chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a pharmacy manager referring to a number of unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # J014851, expiration date: 24-OCT-2014, first dose on 08-AUG-2014 and last dose on 20-OCT-2014; lot # K010732, expiration date: 31-OCT-2015, first dose on 24-OCT-2014 and last dose on 18-NOV-2014; lot # K012921, expiration date: 29-NOV-2015, first dose on 21-NOV-2014 and last dose on 12-DEC-2014; lot # K015951, expiration date: 23-DEC-2015, first dose on 18-DEC-2014 and last dose on 15-JAN-2015; lot # K019921, expiration date: 24-JAN-2016, first dose on 26-JAN-2015 and last dose on 04-MAR-2015; lot # K021624, expiration date: 07-DEC-2016, first dose on 05-MAR-2015 and last dose on 04-MAY-2015; lot # K024031, expiration date: 20-FEB-2016, first dose on 14-MAY-2015 and last dose on 04-AUG-2015; lot # L011535, expiration date: 03-JUL-2016, first dose on 10-AUG-2015 and last dose on 02-SEP-2015; strength, dose and route unknown). The ZOSTAVAX was stored in a clinic freezer which had operated for 13 months with excursions above 5 degree Fahrenheit for 10-20 minutes three times a day. These temperature variations continued until the problem was discovered on 04-SEP-2015. At that time all ZOSTAVAX was sequestered and new vaccines ordered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician referring to a 9 weeks old patient of unknown age. There was no medical history or concurrent condition reported. On 09-SEP-2015 the patient was vaccinated with VAQTA 25/0.5 (unit unknown) (lot # L013324, expiry date 24-APR-2017) (dosage and route were not reported) instead of RECOMBIVAX, for which the patient was indicated. At the time of the report, the patient had not demonstrated an adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Doses of (Oka/Merck) VARIVAX lot# K015971, expiry date 23-SEP-2016 or lot# K021485, expiry date 03-NOV-2016 or lot# K026385, expiry date 15-DEC-2016 or lot# L001333, expiry date 13-JAN-2017 or lot# L005299, expiry date 17-FEB-2017 or lot# L015049, expiry date 29-APR-2017 (routes and sites of administration, doses were not reported) which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 24-SEP-2015- the date of the excursion. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. Patients' medical history and current conditions were not reported. On an unknown date, the patients received second dose of vaccinated with GARDASIL 9, one month after receiving the first dose of GARDASIL 9. No adverse effects were reported. No product quality complaint was reported. The outcome of the inappropriate schedule of drug administration was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a pharmacy manager referring to a number of unspecified patents of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K008868, expiration date: 19-DEC-2015, first dose reported on '23-OCT-2015' and last dose on 06-MAY-2015; lot # K020750, expiration date: 30-APR-2016, first dose on 05-JUN-2015 and last dose on 03-SEP-2015; lot # L005923, expiration date: 17-AUG-2016, first dose on 15-JUL-2015 and last dose on 02-SEP-2015; strength, dose and route unknown). The PROQUAD was stored in a clinic freezer which had operated for 13 months with excursions above 5 degree Fahrenheit for 10-20 minutes three times a day. These temperature variations continued until the problem was discovered on 04-SEP-2015. At that time all PROQUAD was sequestered and new vaccines ordered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to multiple unspecified patients. On unspecified dates, the patients were administered improperly stored M-M-R II injection (lot # K000737, expiration date 16-JAN-2016; lot # L007577, expiration date 05-MAR-2017 and lot # L010488, expiration date 26-MAR-2017) (dose and route were unspecified). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner referring to four female patients of unknown age. There was no medical history or concurrent condition reported. On unspecified dates these four patients received the GARDASIL (dosage, strength, route and lot # were not reported). On unspecified dates, they reported "high risk PAP smears" while on therapy with GARDASIL. There was no concomitant medication reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 28-SEP-2015, the patient was vaccinated with a dose of MMR II (0.5 ml once, lot# reported as L012482, expiry date: 10-APR-2017) subcutaneously. Concomitant therapy was unknown. On 01-OCT-2015, the pharmacist received a call from the patient's "boss", stating that the patient developed a "welt the size of a mug" at the injection site and the injection site was also warm to the touch. No treatment was given. The outcome of the events was reported as not recovered. Additional information is not expected as we have no consent to contact reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates between July 2015 and 11-SEP-2015, these patients were vaccinated with improperly stored GARDASIL 9 (lot # K026246, expiration date: 28-JAN-2017 or lot# L011846, expiration date: 16-JUN-2017, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 12 month old patient. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L010144, expiry date 24-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. The healthcare worker reported that doses of PEDVAXHIB (lot # L009649, expiry date 29-NOV-2017) (dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 15-SEP-2015. At the time of the report, no adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a male patient of unknown age. On 06-OCT-2015, the patient was inadvertently vaccinated with improperly stored GARDASIL (lot # L019127, expiry date: 27-MAY-2017; dose, route not provided). No adverse experience was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 year old patient of an unknown gender. The patient's medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 19 year old patient of unknown gender. Information regarding medical history and concurrent conditions were not reported. On 21-AUG-2015, the patient was vaccinated with first dose of RECOMBIVAX HB (Lot# L000717 and expiry date: 15-APR-2017), 1 ml. On 21-SEP-2015, the patient was vaccinated with second dose of RECOMBIVAX HB (Lot# L000717 and expiry date: 15-APR-2017), 1 ml. This was outside the recommendations per the RECOMBIVAX HB prescribing information. