chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 05-year-old female patient. on 10-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 03-year-old female patient. On 17-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 02-year-old male patient. On 08-MAY-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 02-year-old male patient. On 10-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 02-year-old male patient. On 17-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 12-months-old female patient. On 19-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 03-year-old female patient. On 27-MAR-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: On 4/4/2020 patient then "got a rash (they were little pink bumps) on arms, legs and lower torso".; This spontaneous report as received from a medical assistant refers to a 14-month-old female patient. None pertinent medical history, concomitant medications and drug reactions/allergies were provided.  On 31-MAR-2020, the patient was vaccinated with dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left leg, lot # S020158 and expiration date 30-JUN-2021 and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Recombinant human albumin (rHA), subcutaneously in the left leg, lot # S005249 and expiration date 20-FEB-2021 for indication of routine vaccination. On 04-APR-2020 (reported also as 31-MAR-2020), the patient got a rash (they were little pink bumps) on arms, legs and lower torso. The patient sought for medical attention. The physician advised the treatment with cetirizine hydrochloride (ZYRTEC). The three hours after administration of treatment the rash was gone. No lab diagnostics/studies performed. No product quality complaint (PQC) was involved. The outcome of rash was reported as recovered/resolved on 04-APR-2020.  The causality assessment between the event and the suspect therapies was not provided.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: DID NOT BE COMPLETE DOSES PRIOR TO TRAVEL; TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-764) was received from a consumer on 29-Mar-2019. It describes a 44-year-old adult female consumer who "took unrefrigerated doses" and "did not be complete doses prior to travel", while being on oral Vivotif (one dose every other day) for typhoid prophylaxis.   Case report: The consumer did not refrigerate Vivotif doses and took the first dose on 25-Mar-2019. She was scheduled to take her third dose on 29-Mar-2019. She will be leaving for a 7-day trip on 30-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the events "took unrefrigerated doses" and "did not be complete doses prior to travel" was unknown.  Company's Comment: The causality of the events "took unrefrigerated doses" and "did not complete the full course one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took unrefrigerated doses" and "did not complete the full course one week prior to travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: FORGOT TO TAKE THE LAST DOSE; This spontaneous case report was received from a nurse (PVX2019-678) on 19-Mar-2019. It described a 20-year-old female consumer who "forgot to take the last dose". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the three doses of Vivotif on 11-Mar-2019, 13-Mar-2019, and 15-Mar-2019, and then forgot the last dose.  The action taken with Vivotif with respect to the event "forgot to take the last dose" was not applicable.  The clinical outcome of the event "forgot to take the last dose" was unknown.  Company's Comment: The causality of the event "forgot to take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take the last dose" was considered as not applicable
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: LAST DOSE DUE AFTER LEAVING FOR TRAVEL; This spontaneous case report was received from a pharmacist (PVX2019-686) on 20-Mar-2019. It described a 30-year-old adult female consumer whose "last dose due after leaving for travel". The consumer was receiving oral Vivotif (one dose every other day) (lot no: 300321) for typhoid prophylaxis.  It was reported that the consumer took the two doses of Vivotif on 18-Mar-2019 and 20-Mar-2019, respectively. She was planning to leave for country on 23-Mar-2019 and her last dose would be due on 24-Mar-2019.  The action taken with Vivotif with respect to the event "last dose due after leaving for travel" was not applicable.  The clinical outcome of the event "last dose due after leaving for travel" was unknown.  Company's Comment: The causality of the event "last dose due after leaving for travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "last dose due after leaving for travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Contraindication to vaccination
Clinical narrative: ATE A VERY SMALL PIECE OF GRAPE AFTER TAKING VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-697) on 21-Mar-2019. It described a 36-year-old female consumer who "ate a very small piece of grape after taking Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer ate a very small piece of a grape after taking last dose of Vivotif on 21-Mar-2019.  The action taken with Vivotif with respect to the event "ate a very small piece of grape after taking Vivotif" was not applicable.  The clinical outcome of the event "ate a very small piece of grape after taking Vivotif" was unknown.  Company's Comment: The causality of the event "ate a very small piece of grape after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate a very small piece of grape after taking Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK ONLY TWO DOSE; This spontaneous case report was received from a consumer (PVX2019-715) on 23-Mar-2019. It described a male consumer who "took only two doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took only first two doses of Vivotif on Wednesday and Friday, respectively. Then, the consumer went to country and forgot to bring the remaining doses. The consumer will be coming back on next Wednesday.  The action taken with Vivotif with respect to the event "took only two doses" was not applicable.  