chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Tuberculin test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine live (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date of conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Follow up information was received from the registered nurse and physician via the pregnancy risk registry program on 17-APR-2015. Patient demographics were updated. Patient's concurrent conditions included polycystic ovarian syndrome, latent tuberculosis and history of premature delivery in 2007. Patient did not smoke or use alcohol. She had no illness at the time of vaccination. On 22-DEC-2014, patient was tested for varicella antibodies before vaccination with VZV containing vaccine and the result was negative. Patient was vaccinated with VARIVAX with lot no# K007975 subcutaneously in the left arm on 06-FEB-2015. On 08-FEB-2015, a urine pregnancy test was done which was positive (also reported as unknown). Patient's last menstrual period (LMP) was reported to be 30-DEC-2014 and estimated delivery date to be 17-OCT-2015. Lab tests revealed HCG (human chorionic gonadotropin) level to be 32/50 (units unspecified) on 11-FEB-2015. ABO/RH test in February 2015 showed 3 weeks. On 20-FEB-2015, an Ultrasound showed visible pregnancy at 5 weeks. The patient was seen on 26-FEB-2015 and on 04-MAR-2015, for counselling and she finally chose elective termination since her first child was a special needs child. Elective termination was done at greater than 7 weeks from LMP, in approximately March 2015. Causality for elective termination was not provided. Upon internal review, abortion induced was determined to be medically significant. Additional information has been requested. Reporter information, patient demographics, medical history, lab tests, vaccine information, events and narrative have been updated.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Abortion induced, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine live (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date of conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Follow up information was received from the registered nurse and physician via the pregnancy risk registry program on 17-APR-2015. Patient demographics were updated. Patient's concurrent conditions included polycystic ovarian syndrome, latent tuberculosis and history of premature delivery in 2007. Patient did not smoke or use alcohol. She had no illness at the time of vaccination. On 22-DEC-2014, patient was tested for varicella antibodies before vaccination with VZV containing vaccine and the result was negative. Patient was vaccinated with VARIVAX with lot no# K007975 subcutaneously in the left arm on 06-FEB-2015. On 08-FEB-2015, a urine pregnancy test was done which was positive (also reported as unknown). Patient's last menstrual period (LMP) was reported to be 30-DEC-2014 and estimated delivery date to be 17-OCT-2015. Lab tests revealed HCG (human chorionic gonadotropin) level to be 32/50 (units unspecified) on 11-FEB-2015. ABO/RH test in February 2015 showed 3 weeks. On 20-FEB-2015, an Ultrasound showed visible pregnancy at 5 weeks. The patient was seen on 26-FEB-2015 and on 04-MAR-2015, for counselling and she finally chose elective termination since her first child was a special needs child. Elective termination was done at greater than 7 weeks from LMP, in approximately March 2015. Causality for elective termination was not provided. Upon internal review, abortion induced was determined to be medically significant. Additional information has been requested. Reporter information, patient demographics, medical history, lab tests, vaccine information, events and narrative have been updated.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Ultrasound antenatal screen, Varicella virus test negative
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine live (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date of conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Follow up information was received from the registered nurse and physician via the pregnancy risk registry program on 17-APR-2015. Patient demographics were updated. Patient's concurrent conditions included polycystic ovarian syndrome, latent tuberculosis and history of premature delivery in 2007. Patient did not smoke or use alcohol. She had no illness at the time of vaccination. On 22-DEC-2014, patient was tested for varicella antibodies before vaccination with VZV containing vaccine and the result was negative. Patient was vaccinated with VARIVAX with lot no# K007975 subcutaneously in the left arm on 06-FEB-2015. On 08-FEB-2015, a urine pregnancy test was done which was positive (also reported as unknown). Patient's last menstrual period (LMP) was reported to be 30-DEC-2014 and