vivotif that felt sick from them; Fever; Hea...
Body pain; Vomited once; The patient had three doses of Vivotif that felt sick from them; Fever; Headache; Case reference number US-BN-2024-002208 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1685) on 17-Jul-2024 and concerns a patient of an unspecified demographics. The patient's medical history and concomitant medication details are not provided. On 11-Jul-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for an unknown indication. On 13-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally. On 15-Jul-2024, two days after the second dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. On an unspecified date, as reported the patient had three doses and felt sick from them. The patient felt body pain, fever, and headache, and vomited once. As reported, the patient vomited the day after taking Vivotif so no capsule was vomited intact. At the time of the initial report, the outcome for the events of feeling sick, body pain, fever, headaches, and vomiting was unknown. The reporter assessed the events of feeling sick, body pain, fever, headaches, and vomiting as not serious, and possibly related to the Vivotif. No further information was provided.; Reporter's Comments: A patient of an unspecified demographics felt body pain, fever, and headache, and vomited once, within approximately two days after three doses of Vivotif were administered, at an unknown dose, orally, for an unknown indication. Pain is unlisted and unexpected while vomiting, malaise, pyrexia and headache are all listed and expected according to CCDS v8 and USPI. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details are not provided. Causal relationship is assessed as related due to plausible temporal relationship, known product safety profile (for vomiting, malaise, pyrexia and headache), lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of an unspecified demographics felt body pain, fever, and headache, and vomited once, within approximately two days after three doses of Vivotif were administered, at an unknown dose, orally, for an unknown indication. Pain is unlisted and unexpected while vomiting, malaise, pyrexia and headache are all listed and expected according to CCDS v8 and USPI. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details are not provided. Causal relationship is assessed as related due to plausible temporal relationship, known product safety profile (for vomiting, malaise, pyrexia and headache), lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.
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| 2829367 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took the second and fourth dose of Vivotif vaccine a day later then it was supposed to; ...
The patient took the second and fourth dose of Vivotif vaccine a day later then it was supposed to; Case reference number US-BN-2024-002210 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1708) on 18-Jul-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of Vivotif vaccine (batch number: unknown), at a dose of a pill, orally for typhoid immunization. On unspecified date, reported as a day later than it was supposed to, the patient took the second dose of Vivotif vaccine (batch number: unknown), at a dose reported as pill, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On unspecified date, unknown amount of time after the second dose of Vivotif, the patient took the third dose of Vivotif vaccine (batch number: unknown), at a dose reported as pill, orally. On unspecified date, reported as a day later than it was supposed to, the patient took the fourth dose of Vivotif vaccine (batch number: unknown), at a dose reported as pill, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from consumer via Med Communications (USBAV24-1711) on 19-Jul-2024: New information included confirmation that reporter did not provide consent to disclose personal details and not be contacted for further follow-up, new reference number, and dosage information.; Reporter's Comments: A female patient of unknown age took the second dose of Vivotif vaccine, at a dose reported as pill, orally which is considered as inappropriate schedule of vaccine administered. A day later than it was supposed to, the patient took the fourth dose of Vivotif vaccine, at a dose reported as pill, orally which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality 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 took the second dose of Vivotif vaccine, at a dose reported as pill, orally which is considered as inappropriate schedule of vaccine administered. A day later than it was supposed to, the patient took the fourth dose of Vivotif vaccine, at a dose reported as pill, orally which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829368 | WI | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3003044 |
Incomplete course of vaccination, Product storage error
Incomplete course of vaccination, Product storage error
|
The patient started the vaccination series but did not complete it; The patient started vaccination ...
The patient started the vaccination series but did not complete it; The patient started vaccination series with Vivotif vaccine left by mistake in car for estimated three days; The patient started vaccination series with Vivotif vaccine left by mistake in car for estimated three days; Case reference number US-BN-2024-002257 is a spontaneous case initially received from other health professional via Med Communications (reference number: USBAV24-1768) on 24-Jul-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient left Vivotif vaccine in the car by mistake, estimated for three days (explicitly coded as 'product storage error'). On unspecified dates, the patient started the vaccination series and took unknown number of doses of Vivotif (batch number: 3003044), at an unknown dose, orally, for an unknown indication. As reported, the patient did not complete the vaccination series (explicitly coded as 'product administration error' and 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown demographics left Vivotif vaccine in the car by mistake, estimated for three days, which is considered as product storage error. Reportedly, the patient started the vaccination series and took unknown number of doses of Vivotif for an unknown indication. As reported, the patient did not complete the vaccination series, which is considered as product administration error and incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination, product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Incomplete course of vaccination, product administration error and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics left Vivotif vaccine in the car by mistake, estimated for three days, which is considered as product storage error. Reportedly, the patient started the vaccination series and took unknown number of doses of Vivotif for an unknown indication. As reported, the patient did not complete the vaccination series, which is considered as product administration error and incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination, product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Incomplete course of vaccination, product administration error and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829369 | F | TX | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004009 |
Product storage error
Product storage error
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The patient took two doses of Vivotif vaccine which were left out of the refrigerator for 48 hours; ...
The patient took two doses of Vivotif vaccine which were left out of the refrigerator for 48 hours; The patient took two doses of Vivotif vaccine which were left out of the refrigerator for 48 hours; Case reference number US-BN-2024-002268 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-1792) on 26-Jul-2024 and concerns a female patient of unknown age. The patient had no relevant medical history, reported as no health issues, and the patient was not pregnant. The patient's concomitant medication details were not provided. On unspecified date, the doses of Vivotif were left out of the refrigerator for 48 hours (explicitly coded as 'product storage error'). On 24-Jul-2024, the patient took the affected first dose of Vivotif (batch number: 33004009), at an unknown dose, orally, for indication reported as pre travel. On 26-Jul-2024, two days after first dose of Vivotif, the patient took the affected second dose of Vivotif (batch number: unknown), at an unknown dose, orally (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient received her second Vivotif dose, after the capsule had been stored for 48 hours outside of the refrigerator, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage and administration error are considered listed per company convention. The patient had no relevant medical history. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A female patient received her second Vivotif dose, after the capsule had been stored for 48 hours outside of the refrigerator, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage and administration error are considered listed per company convention. The patient had no relevant medical history. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.
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| 2829370 | M | UT | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004009 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took the third dose of Vivotif three days after the second dose; Case reference number U...
The patient took the third dose of Vivotif three days after the second dose; Case reference number US-BN-2024-002253 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-1791) on 26-Jul-2024 and concerns an 18-year-old male patient. The patient's medical history and concomitant medication were not provided. On 21-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004009), at an unknown dose or route, for immunization against disease caused by salmonella typhi. On 23-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004009), at an unknown dose or route. On 26-Jul-2024, three days after the second dose, the patient took the third dose of Vivotif (batch number: 3004009), at an unknown dose or route (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: An 18-year-old male patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 3 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An 18-year-old male patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 3 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829371 | UT | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration, Incorrect dose administered
Inappropriate schedule of product administration, Incorrect dose administered
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The patient took two capsules of Vivotif at the same time on the first day; The patient took two cap...
The patient took two capsules of Vivotif at the same time on the first day; The patient took two capsules of Vivotif at the same time on the first day; Case reference number US-BN-2024-002262 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-1800) on 29-Jul-2024 and concerns a patient of unknown age or gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the two capsules of Vivotif on the first day at the same time (batch number: unknown), via unknown route and for unknown indication (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown demographics took two capsules of Vivotif on the same day, which is considered overdose and inappropriate schedule of product administration. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patient's medical history and concomitant medication details were not provided. The events are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics took two capsules of Vivotif on the same day, which is considered overdose and inappropriate schedule of product administration. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patient's medical history and concomitant medication details were not provided. The events are not related to Vivotif, but to human error. The case is non-serious.
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| 2829372 | M | UT | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004008 |
Incomplete course of vaccination
Incomplete course of vaccination
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The patient lost the fourth dose of Vivotif vaccine and was able to take only first three doses; Cas...
