chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; 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: pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: 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 to 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: Incorrect RSV shots; 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 wrong vaccine administered 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 wrong vaccine administered (Verbatim: Incorrect RSV shots) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 22-FEB-2024 The reporter stated this winter there were two vaccines available to ward off respiratory syncytial virus, which was particularly dangerous to older adults and infants one of them was Abrysvo, made by Pfizer which was approved for pregnant women, and neither was for young children. The pregnancy outcome was ongoing and pregnancy trimester was unknown. The distinction was apparently slipped by some clinicians and pharmacists and the pregnant women (patients) were mistakenly given the alternative vaccine Arexvy by GlaxoSmithKline, which led to wrong vaccine administered and vaccine exposure during pregnancy. Arexvy had not been tested in pregnant women or children, so information about its effects in those groups was limited. Yet no serious harms from the errors have been confirmed, but the outcome was unknown in a majority of reported cases. The Centers for Disease Control and Prevention warned a pediatric infectious disease physician and an adviser to the agency. The consent to follow up requested.; Sender's Comments:  US-GSK-US2024AMR020844:Master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy 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.; Sender's Comments:  US-GSK-US2024AMR020844:master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy ). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy 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.; Sender's Comments:  US-GSK-US2024AMR020844:Master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy 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.; Sender's Comments:  US-GSK-US2024AMR020844:Master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy 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.; Sender's Comments:  US-GSK-US2024AMR020844:Master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: pregnant women were mistakenly given the alternative vaccine Arexvy; 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: pregnant women were mistakenly given the alternative vaccine Arexvy) and wrong vaccine administered (Verbatim: 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.; Sender's Comments:  US-GSK-US2024AMR020844:Master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy ). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy 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.; Sender's Comments:  US-GSK-US2024AMR020844:Master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy 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; Sender's Comments:  US-GSK-US2024AMR020844:Master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; 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: Pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: 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 to 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: Pregnant women were mistakenly given the alternative vaccine Arexvy; 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: Pregnant women were mistakenly given the alternative vaccine Arexvy) and wrong vaccine administered (Verbatim: 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 to 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.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal weight gain, Acne, Asthenia, Bedridden, Blood testosterone increased
Clinical narrative: Polycystic Ovarian Syndrome: painful, heavy, and irregular periods, an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, multiple cysts in her cervix and ovaries, inability to become pregnant,testosteron high; psoriatic arthritis; psoriasis; bedridden: unable to get up and move around; constellation of adverse symptoms, complications, injuries, and other adverse events; unable to eat; dysautonomia, autoimmune disorder & nervous system disorder; common colds; chronic fatigue; energy decreased; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a an adult (age not specified) female patient. Patient's current conditions, medical history and  concomitant therapy was not reported.On an unknown date, (at 15, 16 years old and as an adult), the patient was vaccinated with the first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, after receiving the third vaccination, the pt became severe and extremely ill, was bed ridden for approximately four days and unable to work, eat, or get up and move around. Thereafter, she became more frequently prone to common colds and struggled with low energy throughout the day; the pt also began experiencing painful, heavy, and irregular periods as well as experiencing an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, after having an ultrasound, they found a cyst in her left ovary, after further tests, they discovered multiple cysts in her cervix and ovaries as large as 11mm, therefore, she was diagnosed with polycystic ovarian syndrome and treated with unspecify medication. Further blood tests have revealed that pt testosterone levels were now abnormally high, and her body is nowfailing to make enough estrogen and progesterone to allow her to get pregnant. As the months progressed, so did pt symptoms; she was seen by multiple physicians and specialists for her complaints which  included chronic fatigue, painful menstrual symptoms, inability to become pregnant, psoriasis, psoriatic arthritis, and ovarian cysts. Pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop severe and debilitating autoimmune injuries including but not limited to polycystic ovarian syndrome and fertility issues, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events. The outcome of the events was not provided. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review, the events of Psoriatic arthropathy and polycystic ovarian syndrome were determined to be medically significant.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical cyst, Dysmenorrhoea, Fatigue, Feeding disorder, Hair growth abnormal