The clinical outcome of the event "took only two doses" was unknown.  Company's Comment: The causality of the event "took only two doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only two dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE THE LAST DOSE; This spontaneous case (PVX2019-713) was received from a caregiver on 25-Mar-2019. It describes a male consumer who "did not take the last dose", while being on Vivotif for an unknown indication.   Case report: The consumer took 3 doses of Vivotif correctly but he did not take the last dose, which was due on 17-Mar-2019. The reporter also stated that he was travelling to another country.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "did not take the last dose" was unknown.  Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED THE LAST DOSE; This spontaneous case (PVX2019-762) was received from a pharmacist on 29-Mar-2019. It describes a 51-year-old adult female consumer who "missed the last dose", while receiving oral Vivotif (one dose every other day) for typhoid prophylaxis.  Case report: The consumer missed the last dose. She took the first dose of Vivotif on 18-Mar-2019 but she forgot to take her last dose, which was due on 24-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed the last dose" was unknown.  Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-718) was received from a pharmacist on 25-Mar-2019. It describes a female consumer who "took two doses in a row", while being on Vivotif for an unknown indication.   Case report: The consumer took the first two doses in a row. The doses were taken on 21-Mar-2019, 22-Mar-2019, and then on 24-Mar-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two doses in a row" was unknown.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE THE LAST DOSE; This spontaneous case (PVX2019-719) was received from a consumer on 25-Mar-2019. It describes a 21-year-old adult female consumer who "did not take the last dose", while being on Vivotif for an unknown indication.   Case report: The consumer took 3 doses of Vivotif on 18-Mar-2019, 20-Mar-2019, and 22-Mar-2019 respectively. After that she went out of town and did not carry the last dose. It was reported that she would not return home until 29-Mar-2019 and thus she missed her last dose, which was due on 24-Mar-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "did not take the last dose" was unknown.  Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Contraindication to vaccination
Clinical narrative: TOOK FIRST DOSE ON A FULL STOMACH; This spontaneous case (PVX2019-725) was received from a pharmacist on 26-Mar-2019. It describes a male consumer who "took first dose on a full stomach", while being on Vivotif for an unknown indication.   Case report: The consumer took the first dose of Vivotif on a full stomach and the next dose on empty stomach.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took first dose on a full stomach" was unknown.  Company's Comment: The causality of the event "took first dose on a full stomach" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose on a full stomach" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK ONLY ONE DOSE; This spontaneous case (PVX2019-765) was received from a pharmacist on 29-Mar-2019. It describes a female consumer who "took only one dose", while being on Vivotif for an unknown indication.   Case report: The consumer only took the first dose of Vivotif and missed the other 3 doses.  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: Inappropriate schedule of product administration
Clinical narrative: TOOK DOSES EVERY DAY; This spontaneous case (PVX2019-782) was received from a physician on 01-Apr-2019. It describes a female consumer who "took doses every day", while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took the Vivotif doses every day instead of every other day. The physician guessed that she took her doses from 27-Mar-2019 to 30-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took doses every day" was unknown.  Company's Comment: The causality of the event "took doses every day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses every day" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case (PVX2019-787) was received from another health care professional on 01-Apr-2019. It describes a male consumer who "took an unrefrigerated dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 29-Mar-2019 and then he left the doses out of the refrigerator for three days. He took the second dose on 31-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 01-Apr-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201904-000254 (PVX2019-780; female) and PVX201904-000255 (PVX2019-781, male) were created and cross-linked in the database.  This case report describes a male consumer who "took two unrefrigerated doses", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took two doses of Vivotif, which was unrefrigerated for 48 to 72 hours at 68-degree Fahrenheit.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201904-000254:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case (PVX2019-790) was received from a consumer on 02-Apr-2019. It describes an elderly male consumer who "took an unrefrigerated dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003242 and expiry date: Nov 2019) for typhoid prophylaxis.   Case report: The consumer did not refrigerate Vivotif for 18 hours and took the first dose on 30-Mar-2019. The exposure time and temperature of the vaccine was acceptable for this lot number. However, he took the second dose on 01-Apr-2019, which was not an effective dose.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK ONLY 2 DOSES AND NEVER FINISHED THE ENTIRE COURSE; This spontaneous case (PVX2019-839) was received from a pharmacist on 09-Apr-2019. It describes a male consumer who "took only 2 doses and never finished the entire course". The consumer was receiving Vivotif capsule for travel.  Case report: The consumer took only 2 doses of Vivotif in Jun 2018, after that he never finished the course.