chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A patient received an expired dose of pneumovax23; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 30-MAR-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R012497, with expiration date of 08-JAN-2020, 5 milligram (strength, frequency, route, and anatomical location were not provided) for prophylaxis. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R012497; expirationdate: 08-JAN-2020; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescriber/administered by a health care provider (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date in 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, she was treated by an HCP for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, she was treated by an HCP for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation concerning a female patient (pt) of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as long-term prevention of shingles and/or zoster-related conditions (dose, vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unspecified date (reported as subsequently after zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. It was reported that as a direct and proximate result of the pt's zoster vaccine live (ZOSTAVAX) vaccination, she had and would continue to suffer ongoing injuries, including but not limited to mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the pt had not recovered from shingles.  The event shingles was considered as related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Forgot the third dose until day 6 and wanted to take their fourth dose on the same day as well; Spontaneous report received on 26DEC2019.  A pharmacist reported that a 65-year-old consumer "forgot the third dose until day 6 and wanted to take their fourth dose on the same day as well" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer took the first and second dose of Vivotif on 21DEC2019 and 23DEC2019 respectively, but forgot to take the third dose as per schedule. The consumer took the third dose on 26DEC2019 at 4 am and wanted to take their fourth dose on the same day as well. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first two doses of Vivotif as per the schedule and forgot to take the third dose until day 6 and wanted to take fourth dose on the same day as well (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer took first two doses of Vivotif as per the schedule and forgot to take the third dose until day 6 and wanted to take fourth dose on the same day as well (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took Vivotif which was left unrefrigerated for a week; Spontaneous report received on 09DEC2019.  A pharmacist reported that a female consumer who "took Vivotif which was left unrefrigerated for a week" (PT: Product storage error), while being on oral Vivotif for typhoid fever prophylaxis. The consumer left Vivotif unrefrigerated for a week and took the unrefrigerated doses. The reporter did not know how many unrefrigerated doses the consumer took. Action taken with Vivotif with respect to the reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer left Vivotif unrefrigerated for a week and took unrefrigerated Vivotif doses (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer left Vivotif unrefrigerated for a week and took unrefrigerated Vivotif doses (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not take Vivotif every other day; Spontaneous report received on 09DEC2019.  A pharmacist reported that a female consumer "did not take Vivotif every other day" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever prophylaxis. On 03DEC2019 and 05DEC2019, the consumer took the first and the second dose of Vivotif respectively, and then she did not skip a day and took the third dose on 06DEC2019. On 08DEC2019, she took her last dose. Action taken with Vivotif with respect to the reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer did not take Vivotif doses every other day (Inappropriate schedule of vaccine administration). Considering the mature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer did not take Vivotif doses every other day (Inappropriate schedule of vaccine administration). Considering the mature of the event, the causality of the event is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not take fourth dose of Vivotif on time; Spontaneous report received on 12DEC2019.  A female consumer reported that she "did not take fourth dose of Vivotif on time" (PT: Product dose omission). She was receiving oral Vivotif for typhoid fever prophylaxis. It was reported that the consumer completed 3 doses of Vivotif every other day, but she forgot to take her fourth dose, which was due on 10DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer forgot to take fourth dose of Vivotif on time (missed dose). Considering the nature of the event, the causality of the event is assessed as not related with Vivotif.; Sender's Comments: It was reported that a consumer forgot to take fourth dose of Vivotif on time (missed dose). Considering the nature of the event, the causality of the event is assessed as not related with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif on days 1, 2,3 , and 5; Spontaneous report received on 12DEC2019.  