chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: FORGOT TO PUT VIVOTIF IN THE REFRIGERATOR AND TOOK ALL THE DOSES; This spontaneous case (PVX2019-1186) was received from a pharmacist on 13-May-2019. It describes a 37-year-old adult female consumer who "forgot to put Vivotif in the refrigerator and took all the doses". The consumer was receiving Vivotif capsules for an unknown indication.  Case report: The consumer forgot to put Vivotif in the refrigerator and took all four doses. She took the first dose on 02-May-2019, the same day that it was picked up. The last dose was taken on 08-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "forgot to put Vivotif in the refrigerator and took all the doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to put Vivotif in the refrigerator and took all the doses" was considered as not applicable
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK FOUR UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1187) was received from a pharmacist on 13-May-2019. It describes a 37-year-old adult female consumer who "took four unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003275) for typhoid fever prophylaxis.  Case report: The consumer took four unrefrigerated dose of Vivotif. The first dose was taken on 06-May-2019 and the last dose on 12-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT COMPLETE DOSES ONE WEEK PRIOR TO TRAVEL; This spontaneous case (PVX2019-1202) was received from a consumer on 14-May-2019. It describes a female consumer who "did not complete doses one week prior to travel", while being on Vivotif for international travel.  Case report: The consumer took the first dose of Vivotif on 07-May-2019 and the last dose on 13-May-2019, respectively. She had an internationally (endemic area) planned travel on 18-May-2019.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not complete doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete doses one week prior to travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE FOURTH DOSE; This spontaneous case (PVX2019-1206) was received from a caregiver on 14-May-2019. It describes a female consumer who "did not take fourth dose", while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took only three doses of Vivotif, a month ago. She did not take the fourth dose till now.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take fourth dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK 2 DOSES OF OPENED VIVOTIF; This spontaneous case (PVX2019-1212) was received from a pharmacist on 15-May-2019. It describes a 12-year-old female consumer who "took 2 doses of opened Vivotif". The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer had trouble in swallowing pills in general, so that, her caregiver opened two doses of Vivotif and placed them in water so that it became easy to swallow.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of opened Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of opened Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ALL FOUR DOSES OF VIVOTIF BUT DID NOT REFRIGERATE IT; A spontaneous case report was received from a caregiver on 20-May-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201905-000394 (PVX2019-1250; younger daughter) and PVX201905-000395 (PVX2019-1251, elder daughter) were created and cross-linked in the database.  This case describes a 16-year-old adolescent female consumer who "took all four doses of Vivotif but did not refrigerate it". The consumer was receiving oral Vivotif (one capsules every other day; lot no: 3003253) for typhoid prophylaxis.  Case report: The consumer took all the four doses of Vivotif but forgot to refrigerate it. The doses were taken on 12-May-2019, 14-May-2019, 16-May-2019, and 18-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000394:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case (PVX2019-1252) was received from a caregiver on 20-May-2019. It describes a 17-year-old female consumer who "took an unrefrigerated dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer did not refrigerate Vivotif doses for several weeks and then she took the first dose on 19-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE A DAY LATE; This spontaneous case (PVX2019-1260) was received from a pharmacist on 20-May-2019. It describes a female consumer who "took third dose a day late", while being on Vivotif for an unknown indication.  Case report: The consumer took the first and second dose of Vivotif on 14-May-2019 and 16-May-2019, respectively. But, she took the third dose on 19-May-2019 instead of 18-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took third dose a day late" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took third dose a day late" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED THE THIRD DOSE; A spontaneous case report was received from a nurse on 20-May-2019 for two consumers.  Based on the information obtained from a nurse, two individual case safety reports PVX201905-000399 (PVX2019-1263; first child) and PVX201905-000400 (PVX2019-1264, second child) were created and cross-linked in the database.  This case describes a male child consumer who "missed the third dose", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif, but missed to take the third dose, which was due on Friday as he went to another location and his mother forgot to carry medication with her.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the third dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000400:
