chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Fall, Fracture, Loss of consciousness, Skin laceration, Surgery
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who on 05-NOV-2007 was vaccinated in the right arm with a dose of GARDASIL.  On the same day the patient also received concomitant therapy Flu vaccine (unspecified).  On 05-NOV-2007, 10 minutes after receiving GARDASIL, the patient passed out, and fell on her face.  She had a laceration over her left eye and fractured her cheek bone.  It was reported that the patient was hospitalized and had several surgeries.  The outcome of the patient was not reported. The reporter considered passed out, a laceration over her left eye and fractured her cheek bone to be disabling.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: Encephalitis post immunisation, Fontanelle bulging, Pyrexia, Somnolence, Vomiting
Clinical narrative: Fever, vomits, bulging fontanel.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: Fontanelle bulging, Pyrexia, Somnolence, Vomiting
Clinical narrative: Fever, vomits, bulging fontanel.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: Fontanelle bulging, Lumbar puncture normal, Pyrexia, Sepsis, Vomiting
Clinical narrative: Fever, vomits, bulging fontanel.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: White blood cell count increased
Clinical narrative: Fever, vomits, bulging fontanel.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Culture throat negative, Dysphagia, Ear, nose and throat examination, Lymphadenopathy, No reaction on previous exposure to drug
Clinical narrative: Pain in cheeks by evening they were very painful and tender like someone punched her. Next morning 8/1 face and neck tender and swollen. Benadryl given. By 5 PM on 8/2 her neck and face was so swollen that pill got caught in esophagus and unable to swallow. Was taken to ER. During this ordeal lips were not swollen only tissue in face and neck not like anaphylaxis. Face swollen to 1 inch under her chin she could not sip water had to be spoon fed. She was admitted to the hospital since they were concerned with airway obstruction given IV prednisone. They thought she had a salivary gland infection so she was started on Clindamycin (antibiotic). She was given a dose at 6 pm and another one at 12 am to which she reacted allergically. kept with Prednisone and Benadryl only after that. She was discharged on 8/5 from medical center. Tongue has yeast infection. Had huge swelling on back and front of ear; it hurt very much could not walk unassisted - this persisted until 8/7/08. Today 8/18 her tongue still very sore, might still have problems with salivary glands because not producing as much saliva as before. After 1st dose of GARDASIL had trouble sleeping, woke up sitting up. While in the hospital mother observed jerking movements spasms in arms and legs every once in a while, while she slept. She had diarrhea after 1st and 2nd dose of GARDASIL.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Parotid duct obstruction, Salivary gland enlargement, Swelling face, Tenderness
Clinical narrative: Pain in cheeks by evening they were very painful and tender like someone punched her. Next morning 8/1 face and neck tender and swollen. Benadryl given. By 5 PM on 8/2 her neck and face was so swollen that pill got caught in esophagus and unable to swallow. Was taken to ER. During this ordeal lips were not swollen only tissue in face and neck not like anaphylaxis. Face swollen to 1 inch under her chin she could not sip water had to be spoon fed. She was admitted to the hospital since they were concerned with airway obstruction given IV prednisone. They thought she had a salivary gland infection so she was started on Clindamycin (antibiotic). She was given a dose at 6 pm and another one at 12 am to which she reacted allergically. kept with Prednisone and Benadryl only after that. She was discharged on 8/5 from medical center. Tongue has yeast infection. Had huge swelling on back and front of ear; it hurt very much could not walk unassisted - this persisted until 8/7/08. Today 8/18 her tongue still very sore, might still have problems with salivary glands because not producing as much saliva as before. After 1st dose of GARDASIL had trouble sleeping, woke up sitting up. While in the hospital mother observed jerking movements spasms in arms and legs every once in a while, while she slept. She had diarrhea after 1st and 2nd dose of GARDASIL.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Auricular swelling, Diarrhoea, Dyskinesia, Dysphagia, Ear pain
Clinical narrative: Pain in cheeks by evening they were very painful and tender like someone punched her. Next morning 8/1 face and neck tender and swollen. Benadryl given. By 5 PM on 8/2 her neck and face was so swollen that pill got caught in esophagus and unable to swallow. Was taken to ER. During this ordeal lips were not swollen only tissue in face and neck not like anaphylaxis. Face swollen to 1 inch under her chin she could not sip water had to be spoon fed. She was admitted to the hospital since they were concerned with airway obstruction given IV prednisone. They thought she had a salivary gland infection so she was started on Clindamycin (antibiotic). She was given a dose at 6 pm and another one at 12 am to which she reacted allergically. kept with Prednisone and Benadryl only after that. She was discharged on 8/5 from medical center. Tongue has yeast infection. Had huge swelling on back and front of ear; it hurt very much could not walk unassisted - this persisted until 8/7/08. Today 8/18 her tongue still very sore, might still have problems with salivary glands because not producing as much saliva as before. After 1st dose of GARDASIL had trouble sleeping, woke up sitting up. While in the hospital mother observed jerking movements spasms in arms and legs every once in a while, while she slept. She had diarrhea after 1st and 2nd dose of GARDASIL.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Facial pain, Fungal infection, Gait disturbance, Glossodynia, Local swelling