A physician reported that a female consumer "took Vivotif on days 1, 2, 3, and 5" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis. The consumer took Vivotif on days 1, 2, 3, and 5, which was not according to the schedule. It was reported that she would be travelling to country on 29DEC2019. Action taken with Vivotif was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif on days 1, 2, 3, and 5 (Inappropriate schedule of vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif on days 1, 2, 3, and 5 (Inappropriate schedule of vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: Missed third dose of Vivotif by 3 days; Spontaneous report received on 13DEC2019.  A pharmacist reported that an adult male consumer who "missed third dose of Vivotif by 3 days" (PT: Product dose omission), while being on Vivotif for immunisation. The consumer missed his third dose by three days, which was due on 09DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed third dose of Vivotif by three days (missed dose). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer missed third dose of Vivotif by three days (missed dose). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took Vivotif with hot coffee; Spontaneous report received on 13DEC2019.  A 56-year-old female consumer reported that she "took Vivotif with hot coffee" (PT: Product administration error), while being on Vivotif for typhoid prophylaxis. On an unknown date in June, the consumer took all four doses of Vivotif and drank coffee each time within 10 minutes after taking Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif with hot coffee (Product administration error). Vivotif should be taken with cold or lukewarm water. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif with hot coffee (Product administration error). Vivotif should be taken with cold or lukewarm water. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Skipped 2 days between the first and second dose; Spontaneous report received on 16DEC2019.  A male consumer reported that he "skipped 2 days between the first and second dose" (PT: Inappropriate schedule of product administration) while being on oral Vivotif for typhoid fever prophylaxis. On 12DEC2019, the consumer took the first dose of Vivotif and took the second dose of Vivotif after two days on 15DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer skipped 2 days between the first and second dose of Vivotif (Inappropriate schedule of vaccine administration). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer skipped 2 days between the first and second dose of Vivotif (Inappropriate schedule of vaccine administration). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took second dose of Vivotif which was left unrefrigerated for 48 hours; Spontaneous report received on 16DEC2019.  A female consumer reported that she "took second dose of Vivotif which was left unrefrigerated for 48 hours" (PT: Product storage error), while being on oral Vivotif (lot number: 3003304) for typhoid fever prophylaxis. On 14DEC2019, the consumer took the first dose and then left the Vivotif unrefrigerated for 48 hours before taking the second dose on 16DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif, which was left unrefrigerated for 48 hours (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. ; Sender's Comments: A consumer took second dose of Vivotif, which was left unrefrigerated for 48 hours (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took a dose of unrefrigerated Vivotif; Spontaneous report received on 16DEC2019.   Based on the information obtained from caregiver (consumer's mother) two individual case safety report 19000468SP (PVX2019-3095-first child) and 19000469SP (PVX2019-3096-second child).  This case (PVX2019-3096) was for a 10-year-old consumer of unknown gender who "took a dose of unrefrigerated Vivotif" (PT: Product storage error), while being oral Vivotif (lot number: 3003279) for typhoid fever prophylaxis. On 15DEC2019, the consumer took the first dose of Vivotif, which was left unrefrigerated since 26NOV2019. Action taken with Vivotif with respect to reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Product storage error). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer took a dose of unrefrigerated Vivotif (Product storage error). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took Vivotif with food; Spontaneous report received on 17DEC2019.  A physician assistant reported that a female consumer "took Vivotif with food" (PT: Product administration error) following immunisation with Vivotif. The consumer took her doses with food. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.  Follow up information was received 03JAN2020.  The reporter's address, phone number, consumer's name and date of birth was provided in the follow up information.  It was updated that the consumer took three doses of Vivotif at the same time with food. The reporter could not remember the exact dates when the consumer took Vivotif doses but informed that it occurred in the week of 17December.  Company Comment: A consumer took three Vivotif doses with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three Vivotif doses with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Did not take her last dose; Took Vivotif on day 1,4, and 6; Spontaneous report received on 17DEC2019.  A caregiver (consumer's mother) reported that her 17-year-old daughter "took Vivotif on day 1, 4, and 6" (PT: Inappropriate schedule of product administration) and she "did not take her last dose" (PT: Product dose omission), while being on Vivotif for immunization . The consumer did not take doses according to the schedule. The three doses were taken on 09DEC2019, 12DEC2019 and 14DEC2019, respectively. Moreover, she did not take her last dose that was scheduled on 16DEC2019. