chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Product dose omission in error
Clinical narrative: Forgot to take the last dose of Vivotif; A spontaneous report was received from a physician on 13OCT2023 regarding a patient of unknown age and gender who "forgot to take the last dose of Vivotif" (PT: Product dose omission in error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient forgot to take the last dose of Vivotif, and it had been two weeks since then.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient forgot to take the last dose of Vivotif, and it had been two weeks since then (product dose omission in error). Vivotif dose should be taken every other day, and the causality of product dose omission in error is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient forgot to take the last dose of Vivotif, and it had been two weeks since then (product dose omission in error). Vivotif dose should be taken every other day, and the causality of product dose omission in error is assessed as not applicable to Vivotif considering the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Vivotif which was out of the refrigerator the first 24 hours; A spontaneous report was received from a pharmacist on 13OCT2023 regarding a female patient of unknown age who took "Vivotif which was out of the refrigerator the first 24 hours" (PT: Product storage error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took two doses of Vivotif which were out of the refrigerator at room temperature for the first 24 hours or less.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a female consumer took two doses of Vivotif which were out of the refrigerator at room temperature for the first 24 hours (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a female consumer took two doses of Vivotif which were out of the refrigerator at room temperature for the first 24 hours (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission in error
Clinical narrative: Took one capsule of Vivotif out of the four and forgot to continue the schedule; A spontaneous report was received from a nurse on 17OCT2023 regarding a patient of unknown age and gender who "took one capsule of Vivotif out of the four and forgot to continue the schedule" (PT: Product dose omission in error). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that last week (as per the report) the patient took one capsule of Vivotif out of the four and forgot to continue the schedule.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took one capsule of Vivotif out of the four and forgot to continue the schedule (product dose omission in error). Vivotif dose should be taken every other day, and the causality of product dose omission in error is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took one capsule of Vivotif out of the four and forgot to continue the schedule (product dose omission in error). Vivotif dose should be taken every other day, and the causality of product dose omission in error is assessed as not applicable to Vivotif considering the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Ate a very small snack 45 minutes before second dose of Vivotif; A spontaneous report was received from a physician assistant on 18OCT2023 regarding a female patient of unknown age who "ate a very small snack 45 minutes before second dose of Vivotif" (PT: Product administration error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient ate a very small snack 45 minutes before her second dose of Vivotif.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer ate a very small snack 45 minutes before her second dose of Vivotif (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that a consumer ate a very small snack 45 minutes before her second dose of Vivotif (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the very last dose Vivotif a day early; A spontaneous report was received from a female patient of unknown age on 23OCT2023 who "took the very last dose Vivotif a day early" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient was taking a course of four Vivotif pills as per the schedule but took the very last dose a day early. Reportedly, the patient took the first dose of Vivotif, skipped a day, took the second one, skipped a day, took the third one, and then did not skip a day for the fourth dose.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a female patient took the very last dose of Vivotif a day early (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a female patient took the very last dose of Vivotif a day early (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Took the first two capsules of Vivotif as scheduled but then didn't take it anymore; A spontaneous report was received from a pharmacist on 23OCT2023 regarding a 60-year-old male patient who "took the first two capsules of Vivotif as scheduled but then didn't take it anymore" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003852) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 14OCT2023, the patient took the first dose of Vivotif followed by the second dose on 16OCT2023 as scheduled. Reportedly, the patient did not take further doses of Vivotif on 18OCT2023 and 20OCT2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took the first dose of Vivotif followed by the second dose on 16OCT2023 as scheduled but did not take further doses (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer took the first dose of Vivotif followed by the second dose on 16OCT2023 as scheduled but did not take further doses (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is assessed as not applicable to Vivotif considering the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Left Vivotif in a paper bag in a dark place outside the refrigerator; A spontaneous report was received from a female patient of unknown age on 26OCT2023 who "left Vivotif in a paper bag in a dark place outside the refrigerator" (PT: Product storage error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003901) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient picked up the Vivotif from the pharmacy on Tuesday and was not informed that the Vivotif had to be refrigerated thus the patient left the medication in a paper bag in a dark place outside the refrigerator where it wasn't cold or hot. Reportedly, the patient took the first capsule of Vivotif on 26OCT2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a female consumer left Vivotif in a paper bag in a dark place outside the refrigerator and took the first capsule (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that a female consumer left Vivotif in a paper bag in a dark place outside the refrigerator and took the first capsule (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error is assessed as not applicable with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product communication issue, Product storage error
