| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2829517 | M | UT | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
|
The patient took second and third dose of Vivotif which were not refrigerated; The patient took seco...
The patient took second and third dose of Vivotif which were not refrigerated; The patient took second and third dose of Vivotif which were not refrigerated and did not take first three doses on an empty stomach; Case reference number US-BN-2024-001853 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0894) on 01-May-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 18-Apr-2024, the patient took first dose of Vivotif (batch number: unknown), orally, at unknown dose, for unknown indication. As reported, the patient did not take vaccine on empty stomach (explicitly coded as 'Product administration error'). On an unspecified date, the patient did not refrigerate Vivotif vaccine. On unspecified dates, unknown amount of time after first dose of Vivotif, the patient took second and third dose of Vivotif (batch number: unknown), orally, at unknown dose, as reported the patient did not take vaccine on empty stomach. As reported the product of Vivotif was out of refrigerator over a week (explicitly coded as 'Product administration error' and 'Product storage 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 male patient of unspecified age took all three doses of Vivotif on an empty stomach, which is considered as product administration error. Additionally it was reported that the product of Vivotif was out of refrigerator over a week, which is considered as product storage error. No associated adverse events were reported. Product administration error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product administration error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age took all three doses of Vivotif on an empty stomach, which is considered as product administration error. Additionally it was reported that the product of Vivotif was out of refrigerator over a week, which is considered as product storage error. No associated adverse events were reported. Product administration error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product administration error are not related to Vivotif, but to a human factor. The case is non-serious.
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| 2829518 | M | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Patient took Vivotif accidentally every day instead of every other day; Case reference number US-BN-...
Patient took Vivotif accidentally every day instead of every other day; Case reference number US-BN-2024-001861 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0913) on 02-May-2024 and concerns male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took Vivotif (batch number: unknown), orally, at unknown dose for unknown indication. As reported, the patient took Vivotif vaccine accidentally every day instead of every other day (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. No further information provided.; Reporter's Comments: A male patient of unspecified age took Vivotif, orally every day instead of every other day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is 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 relevant medical history and concomitant medications 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 male patient of unspecified age took Vivotif, orally every day instead of every other day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is 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 relevant medical history and concomitant medications 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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| 2829519 | F | KS | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Headache, Malaise, Oropharyngeal pain, Pain
Headache, Malaise, Oropharyngeal pain, Pain
|
Body ache; Sore throat; After two doses of Vivotif, patient was not feeling well; Headache; Case ref...
Body ache; Sore throat; After two doses of Vivotif, patient was not feeling well; Headache; Case reference number US-BN-2024-001869 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0919) on 03-May-2024 and concerns female patient of unspecified age (teenager). The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient was vaccinated with first and second dose of Vivotif vaccine (batch number: Unknown), at unknown dose, route, or site of administration for unknown indication. On unspecified date, unknown amount of time after administration of Vivotif vaccine patient was not feeling well and patient experienced headache, body ache and sore throat. At the time of initial report, it was unknown if the patient recovered from the events 'feeling unwell', 'headache', 'ache' and 'sore throat'. The reporter assessed the events as non-serious. Causality assessment was reported as not related to Vivotif vaccine. No further information provided.; Reporter's Comments: A female patient of unspecified age (teenager) was not feeling well and experienced non-serious events of headache, body ache and sore throat on unspecified date, unknown amount of time after the patient was vaccinated with first and the second dose of Vivotif vaccine for unknown indication. Malaise and headache are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst pain and oropharyngeal pain are unlisted and unexpected. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age (teenager) was not feeling well and experienced non-serious events of headache, body ache and sore throat on unspecified date, unknown amount of time after the patient was vaccinated with first and the second dose of Vivotif vaccine for unknown indication. Malaise and headache are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst pain and oropharyngeal pain are unlisted and unexpected. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
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| 2829520 | F | CO | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
|
The patient took one dose of Vivotif vaccine which left at room temperature for nine hours time fram...
The patient took one dose of Vivotif vaccine which left at room temperature for nine hours time frame, maximum temperature reached was temperature 62 Fahrenheit; The patient took one dose of Vivotif vaccine which left at room temperature for nine hours time frame, maximum temperature reached was temperature 62 Fahrenheit; Case reference number US-BN-2024-001870 is a spontaneous case report initially received from a physician via Med Communications (reference number USBAV24-0928) on 06-May-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), at unknown dose, orally, for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit. (explicitly coded as 'Product administration error' and 'Product storage 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 of unspecified age took a dose of Vivotif for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit, which is considered as product administration error and product storage 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age took a dose of Vivotif for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit, which is considered as product administration error and product storage 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829521 | F | CT | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration, Product packaging quantity iss...
Inappropriate schedule of product administration, Product packaging quantity issue
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In the box of Vivotif was only two pills instead of four, because of that patient delayed the third ...
In the box of Vivotif was only two pills instead of four, because of that patient delayed the third dose; In the box of Vivotif was only two pills instead of four, because of that patient delayed the third dose; Case reference number US-BN-2024-001884 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0965) on 08-May-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication was not provided. On an unspecified date, as reported, the patient bought vaccine to travel but in the box there was only two pills instead of four (explicitly coded as 'Package dosage units missing') On unspecified dates, the patient took first and second dose off Vivotif (batch number: unknown), orally, at an unknown dose, for unknown indication. On unspecified date, unknown amount of time after first dose of Vivotif, as reported, the patient missed a dose last night and today the patient took third dose of Vivotif (batch number: unknown), orally, at an unknown dose (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 of unspecified age bought vaccine to travel but in the box, there was only two pills instead of four, which is considered as package dosage units missing. Reportedly, the patient missed a dose last night and today the patient took third dose of Vivotif after the patient took the first and the second dose of Vivotif for unknown indication, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product packaging quantity issue and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product packaging quantity issue and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age bought vaccine to travel but in the box, there was only two pills instead of four, which is considered as package dosage units missing. Reportedly, the patient missed a dose last night and today the patient took third dose of Vivotif after the patient took the first and the second dose of Vivotif for unknown indication, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product packaging quantity issue and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product packaging quantity issue and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829522 | F | KY | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
#3004007 |
Incomplete course of vaccination
Incomplete course of vaccination
|
The patient took the first dose of Vivotif vaccine which did not refrigerate; The patient took the f...
The patient took the first dose of Vivotif vaccine which did not refrigerate; The patient took the first dose of Vivotif vaccine which did not refrigerate; The patient took only first dose and did not take the second, third and fourth dose of Vivotif; Case reference number US-BN-2024-001891 is a spontaneous case report initially received from a other health care professional via Med Communication (reference number: USBAV24-0966) on 08-May-2024 and concerns a 29-years-old female patient. The patient's medical history and concomitant medication was not provided. On an unspecified date, the patient left Vivotif vaccine at room temperature for a week (explicitly coded as 'Product storage error'). On 07-May-2024, the patient took the first dose of Vivotif (batch number: #3004007), orally, at an unknown dose, for unknown indication reported as pre travel (explicitly coded as 'Product administration error'). As reported the patient did not take the second, third and fourth doses 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 vaccine. No further information was provided.; Reporter's Comments: A 29-year-old female patient left Vivotif vaccine at room temperature for a week, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for unknown indication reported as pre travel, which is considered as product administration error. As reported the patient did not take the second, third and the fourth dose of Vivotif, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product administration error and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product storage error, product administration error and incomplete course of vaccination have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 29-year-old female patient left Vivotif vaccine at room temperature for a week, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for unknown indication reported as pre travel, which is considered as product administration error. As reported the patient did not take the second, third and the fourth dose of Vivotif, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product administration error and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product storage error, product administration error and incomplete course of vaccination have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829523 | TN | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
|
The patient took seven days course of Vivotif which did not refrigerate; The patient took seven days...
