chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2650) was received from a pharmacist on 24-Oct-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took a dose of Vivotif on 24-Oct-2019 which had been left at room temperature for two months.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.   Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THREE UNREFRIGERATED DOSES; DID NOT TAKE DOSES ON SCHEDULE; This spontaneous case report (PVX2019-2653) was received from a pharmacist on 24-Oct-2019. It described a female consumer who "took three unrefrigerated doses" (PT: Product storage error), and "did not take doses on schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took one dose of refrigerated Vivotif and then left Vivotif unrefrigerated for seven days before completing the rest of the doses.  Action taken with Vivotif with respect to reported event was not applicable.   The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses", and "did not take doses on schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses", and "did not take doses on schedule" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK LAST DOSE OF VIVOTIF THAT WAS FROZEN; A spontaneous case report was received from a consumer on 24-Oct-2019 for two consumers.   Based on the information obtained from the consumer two individual case safety report PVX201910-000818 (PVX2019-2655; husband) and PVX201910-000819 (PVX2019-2658; wife) were created and cross-linked in the database.   This case (PVX2019-2658) described a female consumer who "took last dose of Vivotif that was frozen" (PT: Product storage error), while being on Vivotif capsule for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif. Then, on 18-Oct-2019, she took last dose that was frozen.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable. US-PVX201910-000818:
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT CONTINUE THE VIVOTIF AFTER TAKING FIRST DOSE; A spontaneous case report was received from a nurse on 25-Oct-2019 for two consumers.  Based on the information obtained from the nurse two individual case safety report PVX201910-000826 (PVX2019-2664; first consumer) and PVX201910-000829 (PVX2019-2665; second consumer) were created and cross-linked in the database.  This case (PVX2019-2664) described a female consumer who "did not continue the Vivotif after taking first dose" (PT: Incomplete course of vaccination), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-Oct-2019. It was reported that she was traveling on 29-Oct-2019, so she will be receiving the injectable typhoid vaccine instead and not continuing the Vivotif.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported 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. US-PaxVax Berna GmbH-PVX201910-000829:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK VIVOTIF THAT WAS NOT REFRIGERATED; This spontaneous case report (PVX2019-2667) was received from a pharmacist on 25-Oct-2019. It described an adult female consumer who "took Vivotif that was not refrigerated" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer did not refrigerate the Vivotif doses and completed full course from 18-Oct-2019 to 24-Oct-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif that was not refrigerated" was considered as not applicable. .; Sender's Comments: Company's Comment: The causality of the event "took Vivotif that was not refrigerated" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: WOULD NOT BE ABLE TO TAKE THE LAST DOSE; This spontaneous case report (PVX2019-2670) was received from a pharmacist on 25-Oct-2019. It described a female consumer who "would not be able to take the last dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 19-Oct-2019. She did not refrigerate her last dose, which was due on 25-Oct-2019. Hence, she did not take it. Also, her pharmacist was unable to provide the replacement on 25-Oct-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "would not be able to take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "would not be able to take the last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT CONTINUE THE VIVOTIF AFTER TAKING FIRST DOSE; A spontaneous case report was received from a nurse on 25-Oct-2019 for two consumers.  Based on the information obtained from the nurse two individual case safety report PVX201910-000826 (PVX2019-2664; first consumer) and PVX201910-000829 (PVX2019-2665; second consumer) were created and cross-linked in the database.  This case (PVX2019-2665) described a female consumer who "did not continue the Vivotif after taking first dose" (PT: Incomplete course of vaccination), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-Oct-2019. It was reported that she was traveling on 29-Oct-2019, so she will be receiving the injectable typhoid vaccine instead and not continuing the Vivotif.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not continue the Vivotif after taking first dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not continue the Vivotif after taking first dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201910-000826:
