chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site extravasation, Injection site induration, Injection site vesicles, Physical examination
Clinical narrative: Information has been received from a registered nurse concerning a healthy 5 year old white female who on 27-NOV-2007 at 9:45 was vaccinated IM with her first dose of VAQTA (lot# 657840/0797U) in the left arm. There was no illness at the time of vaccination. Concomitant vaccinations administered on that day at 9:45 included the second dose of MMR II (lot# "658135/0779U") in the left arm, a dose of DAPTACEL (lot# C2749AA) in the right arm (route not specified) and an SC dose IPOL (lot# A0169) in the right arm. On 28-NOV-2007 at 8:00 the patient developed extensive injection site erythema and induration. At the immediate area around the site there were multiple, small vesicles with a few weeping clear fluid. There were no pustules present and the area was non-tender. Medical attention via doctor visit was required. The outcome was unknown. Follow-up information from the reporting registered nurse indicated that on 29-NOV-2007 upon physical examination the physician noted that the event was an atypical skin reaction at the vaccine site.  The patient was treated with TYLENOL PRN and antibiotic ointment (unspecified) to the open areas. On 30-NOV-2007 upon physician examination the patient's rash on the left upper arm was much improved with significantly less redness, vesicles and no drainage. The physician also advised that the patient should not get the second dose of VAQTA. The patient's outcome was recovered. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Skin reaction
Clinical narrative: Information has been received from a registered nurse concerning a healthy 5 year old white female who on 27-NOV-2007 at 9:45 was vaccinated IM with her first dose of VAQTA (lot# 657840/0797U) in the left arm. There was no illness at the time of vaccination. Concomitant vaccinations administered on that day at 9:45 included the second dose of MMR II (lot# "658135/0779U") in the left arm, a dose of DAPTACEL (lot# C2749AA) in the right arm (route not specified) and an SC dose IPOL (lot# A0169) in the right arm. On 28-NOV-2007 at 8:00 the patient developed extensive injection site erythema and induration. At the immediate area around the site there were multiple, small vesicles with a few weeping clear fluid. There were no pustules present and the area was non-tender. Medical attention via doctor visit was required. The outcome was unknown. Follow-up information from the reporting registered nurse indicated that on 29-NOV-2007 upon physical examination the physician noted that the event was an atypical skin reaction at the vaccine site.  The patient was treated with TYLENOL PRN and antibiotic ointment (unspecified) to the open areas. On 30-NOV-2007 upon physician examination the patient's rash on the left upper arm was much improved with significantly less redness, vesicles and no drainage. The physician also advised that the patient should not get the second dose of VAQTA. The patient's outcome was recovered. Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEP, HEPA
Symptoms: Anorexia, Crying, Inappropriate schedule of drug administration, Irritability, Poor quality sleep
Clinical narrative: Information has been received from a consumer concerning a her 5 month old son with no pertinent medical history or drug allergies who on approximately 16-JUL-2007 was vaccinated with a dose of VAQTA instead of RECOMBIVAX (manufacturer unknown).  There was no concomitant medication.  On 16-JUL-2007 about 24 hours after vaccination, the patient was fussy, was not eating alot, was crying and did not sleep well.  The patient's mother (consumer) also reported that she "just found out in November 2007, that the patient had received the wrong vaccination."  The patient sought medical attention by contacting the physician.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  Follow-up information indicated that the patient was inadvertently vaccinated with a dose of VAQTA instead of RECOMBIVAX HB (MSD).  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/28/2008.  Information has been received from a consumer concerning a her 5 month old son with no pertinent medical history or drug allergies who on approximately 16-JUL-2007 was vaccinated with a dose of VAQTA instead of RECOMBIVAX HB (manufacturer unknown).  There was no concomitant medication.  On 16-JUL-2007 about 24 hours after vaccination (at 4 weeks of age), the patient was fussy, was not eating alot, was crying and did not sleep well.  The patient's mother (consumer) also reported that she "just found out in Novmber 2007, that the patient who was 5 months of age had received the wrong vaccination.  "The patient sought medical attention by contacting the physician.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  Follow-up information indicated that the patient was inadvertantly vaccinated with a dose of VAQTA instead of RECOMBIVAX HB.  