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took Vivotif doses on day 1, 4, and 6 (Inappropriate schedule of vaccine administered) and she also did not take her last dose of Vivotif (missed dose). Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif doses on day 1, 4, and 6 (Inappropriate schedule of vaccine administered) and she also did not take her last dose of vivotif (missed dose). Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Waited two days instead of one after a dose; Spontaneous report received on 20DEC2019.  A non-healthcare professional reported that a female consumer who "waited two days instead of one after a dose" (PT: Inappropriate schedule of product administration), following immunization with Vivotif. She took four doses of Vivotif from 30NOV2019 to 07DEC2019, but she skipped two days instead of one day after taking one of her doses of Vivotif. Thus, she completed the course over eight days. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer waited two days instead of one after a Vivotif dose (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer waited two days instead of one after a Vivotif dose (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the doses after every 2 days; Spontaneous report received on 23DEC2019.  A nurse reported that a female consumer "took the doses after every 2 days" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis. The consumer took the four doses of Vivotif on 12SEP2019, 15SEP2019, 18SEP2019 and 21SEP2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses after every 2 days (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer took Vivotif doses after every 2 days (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not take fourth dose within 10 days; Spontaneous report received on 23DEC2019.  A pharmacist reported that the patient of unknown demographics who "did not take fourth dose within 10 days" (PT: Incomplete course of vaccination), while being on Vivotif for immunisation. The consumer took three doses of Vivotif according to schedule, but the fourth dose could not be taken within 10 days as twelve days had passed since the patient took the first dose. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take fourth dose within 10 days of taking first dose of Vivotif (Incomplete course of vaccination). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer did not take fourth dose within 10 days of taking first dose of Vivotif (Incomplete course of vaccination). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took 4 doses of Vivotif which was stored at 29 degree fahrenheit; Spontaneous report received on 30DEC2019.  A male consumer reported that he "took 4 doses of Vivotif which was stored at 29-degree Fahrenheit" (PT: Product storage error). He was receiving oral Vivotif for typhoid fever prophylaxis. The consumer took all four doses of Vivotif, which was stored in the refrigerator at 29-degree Fahrenheit. He had taken the last dose on 25DEC2019. He stated that he did not know the lot number. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer stored Vivotif in the refrigerator, which was at 29-degree Fahrenheit and took all four doses of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer stored Vivotif in the refrigerator, which was at 29-degree Fahrenheit and took all four doses of Vivotif (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took unrefrigerated course of Vivotif; Spontaneous report received on 31DEC2019.  A pharmacist reported that a male consumer "took unrefrigerated course of Vivotif" (PT: Product storage error). The consumer took Vivotif (lot number: 3003306) for immunisation. On 24DEC2019, the consumer picked up Vivotif. On 25DEC2019, the consumer started Vivotif and completed the Vivotif course but never refrigerated it. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took all four doses of Vivotif which were never refrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not applicable.; Sender's Comments: A consumer took all four doses of Vivotif which were never refrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Gastroenteritis viral, Vomiting
Clinical narrative: STOMACH VIRUS; VOMITING; This spontaneous case report was received from a nurse (PVX2019-476) on 21-Feb-2019. The report describes a 46-year-old female consumer who developed a stomach virus and vomiting following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer completed her last dose of Vivotif yesterday morning and 16 hours later she developed a stomach virus and had vomiting.  The action taken with Vivotif with respect to the events stomach virus and vomiting was not applicable.  The clinical outcome of the events stomach virus and vomiting was unknown.  Company's Comment: In this case, it was reported that a 46-year-old female consumer developed a stomach virus and vomiting following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. The event stomach flu (Gastroenteritis) is an inflammatory condition mainly infectious in etiology and hence the causality of this event was assessed as unlikely with Vivotif. The event vomiting is likely due the gastrointestinal infection and hence, the causality of the event vomiting is assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, it was reported that a 46-year-old female consumer developed a stomach virus and vomiting following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. The event stomach flu (Gastroenteritis) is an inflammatory condition mainly infectious in etiology and hence the causality of this event was assessed as unlikely with Vivotif. The event vomiting is likely due the gastrointestinal infection and hence, the causality of the event vomiting is assessed as unlikely with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Upper respiratory tract infection