Clinical narrative: Pain in cheeks by evening they were very painful and tender like someone punched her. Next morning 8/1 face and neck tender and swollen. Benadryl given. By 5 PM on 8/2 her neck and face was so swollen that pill got caught in esophagus and unable to swallow. Was taken to ER. During this ordeal lips were not swollen only tissue in face and neck not like anaphylaxis. Face swollen to 1 inch under her chin she could not sip water had to be spoon fed. She was admitted to the hospital since they were concerned with airway obstruction given IV prednisone. They thought she had a salivary gland infection so she was started on Clindamycin (antibiotic). She was given a dose at 6 pm and another one at 12 am to which she reacted allergically. kept with Prednisone and Benadryl only after that. She was discharged on 8/5 from medical center. Tongue has yeast infection. Had huge swelling on back and front of ear; it hurt very much could not walk unassisted - this persisted until 8/7/08. Today 8/18 her tongue still very sore, might still have problems with salivary glands because not producing as much saliva as before. After 1st dose of GARDASIL had trouble sleeping, woke up sitting up. While in the hospital mother observed jerking movements spasms in arms and legs every once in a while, while she slept. She had diarrhea after 1st and 2nd dose of GARDASIL.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle spasms, Oral intake reduced, Sleep disorder, Swelling face, Tenderness
Clinical narrative: Pain in cheeks by evening they were very painful and tender like someone punched her. Next morning 8/1 face and neck tender and swollen. Benadryl given. By 5 PM on 8/2 her neck and face was so swollen that pill got caught in esophagus and unable to swallow. Was taken to ER. During this ordeal lips were not swollen only tissue in face and neck not like anaphylaxis. Face swollen to 1 inch under her chin she could not sip water had to be spoon fed. She was admitted to the hospital since they were concerned with airway obstruction given IV prednisone. They thought she had a salivary gland infection so she was started on Clindamycin (antibiotic). She was given a dose at 6 pm and another one at 12 am to which she reacted allergically. kept with Prednisone and Benadryl only after that. She was discharged on 8/5 from medical center. Tongue has yeast infection. Had huge swelling on back and front of ear; it hurt very much could not walk unassisted - this persisted until 8/7/08. Today 8/18 her tongue still very sore, might still have problems with salivary glands because not producing as much saliva as before. After 1st dose of GARDASIL had trouble sleeping, woke up sitting up. While in the hospital mother observed jerking movements spasms in arms and legs every once in a while, while she slept. She had diarrhea after 1st and 2nd dose of GARDASIL.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Mom claimed child had severe diarrhea + projectile vomiting after 2 days of Rotateq administration.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Full blood count, Laboratory test, Urine analysis, Vomiting projectile
Clinical narrative: Mom claimed child had severe diarrhea + projectile vomiting after 2 days of Rotateq administration.
Sex: U
Vaccine: PER
Symptoms: Convulsion
Clinical narrative: Initial report received on 11 August 2008 from another manufacturer who received information from a health care professional.  A patient (gender and age not reported) experienced a seizure after administration of a pertussis vaccine (manufacturer not known; trade name and lot number not reported) several years ago.  No additional information was provided.
Sex: F
Vaccine: DTP
Symptoms: Anaphylactic reaction, Body temperature increased, Pyrexia
Clinical narrative: Initial information was received from another manufacturer on 11 August 2008.  The initial reporter to this manufacturer was a health care professional.  A female patient received an injection of DPT (manufacturer, lot number, and date not reported).  The patient reported an anaphylactic reaction and a fever of 105 degrees F to the pertussis component of DPT.  No further information was provided.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Alpha 1 foetoprotein normal, Amniotic fluid volume increased, Caesarean section, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: A 27-year-old female patient had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2507AA, on 18 October 2007. It was determined that the patient was approximately two months pregnant at the time of vaccination. Last menstrual period and estimated date of delivery were not provided. Per the reporter, the patient did not experience any adverse event. Follow-up report received from a health care professional on 06 August 2008. On an unspecified date, the patient was found to have polyhydramnios. A level 2 ultrasound performed at 28 weeks gestation showed bilateral hydronephrosis in the fetus. The patient went into premature labor at 32 weeks gestation. on 17 March 2008, 35 weeks gestation, the patient went into labor. A Cesarean section was performed resulting in the live birth of a male, born with bilateral hydronephrosis. The reporter indicated that the mother's health during pregnancy had been unremarkable, except for the polyhydramnios. The reporter of this case is the same as case 2008-02516, the report for the above-mentioned baby.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Polyhydramnios, Premature labour, Serology normal, Ultrasound scan abnormal
Clinical narrative: A 27-year-old female patient had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2507AA, on 18 October 2007. It was determined that the patient was approximately two months pregnant at the time of vaccination. Last menstrual period and estimated date of delivery were not provided. Per the reporter, the patient did not experience any adverse event. Follow-up report received from a health care professional on 06 August 2008. On an unspecified date, the patient was found to have polyhydramnios. A level 2 ultrasound performed at 28 weeks gestation showed bilateral hydronephrosis in the fetus. The patient went into premature labor at 32 weeks gestation. on 17 March 2008, 35 weeks gestation, the patient went into labor. A Cesarean section was performed resulting in the live birth of a male, born with bilateral hydronephrosis. The reporter indicated that the mother's health during pregnancy had been unremarkable, except for the polyhydramnios. The reporter of this case is the same as case 2008-02516, the report for the above-mentioned baby.