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a physician via a company representative referring to a female patient of unknown age with high cholesterol; drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (single 0.65 ml; lot # was not provided). Concomitant therapies included LIPITOR. The reporter stated that on an unknown date, the patient developed shingles (herpes zoster) after being vaccinated with ZOSTAVAX. The patient did not received treatment but sought medical attention (office visit). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of herpes zoster was unknown. The relatedness between the event to ZOSTAVAX was not provided. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to a female patient of unknown age. The patient was pregnant. There was no information about patient's medical history, concurrent conditions, drug reactions and allergies. On 05-AUG-2015 the patient was vaccinated with a dose of M-M-R II (lot # L003859, expiry date: 05-FEB-2017). Other suspect therapies included VARIVAX (lot # L010148, expiry date: 24-MAR-2017). Reporting healthcare worker stated that the patient was approximately 5-6 weeks pregnant at the time of report on 01-SEP-2015. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. The pregnancy outcome was outcome pending. No adverse effects were reported. Outcome of the event, exposure during pregnancy was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 05-OCT-2015, the patient was vaccinated with a dose of improperly stored VAQTA 0.5 ml, intramuscularly, lot # L010468, expiry date 02-NOV-2017 (site of administration was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On two separate unknown dates, the patient received a total of two doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Foetal death
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Foetal disorder, Heart rate increased, Hypertension, Laboratory test abnormal, Muscle spasms
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Pathology test, Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Foetal death, Heart rate increased
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Hypertension, Laboratory test abnormal, Muscle spasms, Pathology test, Pneumonia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Amniotic cavity infection, Delivery, Foetal death, Heart rate increased
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Hypertension, Muscle spasms, Pneumonia, Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Foetal exposure during pregnancy, Pathology test, Pneumonia, Premature baby death, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Foetal disorder
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Heart rate increased, Hypertension, Laboratory test abnormal, Muscle spasms, Pathology test
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34-year old female patient who had no current illness. The patient was pregnant (16 weeks). Her concomitant medication included prenatal vitamins. The patient had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection. On 07-Nov-2014, immediately after the ultrasound, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T52208) in the arm. On 08-Nov-2014, in the morning, the patient had leg cramps. Later that afternoon, she had abdominal pain. By 8 pm, she was in pre-term labor. She had extremely high blood pressure and rapid heart rate upon entrance to ER (emergency room). The patient was in labor for at least 6 hours and gave birth to a stillborn 16 weeks gestation baby, just after 2 am. It was later determined to be chorioamnionitis of the placenta and pneumonia in the baby, which resulted in fetal death. The pathology on the placenta and fetus revealed chorioamnionitis (infection of the placenta) and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: US-BEH-2015052684 (fetus case). VAERS case ID: 574857. Follow up (23-Sep-2015): The regulator reported the term 'delivery'. Reporter's Comments: VAERS case ID: 574857. Reporter's comments: The health authority assessed the events as serious (life threatening and led to hospitalisation of the patient for 1 day). It was unknown if the infection was related to administering the flu vaccine. There were no signs of other infections (TORCH factors). The authority reported the terms of 'Pathology test' and 'Laboratory test abnormal'. Sender's Comments: Company comments: Seriousness: Serious.  Hospitalisation. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, chorioamnionitis and all other events are unlisted. Causality: Not related. Time to onset is 1 day. Company causality was considered unrelated to vaccination as primarily chorioamnionitis is bacterial infection of the amnion and chorion membranes. Maternal history relating to previous pregnancy outcomes, cervical insufficiency etc. was unavailable. Although TORCH was excluded, bacterial infection from maternal source such as bacterial vaginosis, bacteria from colon and or urinary tract infection provide more plausible explanation. Overall vaccination which is administered as intramuscular injection in not considered to be implicated in causation of infection and ensuing events, hence not related. Company comment (05-Oct-2015): No change in overall assessment.