Clinical narrative: Pharmacy didn't inform him that product needed to be refrigerated; Didn't refrigerate Vivotif from Wednesday to Sunday; A spontaneous report was received from a male patient of unknown age on 30OCT2023 who "didn't refrigerate Vivotif from Wednesday to Sunday" (PT: Product storage error) as "pharmacy didn't inform him that product needed to be refrigerated" (PT: Product communication issue). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003901; expiry date: 30JUN2024) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient collected Vivotif from the pharmacy and didn't refrigerate it from Wednesday to Sunday as he was not informed by the pharmacy that Vivotif needed to be refrigerated. The patient already took three out of the four capsules. Reportedly, the Vivotif was out of the refrigerator for approximately 96 hours at a maximum temperature of 68 degrees Fahrenheit. Further, it was reported that the patient refrigerated the product yesterday morning (as per the reporting).  The outcome of the reported events was not applicable. The action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer didn't refrigerate Vivotif from Wednesday to Sunday (product storage error) as pharmacy didn't inform him that product needed to be refrigerated (product communication issue) and took three out of the four capsules. Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error and product communication issue is assessed as not applicable to Vivotif due to the nature of the events.; Sender's Comments: It was reported that a consumer didn't refrigerate Vivotif from Wednesday to Sunday (product storage error) as pharmacy didn't inform him that product needed to be refrigerated (product communication issue) and took three out of the four capsules. Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error and product communication issue is assessed as not applicable to Vivotif due to the nature of the events.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took one pill of Vivotif each day, four days in a row without any gaps in between; A spontaneous report was received from a nurse on 02NOV2023 regarding a 66-year-old female patient who "took one pill of Vivotif each day, four days in a row without any gaps in between" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient was about to schedule some travel vaccination with the vaccination clinic and the patient already had a course of "typhoid pills" provided by her primary care doctor. Reportedly, the patient was asked to take one "pill" of Vivotif each day for four days in a row without any gaps in between and had already completed the course of Vivotif vaccine last week (as per the report).  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a female patient took one pill of Vivotif each day, four days in a row without any gaps in between (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a female patient took one pill of Vivotif each day, four days in a row without any gaps in between (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took first pill at 4:16pm, about an hour and half after eaten the pasta; A spontaneous report was received on 05NOV2023 from a female patient of unknown age who "took first pill at 4:16pm, about an hour and half after eaten the pasta" (PT: Product administration error). The patient took Vivotif (Typhoid vaccine live oral Ty21A; route: oral; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that, on 03NOV2023 the patient had not eaten all day and ate a frozen meal of 10 oz of pasta at 2:40 pm. Then the patient took first pill of Vivotif at 4:16 pm, about an hour and half after eaten the pasta and planned dinner at 5:30. Furthermore, the patient took the second dose of Vivotif on 05NOV2023.  The outcome of the reported event was not applicable.  The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took first pill of Vivotif at 4:16 pm, about an hour and half after eating the pasta (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that a consumer took first pill of Vivotif at 4:16 pm, about an hour and half after eating the pasta (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product solubility abnormal
Clinical narrative: Vivotif capsule opened in mouth; A spontaneous report was received from a healthcare professional on 08NOV2023 regarding a young female child whose "Vivotif capsule opened in mouth" (PT: Product administration error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the last dose of Vivotif was given to a young child, and the capsule opened in her mouth.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event not applicable.  No additional information was reported.  Company comment: It was reported that a young female child took last dose of Vivotif and the capsule opened in mouth (product administration error). Vivotif capsule should be swallowed as soon after placing the mouth as possible. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that a young female child took last dose of Vivotif and the capsule opened in mouth (product administration error). Vivotif capsule should be swallowed as soon after placing the mouth as possible. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Have taken the full dosage of Vivotif that was outside of refrigeration over the recommended amount a time; A spontaneous report was received from a male patient of unknown age on 08NOV2023 who "have taken the full dosage of Vivotif that was outside of refrigeration over the recommended amount a time" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003850) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient received the Vivotif capsules with the ice pack and was advised not to keep the medication outside the fridge for more than 12 hours. Reportedly, the patient left the medication outside the refrigerator for more than 15 hours at a maximum temperature of 68 degrees Fahrenheit. On 27SEP2023, the patient took the first dose of Vivotif and further completed the whole course of vaccination. The patient did not experience any adverse events/discomfort.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event not applicable.  No additional information was reported.  Company comment: It was reported that a consumer has taken the full dosage of Vivotif that was outside of refrigeration over the recommended amount a time (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer has taken the full dosage of Vivotif that was outside of refrigeration over the recommended amount a time (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature. The causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Had taken her first two capsules at the same time with other medications; A spontaneous report was received from nurse on 09NOV2023 regarding a female patient of unknown age who "had taken her first two capsules at the same time with other medications" (PT: Product administration error). The patient took Vivotif (Typhoid vaccine live oral Ty21A; route: oral; lot number: unknown) for an immunisation.  The patient's medical history and allergies were not reported, and concomitant medications included atorvastatin and Tylenol.  It was reported that the patient had taken her first two capsules at the same time with other medications. The patient took first dose of Vivotif with atorvastatin on day 01 and second dose of dose of Vivotif with Tylenol on day 03.  The outcome of the reported event was not applicable.  The action taken with Vivotif with respect to the reported event not applicable.  No additional information was reported.  Company comment: It was reported that a female consumer had taken her first two capsules at the same time with other medications (product administration error). The patient took the first dose of Vivotif with atorvastatin on day 01 and second dose of dose of Vivotif with Tylenol on day 03. Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that a female consumer had taken her first two capsules at the same time with other medications (product administration error). The patient took the first dose of Vivotif with atorvastatin on day 01 and second dose of dose of Vivotif with Tylenol on day 03. Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took all 4 doses of Vivotif on consecutive days; A spontaneous report was received from other healthcare professional on 09NOV2023 regarding a patient of unknown age and gender who "took all 4 doses of Vivotif on consecutive days" (PT: Inappropriate schedule of product administration). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for typhoid prophylaxis.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that patient took all 4 doses of Vivotif on consecutive days via oral route. The patient did not follow directions of dosing.  The outcome of the reported event was not applicable.  The action taken with Vivotif with respect to the reported event not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took all 4 doses of Vivotif on consecutive days (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer took all 4 doses of Vivotif on consecutive days (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Took one dose on 06NOV2023 and saw it was expired; A spontaneous report was received from a pharmacist on 09NOV2023 regarding patient of unknown age and gender who "took one dose on 06NOV2023 and saw it was expired" (PT: Expired product administered). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that pharmacist accidently dispensed Vivotif which was expired on 31OCT2023. The patient took one dose on 06NOV2023 and saw it was expired.  The outcome of the reported event was not applicable.  The action taken with Vivotif with respect to the reported event not applicable.  No additional information was reported.  Company comment: It was reported that consumer took one dose of Vivotif on 06NOV2023 and saw it was expired (expired product administered). Considering the nature of the event, the causality of expired product administered is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that consumer took one dose of Vivotif on 06NOV2023 and saw it was expired (expired product administered). Considering the nature of the event, the causality of expired product administered is assessed as not applicable with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Did not refrigerate the product; A spontaneous report was received from physician on 13NOV2023 regarding a female patient who "did not refrigerate the product" (PT: Product storage error). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that patient and her family did not refrigerate the Vivotif. It was kept at 75-degree Fahrenheit (maximum temperature) for two weeks. The patient took Vivotif.  The outcome of the reported event was not applicable.  The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer did not refrigerate the product (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer did not refrigerate the product (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Was supposed to take the second capsule a day before reporting, but the patient forgot; A spontaneous report was received from nurse on 13NOV2023 regarding a 29-year-old male patient who "was supposed to take the second capsule a day before reporting, but the patient forgot" (PT: Product dose omission in error). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that on 10NOV2023 Friday, patient took the first capsule of Vivotif, and patient was supposed to take the second capsule a day before reporting, but the patient forgot.  