Follow-up information indicated that the patient's mother contacted the doctor covering the emergency line due to her son who experienced a fever and constant crying.  The physician advised her to keep an eye on the fever which was expected from the shot which was his second RECOMBIVAX HB (manufacturer unknown).  The physician was not aware at the time he was given the wrong shot VAQTA.  The outcome was unknown.  Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning a her 5 month old son with no pertinent medical history or drug allergies who on approximately 16-JUL-2007 was vaccinated with a dose of VAQTA instead of RECOMBIVAX (manufacturer unknown).  There was no concomitant medication.  On 16-JUL-2007 about 24 hours after vaccination, the patient was fussy, was not eating alot, was crying and did not sleep well.  The patient's mother (consumer) also reported that she "just found out in November 2007, that the patient had received the wrong vaccination."  The patient sought medical attention by contacting the physician.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  Follow-up information indicated that the patient was inadvertently vaccinated with a dose of VAQTA instead of RECOMBIVAX HB (MSD).  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/28/2008.  Information has been received from a consumer concerning a her 5 month old son with no pertinent medical history or drug allergies who on approximately 16-JUL-2007 was vaccinated with a dose of VAQTA instead of RECOMBIVAX HB (manufacturer unknown).  There was no concomitant medication.  On 16-JUL-2007 about 24 hours after vaccination (at 4 weeks of age), the patient was fussy, was not eating alot, was crying and did not sleep well.  The patient's mother (consumer) also reported that she "just found out in Novmber 2007, that the patient who was 5 months of age had received the wrong vaccination.  "The patient sought medical attention by contacting the physician.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  Follow-up information indicated that the patient was inadvertantly vaccinated with a dose of VAQTA instead of RECOMBIVAX HB.  Follow-up information indicated that the patient's mother contacted the doctor covering the emergency line due to her son who experienced a fever and constant crying.  The physician advised her to keep an eye on the fever which was expected from the shot which was his second RECOMBIVAX HB (manufacturer unknown).  The physician was not aware at the time he was given the wrong shot VAQTA.  The outcome was unknown.  Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAPH, HEPA, MMRV, PNC, DTAPH, HEPA, MMRV, PNC
Symptoms: Convulsion, Gaze palsy, Pyrexia, Unresponsive to stimuli, X-ray
Clinical narrative: Information has been received from a health professional concerning a 15-month-old white female, with no pre-existing allergies, birth defects or medical conditions, who on 31-JAN-2008 at 10:11 am was vaccinated subcutaneous in the right thigh with her first dose of PROQUAD (657270/0911U).  There were no illnesses at the time of vaccination.  Concomitant vaccines administered on 31-JAN-2008 at 10:11 am included first intramuscular dose of VAQTA in the left thigh (lot # 656995/0017U), a fourth intramuscular dose of TRIHIBIT (lot # U1986AB + UF053AA) in the left thigh and a fourth intramuscular dose of PREVNAR in the left thigh.  It was also noted the patient was previously vaccinated with the following vaccines: DAPTACEL, IPOL, HIB (unspecified carrier) (manufacturer unknown) administered, PREVNAR and ROTATEQ on 19-APR-2007, 19-DEC-2006 and 20-FEB-2007 and HEPATITIS B (unspecified) administered on 19-DEC-2006, 20-FEB-2007 and 26-JUl-2007.  On 08-FEB-2008, 9 days post vaccination, the patient experienced a prolonged seizure lasting 3 hours (complex febrile convulsions).  The entire sepsis evaluation was negative and the patient was hospitalized overnight.  The patient also had a fever that was improving over the last five days.  On 08-FEB-2008 the patient had a brain CT without contrast and chest x-ray.  CT findings: The appearance of the brain parenchyma is normal.  No mass lesions, shift, or acute intracranial hemorrhage.  The ventricles and cisterna are normal size and configuration, the orbits and visualized paranasal sinuses are unremarkable.  Bone windows reveal no fracture or other osseous abnormalities.  Chest x-ray findings: Single view of the chest is normal cardiac and mediastinal size and shape.  Pulmonary vascularity is normal.  Mild scattered central atelectasis is noted without focal consolidation or pleural effusion.  No osseous abnormalities were detected.  On 08-FEB-2008 the patient recovered.  Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAPH, HEPA, MMRV, PNC, DTAPH, HEPA, MMRV, PNC