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK THIRD DOSE OF VIVOTIF WITH SUGAR FREE GATORADE; This spontaneous case report (PVX2019-2685) was received from consumer on 28-Oct-2019. It described a 13-year-old male consumer who "took third dose of Vivotif with sugar free Gatorade" (PT: Product administration error), while being on oral Vivotif for typhoid fever.  Case report: The consumer took the third dose of Vivotif with sugar-free Gatorade on 26-Oct-2019. Then, after taking Vivotif, he ate a handful of chex cereal and potato chips.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took third dose of Vivotif with sugar free Gatorade" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose of Vivotif with sugar free Gatorade" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2689) was received from a pharmacist on 29-Oct-2019. It described a male consumer who "took an unrefrigerated dose of Vivotif" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: It was reported that the consumer took a dose of unrefrigerated Vivotif after it had been left out for multiple days.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported 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: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT CONTINUE VIVOTIF ON TIME AFTER TAKING TWO DOSES; This spontaneous case report (PVX2019-2694) was received from a non-healthcare professional on 29-Oct-2019. It described a male consumer who "did not continue Vivotif on time after taking two doses" (PT: Incomplete course of vaccination), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took only first and second dose of Vivotif on 14-Oct-2019 and 16-Oct-2019 respectively. Later, he did not take the remaining doses.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not continue Vivotif on time after taking two doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not continue Vivotif on time after taking two doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: DID NOT STORE CAPSULES IN FRIDGE ONCE SOLD, CONTINUED TO TAKE THAT DOSAGE SCHEDULE; This spontaneous case report (PVX2019-2730) was received on 29-Oct-2019. It described a 61-years-old adult female consumer who "did not store capsules in fridge once sold, continued to take that dosage schedule" (PT: Product storage error), while being on Vivotif capsule for unknown indication.  Case report: The consumer did not store Vivotif in fridge and continued to take it. Then, she got another prescription and took dose schedule again.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not store capsules in fridge once sold, continued to take that dosage schedule" was considered as not applicable. .; Sender's Comments: Company's Comment: The causality of the event "did not store capsules in fridge once sold, continued to take that dosage schedule" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case report (PVX201910-000844) was received from a consumer on 04-Nov-2019. It described a female consumer who "took an unrefrigerated dose of Vivotif" (PT: Product storage error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took an unrefrigerated dose of Vivotif.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported 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: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: FORGOT TO TAKE THE SECOND DOSE OF VIVOTIF ON DAY 3; This spontaneous case report (PVX2019-2728) was received from a consumer on 04-Nov-2019. It described a male consumer who "forgot to take the second dose of Vivotif on day 3" (PT: Product dose omission), while being on oral Vivotif for typhoid fever.  Case report: It was reported that the consumer forgot to take the second dose of Vivotif which was scheduled on 03-Nov-2019.  Action taken with Vivotif with respect reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take the second dose of Vivotif on day 3" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take the second dose of Vivotif on day 3" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: FORGOT TO REFRIGERATE AND TOOK ALL FOUR DOSES; This spontaneous case report (PVX2019-2749) was received from a pharmacist on 06-Nov-2019. It described a 67-year-old elderly female consumer who "forgot to refrigerate and took all four doses" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case Report- The consumer took all the four doses of Vivotif which were unrefrigerated.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to refrigerate and took all four doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to refrigerate and took all four doses" 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 report (PVX2019-2743) was received from a nurse on 05-Nov-2019. It described a female consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever.  Case report: The consumer did not take Vivotif according to schedule. The doses were taken on 29-Oct-2019, 31-Oct-2019, 03-Nov-2019, and 05-Nov-2019.   Action taken with Vivotif with respect to reported event was not applicable.  The outcome of the reported event 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: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF ON DAYS 1 AND 2; This spontaneous case report (PVX2019-2759) was received from a pharmacist on 07-Nov-2019. It described a male consumer who "took Vivotif on days 1 and 2" (PT: Inappropriate schedule of product administration). He was receiving oral Vivotif for typhoid fever.  