The patient lost the fourth dose of Vivotif vaccine and was able to take only first three doses; Case reference number US-BN-2024-002271 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-1817) on 30-Jul-2024 and concerns a 19-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 15-Jul-2024, the patient took the first dose of Vivotif vaccine (batch number: 3004008, *expiry date: 31-Oct-2024*), at a dose of a pill, orally, for indication reported as prior to travel. On 17-Jul-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: 3004008, *expiry date: 31-Oct-2024*), at a dose of a pill, orally. On 19-Jul-2024, four days after the first dose of Vivotif, the patient took the third dose of Vivotif vaccine (batch number: 3004008, *expiry date: 31-Oct-2024*), at a dose of a pill, orally. On unspecified date, an unknown amount of time after the first dose of Vivotif, as reported the *patient lost the fourth dose of Vivotif* and was only able to take three pills (explicitly coded as 'incomplete course of vaccination'). At the time of *follow up report*, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. 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 23-Aug-2024: New information included patient initials, Vivotif dosage information and event verbatim was updated.; Reporter's Comments: A 19-year-old male patient lost the fourth dose of Vivotif and was only able to take three pills which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient lost the fourth dose of Vivotif and was only able to take three pills which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829373 | F | NC | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received first two doses of Vivotif on consecutive days; Case reference number US-BN-2024-00...
Patient received first two doses of Vivotif on consecutive days; Case reference number US-BN-2024-002269 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1813) on 30-Jul-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 28-Jul-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally for unknown indication. On 29-Jul-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), as reported, two doses out of four capsules, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age took the second dose of Vivotif for unknown indication, as reported one day after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the second dose of Vivotif for unknown indication, as reported one day after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829374 | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
COVID-19
COVID-19
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COVID-19; Case reference number US-BN-2024-002264 is a spontaneous case initially received from nurs...
COVID-19; Case reference number US-BN-2024-002264 is a spontaneous case initially received from nurse care professional via Med Communications (reference number USBAV24-1809) on 30-Jul-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication details were not provided. On unspecified date, as reported recently the patient completed Vivotif vaccination (batch number: unknown), the dose was unknown, orally, for typhoid fever prophylaxis. On unspecified date, as reported of the middle of Vivotif series the patient experienced COVID-19. It was reported that, provider would now like to prescribe an antibiotic to the patient, but they were unsure if it will interact with Vivotif. At the time of initial report, the patient did not recover from event of COVID-19. The reporter assessed the event of COVID-19 as non-serious. The reporter did not provide causality assessment for event of COVID-19. No further information.; Reporter's Comments: A patient of unknown demographics contracted COVID-19, an unknown amount of time after completing Vivotif vaccination. COVID-19 is unlisted and unlabeled per the CCDS v8.0 and USPI for Vivotif. Medical history and concomitant medications were unknown. Considering the highly contagious nature of the SARS-CoV-2 strain, its known human-to-human airborne mechanism of spreading, as well as the lack of biological plausibility, this event is assessed as not related to Vivotif. The case is non-serious.; Sender's Comments: A patient of unknown demographics contracted COVID-19, an unknown amount of time after completing Vivotif vaccination. COVID-19 is unlisted and unlabeled per the CCDS v8.0 and USPI for Vivotif. Medical history and concomitant medications were unknown. Considering the highly contagious nature of the SARS-CoV-2 strain, its known human-to-human airborne mechanism of spreading, as well as the lack of biological plausibility, this event is assessed as not related to Vivotif. The case is non-serious. USBAV24-1809:
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| 2829375 | M | FL | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took second dose of Vivotif vaccine on day 2, third dose on day 3 and fourth dose on day...
The patient took second dose of Vivotif vaccine on day 2, third dose on day 3 and fourth dose on day 4; Case reference number US-BN-2024-002270 is a spontaneous case report initially received from a physician via Med Communications (reference number USBAV24-1814) on 30-Jul-2024 and concerns a 21-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 24-Jul-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown), at a dose of one tablet, via unknown route for indication reported as travelling to Africa. On 25-Jul-2024, one day after first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown), at a dose of one tablet, via unknown route (explicitly coded as ' Inappropriate schedule of vaccine administered'). On 26-Jul-2024, two days after first dose of Vivotif, the patient took the third dose of Vivotif vaccine (batch number: unknown), at a dose of one tablet, via unknown route (explicitly coded as ' Inappropriate schedule of vaccine administered'). On 27-Jul-2024, three days after first dose of Vivotif, the patient took the fourth dose of Vivotif vaccine (batch number: unknown), at a dose of one tablet, via unknown route (explicitly coded as ' Inappropriate schedule of vaccine administered'). As reported, the patient for mistake took one tablet of Vivotif everyday instead of every other day. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 21-year-old female patient took the second dose of Vivotif vaccine one day after first dose of Vivotift, at a dose of one tablet, via unknown route which is considered as inappropriate schedule of vaccine administered. Two days after first dose of Vivotif, the patient took the third dose of Vivotif vaccine, at a dose of one tablet, via unknown route which is also considered as inappropriate schedule of vaccine administered. Three days after first dose of Vivotif, the patient took the fourth dose of Vivotif vaccine, at a dose of one tablet, via unknown route which is also considered as inappropriate schedule of vaccine administered. Reportedly, the patient for mistake took one tablet of Vivotif everyday instead of every other day. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 21-year-old female patient took the second dose of Vivotif vaccine one day after first dose of Vivotift, at a dose of one tablet, via unknown route which is considered as inappropriate schedule of vaccine administered. Two days after first dose of Vivotif, the patient took the third dose of Vivotif vaccine, at a dose of one tablet, via unknown route which is also considered as inappropriate schedule of vaccine administered. Three days after first dose of Vivotif, the patient took the fourth dose of Vivotif vaccine, at a dose of one tablet, via unknown route which is also considered as inappropriate schedule of vaccine administered. Reportedly, the patient for mistake took one tablet of Vivotif everyday instead of every other day. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1814:
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| 2829376 | F | PA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient received third dose of Vivotif on day four; Case reference number US-BN-2024-002284 is a...
The patient received third dose of Vivotif on day four; Case reference number US-BN-2024-002284 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-1848) on 01-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, via oral use for unknown indication. On an unspecified date, three days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, via oral use. On an unspecified date, four days after the first dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, via oral use (explicitly coded as 'inappropriate schedule of drug administered'). At the time of the initial report, it was unknown it the patient experienced any adverse event due to Vivotif. Additional information received from nurse via Med Communication (reference number: USBAV24-1864) on 02-Aug-2024: information included additional reference number (USBAV24-1864) and reporter details. Non-significant case correction received from other health care professional via Med Communication on 05-Aug-2024 included an additional reference number.(za med comm); Reporter's Comments: A female patient of unknown age took the third dose of Vivotif, four days after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of drug administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown it the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality 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 took the third dose of Vivotif, four days after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of drug administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown it the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829377 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004045 |
Product storage error
Product storage error
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The Vivotif vaccine was stored in the fridge, but the patient noticed uneven refrigeration, took two...
The Vivotif vaccine was stored in the fridge, but the patient noticed uneven refrigeration, took two doses; The Vivotif vaccine was stored in the fridge, but the patient noticed uneven refrigeration, took two doses; Case reference number US-BN-2024-002292 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1859) on 02-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. As reported the Vivotif vaccine was stored in the fridge, but the patient noticed uneven refrigeration, as the milk was starting to freeze, patient also stated that the duration of this first temperature excursion was unknown (explicitly coded as 'product storage error'). On 31-Jul-2024, the patient took the affected first dose of Vivotif (batch number: 3004045), at a dose of one capsule, orally, for indication reported as typhoid vaccine, travelling in about a month (explicitly coded as 'product administration error'). On 02-Aug-2024, two days after the first dose, the patient took the affected second dose of Vivotif (batch number: 3004045), at a dose of one capsule, orally (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age noticed uneven refrigeration when Vivotif vaccine was stored in the fridge as the milk was starting to freeze, patient also stated that the duration of this first temperature excursion was unknown which is considered as product storage error. The patient took the affected first dose of Vivotif, at a dose of one capsule, orally, for indication reported as typhoid vaccine, travelling in about a month which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of one capsule, orally which is also considered as product administration error. Product administration error and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are both 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 noticed uneven refrigeration when Vivotif vaccine was stored in the fridge as the milk was starting to freeze, patient also stated that the duration of this first temperature excursion was unknown which is considered as product storage error. The patient took the affected first dose of Vivotif, at a dose of one capsule, orally, for indication reported as typhoid vaccine, travelling in about a month which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of one capsule, orally which is also considered as product administration error. Product administration error and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829378 | F | WA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received first dose of Vivotif on 02-Aug-2024 and second dose on 03-Aug-2024, consecutively ...
