chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This non-serious case was received from a health professional on 13 October 2008.  A 12-year-old female patient, with no reported medical history.  An 11-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number U2639AA), a right deltoid intramuscular injection of ADACEL (lot number C2996AA) and a subcutaneous injection of VARIVAX to back of left arm (MERCK, lot number 0443X) on 19 September 2008.  The following day, each of the three administration sites showed a 6cm area that was red, painful and swollen and both arms were aching.  The patient was seen in the doctor's office on 22 September 2008.  The symptoms resolved "in a few days after 9/22/08".  The patient had no other symptoms or reactions.
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This non-serious case was received from a health professional on 13 October 2008.  A 12-year-old female patient, with no reported medical history.  An 11-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number U2639AA), a right deltoid intramuscular injection of ADACEL (lot number C2996AA) and a subcutaneous injection of VARIVAX to back of left arm (MERCK, lot number 0443X) on 19 September 2008.  The following day, each of the three administration sites showed a 6cm area that was red, painful and swollen and both arms were aching.  The patient was seen in the doctor's office on 22 September 2008.  The symptoms resolved "in a few days after 9/22/08".  The patient had no other symptoms or reactions.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Meningitis
Clinical narrative: Information was received from a news broadcast Online (October 29, 2008) reporting that after the first shot of GARDASIL, the patient, an 18 year old female, developed an unknown illness causing migraine-like headaches, coupled with symptoms similar to warning signs of meningitis. Ten days later, while being tested for meningitis in the hospital, she suffered several seizure-like episodes that her neurologist said it was caused by swelling in her brain, which the worst the neurologist said he had ever seen. The neurologist was asked if the patient's reaction could have been caused by GARDASIL and he stated "I can't prove it beyond a shadow of a doubt, but there (was) as much evidence as possible in the medical field to link it." The patient was now bed-ridden and recovering at home. Upon internal review, seizure-like episodes was considered to be an other important medical event. The patient's younger sister also had a similar experience (refer to WAES #0810USA05376). No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bedridden, Brain oedema, Convulsion, Familial risk factor, Meningism
Clinical narrative: Information was received from a news broadcast Online (October 29, 2008) reporting that after the first shot of GARDASIL, the patient, an 18 year old female, developed an unknown illness causing migraine-like headaches, coupled with symptoms similar to warning signs of meningitis. Ten days later, while being tested for meningitis in the hospital, she suffered several seizure-like episodes that her neurologist said it was caused by swelling in her brain, which the worst the neurologist said he had ever seen. The neurologist was asked if the patient's reaction could have been caused by GARDASIL and he stated "I can't prove it beyond a shadow of a doubt, but there (was) as much evidence as possible in the medical field to link it." The patient was now bed-ridden and recovering at home. Upon internal review, seizure-like episodes was considered to be an other important medical event. The patient's younger sister also had a similar experience (refer to WAES #0810USA05376). No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine
Clinical narrative: Information was received from a news broadcast Online (October 29, 2008) reporting that after the first shot of GARDASIL, the patient, an 18 year old female, developed an unknown illness causing migraine-like headaches, coupled with symptoms similar to warning signs of meningitis. Ten days later, while being tested for meningitis in the hospital, she suffered several seizure-like episodes that her neurologist said it was caused by swelling in her brain, which the worst the neurologist said he had ever seen. The neurologist was asked if the patient's reaction could have been caused by GARDASIL and he stated "I can't prove it beyond a shadow of a doubt, but there (was) as much evidence as possible in the medical field to link it." The patient was now bed-ridden and recovering at home. Upon internal review, seizure-like episodes was considered to be an other important medical event. The patient's younger sister also had a similar experience (refer to WAES #0810USA05376). No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Heart rate increased, Orthostatic hypotension, Presyncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 15 year old female patient with no known drug reactions or allergies and medical history who on 10-APR-2007 was vaccinated with first dose of GARDASIL (Lot number not provided) 0.5ml, intramuscularly. There was no concomitant medication. On 18-NOV-2008 she received her second dose of GARDASIL (Lot # 661703/0651X) 0.5ml, intramuscularly. On 19-NOV-2008 the patient developed dizziness, nausea, blurred vision, and a feeling of her legs being "heavy and wobbly". It was reported that the patient had difficulty walking due to wobbly legs. The patient was seen in the office that day and was found to have orthostatic hypotension. Urinalysis was performed to rule out dehydration. The patient was advised to increase liquid intake and to rest. An office visit on 20-NOV-2008 revealed the hypotension improved. The patient contacted the office by phone on 21-NOV-2008 and stated the symptom of "wobbly legs" was resolving. Subsequently, she has completely recovered. The patient's difficulty walking due to "wobbly legs" and orthostatic hypotension were considered disabling by the reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Gait disturbance, Nausea, Orthostatic hypotension, Sensation of heaviness
Clinical narrative: Information has been received from a Registered Nurse concerning a 15 year old female patient with no known drug reactions or allergies and medical history who on 10-APR-2007 was vaccinated with first dose of GARDASIL (Lot number not provided) 0.5ml, intramuscularly. There was no concomitant medication. On 18-NOV-2008 she received her second dose of GARDASIL (Lot # 661703/0651X) 0.5ml, intramuscularly. On 19-NOV-2008 the patient developed dizziness, nausea, blurred vision, and a feeling of her legs being "heavy and wobbly". It was reported that the patient had difficulty walking due to wobbly legs. The patient was seen in the office that day and was found to have orthostatic hypotension. Urinalysis was performed to rule out dehydration. The patient was advised to increase liquid intake and to rest. An office visit on 20-NOV-2008 revealed the hypotension improved. The patient contacted the office by phone on 21-NOV-2008 and stated the symptom of "wobbly legs" was resolving. Subsequently, she has completely recovered. The patient's difficulty walking due to "wobbly legs" and orthostatic hypotension were considered disabling by the reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis, Vision blurred
Clinical narrative: Information has been received from a Registered Nurse concerning a 15 year old female patient with no known drug reactions or allergies and medical history who on 10-APR-2007 was vaccinated with first dose of GARDASIL (Lot number not provided) 0.5ml, intramuscularly. There was no concomitant medication. On 18-NOV-2008 she received her second dose of GARDASIL (Lot # 661703/0651X) 0.5ml, intramuscularly. On 19-NOV-2008 the patient developed dizziness, nausea, blurred vision, and a feeling of her legs being "heavy and wobbly". It was reported that the patient had difficulty walking due to wobbly legs. The patient was seen in the office that day and was found to have orthostatic hypotension. Urinalysis was performed to rule out dehydration. The patient was advised to increase liquid intake and to rest. An office visit on 20-NOV-2008 revealed the hypotension improved. The patient contacted the office by phone on 21-NOV-2008 and stated the symptom of "wobbly legs" was resolving. Subsequently, she has completely recovered. The patient's difficulty walking due to "wobbly legs" and orthostatic hypotension were considered disabling by the reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: L dossal asp. uE 9 x 15 1/2 erythema with 2 cm area increase redness and tiredness centrally warm
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: L dossal asp. uE 9 x 15 1/2 erythema with 2 cm area increase redness and tiredness centrally warm
Age: 19.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, HPV4, MEN, HPV4, MEN
Symptoms: Autopsy, Death, Headache, Malaise
Clinical narrative: Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered "possible seizure" as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient's parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient's mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne.  12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx:  Biaxin.  Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive amount. She had a HA the next day and thought it was from the alcohol. She had a PCN allergy and was a non smoker.   12/11/2008 Records received from PCP.  HPV#1 1/18/2008.  HPV#2 3/28/2008. Vaccines deferred 7/29/2008 2' to oral prednisone usage for acne (with Bactrim).  Seen 8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for vaccines 11/26/2008 in good health with normal exam. Additional record also received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes (one 1 month ago and one on the day of death) of waking up in a cold sweat, having urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt made for ? seizure. Pt did not arrive for appt.  3/3/09 Autopsy report received.  COD:  Unable to ascertain after autopsy, microscopic, toxicologic and chemical evaluation.