Case report: The consumer took his first and second dose of Vivotif on consecutive days. He took the first dose on 05-Nov-2019 and took second dose on 06-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif on days 1 and 2" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on days 1 and 2" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK FIRST DOSE OF VIVOTIF WITH FOOD; This spontaneous case report (PVX2019-2783) was received from a consumer on 11-Nov-2019. It described a female consumer who "first dose of Vivotif with food" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took her first dose of Vivotif with food on 09-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "first dose of Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "first dose of Vivotif with food" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE ONE DAY LATE; This spontaneous case report (PVX2019-2785) was received from a consumer on 11-Nov-2019. It described a 29-year-old adult male consumer who "took second dose one day late" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 07-Nov-2019. Then, he took the second dose on 10-Nov-2019 instead of on 09-Nov-2019   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took second dose one day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose one day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THE LAST DOSE OF VIVOTIF LATE; This spontaneous case report (PVX2019-2782) was received from a consumer on 12-Nov-2019. It described a female consumer who "took the last dose of Vivotif late" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif according to the schedule. The doses were taken on 03-Nov-2019, 05-Nov-2019, and 07-Nov-2019, respectively. Then, she took her last dose on 12-Nov-2019.   Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took the last dose of Vivotif late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the last dose of Vivotif late" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE THE LAST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2789) was received from a consumer on 12-Nov-2019. It described a male consumer who "missed to take the last dose of Vivotif" (PT: Product dose omission). She was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif. Then, He lost his last dose. Thus, did not take it on 11-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take the last dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take the last dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK LAST DOSE OF VIVOTIF ONE DAY LATE; This spontaneous case report (PVX2019-2790) was received from a nurse on 12-Nov-2019. It described an 18-year-old female consumer who "took last dose of Vivotif one day late" (PT: Inappropriate schedule of product administration). The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif according to schedule but took the fourth dose one day late.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif one day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif one day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2794) was received from a pharmacist on 12-Nov-2019. It described an adult female consumer who "took unrefrigerated Vivotif" (PT: Product storage error). She was receiving Vivotif for an unknown indication.  Case report: The consumer did not refrigerate Vivotif since picking it up on 06-Nov-2019 and had taken the first dose on the same day. It was reported that he did not know how many unrefrigerated doses she took.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF WITH FOOD; This spontaneous case report (PVX2019-2777) was received from a pharmacist on 11-Nov-2019. It described a 21-year-old female consumer who "took Vivotif with food" (PT: Product administration error). She was receiving oral Vivotif for typhoid fever.  Case report: The consumer took her second or third dose of Vivotif with food last month.   Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED TO TAKE LAST DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-2779) was received from a consumer on 11-Nov-2019. It described a female consumer who "missed to take last dose of Vivotif according to schedule" (PT: Product dose omission), while being on oral Vivotif for typhoid fever.  Case report: The consumer missed to take the last dose of Vivotif, which was due on 10-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed to take last dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last dose of Vivotif according to schedule" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT COMPLETE VIVOTIF PRIOR TO TRAVELING TO THE ENDEMIC AREA; This spontaneous case report (PVX2019-2798) was received from a pharmacist on 12-Nov-2019. It described a 33-year-old female consumer who "did not complete Vivotif prior to traveling to the endemic area" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took first dose of Vivotif on 11-Nov-2019 and would traveling to the endemic area on 13-Oct-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not complete Vivotif prior to traveling to the endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete Vivotif prior to traveling to the endemic area" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE LAST DOSE ON DAY SEVEN; This spontaneous case report (PVX2019-2802) was received from a nurse on 13-Nov-2019. It described a 68-year-old female consumer who "missed to take last dose on day seven" (PT: Product dose omission), while being on oral Vivotif for typhoid fever.  Case report: The consumer took three doses of Vivotif on 04-Nov-2019, 06-Nov-2019, and on 08-Nov-2019, respectively. However, she missed to take the fourth dose on 10-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take last dose on day seven" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last dose on day seven" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE LAST DOSE ON TIME; This spontaneous case report (PVX2019-2828) was received from a consumer on 15-Nov-2019. It described a female consumer who "did not take last dose on time" (PT: Product dose omission). She was receiving oral Vivotif (lot number: 3003297) for typhoid fever prophylaxis.  