chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED TO TAKE FOURTH DOSE ON TIME; This spontaneous case report (PVX2019-2066) was received from a pharmacist on 09-Aug-2019. It described a female consumer who "missed to take fourth dose on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The female consumer took three doses of Vivotif on every other day, but missed to take fourth dose on time, which was due on 08-Aug-2019. The pharmacist was not sure if the fourth dose has already been taken.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take fourth dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take fourth dose on time" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED LAST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2075) was received from a consumer on 12-Aug-2019. It described a 35-year-old adult female consumer who "missed last dose of Vivotif" (PT: Product dose omission), while being on Vivotif for travel.  Case report: The consumer missed to take her last dose of Vivotif, which was due on 09-Aug-2019. She will be travelling to country on 21-Aug-2019. The consumer has not taken the last dose till the time of report.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed last dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed last dose of Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK ONE PILL AND FORGOT ABOUT IT; This spontaneous case report (PVX2019-2080) was received from a pharmacist on 12-Aug-2019. It described a male consumer who "took one pill and forgot about it" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took only first dose of Vivotif on 07-Aug-2019 and after that did not take the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one pill and forgot about it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one pill and forgot about it" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVELING; This spontaneous case report (PVX2019-2097) was received from a nurse on 14-Aug-2019. It described a female consumer who "did not complete immunization one week prior to traveling" (PT: Inappropriate schedule of product administration), while being on Vivotif (lot number: 3003248) for travelling to an endemic area.  Case report: The consumer took the first dose of Vivotif on 13-Aug-2019. On 15-Aug-2019, she will be leaving to endemic area.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case report (PVX2019-2103) was received from a caregiver on 14-Aug-2019. It described a female consumer who "took two unrefrigerated doses of Vivotif" (PT: Product storage error), while being on Vivotif for travelling.  Case report: The consumer took two unrefrigerated doses of Vivotif, which were placed at 75 to 80 degree Fahrenheit for approximately 28 hours. She stated that may be, she took the doses on 10-Aug-2019 and 12-Aug-2019. She will be arriving on 31-Aug-2019.  Concomitant medication included Hepatitis A vaccine.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE THE LAST DOSE THAT WAS DUE YESTERDAY; This spontaneous case report (PVX2019-2122) was received from a nurse on 19-Aug-2019. It described an adult female consumer who "did not take the last dose that was due yesterday" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer was on therapy of Vivotif and forgot to take last dose, which was due yesterday (18-Aug-2019). It was reported that she would be back in town on 21-Aug-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take the last dose that was due yesterday" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the last dose that was due yesterday" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO DOSES THAT WERE NOT STORED IN THE REFRIGERATOR; This spontaneous case report (PVX2019-2128) was received from a pharmacist on 19-Aug-2019. It described a 62-year-old male consumer who "took 2 doses that were not stored in the refrigerator" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer took first two unrefrigerated doses of Vivotif on 15-Aug-2019 and 17-Aug-2019, respectively. The dose was kept in the car over 77-degree Fahrenheit for a day.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took 2 doses that were not stored in the refrigerator" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses that were not stored in the refrigerator" 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 report (PVX2019-2142) was received from a consumer on 21-Aug-2019. It described a female consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took two doses in a row. The doses were taken on 18-Aug-2019, 20-Aug-2019, and 21-Aug-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF ON CONSECUTIVE DAYS INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-2145) was received from a consumer on 21-Aug-2019. It described a 65-year-old elderly female consumer who "took Vivotif on consecutive days instead of every other day" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid prophylaxis.  Case report: The consumer completed full course of Vivotif about 2 weeks ago, but she took all the doses on consecutive days instead of every other day.   Action taken with Vivotif was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVELING; This spontaneous case report (PVX2019-2148) was received from a pharmacist on 21-Aug-2019. It described a female consumer who "did not complete immunization one week prior to traveling" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer was scheduled to take the last dose of Vivotif on Saturday (24-Aug-2019). However, she would be travelling to the endemic area on the same date.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED TO TAKE THIRD DOSE ON DUE DATE; This case (PVX2019-2158) was received from a pharmacist on 23-Aug-2019. It described a 33-year-old male consumer who "missed to take third dose on due date" (PT: Product dose omission), while being on Vivotif for an unknown indication  Case report: The consumer missed to take the third dose of Vivotif that was due on 21-Aug-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take third dose on due date" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third dose on due date" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK LAST DOSE OF VIVOTIF A DAY LATE; This case (PVX2019-2172) was received from a consumer on 26-Aug-2019. It described a female consumer who "took last dose of Vivotif one day late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the last dose of Vivotif on 24-Aug-2019, instead of 23-Aug-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 last dose of Vivotif one day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif one day late" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: DECIDED NOT TO CONTINUE TAKING REMAINING DOSES; TOOK A DOSE OF VIVOTIF AFTER 24 HOUR EXCURSION; This case (PVX2019-2165) was received from a pharmacist on 26-Aug-2019. It described an adult male (20-29 years) consumer who "took a dose of Vivotif after 24 hour of excursion" (PT: Product storage error) and he "decided not to continue taking remaining doses" (PT: Incomplete course of vaccination), while being on Vivotif capsule for an unknown indication.  