Clinical narrative: UPPER RESPIRATORY INFECTION; This spontaneous case (PVX2019-783) was received from nurse on 01-Apr-2019. It describes a 59-year-old male consumer who had upper respiratory infection, while being on Vivotif for an unknown indication.   Case report: The consumer took only three doses of Vivotif in the last week. His last dose was due on 31-Mar-2019, which he missed to take as on the same day he started experiencing upper respiratory infection. He was prescribed azithromycin by his physician. The reporter was unsure of the dosing regimen of the azithromycin, but she stated that she believed it was a Z-pack with 500 mg on the first day and then 250 mg for three more days.  He did not take any concomitant medication at the time of event and he had no remarkable medical history.   Action taken with Vivotif with respect to the event upper respiratory infection was vaccine discontinued.   The consumer had not recovered from the event upper respiratory infection.  Company's Comment: In this case a 54-year-old male consumer experienced upper respiratory infection following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. However, the event upper respiratory infection is an infectious condition with commonly viral or bacterial etiology. Hence, the causality of the event chest infection is assessed as unlikely with Vivotif vaccine.; Sender's Comments: Company's Comment: In this case a 54-year-old male  consumer experienced upper respiratory infection following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event . However, the event  upper respiratory infection is an infectious condition with commonly viral or bacterial etiology.Hence, the causality of the event chest infection is assessed as unlikely with Vivotif vaccine.
Sex: F
Vaccine: TYP, UNK
Symptoms: Ear infection
Clinical narrative: EAR INFECTION; TOOK ANTIBIOTIC WHILE ON VIVOTIF; This spontaneous case (PVX2019-1306) was received from a nurse on 23-May-2019. It describes a 19-year-old adult female consumer who developed ear infection, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis. She also "took amoxicillin while on Vivotif" for ear infection.  Case report: The consumer started taking Vivotif. Later, she developed ear infection, so she started taking amoxicillin for it and stopped taking Vivotif. She would complete amoxicillin course on 28-May-2018.  The nurse reported that she was better now, and she did not take any other medication.  Action taken with Vivotif with respect to the event ear infection was dosage discontinued while with respect to the event "took amoxicillin while on Vivotif" was not applicable.  Action taken with Amoxicillin with respect to the event ear infection and "took amoxicillin while on Vivotif" was not applicable.  The consumer started recovering from the event ear infection while the clinical outcome of the event "took amoxicillin while on Vivotif" was unknown.  The reporter considered the event ear infection unrelated to vaccine.  Company's Comment: In this case, the patient developed an ear infection after receiving Vivotif vaccine. Since ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took amoxicillin while on Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, the patient developed an ear infection after receiving Vivotif vaccine. Since ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took amoxicillin while on Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product dose omission
Clinical narrative: MISSED THIRD DOSE; This spontaneous case (PVX2019-1347) report was received from a caregiver on 27-May-2019. It describes a male consumer who "missed third dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on Wednesday and the second dose on Friday, but he forgot to take the third dose which was due on Sunday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose" was considered as not applicable.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: TOOK A DOSE OF VIVOTIF ON 23-MAY-2019 AND HAS NOT TAKEN ANY DOSES SINCE THEN; This spontaneous case (PVX2019-1377) was received from a nurse on 29-May-2019. It describes a 33-year-old adult male consumer who "took a dose of Vivotif on 23-May-2019 and has not taken any doses since then". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took a dose of Vivotif on 23-May-2019 and then, did not take any further doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took a dose of Vivotif on 23-May-2019 and has not taken any doses since then" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event  "took a dose of Vivotif on 23-May-2019 and has not taken any doses since then" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incorrect dose administered