Case report: The consumer started Vivotif on 04-Nov-2019. She reported that the last dose of Vivotif fell out of the refrigerator on either 08-Nov-2019 or 09-Nov-2019. Thus, she did not take the last dose of Vivotif on 10-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take last dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take last dose on time" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF 15 MINUTES AFTER EATING; This spontaneous case report (PVX2019-2872) was received from a consumer on 21-Nov-2019. It described a female consumer who "took Vivotif 15 minutes after eating" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif 15 minutes after eating on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "took Vivotif 15 minutes after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif 15 minutes after eating" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: DID NOT REFRIGERATE AND TOOK ALL FOUR DOSES; TOOK HER FIRST DOSE IN THE CAR AFTER PICKING IT UP BUT NOTED THAT IT WAS NOT COLD/PHARMACY DID NOT TELL HER TO REFRIGERATE IT OR PROVIDED ANY LEAFLETS OR LABELS ABOUT IT; This spontaneous case report (PVX2019-2874) was received from a consumer on 21-Nov-2019. It described a 31-year-old adult female consumer who "took first dose in the car after picking it up but noted that it was not cold/ pharmacy did not tell her to refrigerate it or provided any leaflets or labels about it" (PT: Product dispensing issue), thus she "did not refrigerate and took all four doses" (PT: Product storage error). She was receiving Vivotif for medical missions.  Case report: The consumer picked Vivotif doses from a pharmacy on 14-Nov-2019, but was not informed to refrigerate it and also did not provide any leaflets or labels about it. Then, she took the first dose in the car after picking it up but noted that it was not cold. She finished the last dose on 20-Nov-2019.  Action taken with Vivotif with respect to reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "took first dose in the car after picking it up but noted that it was not cold/ pharmacy did not tell her to refrigerate it or provided any leaflets or labels about it" and "did not refrigerate and took all four doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took first dose in the car after picking it up but noted that it was not cold/ pharmacy did not tell her to refrigerate it or provided any leaflets or labels about it" and "did not refrigerate and took all four doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE FOUR GRAPES HALF AN HOUR AFTER HER FIRST DOSE; This spontaneous case report (PVX2019-2877) was received from a consumer on 21-Nov-2019. It described a female consumer who "ate four grapes half an hour after her first dose" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 21-Nov-2019 but ate four grapes half an hour after taking it.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient had taken her first Vivotif dose and then after half an hour she ate four grapes (Product administration error). Vivotif dose should be taken one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient had taken her first Vivotif dose and then after half an hour she ate four grapes (Product administration error). Vivotif dose should be taken one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Pregnancy test positive
Clinical narrative: GOT A POSITIVE RESULT ON HER PREGNANCY TEST; TOOK DOSES IN AN INAPPROPRIATE SCHEDULE; This spontaneous case report (PVX2019-2881) was received from a pharmacist on 20-Nov-2019. It described a 40-year-old female consumer who "got a positive result on her pregnancy test" (PT: Exposure during pregnancy) and "took doses in an inappropriate schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took Vivotif in an inappropriate schedule. She started the course on 06-Nov-2019 and completed on 14-Nov-2019. She reported that she was four days late on her period, therefore she did a pregnancy test at home on Monday and the result was positive. She did not confirm her pregnancy by her healthcare professional yet. She had an appointment with healthcare professional to confirm her pregnancy.   Action taken with Vivotif with respect to the reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "got a positive result on her pregnancy test" and "took doses in an inappropriate schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "got a positive result on her pregnancy test" and "took doses in an inappropriate schedule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK VIVOTIF THAT WAS STORED ABOVE THE RECOMMENDED TEMPERATURE RANGE; A spontaneous case report was received from a consumer on 21-Oct-2019 for two consumers.  Based on the information obtained from the consumer two individual case safety report PVX201911-000893 (PVX2019-2878; husband) and PVX201911-000894 (PVX2019-2879; wife) were created and cross-linked in the database.  This case (PVX2019-2878) described a male consumer who "took Vivotif that was stored above the recommended temperature range" (PT: Product storage error). He was receiving oral Vivotif (lot number: 3003297 and expiry date: Sep 2020) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif in his refrigerator above the recommended temperature range for the whole time (52-degree Fahrenheit), and took the first dose of Vivotif on 15-Nov-2019 and his last dose was due on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported events was unknown.  