The patient took seven days course of Vivotif which did not refrigerate; The patient took seven days course of Vivotif which did not refrigerate; Case reference number US-BN-2024-001892 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0988) on 09-May-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported the patient did not know Vivotif vaccine was supposed to be kept refrigerated (explicitly coded as 'Product storage error'). On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif (batch number: unknown), at unknown dose, route, or site 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 event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unspecified gender or age did not know Vivotif vaccine was supposed to be kept refrigerated, which is considered as product storage error. On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified gender or age did not know Vivotif vaccine was supposed to be kept refrigerated, which is considered as product storage error. On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829524 | MT | 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 two doses of Vivotif correctly, but third dose patient took 12 hours later; Case re...
The patient took two doses of Vivotif correctly, but third dose patient took 12 hours later; Case reference number US-BN-2024-001896 is a spontaneous case report initially received from nurse via Med Communications (reference number: USBAV24-0993) on 09-May-2024 and concerns patient of unspecified age and gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took two doses of Vivotif (batch number: unknown) at unknown doses, orally, for typhoid immunization, due to trip. On unspecified date, reported as 12 hours later than Vivotif should be taken, patient took third dose of Vivotif, at unknown dose, 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. No further information provided.; Reporter's Comments: A patient of unspecified age and gender took third dose of Vivotif, 12 hours later than Vivotif should have been taken 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 vaccine. The patient's relevant medical history and concomitant medications 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 and gender took third dose of Vivotif, 12 hours later than Vivotif should have been taken 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 vaccine. The patient's relevant medical history and concomitant medications 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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| 2829525 | GA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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Patient started immunization course with unrefrigerated Vivotif vaccine, maximum temperature was bel...
Patient started immunization course with unrefrigerated Vivotif vaccine, maximum temperature was below 77 degrees of Fahrenheit for 24 hours; Patient started immunization course with unrefrigerated Vivotif vaccine, maximum temperature was below 77 degrees of Fahrenheit for 24 hours; Case reference number US-BN-2024-001897 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV24-0985) on 09-May-2024 and concerns a patient of unspecified age or gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient started immunization course with unknown number of doses of Vivotif (batch number: unknown), at an unknown dose or route of administration, for unknown indication. As reported, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours (explicitly coded as 'product storage error temperature too high' and '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 provided.; Reporter's Comments: A patient of unspecified age or gender started immunization course with unknown number of doses of Vivotif, at an unknown dose or route of administration, for unknown indication. Reportedly, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours which is considered as product storage error temperature too high 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 Vivotif vaccine. The patient's relevant medical history and concomitant medications 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 patient of unspecified age or gender started immunization course with unknown number of doses of Vivotif, at an unknown dose or route of administration, for unknown indication. Reportedly, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours which is considered as product storage error temperature too high 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 Vivotif vaccine. The patient's relevant medical history and concomitant medications 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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| 2829526 | F | ID | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004007 |
Product storage error
Product storage error
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The patient took second dose of Vivotif vaccine which was in refrigerator which stopped working no l...
The patient took second dose of Vivotif vaccine which was in refrigerator which stopped working no longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit.; The patient took second dose of Vivotif vaccine which was in refrigerator which stopped working no longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit.; Case reference number US-BN-2024-001903 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0998) on 09-May-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 first dose of Vivotif (batch number: 3004007), at unknown dose, orally, for unknown indication reported as pre travel. On an unspecified date, as reported in some point yesterday, the patient's refrigerator stopped working and the patient notice that in the morning, it was not longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit (explicitly coded as 'product storage error'). On 09-May-2024, an unknown amount of time after first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004007), at 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 event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient's (unspecified age) refrigerator stopped working and the patient noticed that in the morning, it was not longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit, which is considered as product storage error. Reportedly, the patient took the second dose of Vivotif for unknown indication reported as pre travel, which is considered as product administration error. It was unknown if the patient experienced any adverse event 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient's (unspecified age) refrigerator stopped working and the patient noticed that in the morning, it was not longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit, which is considered as product storage error. Reportedly, the patient took the second dose of Vivotif for unknown indication reported as pre travel, which is considered as product administration error. It was unknown if the patient experienced any adverse event 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829527 | M | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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The patient drank alcohol with dinner and after that took the first dose of Vivotif vaccine; Case re...
The patient drank alcohol with dinner and after that took the first dose of Vivotif vaccine; Case reference number US-BN-2024-001905 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1008) on 10-May-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 09-May-2024, as reported, the patient drank alcohol with dinner and after dinner the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for an unknown indication (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 male patient of unspecified age drank alcohol with dinner and after dinner the patient took the first dose of Vivotif, at unknown dose, orally, for an unknown indication 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 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 male patient of unspecified age drank alcohol with dinner and after dinner the patient took the first dose of Vivotif, at unknown dose, orally, for an unknown indication 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 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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| 2829528 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took fourth dose of Vivotif vaccine which had 12 hours temperature excursion was below 3...
The patient took fourth dose of Vivotif vaccine which had 12 hours temperature excursion was below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees; The patient took fourth dose of Vivotif vaccine which had 12 hours temperature excursion was below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees; Case reference number US-BN-2024-001906 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number USBAV24-1019) on 13-May-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 every other day, the patient took the first, second and third dose of Vivotif (batch number: unknown), at unknown dose or route of administration, for typhoid immunization. On an unspecified date, as reported the patient packed the last capsule in thermos with ice at the bottom and the fourth dose was as reported compromised. As reported, the temperature excursion was 12 hours, below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees (explicitly coded as 'product storage error'). On an unspecified date, reported as every other day, the patient took the fourth dose of Vivoitf (batch number: unknown), at unknown dose or route of administration (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 of unspecified age took the fourth dose of Vivoitf for typhoid immunization, after as reported the patient packed the last capsule in thermos with ice at the bottom and the fourth dose was as reported compromised. As reported, the temperature excursion was 12 hours, below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees, 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 administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age took the fourth dose of Vivoitf for typhoid immunization, after as reported the patient packed the last capsule in thermos with ice at the bottom and the fourth dose was as reported compromised. As reported, the temperature excursion was 12 hours, below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees, 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 administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829529 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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Patient took the second dose of Vivotif vaccine four hours after meal; Case reference number US-BN-2...
Patient took the second dose of Vivotif vaccine four hours after meal; Case reference number US-BN-2024-001907 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number: USBAV24-1029) on 14-May-2024 and concerns a patient of unspecified age or gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, patient took the first dose of Vivotif (batch number: unknown), at unknown dose or route of administration, for unknown indication. On unspecified date, reported as on alternate day, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose or route of administration. As reported, the patient took the second dose of Vivotif four hours after meal (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 provided.; Reporter's Comments: A patient of unspecified age or gender took the second dose of Vivotif for unknown indication four hours after the meal, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age or gender took the second dose of Vivotif for unknown indication four hours after the meal, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829530 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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Patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours; Patien...
Patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours; Patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours; Case reference number US-BN-2024-001913 is a spontaneous case report initially received from a health care professional via Med Communications (reference number: USBAV24-1045) on 14-May-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, second and third dose of Vivotif (batch number: unknown) at an unknown dose, via an unknown route for unknown indication. As reported, the patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours (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 patient of unknown age and gender took the first, second and the third dose of Vivotif for unknown indication. As reported, the patient took the third dose of Vivotif which was exposed to 55οΏ½60-degree Fahrenheit for 16 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first, second and the third dose of Vivotif for unknown indication. As reported, the patient took the third dose of Vivotif which was exposed to 55οΏ½60-degree Fahrenheit for 16 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829531 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004009 |
No adverse event, Product dose omission issue
No adverse event, Product dose omission issue
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The patient did not take the fourth dose of Vivotif as the dog ate it; Case reference number US-BN-2...