Clinical narrative: TOOK VIVOTIF ON DAY 1 AND DAY 2; This spontaneous case (PVX2019-1405) was received from a pharmacist on 31-May-2019. It describes a female consumer who "took Vivotif on day 1 and day 2". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two Vivotif doses on day 1 and day 2.  Action taken with Vitotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif on day 1 and day 2" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on day 1 and day 2" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE A DAY LATE; This spontaneous case (PVX2019-1441) was received from a consumer on 04-Jun-2019. It describes a 14-year-old male consumer who "took second dose a day late". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 31-May-2019 and took the second dose on 03-Jun-2019 instead 02-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 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: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE THIRD DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1463) was received from a consumer on 06-Jun-2019. It describes a female consumer who "did not take third dose of Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first two doses of Vivotif on 28-May-2019 and 30-May-2019, respectively. She did not take the third dose yet.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take third dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take third dose of Vivotif according to schedule" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Sinusitis
Clinical narrative: SINUS INFECTION; This spontaneous case (PVX2019-2224) was received from a pharmacist on 30-Aug-2019. It described an adult female consumer (between 18 to 64 age) who had sinus infection (PT: Sinusitis), after administration of Vivotif for an unknown indication.  Case report: The consumer was on therapy of Vivotif from an unknown date. After started taking Vivotif doses, she developed a sinus infection. The last dose was taken on 28-Aug-2019. On 30-Aug-2019, she went to the physician, who prescribed Keflex for treatment, but he did not have the dosing regimen as he was still deciding whether he should take it.  Action taken with Vivotif with respect to the event was unknown.  The clinical outcome of the reported event was unknown.  Company's Comment: In this case, the consumer developed a sinus infection after receiving Vivotif vaccine. Since sinus infection is an infectious condition, the causality of the event sinus infection is assessed as unlikely with Vivotif vaccine. ; Sender's Comments: Company's Comment: In this case, the consumer developed a sinus infection after receiving Vivotif vaccine. Since sinus infection is an infectious condition, the causality of the event sinus infection is assessed as unlikely with Vivotif vaccine.
Sex: F
Vaccine: TYP, UNK
Symptoms: Urinary tract infection
Clinical narrative: TAKING BACTRIM DS WHILE ON VIVOTIF; UTI; This spontaneous case report (PVX2019-2682) was received from a nurse on 28-Oct-2019. Additional information was received on 29-Oct-2019. It described a female consumer who developed UTI (Urinary tract infection) (PT: Urinary tract infection), while being on Vivotif capsule for travelling. She started "taking Bactrim DS while on Vivotif" (PT: Labelled drug-drug interaction medication error) for UTI.  Case report: The consumer started taking Vivotif from 23-Oct-2019. After her third dose of Vivotif, she developed UTI on 27-Oct-2019. Thus, she started Bactrim DS on 28-Oct-2019.  Action taken with Vivotif with respect to event UTI was vaccine discontinued, while with respect to the event "taking Bactrim DS while on Vivotif" was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, the patient developed a urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "taking Bactrim DS while on Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, the patient developed an urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "taking Bactrim DS while on Vivotif" was considered as not applicable.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rashes after receiving the SHINGRIX vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of rash in a male 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and  experienced rashes. The reporter declined to provide additional information about the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; tenderness at injection site; itch at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site tenderness and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site tenderness and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site tenderness and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix, 3 days ago of the reporting date. Till the time of reporting, the patient was experiencing redness, swelling, tenderness and itch at the shot site.  The patient asked about treatment of these symptoms specially itching.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: itchy hives over her torso; Allergic response; itchy; This case was reported by a nurse via sales rep and described the occurrence of hives in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix. On 1st December 2019, 4 days after receiving Shingrix, the patient experienced hives, allergic reaction and pruritus. The patient was treated with benadryl (nos) (Benadryl), loratadine and prednisone. On an unknown date, the outcome of the hives, allergic reaction and pruritus were unknown.   The reporter considered the hives, allergic reaction and pruritus to be possibly related to Shingrix.  Additional details were provided as follows: Four days after receiving the Shingrix vaccine, patient developed itchy hives,allergic response over her torso and both sides of her body.  There was no scabbing. Difficult to knew the etiology for certain.  Timing would suggest shingrix. This second phase of a reaction to a full week later was confusing. The patient would  used Benadryl 25 mg daily at bedtime and loratadine twice a day during the day. The reporter inquired If not responded adequately to this, can we called for a prescription of prednisone. The second Shingrix vaccine would be given, she should premedicate with Benadryl and use prednisone if needed.