Company Comment: A patient took Vivotif doses where the Vivotif was stored above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.  Additional information (PVX2019-2895) was received by a healthcare professional on 27-Nov-2019.   It was reported that the consumer completed the course of Vivotif. The storage requirement for Vivotif was 36-46 Fahrenheit and the consumer set the refrigerator at 40 Fahrenheit. But the temperature reading on thermometer showed 52 Fahrenheit.  Company Comment: A patient took Vivotif doses where the Vivotif was stored above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient took Vivotif doses where the Vivotif was stored above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. US-PaxVax Berna GmbH-PVX201911-000894:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK VIVOTIF THAT WAS STORED ABOVE THE RECOMMENDED TEMPERATURE RANGE; A spontaneous case report was received from a consumer on 21-Oct-2019 for two consumers.  Based on the information obtained from the consumer two individual case safety report PVX201911-000893 (PVX2019-2878; husband) and PVX201911-000894 (PVX2019-2879; wife) were created and cross-linked in the database.  This case (PVX2019-2879) described a female consumer who "took Vivotif that was stored above the recommended temperature range" (PT: Product storage error). She was receiving oral Vivotif (lot number: 3003297 and expiry date: Sep 2020) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif in her refrigerator which was above the recommended temperature range for the whole time (52 degree Fahrenheit). She took the first dose of Vivotif on 15-Nov-2019 and her last dose was due on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported events was unknown.  Company Comment: A patient took Vivotif doses where the Vivotif was stored in her refrigerator that was above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.  Additional information (PVX2019-2895) was received by a healthcare professional on 27-Nov-2019:  It was reported that the consumer completed the course of Vivotif. The storage requirement for Vivotif was 36-46 Fahrenheit and the consumer set the refrigerator at 40 Fahrenheit. But, the temperature reading on thermometer showed 52 Fahrenheit.  The lot number was confirmed as 3003289.  Company Comment: A patient took Vivotif doses where the Vivotif was stored in her refrigerator that was above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient took Vivotif doses where the Vivotif was stored in her refrigerator that was above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. US-PaxVax Berna GmbH-PVX201911-000893:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK 2 DOSES OF VIVOTIF ON THE SAME DAY; This spontaneous case report (PVX2019-2888) was received from a pharmacist on 22-Nov-2019. It described a female consumer who "took 2 doses of Vivotif on the same day" (PT: Overdose), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: On an unknown date, the consumer took two doses of Vivotif and then stopped taking Vivotif.   Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient took 2 doses of Vivotif on the same day (Overdose). The reason for taking two doses on the same day and further details of the event is limited. Vivotif dose should be taken every other day as per CCDS. Considering the nature of the event, the causality of the event overdose is assessed as not related to Vivotif.; Sender's Comments: A patient took 2 doses of Vivotif on the same day (Overdose). The reason for taking two doses on the same day and further details of the event is limited. Vivotif dose should be taken every other day as per CCDS. Considering the nature of the event, the causality of the event overdose is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: LEFT VIVOTIF UNREFRIGERATED FOR A WEEK BEFORE TAKING 2 DOSES; This spontaneous case report (PVX2019-2891) was received from a consumer on 22-Nov-2019. It described a male consumer who "left Vivotif unrefrigerated for a week before taking 2 doses" (PT: Product storage error), while being on oral Vivotif (lot number: 3003303) for typhoid fever prophylaxis.  Case report: The consumer stated that he took two doses of Vivotif, which have been left unrefrigerated for a week. He took the second dose on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient took two unrefrigerated doses of Vivotif (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient took two unrefrigerated doses of Vivotif (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE LAST DOSE ON TIME; This spontaneous case report (PVX2019-2904) was received from a consumer on 25-Nov-2019. It described a female consumer who "did not take last dose on time" (PT: Product dose omission) while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer reported that she had completed 3 doses of Vivotif but, she did not take her last dose of Vivotif which was due on 24-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company Comment: A patient did not take her last Vivotif dose on due date (Missed dose). Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.; Sender's Comments: A patient did not take her last Vivotif dose on due date (Missed dose). Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: DID NOT REFRIGERATE VIVOTIF FOR TWO MONTHS AND TOOK TWO DOSES FROM IT; This spontaneous case report (PVX2019-2906) was received from a consumer on 25-Nov-2019. It described a female consumer who "did not refrigerate Vivotif for two months and took two doses from it" (PT: Product storage error). She was receiving Vivotif (lot number: 3003297 and expiry date: Sep 2020) for an unknown indication.  