chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Pharmacy said nothing about the fact that Vivotif needed to be refrigerated; Taken 1 dose of Vivotif that was unrefrigerated; A spontaneous report was received from a female patient of unknown age on 27JUN2023 who had "taken 1 dose of Vivotif that was unrefrigerated" (PT: Product storage error) and "pharmacy said nothing about the fact that Vivotif needed to be refrigerated" (PT: Product communication issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history was none and concomitant medications, or known allergies were not reported.  It was reported that the patient picked up prescription for typhoid vaccine and the pharmacy said nothing about the fact that it needed to be refrigerated. Reportedly, the patient administered one dose of Vivotif that was unrefrigerated. Furthermore, the patient restarted the series of Vivotif doses with a new prescription which was received from her physician.  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 had taken 1 dose of Vivotif that was unrefrigerated (product storage error) as the pharmacy said nothing about the fact that Vivotif needed to be refrigerated (product communication issue). Further information regarding event is limited. The causality of product communication issue and product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer had taken 1 dose of Vivotif that was unrefrigerated (product storage error) as the pharmacy said nothing about the fact that Vivotif needed to be refrigerated (product communication issue). Further information regarding event is limited. The causality of product communication issue and product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered dose-3 and dose-4 of Vivotif one day late; A spontaneous report was received from physician on 27JUN2023 regarding 66-year-old male patient who had "administered dose-3 and dose-4 of Vivotif one day late" (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 known allergies were not reported.  It was reported that the patient administered the third dose and fourth dose of Vivotif one day late on 24JUN2023 and 26JUN2023 respectively.  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 provided.  Company comment: It was reported that a consumer administered dose-3 and dose-4 of Vivotif one day late (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer administered dose-3 and dose-4 of Vivotif one day late (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered dose-3 and dose-4 of Vivotif one day late; A spontaneous report was received from physician on 27JUN2023 regarding 64-year-old female patient who had "administered dose-3 and dose-4 of Vivotif one day late" (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 known allergies were not reported.  It was reported that the patient administered the third dose and fourth dose of Vivotif one day late on 24JUN2023 and 26JUN2023 respectively.  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 provided.  Company comment: It was reported that a consumer administered dose-3 and dose-4 of Vivotif one day late (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer administered dose-3 and dose-4 of Vivotif one day late (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed their fourth dose of Vivotif; A spontaneous report was received from pediatrician on 27JUN2023 regarding a patient of unknown age and gender who "missed their fourth dose of Vivotif" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that a patient went on vacation and missed their fourth dose of Vivotif. Reportedly, the fourth dose would be one week late.  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 missed to take their fourth dose of Vivotif (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed to take their fourth dose of Vivotif (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Administered the Vivotif just after his meal; A spontaneous report was received from pharmacist on 28JUN2023 regarding male patient of unknown age who "administered the Vivotif just after his meal" (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 known allergies were not reported.  On 24JUN2023, the patient took the first dose of Vivotif just after the meal. However, took the second and third dose of Vivotif correctly on 26JUN2023 and 28JUN2023 respectively.  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 administered Vivotif just after his meal (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer administered Vivotif just after his meal (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Administered first dose of Vivotif and no doses were given further; A spontaneous report was received from pharmacist on 29JUN2023 regarding a child of unknown age and gender who was "administered first dose of Vivotif and no doses were given further" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the child was administered the first dose of Vivotif on 23JUN2023 and no further doses were given.  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 child was administered first dose of Vivotif and no doses were given further (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a child was administered first dose of Vivotif and no doses were given further (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Administered Vivotif that was left at room temperature for 6 days; A spontaneous report was received from caregiver on 14JUL2023 regarding a 16-year-old male patient who had "administered Vivotif that was left at room temperature for 6 days" (PT: Product storage error). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003832) as an immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered Vivotif that was left at room temperature for 6 days. Additionally, it was reported that the patient administered the third dose of Vivotif on 14JUL2023.  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.  Based on the information available in the document two individual case safety reports 23000323 (mother) and 23000324 (son) were created and cross linked in the database.  