estimated delivery date to be 17-OCT-2015. Lab tests revealed HCG (human chorionic gonadotropin) level to be 32/50 (units unspecified) on 11-FEB-2015. ABO/RH test in February 2015 showed 3 weeks. On 20-FEB-2015, an Ultrasound showed visible pregnancy at 5 weeks. The patient was seen on 26-FEB-2015 and on 04-MAR-2015, for counselling and she finally chose elective termination since her first child was a special needs child. Elective termination was done at greater than 7 weeks from LMP, in approximately March 2015. Causality for elective termination was not provided. Upon internal review, abortion induced was determined to be medically significant. Additional information has been requested. Reporter information, patient demographics, medical history, lab tests, vaccine information, events and narrative have been updated.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Aspiration, Computerised tomogram head abnormal, Cyanosis, Extra dose administered, Respiratory syncytial virus infection
Clinical narrative: Information has been received from a physician via Pfizer (2015060251) referring to a 6 month old female patient. The patient was born at 35 weeks gestation (prematurity). The patient had twin to twin transfer, linking on leap submucous cleft palate and torticollis. The patient's family history included febrile seizure. The patient's brother had kleefstra syndrome and sagittal craniosynostosis. On 10-FEB-2015, the patient was vaccinated with ROTATEQ, 1 vial, oral (lot number was reported as K0074YY, expire date 16-MAR-2016) and PREVNAR 13 0.5 ml, injection (lot number JY9846, expire date not reported). Concomitant therapies included polyvitamin with iron. On 11-FEB-2015, 3 hours later the patient experienced 2 seizures. On the same date, the patient came to the hospital presenting with non-febrile seizures, and then was transferred to a care center for evaluation and admitted. The evaluation included ultrasound (US), electroencephalography (EEG) and magnetic resonance imaging (MRI). So far when the patient admitted, she had had 4 seizures. Later, it was confirmed that the patient had a total of 5 seizures over three days. One of the seizures was lasting two minutes and another one recorded by the EEG was a staring seizure. It was reported the signs included CT scan showing "something" in skull bone but brain matter looking fine; aspiration; turning purple and sick with a respiratory syncytial virus (RSV) infection. During the hospital, the patient was treated with KEPPRA. On 16-FEB-2015, the patient was discharged from hospital. At the time of reporting, no further dose was given yet. The patient was currently treated with TRILEPTAL and pyridoxal-5-phosphate. The outcome of seizure was reported as ongoing. The reporter considered seizure was related to PREVNAR 13 but didn't provided relationship between seizure and ROTATEQ. Per internal review, event of seizures (non-febrile) was considered to be medically significant. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Seizure, Skin discolouration
Clinical narrative: Information has been received from a physician via Pfizer (2015060251) referring to a 6 month old female patient. The patient was born at 35 weeks gestation (prematurity). The patient had twin to twin transfer, linking on leap submucous cleft palate and torticollis. The patient's family history included febrile seizure. The patient's brother had kleefstra syndrome and sagittal craniosynostosis. On 10-FEB-2015, the patient was vaccinated with ROTATEQ, 1 vial, oral (lot number was reported as K0074YY, expire date 16-MAR-2016) and PREVNAR 13 0.5 ml, injection (lot number JY9846, expire date not reported). Concomitant therapies included polyvitamin with iron. On 11-FEB-2015, 3 hours later the patient experienced 2 seizures. On the same date, the patient came to the hospital presenting with non-febrile seizures, and then was transferred to a care center for evaluation and admitted. The evaluation included ultrasound (US), electroencephalography (EEG) and magnetic resonance imaging (MRI). So far when the patient admitted, she had had 4 seizures. Later, it was confirmed that the patient had a total of 5 seizures over three days. One of the seizures was lasting two minutes and another one recorded by the EEG was a staring seizure. It was reported the signs included CT scan showing "something" in skull bone but brain matter looking fine; aspiration; turning purple and sick with a respiratory syncytial virus (RSV) infection. During the hospital, the patient was treated with KEPPRA. On 16-FEB-2015, the patient was discharged from hospital. At the time of reporting, no further dose was given yet. The patient was currently treated with TRILEPTAL and pyridoxal-5-phosphate. The outcome of seizure was reported as ongoing. The reporter considered seizure was related to PREVNAR 13 but didn't provided relationship between seizure and ROTATEQ. Per internal review, event of seizures (non-febrile) was considered to be medically significant. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Aspiration, Computerised tomogram abnormal, Cyanosis, Electroencephalogram abnormal, Malaise
