chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK LAST DOSE ONE DAY LATE; This spontaneous case report (PVX2019-1825) was received from a nurse on 15-Jul-2019. It describes a 28-year-old adult female consumer who "took last dose one day late" (PT: Inappropriate schedule of product administration). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid prophylaxis.  Case report: The consumer took the last dose of Vivotif one day late. The doses were taken on 07-Jul-2019, 09-Jul-2019, 11-Jul-2019, and 14-Jul-2019, respectively.  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 one day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose one day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case report (PVX2019-1824) was received from a consumer on 15-Jul-2019. It describes a 65-year-old female consumer who "took one unrefrigerated dose of Vivotif" (PT: Product storage error). The consumer was receiving oral Vivotif (one dose every other day) (lot no: 3003279 and expiry date: May 2020) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 15-Jul-2019, which was unrefrigerated since 25-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 one unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one unrefrigerated dose of Vivotif" was considered as not applicable.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED A DOSE OF VIVOTIF ON THE SCHEDULED DAY AND TOOK IT THE NEXT DAY; This spontaneous case report (PVX2019-1829) was received from a pharmacist on 15-Jul-2019. It describes a consumer who "missed a dose of Vivotif on the scheduled day and took it the next day" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif a day late. It was reported that the consumer missed a dose of Vivotif on the scheduled day and took it on the next day though, the consumer completed Vivotif course.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed a dose of Vivotif on the scheduled day and took it the next day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose of Vivotif on the scheduled day and took it the next day" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Wrong technique in product usage process
Clinical narrative: TOOK 2 DOSES OF CRUSHED VIVOTIF; A spontaneous case report was received from a pharmacist on 16-Jul-2019 for three consumers.  Based on the information obtained from a pharmacist, three individual case safety reports PVX201907-000597 (PVX2019-1841; first consumer), PVX201907-000598 (PVX2019-1842; second consumer), PVX201907-000605 (PVX2019-1864; third consumer) and were created and cross-linked in the database.  This case describes a female consumer who "took 2 doses of crushed Vivotif" (PT: Wrong technique in product usage process). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid fever prophylaxis.  Case report: It was reported that the caregiver crushed first two capsules of Vivotif and gave it to the consumer. However, the consumer took the rest two doses normally.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000598: US-PaxVax Berna GmbH-PVX201907-000605:
Sex: F
Vaccine: TYP
Symptoms: Wrong technique in product usage process
Clinical narrative: TOOK 2 DOSES OF CRUSHED VIVOTIF; A spontaneous case report was received from a pharmacist on 16-Jul-2019 for three consumers.  Based on the information obtained from a pharmacist, three individual case safety reports PVX201907-000597 (PVX2019-1841; first consumer), PVX201907-000598 (PVX2019-1842; second consumer), and PVX201907-000605 (PVX2019-1864; third consumer) were created and cross-linked in the database.  This case describes a female consumer who "took 2 doses of crushed Vivotif" (PT: Wrong technique in product usage process). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid fever prophylaxis.  Case report: It was reported that the caregiver crushed first two capsules of Vivotif and gave it to the consumer. However, the consumer took the rest two doses normally.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000597: US-PaxVax Berna GmbH-PVX201907-000605:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSE; This spontaneous case report (PVX2019-1847) was received from a pharmacist on 17-Jul-2019. It describes a 62-year-old adult female consumer who "took unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif capsule (one dose every other day) (lot no: 3003276) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 05-Jul-2019, then left it out at room temperature. On next day, she realized that it was unrefrigerated for around 24 hours at 70-75-degree Fahrenheit. Later, she took all the remaining doses. She took the last dose on 11-Jul-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 unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP, UNK
Symptoms: Contraindication to vaccination
Clinical narrative: TOOK ONE ANTIBIOTIC PILL BETWEEN HIS FIRST AND SECOND VIVOTIF DOSES; This spontaneous case report (PVX2019-1856) was received from a nurse on 17-Jul-2019. It describes an adult male consumer who "took one antibiotic pill between his first and second Vivotif doses" (PT: Labelled drug-drug interaction medication error). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid prophylaxis and oral doxycycline (100 mg) for acne like eruption around nose.  Case report: The consumer took one antibiotic pill between his first and second dose of Vivotif. He took first dose on 15-Jul-2019, then took doxycycline on 16-Jul-2019. Later, he took the second dose on 17-Jul-2019.  Action taken with Vivotif and doxycycline was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one antibiotic pill between his first and second Vivotif doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one antibiotic pill between his first and second Vivotif doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-1854) was received from a pharmacist on 17-Jul-2019. It describes a male consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took one dose of Vivotif, which was kept at room temperature for a day.  Action taken with Vivotif was not applicable.  The clinical outcome of the 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: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THREE DOSES IN A ROW; This spontaneous case report (PVX2019-1849) was received from a nurse on 17-Jul-2019. It describes a male consumer who "took three doses in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took three doses in a row. The doses were taken on 14-Jul-2019, 15-Jul-2019, and 16-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took three doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Wrong technique in product usage process