Sex: M
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Foetal disorder, Premature labour, Ultrasound scan abnormal
Clinical narrative: Initial report received from a health care professional on 06 August 2008.  A male infant born, 151 days after receiving a transplacental dose of FLUZONE (lot number U2507AA) on 18 October 2007, was diagnosed with a congenital anomaly, bilateral hydronephrosis.  The baby was born at 35 weeks gestation by Cesarean section.  Bilateral hydronephrosis was detected in a level 2 ultrasound performed at 28 weeks gestation.  The baby's birth weight was 3.8 kg.  Apgar scores were not reported.  Concomitant medication reported for the mother during pregnancy was prenatal vitamins.  During pregnancy, the baby's mother had experienced polyhydramnios in addition to premature labor at 32 weeks gestation.  The reporter indicated that the mother's health had been unremarkable except for the polyhydramnios.  It was reported that the baby's bilateral hydronephrosis resolved at six weeks of age.  No additional details were provided.  The reporter of this case is the same as case 2007-03576.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion missed, Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pain
Clinical narrative: Initial and follow-up information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female with allergy to TORADOL who on 10-JUN-2008 was vaccinated intramuscularly with the first and only 0.5 ml dose of GARDASIL (lot no. 659962/1740U).  There was no concomitant medication.  The physician reported that on 27-MAY-2008 the patient had an ultrasound due to complaints of "pain" and the result was negative.  The patient had a history of "negative menses".  On 12-JUL-2008 the patient had a spontaneous abortion when she was eight weeks pregnant.  On the same day, the patient had an evaluation due to a (+) serum beta-human chorionic gonadotropin (missed abortion).  The patient saw the physician to seek unspecified medical attention.  Upon internal review spontaneous abortion was considered to be an other important medical event.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female with allergy to TORADOL who on 10-JUN-2008 was vaccinated intramuscularly with the first and only 0.5 ml dose of GARDASIL (lot no. 659962/1740U).  There was no concomitant medication.  The physician reported that on 27-MAY-2008 the patient had an ultrasound due to complaints of "pain" and the result was negative.  The patient had a history of "negative menses".  On 12-JUL-2008 the patient had a spontaneous abortion when she was eight weeks pregnant.  On the same day, the patient had an evaluation due to a (+) serum beta-human chorionic gonadotropin (missed abortion).  The patient saw the physician to seek unspecified medical attention.  Upon internal review spontaneous abortion was considered to be an other important medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep paralysis, Sleep study abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a female who an unspecified dates was vaccinated with the first and second doses of GARDASIL.  After the second dose the patient developed "sleep paralysis" who was diagnosed after a patient was seen at sleep lab.  The patient will not receive the third dose of GARDASIL.  Upon internal review, sleep paralysis was determined to be an other important medical event.  Additional information is not expected as the nurse practitioner requested not to be contacted.  8/29/08 Reviewed neuro medical records of 5/22/2008. FINAL DX: isolated sleep paralysis Records reveal patient experienced HA 2 years prior after 2 concussions 1 month apart from sports injuries w/resultant diagnosis of postconcussion syndrome & migraines.  Tx w/Keppra & Topamax, Elavil, Imitrex among other medications.  Currently gets HA once every 2 weeks that are less severe & respond to Advil.  Was having spells of sleep paralysis for over 1 year w/waking & unable to move arms or legs & unable to speak which last for about 1 minute about once a month.  Has abnormal & restless sleep, tired during the day.  Neuro exam was WNL on 5/22/2008.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiplegia, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 19 year old female who was vaccinated with the first dose of GARDASIL 0.5 mL. The physician reported that the patient experienced tingling and numbness in her arm which progressed into paralysis of an entire one side of her body after receiving the vaccination. The patient sought medical attention and was seen by the physician. At the time of reporting, the patient had not recovered. The physician considered tingling and numbness in her arm and paralysis of an entire one side of her body to be disabling. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Condition aggravated, Petit mal epilepsy