Patient received first dose of Vivotif on 02-Aug-2024 and second dose on 03-Aug-2024, consecutively in two days; Case reference number US-BN-2024-002310 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1871) on 05-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 02-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), one capsule, via orally, as reported for travel. On 03-Aug-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), one capsule, via orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age took the second dose of Vivotif (one day after the first dose), one capsule, via orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality 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 took the second dose of Vivotif (one day after the first dose), one capsule, via orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829379 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product dose omission issue
Product dose omission issue
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The patient missed the fourth dose of Vivotif; Case reference number US-BN-2024-002311 is a spontane...
The patient missed the fourth dose of Vivotif; Case reference number US-BN-2024-002311 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-1882) on 05-Aug-2024 and concerns patient of unspecified age or gender. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took three doses of Vivotif (batch number: unknown), at an unknown dose, route or site of administration, for unknown indication. As reported, only a day or longer than a week since (to be confirmed) the patient missed the fourth dose of Vivotif (explicitly coded as 'missed dose'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unspecified age or gender missed the fourth dose of Vivotif which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age or gender missed the fourth dose of Vivotif which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829380 | F | DC | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took four doses of Vivotif every day instead every other day; Case reference number US-B...
The patient took four doses of Vivotif every day instead every other day; Case reference number US-BN-2024-002323 is a spontaneous case initially received from physician via Med Communications (reference number USBAV24-1918) on 08-Aug-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 05-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication. On 06-Aug-2024, one day after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered') On 07-Aug-2024, one day after the second dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered') On 08-Aug-2024, one day after the third dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered') At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient received four doses of Vivotif, given every day one after another, instead of every other day. This is considered inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is considered listed per company convention. Medical history and concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human factors. The case is non-serious.; Sender's Comments: A female patient received four doses of Vivotif, given every day one after another, instead of every other day. This is considered inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is considered listed per company convention. Medical history and concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human factors. The case is non-serious.
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| 2829381 | F | MI | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took first two doses of Vivotif two days in a row; Case reference number US-BN-2024-0023...
The patient took first two doses of Vivotif two days in a row; Case reference number US-BN-2024-002328 is a spontaneous case initially received from nurse via Med Communications (reference number USBAV24-1927) on 09-Aug-2024 and concerns a *61-year-old* female patient. The patient's medical history and concomitant medication details were not provided. *On 18-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004044, expiry date: 30-Nov-2024), four capsules, via oral use, as reported for travel vaccine* On an unspecified date, *reported as one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, via unknown route (explicitly coded as 'Inappropriate schedule of vaccine administered').* At the time of the *follow up report*, the patient *did not experience* any adverse event due to Vivotif vaccine. 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 23-Aug-2024: New information included added patient age, Vivotif dosage information and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 61-year-old female patient received her first Vivotif doses, two days in a row, which is considered inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A 61-year-old female patient received her first Vivotif doses, two days in a row, which is considered inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human error. The case is non-serious.
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| 2829382 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
No adverse event, Product storage error
No adverse event, Product storage error
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The patient left Vivotif vaccine at room temperature for about a week and took second and third dose...
The patient left Vivotif vaccine at room temperature for about a week and took second and third dose; The patient left Vivotif vaccine at room temperature for about a week and took second and third dose; Case reference number US-BN-2024-002327 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1925) on 09-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as four to six days ago, the patient took the first dose of Vivotif vaccine (batch number: unknown), at a dose of capsule, orally for an unknown indication. As reported, the first dose of Vivotif was refrigerated but then the patient left it at room temperature for about a week (explicitly coded as 'Product storage error'). On unspecified date, unknown amount of time after first dose of Vivotif, the patient took the second dose of Vivotif vaccine batch number: unknown), at a dose of capsule, orally (explicitly coded as 'Product administration error'). On unspecified date, unknown amount of time after second dose of Vivotif, the patient took the third dose of Vivotif vaccine batch number: unknown), at a dose of capsule, orally. As reported, the patient realized that Vivotif vaccine should have been refrigerated (explicitly coded as 'Product administration error'). As reported, the patient has not taken fourth dose yet. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient stored Vivotif at room temperature for about a week, and then received her second and third doses. This is considered product storage error and product administration error, which are listed special situations per convention. No associated adverse events were reported. Patient's medical history details were not available. Product storage and administration error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A female patient stored Vivotif at room temperature for about a week, and then received her second and third doses. This is considered product storage error and product administration error, which are listed special situations per convention. No associated adverse events were reported. Patient's medical history details were not available. Product storage and administration error are not related to Vivotif, but to human error. The case is non-serious. USBAV24-1925:
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| 2829383 | M | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient missed last dose of Vivotif that was due on 11-Aug-2024; Case reference number US-BN-2024-00...
Patient missed last dose of Vivotif that was due on 11-Aug-2024; Case reference number US-BN-2024-002334 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1932) on 11-Aug-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first, second and third doses of Vivotif (batch numbers: unknown), one capsule, via oral use for unknown indication. As reported, the patient received three doses of Vivotif and the fourth dose of Vivotif was missed that was due which was left out of the refrigerator for 30 minutes to one hour, reached a maximum temperature of 95 degrees Fahrenheit (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from a consumer via Med Communication (reference number: USBAV24-1943) on 12-Aug-2024: included additional reference number (USBAV24-1943), additional reporter, gender of the patient and confirmation that last dose of Vivotif was not administred.; Reporter's Comments: A male patient did not receive his fourth dose of Vivotif on time, which is considered Inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. Medical history or concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A male patient did not receive his fourth dose of Vivotif on time, which is considered Inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. Medical history or concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human error. The case is non-serious.
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| 2829384 | M | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took second dose of Vivotif on the second day; The patient took antibiotic Doxycycline a...
The patient took second dose of Vivotif on the second day; The patient took antibiotic Doxycycline and Vivotif in the same period; Case reference number US-BN-2024-002333 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-1933) on 09-Aug-2024 and concerns a male patient of unspecified age. The patient's medical history details were not provided. The patient's procedure included surgery. The patient's co-suspect medications included doxycycline (brand name: unknown). On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization. As reported, the patient had been in the middle of taking antibiotic doxycycline (explicitly coded as 'Labelled drug-drug interaction medication error') On an unspecified date, reported as on the second day, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). *Patient was advised from doctor to stop taking Vivotif and to wait two weeks after completion of doxycycline treatment. * On an unspecified date, unknown amount of time after the second dose, patient began the Vivotif regimen again as per doctor's instructions (batch number: unknown), at unknown dose, via unknown route. As reported after waiting one week beyond the period that the doxycycline had left the system. *On an unspecified dates, as reported the patient successfully completed Vivotif treatment (number of doses which patient took to be confirmed). * At the time of the *follow up report, the patient did not experience any adverse event due to Vivotif vaccine, since it was reported patient's health was well. * All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a consumer on 23-Aug-2024: New information included confirmation on the Vivotif usage and dosage information. Follow up information received from a consumer on 19-Sep-2024: New information included confirmation that the patient completed Vivotif treatment and patient did not experience any adverse event due to Vivotif vaccine.; Reporter's Comments: A male patient received the first two doses of Vivotif on two consecutive days, which is considered inappropriate schedule of vaccination. Furthermore, the patient had been receiving co-suspect doxycycline (which is considered labelled drug-drug interaction (DDI) medication error). Inappropriate schedule of vaccine administered and labelled DDI error are listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. Patient had undergone a surgery which required doxycycline use. The events are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A male patient received the first two doses of Vivotif on two consecutive days, which is considered inappropriate schedule of vaccination. Furthermore, the patient had been receiving co-suspect doxycycline (which is considered labelled drug-drug interaction (DDI) medication error). Inappropriate schedule of vaccine administered and labelled DDI error are listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. Patient had undergone a surgery which required doxycycline use. The events are not related to Vivotif, but to human error. The case is non-serious.