Case report: The consumer took a dose of Vivotif on 26-Aug-2019, after the 24 hours excursion. It was also reported that instead of taking the remaining doses, he wanted to get the injectable vaccine.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "took a dose of Vivotif after 24 hour of excursion" and he "decided not to continue taking remaining doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took a dose of Vivotif after 24 hour of excursion" and he "decided not to continue taking remaining doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THREE DOSES ON CONSECUTIVE DAYS; This case (PVX2019-2177) was received form a pharmacist on 27-Aug-2019. It described a 59-year-old male consumer, who "took three doses on consecutive days" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer did not take doses of Vivotif according to the schedule. The doses were taken on day 1, 2, 3, and 5. The last dose was taken on 26-Aug-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took three doses on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses on consecutive days" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE A DOSE SINCE LAST THURSDAY; This case (PVX2019-2180) was received form a consumer on 27-Aug-2019. It described a 53-year-old male consumer, who "did not take a dose since last Thursday" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer did not take remaining doses till the time of the report after taking two doses of Vivotif on 20-Aug-2019 and 22-Aug-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take a dose since last Thursday" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take a dose since last Thursday" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES OF VIVOTIF; This case (PVX2019-2185) was received form a consumer on 27-Aug-2019. It described a female consumer, who "took two unrefrigerated doses of Vivotif" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif that had not been refrigerated and were no longer good to use. The second dose was taken on 27-Aug-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF DOSES WITH FOOD; This case (PVX2019-2190) was received form a pharmacist on 28-Aug-2019. It described a female consumer, who "took Vivotif doses with food" (PT: Product administration error), while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all 4 doses of Vivotif according to schedule from 17-Aug-2019 to 23-Aug-2019, but she took it with food and not an empty stomach.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif doses with food" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-2349) was received from a healthcare professional on 12-Sep-2019. It described a male consumer who "took two doses in a row" (PT: Inappropriate schedule of vaccine administered), while being on Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif according to the schedule. He took the second and the third dose on consecutive days and did not have any problem.  Action taken with Vivotif with respect to the event was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took 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: Incomplete course of vaccination
Clinical narrative: TOOK ONLY ONE DOSE OF VIVOTIF; This spontaneous case (PVX2019-2358) was received from a pharmacist on 13-Sep-2019. It described a male consumer, who "took only one dose of Vivotif" (PT: Incomplete course of vaccination), while being on Vivotif capsule for an unknown indication.  Case report: The consumer took only first dose of Vivotif on 04-Sep-2019, then stopped taking the further doses, because he was traveling temporarily and could not keep it in the refrigerator.   Action taken with Vivotif with respect to the event was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took only one dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose of Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK VIVOTIF AFTER PLACING IT IN THE FREEZER; A spontaneous case report was received from a nurse on 12-Sep-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201909-000734 (PVX2019-2370; male) and PVX201909-000735 (PVX2019-2371; female) were created and cross-linked in the database.  This case report (PVX2019-2370) describes an elderly male consumer (over 65-year-old) who "took Vivotif after placing it in the freezer" (PT: Product storage error), while being on oral Vivotif capsule (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif, which was kept in the freezer for 12 hours at an unknown temperature. The remaining doses were kept in the refrigerator. The dosage dates remained unknown.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif after placing it in the freezer" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif after placing it in the freezer" was considered as not applicable. US-PaxVax Berna GmbH-PVX201909-000735:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK VIVOTIF AFTER PLACING IT IN THE FREEZER; A spontaneous case report was received from a nurse on 12-Sep-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201909-000734 (PVX2019-2370; male) and PVX201909-000735 (PVX2019-2371; female) were created and cross-linked in the database.  This case report (PVX2019-2371) described an elderly female consumer (over 65-year-old) who "took Vivotif after placing it in the freezer" (PT: Product storage error), while being on oral Vivotif capsule (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif, which was kept in the freezer for 12 hours at unknown temperature. The remaining doses were kept in the refrigerator. The dosage dates remained unknown.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.; Sender's Comments:  US-PaxVax Berna GmbH-PVX201909-000734:
Sex: M