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with a history of hospitalization in 2005 due to convulsion who on 12-AUG-2008 was vaccinated at 16:30 with a first dose of GARDASIL (lot # 658556/1060U), 0.5 mL, IM, into the left deltoid. At the same visit, the patient also received ADACEL and MENACTRA into the right deltoid. On 12-AUG-2008, after getting her first dose of GARDASIL, the patient experienced a petit mal seizure lasted for about 15 seconds. No lab tests were performed. The patient recovered at the office and was released. Upon internal review, petit mal seizure was determined to be an other medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Neurological examination normal, Somnolence, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with a history of hospitalization in 2005 due to convulsion who on 12-AUG-2008 was vaccinated at 16:30 with a first dose of GARDASIL (lot # 658556/1060U), 0.5 mL, IM, into the left deltoid. At the same visit, the patient also received ADACEL and MENACTRA into the right deltoid. On 12-AUG-2008, after getting her first dose of GARDASIL, the patient experienced a petit mal seizure lasted for about 15 seconds. No lab tests were performed. The patient recovered at the office and was released. Upon internal review, petit mal seizure was determined to be an other medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Condition aggravated, Petit mal epilepsy
Clinical narrative: Immediately after receiving HPV, pt fainted, closed eyes, laid on table. Then for 12-15 sec had tonic/clonic movements of her hands. Next, woke up groggy but responding. Normal neuro exam 10 min. later. Pt had 1 nonfebrile seizure 3 years ago - no meds.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Neurological examination normal, Somnolence, Syncope, Tonic clonic movements
Clinical narrative: Immediately after receiving HPV, pt fainted, closed eyes, laid on table. Then for 12-15 sec had tonic/clonic movements of her hands. Next, woke up groggy but responding. Normal neuro exam 10 min. later. Pt had 1 nonfebrile seizure 3 years ago - no meds.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Ketoacidosis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 23 year old female with diabetes mellitus who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL (lot # 0152X) and on 21-JUL-2008 was vaccinated with the second dose of GARDASIL (lot # 0250X). Concomitant therapy included ORTHO-CYCLEN, LANTUS, NOVOLOG, montelukast sodium (MSD), finasteride (manufacturer unknown), SIMVASTATIN (manufacturer unknown), XYZAL and minoxidil. The patient experienced dizziness after receiving the first dose (recovered) and also the second dose. The patient was recently hospitalized for ketoacidosis. Medical attention was sought via calling the nurse. At the time of this report, the outcome was unknown for the second episode of dizziness and ketoacidosis. No product quality complaint was involved. The temporal relationship to GARDASIL was unspecified by the N.P.. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Biopsy skin normal, Blood gases abnormal, Blood immunoglobulin G
Clinical narrative: Information has been received from a physician concerning an 83 year old immunocompromised male with Waldenstrom's macroglobulinaemia who was exposed to his wife who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 14-MAY-2008 the patient developed herpes zoster (HZ) on his trunk and extremities, along with severe illnesses including one was not diagnosed as pneumonia bilateral infiltration.  At the time of this report, the outcome was unknown.  A specimen was taken for polymerase chain reaction (PCR) analysis.  The PCR result for the specimen was positive for varicella zoster virus (VZV) (wild-type).  Follow-up information was received from a physician which reported the patient with Waldenstrom's macroglobulinaemia, dementia and Chronic kidney disease (CKD) who on 14-MAY-2008 to 15-MAY-2008 began to develop papular lesions on trunk and lower extremity.  The patient had lower left chest discomfort around this time.  On 17-MAY-2008, the patient was seen in emergency department (ED) and discharged.  On 21-MAY-2008, the patient was admitted to hospital with confusion and short of breath (SOB).  The patient had a disseminated vesicular eruption with lesions at different stage of development.  The patient was hypoxic (ABG 7.42/20/66 on 3L) and had bilateral lower lobe infiltrates.  He also had elevated hepatic transaminases- alanine aminotransferase (ALT) 127 and aspartate aminotransferase (AST) 185.  He was started on IV acyclovir and ZOSYN and vancomycin.  He had a low IgG (around 350) and received IVIG on HD # 3.  He had the base of a lesion unroofed for culture and no virus was isolated.  A skin biopsy was performed and culture was negative as well as VZV antigen by fluorescent antibody.  He had completed a 7 days course of IV acyclovir.  All skin lesions crusted over by the end of therapy.  The patient had improvement in his respiratory status and was discharged to a rehab facility on day 12.  This is one of several reports received from the same source.  Additional information has been requested.  All available medical record will be provided upon requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood product transfusion, Chest discomfort, Confusional state, Dyspnoea, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 83 year old immunocompromised male with Waldenstrom's macroglobulinaemia who was exposed to his wife who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 14-MAY-2008 the patient developed herpes zoster (HZ) on his trunk and extremities, along with severe illnesses including one was not diagnosed as pneumonia bilateral infiltration.  