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| 2829385 | M | UT | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took three doses of Vivotif regularly and did not take the fourth dose due to temperatur...
The patient took three doses of Vivotif regularly and did not take the fourth dose due to temperature excursion; Case reference number US-BN-2024-002341 is a spontaneous case initially received from nurse via Med Communications (reference number USBAV24-1960) on 13-Aug-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 05-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, or site of administration, orally, for unknown indication. On 07-Aug-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, or site of administration, orally. On 09-Aug-2024, two days after the second dose, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, or site of administration, orally. On an unspecified date, as reported, after the third dose, Vivotif vaccine was out of the fridge for one hour, maximum temperature reached around 80-90 Fahrenheit. As reported, the patient did not receive the fourth dose of Vivotif on 11-Aug-2024 (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient did not receive his fourth dose of Vivotif, as it underwent a temperature excursion. This is considered inappropriate schedule of vaccine administered. No associated adverse events were report. Inappropriate schedule of vaccine administered is listed per company convention. Medical history was not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A male patient did not receive his fourth dose of Vivotif, as it underwent a temperature excursion. This is considered inappropriate schedule of vaccine administered. No associated adverse events were report. Inappropriate schedule of vaccine administered is listed per company convention. Medical history was not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human error. The case is non-serious. USBAV24-1960:
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| 2829386 | F | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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Patient took Vivotif vaccine with alcohol; Case reference number US-BN-2024-002339 is a spontaneous ...
Patient took Vivotif vaccine with alcohol; Case reference number US-BN-2024-002339 is a spontaneous case initially received from nurse via Med Communications (reference number USBAV24-1955) on 13-Aug-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), the dose, and site of administration were unknown, orally, for unknown indication. As reported, the patient took a dose with alcohol (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient consumed alcohol while taking Vivotif, which is considered a product administration error. No associated adverse events were reported. Product administration error is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A female patient consumed alcohol while taking Vivotif, which is considered a product administration error. No associated adverse events were reported. Product administration error is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to Vivotif, but to a human error. The case is non-serious. USBAV24-1955:
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| 2829387 | MI | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took two doses of Vivotif vaccine which were left out of the refrigerator at room temper...
The patient took two doses of Vivotif vaccine which were left out of the refrigerator at room temperature since 08-Aug-2024 to 13-Aug-2024; The patient took two doses of Vivotif vaccine which were left out of the refrigerator at room temperature since 08-Aug-2024 to 13-Aug-2024; Case reference number US-BN-2024-002345 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1965) on 14-Aug-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. As reported, the doses of Vivotif were left out of the refrigerator at room temperature since 08-Aug-2024 when patient picked up vaccines from the pharmacy until 13-Aug-2024 (explicitly coded as 'product storage error'). On unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at a dose of capsule, orally for typhoid immunization. As reported, the pharmacist think that the patient took the first dose of Vivotif while it was still refrigerated. On unspecified date, unknown amount of time after first dose of Vivotif, the patient took the affected second dose of Vivotif (batch number: unknown), at a dose of capsule, orally (explicitly coded as 'product administration error'). On unspecified date, unknown amount of time after second dose of Vivotif, the patient took the affected third dose of Vivotif (batch number: unknown), at a dose of capsule, orally (explicitly coded as 'product administration error'). As reported, the pharmacist think that the patient took the second and third dose of Vivotif when vaccines were not refrigerated. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unknown demographics took the affected second and third dose of Vivotif, which were left out of the refrigerator at room temperature since 08-Aug-2024 when patient picked up vaccines from the pharmacy until 13-Aug-2024, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics took the affected second and third dose of Vivotif, which were left out of the refrigerator at room temperature since 08-Aug-2024 when patient picked up vaccines from the pharmacy until 13-Aug-2024, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1965:
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| 2829388 | M | VA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004045 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took three doses of Vivotif three days in a row and one dose left; Case reference number...
The patient took three doses of Vivotif three days in a row and one dose left; Case reference number US-BN-2024-002351 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1977) on 15-Aug-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 12-Aug-2024, the patient took the first dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally, for unknown indication. On 13-Aug-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 14-Aug-2024, one day after the second dose, the patient took the third dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally. The patient did not take the fourth dose, reported as the one dose left (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age took the second dose of Vivotif for unknown indication one day after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, one day after the second dose, the patient took the third dose of Vivotif and the patient did not take the fourth dose, reported as the one dose left, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age took the second dose of Vivotif for unknown indication one day after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, one day after the second dose, the patient took the third dose of Vivotif and the patient did not take the fourth dose, reported as the one dose left, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1977:
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| 2829389 | F | WA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Diverticulum intestinal, Inappropriate schedule of product administration, Infec...
Diverticulum intestinal, Inappropriate schedule of product administration, Infection
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Diverticulosis; Infection; The patient took the first dose of Vivotif on 02-Aug-2024 and and then th...
Diverticulosis; Infection; The patient took the first dose of Vivotif on 02-Aug-2024 and and then the doctor advised patient to stop Vivotif; Case reference number US-BN-2024-002354 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-2004) on 16-Aug-2024 and concerns a female patient of about 70-years-old. The patient's medical history and concomitant medication details were not provided. On 02-Aug-2024, reported as at night, the patient took the first dose of Vivotif (batch number: unknown), at a dose of pill, orally, for typhoid immunization. On unspecified date, reported as the next day, the patient presented diverticulosis and had an infection, so the doctor advised patient to stop Vivotif while taking Augmentin (amoxicillin) prescribed for the infection (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient finished a ten-day course of antibiotic. At the time of initial report, it was unknown if the patient recovered from events of diverticulosis and infection. The reporter assessed the events of diverticulitis and infection as non-serious and possibly related to the Vivotif. No further information was provided.; Reporter's Comments: A 70 years old female patient experienced diverticulosis and had an infection, one day after she took the first dose of Vivotif, at a dose of pill, for typhoid immunization. Reportedly, the doctor advised patient to stop Vivotif while taking Augmentin (amoxicillin) which was prescribed for the infection and that is considered as inappropriate schedule of vaccine administered. Diverticulum and infection are unlisted and unexpected according to CCDS v8 and USPI while inappropriate schedule of product administration is considered listed per company convention. The outcome of diverticulum and infection was unknown. Causal relationship for diverticulum and infection was assessed as related due to plausible temporal relationship and since contributory role of suspect product cannot be excluded. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 70 years old female patient experienced diverticulosis and had an infection, one day after she took the first dose of Vivotif, at a dose of pill, for typhoid immunization. Reportedly, the doctor advised patient to stop Vivotif while taking Augmentin (amoxicillin) which was prescribed for the infection and that is considered as inappropriate schedule of vaccine administered. Diverticulum and infection are unlisted and unexpected according to CCDS v8 and USPI while inappropriate schedule of product administration is considered listed per company convention. The outcome of diverticulum and infection was unknown. Causal relationship for diverticulum and infection was assessed as related due to plausible temporal relationship and since contributory role of suspect product cannot be excluded. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2004:
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| 2829390 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Full blood count abnormal, Inappropriate schedule of product administration
Full blood count abnormal, Inappropriate schedule of product administration
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The patient received two capsules of Vivotif during the first round, and had CBC abnormal; The patie...