Clinical narrative: Information has been received from a physician via Pfizer (2015060251) referring to a 6 month old female patient. The patient was born at 35 weeks gestation (prematurity). The patient had twin to twin transfer, linking on leap submucous cleft palate and torticollis. The patient's family history included febrile seizure. The patient's brother had kleefstra syndrome and sagittal craniosynostosis. On 10-FEB-2015, the patient was vaccinated with ROTATEQ, 1 vial, oral (lot number was reported as K0074YY, expire date 16-MAR-2016) and PREVNAR 13 0.5 ml, injection (lot number JY9846, expire date not reported). Concomitant therapies included polyvitamin with iron. On 11-FEB-2015, 3 hours later the patient experienced 2 seizures. On the same date, the patient came to the hospital presenting with non-febrile seizures, and then was transferred to a care center for evaluation and admitted. The evaluation included ultrasound (US), electroencephalography (EEG) and magnetic resonance imaging (MRI). So far when the patient admitted, she had had 4 seizures. Later, it was confirmed that the patient had a total of 5 seizures over three days. One of the seizures was lasting two minutes and another one recorded by the EEG was a staring seizure. It was reported the signs included CT scan showing "something" in skull bone but brain matter looking fine; aspiration; turning purple and sick with a respiratory syncytial virus (RSV) infection. During the hospital, the patient was treated with KEPPRA. On 16-FEB-2015, the patient was discharged from hospital. At the time of reporting, no further dose was given yet. The patient was currently treated with TRILEPTAL and pyridoxal-5-phosphate. The outcome of seizure was reported as ongoing. The reporter considered seizure was related to PREVNAR 13 but didn't provided relationship between seizure and ROTATEQ. Per internal review, event of seizures (non-febrile) was considered to be medically significant. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, Petit mal epilepsy, Respiratory syncytial virus infection, Seizure, Ultrasound scan
Clinical narrative: Information has been received from a physician via Pfizer (2015060251) referring to a 6 month old female patient. The patient was born at 35 weeks gestation (prematurity). The patient had twin to twin transfer, linking on leap submucous cleft palate and torticollis. The patient's family history included febrile seizure. The patient's brother had kleefstra syndrome and sagittal craniosynostosis. On 10-FEB-2015, the patient was vaccinated with ROTATEQ, 1 vial, oral (lot number was reported as K0074YY, expire date 16-MAR-2016) and PREVNAR 13 0.5 ml, injection (lot number JY9846, expire date not reported). Concomitant therapies included polyvitamin with iron. On 11-FEB-2015, 3 hours later the patient experienced 2 seizures. On the same date, the patient came to the hospital presenting with non-febrile seizures, and then was transferred to a care center for evaluation and admitted. The evaluation included ultrasound (US), electroencephalography (EEG) and magnetic resonance imaging (MRI). So far when the patient admitted, she had had 4 seizures. Later, it was confirmed that the patient had a total of 5 seizures over three days. One of the seizures was lasting two minutes and another one recorded by the EEG was a staring seizure. It was reported the signs included CT scan showing "something" in skull bone but brain matter looking fine; aspiration; turning purple and sick with a respiratory syncytial virus (RSV) infection. During the hospital, the patient was treated with KEPPRA. On 16-FEB-2015, the patient was discharged from hospital. At the time of reporting, no further dose was given yet. The patient was currently treated with TRILEPTAL and pyridoxal-5-phosphate. The outcome of seizure was reported as ongoing. The reporter considered seizure was related to PREVNAR 13 but didn't provided relationship between seizure and ROTATEQ. Per internal review, event of seizures (non-febrile) was considered to be medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chills, Diarrhoea, Erythema, Injection site mass
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Peripheral swelling, Skin exfoliation, Swelling face, Urticaria
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site induration
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site swelling
Clinical narrative: Swollen thigh, not just at site of the shot.