Symptoms: Atelectasis, Chest X-ray abnormal, Computerised tomogram normal, Febrile convulsion, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 15-month-old white female, with no pre-existing allergies, birth defects or medical conditions, who on 31-JAN-2008 at 10:11 am was vaccinated subcutaneous in the right thigh with her first dose of PROQUAD (657270/0911U).  There were no illnesses at the time of vaccination.  Concomitant vaccines administered on 31-JAN-2008 at 10:11 am included first intramuscular dose of VAQTA in the left thigh (lot # 656995/0017U), a fourth intramuscular dose of TRIHIBIT (lot # U1986AB + UF053AA) in the left thigh and a fourth intramuscular dose of PREVNAR in the left thigh.  It was also noted the patient was previously vaccinated with the following vaccines: DAPTACEL, IPOL, HIB (unspecified carrier) (manufacturer unknown) administered, PREVNAR and ROTATEQ on 19-APR-2007, 19-DEC-2006 and 20-FEB-2007 and HEPATITIS B (unspecified) administered on 19-DEC-2006, 20-FEB-2007 and 26-JUl-2007.  On 08-FEB-2008, 9 days post vaccination, the patient experienced a prolonged seizure lasting 3 hours (complex febrile convulsions).  The entire sepsis evaluation was negative and the patient was hospitalized overnight.  The patient also had a fever that was improving over the last five days.  On 08-FEB-2008 the patient had a brain CT without contrast and chest x-ray.  CT findings: The appearance of the brain parenchyma is normal.  No mass lesions, shift, or acute intracranial hemorrhage.  The ventricles and cisterna are normal size and configuration, the orbits and visualized paranasal sinuses are unremarkable.  Bone windows reveal no fracture or other osseous abnormalities.  Chest x-ray findings: Single view of the chest is normal cardiac and mediastinal size and shape.  Pulmonary vascularity is normal.  Mild scattered central atelectasis is noted without focal consolidation or pleural effusion.  No osseous abnormalities were detected.  On 08-FEB-2008 the patient recovered.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Erythema, Flushing, Injection site erythema, Skin test positive, Wheezing
Clinical narrative: Information has been received from a medical assistant concerning an 8 year old male with seasonal allergies and asthma and a history of pulmonary stenosis requiring surgery at 8 years old, eye surgery at 1 & 1/2 years old and a previous vaccination adverse reaction (not known) who 03-MAR-2008 was vaccinated IM with his second dose of VAQTA (lot# 658034/0495U).  Suspect vaccination administered on that same day included the second SC dose of VARIVAX (lot# 659066/1359U).  Other concomitant drug therapy included MSD, ZYRTEC and LISINOPRIL.  Prior to leaving the office that day, the patient experienced difficulty breathing and developed a rash all over.  The patient sought medical attention in the office at the time of the reaction.  No labs or diagnostic studies were performed.  The patient was treated with ALLEGRA and MSD.  He was then given BENADRYL and epinephrine that resolved his symptoms.  The patient was discharged home.  The medical assistant mentioned that the patient had a similar reaction with previous vaccination, but the patient's mother could not remember when or what vaccination was given.  It was noted that the patient received his first IM dose of VAQTA on 12-NOV-2004 and his first SC dose of VARIVAX on 01-AUG-2000.  There was no product quality complaint.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Dyspnoea, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning an 8 year old male with seasonal allergies and asthma and a history of pulmonary stenosis requiring surgery at 8 years old, eye surgery at 1 & 1/2 years old and a previous vaccination adverse reaction (not known) who 03-MAR-2008 was vaccinated IM with his second dose of VAQTA (lot# 658034/0495U).  Suspect vaccination administered on that same day included the second SC dose of VARIVAX (lot# 659066/1359U).  Other concomitant drug therapy included MSD, ZYRTEC and LISINOPRIL.  Prior to leaving the office that day, the patient experienced difficulty breathing and developed a rash all over.  The patient sought medical attention in the office at the time of the reaction.  No labs or diagnostic studies were performed.  The patient was treated with ALLEGRA and MSD.  He was then given BENADRYL and epinephrine that resolved his symptoms.  The patient was discharged home.  The medical assistant mentioned that the patient had a similar reaction with previous vaccination, but the patient's mother could not remember when or what vaccination was given.  It was noted that the patient received his first IM dose of VAQTA on 12-NOV-2004 and his first SC dose of VARIVAX on 01-AUG-2000.  There was no product quality complaint.  Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Dizziness, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a health professional concerning an 18 year old male with no pertinent medical history or drug reaction/allergies, who on 21-FRB-2008, "as part of the patient's normal examination", he was vaccinated with a first 0.5 ml. intramuscular dose of VAQTA (lot# 658172/0800U). Concomitant therapy included tuberculin purified protein derivative (manufacturer unspecified) and MENACTRA. On 22-FEB-2008, the patient presented to the physician's office with dizziness, headache and generalized achiness of upper body. It was noted that he had undergone recent (date not specified) laboratory studies that included a cholesterol, blood count, and urinalysis that were normal. At the time of this report, the patient has not recovered. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report (s) previously submittedon 5/28/2008. Follow-up information was received from the physician who reported having seen the patient at which time a throat culture was done, which "came back positive". It was noted that after 48 hours on "muds" that patient was fine, therefore it had nothing to do with VAQTA. Additional information has been requested. This is an amended report: The code "culture throat positive" has been added as an adverse event.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Blood cholesterol normal, Culture throat positive, Dizziness, Full blood count normal, Headache
Clinical narrative: Information has been received from a health professional concerning an 18 year old male with no pertinent medical history or drug reaction/allergies, who on 21-FRB-2008, "as part of the patient's normal examination", he was vaccinated with a first 0.5 ml. intramuscular dose of VAQTA (lot# 658172/0800U). Concomitant therapy included tuberculin purified protein derivative (manufacturer unspecified) and MENACTRA. On 22-FEB-2008, the patient presented to the physician's office with dizziness, headache and generalized achiness of upper body. It was noted that he had undergone recent (date not specified) laboratory studies that included a cholesterol, blood count, and urinalysis that were normal. At the time of this report, the patient has not recovered. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report (s) previously submittedon 5/28/2008. Follow-up information was received from the physician who reported having seen the patient at which time a throat culture was done, which "came back positive". It was noted that after 48 hours on "muds" that patient was fine, therefore it had nothing to do with VAQTA. Additional information has been requested. This is an amended report: The code "culture throat positive" has been added as an adverse event.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Pain, Urine analysis normal
Clinical narrative: Information has been received from a health professional concerning an 18 year old male with no pertinent medical history or drug reaction/allergies, who on 21-FRB-2008, "as part of the patient's normal examination", he was vaccinated with a first 0.5 ml. intramuscular dose of VAQTA (lot# 658172/0800U). Concomitant therapy included tuberculin purified protein derivative (manufacturer unspecified) and MENACTRA. On 22-FEB-2008, the patient presented to the physician's office with dizziness, headache and generalized achiness of upper body. It was noted that he had undergone recent (date not specified) laboratory studies that included a cholesterol, blood count, and urinalysis that were normal. At the time of this report, the patient has not recovered. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report (s) previously submittedon 5/28/2008. Follow-up information was received from the physician who reported having seen the patient at which time a throat culture was done, which "came back positive". It was noted that after 48 hours on "muds" that patient was fine, therefore it had nothing to do with VAQTA. Additional information has been requested. This is an amended report: The code "culture throat positive" has been added as an adverse event.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Flushing, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no pertinent medical history and no drug reaction/allergies, who on 10-MAR-2008 was vaccinated SC with a first 0.5 mL dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (HSA).  Concomitant therapy included sodium fluoride (+) vitamins (unspecified).  On 10-MAR-2008 about 8-10 hours later the patient's face became flushed and her body stiffened up.  The nurse mentioned that the patient did not respond to her mother for 10 minutes.  After 10 minutes the patient was back to normal and responding accordingly.  No additional information was available.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought through a phone call.  The outcome was reported as recovered on 10-MAR-2008.  There was no product quality complaint.  Additional information has been requested. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Chills, Generalised erythema, Pruritus, Urticaria, Vomiting
