chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PNC13, UNK
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous case initially received from a Pharmacist on 04-Jan-2018, concerning a 66-year-old elderly male patient.  The current conditions of the patient included scabies (since unspecified date) for which the patient was using an unspecified cream. The concomitant medications of the patient included tamsulosin for his prostate and Plaquenil (hydroxychloroquine).  On 03-Oct-2018, the patient was administered was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] for influenza prophylaxis. On the same day, the patient was also administered a non-company suspect vaccine Prevenar 13 [pneumococcal vaccine conj 13v (crm197), dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: S92740 and expiry date: 30-Dec-2019) for an unknown indication.  On 03-Oct-2018, on the same day after the vaccination, the patient experienced itching. As a treatment, the patient got a prescription of loratadine for itching on 23-Dec-2018. The patient was not hospitalized due to the event.  The outcome of the event was not recovered.  The reporter assessed this case as non-serious.  Follow up received from the pharmacist on 05-Feb-2019: The patient's details (address, city, state, county, postal code and phone number) were added in the patient tab. The dose (0.5 ml), route of administration (intramuscular), anatomical location (deltoid), batch number (S92740) and expiry date (30-Dec-2019) of the non-company suspect vaccine Prevnar 13 were added in the product tab. The indication, dose, frequency and start date of the patient's concomitant medication tamsulosin and the dose and start date of Plaquenil (hydroxychloroquine) were added in the product tab. The narrative was amended accordingly.; Reporter's Comments: A 66-year-old, male patient experienced itching on the same after administration of suspect vaccine Fluad (TIV) and co-suspect vaccine Prevenar 13. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine. The causal role of the non-company suspect vaccine (Prevenar 13) cannot be ruled out completely. The condition can also be due to underlying current condition (scabies).
Sex: U
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Pain
Clinical narrative: Guillain-Barre syndrome; Feeling body aches; This is a serious spontaneous case, initially received from other non-health professional on 26-Feb-2019, concerning a patient of an unspecified age and gender.  On 17-Sep-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, batch number: YF37206, dose, route of administration, anatomical location and expiry date: not reported) for an unknown indication.  On an unspecified date after vaccination, the patient experienced feeling of body aches and was treated at the emergency room (ER). The patient was diagnosed with Guillain-Barre Syndrome and was treated at in-patient rehab, physical therapy, occupational therapy and with a neurologist.  The outcome of the events was not reported.  Non-significant follow up received from the reporter on 29-Apr-2019: It was reported that the reporter was tried to reach on 13-Mar-2019, 22-Mar-2019 and 04-Apr-2019 but was unable to obtain the information which was requested. The Med info number (SEQ19-01057) was added in the additional information tab. No changes were made in narrative.; Reporter's Comments: A patient of unspecified age and gender experienced pain and Guillain-Barre Syndrome (GBS), unspecified period of time after receipt of Afluria Quadrivalent vaccine. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty for the event GBS. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported events, company assessed the causality as unassessable. The company assessed the event Guillain-Barre syndrome as serious (medically significant).
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Decreased appetite
Clinical narrative: APPETITE LOST; ABDOMINAL PAIN; This spontaneous case report (819526-1) was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. This report described a 40-year-old female consumer who experienced abdominal pain (PT: Abdominal pain) and appetite lost (PT: Decreased appetite), while being on oral Vivotif (lot number: 3003239) for an unknown indication.  Case report: The consumer took the Vivotif doses on an unknown date and experienced abdominal pain across her entire abdomen. She felt like her internal organs were being slowly enzymatically digested. Also, she experienced little cramping. It was reported that after each dose, she experienced the same events. She completely lost her appetite during that week. Moreover, she had experienced similar events last time when she took this vaccine.  Current illness included springtime allergies and had a history of GIRD.  No action was taken with Vivotif with respect to the events.  The consumer was recovered from the events.  Company's Comment: In this case, it was reported that the consumer experienced abdominal pain and appetite lost after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, abdominal pain and decreased appetite are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced abdominal pain and appetite lost after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, abdominal pain and decreased appetite are labelled as per CCDS.