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED THE THIRD DOSE; A spontaneous case report was received from a nurse on 20-May-2019 for two consumers.  Based on the information obtained from a nurse, two individual case safety reports PVX201905-000399 (PVX2019-1263; first child) and PVX201905-000400 (PVX2019-1264, second child) were created and cross-linked in the database.  This case describes a male child consumer who "missed the third dose", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif, but missed to take the third dose, which was due on Friday as he went to another location and his mother forgot to carry medication with her.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the third dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000399:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: TOOK FIRST THREE DOSES WITH FOOD; TOOK FOURTH DOSE A DAY LATE; This spontaneous case (PVX2019-1289) was received from a pharmacist on 22-May-2019. It describes a female consumer who "took first three doses with food" and also "took fourth dose a day late". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the first three doses of Vivotif 30 min to 1 hour after eating, on every other day. Also, she took the fourth dose on 22-May-2019, which was supposed to be taken on 21-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took first three doses with food" and also "took fourth dose a day late" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took first three doses with food" and also "took fourth dose a day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE A DOSE OF VIVOTIF ON DAY 3; This spontaneous case (PVX2019-1301) was received from a pharmacist on 22-May-2019. It describes a 12-year-old female consumer who "missed to take a dose of Vivotif on day 3". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer missed to take a dose of Vivotif on day 3 (21-May-2019).  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take a dose of Vivotif on day 3" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take a dose of Vivotif on day 3" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES ON CONSECUTIVE DAYS; This spontaneous case (PVX2019-1307) was received from a consumer on 23-May-2019. It describes a male consumer who "took two doses on consecutive days". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took first two doses of Vivotif on consecutive days. The doses were taken on 20-May-2019 and 21-May-2019, respectively.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses on consecutive days" was considered as not applicable.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE LAST DOSE AS PRESCRIBED; This spontaneous case was received from a consumer on 24-May-2019. It describes a consumer who "did not take last dose as prescribed", while being on oral Vivotif capsule for a trip.  Case report: The consumer did not take the last dose as prescribed. The doses were taken on 04-May-2019, 06-May-2019, 08-May-2019, and 15-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take last dose as prescribed" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take last dose as prescribed" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED TO TAKE SECOND DOSE; This spontaneous case (PVX2019-1323) was received from a consumer on 24-May-2019. It describes a 15-year-old adolescent male consumer who "missed to take second dose", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.   Case report: The consumer took the first dose of Vivotif on 21-May-2019 and missed to take the second dose, which was due on 23-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take second dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THE SECOND DOSE; This spontaneous case (PVX2019-1343) report was received from a consumer on 24-May-2019. It describes an adolescent female consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif about one week ago and forgot to take the second dose on time.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: UNABLE TO TAKE SECOND DOSE ON TIME; This spontaneous case (PVX2019-1357) was received from physician on 28-May-2019. It describes a female consumer who was "unable to take second dose on time", while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 25-May-2019 and then, forgot to take the second dose of Vivotif, which was due on 27-May-2019.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "unable to take second dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "unable to take second dose on time" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: TOOK FIRST TWO VIVOTIF DOSES WITH ORANGE JUICE; This spontaneous case (PVX2019-1360) was received from a caregiver on 28-May-2019. It describes an 11-year-old female consumer who "took first two Vivotif doses with orange juice". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took the first two doses of Vivotif with orange juice. The doses were taken on 21-May-2019, 23-May-2019, 25-May-2019, and 27-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took first two Vivotif doses with orange juice" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first two Vivotif doses with orange juice" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: TOOK ONE PILL EACH DAY INSTEAD OF EVERY OTHER DAY; This spontaneous case (PVX2019-1361) was received from a physician on 28-May-2019. It describes a female consumer who "took one pill each day instead of every other day". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took Vivotif doses every day instead of every other day.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one pill each day instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one pill each day instead of every other day" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: DID NOT REFRIGERATE AND TOOK VIVOTIF; A spontaneous case report was received from a pharmacist on 28-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000431 (PVX2019-1351; 42-year-old female) and PVX201905-000432 (PVX2019-1352, 14-year-old female) were created and cross-linked in the database.  This case describes a 42-year-old adult female consumer who "did not refrigerate and took Vivotif". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not refrigerate Vivotif doses for 4 days and completed the course of it.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000432:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: DID NOT REFRIGERATE AND TOOK VIVOTIF; A spontaneous case report was received from a pharmacist on 28-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000431 (PVX2019-1351; 42-year-old female) and PVX201905-000432 (PVX2019-1352, 14-year-old female) were created and cross-linked in the database.  This case describes a 14-year-old adolescent female consumer who "did not refrigerate and took Vivotif". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not refrigerate Vivotif doses for 3 weeks and completed the course of it.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000431:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK 3 UNREFRIGERATED DOSES OF VIVOTIF; A spontaneous case report was received from a caregiver on 29-May-2019 for two consumers.  Based on the information obtained from a caregiver, two individual case safety reports PVX201905-000436 (PVX2019-1366; first daughter) and PVX201905-000437 (PVX2019-1367, second daughter) were created and cross-linked in the database.  This case describes a female consumer who "took 3 unrefrigerated doses of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif at 73 degree Fahrenheit and then, took three unrefrigerated doses. She took the first dose of Vivotif on 25-May-2019.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 3 unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 3 unrefrigerated doses of Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000437:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK LAST DOSE OF VIVOTIF A DAY LATE; This spontaneous case (PVX2019-1396) report was received from a caregiver on 31-May-2019. It describes a female consumer who "took last dose of Vivotif a day late". She was receiving Vivotif for an unknown indication.  Case report: The consumer took the last dose of Vivotif a day late. The doses were taken on days 1, 3, 5, and 8 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif a day late" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif a day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: TOOK  VIVOTIF WHILE ON DOXYCYCLINE; This spontaneous case (PVX2019-1399) report was received from a consumer on 31-May-2019. It describes a female consumer who "took Vivotif while on doxycline" She was receiving Vivotif for an unknown indication and doxycycline tablets (100 mg) for acne.  Case report: The consumer took Vivotif while on therapy with doxycline (100 mg). She took doxycycline daily for acne and it was a 3-month prescription.  Action taken with Vivotif and doxycline was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif while on doxycline" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif while on doxycline" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED THE DAY TO TAKE SECOND DOSE; This spontaneous case (PVX2019-1415) was received from a consumer on 01-Jun-2019. It describes a female consumer who "missed the day to take second dose", while being on Vivotif for an unknown indication.  Case report: The consumer was taking Vivotif, missed to take second dose on scheduled time (Friday) and took it on Saturday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed the day to take second dose" was unknown.  Company's Comment: The causality of the event "missed the day to take second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the day to take second dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THE THIRD DOSE A DAY LATE; This spontaneous case (PVX2019-1421) was received from a consumer on 03-Jun-2019. It describes a female consumer who "took the third dose a day late", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first and the second dose of Vivotif on 28-May-2018 and 30-May-2018, respectively. Then, she took the third dose a day late, on 02-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took the third dose a day late" was unknown.  