chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # were reported as "K023862 exp 25-MAY-2016", "K007228 exp 03-SEP-2016" and "L013545 exp 17-OCT-2016". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were  unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown demographics. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date the patient developed "a high risk type of HPV". The outcome of HPV infection was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 29-APR-2010 the patient was vaccinated with the 1st dose of GARDASIL, (lot # and expiry date not reported). Then on 29-SEP-2010 the patient received the 2nd dose of GARDASIL (Inappropriate schedule of drug administration). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gended.In July 2014, the patient was vaccinated with a first dose of GARDASIL. Then in September 2014, the patient received a second dose of GARDASIL (routes, doses, lot # and exp date were not provided). On 27-JUL-2015, (reported as "today"), the patient was supposed to receive the third dose of the vaccine but they received GARDASIL 9 as the third dose (interchange of vaccine products). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) and refers to a female patient of unknown age. No medical history and concurrent conditions were reported. In 2012, the patient was vaccinated with first dose of GARDASIL injection (lot number, dose, frequency, route and indication not reported) and in 2013, second dose of GARDASIL (lot number, dose, frequency, route and indication not reported) was administered (inappropriate schedule of drug administration). The outcome of inappropriate schedule of drug administration was unknown. No further information was provided. No product quality complaint (PQC) was filed. 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 nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L004654 exp 11-FEB-2017 and lot # reported as "L005300 exp 17-FEB-2017", (route and dose were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 62 year old male patient. On an unknown date, the patient was inadvertently administered a dose of VARIVAX (dose, lot # and expiration date were not provided) instead of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 31-MAR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB lot # K018796, expiration date 24-OCT-2015, adult dose (1.0 ml) instead of a pediatric (0.5 ml) dose which was outside of the recommended per the RECOMBIVAX HB prescribing information. No adverse effects was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a female patient of unknown age. The patient's doctor was suspecting she might have contracted lyme disease. Concomitant therapy included an unspecified antibiotic. There was no medical history reported. On an unknown date, the patient was vaccinated with first dose of ZOSTAVAX (route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced dizziness and nausea. The patient sought unspecified medical attention. The outcome of dizziness and nausea was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as the reporter did not give any contact data.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 24-JUL-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route and anatomical location were not reported) lot # K025766, expiration date 08-JUN-2016, which had been exposed to temperatures outside of the recommended range. No adverse experience was reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring a 12-year-old patient of unknown gender who on 02-JUN-2015, was vaccinated with improperly stored VAQTA lot # K018181, expiration date: 04-JUN-2017 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because all available information has been obtained.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored RECOMBIVAX HB injection 2.5/0.5, lot# K018180, exp. date: 27-SEP-2016 (dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to nine patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unknown date in 2015 (after 02-JUN-2015), the patients were each vaccinated with an improperly stored dose of VAQTA lot # K010579, expiry date 12-FEB-2017. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA011084 as it was received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 28-JUL-2015, the patient was vaccinated with an expired dose of MMR II (lot # J008154, expiry date 08-JUL-2015 ). No adverse experienced was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates the patient were vaccinated with improperly stored PROQUAD (Merck) lot # K010797 expiration date: 04-FEB-2016, K008870 expiration date: 19-DEC-2015, L005297 expiration date: 17-AUG-2016, K007158 expiration date: 12-NOV-2015. There were no concomitant medication or medical history reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Onset of erythema, minor pain and minor induration at site within 12-24 hrs. Area of approximately 19 x 13 cm mild erythema and mild warmth with approximately 3.5 cm area mild induration measured 48 hr after injection. Pt states sxs already improving at this point.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring a 2-year-old patient of unknown gender who on 05-JUN-2015, was vaccinated with improperly stored VAQTA lot # K018181, expiration date: 04-JUN-2017 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because all available information has been obtained.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unknown date in 2015 (after 02-JUN-2015), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # J013394, expiry date 25-AUG-2016. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA013290 as it was received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: C-reactive protein normal, Erythema, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Patient is a 59-year-old retired female with a past medical history significant for diabetes and multiple drug allergies who presents to the office for further evaluation management recommendations after a recent adverse event following immunizations. Patient describes receiving her PREVNAR 13 vaccine on 21 July 2015 and within 2 days noticed that her left arm became red, swollen, and pruritic. (PCV13; Pfizer, lot # L58154, 0.5mL left deltoid, VIS 02/27/13). She initially self treated with topical bacitracin x1 dose with no clinical improvement. Symptoms continued to bother her for several days and she sought medical attention on 27 July where she was prescribed BENADRYL for the pruritus which did improve her itching. Symptoms have subsequently began to improve with minimal pruritus, resolution of swelling, and only a mild 7 x 3 cm area of hyperpigmentation. Patient does endorse some mild subjective fever (she denies taking her temperature). Otherwise, she denies any systemic symptoms such as arthralgias, myalgias, generalized hives, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. No oral lesions.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Skin hyperpigmentation
Clinical narrative: Patient is a 59-year-old retired female with a past medical history significant for diabetes and multiple drug allergies who presents to the office for further evaluation management recommendations after a recent adverse event following immunizations. Patient describes receiving her PREVNAR 13 vaccine on 21 July 2015 and within 2 days noticed that her left arm became red, swollen, and pruritic. (PCV13; Pfizer, lot # L58154, 0.5mL left deltoid, VIS 02/27/13). She initially self treated with topical bacitracin x1 dose with no clinical improvement. Symptoms continued to bother her for several days and she sought medical attention on 27 July where she was prescribed BENADRYL for the pruritus which did improve her itching. Symptoms have subsequently began to improve with minimal pruritus, resolution of swelling, and only a mild 7 x 3 cm area of hyperpigmentation. Patient does endorse some mild subjective fever (she denies taking her temperature). Otherwise, she denies any systemic symptoms such as arthralgias, myalgias, generalized hives, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. No oral lesions.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. These patients were inadvertently administered with an unspecified number of improperly stored doses of PEDVAXHIB (lot # K011077, expiry date: 30-MAR-2017; lot # K026533, expiry date: 07-AUG-2017), on unspecified dates since 09-JUN-2015. Concomitant medications were unspecified. No adverse effect was reported. This is one of the two reports received from the same reporter (MARRS # 1507USA012928). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PEDVAXHIB injection, lot# K015464, exp. date: 09-JUL-2017 and lot# K026533, exp. date: 07-AUG-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. These patients were inadvertently administered with an unspecified number of improperly stored doses of GARDASIL (lot # K011562, expiry date: 08-APR-2017), on unspecified dates since 09-JUN-2015. Concomitant medications were unspecified. No adverse effect was reported. This is one of the two reports received from the same reporter (MARRS # 1507USA013292). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL 9 injection, lot # K026246, exp. date 28-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-JUN-2015, the patient was vaccinated with an improperly store dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified) the route was defaulted to oral. No concurrent medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complains (PQC) involved. NO additional information was provided. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an office manager concerning a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 22-JUL-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II (0.5 ml, subcutaneous, lot # J006994 and expiration date: 14-JUN-2015). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VAQTA injection, lot# L008665, exp. date: 10-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7-22-15 redness, swelling and warmth at the injection site. Patient given ZYRTEC and ibuprofen and will return in 24 hours. 7-23-15 symptoms improved, patient discharged.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
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 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Premature baby death, Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 34 years 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 (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 and resulted pneumonia in the fetus. The outcome was reported as recovered. Linked case: 2015052681 (fetus case). 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'.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.
Sex: U
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 patient (fetus). On 07-Nov-2014, the patient received AFLURIA (batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: 2015052681). The mother gave birth to a stillborn 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death.