Sex: F
Vaccine: TYP, TYP
Symptoms: Electrocauterisation, Epistaxis
Clinical narrative: NOSEBLEEDS; This spontaneous case report (PVX2019-1895) was received from a pharmacist on 22-Jul-2019. It described a female consumer who had nosebleeds (PT: Epistaxis), after administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took Vivotif doses on 15-Jul-2019, 17-Jul-2019, and 19-Jul-2019, respectively. She had nosebleed from 16-Jul-2019 to 22-Jul-2019 except on 19-Jul-2019, because she got nose cauterized on 18-Jul-2019 as a treatment for nosebleed. It was reported that she had never had nosebleeds before in her life prior to this event. On 23-Jul-2019, she did not experience any nosebleeds. She had not taken any medication as treatment other than the nose cauterizations. Moreover, she stated that no other cause for nosebleed was evaluated. The reporter stated that Vivotif may have caused the nosebleeds because Vivotif was the only thing in the last week that changed.  Concomitant medication included Super complex B, Vitamin E (400 IU), Calcium with Vitamin D, Coenzyme Q10, and Vitamin C supplement.  She had no chronic illnesses and she did not have high blood pressure.  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the reported event on 23-Jul-2019.  Company Comment: In this case it was reported that a female consumer had nosebleeds after administration of oral Vivotif. There is a strong temporal relationship between intake of vaccine event. There is no medically relevant history. In view of lack of any alternate explanation, the causality has been assessed as possible for the event.; Sender's Comments: Company Comment: In this case, it was reported that a female consumer had nosebleeds after administration of oral Vivotif. There is a strong temporal relationship between intake of vaccine event. There is no medically relevant history. In view of lack of any alternate explanation, the causality has been assessed as possible for the event.
Sex: F
Vaccine: TYP
Symptoms: Blood pressure increased, Dizziness, Headache
Clinical narrative: BLOOD PRESSURE RAISED UP TO 200; DIZZINESS; HEADACHE; This spontaneous case report (831766-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. It described a 66-year-old female consumer whose "blood pressure raised up to 200" (PT: Blood pressure increased) and developed "headache" (PT: Headache) and "dizziness" (PT: Dizziness), while being on oral Vivotif capsule (Lot. 3003281) for an unknown indication.  Case report: The consumer took first dose of Vivotif in the evening of 28-Aug-2019. She developed headache, dizziness, and her blood pressure raised up to 200 in the morning of 30-Aug-2019. She went to emergency room (ER) where she was treated for comfort but could not remember what she had in the hospital. She was advised by the pharmacy to not take any more Vivotif and her husband was instructed to monitor her symptoms until she could see her primary care doctor. On 03-Sep-2019, she went to pharmacy again and was advised to take Tylenol (acetaminophen) for her headache, and meclizine for her dizziness.  Consumer's allergic history included allergy to Aspirin.  Action taken with Vivotif with respect to reported events was vaccine discontinued.  The consumer had recovered from the reported events.  Company Comment: A consumer took first dose of Vivotif in the evening of 28-Aug-2019, she developed headache, dizziness, and her blood pressure raised up to 200 in the morning of 30-Aug-2019 (Blood pressure increased). Information on consumer's medical history and concomitant medications is limited. Vivotif was discontinued and consumer was treated in the emergency room, which resolved all the events. Considering the case information and potential of Vivotif to cause dizziness and headache, the causality of all the events is assessed as possible with Vivotif. The case is considered serious due to medical significance of the event, blood pressure increased. The event Blood pressure increased is unlisted, and headache and dizziness are listed as per CCDS. ; Sender's Comments: A consumer took first dose of Vivotif in the evening of 28-Aug-2019, she developed headache, dizziness, and her blood pressure raised up to 200 in the morning of 30-Aug-2019 (Blood pressure increased). Information on consumer's medical history and concomitant medications is limited. Vivotif was discontinued and consumer was treated in the emergency room, which resolved all the events. Considering the case information and potential of Vivotif to cause dizziness and headache, the causality of all the events is assessed as possible with Vivotif. The case is considered serious due to medical significance of the event, blood pressure increased. The event Blood pressure increased is unlisted, and headache and dizziness are listed as per CCDS.