The patient received two capsules of Vivotif during the first round, and had CBC abnormal; The patient received two capsules of Vivotif during the first round, then patient had CBC abnormal, all immunizations were stopped, subsequently, the patient began a second round of Vivotif.; Case reference number US-BN-2024-002381 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2053) on 21-Aug-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first and second doses of the first round of Vivotif (batch number: unknown), at an unknown dose and route of administration for unknown indication. As reported, all immunizations were stopped due to CBC abnormal, subsequently, the patient began a second round of Vivotif (explicitly coded as 'inappropriate schedule of vaccine administered'). On an unspecified date, as reported the patient received the first dose of the second round of Vivotif (batch number: unknown), at an unknown dose and route of administration. At the time of the initial report, it was unknown if the patient recovered from the event CBC abnormal. The reporter assessed the event CBC abnormal as non-serious and causality was assessed as possible for the event CBC abnormal. No further information was provided.; Reporter's Comments: A patient of unknown demographics developed abnormal full blood count, an unspecified amount of time after receiving two doses of Vivotif. As a results, the patient's immunizations were put on hold, until eventually a new vaccination round of Vivotif was started on an unknown date (which is considered inappropriate schedule of vaccine administered). Full blood count abnormal is unlisted and unexpected per CCDS v8.0 and USPI for Vivotif. Inappropriate schedule of vaccination is listed per company convention. Medical history was unknown. It was unknown whether there was an increase or decrease to a single or multiple lines of peripheral blood cells. More information about the patient's underlying conditions would be helpful to put the case into context. The event is assessed as related, because contributory role of Vivotif cannot be ruled out, due to the suggestive temporal sequence. Inappropriate schedule of vaccine administration is not related to Vivotif, but to human factors. The case is non-serious.; Sender's Comments: A patient of unknown demographics developed abnormal full blood count, an unspecified amount of time after receiving two doses of Vivotif. As a results, the patient's immunizations were put on hold, until eventually a new vaccination round of Vivotif was started on an unknown date (which is considered inappropriate schedule of vaccine administered). Full blood count abnormal is unlisted and unexpected per CCDS v8.0 and USPI for Vivotif. Inappropriate schedule of vaccination is listed per company convention. Medical history was unknown. It was unknown whether there was an increase or decrease to a single or multiple lines of peripheral blood cells. More information about the patient's underlying conditions would be helpful to put the case into context. The event is assessed as related, because contributory role of Vivotif cannot be ruled out, due to the suggestive temporal sequence. Inappropriate schedule of vaccine administration is not related to Vivotif, but to human factors. The case is non-serious.
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| 2829391 | F | MT | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004044 |
Abdominal pain, Abdominal pain upper, Malaise, Nausea
Abdominal pain, Abdominal pain upper, Malaise, Nausea
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Patient had severe stomach cramps; Patient felt very sick; Very nauseated; Case reference number US-...
Patient had severe stomach cramps; Patient felt very sick; Very nauseated; Case reference number US-BN-2024-002382 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2087) on 22-Aug-2024 and concerns a 46-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 21-Aug-2024 at 05:30 PM, as reported an hour before the meal, the patient took the first dose of Vivotif (batch number: 3004044), at an unknown dose, via oral use for immunization against disease caused by salmonella typhi. On the same day, as reported two to three hours after the dose, the patient experienced severe stomach cramps, felt very nauseated, felt very sick and did not receive any treatment for the events. At the time of the initial report, it was unknown if the patient recovered from the events 'stomach cramps', 'nausea' and 'feeling sick'. The reporter assessed the events 'stomach cramps', 'nausea' and 'feeling sick' as non-serious and causality was assessed as possible for the events 'stomach cramps', 'nausea' and 'feeling sick'. No further information was provided.; Reporter's Comments: A 46-year-old female patient experienced non-serious events of stomach cramps, felt very nauseated and very sick on the day 0 after the patient took the first dose of Vivotif for immunization against disease caused by salmonella typhi. Malaise is listed for Vivotif per CCDS v8 and unexpected per USPI, nausea is listed per both CCDS v8 and USPI, whilst abdominal pain upper is considered as listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A 46-year-old female patient experienced non-serious events of stomach cramps, felt very nauseated and very sick on the day 0 after the patient took the first dose of Vivotif for immunization against disease caused by salmonella typhi. Malaise is listed for Vivotif per CCDS v8 and unexpected per USPI, nausea is listed per both CCDS v8 and USPI, whilst abdominal pain upper is considered as listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
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| 2829392 | M | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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Patient received four doses of Vivotif in consecutive days, instead of every other day; Case referen...
Patient received four doses of Vivotif in consecutive days, instead of every other day; Case reference number US-BN-2024-002380 is a spontaneous case initially received from physician via Med Communication (reference number: USBAV24-2068) on 22-Aug-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took four doses of Vivotif (batch number: unknown), four capsules, via oral use for unknown indication. As reported, the patient received Vivotif doses in consecutive days, instead of every other day (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A male patient of unknown age took four doses of Vivotif for unknown indication. As reported, the patient received Vivotif doses in consecutive days, instead of every other day, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took four doses of Vivotif for unknown indication. As reported, the patient received Vivotif doses in consecutive days, instead of every other day, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829393 | F | MN | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient received four doses of Vivotif, three of those doses being taken were unrefrigerated; Th...
The patient received four doses of Vivotif, three of those doses being taken were unrefrigerated; The patient received four doses of Vivotif, three of those doses being taken were unrefrigerated; Case reference number US-BN-2024-002391 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2092) on 23-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 16-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), one capsule, via oral use for unknown indication. On 18-Aug-2024, two days after the first dose, the patient was vaccinated with the second dose of Vivotif (batch number: unknown), one capsule, via oral use (explicitly coded as 'product storage error' and 'product administration error'). On 20-Aug-2024, four days after the first dose, the patient was vaccinated with the third dose of Vivotif (batch number: unknown), one capsule, via oral use (explicitly coded as 'product storage error' and 'product administration error'). On 22-Aug-2024, six days after the first dose, the patient was vaccinated with the fourth dose of Vivotif (batch number: unknown), one capsule, via oral use. As reported, three of those doses were taken unrefrigerated (explicitly coded as 'product storage error' and 'product administration error'). As reported, patient had no adverse reactions from administration of Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unknown age took the first, second, third and the fourth dose of Vivotif for unknown indication. As reported, three of those doses were taken unrefrigerated, which is considered as product storage error and product administration error. The patient had no adverse reactions from administration of Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the first, second, third and the fourth dose of Vivotif for unknown indication. As reported, three of those doses were taken unrefrigerated, which is considered as product storage error and product administration error. The patient had no adverse reactions from administration of Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829394 | NJ | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Dizziness
Dizziness
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The patient was feeling a little woozy; The patient took four Vivotif vaccine capsules, after meals,...
The patient was feeling a little woozy; The patient took four Vivotif vaccine capsules, after meals, but Vivotif was not refrigerated.; The patient took four Vivotif vaccine capsules, after meals, but Vivotif was not refrigerated.; Case reference number US-BN-2024-002400 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2111) on 26-Aug-2024, and concerns a 75-year-old patient, unspecified gender. The patient's medical history was not provided, reported that the patient was in good health. The patient's concomitant medication details were not reported. On an unspecified date, reported as one every other day for four days, after meals, the patient took the four Vivotif (batch number: unknown) capsules, at an unknown dose, orally, for typhoid immunization. The patient didn't notice it had to be refrigerated (explicitly coded as 'product storage error' and 'product administration error'). On an unspecified date, the patient experienced a feeling of a little woozy. At the time of the initial report, it was unknown if the patient had recovered from the woozy event. The reporter assessed the event of woozy as not serious and possibly related to Vivotif. Additional information received from healthcare professional via Med Communications on 27-Aug-2024 included additional reference number and additional reporter.; Reporter's Comments: A 75-year-old patient of unspecified gender didn't notice that Vivotif had to be refrigerated when taking the four Vivotif capsules, (at an unknown dose, orally, for typhoid immunization) which is considered as product storage error and product administration error. Unknown time after starting suspect product the patient experienced a feeling of a little woozy. Product storage error and product administration error are both considered listed per company conventions. Dizziness is listed according to CCDS v8 however unexpected according to USPI. At this point, it was unknown if the patient had recovered from dizziness. The patient's medical history was not provided, reported that the patient was in good health and concomitant medication details were not reported. Dizziness is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 75-year-old patient of unspecified gender didn't notice that Vivotif had to be refrigerated when taking the four Vivotif capsules, (at an unknown dose, orally, for typhoid immunization) which is considered as product storage error and product administration error. Unknown time after starting suspect product the patient experienced a feeling of a little woozy. Product storage error and product administration error are both considered listed per company conventions. Dizziness is listed according to CCDS v8 however unexpected according to USPI. At this point, it was unknown if the patient had recovered from dizziness. The patient's medical history was not provided, reported that the patient was in good health and concomitant medication details were not reported. Dizziness is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2111:
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| 2829395 | F | WI | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
No adverse event, Product storage error
No adverse event, Product storage error
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Patient received one dose of Vivotif capsule which was out of the refrigerator for 22 hours and the ...