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: TAKING VIVOTIF WHILE ON THE TRIP TO THE ENDEMIC AREA; This spontaneous case report (PVX2019-2372) was received from a consumer on 18-Sep-2019. It described a 27-year-old male consumer who was "taking Vivotif while on the trip to the endemic area" (PT: Inappropriate schedule of product administration), while being on Vivotif (take one dose every other day) for typhoid prophylaxis.  Case report: The consumer started taking Vivotif doses form an unknown date. It was reported that, he was still taking doses, while he was midway through his trip to the endemic area.  Action taken with Vivotif with respect to the event was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "taking Vivotif while on the trip to the endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "taking Vivotif while on the trip to the endemic area" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK FOUR DOSES OF VIVOTIF IN A ROW; This spontaneous case report (PVX2019-2401) was received from a nurse on 19-Sep-2019. It described a female consumer who "took four doses of Vivotif in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took all the four doses of Vivotif in a row instead of normal schedule in last month.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took four doses of Vivotif in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four doses of Vivotif in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE THIRD AND FOURTH DOSE ON TIME; This spontaneous case report (PVX2019-2412) was received from a consumer on 23-Sep-2019. It described a female consumer who "did not take third and fourth dose on time" (PT: Inappropriate schedule of product administration), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 14-Sep-2019, 16-Sep-2019, 21-Sep-2019, and 23-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take third and fourth dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take third and fourth dose on time" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2415) was received from a consumer on 23-Sep-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 22-Sep-2019, which was left unrefrigerated for 3 weeks.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE A DAY LATE; This spontaneous case report (PVX2019-2417) was received from a pharmacist on 23-Sep-2019. It described a female consumer who "took second dose a day late" (PT: Inappropriate schedule of product administration), while on Vivotif for an unknown indication.  Case report: The consumer took the second dose of Vivotif a day late. The doses were taken on 18-Sep-2019 and 21-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-2426) received from a physician on 24-Sep-2019. It described a male consumer who "took two unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif (one dose every other day) (lot number: 3003281) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif, which was left unrefrigerated for 2 hours at 73-74-degree Fahrenheit, which was good to use. Then, he continued to take the remaining doses, which were not good to use. The doses were taken on 19-Sep-2019, 21-Sep-2019, and 23-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "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: Product administration error
Clinical narrative: TOOK FIRST DOSE WITH FOOD; This spontaneous case report (PVX2019-2430) was received from a consumer on 24-Sep-2019. It described a 50-year-old male consumer who "took first dose with food" (PT: Product administration error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif with food on 23-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took first dose with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose with food" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK ONE DOSE A WEEK AGO AND THEN FORGOT ABOUT THE REST; This spontaneous case report (PVX2019-2455) was received from a pharmacist on 27-Sep-2019. It described a male consumer who "took one dose a week ago and then forgot about the rest" (PT: Incomplete course of vaccination), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took only one dose of Vivotif a week ago and then forgot about the rest.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose a week ago and then forgot about the rest" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose a week ago and then forgot about the rest" was considered as not applicable.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy about 5 min after administration. Her vital signs were stable. The dizziness lasted about 5-10 minutes and then it resolved.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Lethargy, Pallor, Screaming, Somnolence
Clinical narrative: 4 Month old female returned to the office at 1:30 reporting an unusual episode: @ 1:00 pm today mom reported that pt was in car seat and started screaming mom got her out of the car seat and pt became lethargic and pale. Unable to keep her awake. Episode lasted 5 mins or so. Checked Pulse and O2 in office. HR of 146 and O2% of 97 temp 98.8r
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient received her second Shingrix shot in the series. She has reported to the pharmacy she still has arm pain.  She has made her physician aware, and he will monitor in another few weeks.  It is extremely sore in the evening and is still sore to sleep on the left arm muscle.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Urticaria
Clinical narrative: Patient experienced rapid heart rate and hives.  He took benadryl to treat his symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Swollen leg and itchy red rash covering entire thigh where injected
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Injection site reaction, Lumbar puncture, Magnetic resonance imaging brain normal, Muscular weakness, Pain in extremity
Clinical narrative: Red rash at injection site on same day as vaccination. On 11/10/2016 developed 6th cranial nerve palsy. ER suggested brain MRI (normal) and lumbar puncture due to possible GBS. In hospital developed severe leg pain and weakness. GBS was never confirmed nor denied.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Rash erythematous, VIth nerve paralysis
Clinical narrative: Red rash at injection site on same day as vaccination. On 11/10/2016 developed 6th cranial nerve palsy. ER suggested brain MRI (normal) and lumbar puncture due to possible GBS. In hospital developed severe leg pain and weakness. GBS was never confirmed nor denied.