Age: 1.54
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on legs.
Age: 0.31
Sex: M
Vaccine: DTAP, IPV, RVX
Symptoms: Crying, Lethargy, Screaming, Vision blurred
Clinical narrative: High pitched screaming/crying un-consolable for over 3 hours, very lethargic, unable to focus eyes.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: High fever-rash.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Patient was given the Rotavirus and vomited 2 minutes after.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Filing the form on behalf of patient complaint from vaccination received in 2013/10/24. Patient reports "shaking violently", to pharmacy corporate on 4/21/15.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown ages with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with a dose of PROQUAD route, anatomical location, lot# and expiration date were not reported), that had been improperly stored. There was no concomitant therapy reported. No adverse effects reported. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Feeling abnormal, Pallor
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of male and female patients. No relevant medical history or current conditions were reported. Within the last six month since an unknown date, these patients were vaccinated with GARDASIL (dose, route, lot# and expiration date not reported). Concomitant therapies included MENACTRA and "TDAP". On unknown dates these patients had been getting dizzy, been very pale and "spaced out" after the vaccination of GARDASIL while lying down. No further explanation of "spaced out" was provided. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Morbillivirus test positive, Polymerase chain reaction, Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: Child developed URI sx, fever, and rash. Measles PCR positive.
Age: 1.53
Sex: M
Vaccine: MMR
Symptoms: Irritability, Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia, Rash generalised
Clinical narrative: Child woke up with rash from head to toe, fever, increased fussiness. Was tested for measles and PCR was positive.
Age: 1.38
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Pt went to ER for fever and sz like activity.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Per dr at the urgent care clinic patient came in the next day after administration with ache, fever, soreness around injection site.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dosage, dose number and lot number unknown). It was reported that a patient that was indicated for (Merck) VARIVAX received ZOSTAVAX. 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 certified medical assistant refers to unspecified patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored (Merck) VARIVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored ROTATEQ (expiration date, dose and route were not reported) route default as oral. Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 0.51
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 6 month old infant with unknown gender. No pertinent medical history was reported. On 10-APR-2015, infant was vaccinated with PNEUMOVAX 23 (lot # K020214 and expiration date 25-MAR-2016) in error. No adverse experience observed. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product quality issue, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with an unspecified number of doses of PROQUAD (Merck) (lot#, dose, route and site of administration were not reported) that were reconstituted with sterile diluent (manufacturer unknown). The doses were reconstituted with 0.6 ml of sterile diluent (manufacturer unknown) and were not reconstituted with the entire volume of the supplied sterile diluent (manufacturer unknown) as recommended in the prescribing information. 0.5 ml of vaccine was drawn up for administration after reconstitution. No adverse events were reported. Product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown dates, the patient were vaccinated with an unspecified number of doses of MMR II (lot#, albumin status, dose, route and site of administration were not reported) that were reconstituted with sterile diluent (manufacturer unknown). The doses were reconstituted with 0.6 ml of sterile diluent (manufacturer unknown) and were not reconstituted with the entire volume of the supplied sterile diluent (manufacturer unknown) as recommended in the prescribing information 0.5 ml of vaccine was drawn up for administration after reconstitution. No adverse events were reported. Product quality complaint was involved. This is one of several reports from the same reporter. 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 certified medical assistants refers to unspecified a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored PROQUAD (Merck) (expiration date, dose and route were not reported) lot # K020751. Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-APR-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot # was not reported), 0.5 ml, subcutaneous (site of administration was not reported). (Merck) VARIVAX was exposed to -10.82 C for 7 hours. No concomitant medication was reported. No adverse effects were reported. 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 non medical healthcare worker refers to an unspecified patient of unknown age and gender. No pertinent medical history was reported. on an unknown date in March 2015, the patient was vaccinated with improperly stored dose of GARDASIL (lot # K007828 and expiration date 02-MAR-2017) (dose and route were not reported). No adverse events were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Dyspnoea, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Wheezing and difficulty breathing, swollen glands in neck, swelling and pain in injection arm. Pain in hip and shoulder joints, pain in leg and arm muscles, mild rash at and above injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Myalgia, Pain in extremity, Rash, Wheezing