The outcome of the reported event was not applicable.  The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer was supposed to take the second capsule a day before reporting but forgot (product dose omission in error). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission in error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer was supposed to take the second capsule a day before reporting but forgot (product dose omission in error). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission in error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: Forgot to take the fourth dose; A spontaneous report was received from other healthcare professional on 15NOV2023 regarding a patient of unknown age and gender who "forgot to take the fourth dose" (PT: Product dose omission in error). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that patient forgot to take the fourth dose of Vivotif.  The outcome of the reported event was not applicable.  The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer forgot to take the fourth dose (product dose omission in error). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission in error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer forgot to take the fourth dose (product dose omission in error). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission in error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Fear, Fear of disease, Intensive care, Loss of consciousness
Clinical narrative: She kept blacking out; Her blood pressure dropped so low; got really sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of blackout in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blackout (Verbatim: She kept blacking out) (serious criteria hospitalization and GSK medically significant), low blood pressure (Verbatim: Her blood pressure dropped so low) (serious criteria hospitalization) and sickness (Verbatim: got really sick) (serious criteria hospitalization). The outcome of the blackout, low blood pressure and sickness were not reported.   It was unknown if the reporter considered the blackout, low blood pressure and sickness to be related to Shingrix.     It was unknown if the company considered the blackout, low blood pressure and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The case was received from the patient's brother/sister via interactive digital media. The reporter reported that, the patient got shingles vaccine that very same day she got really sick. The patient kept blacking out. The patient's blood pressure dropped so low that she stayed in the intensive care unit for 2 days. The reporter was afraid of shingles but also afraid of the shingles shot.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: She kept blacking out; Her blood pressure dropped so low; got really sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of blackout in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blackout (Verbatim: She kept blacking out) (serious criteria hospitalization and GSK medically significant), low blood pressure (Verbatim: Her blood pressure dropped so low) (serious criteria hospitalization) and sickness (Verbatim: got really sick) (serious criteria hospitalization). The outcome of the blackout, low blood pressure and sickness were not reported.   It was unknown if the reporter considered the blackout, low blood pressure and sickness to be related to Shingrix.     It was unknown if the company considered the blackout, low blood pressure and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The case was received from the patient's brother/sister via interactive digital media. The reporter reported that, the patient got shingles vaccine that very same day she got really sick. The patient kept blacking out. The patient's blood pressure dropped so low that she stayed in the intensive care unit for 2 days. The reporter was afraid of shingles but also afraid of the shingles shot.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had 2 vaccine s and still got shingles./ Suspected vaccination failure; Know several had 2 vaccine s and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patients experienced vaccination failure (Verbatim: had 2 vaccine s and still got shingles./ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Know several had 2 vaccine s and still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 This case was reported by consumer via interactive digital media. The reporter known several patients who had 2 vaccines and still got shingles. The reporter reported that the vaccine did not work. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory details were unknown at a time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles; back pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and back pain (Verbatim: back pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the back pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and back pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and back pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 This case was reported by a patient via interactive digital media. The patient got the Shingrix vaccine and still got shingles. At the time of reporting the patient still had back pain after 1 and half year. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Bell's palsy
Clinical narrative: Patient stated she was diagnosed with Bells Palsey recently.  Came in to ask about the reaction due to her flu shot in September.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; very painful nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: very painful nerve pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2024 The case was received from the consumer via interactive digital media. The patient got both shots and still had a horrible case of shingles on the right side. 5 months later, the patient still having very painful nerve pain. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: After incident clinic supervisor was notified as well as patients provider. PCP stated there would not be any reactions and pt would not need to be revaccinated.  Mother of child was then called and information from provider was relayed.