Company's Comment: The causality of the event "took the third dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the third dose a day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1431) was received from a caregiver on 03-Jun-2019. It describes a 17-year-old female consumer who "did not take Vivotif according to schedule". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer did not take Vivotif according to the schedule. The doses were taken on 25-May-2019, 27-May-2019, 30-May-2019, and 03-Jun-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "did not take Vivotif according to schedule" was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVEL; TOOK TWO UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1443) was received from a consumer on 02-Jun-2019. It describes a 50-year-old adult female consumer who "took two unrefrigerated doses" and "did not complete her immunization one week prior to travel ", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer did not refrigerate Vivotif doses and took two doses on 31-May-2019 and 02-Jun-2019, respectively. She had a planned trip on 09-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "did not complete her immunization one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and "did not complete her immunization one week prior to travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; A spontaneous case report was received from a physician on 04-Jun-2019 for two consumers.  Based on the information obtained from the physician, two individual case safety reports PVX201906-000454 (PVX2019-1437; son) and PVX201906-000455 (PVX2019-1438, daughter) were created and cross-linked in the database.  This case describes a male consumer who "took an unrefrigerated dose of Vivotif". He was receiving Vivotif for an unknown indication.  Case report: The consumer took an unrefrigerated dose of Vivotif on 02-Jun-2019. He had no side effects.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000455:
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: TOOK VIVOTIF WITH DOXYCYCLINE; This spontaneous case (PVX2019-1419) was received from a nurse on 03-Jun-2019. It describes a 23-year-old female consumer who "took Vivotif with doxycycline". The consumer was receiving Vivotif for an unknown indication and doxycycline (100 mg; daily) for acne.  Case report: The consumer took Vivotif with doxycycline. She started doxycycline for acne before taking Vivotif and still she was taking it. However, she completed Vivotif course.  Action taken with Vivotif and doxycycline was not applicable.  The clinical outcome of the event "took Vivotif with doxycycline" was unknown.  Company's Comment: The causality of the event "took Vivotif with doxycycline" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with doxycycline" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1470) was received from a pharmacist on 07-Jun-2019. It describes an 8-year-old male child consumer who "took two doses in a row", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took two doses in a row. The doses were taken on 05-Jun-2019 and 06-Jun-2019, respectively. He had a planned trip on 12-Jun-2019 for 2 months.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK ONE DOSE OF VIVOTIF AND DID NOT COMPLETE THE REMAINING DOSES; This spontaneous case (PVX2019-1460) was received from a consumer on 06-Jun-2019. It describes a female consumer who "took one dose of Vivotif and did not complete the remaining doses". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took only a dose of Vivotif on 31-May-2019. Then, left the remaining doses out of the refrigerated and did not take the remaining unrefrigerated doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one dose of Vivotif and did not complete the remaining doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of Vivotif and did not complete the remaining doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ALL UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1485) was received from a pharmacist on 10-Jun-2019. It describes an adult male consumer who "took all unrefrigerated doses of Vivotif." The consumer was receiving oral Vivotif (one capsule every other day) (lot number: 3003272) for typhoid prophylaxis.  Case report: The consumer did not place the Vivotif in proper storage condition and took all the doses. The first dose was taken on 01-Jun-2019 and the last dose on 07-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ALL UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1487) was received from a pharmacist on 10-Jun-2019. It describes a 22-year-old adult female consumer who "took all unrefrigerated doses of Vivotif". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all the unrefrigerated doses of Vivotif last week. She had a planned trip on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Ear infection
Clinical narrative: EAR INFECTION; This spontaneous case (PVX2019-1575) report was received from a pharmacist on 17-Jun-2019. It describes a male consumer who developed ear infection, after the administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif and his last dose was due on 18-Jun-2019. He developed ear infection on 16-Jun-2019.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  The reporter considered the event unrelated to Vivotif.  Company's Comment: In this case, a male consumer developed ear infection, after the administration of oral Vivotif. Due to the fact that ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, a male consumer developed ear infection, after the administration of oral Vivotif. Due to the fact that ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Labelled drug-drug interaction medication error, Urinary tract infection