Age: 39.0
Sex: F
Vaccine: UNK, VARCEL, UNK, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: The patient was administered on 03-MAR-2020 a dose of VARIVAX. On 26-MAR-2020, the patient took a home pregnancy test and the result was positive. On 15-APR-2020, an ultrasound showed the patient was 8 weeks pregnant.; This spontaneous prospective pregnancy report was received from a physician referring to a 39 year old female patient. The patient had no pertinent medical history, drug allergies or reactions or concomitant medications. The patient's last menstrual period (LMP) was on 19-FEB-2020.  On 03-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) via subcutaneously, as prophylaxis since a previous blood work did not show immunity. (valid lot # s002084 expiration date 21-JAN-2020) (vaccination scheme frequency and anatomical location were not provided). Other suspect therapy included Sterile diluent (MERCK STERILE DILUENT). Additionallly, on this same date an urine pregnancy test was performed at the physician office and it was negative. On 26-MAR-2020 the patient called the physician office as she took a home pregnancy test and the result was positive. The patient was seen on 15-MAR-2020, and an ultrasound was performed which showed the patient was 8 weeks pregnant, being pregnant at the time varicella virus vaccine live (oka/merck)(VARIVAX) was administered (exposure during pregnancy). The patient's due date was 25-NOV-2020.
Age: 39.0
Sex: F
Vaccine: UNK, VARCEL, UNK, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: The patient was administered on 03-MAR-2020 a dose of VARIVAX. On 26-MAR-2020, the patient took a home pregnancy test and the result was positive. On 15-APR-2020, an ultrasound showed the patient was 8 weeks pregnant.; This spontaneous prospective pregnancy report was received from a physician referring to a 39 year old female patient. The patient had no pertinent medical history, drug allergies or reactions or concomitant medications. The patient's last menstrual period (LMP) was on 19-FEB-2020.  On 03-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) via subcutaneously, as prophylaxis since a previous blood work did not show immunity. (valid lot # s002084 expiration date 21-JAN-2020) (vaccination scheme frequency and anatomical location were not provided). Other suspect therapy included Sterile diluent (MERCK STERILE DILUENT). Additionallly, on this same date an urine pregnancy test was performed at the physician office and it was negative. On 26-MAR-2020 the patient called the physician office as she took a home pregnancy test and the result was positive. The patient was seen on 15-MAR-2020, and an ultrasound was performed which showed the patient was 8 weeks pregnant, being pregnant at the time varicella virus vaccine live (oka/merck)(VARIVAX) was administered (exposure during pregnancy). The patient's due date was 25-NOV-2020.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.  On 31-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S022755, expiration date: 02-JUL-2021, but upon internal validation established as 22-JUL-2021 (dose, unit, route and anatomical location were not reported) for prophylaxis. There were no previous temperatures excursion. The vaccine was exposed at the temperature -13.4 degrees Celsius for 1 hour and 30 minutes. Data digital logger was involved. No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; the patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse regarding a patient of unknown age, gender and race.  The patient's concurrent conditions, pertinent medical history and drug reactions / allergies were not reported.   On 30-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number S024366, expiration date 06-AUG-2021, for prophylaxis (dose and route of administration were not reported). A properly stored sterile diluent (lot number R019504, expiration date 04-NOV-2020) was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX).  There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -14 (°C) degrees Celsius to -10 °C (-12.2°C) for 4 days, 11 hours and 40 minutes. Data logger was involved. There were no previous excursions reported.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Insomnia
Clinical narrative: NOT ABLE TO SLEEP; STOMACH ACHE; This spontaneous case report (PVX2019-1692) was received from a consumer on 28-Jun-2019. It describes a 67-year-old elderly male consumer who had stomach ache and not able to sleep, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 26-Jun-2019. After 12 hours, he had stomach ache and was not able to sleep. He stated that he never had stomach aches before, and he had no history of gastrointestinal illnesses.  Concomitant medication included Aciphex (rabeprazole), Lexapro (escitalopram), xiidra (lifitegrast), Exforge (amlodipine), oxazepam, Vitamin C (L-ascorbic acid), vitamin D3 (cholecalciferol), and glucosamine chondroitin.  Action taken with Vivotif with respect to the events was unknown.  The consumer had recovered from the event stomach ache on 28-Jun-2019, while the outcome for the event not able to sleep was unknown.  Company's Comment: In this case, it was reported that a male consumer who had stomach ache and not able to sleep, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach ache is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer who had stomach ache and not able to sleep, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach ache is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Migraine, Product storage error, Self-induced vomiting