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took only 2 doses and never finished the entire course" was unknown.  Company's Comment: The causality of the event "took only 2 doses and never finished the entire course" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only 2 doses and never finished the entire course" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE THE FOURTH DOSE; This spontaneous case (PVX2019-843) was received from a consumer on 09-Apr-2019. It describes a male consumer who "missed to take the fourth dose". The consumer was receiving oral Vivotif for typhoid fever prophylaxis.   Case report: The consumer took 3 doses of Vivotif. After that, she went out of town over the weekend and did not carry the last dose. Thus, she missed her last dose.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed to take the fourth dose" was unknown.  Company's Comment: The causality of the event "missed to take the fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take the fourth dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED THE THIRD DOSE; This spontaneous case (PVX2019-844) was received from a nurse on 09-Apr-2019. It describes a 19-year-old adult female consumer who "missed the third dose", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.   Case report: The consumer took 2 doses of Vivotif on 04-Apr-2019 and 06-Apr-2019, respectively. After that, she left the remaining doses in a hotel's fridge. Thus, she missed her third dose, which was due on 08-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed the third dose" was unknown.  Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW/ WOULD BE TRAVELLING TO AN ENDEMIC AREA WITHOUT COMPLETING THE VIVOTIF COURSE; This spontaneous case (PVX2019-881) was received from a consumer on 15-Apr-2019. It describes a female consumer who "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took two doses of Vivotif on consecutive days. The doses were taken on 14-Apr-2019 and 15-Apr-2019, respectively. She would be travelling to Singapore on coming Wednesday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course" was unknown.  Company's Comment: The causality of the event "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE 24 HOURS AFTER THE SECOND DOSE; This spontaneous case (PVX2019-901) was received from a caregiver on 16-Apr-2019. It describes a female consumer who "took third dose 24 hours after the second dose". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took third dose 24 hours after the second dose of Vivotif. The doses were taken on 11-Apr-2019, 13-Apr-2019, and 14-Apr-2019 respectively.  Action taken with Vivotif was unknown.   The clinical outcome of the event "took third dose 24 hours after the second dose" was unknown.   Company's Comment: The causality of the event "took third dose 24 hours after the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose 24 hours after the second dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; This spontaneous case (PVX2019-913) was received from a consumer on 17-Apr-2019. It describes a 20-year-old female consumer who "took two unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took two unrefrigerated doses of Vivotif on 14-Apr-2019 and 16-Apr-2019, respectively.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: UNABLE TO FINISH LAST DOSE BEFORE TRAVELLING; This spontaneous case (PVX2019-928) was received from a pharmacist on 18-Apr-2019. It describes a 75-year-old elderly male consumer who was "unable to finish last dose before travelling. The consumer was receiving Vivotif (lot no: 3003253 and expiry date Dec 2019) as a travel vaccine.   Case report: The consumer took the first dose of Vivotif on 16-Apr-2019. He stated that he would not be able to take the final dose before travelling to the endemic area.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "unable to finish last dose before travelling" was unknown.  Company's Comment: The causality of the event "unable to finish last dose before travelling" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "unable to finish last dose before travelling" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Epistaxis, Pharyngeal haemorrhage, Tongue biting
Clinical narrative: BLOODY NOSE; BLOOD IN THROAT; STOMACH PAIN; DIARRHEA; BIT HIS TOGNUE; This spontaneous case (PVX2019-973) was received from a consumer on 23-Apr-2019. It describes an 18-year-old adult male consumer (height: 66 inches/ 167.64 cm and weight: 140 pounds/ 63.50 kg) who bit his tongue, had stomach pain, diarrhea, bloody nose, and blood in his throat following the intake of oral Vivotif (one capsule every other day) for typhoid prophylaxis.   Case report: The consumer took two doses of Vivotif on 19-Apr-2019 and 21-Apr-2019, respectively. On 20-Apr-2019, he bit his tongue. He applied ice on it regularly. On 21-Apr-2019, 12 hours after taking the second dose, he had stomach pain followed by diarrhea, which he believed was possibly related to the vaccine. On 23-Apr-2019, he had an episode of bloody nose and had some blood from his throat as well, and he drank water to treat it. His nose bled for 30 minutes whereas blood in his throat was still present at the time of the report. However, he did not attribute these to the vaccine.  The consumer's concurrent medical condition included a rug rash which he got from a fall on 16-Apr-2019 and he was recovering from that. He did not smoke or drink alcohol.   The consumer's medical history included asthma and he was also allergic to amoxicillin (rash) and penicillin (rash). He reported that he did not a have history of commonly getting a bloody nose.  Action taken with Vivotif with respect to the events was unknown.  The consumer had recovered from the events, diarrhea and stomach pain on 22-Apr-2019, while the events bloody nose and blood in his throat were not resolved. He had been recovering from the event bit his tongue.  