Clinical narrative: TOOK 2 DOSES OF CRUSHED VIVOTIF; A spontaneous case report was received from a pharmacist on 16-Jul-2019 for three consumers.  Based on the information obtained from a pharmacist, three individual case safety reports PVX201907-000597 (PVX2019-1841; first consumer), PVX201907-000598 (PVX2019-1842; second consumer), and PVX201907-000605 (PVX2019-1864; third consumer) were created and cross-linked in the database.  This case describes a female consumer who "took 2 doses of crushed Vivotif" (PT: Wrong technique in product usage process). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid fever prophylaxis.  Case report: It was reported that the caregiver crushed first two capsules of Vivotif and gave it to the consumer. However, the consumer took the rest two doses normally.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000597: US-PaxVax Berna GmbH-PVX201907-000598:
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: MISSED TO TAKE FOURTH DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1860) was received from a caregiver on 18-Jul-2019. It describes a 14-year-old male consumer who "missed to take fourth dose of Vivotif according to schedule" (PT: Intentional dose omission), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer did not take fourth dose of Vivotif according to schedule because, it was left out of the fridge for 48 hours after the third dose and no longer good to use. He took the first dose on 11-Jul-2019 and his last dose was due on 17-Jul-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 fourth dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take fourth dose of Vivotif according to schedule" was considered as not applicable.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1963) was received from a consumer on 30-Jul-2019. It described a male consumer who "took unrefrigerated doses" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer left Vivotif doses at room temperature for 3 to 4 days and then took 2 doses. Later, he refrigerated it and took remaining 2 doses. He was not sure of the exact dates of the doses taken, but it had occurred a couple of weeks ago.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK THREE DOSES THAT WERE NEVER REFRIGERATED; This case (PVX2019-2191) was received form a nurse on 28-Aug-2019. It described a male consumer, who "took three doses that were never refrigerated" (PT: Product storage error), while being on Vivotif (lot number: 3003282) for an unknown indication.  Case report: The consumer took first three doses of Vivotif that were never refrigerated. The doses were taken on 24-Aug-2019, 26-Aug-2019, and 28-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 that were never refrigerated" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses that were never refrigerated" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This case (PVX2019-2196) was received form a pharmacist on 28-Aug-2019. It described an adult male consumer (age in between 18 to 64 years), 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 the first there doses as directed. However, the third and the fourth dose of Vivotif were taken in a row.  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: Product storage error
Clinical narrative: TOOK ONE UNREFRIGERATED DOSE; This case (PVX2019-2201) was received from a consumer on 28-Aug-2019. It described a 30-year-old male consumer who "took one unrefrigerated dose" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer took an unrefrigerated dose of Vivotif on 28-Aug-2019. He will be travelling on 11-Sep-2019.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of reported event was unknown.  Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK LAST DOSE ON DAY 6; This case (PVX2019-2208) was received from a nurse on 29-Aug-2019. It described an adult female consumer who "took last dose on day 6" (PT: Inappropriate schedule of product administration), while being on oral Vivotif capsule for typhoid prophylaxis.  Case report: The consumer took the last dose of Vivotif on day 6. The doses were taken on 23-Aug-2019, 25-Aug-2019, 27-Aug-2019, and 28-Aug-2019.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of reported events was unknown.  Company's Comment: The causality of the event "took last dose on day 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose on day 6" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This case (PVX2019-2213) was received from a nurse on 29-Aug-2019. It described a male consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), while being oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif in a row on 28-Aug-2019 and 29-Aug-2019, respectively.  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 event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE A TINY PIECE OF CHEESE AFTER TAKING FOURTH DOSE; This case (PVX2019-2221) was received from a consumer on 29-Aug-2019. It described a 31-year-old adult male consumer who "ate a tiny piece of cheese after taking fourth dose" (PT: Product administration error), while being on Vivotif for an unknown indication.  Case report: The consumer took the first and the fourth dose of Vivotif on 23-Aug-2019 and 29-Aug-2019, respectively. But accidentally, he had a tiny piece of cheese after half an hour of taking the fourth dose.  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 "ate a tiny piece of cheese after taking fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate a tiny piece of cheese after taking fourth dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK 2 UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 29-Aug-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201908-000701 (PVX2019-2217; wife) and PVX201908-000702 (PVX2019-2218; husband) were created and cross-linked in the database.  