Clinical narrative: TOOK BACTRIM WHILE ON VIVOTIF; URINARY TRACT INFECTION; This spontaneous case report (PVX2019-2101) was received from a consumer on 14-Aug-2019. It described a 54-year-old adult female consumer who had "urinary tract infection" (UTI) (PT: Urinary tract infection), after the administration of Vivotif capsule for an unknown indication. She "took Bactrim while on Vivotif" (PT: Labelled drug-drug interaction medication error) for UTI.  Case report: The consumer took two doses of Vivotif two months ago. On fourth day of Vivotif therapy, she got UTI. The consumer took Bactrim (sulfamethoxazole) as a treatment for 7 days. It was reported that, within the third dose of Bactrim, the UTI symptoms went away. She stated that she did not have UTI in 25 years and thought maybe it was a coincidence.  The consumer's medical history included cold sores, hormones imbalance, and also she had a pacemaker.  Concomitant medication included hydrochlorothiazide and spironolactone as diuretics, estradiol for hormones and Valtrex (valacyclovir) for cold sores.  Action taken with Vivotif with respect to the event "urinary tract infection" was unknown, while with respect to the event "took Bactrim while on Vivotif" was not applicable. Action taken with Bactrim with reported events was not applicable.  The clinical outcome of the event "urinary tract infection" was resolved, while that of the event "took Bactrim while on Vivotif" was unknown.  Company's Comment: In this case, the consumer developed urinary tract infection (UTI) after receiving Vivotif vaccine. Due to the fact that UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Bactrim while on Vivotif" was considered as not applicable.  Follow-up information was received on 04-Nov-2019 with number (PVX2019-2733).  Additional reported nurse was added.  The start date of UTI was confirmed as May-2019. ; Sender's Comments: Company's Comment: In this case, the consumer developed urinary tract infection (UTI) after receiving Vivotif vaccine. Due to the fact that UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Bactrim while on Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; This spontaneous case report (PVX2019-2384) received from a pharmacist on 20-Sep-2019. It described a female consumer who developed urinary tract infection (UTI) (PT: Urinary tract infection), while on therapy with Vivotif for an unknown indication.  Case report: The consumer started taking Vivotif and developed urinary tract infection. She did not know the exact date when the bladder infection began, it might have started after taking Vivotif. She was prescribed ciprofloxacin (500 mg, one tablet twice daily for 10 days) for bladder infection. It was reported that the consumer was due to finish Vivotif on Saturday. The consumer had not started ciprofloxacin until the time of report.  The patient's medical history included UTI. She had no known drug allergies.  Concomitant medications included aspirin (81 mg; once daily) and inhaler ProAir HFA (albuterol sulfate; 90 mcg, 1-2 puffs every 3 or 4 hours as needed for quick relief).  Action taken with Vivotif with respect to the event was unknown.  The consumer had not recovered from the reported event.  Company's Comment: In this case, the consumer developed urinary tract infection (UTI) after starting Vivotif vaccine. Due to the fact that UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, the consumer developed urinary tract infection (UTI) after starting Vivotif vaccine. Due to the fact that UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Atypical pneumonia, Ear infection
Clinical narrative: EAR INFECTION; WALKING PNEUMONIA; This spontaneous case report (PVX2019-2529) was received from a nurse on 09-Oct-2019. It described a male consumer who developed walking pneumonia (PT: Atypical pneumonia) and an ear infection (PT: Ear infection), while being on oral Vivotif one dose every other day for typhoid fever.  Case report: The consumer took three doses of Vivotif as per schedule.  On an unknown date, he was diagnosed with walking pneumonia and an ear infection and it was getting worse. He was prescribed an antibiotic, but he did not started it.   Action taken with Vivotif with respect to reported events was unknown.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, the patient developed walking pneumonia and an ear infection after receiving Vivotif vaccine. Due to the fact that walking pneumonia and an ear infection are infectious in etiology the causality of the event was assessed as unlikely with Vivotif. ; Sender's Comments: Company's Comment: In this case, the patient developed walking pneumonia and an ear infection after receiving Vivotif vaccine. Due to the fact that walking pneumonia and an ear infection are infectious in etiology the causality of the event was assessed as unlikely with Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Mild fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient wanted to know did the vaccine cause a mild fever.