Company's Comment: In this case, an 18-year-old adult male consumer bit his tongue, had stomach pain, diarrhea, bloody nose, and blood in his throat following the intake of oral Vivotif. The causality has been assessed as not related for the events "bit his tongue, bloody nose, and blood in his throat" as they related to trauma incurred by the consumer. The events "stomach pain and diarrhea" were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif has been assessed as possible.; Sender's Comments: Company's Comment: In this case, an 18-year-old adult male consumer bit his tongue, had stomach pain, diarrhea, bloody nose, and blood in his throat following the intake of oral Vivotif. The causality has been assessed as not related for the events "bit his tongue, bloody nose, and blood in his throat" as they related to trauma incurred by the consumer. The events "stomach pain and diarrhea" were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif has been assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE THIRD DOSE ON TIME; This spontaneous case (PVX2019-977) was received from a pharmacist on 23-Apr-2019. It describes an adult female consumer who "did not take third dose on time", while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif on 18-Apr-2019 and 20-Apr-2019, respectively. Then, she left Vivotif unrefrigerated and threw out the remaining two doses. Thus she missed the third dose which was due on 22-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "did not take third dose on time" was unknown.  Company's Comment: The causality of the event "did not take third dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take third dose on time" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: FORGOT TO THE TAKE LAST DOSE; This spontaneous case (PVX2019-1029) was received from a pharmacist on 29-Apr-2019. It describes a female child consumer who "forgot to the take last dose", while being on Vivotif for an unknown indication.  Case report: The consumer missed to take the last dose of Vivotif, which was due on 24-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "forgot to the take last dose" was unknown.  Company's Comment: The causality of the event "forgot to the take last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to the take last dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case (PVX2019-1051, PVX2019-1052) was received form a pharmacist on 30-Apr-2019. It describes a 43-year-old male consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003253) for typhoid fever prophylaxis.  Case report: The consumer took an unrefrigerated dose of Vivotif on 29-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1064) was received from consumer on 01-May-2019. It describes a 37-year-old female consumer who "took unrefrigerated doses", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took unrefrigerated doses of Vivotif. The first and last dose were taken on 01-Apr-2019 and 07-Apr-2019, respectively.  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 TWO DOSES IN A ROW; This spontaneous case (PVX2019-1081) was received from a nurse on 02-May-2019. It describes a 32-year-old female consumer who "took two doses in a row". The consumer was receiving oral Vivotif for typhoid prophylaxis.  Case report: The consumer took first two doses in a row. 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 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: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1128) was received from a caregiver on 07-May-2019. It describes a male consumer who "took unrefrigerated doses", while being on oral Vivotif (one dose every other day; lot no: 3003275 and expiry date: May 2020) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 02-May-2019 after it was unrefrigerated for 4 hours, which was good to use. Later, he did not refrigerate the remaining doses and took another two doses on 04-May-2019 and 06-May-2019, respectively.  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: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK FIRST DOSE AND FORGOT TO TAKE OTHER DOSES; This spontaneous case (PVX2019-1402) report was received from a pharmacist on 31-May-2019. It describes a male consumer who "took first dose and forgot to take other doses". She was receiving Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 26-May-2019 and then, forgot to take other doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took first dose and forgot to take other doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose and forgot to take other doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK FOURTH DOSE A DAY EARLY; This spontaneous case (PVX2019-1420) was received from a consumer on 03-Jun-2019. It describes a male consumer who "took fourth dose a day early", while being on oral Vivotif (one capsule every other day) for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif on every other day. His fourth dose was due on 04-Jun-2019 but he took it on 03-Jun-2019.   Action taken with Vivotif was not applicable.  The clinical outcome of the event "took fourth dose a day early" was unknown.   Company's Comment: The causality of the event "took fourth dose a day early" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose a day early" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THE FIRST DOSE OF VIVOTIF ABOUT 4 DAYS AGO AND HAS NOT TAKEN THE REMAINING DOSES YET; This spontaneous case report (PVX2019-2897) was received from a consumer on 21-Nov-2019. It described a 25-year-old male consumer who "took the first dose of Vivotif about 4 days ago and has not taken the remaining doses yet" (PT: Product dose omission). He was receiving oral Vivotif for typhoid fever.  Case report: The consumer took first dose of Vivotif four days before reporting. It was reported that the consumer has not taken the remaining doses till the time of reporting.  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 events "took the first dose of Vivotif about 4 days ago and has not taken the remaining doses yet" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the events "took the first dose of Vivotif about 4 days ago and has not taken the remaining doses yet" was considered as not applicable.