Age: 19.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Injection site erythema, Injection site reaction, Rash macular, Urticaria
Clinical narrative: Pt given Twinrix shot in R Deltoid. Pt then began to break out in hives, skin around injection site began to redden and become blotchy.
Age: 19.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pruritus, Injection site reaction, Rash
Clinical narrative: Pt given Twinrix shot in R Deltoid. Pt then began to break out in hives, skin around injection site began to redden and become blotchy.
Age: 19.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Rash erythematous, Rash macular, Throat clearing, Vitreous floaters
Clinical narrative: Pt given Twinrix shot in R Deltoid. Pt then began to break out in hives, skin around injection site began to redden and become blotchy.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: I went to work that night got my shot earlier that day I went to work that night and I failed the sharp pain come through my left leg in the remains to this day and it messed up my feet my feet puffed out to the point I cannot wear my regular size shoes I wear a size 10 I have to buy a 10 and a half
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired ProQuad.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2024 The case was received from the patient via interactive digital media. The patient got the shot and had to pay 180 dollars for it and guess what he/she had now (at the time of reporting). This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The patient self-reported this case. The reporter reported that tons of people had awful side effects and many developed Shingles. The reporter stated that took Vitamin D. The consent for follow-up no not as per process.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: Burning Itching Rash; Burning Itching Rash; This non-serious case was reported by a consumer and described the occurrence of burning sensation in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Five years ago contracted Shingles after having the non effective vaccine), blister (over a square foot of blisters, had blisters for seven months, 210 days) and post herpetic neuralgia (for two years).   On 12-DEC-2023, the patient received Shingrix. On 12-DEC-2023, 4 hrs after receiving Shingrix, the patient experienced burning sensation (Verbatim: Burning Itching Rash) and itchy rash (Verbatim: Burning Itching Rash). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the burning sensation and itchy rash were not resolved.   It was unknown if the reporter considered the burning sensation and itchy rash to be related to Shingrix.     It was unknown if the company considered the burning sensation and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt date: 24-FEB-2024 The reporter was a patient. The patient reported that burning itching rash came up within four hours after Shingrix injection. Patient reported that five years ago he contracted shingles after having the noneffective vaccine. patient had over a square foot of blisters. Patient did not have for two or three weeks. Patient had blisters for seven months. 210 days. Then post herpetic neuralgia for two years. Patient received benadryl for treatment of Shingrix symptoms. The reporter reported that the symptoms were treated. The reporter requested to consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Mobility decreased, Muscle spasms
Clinical narrative: sounds like burstitis; cannot move left side; terrible back spasms; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of mobility decreased in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-FEB-2024, the patient received Shingrix. In FEB-2024, an unknown time after receiving Shingrix, the patient experienced mobility decreased (Verbatim: cannot move left side) and spasms (Verbatim: terrible back spasms). On an unknown date, the patient experienced bursitis (Verbatim: sounds like burstitis). The outcome of the mobility decreased, spasms and bursitis were not reported.   It was unknown if the reporter considered the mobility decreased, spasms and bursitis to be related to Shingrix.     It was unknown if the company considered the mobility decreased, spasms and bursitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-FEB-2024 The patient received the Shingrix shot one day prior to the reporting date and she has had terrible back spasms and could not move left side. Advice patient that sounds like bursitis. Follow-up would not be possible as no contact details were available
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 25 children under age 2 received a vaccination; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 25 children under age 2 received a vaccination). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. 25 babies received Arexvy which led to inappropriate age at vaccine administration. The follow up would not possible as no contact details were available. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:SAME REPORTER US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027437:Original Case : US2024AMR027335