At the time of this report, the outcome was unknown.  A specimen was taken for polymerase chain reaction (PCR) analysis.  The PCR result for the specimen was positive for varicella zoster virus (VZV) (wild-type).  Follow-up information was received from a physician which reported the patient with Waldenstrom's macroglobulinaemia, dementia and Chronic kidney disease (CKD) who on 14-MAY-2008 to 15-MAY-2008 began to develop papular lesions on trunk and lower extremity.  The patient had lower left chest discomfort around this time.  On 17-MAY-2008, the patient was seen in emergency department (ED) and discharged.  On 21-MAY-2008, the patient was admitted to hospital with confusion and short of breath (SOB).  The patient had a disseminated vesicular eruption with lesions at different stage of development.  The patient was hypoxic (ABG 7.42/20/66 on 3L) and had bilateral lower lobe infiltrates.  He also had elevated hepatic transaminases- alanine aminotransferase (ALT) 127 and aspartate aminotransferase (AST) 185.  He was started on IV acyclovir and ZOSYN and vancomycin.  He had a low IgG (around 350) and received IVIG on HD # 3.  He had the base of a lesion unroofed for culture and no virus was isolated.  A skin biopsy was performed and culture was negative as well as VZV antigen by fluorescent antibody.  He had completed a 7 days course of IV acyclovir.  All skin lesions crusted over by the end of therapy.  The patient had improvement in his respiratory status and was discharged to a rehab facility on day 12.  This is one of several reports received from the same source.  Additional information has been requested.  All available medical record will be provided upon requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoxia, Lung infiltration, Rash papular, Rash vesicular, Secondary transmission
Clinical narrative: Information has been received from a physician concerning an 83 year old immunocompromised male with Waldenstrom's macroglobulinaemia who was exposed to his wife who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 14-MAY-2008 the patient developed herpes zoster (HZ) on his trunk and extremities, along with severe illnesses including one was not diagnosed as pneumonia bilateral infiltration.  At the time of this report, the outcome was unknown.  A specimen was taken for polymerase chain reaction (PCR) analysis.  The PCR result for the specimen was positive for varicella zoster virus (VZV) (wild-type).  Follow-up information was received from a physician which reported the patient with Waldenstrom's macroglobulinaemia, dementia and Chronic kidney disease (CKD) who on 14-MAY-2008 to 15-MAY-2008 began to develop papular lesions on trunk and lower extremity.  The patient had lower left chest discomfort around this time.  On 17-MAY-2008, the patient was seen in emergency department (ED) and discharged.  On 21-MAY-2008, the patient was admitted to hospital with confusion and short of breath (SOB).  The patient had a disseminated vesicular eruption with lesions at different stage of development.  The patient was hypoxic (ABG 7.42/20/66 on 3L) and had bilateral lower lobe infiltrates.  He also had elevated hepatic transaminases- alanine aminotransferase (ALT) 127 and aspartate aminotransferase (AST) 185.  He was started on IV acyclovir and ZOSYN and vancomycin.  He had a low IgG (around 350) and received IVIG on HD # 3.  He had the base of a lesion unroofed for culture and no virus was isolated.  A skin biopsy was performed and culture was negative as well as VZV antigen by fluorescent antibody.  He had completed a 7 days course of IV acyclovir.  All skin lesions crusted over by the end of therapy.  The patient had improvement in his respiratory status and was discharged to a rehab facility on day 12.  This is one of several reports received from the same source.  Additional information has been requested.  All available medical record will be provided upon requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning an 83 year old immunocompromised male with Waldenstrom's macroglobulinaemia who was exposed to his wife who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 14-MAY-2008 the patient developed herpes zoster (HZ) on his trunk and extremities, along with severe illnesses including one was not diagnosed as pneumonia bilateral infiltration.  At the time of this report, the outcome was unknown.  A specimen was taken for polymerase chain reaction (PCR) analysis.  The PCR result for the specimen was positive for varicella zoster virus (VZV) (wild-type).  Follow-up information was received from a physician which reported the patient with Waldenstrom's macroglobulinaemia, dementia and Chronic kidney disease (CKD) who on 14-MAY-2008 to 15-MAY-2008 began to develop papular lesions on trunk and lower extremity.  The patient had lower left chest discomfort around this time.  On 17-MAY-2008, the patient was seen in emergency department (ED) and discharged.  On 21-MAY-2008, the patient was admitted to hospital with confusion and short of breath (SOB).  The patient had a disseminated vesicular eruption with lesions at different stage of development.  The patient was hypoxic (ABG 7.42/20/66 on 3L) and had bilateral lower lobe infiltrates.  He also had elevated hepatic transaminases- alanine aminotransferase (ALT) 127 and aspartate aminotransferase (AST) 185.  