This case (PVX2019-2217) describes a female consumer who "took 2 unrefrigerated doses" (PT: Product storage error), while on therapy with Vivotif for an unknown indication.  Case report: The consumer took first two unrefrigerated doses of Vivotif on 27-Aug-2019 and 29-Aug-2019, respectively. The lot number was either 3003280 or 3003282.  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 2 unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201908-000702:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK 2 UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 29-Aug-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201908-000701 (PVX2019-2217; wife) and PVX201908-000702 (PVX2019-2218; husband) were created and cross-linked in the database.  This case (PVX2019-2218) describes a male consumer who "took 2 unrefrigerated doses" (PT: Product storage error), during therapy with Vivotif for an unknown indication.  Case report: The consumer took first two unrefrigerated doses of Vivotif on 27-Aug-2019 and 29-Aug-2019, respectively. The lot number was either 3003280 or 3003282.  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 2 unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201908-000701:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK LAST DOSE 24 HOURS LATE; This spontaneous case report (PVX2019-2492) was received from a nurse on 04-Oct-2019. It described a female consumer who "took last dose 24 hours late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took Vivotif on days 1, 3, 5, and 8. The consumer took her last dose of Vivotif 24 hours late, on an unknown date (day 8).   Action taken with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose 24 hours late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose 24 hours late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK LAST DOSE LATE; ATE DINNER AFTER TAKING VIVOTIF; This spontaneous case report (PVX2019-2498) was received from a nurse on 04-Oct-2019. It described a female consumer who "took last dose late" (PT: Inappropriate schedule of product administration) and "ate dinner after taking Vivotif" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took Vivotif on 19-Sep-2019, 21-Sep-2019, 23-Sep-2019, and 03-Oct-2019. The reporter also stated that she ate dinner after taking the last dose of Vivotif.  Action taken with respect to reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "took last dose late" and "ate dinner after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose late" and "ate dinner after taking Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF ON CONSECUTIVE DAYS; This spontaneous case report (PVX2019-2500) was received from a nurse on 07-Oct-2019. It described a female consumer who "took Vivotif on consecutive days" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer stated that, she took Vivotif yesterday and today continuously. She had two doses left.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK FIRST DOSE AND FORGOT TO TAKE THE REMAINING DOSES; This spontaneous case report (PVX2019-2507) was received from a pharmacist on 07-Oct-2019. It described a male consumer who took first dose and forgot to take the remaining doses (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.   Case report: The consumer started oral Vivotif on 02-Oct-2019. He took the first dose and then forgot to take the remaining doses.  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 and forgot to take the remaining doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose and forgot to take the remaining doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: FORGOT TO TAKE LAST DOSE; This spontaneous case report (PVX2019-2513) was received from a consumer on 08-Oct-2019. It described a female consumer who "forgot to take last dose" (PT: Product dose omission), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took first three doses of Vivotif, but forgot to take the fourth dose, which was due on 07-Oct-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2520) was received from a consumer on 08-Oct-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif (lot number: 3003297) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 08-Oct-2019, which was unrefrigerated.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP, UNK
Symptoms: Contraindication to vaccination
Clinical narrative: TOOK AUGMENTIN WHILE ON VIVOTIF THERAPY; This spontaneous case report (PVX2019-2505) was received from a nurse on 07-Oct-2019. It described a female consumer who "took Augmentin while on Vivotif therapy" (PT: Labelled drug-drug interaction medication error). The consumer was receiving oral Vivotif (company suspect) for typhoid fever and oral Augmentin (amoxicillin/clavulanate potassium) (non-company suspect) for an ear infection.  Case report: The consumer took the first dose of Vivotif on 03-Oct-2019. Along with Vivotif, she also started taking Augmentin (twice a day) for an ear infection on 04-Oct-2019, 05-Oct-2019, and 06-Oct-2019. She took two doses of Vivotif and would be taking her third dose on 07-Oct-2019. The nurse reported that she was not sure, when the ear infection started and if it was prior to starting Vivotif or not.  Action taken with Vivotif and Augmentin 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 Augmentin while on Vivotif therapy" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Augmentin while on Vivotif therapy" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-2526) was received from a pharmacist on 09-Oct-2019. It described a 67-year-old female consumer who "took unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif capsule for typhoid prophylaxis.  Case report: The consumer did not refrigerate Vivotif doses and she took all the doses.