chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TTOX, TYP
Symptoms: Influenza, Influenza virus test positive, Pyrexia, Respiratory tract congestion
Clinical narrative: INFLUENZA; This spontaneous case report was received from a nurse (PVX2019-346) on 07-Feb-2019 and an additional information on 11-Feb-2019. The report describes a 20-year-old adult male consumer who had influenza following the intake of oral Vivotif capsule (one dose every other day) for typhoid prophylaxis.   The consumer had a history of mono (Epstein Barr) about 4 to 5 years ago.  The consumer's concomitant medication included Tetanus shot (tetanus and diphtheria toxoid) which was received on Monday (04-Feb-2019).  It was reported that the consumer took the first dose of Vivotif on 04-Feb-2019. On 06-Feb-2019, he had high fever (102.6 degree Fahrenheit) and felt congestion. In the middle of the night, it was down to 100.6 degree Fahrenheit. On 07-Feb-2019, his temperature was 100 degree Fahrenheit. She stated that fever did not came back yet and was staying down.   An additional information was received on 11-Feb-2019 stated that the consumer was diagnosed with influenza. Furthermore, he did not take any other medications for his symptoms of congestion and fever.  The action taken with Vivotif with respect to the event influenza was dosage discontinued.  The clinical outcome of the event influenza was resolving.  Company's Comment: In this case, a 20-year-old male consumer developed influenza following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event influenza. However, the event influenza is an infectious condition with commonly viral etiology. Hence, the causality of the event influenza is assessed as unlikely with Vivotif vaccine. ; Sender's Comments: Company's Comment: In this case, a 20-year-old male consumer developed influenza following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event influenza. However, the event influenza is an infectious condition with commonly viral etiology. Hence, the causality of the event influenza is assessed as unlikely with Vivotif vaccine.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: FORGOT TO TAKE THIRD AND FOURTH DOSE OF VIVOTIF ON TIME; A spontaneous case report was received from a pharmacist on 17-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000389 (PVX2019-1238; wife) and PVX201905-000390 (PVX2019-1239, husband) were created and cross-linked in the database.  This case describes a female consumer who "forgot to take third and fourth dose of Vivotif on time". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif on 10-May-2019 and 12-May-2019, respectively. Then, she forgot to take the remaining doses.  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 take third and fourth dose of Vivotif on time" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "forgot to take third and fourth dose of Vivotif on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000390:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not take Vivotif according to schedule; Spontaneous report received on 05DEC2019.  A pharmacist reported that a 31-year-old female consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever. On 22NOV2019 and 24NOV2019, the consumer took first and second dose of Vivotif respectively. Then, she did not take her remaining two doses according to schedule. Action taken with Vivotif with respect to the reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer did not take last two doses of Vivotif according to the schedule (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer did not take last two doses of Vivotif according to the schedule (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took two doses daily for 2 consecutive days; Spontaneous report received on 07DEC2019. Follow up information was received on 11DEC2019.  A pharmacist reported that a female consumer "took two doses daily for 2 consecutive days" (PT: Inappropriate schedule of product administration), while being on Vivotif for immunisation. The consumer took the first two doses of Vivotif on consecutive days and took the remaining two doses on every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first two doses of Vivotif daily for two consecutive days (Inappropriate schedule of vaccine administration). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer took first two doses of Vivotif daily for two consecutive days (Inappropriate schedule of vaccine administration). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took three doses of Vivotif which were unrefrigerated; Spontaneous report received on 09DEC2019.  A female consumer reported that she "took three doses of Vivotif which were unrefrigerated" (PT: Product storage error). She was receiving oral Vivotif (lot number: 3003297; expiry date: SEP2020) for typhoid fever prophylaxis/ trip. The consumer took the first dose of Vivotif, which was left unrefrigerated. Then she refrigerated the remaining dose after her first dose. However, she took three doses of Vivotif that were already unrefrigerated. She took the third dose of Vivotif on 08DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. Outcome of the reported event was unknown at the time of report.  Company Comment: A consumer took three doses of Vivotif which were unrefrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer took three doses of Vivotif which were unrefrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not complete the Vivotif course; Spontaneous report received on 09DEC2019.  A healthcare professional reported that a 15-year-old female consumer "did not complete the Vivotif course" (PT: Incomplete course of vaccination). She was receiving oral Vivotif for typhoid fever. The consumer did not take the last dose of Vivotif on 30NOV2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take the last dose of Vivotif and did not complete the Vivotif course (Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related. ; Sender's Comments: A consumer did not take the last dose of Vivotif and did not complete the Vivotif course (Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed her third dose of Vivotif; Spontaneous report received on 13DEC2019.  A pharmacist reported that a female consumer who "missed her third dose of Vivotif" (PT: Product dose omission), while being on Vivotif for typhoid prophylaxis. The consumer took first two doses of Vivotif on 07DEC2019 and 09DEC2019 respectively. Then, she did not take any further doses, so she had two doses left till now. Action taken with Vivotif with respect to reported event was not applicable. At the time of report, the outcome of the reported event was unknown.  