Age: 19.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, HPV4, MEN, HPV4, MEN
Symptoms: Death, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered "possible seizure" as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient's parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient's mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne.  12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx:  Biaxin.  Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive amount. She had a HA the next day and thought it was from the alcohol. She had a PCN allergy and was a non smoker.   12/11/2008 Records received from PCP.  HPV#1 1/18/2008.  HPV#2 3/28/2008. Vaccines deferred 7/29/2008 2' to oral prednisone usage for acne (with Bactrim).  Seen 8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for vaccines 11/26/2008 in good health with normal exam. Additional record also received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes (one 1 month ago and one on the day of death) of waking up in a cold sweat, having urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt made for ? seizure. Pt did not arrive for appt.  3/3/09 Autopsy report received.  COD:  Unable to ascertain after autopsy, microscopic, toxicologic and chemical evaluation.
Age: 8.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Feeling cold, Hypersensitivity, Oropharyngeal pain, Pallor
Clinical narrative: Patient c/o feeling cold, pale and pale around lips, pain in throat, abdominal pain, vomiting x 1.
Age: 8.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Vomiting
Clinical narrative: Patient c/o feeling cold, pale and pale around lips, pain in throat, abdominal pain, vomiting x 1.
Age: 8.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Feeling cold, Oropharyngeal pain, Pallor, Vomiting
Clinical narrative: Patient c/o feeling cold, pale and pale around lips, pain in throat, abdominal pain, vomiting x 1.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Dizziness, Fall, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient received HAVRIX, FLUZONE, GARDASIL.  After receiving shots she was sitting on chair and felt really dizzy --> Fell on to floor (+LOC).  She woke up on the floor.  Approximately 5 to 10 after event, no pain,  vitals normal, A&O X3.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Rash generalised
Clinical narrative: 11/27/2008 pt noticed red area at injection site size of a quarter warm to touch and swollen.  C/o rash all over.  Pt advised to put ice pack on area and take BENADRYL which did help when pt got hot and made worse over time 11/27/08 + 11/28/08 + 11/29/08 area went away.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Lacrimation increased, Wheezing
Clinical narrative: 11/20/08, client called to inform County Health Division that after receiving INFLUENZA vaccine at 3:30 pm on 11/19/08. At about 6:30 pm, developed watery eyes, wheezing difficulty breathing and was driven to hosp. ER by a friend. At ER was started on IV fluids, given antihistamine steroids and a breathing treatment. Client was discharged home at 8 pm with a prescription for a steroid x 4 days and prn antihistamine. Client recovered by 11/20/08. Returning to work that AM. Had never had a flu shot previously. Tetanus vacc. 4 mons prior - no reactions.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Client has hardness, redness, swelling, warmth, and itching at VARIVAX injection site- right arm.  Client's mother reports area is the size of her hand.  Client seen by her doctor and BENADRYL recommended and ice to site.
Age: 1.02
Sex: U
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Paraesthesia
Clinical narrative: Nov. 15, 08 developed left upper face and head tingling and tender to touch. Saw her doctor on Nov. 18, 08 and was put on VALTREX. On Nov.21, 08 developed more symptoms on left eye and was put on PREDNISONE for 7 days, also saw 2 opthamologist. As of Dec. 8, 2008 patient was much improved.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Hot flush, Hyperhidrosis, Tremor
Clinical narrative: Within 3 hrs of receiving the vaccine, I began shaking uncontrollably. This lasted weeks. Freezing followed by hot flashes where I would be drenched with perspiration. It is now a month later and I am improving, but still experiencing some symptoms.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician who heard from another physician concerning a female who was in high school and was vaccinated with a dose of GARDASIL. Later on during the day ended up, the patient experienced seizure that lasted almost an hour. After the seizure was under control, the patient was taken the clinic for follow-up where it was determined that the seizure was related to therapy with GARDASIL. The patient's outcome was unknown. Upon internal review, seizure was determined to be an other medical event. No further information is available.