Clinical narrative: Information has been received from a physician office manager concerning a 4 year old male (healthy child) with no reactions or allergies in the past, who on 10-MAR-2005 and 27-MAR-2008 was vaccinated with a first (tolerated well) and second doses of MMR II (lot number: /0971P and lot number: /1943U). There was no concomitant medication on 27-MAR-2008. On 27-MAR-2008, ten minutes after receiving the second dose of the vaccine, patient complained of abdominal pain. The patient then proceeded to vomit 4-5 times. The patient developed itchiness and erythemia. The patient was given antihistamine and was monitored in office for 2 hours then discharged to home. Office reports this vial was the first used in a 10-pack box. Lot check was being requested on 1943U. No additional information was available at the time. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Abdominal pain, Erythema, No reaction on previous exposure to drug, Pruritus, Vomiting
Clinical narrative: Information has been received from a physician office manager concerning a 4 year old male (healthy child) with no reactions or allergies in the past, who on 10-MAR-2005 and 27-MAR-2008 was vaccinated with a first (tolerated well) and second doses of MMR II (lot number: /0971P and lot number: /1943U). There was no concomitant medication on 27-MAR-2008. On 27-MAR-2008, ten minutes after receiving the second dose of the vaccine, patient complained of abdominal pain. The patient then proceeded to vomit 4-5 times. The patient developed itchiness and erythemia. The patient was given antihistamine and was monitored in office for 2 hours then discharged to home. Office reports this vial was the first used in a 10-pack box. Lot check was being requested on 1943U. No additional information was available at the time. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Mass
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 5 year old female who on 10-AUG-2007 at 10:54 was vaccinated SC with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655414/1470F). Additional suspect vaccination also administered at 10:54 included a SC second dose of varicella virus vaccine live (Oka/Merck) (MSD) (Lot # 658024/0833U). Immediately after vaccination (previously reported as "two minutes after vaccination") the patient had a fainting episode. The physician shook the patient and she woke up. It was reported that the fainting episode lasted 10 seconds. The patient completely recovered on 10-AUG-2007. No further information was provided. There was no product quality complaint involved. Additional information is not expected. This patient also had adverse experiences after therapy with varicella virus vaccine live (Oka/Merck) (WAES # 0708USA04046).
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 5 year old female who on 10-AUG-2007 at 10:54 was vaccinated SC with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655414/1470F). Additional suspect vaccination also administered at 10:54 included a SC second dose of varicella virus vaccine live (Oka/Merck) (MSD) (Lot # 658024/0833U). Immediately after vaccination (previously reported as "two minutes after vaccination") the patient had a fainting episode. The physician shook the patient and she woke up. It was reported that the fainting episode lasted 10 seconds. The patient completely recovered on 10-AUG-2007. No further information was provided. There was no product quality complaint involved. Additional information is not expected. This patient also had adverse experiences after therapy with varicella virus vaccine live (Oka/Merck) (WAES # 0708USA04046).
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 09-JUN-2008, was vaccinated with a second dose of GARDASIL (Lot reported as "0070X"). About 12 hours later, by midnight, the patient had a seizure and went to the emergency room (ER). She had a CT scan and bloodwork done while in the ER and the results came back normal for both tests, so the patient was sent home. On 10-JUN-2008 at 0600, the patient experienced a second seizure and this time the ER chose to admit the patient for a 48 hour observation. The patient had an EKG, an MRI and a neurology consult while in the hospital. At the time of this report, the patient's outcome was unknown. It was also reported that the patient received her first dose of GARDASIL on 07-APR-2008. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electrocardiogram, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 09-JUN-2008, was vaccinated with a second dose of GARDASIL (Lot reported as "0070X"). About 12 hours later, by midnight, the patient had a seizure and went to the emergency room (ER). She had a CT scan and bloodwork done while in the ER and the results came back normal for both tests, so the patient was sent home. On 10-JUN-2008 at 0600, the patient experienced a second seizure and this time the ER chose to admit the patient for a 48 hour observation. The patient had an EKG, an MRI and a neurology consult while in the hospital. At the time of this report, the patient's outcome was unknown. It was also reported that the patient received her first dose of GARDASIL on 07-APR-2008. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal growth retardation, Intra-uterine death, Placental disorder, Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry for GARDASIL through a nurse concerning a 23 year old female with an allergy to FLAGYL who in August 2007, was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The reporter stated that the patient received her first dose of GARDASIL while pregnant in another office (LMP = 11-JUL-2007).  It was reported that the patient had an ultrasound (no additional information provided).  The patient sought unspecified medical attention by seeing the physician.  Follow-up phone call information from a nurse reported that the patient had a intrauterine fetal demise (IUFD) at 25 weeks gestation on 08-JAN-2008.  There were placental abnormalities and severe intrauterine growth retardation (IUGR).  No other information was provided.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Laboratory test, Pain in extremity, X-ray