The patient did not take the fourth dose of Vivotif as the dog ate it; Case reference number US-BN-2024-001915 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-1039) on 14-May-2024 and concerns a *64-year-old female patient.* The patient's medical history and concomitant medication details were not provided. *On 09-May-2024,* the patient took the first dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule,* orally, for typhoid immunization. *On 11-May-2024, three days after the first dose of Vivotif,* the patient took the second dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule, orally.* *On 13-May-2024, five days after the first dose of Vivotif,* the patient took the third dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule, orally.* As reported, the patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it (explicitly coded as 'missed dose'). *As reported, 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 (*). Additional information received from a nurse on 15-May-2024: New information included confirmation that the patient did not take the fourth dose of Vivotif. Follow up information received from a nurse on 28-May-2024: New information included added patient demographic details, Vivotif dosage information and confirmation on the fourth dose of Vivotif, and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 64-year-old female patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it, which is considered as missed dose. Reportedly, the patient did not experience any adverse event 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 64-year-old female patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it, which is considered as missed dose. Reportedly, the patient did not experience any adverse event 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829532 | M | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took the third dose of Vivotif vaccine was stored at 60 degrees Fahrenheit for at least ...
The patient took the third dose of Vivotif vaccine was stored at 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours; The patient took the third dose of Vivotif vaccine was stored at 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours; Case reference number US-BN-2024-001918 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-1046) on 14-May-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 and second dose of Vivotif (batch number: unknown), at an unknown, dose, orally, for unknown indication. On an unspecified date, the third dose of Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours (explicitly coded as 'Product storage error'). On unspecified date, an unknown amount of time after second dose of Vivotif, the patient took the affected third 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 male patient of unknown age took the affected third dose of Vivotif for unknown indication after Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 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 administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the affected third dose of Vivotif for unknown indication after Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 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 administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829533 | M | FL | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3003852 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient completed course with Vivotif vaccine that had expiration date in Mar-2024; Case reference n...
Patient completed course with Vivotif vaccine that had expiration date in Mar-2024; Case reference number US-BN-2024-001921 is a spontaneous case report initially received from pharmacist via Med Communication (reference number: USBAV24-1060) on 16-May-2024 and concerns 52-year-old male patient. The patient's relevant medical history and concomitant medications were not provided. On 23-Apr-2024, pharmacist dispensed a prescription of Vivotif that was expired in March. *On an unspecified date (to be confirmed), the patient took the first dose of Vivotif* (batch number: 3003852; expiration date: Mar-2024), one capsule, orally, for indication reported as typhoid immunization (explicitly coded as 'expired vaccine used'). *On 24-Apr-2024, reported as approximately, unknown amount of time after the first dose, the patient took the second dose of Vivotif (batch number: 3003852; expiration date: Mar-2024), one capsule, orally (explicitly coded as 'expired vaccine used').* *On 26-Apr-2024, reported as approximately, two days after the second dose, the patient took the third dose of Vivotif (batch number: 3003852; expiration date: Mar-2024), one capsule, orally (explicitly coded as 'expired vaccine used').* *On 28-Apr-2024, reported as approximately, two days after the third dose, the patient took the fourth dose of Vivotif (batch number: 3003852; expiration date: Mar-2024), one capsule, orally. As reported, there were no deviation issues during the administration of Vivotif (explicitly coded as 'expired vaccine used')* *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 (*). Non-significant case correction was received from reporter on 26-Jun-2024 included: reporter's email address. Follow up information received from a pharmacist on 27-Jun-2024: New information included added patient initials, Vivotif dosage information and confirmation of absence of deviation issues and adverse events during the administration of Vivotif.; Reporter's Comments: A 52-year-old male patient was vaccinated with four oral doses of Vivotif vaccine, each of which had expired in March 2024; for indication of typhoid immunization. This is considered as expired vaccine used, as on 23-Apr-2024, the pharmacist dispensed Vivotif with expiration date in March. No associated adverse events were reported. Expired product administered is listed per company conventions. The patient's relevant medical history and concomitant medications were not provided. Expired product administered is assessed as not related to suspect product but to human error. The case is non-serious.; Sender's Comments: A 52-year-old male patient was vaccinated with four oral doses of Vivotif vaccine, each of which had expired in March 2024; for indication of typhoid immunization. This is considered as expired vaccine used, as on 23-Apr-2024, the pharmacist dispensed Vivotif with expiration date in March. No associated adverse events were reported. Expired product administered is listed per company conventions. The patient's relevant medical history and concomitant medications were not provided. Expired product administered is assessed as not related to suspect product but to human error. The case is non-serious.
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| 2829534 | M | IA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient took first and second dose of Vivotif, and forgot to take third dose; Case reference number ...
Patient took first and second dose of Vivotif, and forgot to take third dose; Case reference number US-BN-2024-001922 is a spontaneous case report initially received from pharmacist via Med Communication (reference number: USBAV24-1064) on 16-May-2024 and concerns male patient. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient was vaccinated with first dose of Vivotif vaccine (batch number: unknown), at unknown dose, reported as four capsules, at an unknown route of administration, for unknown indication. On unspecified date, the patient was vaccinated with second dose of Vivotif vaccine (batch number: unknown), at unknown dose, reported as four capsules, at an unknown route of administration. As reported, the patient took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later (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. No further information provided.; Reporter's Comments: This case concerns a male patient who took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later 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 vaccine. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns a male patient who took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later 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 vaccine. The patient's relevant medical history and concomitant medications 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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| 2829535 | CO | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004008 |
Product storage error
Product storage error
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The patient left Vivotif in the car for one hour and 40 minutes, the maximum temperature reached was...
The patient left Vivotif in the car for one hour and 40 minutes, the maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened; The patient left Vivotif in the car for one hour and 40 minutes, the maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened; Case reference number US-BN-2024-001926 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-1073) on 17-May-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 left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened (explicitly coded as 'product storage error'). On an unspecified date, the patient took a first dose of Vivotif (batch number: 3004008) at an unknown dose, orally, 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 event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first dose of Vivotif for typhoid immunization, after the patient left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first dose of Vivotif for typhoid immunization, after the patient left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829536 | M | KS | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004008 |
Product storage error
Product storage error
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The patient took third dose of Vivotif which left in his envelope in car overnight about 26 hours; T...
The patient took third dose of Vivotif which left in his envelope in car overnight about 26 hours; The patient took third dose of Vivotif which left in his envelope in car overnight about 26 hours; Case reference number US-BN-2024-001941 is a spontaneous case report initially received from other health care professional via Med Communications (reference number USBAV24-1122) on 22-May-2024 and concerns a 19-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 18-May-2024, the patient took the first dose of Vivotif (batch number: 3004008), at unknown dose, orally, for unknown indication reported as pre travel. On 20-May-2024, two days after first dose of Vivoitf, the patient took the second dose of Vivotif (batch number: 3004008), at unknown dose, orally. On an unspecified date, as reported, the patient left in car Vivotif with his envelope overnight for about 26 hours, the temperature was cool but was not at a normal refrigerated temperature (explicitly coded 'Product storage error'). On 22-May-2024, two days after second dose of Vivoitf, the patient took the third dose of Vivotif (batch number: 3004008), at 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 event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 19-year-old male patient left in car Vivotif with his envelope overnight for about 26 hours (the temperature was cool but was not at a normal refrigerated temperature) which is considered as product storage error. Two days after second dose of Vivoitf, the patient took the third dose of Vivotif, at unknown dose, orally which is considered as product administration error. Product storage error and product administration error are both 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. 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 left in car Vivotif with his envelope overnight for about 26 hours (the temperature was cool but was not at a normal refrigerated temperature) which is considered as product storage error. Two days after second dose of Vivoitf, the patient took the third dose of Vivotif, at unknown dose, orally which is considered as product administration error. Product storage error and product administration error are both 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. 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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| 2829537 | F | NJ | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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Two doses of Vivotif were taken with food and two on an empty stomach; Case reference number US-BN-2...