Company comment: It was reported that a consumer administered Vivotif that was left at room temperature for 6 days (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer administered Vivotif that was left at room temperature for 6 days (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment. 23000323:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took Vivotif that was kept in her car for several hours; A spontaneous report was received from nurse practitioner on 17JUL2023 regarding a female patient of unknown age who took "took Vivotif that was kept in her car for several hours" (PT: Product storage error). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003832) as an immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient received insulated packages of Vivotif and was told to put it in the fridge. Reportedly, the patient did not make it home until 3:30 that afternoon (as per the report) and kept the capsules in her car for several hours (approximately 6 hours) before taking it home and putting it in the refrigerator. It was stated that the temperature of the car was unknown, but it felt like room temperature, and everything was warm. Furthermore, it was reported that the patient took the same pills of Vivotif and only one was left.  The outcome of the reported event 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 took Vivotif that was kept in her car for several hours (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif that was kept in her car for several hours (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered Vivotif on days 1, 2,4 and 6; A spontaneous report was received from a nurse on 19JUL2023 regarding a male patient of unknown age who "administered Vivotif on days 1, 2,4 and 6" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003824) for immunisation.  The patient's medical history, concomitant medications and allergies were not reported.  It was reported that the patient administered the four doses of Vivotif on days 1, 2,4 and 6 instead of as it was described in the labelling document.  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 administered Vivotif on days 1, 2,4 and 6 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer administered Vivotif on days 1, 2,4 and 6 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took Vivotif which was left out at room temperature for 2 weeks; A spontaneous report was received from a clinical pharmacist on 18JUL2023 along with the additional information on 19JUL2023 regarding a patient of unknown age and gender who "took Vivotif which was left out at room temperature for 2 weeks" (PT: Product storage error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) as a prophylactic vaccination against typhoid.  The patient's medical history, concomitant medications and allergies were not reported.  On 18JUL2023, the patient took the first Vivotif dose which was left out at room temperature (temperature would be from 65-70 degrees Fahrenheit) for 2 weeks. Reportedly, the patient was leaving for an unspecified place within a 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 consumer took Vivotif which was left out at room temperature for 2 weeks (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif which was left out at room temperature for 2 weeks (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the second dose of Vivotif without skipping a day; A spontaneous report was received from a nurse on 27JUL2023 regarding a female patient of unknown age who "took the second dose of Vivotif without skipping a day" (PT: Inappropriate schedule of product administration). 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.  On 26JUL2023 at 8 in the morning the patient took the first dose of Vivotif, and by mistake took the second dose on 27JUL2023 at 8 in the morning, without skipping a day.  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 second dose of Vivotif without skipping a day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the second dose of Vivotif without skipping a day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got them as well. After the shot/ 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: I got them as well. After the shot/ 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.   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: 25-Feb-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingrix vaccine and experienced shingles as well. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took shingles vaccine and then got shingles/ 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: took shingles vaccine and then got shingles/ 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.   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: 26-Feb-2024 This case was reported by a patient via (Facebook) interactive digital media. The reporter reported that his or her sibling received Shingrix vaccine and then experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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. This US2024AMR025324 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR025324:Same reporter different patient
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Vaccination failure