Clinical narrative: Polycystic Ovarian Syndrome: painful, heavy, and irregular periods, an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, multiple cysts in her cervix and ovaries, inability to become pregnant,testosteron high; psoriatic arthritis; psoriasis; bedridden: unable to get up and move around; constellation of adverse symptoms, complications, injuries, and other adverse events; unable to eat; dysautonomia, autoimmune disorder & nervous system disorder; common colds; chronic fatigue; energy decreased; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a an adult (age not specified) female patient. Patient's current conditions, medical history and  concomitant therapy was not reported.On an unknown date, (at 15, 16 years old and as an adult), the patient was vaccinated with the first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, after receiving the third vaccination, the pt became severe and extremely ill, was bed ridden for approximately four days and unable to work, eat, or get up and move around. Thereafter, she became more frequently prone to common colds and struggled with low energy throughout the day; the pt also began experiencing painful, heavy, and irregular periods as well as experiencing an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, after having an ultrasound, they found a cyst in her left ovary, after further tests, they discovered multiple cysts in her cervix and ovaries as large as 11mm, therefore, she was diagnosed with polycystic ovarian syndrome and treated with unspecify medication. Further blood tests have revealed that pt testosterone levels were now abnormally high, and her body is nowfailing to make enough estrogen and progesterone to allow her to get pregnant. As the months progressed, so did pt symptoms; she was seen by multiple physicians and specialists for her complaints which  included chronic fatigue, painful menstrual symptoms, inability to become pregnant, psoriasis, psoriatic arthritis, and ovarian cysts. Pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop severe and debilitating autoimmune injuries including but not limited to polycystic ovarian syndrome and fertility issues, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events. The outcome of the events was not provided. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review, the events of Psoriatic arthropathy and polycystic ovarian syndrome were determined to be medically significant.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Heavy menstrual bleeding, Impaired work ability, Infection susceptibility increased, Infertility female, Malaise
Clinical narrative: Polycystic Ovarian Syndrome: painful, heavy, and irregular periods, an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, multiple cysts in her cervix and ovaries, inability to become pregnant,testosteron high; psoriatic arthritis; psoriasis; bedridden: unable to get up and move around; constellation of adverse symptoms, complications, injuries, and other adverse events; unable to eat; dysautonomia, autoimmune disorder & nervous system disorder; common colds; chronic fatigue; energy decreased; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a an adult (age not specified) female patient. Patient's current conditions, medical history and  concomitant therapy was not reported.On an unknown date, (at 15, 16 years old and as an adult), the patient was vaccinated with the first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, after receiving the third vaccination, the pt became severe and extremely ill, was bed ridden for approximately four days and unable to work, eat, or get up and move around. Thereafter, she became more frequently prone to common colds and struggled with low energy throughout the day; the pt also began experiencing painful, heavy, and irregular periods as well as experiencing an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, after having an ultrasound, they found a cyst in her left ovary, after further tests, they discovered multiple cysts in her cervix and ovaries as large as 11mm, therefore, she was diagnosed with polycystic ovarian syndrome and treated with unspecify medication. Further blood tests have revealed that pt testosterone levels were now abnormally high, and her body is nowfailing to make enough estrogen and progesterone to allow her to get pregnant. As the months progressed, so did pt symptoms; she was seen by multiple physicians and specialists for her complaints which  included chronic fatigue, painful menstrual symptoms, inability to become pregnant, psoriasis, psoriatic arthritis, and ovarian cysts. Pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop severe and debilitating autoimmune injuries including but not limited to polycystic ovarian syndrome and fertility issues, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events. The outcome of the events was not provided. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review, the events of Psoriatic arthropathy and polycystic ovarian syndrome were determined to be medically significant.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Mobility decreased, Nasopharyngitis, Oestrogen deficiency, Ovarian cyst