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: injection site is still red; injection site is still red and itchy; a rash or something near some of the edge of the site; a rash or something near some of the edge of the site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site itching, injection site rash and injection site reaction. On an unknown date, the outcome of the injection site erythema, injection site itching, injection site rash and injection site reaction were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site rash and injection site reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that it had been almost a week since the vaccination and the injection site was still red and itchy with a rash or something near some of the edge of the site.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: What do I put on the injection site to reduce the swelling and; What do I put on the injection site to reduce the swelling and pain; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, fever and chills. On an unknown date, the outcome of the injection site swelling, injection site pain, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient got an injection yesterday (date of reporting 10th March 2020) from his doctor and he was experiencing pain and swelling at the site and had a low grade fever and chills. The patient had a concern that what do he put on the injection site to reduce the swelling and pain.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Somnolence
Clinical narrative: I Have been very tired; I have to nap several times a day; I also have periodic headaches; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, somnolence and headache. On an unknown date, the outcome of the fatigue, somnolence and headache were unknown.   It was unknown if the reporter considered the fatigue, somnolence and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the the patient was not reported but selected as an adult as per vaccine indication. The patient received dose of Shingrix in 1st week of February 2020 and had very tired, had to nap several times a day, and periodic headaches.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Vaccine positive rechallenge
Clinical narrative: minor headache; fever; chills/shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia and Shingrix with an associated reaction of chills (For the tolerability of 1st dose, refer case US2020AMR046605 reported for same patient.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache and 1 day after receiving Shingrix, the patient experienced fever and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that he  just had his 2nd Shingrix dose and he was wondering how long, on average, do the common side effects last? This dose he started with a minor headache last night but by this morning he was full on fever, chills, shivering etc. The patient was just curious as to how long this might last.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity, Pruritus
Clinical narrative: Itching; Pain shouting from her shoulder to her back and to her leg; Pain shouting from her shoulder to her back and to her leg; pain shouting from her shoulder to her back and to her leg; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus, shoulder pain, back pain and leg pain. On an unknown date, the outcome of the pruritus, shoulder pain, back pain and leg pain were unknown.   It was unknown if the reporter considered the pruritus, shoulder pain, back pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physical therapist reported that the patient experienced itching and pain shouting from her shoulder to her back and to her leg.  The reporter did not consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020AMR032820.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: the patient received first dose of Shingrix and on an unknown date developed shingles after receiving the Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist had no further information of when the patient developed the shingles, the resolution, lot number, or route. Did not consent to follow-up.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   Concurrent medical conditions included fractured hip (on crutches).   On 5th January 2020, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated the patient had a lot of things going on with broken hip and on crutches. The patient received Shingrix in right deltoid. The patient was still experiencing injection site soreness.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: warm feeling in fingertips; tingling in fingertips; This case was reported by a pharmacist via call center representative and described the occurrence of feeling of warmth in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number L949T, expiry date 16th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 12th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th March 2020, 2 sec after receiving Shingrix, the patient experienced feeling of warmth and tingling of extremity. On an unknown date, the outcome of the feeling of warmth and tingling of extremity were unknown.   It was unknown if the reporter considered the feeling of warmth and tingling of extremity to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of shingrix vaccine in left arm and experienced warm feeling and tingling in his left fingers after the injection. There were no reports of events with dose 1 of shingrix. The reporter consented to follow up.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: sore arm; "didn't feel well"; nausea; "stomach upset"; tired; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 6th March 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling unwell, nausea, upset stomach, tiredness and low grade fever. On 9th March 2020, the outcome of the pain in arm, feeling unwell, nausea, upset stomach and tiredness were recovered/resolved. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, nausea, upset stomach, tiredness and low grade fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose and on same day started with a sore arm, nausea, upset stomch, tiredness, low grade fever and patient did not felt well.  