Clinical narrative: She died; got shingle vaccine then she got it/Suspected vaccination failuer; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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 unknown cause of death (Verbatim: She died) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: got shingle vaccine then she got it/Suspected vaccination failuer) (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. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death, vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the unknown cause of death, vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-Feb-2024 This case was reported by a patient's child via interactive digital media. The reporter reported that the patient received Shingles vaccine then she got shingles. The patient died after few months and later after not being able to get rid of shingles. The reporter stated that if the patient did not receive the Shingles vaccine, she would not had to suffer it bad. Never trust it gain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Adult patient that was given a peds dose of Hep A by error; Adult patient that was given a peds dose of Hep A by error; This non-serious case was reported by a nurse via sales rep and described the occurrence of underdose in a adult male patient who received HAV (Havrix 720) for prophylaxis.   On 20-FEB-2024, the patient received the 1st dose of Havrix 720. On 20-FEB-2024, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: Adult patient that was given a peds dose of Hep A by error) and adult use of a child product (Verbatim: Adult patient that was given a peds dose of Hep A by error). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 22-Feb-2024 The reporter reported that in one of the clinics, an adult patient that was given a pediatric dose of Hepatitis A by error, which led to underdose and adult use of a child product. The patient received the vaccine on Tuesday. The reporter reviewed the package insert online at immunize.org b but did not see any guidance on how to resolve the error that was patient brought back in for another pediatric dose to complete the first dose of the series and then will receive the adult dose for the second dose of the series, comes for adult dose as soon as possible and then second dose is also adult dose, no need to adjust first series and just administer adult dose for second dose of the series, etc.  The reporter asked are you able to provide recommendation or documentation on next steps or who I shall reach out to. The reporter stated that there was no symptoms just need to know how to complete the series.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: when there was a backorder situation, people were going past the 6 month window; This non-serious case was reported by a other health professional and described the occurrence of product supply issue in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced product supply issue (Verbatim: when there was a backorder situation, people were going past the 6 month window). The outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 20-FEB-2024 and 21-FEB-2024 The healthcare professional (HCP) stated that he recalls at one time when there was a backorder situation, people were going past the 6 month window but he had no specific patient details to share. The reporter stated, from time to time, he did encounter patients who go past the 6 month window. The reporter mentioned, information unable to conclude what greater than 6 months not necessary to restart schedule means. The reporter asked, what was the longest a person could hold off before getting the second dose and not had to restart 2 doses.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: put her down; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: put her down). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-FEB-2024 The patient received Shingles vaccine experienced event as put her down. The reporter consented to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female 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 vaccine exposure during pregnancy (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Sex: F
Vaccine: RSV
Symptoms: Product use issue, Wrong product administered
Clinical narrative: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female 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 vaccine exposure during pregnancy (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female 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 vaccine exposure during pregnancy (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to wrong vaccine administered and vaccine exposure during pregnancy. The consent to follow up requested. This case was 1 of 128 linked cases reported by the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: vaccines reached a temperature of minus 24 degree C for a cumulative 312 hours; This non-serious case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient did not receive Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced intercepted product storage error (Verbatim: vaccines reached a temperature of minus 24 degree C for a cumulative 312 hours). The outcome of the intercepted product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-FEB-2024 The nurse contacted GSK to solicit thermostability information for Priorix.  The vaccines reached a temperature of minus 24 degree Celsius for a cumulative 312 hours which led to intercepted product storage error. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been link with US2024022686, reported by the same reporter; Sender's Comments:  US-GSK-US2024022686:For one patient
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: vaccines reached a temperature of minus 24 degree C for a cumulative 312 hours; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received MMR (Priorix) (batch number 3247X, expiry date 11-MAY-2024) for prophylaxis.   On 20-FEB-2024, the patient received the 1st dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: vaccines reached a temperature of minus 24 degree C for a cumulative 312 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-FEB-2024 The nurse contacted GSK to solicit thermostability information for Priorix.  The vaccines reached a temperature of minus 24 degree Celsius for a cumulative 312 hours which led to incorrect storage of drug. The nurse reported that a dose of Priorix had been administered after the mentioned excursion.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been link with US2024AMR027164, reported by the same reporter; Sender's Comments:  US-GSK-US2024AMR027164:Original Case : US2024022686