Two doses of Vivotif were taken with food and two on an empty stomach; Case reference number US-BN-2024-001947 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-1143) on 24-May-2024 and concerns a female patient. 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) orally, at an unknown dose, for unknown indication. As reported, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an 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. No further information was provided.; Reporter's Comments: A female patient, took four doses of Vivotif orally, at an unknown dose, for unknown indication. Reportedly, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an 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. 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, took four doses of Vivotif orally, at an unknown dose, for unknown indication. Reportedly, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an 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. 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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| 2829538 | F | CO | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took doses of Vivotif at room temperature, did not store in the refrigerator; The patien...
The patient took doses of Vivotif at room temperature, did not store in the refrigerator; The patient took doses of Vivotif at room temperature, did not store in the refrigerator; Case reference number US-BN-2024-001948 is a spontaneous case initially received from a health care professional via Med Communications (reference number: USBAV24-1145) on 24-May-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took doses of Vivotif (batch numbers: unknown), without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi (explicitly coded as 'product storage error' and '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 took doses of Vivotif, without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi 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 Vivotif vaccine. The patient's relevant medical history and concomitant medications 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 unspecified age took doses of Vivotif, without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi 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 Vivotif vaccine. The patient's relevant medical history and concomitant medications 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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| 2829539 | F | VA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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The patient took first and second dose of Vivotif vaccine with hot coffee; Case reference number US-...
The patient took first and second dose of Vivotif vaccine with hot coffee; Case reference number US-BN-2024-001963 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 28-May-2024 and concerns a 32-years-old female patient. The patient's medical history and concomitant medication details were not provided. On *11-May-2024*, the patent took *the first* dose of Vivotif (batch number: *3004008; expiration date 31-Oct-2024), one capsule*, orally *through mouth*, for typhoid immunization, reported as prevention of typhoid fever. As reported, the patent took Vivotif vaccine with hot coffee (explicitly coded as 'Product administration error'). *On 13-May-2024, two days after first dose of Vivotif, the patent took the second dose of Vivotif (batch number: 3004008; expiration date 31-Oct-2024), one capsule, orally through mouth, As reported, the patent took Vivotif vaccine with hot coffee (explicitly coded as 'Product administration error').* * On an unspecified date, unknown amount of time after second dose of Vivotif, the patent took the third dose of Vivotif (batch number: unknown), at unknown dose, route or site administration.* *On 14-May-2024, unknown amount of time after third dose of Vivotiv, the patent took the fourth dose of Vivotif (batch number: 3004008; expiration date 31-Oct-2024), one capsule, orally through mouth.* *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 (*). Additional information received form Bavarian Nordic on 28-May-2024 included indication for Vivotif vaccine and local BN case ID (BN_2024_02850). Additional information received from reporter on 29-May-2024 included demographic information of patient, gender and age, and confirmation that the patient took Vivotif vaccine with hot coffee. Follow up information received from nurse on 14-Jun-2024 included: patent's initial, dosing information for first, second and fourth dose of Vivotif, dates, route, volume, batch number and expiration date and confirmation that the patient did not experience any adverse events.; Reporter's Comments: A 32-year-old female patient took Vivotif for typhoid immunization. Reportedly, the patent took the first and the second dose of Vivotif vaccine with hot coffee which is considered as product administration error. Product administration error is considered listed per company convention. The patient did not experience 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 32-year-old female patient took Vivotif for typhoid immunization. Reportedly, the patent took the first and the second dose of Vivotif vaccine with hot coffee which is considered as product administration error. Product administration error is considered listed per company convention. The patient did not experience 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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| 2829540 | M | MD | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3003908 |
Product storage error
Product storage error
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Patient took first dose of Vivotif this morning but says the package that was left in a hot car for ...
Patient took first dose of Vivotif this morning but says the package that was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour; Patient took first dose of Vivotif this morning but says the package that was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour; Case reference number US-BN-2024-001965 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-1173) on 29-May-2024 and concerns a 31-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 29-May-2024, the patient took the first dose of Vivotif (batch number: 3003908, expiry date: Jun-2024) at an unknown dose, via oral use, for typhoid prophylaxis. As reported, patient took first dose of Vivotif this morning but says the package was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour (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 31-year-old male patient took the first dose of Vivotif, after storing it in a hot car and then for an hour indoors (which is considered product storage error and product administration error). No associated adverse events were reported. Product storage error and administration error are listed as per company conventions. No medical information was available. The events are considered not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A 31-year-old male patient took the first dose of Vivotif, after storing it in a hot car and then for an hour indoors (which is considered product storage error and product administration error). No associated adverse events were reported. Product storage error and administration error are listed as per company conventions. No medical information was available. The events are considered not related to Vivotif, but to human error. The case is non-serious.
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| 2829541 | IL | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Incomplete course of vaccination
Incomplete course of vaccination
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Patient had reaction after first dose of Vivotif and patient will not complete vaccination; Patient ...
Patient had reaction after first dose of Vivotif and patient will not complete vaccination; Patient had reaction after first dose of Vivotif and patient will not complete vaccination; Case reference number US-BN-2024-001969 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1154) on 28-May-2024 and concerns a patient of unspecified age and gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally for unknown indication. On unspecified date, unknown amount of time after taking the first dose of Vivotif, the patient experienced unspecified adverse reaction, and as reported the patient will not complete the vaccination (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, the outcome of the adverse reaction was unknown. The reporter assessed the adverse reaction as non-serious and related to Vivotif. No further information was provided.; Reporter's Comments: A patient of unspecified age and gender experienced unspecified adverse reaction, unknown time after taking the first dose of Vivotif and as reported the patient will not complete the vaccination which is considered as incomplete course of vaccination. Adverse reaction and incomplete course of vaccination are both considered listed per company conventions. The outcome of the adverse reaction was unknown. The patient's relevant medical history and concomitant medications were not provided. Adverse reaction is conservatively assessed as related due to lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender experienced unspecified adverse reaction, unknown time after taking the first dose of Vivotif and as reported the patient will not complete the vaccination which is considered as incomplete course of vaccination. Adverse reaction and incomplete course of vaccination are both considered listed per company conventions. The outcome of the adverse reaction was unknown. The patient's relevant medical history and concomitant medications were not provided. Adverse reaction is conservatively assessed as related due to lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829542 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Rash
Rash
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Rash; Case reference number US-BN-2024-001970 is a spontaneous case report initially received from a...
Rash; Case reference number US-BN-2024-001970 is a spontaneous case report initially received from a pharmacist via Emergent BioSolutions (reference number: EMG2024-621) on 26-May-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patent took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication. On an unspecified date, the patient developed rash. At the time of initial report, it was unknown if the patient recovered from the event of rash. The reporter did not provide seriousness and causality assessment for event of rash. No further information was provided.; Reporter's Comments: A patient of unspecified gender or age developed rash, unknown time after taking the first dose of Vivotif, at unknown dose, orally, for unknown indication. Rash is listed and expected according to CCDS v8 and USPI for Vivotif. At this point, it was unknown if the patient recovered from the event of rash. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of unspecified gender or age developed rash, unknown time after taking the first dose of Vivotif, at unknown dose, orally, for unknown indication. Rash is listed and expected according to CCDS v8 and USPI for Vivotif. At this point, it was unknown if the patient recovered from the event of rash. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.
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| 2829543 | M | NC | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Nausea, Product storage error
Nausea, Product storage error
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Patient received one dose of Vivotif and felt very nauseated; Patient received first dose of Vivotif...