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Atelectasis, Chills, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 96 year old female who in October 2008 was vaccinated with PNEUMOVAX (Lot# 662599/1076X, therapy date, route, site unknown).  "In the last 10 days", approximately 19-OCT-2008, the patient developed severe local reactions in the injection arm.  She experienced welts and swelling on the arm.  She also developed a fever and had trouble breathing.  She sought medical attention and was hospitalized for the fever but has since been released.  A lot check is requested for PNEUMOVAX lot # 662599/1076X.  At the time of this report on 29-OCT-2008, the patient was recovering.  This is one of several reports received from the same source.  Follow-up information was received from the physician and medical records that the patient was a 95 year old female with hypertension, anaemia, depression, headache, osteoporosis, hyponatraemia, hypocholesterolaemia and osteoarthritis and a history of cerebrovascular accident and transient ischaemic attack who on 22-OCT-2008 was vaccinated with PNEUMOVAX on left deltoid (Lot# 662599/1076X, therapy route unknown).  Concomitant therapy included NORVASC, aspirin, ZOLOFT, PRILOSEC, XALATAN and multivitamin.  The patient retired and had no smoking or drinking.  On 23-OCT-2008 the patient experienced chills, cough, dyspnea and redness of upper extremity.  She sought medical attention and was hospitalized for 2 days from 23-OCT-2008 to 25-OCT-2008.  At the hospital, the patient was started prior to admission on nitrofurantoin for urinary tract infection.  Discharge summary reported principal diagnosis as "small left pleural effusion atelectasis".  Other diagnoses included: "transient febrile, Pneumovax, Redness of upper extremity status post pneumonia injection, urinary tract infection, hyponatremia, hypertension".  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  No further information is available.  All available medical records will be provided upon request.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypertension, Hyponatraemia, Local reaction, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 96 year old female who in October 2008 was vaccinated with PNEUMOVAX (Lot# 662599/1076X, therapy date, route, site unknown).  "In the last 10 days", approximately 19-OCT-2008, the patient developed severe local reactions in the injection arm.  She experienced welts and swelling on the arm.  She also developed a fever and had trouble breathing.  She sought medical attention and was hospitalized for the fever but has since been released.  A lot check is requested for PNEUMOVAX lot # 662599/1076X.  At the time of this report on 29-OCT-2008, the patient was recovering.  This is one of several reports received from the same source.  Follow-up information was received from the physician and medical records that the patient was a 95 year old female with hypertension, anaemia, depression, headache, osteoporosis, hyponatraemia, hypocholesterolaemia and osteoarthritis and a history of cerebrovascular accident and transient ischaemic attack who on 22-OCT-2008 was vaccinated with PNEUMOVAX on left deltoid (Lot# 662599/1076X, therapy route unknown).  Concomitant therapy included NORVASC, aspirin, ZOLOFT, PRILOSEC, XALATAN and multivitamin.  The patient retired and had no smoking or drinking.  On 23-OCT-2008 the patient experienced chills, cough, dyspnea and redness of upper extremity.  She sought medical attention and was hospitalized for 2 days from 23-OCT-2008 to 25-OCT-2008.  At the hospital, the patient was started prior to admission on nitrofurantoin for urinary tract infection.  Discharge summary reported principal diagnosis as "small left pleural effusion atelectasis".  Other diagnoses included: "transient febrile, Pneumovax, Redness of upper extremity status post pneumonia injection, urinary tract infection, hyponatremia, hypertension".  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  No further information is available.  All available medical records will be provided upon request.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Pleural effusion, Pyrexia, Urinary tract infection, Urticaria