Clinical narrative: Wheezing and difficulty breathing, swollen glands in neck, swelling and pain in injection arm. Pain in hip and shoulder joints, pain in leg and arm muscles, mild rash at and above injection site.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Erythema, Headache, Mobility decreased, Peripheral swelling
Clinical narrative: Child is experiencing shivering, headache, swollen red arm, he can't touch or move it, and slight fever 99.6.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Tenderness
Clinical narrative: Child is experiencing shivering, headache, swollen red arm, he can't touch or move it, and slight fever 99.6.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurernt conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with doses of (Oka/Merck) VARIVAX, (strength dose, route, anatomical location, lot number and expiration date were not reported) which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of an unknown age and an unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the several reports from the same reporter. 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 regarding unspecified patients of unknown demographics. There was no information regarding concurrent conditions and historical medication. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX which was exposed to 12F for 40 minutes. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. 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 Licensed Practical Nurse refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medication was not reported. On 17-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (route, dose, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
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 an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 4 year old patient of unknown gender. There was no information regarding concurrent condition and historical medication. On 17-APR-2015, the patient was vaccinated with expired dose of PROQUAD (Merck), lot# J010159, expiration date-23-FEB-2015. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with a total of five doses of improperly stored PROQUAD (Merck) (dose and route of administration were not reported, lot # K023364 with expiration date: 20-MAY-2016). It was also reported that on an unknown date five patients were administered improperly stored doses of VARIVAX (Merck) (captured in MARRS # 1504USA001740). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of an unknown age and an unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the several reports 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 as received from a certified medical assistants refers to unspecified a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored GARDASIL (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event, Underdose
Clinical narrative: Information has been received from a registered nurse referring to an adult patient of unknown age and gender. No relevant medical  history or concurrent conditions were reported. On an unknown date in JUL-2014 the patient was vaccinated with 0.5ml dose of pediatric formulation of RECOMBIVAX HB (lot# and expiration date not reported; intramuscular) (underdose). Then the patient received two doses of pediatric formulation RECOMBIVAX HB (drug maladministration) for the second dose in NOV-2014 (inappropriate schedule) and the third dose in jAN-2015. No adverse effects were reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant referring to a 10 year old male patient with no pertinent medical history or drug allergies. The patient was vaccinated with the first dose of GARDASIL (dose and route not reported; lot# reported as K0004204, expiration date 12-JAN-2017) on 20-AUG-2014, 23-OCT-2014 and 26-FEB-2015. The third dose was administered in the left deltoid. On 26-FEB-2015, the patient fainted at home. The patient's mother sought medical attention by calling the physician's office on the same day. No treatment was given for the event and there were no lab diagnostics studies performed. The outcome of the event was reported as recovered on an unknown date in 2015. This is one of several reporters received from the same reporter. 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 an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized injection site redness and swelling.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Rash, Rash pruritic
Clinical narrative: Rash arm, swollen inj site, face pruritic rash occurred within 24 hours of vaccination.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: (R) deltoid with 6-7 cm erythematous, splotchy, pruritic area and one 1mm erythematous papule centrally.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Localized injection site swelling.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Skin exfoliation, Skin warm
Clinical narrative: Patient c/o redness, swelling at injection site of left deltoid on evening of injection (03-17-15) the swelling and redness continued for 3 days, extended to mid upper arm. The arm was hot, skin peeled. Ice was applied per patient.