Company Comment: A consumer missed her third dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.; Sender's Comments: A consumer missed her third dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Drank some herbal tea 30 minutes after last dose of Vivotif; Spontaneous report received on 13DEC2019.  A female consumer reported that she "drank some herbal tea 30 minutes after taking the last dose of Vivotif" (PT: Product administration error) while being on oral Vivotif for typhoid fever prophylaxis. One year before reporting, the consumer took all four doses of Vivotif but she drank some herbal tea 30 minutes after taking her last dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer drank some herbal tea 30 minutes after taking the last dose of Vivotif (Product administration error). Considering the nature of the event, the causality is assessed as not related to Vivotif.; Sender's Comments: A consumer drank some herbal tea 30 minutes after taking the last dose of Vivotif (Product administration error). Considering the nature of the event, the causality is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took unrefrigerated Vivotif; Spontaneous report received on 16DEC2019.  A pharmacist reported that a female consumer who "took unrefrigerated Vivotif" (PT: Product storage error), while being on Vivotif for immunisation. The consumer took the first dose of Vivotif and then left the rest of the doses unrefrigerated before taking them. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took unrefrigerated Vivotif doses (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer took unrefrigerated Vivotif doses (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took fourth dose on day 6; Spontaneous report received on 17DEC2019.  A female consumer reported that she "took fourth dose on day 6" (PT: Inappropriate schedule of product administration) while being on oral Vivotif for typhoid fever prophylaxis. The consumer took the first three doses of Vivotif according to schedule on day 1, 3, and 5 respectively but took the fourth dose on day six instead of day seven. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took the first three doses of Vivotif according to the schedule but took the fourth dose on day 6 instead of day 7 (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took the first three doses of Vivotif according to the schedule but took the fourth dose on day 6 instead of day 7 (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif on days 1,2,3,4; Spontaneous report received on 17DEC2019.  A physician reported that a male consumer "took Vivotif on days 1, 2, 3, and 4" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis. The consumer took the all the four doses of Vivotif on consecutive days (on 13DEC2019, 14DEC2019, 15DEC2019, and 16DEC2019) instead of every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took all four doses of Vivotif on consecutive days instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. ; Sender's Comments: A consumer took all four doses of Vivotif on consecutive days instead of every other day ( Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took Vivotif 45 minutes after eating raspberries; Spontaneous report received on 18DEC2019.  A consumer reported that she "took Vivotif 45 minutes after eating raspberries" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis. On 18DEC2019, the consumer took the first dose of Vivotif 45 minutes after eating raspberries. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif dose 45 minutes after eating raspberries" (Product administration error). Considering the case information, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif dose 45 minutes after eating raspberries" (Product administration error). Considering the case information, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took fourth dose of Vivotif 12 hours late; Spontaneous report received on 24DEC2019.  A female consumer reported that she took fourth dose of Vivotif 12 hours late (PT: Inappropriate schedule of product administration), while being on Vivotif for immunisation. The consumer reported that she took her first three doses of Vivotif according to the schedule, but took the last dose 12 hours late. She stated that instead of taking the last dose at night of 23DEC2019, she took it the next morning on 24DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took fourth dose of Vivotif 12 hours late (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event. ; Sender's Comments: A consumer took fourth dose of Vivotif 12 hours late (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took one dose of unrefrigerated Vivotif; Spontaneous report received on 24DEC2019.  A male consumer reported that he "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif (lot number: 3003303) for typhoid fever prophylaxis. It was reported that the consumer was advised to take one dose every other day and complete Vivotif course at least 1 week prior to potential exposure. On 23DEC2019, the consumer took first dose of Vivotif which was left unrefrigerated for a week. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took one dose of Vivotif which was left unrefrigerated for a week (Incorrect product storage). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer took one dose of Vivotif which was left unrefrigerated for a week (Incorrect product storage). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took Vivotif which was left out of the refrigerator for little less than 24 hours; Spontaneous report received on 27DEC2019.  A male consumer reported that he "took Vivotif which was left out of the refrigerator for little less than 24 hours" (PT: Product storage error). He was receiving Vivotif for immunisation. On 23DEC2019, the consumer stated that he left the Vivotif out of refrigerator for a little less than 24 hours at 68 degree Fahrenheit. He did not have the lot number. On 27DEC2019, he took the dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Incorrect product storage). The causality of the event is assessed as not applicable due to the nature of the event.; Sender's Comments: A consumer took a dose of unrefrigerated Vivotif (Incorrect product storage). The causality of the event is assessed as not applicable due to the nature of the event.