He was started on IV acyclovir and ZOSYN and vancomycin.  He had a low IgG (around 350) and received IVIG on HD # 3.  He had the base of a lesion unroofed for culture and no virus was isolated.  A skin biopsy was performed and culture was negative as well as VZV antigen by fluorescent antibody.  He had completed a 7 days course of IV acyclovir.  All skin lesions crusted over by the end of therapy.  The patient had improvement in his respiratory status and was discharged to a rehab facility on day 12.  This is one of several reports received from the same source.  Additional information has been requested.  All available medical record will be provided upon requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old patient with high blood pressure and high cholesterol, and no known drug reactions/allergies.  On 26-FEB-2008, the patient was vaccinated with ZOSTAVAX (Oka/Merck).  The physician reported that during the week of 12-AUG-2008, the patient developed a "nice case" of shingles on his right chest.  The patient is being treated with acyclovir.  The patient sought medical attention at physician's office.  At the time of the report the patient has not recovered.  The physician considered the shingles to be an other important medical event, as it required.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anorexia, Chills, Menstruation irregular, Nausea
Clinical narrative: Fainted after first shot (10 mins after), fever, chills, pain 3 days after.  Then had stomach problems for month after.  Vomiting, stomach pains, was hospitalized, and found nothing.  In ICU for 2 days.  Still has no need to eat.  Nausea, no menstrual cycle for month, no period for 3-4 months at a time.  Lost a lot of weight.  Sick in stomach. 8/22/08-records received for DOS 8/7/08 and 8/9/08-Diagnostic laparoscopy. Normal pelvic findings. C/O abdominal pain. One month prior began having vague abdominal pain mostly in lower abdomen on right side. Impression: post op ileus. Ten days prior flexible sigmoidoscopy normal with internal hemorrhoids. Returned after laparoscopy with C/O abdominal pain with nausea. NG tube placement.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oral intake reduced, Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: Fainted after first shot (10 mins after), fever, chills, pain 3 days after.  Then had stomach problems for month after.  Vomiting, stomach pains, was hospitalized, and found nothing.  In ICU for 2 days.  Still has no need to eat.  Nausea, no menstrual cycle for month, no period for 3-4 months at a time.  Lost a lot of weight.  Sick in stomach. 8/22/08-records received for DOS 8/7/08 and 8/9/08-Diagnostic laparoscopy. Normal pelvic findings. C/O abdominal pain. One month prior began having vague abdominal pain mostly in lower abdomen on right side. Impression: post op ileus. Ten days prior flexible sigmoidoscopy normal with internal hemorrhoids. Returned after laparoscopy with C/O abdominal pain with nausea. NG tube placement.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Fainted after first shot (10 mins after), fever, chills, pain 3 days after.  Then had stomach problems for month after.  Vomiting, stomach pains, was hospitalized, and found nothing.  In ICU for 2 days.  Still has no need to eat.  Nausea, no menstrual cycle for month, no period for 3-4 months at a time.  Lost a lot of weight.  Sick in stomach. 8/22/08-records received for DOS 8/7/08 and 8/9/08-Diagnostic laparoscopy. Normal pelvic findings. C/O abdominal pain. One month prior began having vague abdominal pain mostly in lower abdomen on right side. Impression: post op ileus. Ten days prior flexible sigmoidoscopy normal with internal hemorrhoids. Returned after laparoscopy with C/O abdominal pain with nausea. NG tube placement.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Throat tightness, Urticaria
Clinical narrative: Mom called just over 2 1/2 hrs after administration stating pt had hives, throat felt like it was closing.  Advised to call 911.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Red, itch, swollen, hot, painful, cellulitis - needed RX.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Swelling
Clinical narrative: Red, itch, swollen, hot, painful, cellulitis - needed RX.
Age: 1.2
Sex: M
Vaccine: DTAP, IPV, PNC, VARCEL
Symptoms: Diet refusal, Erythema, Rash papular
Clinical narrative: Pt got DTA, IPV, PCV, VZV on 8/12/08. Mom noticed 3 red raised bumps on (R) thigh and 1 beside (R) eye on evening of 8/12/08. Child refused supper 8/12 and breakfast and lunch on 8/13/08. No fever, itching or any other problems noted. Mom gave Tylenol 8/12 and 8/13. To give Benadryl and see Pediatrician as needed.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt was called 8-4-08 about lab results and told me that the day after receiving VARIVAX injection 8-2-08 her (R) upper arm was swollen. Site better on 8-4-08.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy, Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash of face, thorax, arms and proximal legs. Exanthem of palate and buccal mucosa. Posterior cervical adenopathy.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Dizziness, Headache
Clinical narrative: Temperature the evening after vaccines 101. The next day 103.6. Headache and dizziness.