Clinical narrative: Polycystic Ovarian Syndrome: painful, heavy, and irregular periods, an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, multiple cysts in her cervix and ovaries, inability to become pregnant,testosteron high; psoriatic arthritis; psoriasis; bedridden: unable to get up and move around; constellation of adverse symptoms, complications, injuries, and other adverse events; unable to eat; dysautonomia, autoimmune disorder & nervous system disorder; common colds; chronic fatigue; energy decreased; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a an adult (age not specified) female patient. Patient's current conditions, medical history and  concomitant therapy was not reported.On an unknown date, (at 15, 16 years old and as an adult), the patient was vaccinated with the first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, after receiving the third vaccination, the pt became severe and extremely ill, was bed ridden for approximately four days and unable to work, eat, or get up and move around. Thereafter, she became more frequently prone to common colds and struggled with low energy throughout the day; the pt also began experiencing painful, heavy, and irregular periods as well as experiencing an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, after having an ultrasound, they found a cyst in her left ovary, after further tests, they discovered multiple cysts in her cervix and ovaries as large as 11mm, therefore, she was diagnosed with polycystic ovarian syndrome and treated with unspecify medication. Further blood tests have revealed that pt testosterone levels were now abnormally high, and her body is nowfailing to make enough estrogen and progesterone to allow her to get pregnant. As the months progressed, so did pt symptoms; she was seen by multiple physicians and specialists for her complaints which  included chronic fatigue, painful menstrual symptoms, inability to become pregnant, psoriasis, psoriatic arthritis, and ovarian cysts. Pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop severe and debilitating autoimmune injuries including but not limited to polycystic ovarian syndrome and fertility issues, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events. The outcome of the events was not provided. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review, the events of Psoriatic arthropathy and polycystic ovarian syndrome were determined to be medically significant.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Polycystic ovarian syndrome, Progesterone deficiency, Psoriasis, Psoriatic arthropathy, Ultrasound ovary abnormal
Clinical narrative: Polycystic Ovarian Syndrome: painful, heavy, and irregular periods, an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, multiple cysts in her cervix and ovaries, inability to become pregnant,testosteron high; psoriatic arthritis; psoriasis; bedridden: unable to get up and move around; constellation of adverse symptoms, complications, injuries, and other adverse events; unable to eat; dysautonomia, autoimmune disorder & nervous system disorder; common colds; chronic fatigue; energy decreased; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a an adult (age not specified) female patient. Patient's current conditions, medical history and  concomitant therapy was not reported.On an unknown date, (at 15, 16 years old and as an adult), the patient was vaccinated with the first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, after receiving the third vaccination, the pt became severe and extremely ill, was bed ridden for approximately four days and unable to work, eat, or get up and move around. Thereafter, she became more frequently prone to common colds and struggled with low energy throughout the day; the pt also began experiencing painful, heavy, and irregular periods as well as experiencing an overwhelming amount of hormonal acne, facial hair growth, and unexplained weight gain, after having an ultrasound, they found a cyst in her left ovary, after further tests, they discovered multiple cysts in her cervix and ovaries as large as 11mm, therefore, she was diagnosed with polycystic ovarian syndrome and treated with unspecify medication. Further blood tests have revealed that pt testosterone levels were now abnormally high, and her body is nowfailing to make enough estrogen and progesterone to allow her to get pregnant. As the months progressed, so did pt symptoms; she was seen by multiple physicians and specialists for her complaints which  included chronic fatigue, painful menstrual symptoms, inability to become pregnant, psoriasis, psoriatic arthritis, and ovarian cysts. Pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop severe and debilitating autoimmune injuries including but not limited to polycystic ovarian syndrome and fertility issues, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events. The outcome of the events was not provided. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review, the events of Psoriatic arthropathy and polycystic ovarian syndrome were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC; HBP reported expired VAIVAX was administered to a patient on 07FEB2024. Product has been stored according to PI. No additional details provided. No additional AE/no PQC.; This spontaneous report was received from a health business professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-FEB-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, administered as prophylaxis (lot #W003819, has been verified to be valid; expiration date reported and established as 02-FEB-2024) (expired product administered) (strength, and route of administration were not provided). No additional adverse events.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy 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 to 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.; Sender's Comments:  US-GSK-US2024AMR020844:Master case