Clinical narrative: MIGRAINE HEADACHE; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a pharmacist (PVX2019-004) on 02-Jan-2019. The report describes a 20-year-old female consumer who had migraine headache following the intake of Vivotif for typhoid prophylaxis. The consumer also "took an unrefrigerated dose".  It was reported that the consumer picked up Vivotif and left it out of the refrigerator for 26 hours before taking a dose yesterday (01-Jan-2019). She had a migraine headache this morning (02-Jan-2019). She had vomited after taking the first dose, but later clarified that she forced herself to vomit because she heard that the vaccine was unstable if it was kept unrefrigerated.  The action taken with Vivotif with respect to the event migraine headache was unknown, while with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the events migraine headache and "took an unrefrigerated dose" was unknown.  Company's Comment: In this case, it was reported that 20-year-old female consumer experienced migraine headache following the intake of Vivotif. The event occurred after the consumer forced herself to vomit the dose and there is limited information regarding the medical history in this case.  Migraine headache is unlabeled as per CCDS. Hence, the causality of the event "migraine headache" with Vivotif is assessed unlikely. The consumer also "took an unrefrigerated dose". The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: In this case, it was reported that 20-year-old female consumer experienced migraine headache following the intake of Vivotif. The event occurred after the consumer forced herself to vomit the dose and there is limited information regarding the medical history in this case.  Migraine headache is unlabeled as per CCDS. Hence, the causality of the event "migraine headache" with Vivotif is assessed unlikely. The consumer also "took an unrefrigerated dose". The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE ON DAY 5; This spontaneous case report was received from a consumer (PVX2019-138) on 15-Jan-2019. The report describes a 23-year-old adult male consumer who "took second dose of day 5". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer did not follow the directions for Vivotif properly. He took the doses on 07-Jan-2019, 11-Jan-2019, 13-Jan-2019, and 15-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took second dose of day 5" was not applicable.  The clinical outcome of the event "took second dose of day 5" was unknown.  Company's Comment: The causality of the event "took second dose of day 5" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose of day 5" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE ON DAY 4; This spontaneous case report was received from a nurse (PVX2019-162) on 17-Jan-2019. The report describes a 30-year-old adult female consumer who "took second dose on day 4". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the second dose on day 4. The doses were taken on Sunday (13-Jan-19) and Wednesday (16-Jan-19), respectively.  The action taken with Vivotif with respect to the event "took second dose on day 4" was not applicable.  The clinical outcome of the event "took second dose on day 4" was unknown.  Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: MISSED THIRD DOSE; TOOK TWO DOSES WITH FOOD; A spontaneous case report was received from a consumer on 17-Jan-2019 for three consumers.  Based on the information obtained from the consumer, three individual case safety reports PVX201901-000046 (PVX2019-172; mother), PVX201901-000047 (PVX2019-173; son) and PVX201901-000048 (PVX2019-174; husband) were created and cross-linked in the database.  This case report describes an adult female consumer who "missed third dose" and "took two doses with food". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the doses of Vivotif on 12-Jan-2019 and 14-Jan-2019 with a snack, milk and drink. She also missed her third dose which was due on 16-Jan-2019.  The action taken with Vivotif with respect to events "missed third dose" and "took two doses with food" was not applicable.  The clinical outcome of the events "missed third dose" and "took two doses with food" was unknown.  