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching, Neuralgia
Clinical narrative: caused muscles to twitch; nerves fired up; This case was reported by a consumer and described the occurrence of muscle twitching in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix 50 mcg at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle twitching and nerve pain. On an unknown date, the outcome of the muscle twitching and nerve pain were recovered/resolved.   It was unknown if the reporter considered the muscle twitching and nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, received Shingrix vaccine early in the morining and experienced side effect by super time. The reporter stated that, after vaccination, the patient experienced nerve fired up which causesed muscle to twitch. The reporter stated that, side effects gone by lunch next day.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain in extremity, Sleep disorder
Clinical narrative: says arm hurt bad enough that it impacted sleep; it impacted sleep; Reports doesn't feel well; is very tired; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2020, the patient received the 1st dose of Shingrix .5 ml. In April 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, sleep disturbance, feeling unwell and tiredness. On an unknown date, the outcome of the pain in arm, feeling unwell and tiredness were not recovered/not resolved and the outcome of the sleep disturbance was unknown.   The reporter considered the pain in arm, sleep disturbance, feeling unwell and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient's age could be 55 or 56 years old. Reporter said arm hurt bad enough that it impacted sleep.  Reporter does not feel well, was very tired.  Reporter believed the events to be related to vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: They are noticing some strange reactions to Shingrix; This case was reported by a consumer and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The reporter mentioned that physician was noticing some strange reactions to Shingrix. This case is linked to the case US2020AMR059714 and US2020AMR059707 reported by the reporter for herself.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the wife of the patient. The age at the vaccination was not reported. The reporter was checking to see how long side effects last, her husband got his shot yesterday (the day of reporting) and had started have a low grade fever.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Injection site myalgia; First dose of Shingrix on 31May2019, the second dose on 6Aug2019 and a third dose on 7Mar2020; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.    Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 9th March 2020 (please refer case US2020043599 )) and Shingrix (2nd dose received 6th August 2019).   On 7th March 2020, the patient received the 3rd dose of Shingrix. On 7th March 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were received as follows: The patient received 3rd dose, which led to extra dose administered. The reporter consented to follow up. Pharmacist did not provide date of birth of the patient nor expiration date and batch number of the vaccines.   Upon internal review, the following correction were made on 7th April 2020 as follows: On 6th August 2019, the patient received the 2nd dose of Shingrix, less than 9 months after vaccination, experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain were unknown.  It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: some patients have experienced nerve damage after getting the Shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of nerve damage in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve damage. On an unknown date, the outcome of the nerve damage was unknown.   It was unknown if the reporter considered the nerve damage to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The reporter stated that her girl friend told her that some patients had experienced nerve damage after getting the Shingrix vaccine. No further details were provided. This case is linked to the case US2020058350, reported for the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: Flu; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter did not had any patient or vaccine details as the customer mentioned that was at home and does not have any data at the moment. The age group was selected as an adult as per indicated age of Shingrix. Pharmacist called asking for medical information for a patient that receive the first dose of Shingrix and due to the social distancing and the situation with the COVID-19 would not be able to come to get the second dose. Also mentioned that the patient did not came for the second dose due to a flu. Consented to follow up. This case is linked to the case US2020059042, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Seizure
Clinical narrative: Seizure; received a third dose; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received both doses in 2019, but did not recall the exact date on pharmacy).   On 3rd March 2020, the patient received the 3rd dose of Shingrix (intramuscular). On 3rd March 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. In April 2020, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure and extra dose administered were unknown.   It was unknown if the reporter considered the seizure to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient's wife. The patient received 3rd dose of Shingrix on left upper deltoid at the clinic, which led to extra dose administered. A month after vaccination, the patient experienced seizure and was wondering if the cause of the seizure is related to receiving the third dose. The patient referred to their healthcare professional. The reporter consented to follow up.