Patient received one dose of Vivotif capsule which was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degrees Fahrenheit; Patient received one dose of Vivotif capsule which was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degrees Fahrenheit; Case reference number US-BN-2024-002406 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2114) on 26-Aug-2024 and concerns a 48-year-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication. As reported, the administered Vivotif dose was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degree Fahrenheit (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A 48-year-old female patient took a dose of Vivotif, which had been out of the refrigerator for 22 hours, reaching a maximum surrounding temperature of 80 deg F (equivalent to 26 deg C). This is considered product storage error and product administration error - listed as per company convention. No associated adverse events were reported. Medical history information was unavailable. The product storage and administration error are not related to Vivotif, but to human factors. The case is non-serious.; Sender's Comments: A 48-year-old female patient took a dose of Vivotif, which had been out of the refrigerator for 22 hours, reaching a maximum surrounding temperature of 80 deg F (equivalent to 26 deg C). This is considered product storage error and product administration error - listed as per company convention. No associated adverse events were reported. Medical history information was unavailable. The product storage and administration error are not related to Vivotif, but to human factors. The case is non-serious.
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| 2829396 | F | TX | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004045 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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The patient received second dose of Vivotif on 25-Aug-2024 and third dose on 26-Aug-2024; Case refer...
The patient received second dose of Vivotif on 25-Aug-2024 and third dose on 26-Aug-2024; Case reference number US-BN-2024-002401 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2117) on 26-Aug-2024 and concerns a 48-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 23-Aug-2024, the patient took the first dose of Vivotif (batch number: 3004045), at an unknown dose, orally, for indication reported as protection against typhoid fever. On 25-Aug-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004045), at an unknown dose, orally. On 26-Aug-2024, three days after the first dose, the patient took the third dose of Vivotif (batch number: 3004045), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient took the Vivotif vaccine two days in a row thinking that the previous dose was administered on Saturday instead of Sunday. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 48-year-old female patient took the third dose of Vivotif for indication reported as protection against typhoid fever, on the day 1 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 48-year-old female patient took the third dose of Vivotif for indication reported as protection against typhoid fever, on the day 1 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829397 | F | NJ | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took Vivotif, but did not refrigerate it; The patient took Vivotif, but did not refriger...
The patient took Vivotif, but did not refrigerate it; The patient took Vivotif, but did not refrigerate it; Case reference number US-BN-2024-002405 is a spontaneous case initially received from a healthcare professional via Med Communications (reference number: USBAV24-2137) on 27-Aug-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, reported as believed that the entire course was done, the patient took doses of Vivotif (batch number: unknown), at an unknown dose or route of administration, for an unknown indication. As reported, the patient took Vivotif but did not refrigerate it while taking it (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age did not refrigerate Vivotif while taking it which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age did not refrigerate Vivotif while taking it which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2137:
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| 2829398 | F | IN | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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The patient took all four doses of Vivotif vaccine with food and not on empty stomach; Case referenc...
The patient took all four doses of Vivotif vaccine with food and not on empty stomach; Case reference number US-BN-2024-002413 is a spontaneous case initially received from other health professional via Med Communication (reference number USBAV24-2168) on 29-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. On unspecified dates, the patient took the first, second, third and fourth dose of Vivotif vaccine (batch number: unknown), at a dose of a capsule, orally, for typhoid immunization. As reported, the patient took all four Vivotif tablets with food and not on empty stomach (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from Med Communications on 29-Aug-2024, included additional reference number, dosage, and patient's and reporter's details. Additional information received from Med Communications on 29-Aug-2024, included additional reference number. Additional information received from Med Communications on 03-Sep-2024, included additional reference number, reporter's detail and confirmation that patient took all four doses of Vivotif with food and not on empty stomach.; Reporter's Comments: A female patient of unknown age took all four Vivotif tablets with food and not on empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication were not provided. Causality 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 took all four Vivotif tablets with food and not on empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2168:
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| 2829399 | M | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Incomplete course of vaccination
Incomplete course of vaccination
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The patient reports that it has been 1.5 weeks since taking the first dose of Vivotif and no further...
The patient reports that it has been 1.5 weeks since taking the first dose of Vivotif and no further doses taken; Case reference number US-BN-2024-002457 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2323) on 10-Sep-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as a week and a half ago, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for protection against typhoid fever. As reported, the patient took the first dose of Vivotif, but a road trip came up and since the vaccine needed to be refrigerated, the patient did not bring it on the trip and was wondering if to continue with the remaining doses on alternate days or to do the series over (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif for protection against typhoid fever, but a road trip came up and since the vaccine needed to be refrigerated, the patient did not bring it on the trip and was wondering if to continue with the remaining doses on alternate days or to do the series over, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif for protection against typhoid fever, but a road trip came up and since the vaccine needed to be refrigerated, the patient did not bring it on the trip and was wondering if to continue with the remaining doses on alternate days or to do the series over, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829400 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Incomplete course of vaccination
Incomplete course of vaccination
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Patient received first dose of Vivotif and did not take the remaining three doses for couple of week...
Patient received first dose of Vivotif and did not take the remaining three doses for couple of weeks; Case reference number US-BN-2024-002456 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2319) on 10-Sep-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at a dose of capsule, orally, for typhoid Immunization. As reported, the patient did not resume taking the rest three doses and the reporter believed that it had been a couple of weeks since the patient took the first dose of Vivotif (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown age and gender did not resume taking the rest three doses, and the reporter believed that it had been a couple of weeks since the patient took the first dose of Vivotif for typhoid Immunization, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender did not resume taking the rest three doses, and the reporter believed that it had been a couple of weeks since the patient took the first dose of Vivotif for typhoid Immunization, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829401 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took a dose of Vivotif vaccine which was left out of fridge on temperature more or less ...
The patient took a dose of Vivotif vaccine which was left out of fridge on temperature more or less 70 degrees Fahrenheit for 20 to 23 hours; The patient took a dose of Vivotif vaccine which was left out of fridge on temperature more or less 70 degrees Fahrenheit for 20 to 23 hours; Case reference number US-BN-2024-002482 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-2345) on 12-Sep-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the doses of Vivotif were left out of the refrigerator for a temperature of more or less 70 degrees Fahrenheit for 20 to 23 hours (explicitly coded as 'product storage error'). On 11-Sep-2024, the patient took the affected first dose of Vivotif (batch number: unknown), at an unknown dose and route, for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unknown demographics took the affected first dose of Vivotif for unknown indication, which was left out of the refrigerator for a temperature of more or less 70 degrees Fahrenheit for 20 to 23 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serous; Sender's Comments: A patient of unknown demographics took the affected first dose of Vivotif for unknown indication, which was left out of the refrigerator for a temperature of more or less 70 degrees Fahrenheit for 20 to 23 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serous
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| 2829402 | F | OR | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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The patient took one or two doses of Vivotif vaccine together with Vitamin gummies at the same time;...
The patient took one or two doses of Vivotif vaccine together with Vitamin gummies at the same time; Case reference number US-BN-2024-002481 is a spontaneous case initially received from a consumer via Med Communications (reference number USBAV24-2347) on 12-Sep-2024 and concerns a female patient of unspecified age. The patient's medical history details was not provided. The patient's concomitant medications included vitamin gummies (brand name unknown). On unspecified dates, the patient took the first, second, third, and fourth dose of Vivotif (batch number: unknown), at a dose of a capsule, orally, for typhoid Immunization. As reported, the patient took one or two Vivotif capsules with vitamin gummies at the same time, because normally the patient took all medications at the same time (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age took one or two Vivotif capsules for typhoid Immunization with vitamin gummies at the same time, because normally the patient took all medications at the same time, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history was not provided, and concomitant medications included vitamin gummies. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age took one or two Vivotif capsules for typhoid Immunization with vitamin gummies at the same time, because normally the patient took all medications at the same time, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history was not provided, and concomitant medications included vitamin gummies. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829403 | M | AZ | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004044 |
Product storage error
Product storage error
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The patient took one dose of Vivotif, it was left out of the fridge for one week, reached a maximum ...