Company's Comment: The causality of the events "missed third dose" and "took two doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "missed third dose" and "took two doses with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000047: US-PaxVax Berna GmbH-PVX201901-000048:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: TOOK SECOND DOSE ON DAY 4; TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a caregiver on 17-Jan-2019 for three consumers.  Based on the information obtained from the caregiver, three individual case safety reports PVX201901-000046 (PVX2019-172; mother), PVX201901-000047 (PVX2019-173; son) and PVX201901-000048 (PVX2019-174; husband) were created and cross-linked in the database.  This case report describes a male child who "took second dose on day 4" and "took Vivotif with food". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 14-Jan-2019 after dinner. He took the second dose on 17-Jan-2019 with breakfast.  The action taken with Vivotif with respect to events "took second dose on day 4" and "took Vivotif with food" was not applicable.  The clinical outcome of the events "took second dose on day 4" and "took Vivotif with food" was unknown.  Company's Comment: The causality of the events "took second dose on day 4" and "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took second dose on day 4" and "took Vivotif with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000046: US-PaxVax Berna GmbH-PVX201901-000048:
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF WITH COFFEE; A spontaneous case report was received from a caregiver on 17-Jan-2019 for three consumers.  Based on the information obtained from the caregiver, three individual case safety reports PVX201901-000046 (PVX2019-172; mother), PVX201901-000047 (PVX2019-173; son) and PVX201901-000048 (PVX2019-174; husband) were created and cross-linked in the database.  This case report describes a male consumer who "took Vivotif with coffee". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took a dose of Vivotif with coffee.  The action taken with Vivotif with respect to event "took Vivotif with coffee" was not applicable.  The clinical outcome of the event "took Vivotif with coffee" was unknown.  Company's Comment: The causality of the event "took Vivotif with coffee" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with coffee" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000047: US-PaxVax Berna GmbH-PVX201901-000046:
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED ONE OR TWO DOSES OF VIVOTIF; This spontaneous case report was received from a nurse (PVX2019-185) on 18-Jan-2019. The report describes a consumer who "missed one or two dose of Vivotif". The consumer was receiving Vivotif for unknown indication.  It was reported that the consumer missed one or two dose of Vivotif in this week. The reporter did not know how many doses were missed or when they were missed.  The action taken with Vivotif with respect to the event "missed one or two dose of Vivotif" was not applicable.  The clinical outcome of the event "missed one or two dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed one or two dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed one or two dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report was received from a caregiver (PVX2019-192) on 18-Jan-2019. The report describes a 20-year-old female consumer who "did not take Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003240) for trip.  It was reported that the consumer took four doses of Vivotif in an inappropriate way. She took it on day 1, 3, 6, and 8 respectively.   The action taken with Vivotif with respect to the event "did not take Vivotif according to schedule" was not applicable.  The clinical outcome of the event "did not take Vivotif according to schedule" was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THE SECOND DOSE OF VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-209) on 22-Jan-2019. The report describes a 72-year-old male consumer who "missed the second dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the first dose of Vivotif on Friday and missed his second dose which was due on Sunday.  The action taken with Vivotif with respect to the event "missed the second dose of Vivotif" was not applicable.  The clinical outcome of the event "missed the second dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed the second dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error, Product storage error