Patient received one dose of Vivotif and felt very nauseated; Patient received first dose of Vivotif which was left out of the fridge for about a week; Patient received first dose of Vivotif which was left out of the fridge for about a week; Case reference number US-BN-2024-002109 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1448) on 24-Jun-2024 and concerns an 18-year-old male patient. The patient's medical history and concomitant medication were not provided. On 23-Jun-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid immunization. As reported, patient received first dose of Vivotif which was left out of the fridge for about a week (explicitly coded as 'product storage error' and 'product administration error'). On an unspecified date, the patient felt very nauseated. At the time of the initial report, it was unknown if the patient recovered from nauseated. The reporter assessed the event nauseated as non-serious and causality as possible for the event nauseated. No further information was provided.; Reporter's Comments: An 18-year-old male patient felt nauseated within one day after he took the first dose of Vivotif, at an unknown dose, orally for typhoid immunization. Reportedly, the patient received first dose of Vivotif which was left out of the fridge for about a week, and that is considered as product storage error and product administration error. Nausea is listed and expected according to CCDS v8 and USPI while product storage error and product administration error are both considered listed per company conventions. The outcome of event nausea was unknown. The patient's medical history and concomitant medication were not provided. Nausea is assessed as related due to plausible temporal relationship, 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: An 18-year-old male patient felt nauseated within one day after he took the first dose of Vivotif, at an unknown dose, orally for typhoid immunization. Reportedly, the patient received first dose of Vivotif which was left out of the fridge for about a week, and that is considered as product storage error and product administration error. Nausea is listed and expected according to CCDS v8 and USPI while product storage error and product administration error are both considered listed per company conventions. The outcome of event nausea was unknown. The patient's medical history and concomitant medication were not provided. Nausea is assessed as related due to plausible temporal relationship, 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.
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| 2829544 | M | NC | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took the first dose of Vivotif vaccine which was kept out of the refrigerator for about ...
The patient took the first dose of Vivotif vaccine which was kept out of the refrigerator for about one week; The patient took the first dose of Vivotif vaccine which was kept out of the refrigerator for about one week; Case reference number US-BN-2024-002133 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1448) on 24-Jun-2024 and concerns a 14-year-old male patient. The patient's medical history and concomitant medication were not provided. On 23-Jun-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown) at dose of one capsule, orally for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge for five days, from 17-Jun-2024 (explicitly coded as 'product storage error' and '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 14-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and the vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to the 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 14-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and the vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to the 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829545 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient had inadvertently taken the first two doses of Vivotif 24 hours apart, instead of 48 hours; ...
Patient had inadvertently taken the first two doses of Vivotif 24 hours apart, instead of 48 hours; Case reference number US-BN-2024-002168 is a spontaneous case initially received from phycisian via Emergent (reference number: EMG2024-757) on 06-Jul-2024 and concerns a 15-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 or route for unknown indication. On an unspecified date, 24 hours after the first dose, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose or route (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. No further information was provided.; Reporter's Comments: A 15-year-old female patient took the second dose of Vivotif, 24 hours 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 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 15-year-old female patient took the second dose of Vivotif, 24 hours 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 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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| 2829546 | M | MI | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Drug intolerance, Inappropriate schedule of product administration
Drug intolerance, Inappropriate schedule of product administration
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Patient could not tolerate the oral typhoid; The patient took three doses and sent back a partial pa...
Patient could not tolerate the oral typhoid; The patient took three doses and sent back a partial pack; Case reference number US-BN-2024-002169 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-1589) on 08-Jul-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication were not provided. On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack (explicitly coded as 'Inappropriate schedule of vaccine administered'). On an unspecified date, the patient could not tolerate the oral typhoid. At the time of the initial report, it was unknown if the patient recovered from the event 'drug intolerance'. The reporter assessed the seriousness of the event 'drug intolerance' as non-serious, and causality for the event 'drug intolerance' was provided as possible. Additional information received from a health care professional on 10-Jul-2024: included confirmation how many doses of Vivotif patient took. Additional information received from a health care professional via Med Communication (reference number: USBAV24-1616) on 10-Jul-2024: included additional reference number (USBAV24-1616).; Reporter's Comments: A male patient of unknown age took the first, second and the third dose of Vivotif for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack, which is considered as inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, the patient could not tolerate the oral typhoid. Drug intolerance and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The causality for drug intolerance is considered as possibly related to Vivotif. 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 the first, second and the third dose of Vivotif for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack, which is considered as inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, the patient could not tolerate the oral typhoid. Drug intolerance and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The causality for drug intolerance is considered as possibly related to Vivotif. 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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| 2829547 | ID | 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 the first and second doses of Vivotif every other day, however, the patient too...
The patient received the first and second doses of Vivotif every other day, however, the patient took the third dose on sunday instead of saturday; Case reference number US-BN-2024-002230 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV24-1728) on 22-Jul-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 an unknown dose, orally, for typhoid immunization. On an unspecified date, reported as every other day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally. On 21-Jul-2024, reported as on Sunday, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. As reported, the patient took the third dose on Sunday instead of Saturday (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 patient of unknown age and gender took the third dose of Vivotif for typhoid immunization. As reported, the patient took the third dose on Sunday instead of Saturday, 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 patient of unknown age and gender took the third dose of Vivotif for typhoid immunization. As reported, the patient took the third dose on Sunday instead of Saturday, 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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| 2829548 | F | OR | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004007 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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The patient took second dose of Vivotif one day early, and the third dose one day late; Case referen...
The patient took second dose of Vivotif one day early, and the third dose one day late; Case reference number US-BN-2024-002242 is a spontaneous case initially received from nurse care professional via Med Communications (reference number USBAV24-1755) on 23-Jul-2024 and concerns a 41-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: 3004007, *expiry date: 31-Oct-2024), one capsule,* orally, for immunization against disease caused by salmonella typhi *and travel.* *On 19-Jul-2024,* one day after the first dose of Vivotif, reported as one day early, the patient took the second dose of Vivotif (batch number: 3004007, *expiry date: 31-Oct-2024), one capsule, orally* (explicitly coded as 'Inappropriate schedule of vaccine administered'). *On 21-Jul-2024,* three days after the first dose of Vivotif, reported as one day late, the patient took the third dose of Vivotif (batch number: 3004007, *expiry date: 31-Oct-2024),* one capsule, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). *On 24-Jul-2024, six days after the first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024), one capsule, orally*. *As reported, 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 04-Sep-2024: New information included added patient initials, Vivotif dosage information and confirmation on adverse events during the administration of Vivotif. Additional information received from a nurse on 09-Sep-2024: information included confirmation on the date of birth.; Reporter's Comments: A 41-year-old female patient took the second dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 1 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, the patient took the third dose of Vivotif, on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 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 41-year-old female patient took the second dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 1 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, the patient took the third dose of Vivotif, on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 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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| 2829549 | IL | 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 received one dose of Vivotif, which was left out of the refrigerator for two hours, reac...
The patient received one dose of Vivotif, which was left out of the refrigerator for two hours, reached a maximum temperature of 70 degrees Fahrenheit; The patient received one dose of Vivotif, which was left out of the refrigerator for two hours, reached a maximum temperature of 70 degrees Fahrenheit; Case reference number US-BN-2024-002309 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1868) on 05-Aug-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 first dose of Vivotif (batch number: unknown), at an unknown dose, route for unknown indication. As reported the patient took one dose of Vivotif, which was left out of the refrigerator for two hours and reached a maximum temperature of 70 degrees 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 patient of unknown demographics received a dose of Vivotif, which had been stored outside of a fridge for two hours, reaching a maximum temperature of 70 deg F (equivalent to 21 deg C). This is considered product storage error and product administration error, which are listed situations as per company convention. No associated adverse events were reported at this time. The patient's medical history and concomitant medication details were not provided. 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 patient of unknown demographics received a dose of Vivotif, which had been stored outside of a fridge for two hours, reaching a maximum temperature of 70 deg F (equivalent to 21 deg C). This is considered product storage error and product administration error, which are listed situations as per company convention. No associated adverse events were reported at this time. The patient's medical history and concomitant medication details were not provided. 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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| 2829550 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient took the first, second and third dose of Vivotif vaccine and realized that did not refri...