Age: 53.0
Sex: F
Vaccine: PNC
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever & shortness of breath, swelling at injection site, redness at injection site
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: SHINGRIX was reconstituted with sterile water instead of diluent from manufacturer. No adverse effects reported, but patient may not have adequate coverage against shingles.
Sex: M
Vaccine: FLUX
Symptoms: Adverse event, Product administered to patient of inappropriate age
Clinical narrative: Stay in hospital was extended to allow for observation due to an unspecified event; less than one months old male patient received influenza vaccination; Initial information received on 14-Apr-2020 regarding an unsolicited valid serious case from a other health care Professional issued from a literature article.    This case is linked to cases 2020SA104035, 2020SA104132 and 2020SA099054.  This case involves Infant male patient (less than one month) who received vaccine INFLUENZA VACCINE  (product administered to patient of inappropriate age) and stayed in hospital was extended to allow for observation due to an unspecified event (hospitalisation).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for immunisation.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious event and stay in hospital was extended to allow for observation due to an unspecified event (hospitalisation) on an unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized for an unspecified event.  It was an actual medication error due to product administered to patient of inappropriate age.  Laboratory details were not reported.  Final diagnosis was hospitalisation.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of hospitalisation.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information available on batch number for this case.; Sender's Comments: This case involves Infant male patient (less than one month) who stayed in hospital was extended to allow for observation on an unknown latency after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was not reported. Concomitant medication included HEPATITIS B VACCINE. Medical history, concurrent condition and lab data ruling out other etiologies would be needed for complete assessment. Based on the reported information the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Age inappropriate influenza vaccination in infants less than 6 months old.; high fever; Initial information received on 14-Apr-2020 regarding an unsolicited valid serious case from a healthcare professional issued from a literature article.   This case is linked with 2020SA099054, 2020SA104167,2020SA104035 (same reporter)  This case involves a 5 months old male patient who developed high fever (pyrexia), while he received vaccine INFLUENZA VACCINE (unknown manufacturer).  The medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious high fever (pyrexia), 7 hours later following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was an actual medication error due to product administered to patient of inappropriate age.  Laboratory details were not reported.  Final diagnosis was high fever.   The patient was treated with PARACETAMOL (TYLENOL) and a tepid bath every hour for Pyrexia.  The patient recovered from the events pyrexia on an unknown date.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information available on batch number for this case.; Sender's Comments: This case concerns a 5 months old infant who presented with high fever (pyrexia), 7 hours after vaccination with INFLUENZA VACCINE (unknown manufacturer) . The time to onset is compatible. However, since patient is just five months old therefore no medical condition was reported at the time of vaccination. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Anxiety, Depression, Disability, Fatigue
Clinical narrative: 10/28/2016 Flu like symptoms for 3 days.  10/2/2016 Extreme inflammatory, migrating pain treated with anti-inflammatory medications, tylenol, prednisone, solumedrol, plaquenil, methotrexate, enbrel.  At this time still have random debilitating flares, daily  chronic fatigue and pain resulting in occasional complete disability, continuous partial disability, anxiety and depression.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Influenza like illness, Pain, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: 10/28/2016 Flu like symptoms for 3 days.  10/2/2016 Extreme inflammatory, migrating pain treated with anti-inflammatory medications, tylenol, prednisone, solumedrol, plaquenil, methotrexate, enbrel.  At this time still have random debilitating flares, daily  chronic fatigue and pain resulting in occasional complete disability, continuous partial disability, anxiety and depression.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Injection site red, hot, swollen and hurt. Rash developed, spreading across chest and neck. Welts formed on neck and chest.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Injection site red, hot, swollen and hurt. Rash developed, spreading across chest and neck. Welts formed on neck and chest.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; 1 patient who received only 1 vaccine that had undergone a temperature excursion; Information has been received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications.  On 16-OCT-2019, the patients were vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # R030810 and expiration date of 24-OCT-2020, hepatitis a vaccine, inactivated(VAQTA) lot # S007770 and expiration date of 24-JUL-2020, and lot # S021092 and expiration date of 18-MAY-2020 (route of administration and anatomical location were not reported), and doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally lot # R033252 and expiration date of 29-JUN-2020 and lot # R033256 and expiration date of 23-JUN-2020, for prophylaxis, which were stored in the range of above 47 Fahrenheit degrees to 35 Fahrenheit degrees or 9 Celsius degrees (9.5 Celsius degrees) for 35 minutes. Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. No previous temperature excursion was reported. No adverse events were reported.   Digital data logger was not involved.  Follow up information received from office manager on 20-APR-2020.  