Clinical narrative: TOOK A DOSE WITH FOOD; TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-208) on 22-Jan-2019 and a follow-up information was received on 23-Jan-2019. The report describes a female consumer who "took unrefrigerated doses" and "took a dose with food" The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer picked up Vivotif and left it unrefrigerated for 24 hours at room temperature before taking the first dose. Afterwards, the consumer refrigerated the Vivotif. When the consumer took the second dose of Vivotif, she took it with food.   The action taken with Vivotif with respect to the events "took unrefrigerated doses" and "took a dose with food" was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "took a dose with food" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "took a dose with food" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and "took a dose with food" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: DID NOT COMPLETE THE COURSE OF VIVOTIF ONE WEEK BEFORE TRAVEL; This spontaneous case report was received from a pharmacist (PVX2019-206) on 22-Jan-2019. The report describes a 49-year-old adult female consumer who "did not complete the course of Vivotif one week before travel". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer started Vivotif today and would be travelling during her last dose.  The action taken with Vivotif with respect to the event "did not complete the course of Vivotif one week before travel" was not applicable.  The clinical outcome of the event "did not complete the course of Vivotif one week before travel" was unknown.  Company's Comment: The causality of the event "did not complete the course of Vivotif one week before travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete the course of Vivotif one week before travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE 50 MINUTES AFTER TAKING THE DOSE; This spontaneous case report was received from a consumer (PVX2019-217) on 23-Jan-2019. The report describes a 19-year-old adult female consumer who "ate 50 minutes after taking the dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 23-Jan-2019 and accidentally ate 50 minutes after taking it instead of waiting an hour.  The action taken with Vivotif with respect to the event "ate 50 minutes after taking the dose" was not applicable.  The clinical outcome of the event "ate 50 minutes after taking the dose" was unknown.  Company's Comment: The causality of the event "ate 50 minutes after taking the dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate 50 minutes after taking the dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; DID NOT TAKE THE LAST DOSE; This spontaneous case report was received from a consumer (PVX2019-227) on 24-Jan-2019. The report describes a female consumer who "took unrefrigerated doses" and "did not take the last dose". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the first dose of Vivotif on 15-Jan-2019 then took two more doses which are unrefrigerated. She did not take the last dose.   The action taken with Vivotif with respect to the events "took unrefrigerated doses" and "did not take the last dose" was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "did not take the last dose" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "did not take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and "did not take the last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Dyspnoea, Vomiting
Clinical narrative: HEAVY BREATHING; DIARRHEA; SEVERE STOMACH PAIN; THROWING UP; This spontaneous case report was received from a consumer (PVX2019-522) on 26-Feb-2019. The report described a 24-year-old female consumer who had heavy breathing, diarrhea, severe stomach pain, and throwing up following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the first dose of Vivotif last night at around 10:00 PM on an empty stomach. On 26-Feb-2019, she had breakfast and drank water, then right after breakfast she started throwing up and experienced severe stomach pain and diarrhea. She was also having heavy breathing. She stated that the adverse events were coming in waves. She clarified that about every 5 minutes, she will need to throw up and her stomach will cramp up really bad and then it will go away and then start again. She stated that it was ongoing since it started and did not resolve.   She stated that she did not take any treatment for the adverse events. She did not have exposure to any unhygienic food or water recently and was doing the normal daily routine. She ate a bagel for breakfast and that she eats the same thing every single day.  The action taken with Vivotif with respect to the events heavy breathing, diarrhea, severe stomach pain, and throwing up and was unknown.  The clinical outcome of the events heavy breathing, diarrhea, severe stomach pain, and throwing up was not resolved.  Company's Comment: In this case, it was reported that the consumer experienced "heavy breathing, diarrhea, severe stomach pain and throwing up" after intake of Vivotif. There is temporal association between the intake of the vaccine and the events. Also, the events "diarrhea, severe stomach pain and throwing up" are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "heavy breathing, diarrhea, severe stomach pain and throwing up" after intake of Vivotif. There is temporal association between the intake of the vaccine and the events. Also, the events "diarrhea, severe stomach pain and throwing up" are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Decreased appetite, Listless