Age: 15.0
Sex: M
Vaccine: MNQ, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient was given ZOSTAVAX vaccination in place of VARIVAX vaccination.  No adverse s/s occurred.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Per pt report she developed a fever of 103, had a headache and general malaise approx one hour after being given the injection. She also reports taking Ibuprofen 400 mg. No other treatment received.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 8cm erythematous, swollen, tender area at injection site to left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Local reaction, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Right arm swollen, red, warm, pruritic circumference 21cm vs 17cm left 15cm (shoulder to elbow) centered posterior arm (No systemic symptoms) (probable site of varicella) Localized site reaction
Age: 0.2
Sex: F
Vaccine: UNK
Symptoms: C-reactive protein increased, Full blood count normal, Irritability, Urine analysis normal
Clinical narrative: Severe irritability x 2 days after receiving 2 month shots.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Body temperature increased, Headache, Pain
Clinical narrative: Low grade temperature, "aching all over" HA, stomach pain, up all night Monday went to immediate care Monday night physician prescribed pain med - Hydrocodone; He stated probably symptoms from vaccine
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia, Pruritus generalised
Clinical narrative: Client reports "internal" itching throughout body and joint pain since receiving Hepatitis TWINRIX on 5/22/08. Returned to clinic 8/13/08 with these complaints.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Crying, Pruritus
Clinical narrative: Child c/o severe itching on legs bilat.  Crying uncontrollably.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Local reaction, Oedema peripheral
Clinical narrative: Dad phoned localized reaction to right arm with swelling. Denies drainage. Varicella vaccine given at this site.
Age: 22.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Blood pressure, Dyskinesia, Fall, Gaze palsy, Muscle rigidity
Clinical narrative: Pt received TYPHOID, YELLOW FEVER, and POLIO at 325 PM. At 330, pt became unresponsive and began falling to one side of the chair with rigid extremities and eyes rolled back in his head and tongue protruded. After approximately 3 minutes, pt's color began to come back and pt was responsive and helped into room 1 and on exam table with feet elevated. BP 84/56, pulse faint. After another 5 min, BP 108/70, pulse strong and 80. Pt color returned and pt able to sit up and stated he felt much better. Pt stated this happened to him when blood was taken once. Pt left ambulatory with help with his mom and siblings.
Age: 22.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Pulse pressure decreased, Unresponsive to stimuli
Clinical narrative: Pt received TYPHOID, YELLOW FEVER, and POLIO at 325 PM. At 330, pt became unresponsive and began falling to one side of the chair with rigid extremities and eyes rolled back in his head and tongue protruded. After approximately 3 minutes, pt's color began to come back and pt was responsive and helped into room 1 and on exam table with feet elevated. BP 84/56, pulse faint. After another 5 min, BP 108/70, pulse strong and 80. Pt color returned and pt able to sit up and stated he felt much better. Pt stated this happened to him when blood was taken once. Pt left ambulatory with help with his mom and siblings.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Facial palsy
Clinical narrative: Vaccine recipient developed right facial nerve palsy 24 hours after vaccine administered.  Palsy is persistent now 10 days later.  Not progressing at this time.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm skin & swelling on the injection site + redness on the injection site.  Left deltoid (Tdap).  Size of swelling 30 mm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: 8/7 Mother present with child states noted red/inflamed area after child went swimming; 8/6 - No fever reported. Mother relate child "not fussy - 70mm x 80mm red inflamed area on right deltoid 8/15/08; Mother present with child; reaction cleared - very minimal redness remain. No further problem reported.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: I received the Tdap vacc 7/18/08 approx 10:30am by above person at the time vacc was given I told her this was a very painful shot.  That evening at 9:00pm my arm was swollen, red at injection site and painful to the touch.  Before going to bed that night I had developed a temp of 102 degrees E.  By morning I woke up temp decreased but couldn't move or use arm for 4 days and I felt like I had the flu as well for 4 days.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: I received the Tdap vacc 7/18/08 approx 10:30am by above person at the time vacc was given I told her this was a very painful shot.  That evening at 9:00pm my arm was swollen, red at injection site and painful to the touch.  Before going to bed that night I had developed a temp of 102 degrees E.  By morning I woke up temp decreased but couldn't move or use arm for 4 days and I felt like I had the flu as well for 4 days.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope vasovagal
Clinical narrative: Patient presented at approx 10:10AM to receive a yellow fever shot.  Patient advised that he felt OK before receiving the shot.  Once the shot was given the patient began to sweat, we sat him down in a chair where he lot consciousness for a few seconds.  EMS was called. The patient advised he had not eaten.  He was given water and glucose and transported to medical center.  Patient was released same day back to work.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Syncope, Tremor
Clinical narrative: Patient fainted and fell to ground from standing position approximately 5-8 minutes after vaccination with GARDASIL (HPV) vaccine.  Patient was unconscious for less than one minute.  She shook briefly and yelled out prior to awakening.  Patient had hit front of head on stool when fell.  (Patient was sitting on chair when received vaccine).