Age: 0.24
Sex: F
Vaccine: PNC13, RV1
Symptoms: Blood electrolytes normal, Diarrhoea haemorrhagic, Haemoglobin normal, Occult blood positive
Clinical narrative: Bloody diarrhea.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Neuralgia, Pain, Pain in extremity
Clinical narrative: Very severe excruciating pain in left arm. Could not move arm.  Felt like nerve pain, very sharp, and stinging.  Pain subsided over 3 days.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. On 07-APR-2015, the patient was inadvertently vaccinated with an expired dose of (Merck) VARIVAX dose and route were not reported (lot# was not provided, expiration date: 15-MAR-2015). No adverse effects reported. 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 registered nurse via GlaxoSmithKline, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored (Merck) VARIVAX dose and route were not reported (lot# K005428, exp.date: 15-APR-2016; lot# reported as K011800, exp.date: 21-AUG-2016; lot# reported as K021836, exp.date: 10-NOV-2016). No adverse events were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified patients of unknown ages and genders who between 06-MAR-2015 and 15-APR-2015 were inadvertently vaccinated with an improperly stored doses (incorrect product storage) of GARDASIL (lot # K009202, expiration date 17-FEB-2016) (dose and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 80 year old male patient. The patient's medical history and drug allergies were not specified by the reporter. On 06-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (19400 PFU (Plaque-Forming Unit(s)), lot# reported as K020186, expiration date January 2016, dose and route of administration were not reported). The patient's concomitant medication was not specified by the reporter. Approximately in 2015, the patient experienced pain on the backside of his arm and the side of his chest. No treatment was given for the adverse events. The patient sought medical attention by speaking with the pharmacist. The outcome of the pain on the backside of the arm and the side of the chest was reported as not recovered. Causality assessment between the pain on the backside of the arm and the side of his chest and the therapy with ZOSTAVAX was not provided. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified patients of unknown ages and genders who between 06-MAR-2015 and 15-APR-2015 were inadvertently vaccinated with an improperly stored doses (incorrect product storage) of ROTATEQ (lot # K005397, expiration date 29-FEB-2016 and lot # reported as K016278, expiration date 21-APR-2016) (dose not reported) by oral route. No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Decreased appetite, Dizziness, Headache, Nausea, Neck pain
Clinical narrative: Loss of appetite, nausea, headache, dizzy, neck ache (as described by patient).
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Visual impairment
Clinical narrative: Vision changes in left eye, patient only as sight in one eye to start with.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Large puffy rash all over arm from shoulder to just above elbow, spreading outwards from site where shot was given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Altered state of consciousness, Complex partial seizures, Confusional state, Electroencephalogram abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient and I, her mother, were playing.  She asked me to build her a boat with blocks.  I asked her to get the instructions off of the couch and she looked confused and made no response to the request.  I repeated the request and she looked off to the right (the couch was on her left).  I then realized that something was wrong.  I moved to her and asked her to look at me, she didn't respond.  She continued to look off to the right.  I stood up to get my husband in the other room and she began to have a series of dry heaves.  After she stopped heaving, I again asked her to look at me.  She still did not respond.  She was still staring off to the right and her jaw was opening/closing in a continuous biting movement.  I picked her up and took her to my husband.  He sat down with her and about 30-45 seconds later she snapped out of her altered state. She was able to tell us her name and where she was.  She immediately tried to go to sleep and was next to impossible to wake when we arrived at the ER.  She had no recollection of the event. From onset to completion I estimate that the episode of altered mental state lasted 2-3 minutes. At the ER she was given an MRI that was negative for abnormal findings.  We were given a referral to a Pediatric Neurologist for the following week.  The Neurologist performed a sleep-deprived EEG that was reported as abnormal for two occurrences of a brief burst activity with 1 or 2 spike wave discharges in bilateral synchronous distribution, followed by a high-voltage slow wave of 1 second during hyperventilation and in the sleep state.  Prior to this incident, and since, to this date, patient has not had any episodes of an altered mental state.  The Pediatric Neurologist believes that she experienced a complex-partial seizure.  No ongoing treatment is implemented at this time.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Retching, Somnolence, Staring, Trismus, Unresponsive to stimuli