On 20-APR-2020, a call was placed to the nurse and the call was answered by office manager which made the report valid. The office manager reported that it appeared that there had been only one male patient of 6 months old who received only rotavirus vaccine, live, oral, pentavalent (ROTATEQ) that had undergone a temperature excursion.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Administered on the same day; This spontaneous report was received from a nurse regarding a patient of unspecified age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 08-APR-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: rha) (lot number and expiry date reported as S002495 and 23-JUL-2020 respectively) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number and expiry date reported as S004862 and 18-FEB-2021 respectively) for prophylaxis on the same day (Inappropriate schedule of product administration) and also other suspect therapy included sterile diluent for prophylaxis (dose, route and strength not reported) (lot number and expiry date reported as N029293 and 25-APR-2020 respectively). The patient experienced no symptoms. There was no product quality complaint reported. Outcome of the event was unknown.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; patient was administered a dose of properly stored but expired PEDVAXHIB; This spontaneous report as received from a registered nurse refers to a 12-month old female patient. Information regarding the patient's concurrent conditions, drug allergies or reactions, and concomitant medications was not provided.   On 14-APR-2020 the patient was vaccinated with a properly stored but expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) injection as prophilaxys, lot # N014943 and expiration date 05-MAR-2020 (dose number and frequencyof vaccination scheme, route of administration and anatomical location were not reported). No additional adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Eye pain, Ophthalmic herpes simplex
Clinical narrative: Severe pain in his right eye and was diagnosed with herpes simplex dendritic keratitis; Double vision; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 01-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of singles. On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered severe pain in his right eye and was diagnosed with herpes simplex dendritic keratitis. He also suffered double visión as a result of this diagnosis. It was also specified that the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, ophthalmic herpes simplex was considered medically significant. Additionally, the events were considered to be disabling due to serious, permanent and incurable injuries.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: patient had an injection site reaction with redness and soreness after he was administered PNEUMOVAX 23; patient had an injection site reaction with redness and soreness after he was administered PNEUMOVAX 23; This spontaneous report was received from a currently 76-year-old male physician referring to himself. The patient's pertinent concurrent conditions included lymphoma. The patient had previous seasonal allergy and allergies to cats and dogs, also it was reported that the patient had a previous injection site reaction to testosterone cypionate. His concomitant medications included testosterone cypionate, omeprazole (PRILOSEC), rosuvastatin calcium (CRESTOR), unspecified chemotherapy and radiation.   On an unspecified date in April 2019,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength, number of administered dose, vaccine scheme frequency, lot number and expiration date were not provided). After the patient was vaccinated, he experienced injection site reaction with redness and soreness (injection site erythema and injection site pain).  The patient did not seek medical attention, no treatment was given to the patient and no laboratory diagnostic or studies were performed. The patient recovered from the event couple days after pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered.  As the patient reported having an adverse reaction to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23), therefore the causality was being considered as related.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: I did have a mild headache; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was aware that his/her second dose should be completed within 2-6 months of the initial dose.  In the current state of the world with regard to the COVID virus outbreak the reporter was concerned to complete second dose. The reporter was fearful that if he/she developed symptoms following the injection it may be difficult to differentiate from COVID viral symptoms. After receiving the Shingrix, the patient did not have a fever but  did have a mild headache for about 24 hours.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster, Rash, Vaccination failure
Clinical narrative: shingles diagnosis following Shingrix series; shingles diagnosis; Pain on right ear / right ear pain as sharp stabs of pain radiating inward on external ear; Rash rash as located underneath earlobe and radiating along right jaw line; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 23rd March 2020, unknown after receiving Shingrix and Shingrix, the patient experienced ear pain and rash. On 24th March 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with decadron (nos) (Decadron). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the ear pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, ear pain and rash to be related to Shingrix and Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient received a Shingrix series. No lot number or expiration date provided. No date of administration of dose one or two of series provided. On n Monday morning but exact time provided, the patient experienced right ear pain as sharp stabs of pain radiating inward on external ear. On n Monday night just before bed, but exact time provided, the patient experienced rash as located underneath earlobe and radiating along right jaw line.  The patient received a Decadron injection and a prescription for Valtrex and was diagnosed with shingles. On 25th March 2020, the symptoms were begun to abate. no additional details were given. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.