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received MMR (Priorix) (batch number 3247X, expiry date 11-MAY-2024) for prophylaxis.   On 20-FEB-2024, the patient received the 1st dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-FEB-2024 Th nurse contacted GlaxoSmithKline to solicit thermostability information for Priorix and stated that the vaccines reached a temperature of minus 24 degree Celsius for a cumulative 312 hours.  They commented that a dose of Priorix had been administered after the mentioned excursion which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Vaccine administered underage; patient was supposed to get Pentacel but they were out of stock and Kinrix was grabbed as a replacement; administration of Kinrix was the patient's 2nd dose of DTaP and 2nd dose of IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included DTap (on an unknown date received 1st dose.) and IPV (on an unknown date received 1st dose.).   On 19-FEB-2024, the patient received Kinrix. On 19-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Vaccine administered underage), wrong vaccine administered (Verbatim: patient was supposed to get Pentacel but they were out of stock and Kinrix was grabbed as a replacement) and inappropriate schedule of vaccine administered (Verbatim: administration of Kinrix was the patient's 2nd dose of DTaP and 2nd dose of IPV). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 20-FEB-2024 A nurse reported that a 4-month-old patient received Kinrix as 2nd dose of DTaP and 2nd dose of IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The patient was supposed to get Pentacel but were out of stock and Kinrix was grabbed as a replacement which led to wrong vaccine administered. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Cyanosis, Haemorrhage, Injection site bruising, Injection site erythema
Clinical narrative: redness at injection site; pain and swelling of injection site; bruising at injection site; Injection site pain; Back becoming sore; Blueness; Blood coming up; This serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2024, the patient received Shingrix (right arm). On 15-FEB-2024, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site) (serious criteria other: Serious as per reporter), injection site swelling (Verbatim: pain and swelling of injection site) (serious criteria other: Serious as per reporter), injection site bruising (Verbatim: bruising at injection site) (serious criteria other: Serious as per reporter), injection site pain (Verbatim: Injection site pain) (serious criteria other: Serious as per reporter), sore back (Verbatim: Back becoming sore) (serious criteria other: Serious as per reporter), blue skin (Verbatim: Blueness) (serious criteria other: Serious as per reporter) and skin bleeding (Verbatim: Blood coming up) (serious criteria other: Serious as per reporter). The outcome of the injection site erythema, injection site swelling, injection site bruising, injection site pain and sore back were not resolved and the outcome of the blue skin and skin bleeding were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site bruising, injection site pain, sore back, blue skin and skin bleeding to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site bruising, injection site pain, sore back, blue skin and skin bleeding to be related to Shingrix.   Additional Information: GSK receipt date: 20-FEB-2024 The reporter reported that patient had received Shingrix vaccine and experienced redness, swelling and bruising at the site of her Shingrix vaccine was administered and the reaction continuing to worsen and become more painful, and now her back is also sore (caller specified sore, not painful). The reporter called at pharmacy that she got the vaccine at and they referred her to call GSK because she was getting worse. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: redness at injection site; pain and swelling of injection site; bruising at injection site; Injection site pain; Back becoming sore; Blueness; Blood coming up; This serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2024, the patient received Shingrix (right arm). On 15-FEB-2024, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site) (serious criteria other: Serious as per reporter), injection site swelling (Verbatim: pain and swelling of injection site) (serious criteria other: Serious as per reporter), injection site bruising (Verbatim: bruising at injection site) (serious criteria other: Serious as per reporter), injection site pain (Verbatim: Injection site pain) (serious criteria other: Serious as per reporter), sore back (Verbatim: Back becoming sore) (serious criteria other: Serious as per reporter), blue skin (Verbatim: Blueness) (serious criteria other: Serious as per reporter) and skin bleeding (Verbatim: Blood coming up) (serious criteria other: Serious as per reporter). The outcome of the injection site erythema, injection site swelling, injection site bruising, injection site pain and sore back were not resolved and the outcome of the blue skin and skin bleeding were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site bruising, injection site pain, sore back, blue skin and skin bleeding to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site bruising, injection site pain, sore back, blue skin and skin bleeding to be related to Shingrix.   Additional Information: GSK receipt date: 20-FEB-2024 The reporter reported that patient had received Shingrix vaccine and experienced redness, swelling and bruising at the site of her Shingrix vaccine was administered and the reaction continuing to worsen and become more painful, and now her back is also sore (caller specified sore, not painful). The reporter called at pharmacy that she got the vaccine at and they referred her to call GSK because she was getting worse. The reporter did not consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: possibility of a dose of Bexsero being administered to a patient under 10 years of age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: possibility of a dose of Bexsero being administered to a patient under 10 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-FEB-2024 The reporter reported that the patient had received Bexsero vaccine under the 10 years of age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.