The patient took the first, second and third dose of Vivotif vaccine and realized that did not refrigerated vaccines; The patient took the first, second and third dose of Vivotif vaccine and realized that did not refrigerated vaccines; Case reference number US-BN-2024-002344 is a spontaneous case initially received from a consumer via Emergent BioSolutions (reference number: EMG2024-874) 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 unspecified date, the doses of Vivotif were not refrigerated (explicitly coded as 'product storage error'). On an unspecified date, the patent took the first dose of Vivotif (batch number: unknown), at a dose of pill, orally, for typhoid immunization (explicitly coded as 'product administration error'). On an unspecified date, unknown amount of time after first dose of Vivotif, the patent took the second dose of Vivotif (batch number: unknown), at a dose of pill, orally (explicitly coded as 'product administration error'). On an unspecified date, unknown amount of time after second dose of Vivotif, the patent took the third dose of Vivotif (batch number: unknown), at a dose of pill, orally (explicitly coded as 'product administration error'). As reported, the patient took three pills of Vivotif out of the four pills due to travel and realised that did not refrigerate Vivotif. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. Additional information received from consumer via Med Communication (reference number: USBAV24-1970) on 14-Aug-2024: Information included patient details and Vivotif dosing information. Non-significant case correction received from Emergent on 27-Aug-2024 included confirmation of initial receipt date.; Reporter's Comments: A female patient received three doses of Vivotif, after not refrigerating them, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are 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 Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A female patient received three doses of Vivotif, after not refrigerating them, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are 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 Vivotif, but to a human error. The case is non-serious.
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| 2829551 | IN | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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The patients took Vivotif every other day with food instead of taking it on empty stomach; Case refe...
The patients took Vivotif every other day with food instead of taking it on empty stomach; Case reference number US-BN-2024-002412 is a spontaneous case report initially received from a consumer via Emergent BioSolutions (reference number: EMG2024-928) on 29-Aug-2024 and concerns two patients unspecified age, husband and wife. The patients' medical history and concomitant medication details were not provided. On an unspecified date, reported as every other day, the patients took the first, second, third and fourth dose of Vivotif vaccine (batch number: unknown), at a dose of capsule, orally, for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach (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. Additional information received from Med Communications on 29-Aug-2024, at 09:04, included additional reference number, route of Vivotif administration, dosage, and patients' details. Additional information received from Med Communications on 29-Aug-2024, at 09:05 included additional reference number.; Reporter's Comments: Two patients of unspecified age, husband and wife took the first, second, third and the fourth dose of Vivotif vaccine for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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: Two patients of unspecified age, husband and wife took the first, second, third and the fourth dose of Vivotif vaccine for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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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| 2829552 | 03/04/2025 |
TYP |
UNKNOWN MANUFACTURER |
Unknown |
Abdominal discomfort, Abdominal pain, Faeces discoloured
Abdominal discomfort, Abdominal pain, Faeces discoloured
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Clay colored stools; Discomfort from stomach; Abdominal pain; Case reference number US-BN-2024-00254...
Clay colored stools; Discomfort from stomach; Abdominal pain; Case reference number US-BN-2024-002542 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2024_02980) on 24-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 a dose of typhoid vaccine (brand name: unknown, batch number: unknown), at dose of one capsule, via unknown route and for unknown indication. On an unspecified date, unknown amount of time after taking the typhoid vaccine, the patient experienced abdominal pain, clay colored stools and discomfort from stomach. At the time of the initial report, the outcome for the events of abdominal pain, clay colored stools and discomfort from stomach was unknown. The reporter did not provide seriousness and causality assessment for the events of abdominal pain, clay colored stools and discomfort from stomach. Additional information received from Bavarian Nordic on 25-Sep-2024 included confirmation of county of occurrence.; Reporter's Comments: A patient of unknown age and gender experienced non-serious events of abdominal pain, clay colored stools and discomfort from stomach on an unspecified date, unknown amount of time after the patient took a dose of typhoid vaccine for unknown indication. Abdominal pain is listed and expected for Typhoid vaccine per CCDS v8 and USPI, whilst faeces discoloured and abdominal discomfort are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Typhoid vaccine. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender experienced non-serious events of abdominal pain, clay colored stools and discomfort from stomach on an unspecified date, unknown amount of time after the patient took a dose of typhoid vaccine for unknown indication. Abdominal pain is listed and expected for Typhoid vaccine per CCDS v8 and USPI, whilst faeces discoloured and abdominal discomfort are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Typhoid vaccine. This case is considered as non-serious.
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| 2829553 | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product dose omission issue
Product dose omission issue
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The patient missed a day to take a dose of Vivotif; Case reference number US-BN-2024-002636 is a spo...
The patient missed a day to take a dose of Vivotif; Case reference number US-BN-2024-002636 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV24-2672) on 10-Oct-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 a dose of Vivotif (batch number: unknown), at an unknown dose, orally, for indication Typhoid immunization. As reported the patient missed a day of took of Vivotif vaccine (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 vaccine. Additional information received from pharmacist via Med Communications (reference number: USBAV24-2674) on 10-Oct-2024 and included additional reference number.; Reporter's Comments: A patient of unknown age or gender missed a day while taking Vivotif vaccine 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 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 patient of unknown age or gender missed a day while taking Vivotif vaccine 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 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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| 2829554 | IL | 03/04/2025 |
TYP TYP |
BERNA BIOTECH, LTD. UNKNOWN MANUFACTURER |
Unknown Unknown |
Diarrhoea, Incomplete course of vaccination, Interchange of vaccine products, Na...
Diarrhoea, Incomplete course of vaccination, Interchange of vaccine products, Nausea; Diarrhoea, Incomplete course of vaccination, Interchange of vaccine products, Nausea
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Patient had nausea after receiving fist dose of Vivotif; The patient had one or two bouts of diarrhe...
Patient had nausea after receiving fist dose of Vivotif; The patient had one or two bouts of diarrhea after second dose of Vivotif; Patient experienced diarrhea after third dose of Vivotif; Patient had never taken the fourth dose of Vivotif; The patient took three doses of Vivotif and dose of Typhoid IM; Case reference number US-BN-2024-002677 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2771) on 21-Oct-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose (pill), and route of administration, for unknown indication. On an unspecified date, reported as after receiving the first dose of Vivotif patient experienced *a bit of* nausea. On unspecified date, unknown amount of time after administration of first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose (pill) and route of administration. On an unspecified date, reported as after receiving the second dose of Vivotif patient experienced *one or two bouts* of diarrhea. On unspecified date, unknown amount of time after administration of first dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose (pill) and route of administration. On an unspecified date, reported as after receiving the third dose of Vivotif patient experienced severe diarrhea. As reported patient had never taken the fourth dose of Vivotif, since side effects were too severe (explicitly coded as 'incomplete course of vaccination'). *On an unspecified date, the patient a dose received Typhoid (batch number: unknown), at unknown dose or site of administration, intramuscularly for unknown indication (explicitly coded as 'interchange of vaccine products'). * *At the time of the follow up report, it was unknown if the patient recovered from the events of 'diarrhea' after second and third dose of Vivotif and nausea. * The reporter did not provide seriousness and causality assessment for the events of nausea and *'diarrhea' after second and third dose of Vivotif. * Additional information received from a nurse on 23-Oct-2024: Information included Vivotif dosage information, events (nausea and diarrhea). 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 05-Nov-2024: New information included added reporter details, confirmation for adverse events and that the patient did not take the last dose of Vivotif, and that the patient received Typhoid IM instead.; Reporter's Comments: A patient of unknown age and gender experienced nausea after taking the first dose of Vivotif for unknown indication. Also, on an unspecified date, reported as after receiving the second dose of Vivotif the patient experienced diarrhea. Following the third dose of Vivotif, the patient experienced diarrhea again. Since side effects were severe, the patient did not receive the fourth dose of Vivotif, and was administered intramuscular Typhoid instead (which is considered incomplete course of vaccination and interchange of vaccine products). Diarrhoea and nausea are listed and expected for Vivotif per CCDS v8 and USPI, whilst incomplete course of vaccination and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, as well as the two-time occurrence of diarrhea, the reported events are considered related to Vivotif. Incomplete course of vaccination and interchange of vaccine products are not related to the suspect vaccine, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender experienced nausea after taking the first dose of Vivotif for unknown indication. Also, on an unspecified date, reported as after receiving the second dose of Vivotif the patient experienced diarrhea. Following the third dose of Vivotif, the patient experienced diarrhea again. Since side effects were severe, the patient did not receive the fourth dose of Vivotif, and was administered intramuscular Typhoid instead (which is considered incomplete course of vaccination and interchange of vaccine products). Diarrhoea and nausea are listed and expected for Vivotif per CCDS v8 and USPI, whilst incomplete course of vaccination and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, as well as the two-time occurrence of diarrhea, the reported events are considered related to Vivotif. Incomplete course of vaccination and interchange of vaccine products are not related to the suspect vaccine, but to a human factor. The case is non-serious.