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 16-APR-2008 was vaccinated in the left arm with a dose of GARDASIL (uncertain if it was the first dose). Concomitant therapy included YAZ for birth control. On 18-APR-2008 the patient experienced persistent pain in the left arm that prevented the arm from being raised. There was no swelling and no induration. The patient still had the arm pain as of 06-JUN-2008 when the patient was seen in the office. The patient was told to use ice therapy, but the ice was reported to make the pain worse. The patient had been placed on DIFLUCAN and VOLTAREN. On an unknown date, x-ray and unspecified lab tests were performed and no result was provided. The patient's persistent pain in the left arm was considered to be disabling. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 16-APR-2008 was vaccinated in the left arm with a dose of GARDASIL (uncertain if it was the first dose). Concomitant therapy included YAZ for birth control. On 18-APR-2008 the patient experienced persistent pain in the left arm that prevented the arm from being raised. There was no swelling and no induration. The patient still had the arm pain as of 06-JUN-2008 when the patient was seen in the office. The patient was told to use ice therapy, but the ice was reported to make the pain worse. The patient had been placed on DIFLUCAN and VOLTAREN. On an unknown date, x-ray and unspecified lab tests were performed and no result was provided. The patient's persistent pain in the left arm was considered to be disabling. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Dehydration, Diarrhoea, Vomiting
Clinical narrative: 2-3 d after receiving rotavirus, developed diarrhea and vomiting requiring hospitalization for dehydration 8/8/08-records received-Progress note dated 6/26/08 -follow up visit after hospitalization on 6/8-6/10/08 for dehydration and watery non-bloody diarrhea. Loose stools continued until 6/17/08-then no stools for 2 days, straining to have BM for 10 days. Passes gas.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: See copy of medical records for initial visits.  Patient was admitted to hospital and still an inpatient as of 5/13/08.  DX: GBS.  Hospital progress notes also attached.  7/22/2008 MR received for DOS  3/03-5/23/2008 with D/C DX: Guillain-Barre Syndrome. 2ndary DX:  SIADH, constipation, R hand 5th metacarpal fracture and depression. Pt presented on 3/3/08 with 4 day hx of progressive ascending numbness and motor weakness which began at the ankles to the upper extremities. Pt developed respiratory distress and decreased vital capacity and was intubated on 3/09/08 x 7 days and extubated. No further respiratory issues. Tx with IVIG. Pt then developed SIADH and was tx with fluid restriction. Pt showed some sensation and motor function improvement although now c/o depression and continued pain in the feet. Choriform movements noted by neurology and tx with clonazapam with resolution of sx. Pt developed bilateral ankle contractures. D/C 5/23/08 to continue outpt rehab.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, FLU3, HEPAB, MMRV, MNQ, TDAP
Symptoms: Areflexia, Asthenia, Dysaesthesia, Gait disturbance, Hyperaesthesia
Clinical narrative: See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, FLU3, HEPAB, MMRV, MNQ, TDAP
Symptoms: Hypoaesthesia, Nervous system disorder, Paraesthesia, Peripheral sensory neuropathy
Clinical narrative: See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, FLU3, HEPAB, MMRV, MNQ, TDAP
Symptoms: Balance disorder, Blood product transfusion, CSF culture negative, CSF lymphocyte count increased, CSF monocyte count decreased
Clinical narrative: See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, FLU3, HEPAB, MMRV, MNQ, TDAP
Symptoms: CSF protein increased, CSF white blood cell count increased, Diarrhoea, Electromyogram abnormal, Facial palsy
Clinical narrative: See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, FLU3, HEPAB, MMRV, MNQ, TDAP
Symptoms: Hypoaesthesia, Hyporeflexia, Lumbar puncture abnormal, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, FLU3, HEPAB, MMRV, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Sensory disturbance
Clinical narrative: See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Inappropriate schedule of drug administration, Oedema peripheral
Clinical narrative: 2" red raised area on L arm.  Applying cold pack and giving TYLENOL.