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Had taken an unrefrigerated dose; Did not experience any adverse effects; Spontaneous report received on 30DEC2019.  A 69-year-old male consumer reported that he "had taken an unrefrigerated dose" (PT: Product storage error) and did not experience any adverse effects (PT: No adverse event) while being on Vivotif (lot number: 3003302; expiry date: Sep 2020) for immunisation. The consumer took one dose unrefrigerated Vivotif (21DEC2019 or 28DEC2019) and did not experienced any adverse effect due to that unrefrigerated dose. He stated that he was not taking any concomitant medications. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took an unrefrigerated dose of Vivotif (incorrect product storage) and did not experience any adverse event (No adverse event). The causality of both the events is assessed as not applicable.; Sender's Comments: A consumer took an unrefrigerated dose of Vivotif (incorrect product storage) and did not experience any adverse event (No adverse event). The causality of both the events is assessed as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Cellulitis
Clinical narrative: CELLULITIS ON HER LEFT ARM; STARTED AUGMENTIN WHILE ON VIVOTIF; This spontaneous case report was received from a nurse (PVX2019-401) on 12-Feb-2019. The report describes a 62-year-old adult female consumer who had cellulitis on her left arm following the intake of oral Vivotif (one capsule every other day) for typhoid prophylaxis. The consumer "started Augmentin while on Vivotif" for cellulitis.  The consumer was having PCOS (Polycystic ovary syndrome). She did not have any drug allergy.  The consumer's concomitant medication included metformin (500 mg dose; once in a day orally) for PCOS. Her past medication included Shingrix (on left deltoid) which was received on 08-Feb-2019.  It was reported that the consumer took the first and the second dose of Vivotif on 09-Feb-2019 and 11-Feb-2019, respectively. On 11-Feb-2019, she was diagnosed with cellulitis on her left arm for which on the same day she started Augmentin therapy for 10 days. The reporter stated that she had the signs or symptoms of cellulitis before starting Vivotif.   She believed that this was not related to Vivotif as she had taken Vivotif in the past and did not had these reactions at that time. The reporter stated that the consumer had an injection in the arm, where she developed the symptoms but she did not have the name of the injectable product.  The action taken with Vivotif with respect to the event cellulitis was unknown while with respect to the event "started Augmentin while on Vivotif" was not applicable.  The action taken with Augmentin with respect to the events cellulitis and "started Augmentin while on Vivotif" was not applicable.  The clinical outcome of the event cellulitis was unknown while with respect to the event "started Augmentin while on Vivotif" was unknown.  Company's comment: In this case, it was reported that a 62-year-old adult female consumer developed cellulitis following the administration oral Vivotif on 11-Feb-2019.She had signs or symptoms of cellulitis before starting Vivotif and had received Shingrix injection (on left deltoid) on 08-Feb-2019 . Also, cellulitis is an infectious condition and there is a possibility that the event could have occurred due to the injectable Shingrix vaccine received by consumer. Hence, the causality of the event cellulitis is assessed as unlikely with oral vivotif vaccine.The causality of the event "started Augmentin while on Vivotif" was considered as not applicable. ; Sender's Comments: Company's comment: In this case, it was reported that a 62-year-old adult female consumer developed cellulitis following the administration oral Vivotif on 11-Feb-2019.She had signs or symptoms of cellulitis before starting Vivotif and had received Shingrix injection (on left deltoid) on 08-Feb-2019 . Also, cellulitis is an infectious condition and there is a possibility that the event could have occurred due to the injectable Shingrix vaccine received by consumer. Hence, the causality of the event cellulitis is assessed as unlikely with oral vivotif vaccine.The causality of the event "started Augmentin while on Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK FOURTH DOSE ON DAY 8; TOOK AN UNREFRIGERATED DOSE; This spontaneous case (PVX2019-946) was received from a pharmacist on 22-Apr-2019. It describes a female consumer who "took fourth dose on day 8" and "took an unrefrigerated dose", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif according to the schedule but took the fourth dose on day 8 (Saturday). Also, the last dose was kept unrefrigerated for 12 hours.  Action taken with Vivotif was not applicable.   The clinical outcome of the events "took fourth dose on day 8" and "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took fourth dose on day 8" and "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose on day 8" and "took an unrefrigerated dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: MISSED A DOSE; This spontaneous case (PVX2019-979) was received from a nurse on 23-Apr-2019. It describes an adult male consumer who "missed a dose", while being on Vivotif for an unknown indication.  Case report: The consumer missed a dose of Vivotif, which was due on 22-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed a dose" was unknown.  