Clinical narrative: LISTLESS; NO APPETITE; ABDOMINAL CRAMPING; This spontaneous case (PVX2019-786) was received from nurse on 01-Apr-2019. It describes a 12-year-old female consumer who felt listless and experienced abdominal cramping and had no appetite, while being on Vivotif for an unknown indication.  Case report: The consumer took three doses of Vivotif so far. The doses were taken on 28-Mar-2019, 30-Mar-2019, and 01-Apr-2019 respectively. After the second dose, she experienced terrible abdominal cramping, felt listless, and had no appetite. On 01-Apr-2019, after taking the third dose the events got worse.  She was not taking any concomitant medication and did not take any treatment medications for the events. She did not have any other medical history. She did not eat any unhygienic food or water.  Action taken with Vivotif with respect to the events listless, abdominal cramping, and no appetite was unknown.  The consumer had not recovered from the events listless, abdominal cramping, and no appetite.  Company's Comment: In this case, it was reported that the consumer experienced abdominal cramping, felt listless, and had no appetite after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced abdominal cramping, felt listless, and had no appetite after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Flushing, Pyrexia
Clinical narrative: SUPER FLUSHED/ KIND OF LIKE FEVER; This spontaneous case (PVX2019-857) was received from a consumer on 10-Apr-2019. It describes a 25-year-old female consumer who felt super flushed/ kind of like fever, after the administration of Vivotif (lot no: 3003253) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 10-Apr-2019, then after within 10 minutes she felt super flushed. She also felt like she had fever.   The consumer had no medical history.  The consumer was not taking any concomitant medication at the time of this report.  Action taken with Vivotif was unknown.   The consumer had not recovered from the event super flushed/ kind of like fever.  Company's Comment: In this case, it was reported that the consumer felt super flushed/ kind of like fever within 10 minutes of Vivotif administration. There seems to be a strong temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer felt super flushed/ kind of like fever within 10 minutes of Vivotif administration. There seems to be a strong temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Product physical issue
Clinical narrative: VIVOTIF OPENED UP IN HER MOUTH AS SHE TOOK IT; This spontaneous case (PVX2019-1185) was received from a consumer on 13-May-2019. It describes a 62-year-old adult female consumer whose "Vivotif opened up in her mouth as she took it". The consumer was receiving oral Vivotif capsule for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 07-May-2019. On 11-May-2019, when she took the third dose, the capsule opened in her mouth. She took the dose and afterwards, she drank a ton of water.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "Vivotif opened up in her mouth as she took it" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "Vivotif opened up in her mouth as she took it" was considered as not applicable.
Sex: U
Vaccine: TYP
Symptoms: Rash, Skin hyperpigmentation
Clinical narrative: HYPERPIGMENTATION OF THE SKIN; RASH; This spontaneous case (PVX2019-1333) report was received from a consumer on 23-May-2019. It describes a consumer who had rash with hyperpigmentation of the skin, after the administration of Vivotif for an unknown indication.  Case report: The consumer developed rash after 2 doses of Vivotif. She went to Clinic for rash, as she was not sure what it was. The rash was completely flat and did not bother her. However, it was labelled as hyperpigmentation of skin by the clinic which she visited. She stated that the rash was still there, and she did not know if it was getting better.  She did not take any treatment for the events.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that the consumer had rash and hyperpigmentation of skin after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had rash and hyperpigmentation of skin after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Rash