Case report: The consumer did not know Vivotif doses had to be refrigerated and she took first two doses on 23-Nov-2019 and 25-Nov-2019 respectively. Later, she noticed Vivotif need to be refrigerated. Thus, she wanted a replacement.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not refrigerate Vivotif for two months and took two doses from it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not refrigerate Vivotif for two months and took two doses from it" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE GRAPES 30 MINUTES AFTER TAKING FIRST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2925) was received from a consumer on 27-Nov-2019. It described a female consumer who "ate grapes 30 minutes after taking first dose of Vivotif" (PT: Product administration error). She was receiving oral Vivotif (lot number: 3003296) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 27-Nov-2019 and after 30 minutes she ate grapes.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "ate grapes 30 minutes after taking first dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate grapes 30 minutes after taking first dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: DID NOT TAKE SECOND DOSE ON TIME; This spontaneous case report (PVX2019-2935) was received from a consumer on 27-Nov-2019. It described a female consumer who "did not take second dose on time" (PT: Product dose omission), while being on oral Vivotif (lot number: 3003297) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-Nov-2019 and then she left Vivotif unrefrigerated for 2 days after taking the first dose. She did not take the second dose which was due on 26-Nov-2019 as the vaccine was no longer good to use.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: It was reported that a consumer did not take the second dose of Vivotif on due date (missed dose) as she left the Vivotif unrefrigerated for two days after taking the first dose. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.; Sender's Comments: It was reported that a consumer did not take the second dose of Vivotif on due date (missed dose) as she left the Vivotif unrefrigerated for two days after taking the first dose. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE FOOD 20 MINUTES AFTER TAKING VIVOTIF; This spontaneous case report (PVX2019-2924) was received from a consumer on 26-Nov-2019. It described a 42-year-old male consumer who "ate food 20 minutes after taking Vivotif" (PT: Product administration error). He was receiving oral Vivotif for a typhoid fever.  Case report: The consumer took his first dose of Vivotif and then ate food 20 min later.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "ate food 20 minutes after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate food 20 minutes after taking Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK COURSE OF UNREFRIGERATED VIVOTIF; A spontaneous case report was received from a consumer on 02-Dec-2019.  Based on the information obtained from the consumer two individual case safety report PVX201912-000916 (PVX2019-2938) and PVX201912-000917 (PVX2019-2939) were created and cross-linked in the database.  This case (PVX2019-2938) described a female consumer who "took course of unrefrigerated Vivotif" (PT: Product storage error). She received Vivotif for typhoid prophylaxis.  Case report: The consumer left Vivotif doses out of refrigerator for at least a week and then took all doses. It was reported that it had occurred about a month ago.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer left Vivotif out of the refrigerator for at least a week and then took the entire course of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer left Vivotif out of the refrigerator for at least a week and then took the entire course of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. US-PaxVax Berna GmbH-PVX201912-000917:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES OF VIVOTIF IN A ROW; This spontaneous case report (PVX2019-2942) was received from a pharmacist on 02-Dec-2019. It described a 7-year-old female consumer who "took two doses of Vivotif in a row" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for an unknown indication.  Case report: The consumer took first two doses of Vivotif in a row, which were taken a day apart.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company Comment: A consumer tool first two doses of Vivotif a day apart (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer tool first two doses of Vivotif a day apart (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK 4 DOSES OF VIVOTIF THAT WAS UNREFRIGERATED FOR 2 DAYS; This spontaneous case report (PVX2019-2946) was received from a pharmacist on 02-Dec-2019. It described a consumer who "took four doses of Vivotif that was unrefrigerated for 2 days" (PT: Product storage error). She was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer left Vivotif unrefrigerated for 2 days and then refrigerated afterwards. However, the consumer took all the doses from it. It was reported that this was happened last year.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company Comment: A consumer left Vivotif unrefrigerated for 2 days and then refrigerated it afterwards and completed the full course of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer left Vivotif unrefrigerated for 2 days and then refrigerated it afterwards and completed the full course of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.