Company's Comment: The causality of the event "missed a dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: FORGOT TO TAKE LAST DOSE; This spontaneous case (PVX2019-1015) was received from a pharmacist on 25-Apr-2019. The report described a male consumer who "forgot to take last dose", while being on Vivotif for an unknown indication.  Case report: The consumer took three doses of Vivotif but forgot to take the last one.  Action taken with Vivotif with was not applicable.  The clinical outcome of the event "forgot to take last dose" was unknown.  Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take last dose" 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 (PVX2019-1021) was received from a pharmacist on 26-Apr-2019. It describes a female consumer who "took the last dose late", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer missed to take the last dose of Vivotif, which was due on 23-Apr-2019 and took it on 26-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took the last dose of Vivotif late" 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: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: FORGOT TO TAKE LAST DOSE; This spontaneous case (PVX2019-1043) was received from a caregiver on 27-Apr-2019. It describes a female consumer who "forgot to take last dose", while being on Vivotif capsule for an unknown indication.  Case report: The consumer took the first three Vivotif doses on 20-Apr-2019, 22-Apr-2019, and 24-Apr-2019 respectively. She forgot to take the last dose, which was due on 26-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "forgot to take last dose" was unknown.  Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: DID NOT COMPLETE VACCINATION COURSE PRIOR TO TRAVEL; TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1031) was received from a pharmacist on 29-Apr-2019. It describes a 23-year-old adult female consumer who "took unrefrigerated doses" and "did not complete vaccination course prior to travel". The consumer was receiving Vivotif (3003241) for an unknown indication.  Case report: The consumer took three unrefrigerated doses of Vivotif. The first dose was taken on 23-Apr-2019. She had a planned trip on 30-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "did not complete vaccination course prior to travel" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "did not complete vaccination course 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 vaccination course prior to travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON DAY 6; This spontaneous case (PVX2019-1066) was received from pharmacist on 01-May-2019. It describes a 58-year-old female consumer who "took third dose on day 6", while being on Vivotif for an unknown indication.  Case report: The consumer took the third dose on day 6. The doses were taken on 25-Apr-2019, 27-Apr-2019, and 30-Apr-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took third dose on day 6" was unknown.  Company's Comment: The causality of the event "took third dose on day 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 6" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK FIRST DOSE AFTER EATING MEAL; This spontaneous case (PVX2019-1075) was received from consumer on 01-May-2019. It describes a 48-year-old female consumer who "took first dose after eating meal". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif 1-1.5 hours after a meal on 29-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took first dose after eating meal" was unknown.  Company's Comment: The causality of the event "took first dose after eating meal" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose after eating meal" 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 (PVX2019-1076) was received from nurse on 01-May-2019. It describes a 24-year-old adult male consumer who "took two doses on consecutive days", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took first two doses on consecutive days. The doses were taken on 30-Apr-2019 and 01-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two doses on consecutive days" 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: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: FORGOT TO TAKE LAST TWO DOSES; This spontaneous case (PVX2019-1079) was received from caregiver on 02-May-2019. It describes a 17-year-old male consumer who "forgot to take last two doses". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took first and second dose of Vivotif on 21-Apr-2019 and 23-Apr-2019, respectively. He forgot to take the last two doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "forgot to take last two doses" was unknown.  Company's Comment: The causality of the event "forgot to take last two doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take last two doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Culture stool, Diarrhoea haemorrhagic, Polymerase chain reaction positive, Salmonella test positive