Clinical narrative: RASH; This spontaneous case (PVX2019-1354) was received from a nurse on 28-May-2019. It describes a female consumer who developed rash, after the administration of oral Vivotif for typhoid prophylaxis.  Case report: The consumer started taking Vivotif from 16-May-2019. She reported that she developed rash, but she could not remember if it occurred before or after taking Vivotif. She stated that the rash started on her palms and face, spread to her ankles, a little on her calves, behind her knees, legs, and thighs. Thus, she felt itchiness over her body. She started taking oral prednisone (taper down from 50 mg) for the event from 27-May-2019.  The consumer had no medical history, no illnesses at the time or one month prior to vaccination and had no known drug allergies.   The consumer had taken Vivotif before and completely fine at that time.  Action taken with Vivotif was unknown.  Company's Comment: In this case, it was reported that the consumer had rash after intake Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labeled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had rash after intake Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labeled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Product physical issue
Clinical narrative: TOOK BROKEN CAPSULE; This spontaneous case (PVX2019-1545, PTC-000064) was received from a pharmacist on 14-Jun-2019. It describes a 36-year-old adult female consumer who "took broken capsule". The consumer was receiving oral Vivotif (one capsule every other day) (lot number: 3003277 and expiry date: May 2020) for typhoid prophylaxis.  Case report: The consumer found that one capsule of Vivotif inside the pack was broken and the powder spread out of it but she took that broken capsule on 14-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took broken capsule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took broken capsule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product physical issue
Clinical narrative: TOOK PART OF A BROKEN CAPSULE; This spontaneous case report (PVX2019-1665, PTC-000066) was received from a pharmacist on 26-Jun-2019. It describes a male consumer who "took part of a broken capsule". She was receiving Vivotif capsule (lot number: 3003272 and expiry date: Apr 2020) for an unknown indication.  Case report: The consumer reported that there was a broken capsule in the box and he took the part of that broken capsule.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took part of a broken capsule" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took part of a broken capsule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product physical issue
Clinical narrative: TOOK STICKY CAPSULE WITH RESIDUE; This spontaneous case report (PVX2019-1734) was received from a nurse on 01-Jul-2019. It describes a 65-year-old male consumer who "took sticky capsule with residue" (PT: Product physical issue), while being on Vivotif (lot number: 3003277 and expiry date: 31-May-2019) for an unknown indication.  Case report: The consumer took two dose of Vivotif but when he was taking the third dose, he observed that the capsule stick on the pack and some residue was left inside the pack. He took that capsule.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took sticky capsule with residue" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took sticky capsule with residue" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Fatigue, Headache, Malaise, Nausea
Clinical narrative: MILD SORE THROAT; NOT FEELING WELL/ ICKY; FEELING EXTRA RUN DOWN; MILD HEADACHES; HER STOMACH FELT FUNNY; NAUSEOUS; This spontaneous case report (PVX2019-2632) was received from a consumer on 22-Oct-2019. It described a female consumer who "felt nauseous" (PT: Nausea), had been feeling extra run down (PT: Fatigue), not feeling well/icky (PT: Malaise), had mild sore throat (PT: Oropharyngeal pain), her stomach felt funny (PT: abdominal discomfort) and had mild headaches (PT: Headache) while being on oral Vivotif (company suspect) in every other day.  Case report: The consumer completed all four doses of Vivotif either on 14-Oct-2019 or 15-Oct-2019. She stated that she felt nauseous only during the day of her second dose and fourth dose. Since then, had been feeling extra run down, not feeling well and icky and just wanted to sit down and take a nap. The consumer also reported a mild sore throat, but she was not coughing, and it was not unbearable. She was not eating a lot and not eating heavily, since her stomach felt funny. She also had mild headaches for which she was not worried about and thought maybe she just needed more sleep. She would take Aleve for her headache.  The consumer's medical history included occasional back aches and takes muscle relaxer.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: In this case, it was reported that a female consumer "felt nauseous", had been feeling extra run down, not feeling well/icky, her stomach felt funny and had mild headaches while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Owing to the nature of the event the causality of the event "had mild sore throat" has been assessed as unlikely.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer "felt nauseous", had been feeling extra run down, not feeling well/icky, her stomach felt funny and had mild headaches while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Owing to the nature of the event, the causality of the event "had mild sore throat" has been assessed as unlikely.