Age: 19.0
Sex: F
Vaccine: TTOX
Symptoms: Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: Tingling; Sweaty; Nausea
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis left arm, treated with Bactrim DS 1 BID for 7 days.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cough, Pharyngolaryngeal pain, Upper respiratory tract congestion
Clinical narrative: 6 hours after MENACTRA onset congestion, cough, sore throat, - observe
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: Erythema, swelling over right leg, papular urticaria over entire body.  Atarax given for itching.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: No adverse event noted; Inappropriate vaccine given (DTaP given instead of Tdap)
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Breath sounds abnormal, Diarrhoea, Ear disorder, Faeces discoloured, Faeces hard
Clinical narrative: Information in the form of medical records was received from a pediatrician, regarding a 12 week old female infant with thrush, and a history of contact dermatitis, newborn feeding problems, neonatal jaundice, shoulder dystocia and an upper respiratory infection, who on 11-DEC-2007 was vaccinated with the first dose of ROTATEQ. Concomitant vaccines administered included the first doses of PEDIARIX, PREVNAR, and ACTHIB. On 03-JAN-2008, the infant was brought to the physician with diarrhea of 5 days duration and watery, yellow green stool with onset 6-7 days prior to visit; she had also vomiting up to 4 times daily. The infant was diagnosed with viral enteritis. Skin turgor and elasticity were good, with no dehydration noted. On 14-FEB-2008, the infant was brought to the pediatrician's office for a routine 4 month old check up. The child was noted as "healthy child with normal growth." A second dose of ROTATEQ, PEDIARIX, PREVNAR, and ACTHIB were administered. On 20-FEB-2008, the infant was brought to the office with the mother's report that the infant had no stool for 2 days over the weekend. Treatment included glycerin chip, with a hard stool resulting. On 19-FEB-2008, the infant had no stool, and glycerin was again administered, with a yellow and soft resulting. The mother had been giving 1 -2 drops in a bottle once daily. Treatment prescribed included Karo syrup, 1 tsp per bottle for 2 bottles and adjust as necessary. The physician noted that the parents had symptoms of an upper respiratory infection. On 27-FEB-2008, the infant was brought to the physician with reports of congestion and cough for 1 week, but with no fever. An upper respiratory infection was diagnosed. On 07-MAR-2008, the infant was seen by the physician with improvements other nasal symptoms, no respiratory distress, but "her breathing is more rattling." The physician assessed the URI as improving. On 28-MAR-2008, the infant was brought to the physician with her mother's reports of "for the last 4 days she's been pulling at ears." There was no fever nor URI symptoms noted, and the physician diagnosed teething syndrome. The outcome of teething syndrome was unknown at the time of this report. Additional information has been requested. All medical records will be provided upon request.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastroenteritis viral, Nasal disorder, Sick relative, Teething, Upper respiratory tract infection
Clinical narrative: Information in the form of medical records was received from a pediatrician, regarding a 12 week old female infant with thrush, and a history of contact dermatitis, newborn feeding problems, neonatal jaundice, shoulder dystocia and an upper respiratory infection, who on 11-DEC-2007 was vaccinated with the first dose of ROTATEQ. Concomitant vaccines administered included the first doses of PEDIARIX, PREVNAR, and ACTHIB. On 03-JAN-2008, the infant was brought to the physician with diarrhea of 5 days duration and watery, yellow green stool with onset 6-7 days prior to visit; she had also vomiting up to 4 times daily. The infant was diagnosed with viral enteritis. Skin turgor and elasticity were good, with no dehydration noted. On 14-FEB-2008, the infant was brought to the pediatrician's office for a routine 4 month old check up. The child was noted as "healthy child with normal growth." A second dose of ROTATEQ, PEDIARIX, PREVNAR, and ACTHIB were administered. On 20-FEB-2008, the infant was brought to the office with the mother's report that the infant had no stool for 2 days over the weekend. Treatment included glycerin chip, with a hard stool resulting. On 19-FEB-2008, the infant had no stool, and glycerin was again administered, with a yellow and soft resulting. The mother had been giving 1 -2 drops in a bottle once daily. Treatment prescribed included Karo syrup, 1 tsp per bottle for 2 bottles and adjust as necessary. The physician noted that the parents had symptoms of an upper respiratory infection. On 27-FEB-2008, the infant was brought to the physician with reports of congestion and cough for 1 week, but with no fever. An upper respiratory infection was diagnosed. On 07-MAR-2008, the infant was seen by the physician with improvements other nasal symptoms, no respiratory distress, but "her breathing is more rattling." The physician assessed the URI as improving. On 28-MAR-2008, the infant was brought to the physician with her mother's reports of "for the last 4 days she's been pulling at ears." There was no fever nor URI symptoms noted, and the physician diagnosed teething syndrome. The outcome of teething syndrome was unknown at the time of this report. Additional information has been requested. All medical records will be provided upon request.