Age: 14.0
Sex: F
Vaccine: MEN, TTOX
Symptoms: Hypersomnia, Pyrexia
Clinical narrative: Woke up at 7am the next morning w/ a 101.6 fever.  Ran a temperature off and on all day and slept all day.  No fever the next day but still napped - very unusual behavior for her.  Okay by following day.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Fever 102.9, Dizzy, lightheaded, nausea, HA treated with Tylenol/ibuprofen. Symptoms lasted approx 24 hours
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Flushing, Nasal congestion
Clinical narrative: One hour after vaccines, child returns to clinic c/o extremely stuffy and congested nose, and flushed face.  No chest pain, no wheezing, no edema.  Vital signs - within normal limits.  Gave Benadryl, observation.  Mother requested ER, mother frantic, so 911 was called.  Child was given Prednisone in ER, and discharged home.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis on site of vaccine provider Rxid medication. Child re-evaluated doing better 8/31/08
Sex: U
Vaccine: UNK
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Rash, fever (varicella-like rash).
Age: 37.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, itchy, swollen area around inj. site - 4 inches in diameter - treated with antibiotics & antihistamine.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Skin lesion
Clinical narrative: Rash - scattered lesions - papules on face, head, neck, trunk, arms and legs.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Diarrhoea, Haematochezia, Irritability, White blood cells stool negative
Clinical narrative: Fussy x 1 wk after vaccines (8/5/08), blood in stool x 1 on 8/11/08, "runny stools" x few days.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Fever began at night time. Mom gave Tylenol but it provided no relief. Fever 102.8 per ER report at 00:00 hours. Received Tylenol and Motrin in ER. F/U at PCP in 2 days.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: 8/13/2008, child developed fever and was fussy after receiving 2 month vaccines.  Parents both called nurse advice line at clinic reported symptoms - advised Tylenol.  Went to ER later that next a.m.  8/14/08 baby seems fine now.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Syncope
Clinical narrative: Administered HPV vaccine, had patient wait for a little while afterwards in chair. Parent said she didn't feel well and then she fainted.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Platelet count normal, Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: 5x macular papular rash over trunk, extremities started 8/1/08. Pruritic; Fever. 99deg oral. Tx: Benadryl, Tylenol for sx. Patient finished course of prednisone 7/22/08. Did not inform staff here.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pyrexia, Rash papular
Clinical narrative: Systemic papular rash over upper torso.  Diurnal fevers since injection.  Given antihistamine.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash generalised
Clinical narrative: Pt received Smallpox and Typhoid and Anthrax at 1300 then noticed rash on arm, stomach and back at 1600. Reported to Unit medic and was brought to provider.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC
Symptoms: Crying, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Following immunization today - Patient extreme pain at injection site and leg, redness, edema, hot to touch and constant crying. Fever unknown as he has received doses of Tylenol/Motrin. Reacted a little worse with 1st dose in April - also received PREVNAR in same leg at that time
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Blood pressure, Fall, Head injury, Heart rate normal
Clinical narrative: Patient was given vaccine.  I asked if she felt ok?  She stated that she was fine.  Mom was in room with us.  She was standing there as I had turned my back to get paper work to give mom.  Heard a thump as she fell and bumped head on right side forehead.  She came back too.  Vitals were taken, B/P was 100/76, pulse was 80.  She was taken by a wheel chair to lie down.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Dizziness, Headache, Nausea
Clinical narrative: Elevated temp - dizziness, nauseated, H/A started day after injection and lasted 2 days.  No treatment necessary.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Emotional distress, Hypotonia
Clinical narrative: Gave pt vaccine. As I was pulling needle out of deltoid muscle pt looked at me and stated she felt like she was going to pass out. As she said that pt dropped her head and went limp in chair. Put pt in Trendleberg position and paged doctor. Stat overheard and got cold rag. Mom was by patient side entire time. Pt then woke up emotional and fine and stated she had not eaten that morning. Pt hung around office. Color came back in face and pt was able to walk out of office with mother. Pt called next day to doctor and they said she was fine.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood pressure, Convulsion, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Within 5 minutes after injections the patient fainted and had mild seizure-like activity.  Pt was diaphoretic and incontinent of urine.  The patient regained consciousness and walked to exam table to lie down with RN assistance.  Blood pressures taken twice 15 minutes apart, patient monitored for 30 minutes then released to mother's care.  Patient walked out of clinic.  Patient referred to PCP for follow up care.  Mom states pt had anxiety related to medical treatment and the use of needles.