Clinical narrative: Information has been received from a physician concerning a 96 year old female who in October 2008 was vaccinated with PNEUMOVAX (Lot# 662599/1076X, therapy date, route, site unknown).  "In the last 10 days", approximately 19-OCT-2008, the patient developed severe local reactions in the injection arm.  She experienced welts and swelling on the arm.  She also developed a fever and had trouble breathing.  She sought medical attention and was hospitalized for the fever but has since been released.  A lot check is requested for PNEUMOVAX lot # 662599/1076X.  At the time of this report on 29-OCT-2008, the patient was recovering.  This is one of several reports received from the same source.  Follow-up information was received from the physician and medical records that the patient was a 95 year old female with hypertension, anaemia, depression, headache, osteoporosis, hyponatraemia, hypocholesterolaemia and osteoarthritis and a history of cerebrovascular accident and transient ischaemic attack who on 22-OCT-2008 was vaccinated with PNEUMOVAX on left deltoid (Lot# 662599/1076X, therapy route unknown).  Concomitant therapy included NORVASC, aspirin, ZOLOFT, PRILOSEC, XALATAN and multivitamin.  The patient retired and had no smoking or drinking.  On 23-OCT-2008 the patient experienced chills, cough, dyspnea and redness of upper extremity.  She sought medical attention and was hospitalized for 2 days from 23-OCT-2008 to 25-OCT-2008.  At the hospital, the patient was started prior to admission on nitrofurantoin for urinary tract infection.  Discharge summary reported principal diagnosis as "small left pleural effusion atelectasis".  Other diagnoses included: "transient febrile, Pneumovax, Redness of upper extremity status post pneumonia injection, urinary tract infection, hyponatremia, hypertension".  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  No further information is available.  All available medical records will be provided upon request.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Varicella post vaccine, Varicella zoster serology negative, Virus culture negative
Clinical narrative: Information has been received from a published article, title as stated above, from an physician concerning a 4 year old female (case patient 2) with alveolar rhabdomyosarcoma who was vaccinated with VARIVAX (Oka/Merck).  This report was part of a post-marketing surveillance program describing the outbreak of varicella with likely breakthrough disease in a population of pediatric cancer patients receiving treatment for cancer in a healthcare setting with an affiliated group housing facility.  In October 2004, 3 days after the identification of the index subject with possible herpes zoster, the subject presented with papulovesicular lesions on her back, scalp, and trunk.  Her lesions tested negative for VZV by fluorescent antibody test and by viral culture.  She received a diagnosis of varicella on the basis of clinical characteristics and known varicella exposure from the index subject living in the same housing facility.  Subsequently, the subject was admitted to the hospital and given acyclovir therapy.  It was reported that the subject had documented VZV antibody titer prior to exposure, considering likely breakthrough disease (defined as varicella with onset at least 42 days after vaccination).  The subject did not experience any medical complications related to varicella.  At this time, relationship of breakthrough varicella to study therapy is unknown.  Results of the study revealed that in approximately 16 days, varicella had been detected in 7 children (the index case, 5 secondary cases and 1 tertiary case).  Of the 7 identified cases, 4 appeared to be cases of breakthrough disease in previously vaccinated children.  The outbreak resulted in the exposure of 82 families at a pediatric group housing facility, 28 children at the schoolroom and 77 patients, 150 family members, and 9 staff members at 3 outpatient clinics.  This study highlights the important role that breakthrough varicella can play in healthcare centers with affiliated group housing.  Formal recommendations on the management of exposed individuals who have been vaccinated should be made aware in such settings, especially if immunocompromised hosts are present.  This article also discussed the experience of a 3-year-old boy, a 7-year-old boy and a female child while on therapy with VARIVAX (Oka/Merck) (WAES # 0812USA01703, 0812USA01704 and 0812USA01705).  This is one of several reports from the same source.  Additional information has been requested.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab, Varicella post vaccine, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a published article, title as stated above, from a physician concerning a 3 year old male (case patient 5) with acute lymphoblastic leukemia who was vaccinated with VARIVAX (Merck). This report was part of a post-marketing surveillance program describing the outbreak of varicella with likely breakthrough disease in a population of pediatric cancer patients receiving cancer treatment in a healthcare setting with an affiliated group housing facility. In October 2004, approximately 7 days after identification of the index subject, the subject presented with vesicular, crusted lesions on his scalp and shoulders. His lesions tested positive for VZV by