The patient took one dose of Vivotif, it was left out of the fridge for one week, reached a maximum temperature of 78F; The patient took one dose of Vivotif, it was left out of the fridge for one week, reached a maximum temperature of 78F; Case reference number US-BN-2024-002499 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2391) on 16-Sep-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the Vivotif vaccine was left out of the fridge for one week, reached a maximum temperature of 78-degree Fahrenheit (explicitly coded as 'product storage error'). On 16-Sep-2024, the patient took the first dose of Vivotif (batch number: 3004044), at an unknown dose, orally use for typhoid immunization (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif which was left out of the fridge for one week and reached a maximum temperature of 78-degree Fahrenheit (considered as product storage error) at an unknown dose, orally use for typhoid immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif which was left out of the fridge for one week and reached a maximum temperature of 78-degree Fahrenheit (considered as product storage error) at an unknown dose, orally use for typhoid immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829404 | F | OR | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004061 |
Product storage error
Product storage error
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The patient took the first dose of Vivotif which was left unrefrigerated for over a week; The patien...
The patient took the first dose of Vivotif which was left unrefrigerated for over a week; The patient took the first dose of Vivotif which was left unrefrigerated for over a week; Case reference number US-BN-2024-002509 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2407) on 17-Sep-2024 and concerns an adult female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the doses of Vivotif were left unrefrigerated for over a week (explicitly coded as 'product storage error'). On 15-Sep-2024, the patient took the affected first dose of Vivotif (batch number: 3004061), at an unknown dose, orally, for an unknown indication (explicitly coded as 'product administration error'). As reported, the patient ordered Vivotif again for the patient's husband and heard that Vivotif vaccine was supposed to be refrigerated. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: An adult female patient took the affected first dose of Vivotif which were left unrefrigerated for over a week (considered as product storage error), at an unknown dose, orally, for an unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed ad not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient took the affected first dose of Vivotif which were left unrefrigerated for over a week (considered as product storage error), at an unknown dose, orally, for an unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed ad not related to suspect product but to human factor. The case is non-serious.
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| 2829405 | M | ID | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took four doses of Vivotif which were left unrefrigerated at the normal room temperature...
The patient took four doses of Vivotif which were left unrefrigerated at the normal room temperature of 80 Fahrenheit; The patient took four doses of Vivotif which were left unrefrigerated at the normal room temperature of 80 Fahrenheit; Case reference number US-BN-2024-002506 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2402) on 17-Sep-2024 and concerns a 19-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as at the end of August, the doses of Vivotif were left unrefrigerated at a normal room temperature of 80 Fahrenheit (explicitly coded as 'product storage error'). As reported, the Vivotif vaccine was left out of the refrigerator the whole time after picking up the vaccine. On 23-Aug-2024, the patient took the affected first dose of Vivotif (batch number: unknown), at a dose of a capsule, orally, for an indication reported as pre travel for mission trip (explicitly coded as 'product administration error'). On 25-Aug-2024, two days after the first dose, the patient took the affected second dose of Vivotif (batch number: unknown), at a dose of a capsule, orally (explicitly coded as 'product administration error'). On 27-Aug-2024, four days after the first dose, the patient took the affected third dose of Vivotif (batch number: unknown), at a dose of a capsule, orally (explicitly coded as 'product administration error'). On 29-Aug-2024, six days after the first dose, the patient took the affected fourth dose of Vivotif (batch number: unknown), at a dose of a capsule, orally (explicitly coded as 'product administration error') At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 19-year-old male patient took the affected first dose of Vivotif which were left unrefrigerated at a normal room temperature of 80 Fahrenheit (considered as product storage error), at a dose of a capsule, orally, for an indication reported as pre travel for mission trip which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Four days after the first dose, the patient took the affected third dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Six days after the first dose, the patient took the affected fourth dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient took the affected first dose of Vivotif which were left unrefrigerated at a normal room temperature of 80 Fahrenheit (considered as product storage error), at a dose of a capsule, orally, for an indication reported as pre travel for mission trip which is considered as product administration error. Two days after the first dose, the patient took the affected second dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Four days after the first dose, the patient took the affected third dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Six days after the first dose, the patient took the affected fourth dose of Vivotif, at a dose of a capsule, orally which is also considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829406 | F | TX | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004062 |
Product storage error
Product storage error
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The patient took Vivotif vaccine which did not refrigerate, maximum reached temperature was 77 Fahre...
The patient took Vivotif vaccine which did not refrigerate, maximum reached temperature was 77 Fahrenheit degrees; The patient took Vivotif vaccine which did not refrigerate,maximum reached temperature was 77 Fahrenheit degrees; Case reference number US-BN-2024-002523 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2438) on 19-Sep-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as since 14-Sep-2024, the patient did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees (explicitly coded as 'Product storage error'). On 14-Sep-2024, the patient took the first dose of Vivotif vaccine (batch number: 3004062), at unknown dose, route or site of administration, for immunization (explicitly coded as 'Product administration error') At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age, did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees which is considered as product storage error. The patient took the first dose of Vivotif vaccine, at unknown dose, route or site of administration, for immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age, did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees which is considered as product storage error. The patient took the first dose of Vivotif vaccine, at unknown dose, route or site of administration, for immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829407 | F | TX | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004062 |
Product storage error
Product storage error
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Patient took Vivotif doses which were left at room temperature for a week and the maximum temperatur...
Patient took Vivotif doses which were left at room temperature for a week and the maximum temperature reached 25๏ฟฝC; Patient took Vivotif doses which were left at room temperature for a week and the maximum temperature reached 25๏ฟฝC; Case reference number US-BN-2024-002524 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2440) on 19-Sep-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as for a week, the patient left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees (explicitly coded as 'product storage error') On unspecified dates, the patient took the unspecified number of doses, as reported did the entire course of Vivotif (batch number: 3004062) at an unknown dose, route for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Additional information received from a pharmacist via Med Communication (reference number: USBAV24-2446) on 19-Sep-2024: Information included additional reference number (USBAV24-2446) and gender.; Reporter's Comments: A female patient of unknown age left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees which is considered as product storage error. The patient took the unspecified number of doses, as reported did the entire course of Vivotif, at an unknown dose, route for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both 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 left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees which is considered as product storage error. The patient took the unspecified number of doses, as reported did the entire course of Vivotif, at an unknown dose, route for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829408 | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product dose omission issue
Product dose omission issue
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Patient missed to take third dose of Vivotif yesterday; Case reference number US-BN-2024-002547 is a...
Patient missed to take third dose of Vivotif yesterday; Case reference number US-BN-2024-002547 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2514) on 25-Sep-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first and second dose of Vivotif (batch numbers: unknown) at an unknown dose, orally for unknown indication. As reported the patient missed to take third dose of Vivotif yesterday (explicitly coded as 'missed dose') At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported the patient missed to take the third dose of Vivotif on time, which is considered as missed dose. It was unknown if the patient experienced any adverse events due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported the patient missed to take the third dose of Vivotif on time, which is considered as missed dose. It was unknown if the patient experienced any adverse events due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829409 | F | DC | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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Patient took the Vivotif vaccine 20 min after eating; Case reference number US-BN-2024-002546 is a s...
Patient took the Vivotif vaccine 20 min after eating; Case reference number US-BN-2024-002546 is a spontaneous case initially received from healthcare professional via Med Communications (reference number: USBAV24-2511) on 25-Sep-2024 and concerns a 42-year-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported the patient ate and after 20 min took a dose of Vivotif (batch number: unknown) at an unknown dose or route of administration, for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A 42-year-old female patient ate and after 20 min took a dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 42-year-old female patient ate and after 20 min took a dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829410 | F | AZ | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004045 |
Feeling abnormal, Overdose
Feeling abnormal, Overdose
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The patient took two doses of Vivotif on the same day (one own dose and one dose of husband) and fel...