Clinical narrative: TESTED POSITIVE FOR SALMONELLA INFECTION; This spontaneous case (PVX2019-1090) was received from a nurse on 02-May-2019. It describes a 19-year-old adult female consumer who was tested positive for salmonella infection, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all the four doses of Vivotif from 23-Apr-2019 to 29-Apr-2019. On 29-Apr-2019, she had bloody diarrhea. Later, she underwent polymerase chain reaction (PCR) test for her stool on 01-May-2019, which was positive for salmonella. The nurse said that a culture test was also performed but the results were awaited at the time of the report. The nurse believed that the patient was fine and having no diarrhea at the time of the report.  The consumer had a medical history of irritable bowel syndrome and previously had bloody diarrhea intermittently, before taking Vivotif (gap not specified).  Action taken with Vivotif was unknown.  The clinical outcome for the event salmonella infection was unknown.  Company's Comment: In this case, it was reported that the consumer was tested positive for salmonella infection within ten days of administration of oral Vivotif.  The protective action starts about ten days after taking the last vaccine dose. Also, the vaccine strain cannot be detected in the stool after the usual dose. Hence the event is a natural infection and the causality has been assessed as not related to Vivotif vaccine.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer was tested positive for salmonella infection within ten days of  administration of oral Vivotif.  The protective action starts about ten days after taking the last vaccine dose. Also, the vaccine strain cannot be detected in the stool after the usual dose. Hence the event is a natural infection and the causality has been assessed as not related to vivotif vaccine.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE A DAY LATE; This spontaneous case (PVX2019-1096) was received from a consumer on 03-May-2019. It describes a male consumer who "took second dose a day late", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the second dose a day late. The doses were taken on 30-Apr-2019 and 03-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took second dose a day late" was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK THE DOSES WITH FOOD; TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1098) was received from a consumer on 03-May-2019. It describes an 18-year-old male consumer who "took unrefrigerated doses" and "took the doses with food", while being on Vivotif for an unknown indication.  Case report: The consumer took Vivotif doses with food. They were stored incorrectly. She stated that door of the refrigerator was open for at least 8 hours. She also had snacks within an hour before or after taking doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "took the doses with food" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "took the doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and also "took the doses with food" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK 4 UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1094) was received from a nurse on 03-May-2019. It describes a 20-year-old female consumer who "took 4 unrefrigerated doses", while receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took 4 unrefrigerated doses of Vivotif. The doses were taken from 30-Mar-2019 to 05-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took 4 unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took 4 unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 4 unrefrigerated doses" 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 (PVX2019-1111) was received from a caregiver on 06-May-2019. It describes a 67-year-old male consumer who "took two doses in a row", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 02-May-2019, 04-May-2019, and 05-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two doses in a row" 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: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON DAY 8; This spontaneous case (PVX2019-1113) was received from a nurse on 06-May-2019. It describes a female consumer who "took third dose on day 8", while being on Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 28-Apr-2019, 30-Apr-2019, and 05-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took third dose on day 8" was unknown.  Company's Comment: The causality of the event "took third dose on day 8" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 8" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK ONLY ONE DOSE; This spontaneous case (PVX2019-1127) was received from a physician on 06-May-2019. It describes an adult female consumer who "took only one dose". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif 10 days ago. She did not take any other dose yet.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took only one dose" was unknown.  Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE LAST DOSE; This spontaneous case (PVX2019-1130) was received from a pharmacist on 07-May-2019. It describes a 27-year-old female consumer who "missed to take last dose", while being on Vivotif for travelling.  Case report: The consumer took three doses of Vivotif in Dec 2018. She missed to take the last dose.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed to take last dose" was unknown.  Company's Comment: The causality of the event "missed to take last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1132) was received from a pharmacist on 07-May-2019. It describes a male consumer who "took unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took 3 unrefrigerated doses of Vivotif.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE WITHIN 1 HOUR AFTER THE MEAL; This spontaneous case (PVX2019-1145) was received from a pharmacist on 08-May-2019. It describes an adolescent female consumer who "took second dose within 1 hour after the meal", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on Saturday correctly, but took the second dose on Monday within 1 hour after eating a meal. She did not know the exact dates on which the doses were taken.