fluorescent antibody test. The subject was exposed to varicella through the index subject who had been living in the same housing facility. Subsequently, the subject was admitted to the hospital and given acyclovir therapy. It was reported that the subject had documented VZV antibody titer prior to exposure, considering likely breakthrough disease (defined as varicella with onset at least 42 days after vaccination). The subject did not experience medical complications related to varicella. At this time, relationship of breakthrough varicella to study therapy is unknown. Results of the study revealed that in approximately 16 days, varicella had been detected in 7 children (the index case, 5 secondary cases and 1 tertiary case). Of the 7 identified cases, 4 appeared to be cases of breakthrough disease in previously vaccinated children. The outbreak resulted in the exposure of 82 families at a pediatric group housing facility, 28 children at the schoolroom and 77 patients, 150 family members, and 9 staff members at 3 outpatient clinics. The study highlights the important role that breakthrough varicella can play in healthcare centers with affiliated group housing. Formal recommendations on the management of exposed individuals who have been vaccinated should be made aware in such settings, especially if immunocompromised hosts are present. This article also discussed the experience of a 4-year old female, a female child and a 7-year old boy while on therapy with VARIVAX (Merck) (WAES # 0812USA00618, 0812USA01704 and 0812USA01705). This is one of several reports from the same source. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse through a Merck pregnancy registry concerning an 18 year old female with no pertinent medical history, drug reactions/allergies or concomitant medication use who on 07-NOV-2007 was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of the GARDASIL (lot#656049/0187U). The patient was found to be pregnant post vaccination. Patient sought unspecified medical attention and pregnancy was confirmed with a positive urine pregnancy test. Date of LMP is 30-SEP-2007 and estimate delivery date is 06-JUL-2008. Follow-up information has been received from the nurse, which reported that the patient had a first trimester termination of her pregnancy (date unspecified). The patient was very upset at the unexpected pregnancy and had personal reasons to choose a termination. The reported also stated that it was not chosen because the patient had received the GARDASIL. The patient was fine and did not have any complications. Upon internal review, abortion induced was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Facial palsy, Vaccination complication
Clinical narrative: Individual reported to employer that one week post vaccination expereinced and was diagnosed with Bell's Palsy;  primary care physician indicated that he felt is was related to the influenza vaccination
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient was given PPD Vaccine 0.5ml IM by mistake in the right deltoid. Patient was to receive Tdap 0.5ml IM. Patient was briefed on possible side effects and what to do by Dr.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4, TTOX
Symptoms: Hypoacusis, Hypotension, Immediate post-injection reaction, Monoplegia, Nausea
Clinical narrative: Immediatly following the vaccine of the Gardisil or HPV she lost partial hearing and had leg paralysis. She fainted and felt nauseated. She was excused to leave less than 10 minutes later. Less than 2 hours later the leg paralysis returned as did the fainting and nausea. The ER doctor stated she had severe low blood pressure that could be causing the inability to use her legs.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4, TTOX
Symptoms: Syncope
Clinical narrative: Immediatly following the vaccine of the Gardisil or HPV she lost partial hearing and had leg paralysis. She fainted and felt nauseated. She was excused to leave less than 10 minutes later. Less than 2 hours later the leg paralysis returned as did the fainting and nausea. The ER doctor stated she had severe low blood pressure that could be causing the inability to use her legs.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia, Palpitations, Paraesthesia, Pruritus
Clinical narrative: Day following injection, pt reports feelings of "pounding heart" and shortness of breath. This symptoms resolved same day. When seen in office on 12/8 reporting: no pain but some residual feelings of L arm numbness/tingling  radiating down to fingers - feeling "like her finger are falling asleep."
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Type 2 diabetes mellitus
Clinical narrative: Day following injection, pt reports feelings of "pounding heart" and shortness of breath. This symptoms resolved same day. When seen in office on 12/8 reporting: no pain but some residual feelings of L arm numbness/tingling  radiating down to fingers - feeling "like her finger are falling asleep."