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| 2829555 | M | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Contraindication to vaccination, Labelled drug-disease interaction medication er...
Contraindication to vaccination, Labelled drug-disease interaction medication error, No adverse event
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The patient with lactose intolerance received dose of Vivotif; The patient with lactose intolerance ...
The patient with lactose intolerance received dose of Vivotif; The patient with lactose intolerance received dose of Vivotif; Case reference number US-BN-2024-002698 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2751) on 17-Oct-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication were not provided. The patient's current condition included lactose intolerance. On unspecified date, the patient took a dose of Vivotif (batch number: unknown) at unknown dose, or route of administration for unknown indication. As reported, the patient was lactose intolerant (explicitly coded as 'contraindicated product administered' and 'labelled drug-disease interaction error'). At the time of the initial report, the patient did not experience any adverse events due to Vivotif, since it was reported that patient did not have any incidence. The case is linked with the case US-BN-2024-002661, containing the same reporter. No further information was provided.; Reporter's Comments: A male patient of unknown age took a dose of Vivotif, at unknown dose, route of administration for unknown indication. Reportedly, the patient was lactose intolerant which is considered as contraindicated product administered and labelled drug-disease interaction medication error. Contraindicated product administered and labelled drug-disease interaction medication error are both considered listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif. The patient's medical history and concomitant medication information was not provided while current condition included lactose intolerance. Contraindicated product administered and labelled drug-disease interaction error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A male patient of unknown age took a dose of Vivotif, at unknown dose, route of administration for unknown indication. Reportedly, the patient was lactose intolerant which is considered as contraindicated product administered and labelled drug-disease interaction medication error. Contraindicated product administered and labelled drug-disease interaction medication error are both considered listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif. The patient's medical history and concomitant medication information was not provided while current condition included lactose intolerance. Contraindicated product administered and labelled drug-disease interaction error are not related to Vivotif, but to human error. The case is non-serious.
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| 2829556 | F | FL | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Rash
Rash
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The patient had rash on the neck and trunk; Case reference number US-BN-2024-002739 is a spontaneous...
The patient had rash on the neck and trunk; Case reference number US-BN-2024-002739 is a spontaneous case initially received from other health care professional via Bavarian Nordic (reference number: BN_2024_03049) on 04-Nov-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 a dose of Vivotif (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication. On an unspecified date, unknown amount of time after vaccination with Vivotif, the patient had rash on neck and trunk. At the time of initial report, it was unknown if the patient recovered from event of 'rash'. The reporter did not provide seriousness and causality assessment for event of 'rash'. No further information was provided.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of rash on neck and trunk an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Rash is listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of rash on neck and trunk an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Rash is listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
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| 2829557 | F | CO | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Heart rate increased, Oral pruritus, Pruritus
Heart rate increased, Oral pruritus, Pruritus
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Increased heart rate (could feel heartbeat in her teeth); Itching on the roof of mouth; Itching on t...
Increased heart rate (could feel heartbeat in her teeth); Itching on the roof of mouth; Itching on the top of head; Case reference number US-BN-2024-002771 is a spontaneous case initially received from other health care professional via Bavarian Nordic (reference number: BN_2024_03074) on 11-Nov-2024 and concerns a female patient of unspecified 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 unknown dose, route or site of administration, for unknown indication. On unspecified date, for unknown amount of time from a first dose of Vitotif vaccine, the patient experienced adverse events of itching on the roof of mouth, itching on the top of head, and increased heart rate (could feel heartbeat in teeth). At the time of the initial report, it was unknown if the patient recovered from the events of 'heart rate increased', 'oral pruritus', and 'itchy scalp'. The reporter did not provide a seriousness and causality assessment for events of 'heart rate increased', 'oral pruritus', and 'itchy scalp'. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of itching on the roof of mouth, itching on the top of head, and increased heart rate an unknown amount of time after the patient took the first dose of Vivotif vaccine for unknown indication. Heart rate increased and oral pruritus are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst pruritus is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age experienced non-serious events of itching on the roof of mouth, itching on the top of head, and increased heart rate an unknown amount of time after the patient took the first dose of Vivotif vaccine for unknown indication. Heart rate increased and oral pruritus are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst pruritus is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
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| 2829558 | M | NY | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004085 |
Extra dose administered, Inappropriate schedule of product administration
Extra dose administered, Inappropriate schedule of product administration
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The patient received first dose of Vivotif on Friday and second dose on Saturday instead of Sunday, ...
The patient received first dose of Vivotif on Friday and second dose on Saturday instead of Sunday, the third dose on day four, the forth dose on day six, and fifth dose on day eight; The patient took five doses of Vivotif vaccine as it was suggested to the patient not to count the first administered dose; Case reference number US-BN-2024-002866 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-3250) on 09-Dec-2024 and concerns a 55-year-old male patient. The patient had no relevant medical history and concomitant medication details were not provided. On 06-Dec-2024, reported as Friday, the patient received the first dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally, for indication reported as pre travel. On 07-Dec-2024, one day after the first dose of Vivotif, the patient received the second dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally. As reported the patient received second dose of Vivotif on Saturday instead of Sunday (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 09-Dec-2024, three days after the first dose of Vivotif, the patient received the third dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered').* *On 11-Dec-2024, five days after the first dose of Vivotif, the patient received the fourth dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered').* *On 13-Dec-2024, seven five days after the first dose of Vivotif, the patient received the fifth dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally (explicitly coded as 'Extra dose administered').* As reported, the patient was instructed to receive the third dose of Vivotif on 09-Dec-2024, and to take the last dose on Wednesday 11-Dec-2024 to get back on schedule. *The patient was suggested to not count dose administered on 06-Dec-2024 and complete a four dose schedule because it was not skiped a day between first and second dose of Vivotif and following follow up information provided from Bavarian Nordic.* *At the time of this follow up, the patient did not experience 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 the reporter on 23-Dec-2024, new information included: patient details, Vivotif dosing information for the third, fourth and fifth dose, batch number and expiration date for the first and second dose of Vivotif, confirmation that the patient did not experience any adverse events due to Vivotif vaccine.; Reporter's Comments: A 55-year-old male patient received the second dose of Vivotif, for indication reported as pre travel, one day after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Three days after the first dose, of Vivotif, the patient received the third dose of Vivotif at a dose of one capsule, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose of Vivotif, the patient received the fourth dose of Vivotif, at a dose of one capsule, orally which is also considered as inappropriate schedule of vaccine administered. Seven five days after the first dose of Vivotif, the patient received the fifth dose of Vivotif, at a dose of one capsule, orally which is considered as extra dose administered. Inappropriate schedule of product administration and extra dose administered are both considered as listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif vaccine. The patient had no relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and extra dose administered are assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 55-year-old male patient received the second dose of Vivotif, for indication reported as pre travel, one day after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Three days after the first dose, of Vivotif, the patient received the third dose of Vivotif at a dose of one capsule, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose of Vivotif, the patient received the fourth dose of Vivotif, at a dose of one capsule, orally which is also considered as inappropriate schedule of vaccine administered. Seven five days after the first dose of Vivotif, the patient received the fifth dose of Vivotif, at a dose of one capsule, orally which is considered as extra dose administered. Inappropriate schedule of product administration and extra dose administered are both considered as listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif vaccine. The patient had no relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and extra dose administered are assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829559 | M | 03/04/2025 |
SMALLMNK |
BAVARIAN NORDIC |
96867 |
Incorrect route of product administration, Underdose
Incorrect route of product administration, Underdose
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Jynneos vaccines were administered at dose of 0.1 ml intradermally; Jynneos vaccines were administer...