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took second dose within 1 hour after the meal" was unknown.  Company's Comment: The causality of the event "took second dose within 1 hour after the meal" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose within 1 hour after the meal" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: TOOK THREE UNREFRIGERATED DOSES; DID NOT TAKE DOSES ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1137) was received from pharmacist on 07-May-2019. It describes a 19-year-old male consumer who "took 3 unrefrigerated doses" and "did not take doses according to schedule", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took three unrefrigerated doses. Also, she did not take doses according to the schedule. The doses were taken on Tuesday, Thursday, and Monday. He did not take the fourth dose as he was recommended to speak with physician. He stated that he would be leaving for an endemic area in about a week.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" and "did not take doses according to 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 according to schedule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK FIRST DOSE OF VIVOTIF IMMEDIATELY AFTER EATING; This spontaneous case (PVX2019-1138) was received from a pharmacist on 07-May-2019. It describes a 34-year-old male consumer who "took first dose of Vivotif immediately after eating". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif immediately after eating on either 06-May-2019 or 07-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took first dose of Vivotif immediately after eating" was unknown.  Company's Comment: The causality of the event "took first dose of Vivotif immediately after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose of Vivotif immediately after eating" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED A DOSE OF VIVOTIF; This spontaneous case (PVX2019-1149) was received from a pharmacist on 08-May-2019. It describes a 22-year-old female consumer who "missed a dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer skipped a dose of Vivotif, but she did not know which dose was missed and she started taking the doses.   Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed a dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed a dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "missed a dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT COMPLETE DOSES PRIOR TO TRAVEL TO AN ENDEMIC AREA; This spontaneous case (PVX2019-1176) was received from a consumer on 10-May-2019. It describes a female consumer who "did not complete doses prior to travel to an endemic area". The consumer was receiving Vivotif for a trip (endemic area).  Case report: The consumer took the first dose of Vivotif on 06-May-2019. She had a planned trip on 10-May-2019 (tonight). She already had taken two doses.  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 complete doses prior to travel to an endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete doses prior to travel to an endemic area" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE THIRD DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1158) was received from a nurse on 09-May-2019. It describes a 51-year-old female consumer who "did not take third dose of Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on Friday (day 1) and the second dose on Sunday (day 3). However, she missed to take the third dose, which was due on Tuesday (day 5).  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 third dose of Vivotif according to schedule" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "did not take third dose of Vivotif according to 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 (PVX2019-1163) was received from a pharmacist on 10-May-2019. It describes a 57-year-old female consumer who "took an unrefrigerated dose of Vivotif". The consumer was receiving Vivotif (lot number: 3003275) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 09-May-2019, which was unrefrigerated for at least 24 hours.  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: Product administration error
Clinical narrative: ATE A PIECE OF CAKE THEN, AFTER 30 MINUTES TOOK A DOSE OF VIVOTIF; This spontaneous case (PVX2019-1182) was received from a healthcare professional on 13-May-2019. It describes a female consumer who "ate a piece of cake then, after 30 minutes took a dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer ate a piece of cake and then, after 30 minutes she took the first dose of Vivotif. Also, she ate dinner about 1 hour later.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "ate a piece of cake then, after 30 minutes took a dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate a piece of cake then, after 30 minutes took a dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED TO TAKE THIRD DOSE; This spontaneous case (PVX2019-1179) was received from a pharmacist on 13-May-2019. It describes a female consumer who "missed to take third dose", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose and the second dose of Vivotif on 07-May-2019 and 09-May-2019, respectively. Then, she missed to take the third dose on the scheduled 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 to take third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third dose" was considered as not applicable.