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Headache, Lymphadenopathy, Musculoskeletal pain, Nasal discomfort
Clinical narrative: Experienced high fever(102) x3 days, runny nose, headache, soreness in shoulders, arms, hands and nose. Day three experienced cough, sore throat and swollen lymph glands in neck.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Experienced high fever(102) x3 days, runny nose, headache, soreness in shoulders, arms, hands and nose. Day three experienced cough, sore throat and swollen lymph glands in neck.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Fluvirin .25 was given to this 3 year old.  The vaccine is licensed for 4 years and up.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Diarrhoea, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: 9/1/2008 fever, vomiting and diarrhea; 9/3/2008 had 3 seizures, requiring hospitalization. CT, MRI, EEG all normal. Treated with ativan and phenobarbital initially, now on maintanence phenobarbital.  12/18/08 Reviewed hospital medical records of 9/03-9/07/2008. FINAL DX: new onset seizures Records reveal patient experienced witnessed generalized seizures lasting 1-2 min x 3 on day of admission.  Had concurrent fever, vomiting & diarrhea.  Loaded w/antiseizure meds.  No further seizures in hospital.  D/C to home on continued meds & w/neuro f/u.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: 9/1/2008 fever, vomiting and diarrhea; 9/3/2008 had 3 seizures, requiring hospitalization. CT, MRI, EEG all normal. Treated with ativan and phenobarbital initially, now on maintanence phenobarbital.  12/18/08 Reviewed hospital medical records of 9/03-9/07/2008. FINAL DX: new onset seizures Records reveal patient experienced witnessed generalized seizures lasting 1-2 min x 3 on day of admission.  Had concurrent fever, vomiting & diarrhea.  Loaded w/antiseizure meds.  No further seizures in hospital.  D/C to home on continued meds & w/neuro f/u.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Chills, Full blood count, Headache, Pyrexia, Stomatitis
Clinical narrative: fainted with injectionat 330 pm, in night fever shakes, chills later fever. today HA , fever 102.5 emesis post motrin "mouth feels funny"
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: fainted with injectionat 330 pm, in night fever shakes, chills later fever. today HA , fever 102.5 emesis post motrin "mouth feels funny"
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Induration, Mass, Pain, Pruritus
Clinical narrative: 03dec08 Pt received vaccine, Had Hard lump and pain in area got worse around 20:00. 05dec08 Area of lump around 60mm Pt had extreme pain in area, tenderness, swelling, and itching. 10dec08 pt noticed rash extreme itching area was red swelling and warm to the touch small amount of streaking. Area was about 60mm.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Rash, Skin striae, Skin warm, Swelling, Tenderness
Clinical narrative: 03dec08 Pt received vaccine, Had Hard lump and pain in area got worse around 20:00. 05dec08 Area of lump around 60mm Pt had extreme pain in area, tenderness, swelling, and itching. 10dec08 pt noticed rash extreme itching area was red swelling and warm to the touch small amount of streaking. Area was about 60mm.
Age: 47.0
Sex: U
Vaccine: TTOX
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Rash, Skin warm
Clinical narrative: On Dec 3 2008 I had Tetanus shot on the upper left arm. Pain started at night as I can't sleep on my left side. Left arm pain got worse and can't be touched. On Dec 9th the arm pain was better but pain got into elbow, wrist and fingers. In fact 3 fingers got numb. Could not perform work. Went to see Doctor in the PM. The upper arm area is red (looked like rash) and hot. Doctor could not tell if it is infection or allergic reaction. He gave me antibiotics. The medicine seems to work and today I can type again.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Dizziness, Dyskinesia, Fall, Gaze palsy
Clinical narrative: ABOUT 5-8 MINUTES AFTER CASE RECEIVED TDaP VACCINE SHE FELT DIZZY, SAT DOWN BUT FAINTED AND FELL TO THE FLOOR ANYWAY. MOM DESCRIBES CASES EYES ROLLING IN THE BACK OF HER HEAD, HER BACK ARCHING AND SPASMODIC JERKS OF HER ARMS AND TO A LESSER EXTENT HER LEGS. EPISODE LASTED 5-10 SECONDS THEN SHE WOKE-UP WITH NO MEMORY OF PASSING OUT. AT THAT TIME BP 108/60, HR 72, AND RR 16,NO OTHER VITAL SIGNS WERE DONE. SHE WAS ABLE TO STAND WITHOUT DIZZINESS ABOUT 30 MINUTES LATER, WENT TO AN URGENT CARE CENTER WHERE THEY DID NOT SEE HER BUT REFERRED HER ON TO EMERGENCY ROOM. PT. AND MOM OPTED NOT TO GO TO ER, MOM SAYS SHE IS COMPLETELY RECOVERED NOW AND HAS FOLLOW-UP SCHEDULED WITH HER PEDIATRICIAN.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Muscle spasms, Opisthotonus, Syncope