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information in the form of medical records was received from a pediatrician, regarding a 12 week old female infant with thrush, and a history of contact dermatitis, newborn feeding problems, neonatal jaundice, shoulder dystocia and an upper respiratory infection, who on 11-DEC-2007 was vaccinated with the first dose of ROTATEQ. Concomitant vaccines administered included the first doses of PEDIARIX, PREVNAR, and ACTHIB. On 03-JAN-2008, the infant was brought to the physician with diarrhea of 5 days duration and watery, yellow green stool with onset 6-7 days prior to visit; she had also vomiting up to 4 times daily. The infant was diagnosed with viral enteritis. Skin turgor and elasticity were good, with no dehydration noted. On 14-FEB-2008, the infant was brought to the pediatrician's office for a routine 4 month old check up. The child was noted as "healthy child with normal growth." A second dose of ROTATEQ, PEDIARIX, PREVNAR, and ACTHIB were administered. On 20-FEB-2008, the infant was brought to the office with the mother's report that the infant had no stool for 2 days over the weekend. Treatment included glycerin chip, with a hard stool resulting. On 19-FEB-2008, the infant had no stool, and glycerin was again administered, with a yellow and soft resulting. The mother had been giving 1 -2 drops in a bottle once daily. Treatment prescribed included Karo syrup, 1 tsp per bottle for 2 bottles and adjust as necessary. The physician noted that the parents had symptoms of an upper respiratory infection. On 27-FEB-2008, the infant was brought to the physician with reports of congestion and cough for 1 week, but with no fever. An upper respiratory infection was diagnosed. On 07-MAR-2008, the infant was seen by the physician with improvements other nasal symptoms, no respiratory distress, but "her breathing is more rattling." The physician assessed the URI as improving. On 28-MAR-2008, the infant was brought to the physician with her mother's reports of "for the last 4 days she's been pulling at ears." There was no fever nor URI symptoms noted, and the physician diagnosed teething syndrome. The outcome of teething syndrome was unknown at the time of this report. Additional information has been requested. All medical records will be provided upon request.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Arthralgia, Fatigue, Headache, Hot flush
Clinical narrative: Pt states that for the past 5-6 days she has had a HA in mid forehead.  HA always present to some degree but does vary considerably in intensity.  Pt also c/o anterior neck discomfort earlier in day (not necessarily worse w/ swallowing) that has improved on its own.  She denies stiff neck or posterior neck pain.  She also c/o generalized fatigue, numbness and tingling in both her legs, "hot flashes", and sore muscles throughout her body.  She states her skin feels very sensitive to touch.  She states she has had increased anxiety in recent days (unsure why) and has been very irritable.  She adamantly denies any suicidal or homicidal thoughts/plans.  LMP 1 1/2 weeks ago > normal.  This 18-year-old has been in a couple of times now for this complaint.  She has seen Dr.  All of these symptoms started directly after her HPV vaccination.  This is discussed  in detail in Dr's notes.  The patient's current symptoms include numbness, malaise, swollen glands, joint pain, muscle pain, fatigue, increase in her headache frequency and hot flashes.  She even noticed that her right ear clicks after the injection.  In general, she does not feel well.  The respite from school has helped somewhat.  She is less stressful, but still, according to her and her mother, continues to be very anxious with lots of mood irritability.  She still does go to the gym daily and run.  She enjoys visiting with her friends.  Her sleep is still quite poor.  The AMBIEN has helped.  This recent episode was overlaid with a viral illness.  I reviewed her blood work from a couple of weeks ago with them again and that all looked normal.  This 18-year-old was seen by me last week in the same-day clinic.  I felt she might be depressed.  She was reacting to sore throat, fatigue, and insomnia.  Her lab studies are all perfectly normal.  Her strep screen was negative.  Her monotest was negative as well as a CBC and thyroid testing.  Today, she presents with her mother and history is more complete in that she had GARDASIL vaccine in October and then in December.  Her symptoms started in October, shortly after the first injection and got worse after the second injection.  Her symptoms, though somewhat vague, seem to be pretty consistent in that they include nausea, fatigue, difficulty sleeping, and now she is having some numbness in her calves when she crosses her legs.  Her mother did take her away for a week to get away from all the stress of home life and school, but her symptoms did not improve.  She was given some AMBIEN and did take that once during this last week.  Overall, her appetite has been okay.  While she has some teenage worries, she denies depression.