Clinical narrative: Patient and I, her mother, were playing.  She asked me to build her a boat with blocks.  I asked her to get the instructions off of the couch and she looked confused and made no response to the request.  I repeated the request and she looked off to the right (the couch was on her left).  I then realized that something was wrong.  I moved to her and asked her to look at me, she didn't respond.  She continued to look off to the right.  I stood up to get my husband in the other room and she began to have a series of dry heaves.  After she stopped heaving, I again asked her to look at me.  She still did not respond.  She was still staring off to the right and her jaw was opening/closing in a continuous biting movement.  I picked her up and took her to my husband.  He sat down with her and about 30-45 seconds later she snapped out of her altered state. She was able to tell us her name and where she was.  She immediately tried to go to sleep and was next to impossible to wake when we arrived at the ER.  She had no recollection of the event. From onset to completion I estimate that the episode of altered mental state lasted 2-3 minutes. At the ER she was given an MRI that was negative for abnormal findings.  We were given a referral to a Pediatric Neurologist for the following week.  The Neurologist performed a sleep-deprived EEG that was reported as abnormal for two occurrences of a brief burst activity with 1 or 2 spike wave discharges in bilateral synchronous distribution, followed by a high-voltage slow wave of 1 second during hyperventilation and in the sleep state.  Prior to this incident, and since, to this date, patient has not had any episodes of an altered mental state.  The Pediatric Neurologist believes that she experienced a complex-partial seizure.  No ongoing treatment is implemented at this time.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia test, Cardiac function test, Disturbance in attention, Dizziness, Ear, nose and throat examination
Clinical narrative: Initial symptoms: Low grade fever; severe dizziness; severe nausea; headache. Since 7/13: fainted 4 times; severe headaches with episodes that are seizure-like; regular, reoccurring low grade fevers; visual and auditory disturbances; difficulty concentrating; heart palpitations; severe fatigue. Cardiologist says she now has POTS related symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hearing impaired, Laboratory test, Nausea
Clinical narrative: Initial symptoms: Low grade fever; severe dizziness; severe nausea; headache. Since 7/13: fainted 4 times; severe headaches with episodes that are seizure-like; regular, reoccurring low grade fevers; visual and auditory disturbances; difficulty concentrating; heart palpitations; severe fatigue. Cardiologist says she now has POTS related symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Postural orthostatic tachycardia syndrome, Pyrexia, Seizure like phenomena, Syncope
Clinical narrative: Initial symptoms: Low grade fever; severe dizziness; severe nausea; headache. Since 7/13: fainted 4 times; severe headaches with episodes that are seizure-like; regular, reoccurring low grade fevers; visual and auditory disturbances; difficulty concentrating; heart palpitations; severe fatigue. Cardiologist says she now has POTS related symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: Initial symptoms: Low grade fever; severe dizziness; severe nausea; headache. Since 7/13: fainted 4 times; severe headaches with episodes that are seizure-like; regular, reoccurring low grade fevers; visual and auditory disturbances; difficulty concentrating; heart palpitations; severe fatigue. Cardiologist says she now has POTS related symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, pain at injection site left upper arm extending to left elbow. Treatment with Allegra.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: Small circular rash at injection site; immediately after vaccine given. No treatment, watch site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Mom reports slightly itchy rash on neck and anterior chest papular in nature approx 3 hrs after vaccine. No other symptoms. No fever. Mom gave BENADRYL.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Fatigue, Headache, Seizure like phenomena, Syncope
Clinical narrative: Severe headaches that had seizure-like component; syncope episodes;  visual disturbances; difficulty concentrating; fatigue.  Continues to struggle with chronic headaches.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: Severe headaches that had seizure-like component; syncope episodes;  visual disturbances; difficulty concentrating; fatigue.  Continues to struggle with chronic headaches.