The patient stated that all these symptoms resolved after three days except for the low grade fever which continued till the time of reporting. The patient stated that she did discuss these symptoms with her health care provider. The reporter consented to follow up.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: sore arm; "didn't feel well"; nausea; "stomach upset"; tired; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 6th March 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling unwell, nausea, upset stomach, tiredness and low grade fever. On 9th March 2020, the outcome of the pain in arm, feeling unwell, nausea, upset stomach and tiredness were recovered/resolved. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, nausea, upset stomach, tiredness and low grade fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose and on same day started with a sore arm, nausea, upset stomch, tiredness, low grade fever and patient did not felt well.  The patient stated that all these symptoms resolved after three days except for the low grade fever which continued till the time of reporting. The patient stated that she did discuss these symptoms with her health care provider. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Fever; Flu-like symptoms; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a female 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 2 months after receiving Shingrix, the patient experienced fever, influenza-like symptoms and muscle pain. On an unknown date, the outcome of the fever, influenza-like symptoms and muscle pain were unknown.   The reporter considered the fever, influenza-like symptoms and muscle pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. In 2020, the patient had fever, muscle aches, and flu-like symptoms.  The reporter did not consent to follow up.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Headache
Clinical narrative: blisters are appearing on her face; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 17th March 2020, 11 days after receiving Shingrix, the patient experienced headache. On 18th March 2020, the patient experienced blister. On an unknown date, the outcome of the headache and blister were unknown.   It was unknown if the reporter considered the headache and blister to be related to Shingrix.  Additional details were received as follows: The patient with a history of shingles reported that she received dose 1 of Shingrix.  The patient reported that she developed a headache on 17th March 2020.  On 8th March 2020, the patient reported the headache continuing but that blisters are appearing on her face where she once had shingles.  A physician has not yet been consulted to verify shingles. The reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The age group adult selected as per vaccine specification.  The reporter stated that, almost everyone complained of a sore arm after Shingrix similar to what people feel after the flu shot. The reporter did not consented to follow up.  The reporter could not provide any additional details regarding patients.  This case was linked with case US2020050264 (flu vaccine case), reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; May have also had chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were unknown.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix  Additional details were received as follows: The patient had sore arm after first dose of Shingrix.  Caller had Shingrix first dose.  The patient might have also had chills but she was not sure. Caller did not remember which arm she had the first dose administered into. The reporter did not consented to follow up.  The reporter did not wish to give physician's information. The reporter were not able to be given information about efficacy beyond 6 months for second dose. Ref to hcp and gave info regarding Medical information speaking to hcp's in regards to any other data available. The reporter did not wish to give address.  This case was linked with case US2020051451 (Husband's case), reported by the same reporter.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Malaise, Oropharyngeal pain, Pyrexia, Weight increased
Clinical narrative: sick; fever; cough; sore throat; put on a few pounds/gained about 10lbs; This is a spontaneous report from a contactable consumer, the patient.  A 67-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 02Jan2020 as a single dose for immunisation.  Medical history included indigestion from an unknown date and unknown if ongoing.  Ongoing concomitant medications included omeprazole (MANUFACTURER UNKNOWN) taken for indigestion from an unknown date.  On an unknown date in Jan2020, the patient experienced sickness, fever, cough, and sore throat. In 2020, he put on a few pounds/gained about 10 pounds (lbs). The clinical course was as follows:  On 02Jan2020, the patient had an annual physical (results not provided) and at the request of his doctor he received the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) due to his age. The patient was not a sickly person. About 2-3 days later, he got sick. He had a fever and cough like never before to the point of "passing out 3-4 times a day" and then would go hours with no cough. He called the doctor and was told to give it a couple days and if he was not feeling better to come into the office. He went through the weekend and by then he started feeling better so he didn't go in. The patient stated that he "felt like he had the corona virus and suggest that maybe where they produce, there was some cross contamination" and that was how he got sick. However, the patient also stated that he was unsure that he actually had the corona virus. The patient also mentioned that he had put on few pounds and had gained about 10 lbs since an unknown date in 2020. The clinical outcomes of sickness, fever, cough, and sore throat were recovered in Jan2020 after about 10 days; while that of put on a few pounds/gained about 10 lbs was unknown.   The batch/lot numbers for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), were not provided and will be requested during follow up.