Jynneos vaccines were administered at dose of 0.1 ml intradermally; Jynneos vaccines were administered at dose of 0.1 ml intradermally; Case reference number US-BN-2024-002867 is a spontaneous case initially received from other health care professional via Med Communications (reference number: USBAV24-2977) on 11-Nov-2024 and concerns a *31-year-old, male* patient. The patient's medical history and concomitant medication details were not provided. On *02-November-2024*, the patient received dose of Jynneos vaccine (batch number: *96867; expiration date: 30-Apr-2026*) at dose 0.1 ml, intradermally *in the left forearm*, for unknown indication (explicitly coded as 'Intradermal injection' and 'vaccine underdose'). *The patient did not received any further doses of Jynneos vaccine. * At the time of the *follow-up*, it was unknown if the patients experienced any adverse events due to Jynneos. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from health care professional on 17-Jan-2025: New information included dosing information, demografic information of the patient.; Reporter's Comments: This case report concerns an unspecified number of patients of unspecified gender or age. The patients received doses of Jynneos vaccines, at dose 0.1 ml, intradermally, at unknown site of administration for unknown indication which is considered as intradermal injection and vaccine underdose. Injection and underdose are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. 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.Based on the follow-up information received, there is no change in the Company's assessment.; Sender's Comments: This case report concerns an unspecified number of patients of unspecified gender or age. The patients received doses of Jynneos vaccines, at dose 0.1 ml, intradermally, at unknown site of administration for unknown indication which is considered as intradermal injection and vaccine underdose. Injection and underdose are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. 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.Based on the follow-up information received, there is no change in the Company's assessment.
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| 2829560 | F | CO | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004044 |
Expired product administered, Incomplete course of vaccination, No adverse event
Expired product administered, Incomplete course of vaccination, No adverse event
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The patient took the pills last minute and the box obtained from vendor had a short date on it and e...
The patient took the pills last minute and the box obtained from vendor had a short date on it and expired on 30-Nov-2024; The patient received only one dose of Vivotif, then realised that box expired; Case reference number US-BN-2024-002886 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3231) on 06-Dec-2024 and concerns a *31-years-old female patient (also reported as 25 years) *. The patient's medical history and concomitant medication details were not provided. On *29-Nov-2024*, the patient took first dose of Vivotif (batch number: *3004044* and expiration date: 30-Nov-2024), *at a dose of one capsule, orally, for indication reported as pre-travel* (explicitly coded as 'expired vaccine used'). The patient who picked up the vaccine two months ago and took the pills last minute and the box obtained from vendor had a short date on it and expired on 11/30. *As reported, the patient received only one dose of Vivotif, then realised that box expired (explicitly coded as 'incomplete course of vaccination') *. At the time of the *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 pharmacist on 22-Jan-2025: New information included added patient demographics, Vivotif dosing details and confirmed that patient did not experience any adverse event due to Vivotif.; Reporter's Comments: A 31-year-old female patient (also reported as 25 years) took the first dose of Vivotif (expiration date: 30-Nov-2024) for unknown indication, which is considered as expired vaccine used. As reported, the patient received only one dose of Vivotif, then realised that box expired, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Expired product administered and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 31-year-old female patient (also reported as 25 years) took the first dose of Vivotif (expiration date: 30-Nov-2024) for unknown indication, which is considered as expired vaccine used. As reported, the patient received only one dose of Vivotif, then realised that box expired, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Expired product administered and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829561 | F | 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 did not notice and took all four Vivotif capsules instead of one capsule every other day...
The patient did not notice and took all four Vivotif capsules instead of one capsule every other day; The patient did not notice and took all four Vivotif capsules instead of one capsule every other day; Case reference number US-BN-2024-002905 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3328) on 18-Dec-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 got Vivotif and was aware it should be taken every other day, however, did not notice it was just one capsule and took all four doses of Vivotif (batch number: unknown), at a dose of four capsules, orally, for an unknown indication (explicitly coded as 'inappropriate schedule of vaccine administered' and 'vaccine overdose'). 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 unknown age got Vivotif and was aware it should be taken every other day, however, did not notice it was just one capsule and took all four doses of Vivotif for an unknown indication, which is considered as inappropriate schedule of vaccine administered and vaccine overdose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and overdose 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 got Vivotif and was aware it should be taken every other day, however, did not notice it was just one capsule and took all four doses of Vivotif for an unknown indication, which is considered as inappropriate schedule of vaccine administered and vaccine overdose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829562 | F | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product storage error
Product storage error
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The patient received first dose of Vivotif capsule when it had been in the counter for about a week ...
The patient received first dose of Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated; The patient received first dose of Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated; Case reference number US-BN-2024-002912 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-3349) on 19-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. As reported, the patient is travelling in two weeks and had left the Vivotif in the counter for 2 weeks. On unspecified date, the patient received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated (batch number: unknown) at a dose of one capsule, orally, for indication reported as travelling (explicitly coded as οΏ½product storage error temperature too high', and '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 unknown age received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated, at a dose of one capsule, orally, for indication reported as travelling which is considered as product storage error temperature too high, 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 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 unknown age received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated, at a dose of one capsule, orally, for indication reported as travelling which is considered as product storage error temperature too high, 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 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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| 2829563 | 78 | F | NY | 03/04/2025 |
COVID19 COVID19 RSV RSV |
PFIZER\BIONTECH PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LN2216 LN2216 3KB44 3KB44 |
Asthenia, Balance disorder, Bone pain, Burning sensation, Dizziness; Feeling col...
Asthenia, Balance disorder, Bone pain, Burning sensation, Dizziness; Feeling cold, Hyperhidrosis; Asthenia, Balance disorder, Bone pain, Burning sensation, Dizziness; Feeling cold, Hyperhidrosis
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Bone pain, Balance issues. weakness, dizziness, burning sensation throughout body, severe temperatur...
Bone pain, Balance issues. weakness, dizziness, burning sensation throughout body, severe temperature fluctuations (freezing then sweating),
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| 2829564 | 34 | M | SC | 03/04/2025 |
HPV9 |
MERCK & CO. INC. |
1965046 |
Injection site nodule
Injection site nodule
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The patient developed a localized lump (knot) on the left arm where the Gardasil injection was admin...
The patient developed a localized lump (knot) on the left arm where the Gardasil injection was administered.
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| 2829565 | 69 | F | FL | 03/04/2025 |
COVID19 PNC20 |
PFIZER\BIONTECH PFIZER\WYETH |
LT5636 lj5283 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Pt requested to receive the Prevnar 20 shot. State Shots system wasn't checked but pt had recei...
Pt requested to receive the Prevnar 20 shot. State Shots system wasn't checked but pt had received a dose of the Prevnar 20 back in November of 2022. There are currently no treatments or symptoms the pt has reported to us.
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| 2829566 | 7 | F | WA | 03/04/2025 |
IPV |
SANOFI PASTEUR |
W1c741M |
Circumstance or information capable of leading to medication error, No adverse e...
Circumstance or information capable of leading to medication error, No adverse event
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No adverse reaction in patient. This was a vaccine error or suspected error. The IPOL is a 10 dose...
No adverse reaction in patient. This was a vaccine error or suspected error. The IPOL is a 10 dose vial and 11 doses were pulled from vial. According to system, the 11th dose is invalid. We had siblings vaccinated together and we are unsure of who actually received the 11th dose, so was told we needed to delete both, notify the parents and recommend re vaccination, in addition to creating this VAERS report. Parents were notified.
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