The patient took two doses of Vivotif on the same day (one own dose and one dose of husband) and felt weird; The patient took two doses of Vivotif on the same day (one own dose and one dose of husband) and felt weird; The patient took two doses of Vivotif on the same day (one own dose and one dose of husband) and felt weird; Case reference number US-BN-2024-002548 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-2513) on 25-Sep-2024 and concerns a 71-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 22-Sep-2024, the patient took the first dose of Vivotif (batch number: 3004045, expiry date: 30-Nov-2024), at a dose of one capsule, orally as, for indication reported as for pre-travel. On 24-Sep-2024, two days after the first dose, the patient took the second and third dose of Vivotif (batch number: 3004045, expiry date: 30-Nov-2024) at an unknown dose, orally. As reported, the patient took own dose and husband's dose of Vivotif, as the patient was worried to get typhoid (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered'). On the same day, the patient felt weird. At the time of the initial report, the patient did not recover from the event of felt weird, reported as ongoing. The reporter assessed the event of felt weird as non-serious and not related to the product of Vivotif. No further information was provided.; Reporter's Comments: A 71-year-old female patient took own dose and husband's dose of Vivotif for indication reported as for pre-travel, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. Reportedly, on the day 0 after the vaccination, the patient felt weird. Feeling abnormal, underdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of feeling abnormal is assessed as related to Vivotif. Underdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 71-year-old female patient took own dose and husband's dose of Vivotif for indication reported as for pre-travel, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. Reportedly, on the day 0 after the vaccination, the patient felt weird. Feeling abnormal, underdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of feeling abnormal is assessed as related to Vivotif. Underdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829411 | M | MA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004045 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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The patient took the third dose of Vivotif one day earlier and the fourth dose took five days after ...
The patient took the third dose of Vivotif one day earlier and the fourth dose took five days after first dose; Case reference number US-BN-2024-002572 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-2554) on 30-Sep-2024 and concerns a 32-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 26-Sep-2024, the patient took the first dose of Vivotif (batch number: *3004045, expiration date: 30-Oct-2024) one capsule*, orally, for typhoid immunization due to international travel. On 28-Sep-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: *3004045, expiration date: 30-Oct-2024) one capsule*, orally. On 29-Sep-2024, as reported one day earlier, three days after first dose of Vivotif, the patient took the third dose of Vivotif (batch number: *3004045, expiration date: 30-Oct-2024), one capsule*, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient took capsules correctly one hour before food, in the morning. *On 01-Oct-2024, five days after the first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: 3004045, expiration date: 30-Oct-2024) one capsule, orally. (explicitly coded as 'inappropriate schedule of vaccine administered'). * At the time of the *follow-up* report, it was *reported that the patient did not experience* any adverse event due to the Vivotif vaccination. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from the nurse on 09-Oct-2024: New information included patient initials, dosing information for Vivotif and confirmation that the patient did not experience any adverse event due to the Vivotif vaccination.; Reporter's Comments: A 32-year-old male patient took the third dose of Vivotif for typhoid immunization due to international travel, three days after the first dose was administered, which is considered as inappropriate schedule of vaccine administered. Five days after the first dose of Vivotif, the patient took the fourth dose of Vivotif, one capsule, orally which is also considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to the Vivotif vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 32-year-old male patient took the third dose of Vivotif for typhoid immunization due to international travel, three days after the first dose was administered, which is considered as inappropriate schedule of vaccine administered. Five days after the first dose of Vivotif, the patient took the fourth dose of Vivotif, one capsule, orally which is also considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to the Vivotif vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829412 | NC | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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Vivotif was kept at the temperature that got up to 60 degrees (unit not provided), and one capsule w...
Vivotif was kept at the temperature that got up to 60 degrees (unit not provided), and one capsule was administered after excursion; Vivotif was kept at the temperature that got up to 60 degrees (unit not provided), and one capsule was administered after excursion; Case reference number US-BN-2024-002570 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2558) on 30-Sep-2024 and concerns one male and one female patient (MULTI2) of unspecified age. The patients' medical history and concomitant medication details were not provided. On an unspecified date, as reported, Vivotif vaccine was stored in a cooler, but it got up to 60 degrees (unit not provided) (explicitly coded as 'product storage error'). On an unspecified date, after temperature excursion, the patients took the first dose of Vivotif (batch number: unknown), at an unknown dose, route, for a trip (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Additional information received from the consumer via Med Communications on 30-Sep-2024 included an additional reference number (USBAV24-2559), the case is crosslinked by same reporter. Additional information received from Bavarian Nordic on 01-Oct-2024 included additional reference number (BN_2024_02995).; Reporter's Comments: One male and one female patient of unspecified age took the first dose of Vivotif, which was stored in a cooler, but it got up to 60 degrees, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: One male and one female patient of unspecified age took the first dose of Vivotif, which was stored in a cooler, but it got up to 60 degrees, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829413 | F | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004043 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Patient took first dose of Vivotif on 30-Sep-2024, second dose on 02-Oct-2024, third dose on 07-Oct-...
Patient took first dose of Vivotif on 30-Sep-2024, second dose on 02-Oct-2024, third dose on 07-Oct-2024 (seven days after the first dose), and fourth dose on 09-Oct-2024 (nine days after the first dose).; Case reference number US-BN-2024-002622 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-2645) on 07-Oct-2024 and concerns a 45-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 30-Sep-2024, the patient took the first dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally for pre travel. On 02-Oct-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally. On 07-Oct-2024, seven days after the first dose, the patient took the third dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the third dose (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 09-Oct-2024, nine days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the fourth dose (explicitly coded as 'inappropriate schedule of vaccine administered').* *At the time of this follow-up report, the patient did not experience any adverse event due to Vivotif.* 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 14-Nov-2024: New information included Vivotif dosing details added and confirmation of absence of adverse events.; Reporter's Comments: A 45-year-old female patient took the third dose of Vivotif, seven days after the first dose, at a dose of one capsule, orally. Reportedly, the patient initially lost the doses in the refrigerator, and once found took the third dose which is considered as inappropriate schedule of vaccine administered. Also, nine days after the first dose, the patient took the fourth dose of Vivotif, at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the fourth dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company conventions. the patient did not experience any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 45-year-old female patient took the third dose of Vivotif, seven days after the first dose, at a dose of one capsule, orally. Reportedly, the patient initially lost the doses in the refrigerator, and once found took the third dose which is considered as inappropriate schedule of vaccine administered. Also, nine days after the first dose, the patient took the fourth dose of Vivotif, at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the fourth dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company conventions. the patient did not experience any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829414 | F | NC | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Incomplete course of vaccination, Incorrect dose administered
Incomplete course of vaccination, Incorrect dose administered
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Patient took three doses of Vivotif as prescribed, but did not take fourth dose as scheduled; Last d...
Patient took three doses of Vivotif as prescribed, but did not take fourth dose as scheduled; Last dose of Vivotif left out of the refrigerator at room temperature for days or a week; Case reference number US-BN-2024-002628 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2635) on 07-Oct-2024 and concerns a 31-year-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified dates, reported as per prescribed, the patient took the first, second and third dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally for an unknown indication. On unspecified date, the patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week (explicitly coded as 'product storage error'). On 01-Oct-2024, as reported was due date for the last dose, but the patient never took the fourth dose of Vivotif on that day (explicitly coded as 'Inappropriate schedule of product administration'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from pharmacist on 09-Oct-2024 included: information about reporter and conformation that the patient did not take fourth dose of Vivotif on 10-Oct-2024.; Reporter's Comments: A 31-year-old female patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week which is considered as product storage error. Reportedly, the patient never took the fourth dose of Vivotif the scheduled day which is considered as inappropriate schedule of product administration. Inappropriate schedule of product administration and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 31-year-old female patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week which is considered as product storage error. Reportedly, the patient never took the fourth dose of Vivotif the scheduled day which is considered as inappropriate schedule of product administration. Inappropriate schedule of product administration and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.
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