Clinical narrative: ABOUT 5-8 MINUTES AFTER CASE RECEIVED TDaP VACCINE SHE FELT DIZZY, SAT DOWN BUT FAINTED AND FELL TO THE FLOOR ANYWAY. MOM DESCRIBES CASES EYES ROLLING IN THE BACK OF HER HEAD, HER BACK ARCHING AND SPASMODIC JERKS OF HER ARMS AND TO A LESSER EXTENT HER LEGS. EPISODE LASTED 5-10 SECONDS THEN SHE WOKE-UP WITH NO MEMORY OF PASSING OUT. AT THAT TIME BP 108/60, HR 72, AND RR 16,NO OTHER VITAL SIGNS WERE DONE. SHE WAS ABLE TO STAND WITHOUT DIZZINESS ABOUT 30 MINUTES LATER, WENT TO AN URGENT CARE CENTER WHERE THEY DID NOT SEE HER BUT REFERRED HER ON TO EMERGENCY ROOM. PT. AND MOM OPTED NOT TO GO TO ER, MOM SAYS SHE IS COMPLETELY RECOVERED NOW AND HAS FOLLOW-UP SCHEDULED WITH HER PEDIATRICIAN.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT GIVE PNEUMOCOCCAL VACCINE POLYVALENT 23 0.5 ML IM X 1 DOSE IN ER. PRESENTED 24 HOURS LATER WITH REDNESS AND SELLING AT INJECTION SITE AND DOWN SHOULDER AREA.  GIVE BENADRYL 50 MG PO TID AND SOLU-MEDROL 125MG X 1 DOSE
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral, Pain, Rash, Wrong drug administered
Clinical narrative: Patient received DTaP (5th dose) instead of Td (patient is 9 y.o.). 24 hours post vaccination, patient's father reported extensive limb swelling from shoulder to elbow, rash, heat, pain. No hives or symptoms of respiratory distress. Patient has history of food allergies but no reported contraindications or reactions to prior doses of DTaP.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed rash on hands and feet one hour after vaccine administered. Benadryl 25 mg po and Tylenol 650 mg po given.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dry throat, Hyperhidrosis, Myalgia
Clinical narrative: Employee received flu mist 11/18/08. On 11/23 he relates developed symptoms of dry thraot, cough, and sweats. States developed body aches 11/23/08. Reported to EHOS 12/01.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: Maculo papular rash c/w papular urticaria on back, abdomen and lower extremeties occuring approximately 24 hours after vaccine administration. Also noted to have loose stools.  Treatment with Benadryl 6.25 mg x 1 po then PRN for pruritis q 8 hours with close follow up and referral to Allergy for evaluation for possible egg allergy.
Age: 13.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Blood glucose increased, Full blood count, Platelet count increased
Clinical narrative: Platelet count went from 102,000 to 37,000 two weeks post Flu Mist. Blood Sugars began increasing and remain high. Platelet count 12/8/08 still low at 39,000
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: RECEIVED CHICKENPOX VACCINE 2 DAYS AGO. NOTICED TODAY REDNESS AROUND THE SITE AND WARM TO THE TOUCH. REDNESS MEASURED 4.5CM X 5CM. ALSO COMPLAINED OF PAIN AT INJECTION SITE. ADVIDED SYMPTOMATIC TREATMENT.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Skin hypopigmentation, Skin lesion
Clinical narrative: client noted mild soreness (1 on 0-10 scale) for approximatly 2 days following varicella zoster vaccination at the injection site with no other symptoms.  client's spouse noticed a round lesion on the upper outer aspect of right upper arm approximatly two weeks after date of varicella vaccination.  I observed the lesion in my office on 12-03-2008 to be approximatly 20mm in diameter marked by a 3mm flat band of unpigminted (blanched) skin at upper outer aspect of right arm.  My memory and documentation X2 indicate giving the VZ vaccination at the upper outer aspect of the left arm.  This was also witnessed by a student nurse in the room.  see section 14 MMR vaccine
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Feeling jittery, Injection site induration, Injection site mass
Clinical narrative: After 2nd HPV vaccine patient reported feeling fine for 6 hours, then got excessively sleepy for 2 weeks after and had swollen arm with a large hard lump the size of a golf ball at vaccine admin stie.  At least 1 week after had episodes of feeling faint, dizzy, and shortness of breath.  Felt light-headed and jittery for 2 weeks thereafter.  Self-treated with hot compresses on vaccine site and benadryl.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Somnolence
Clinical narrative: After 2nd HPV vaccine patient reported feeling fine for 6 hours, then got excessively sleepy for 2 weeks after and had swollen arm with a large hard lump the size of a golf ball at vaccine admin stie.  At least 1 week after had episodes of feeling faint, dizzy, and shortness of breath.  Felt light-headed and jittery for 2 weeks thereafter.  Self-treated with hot compresses on vaccine site and benadryl.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Patient recieved Rotateq oral vaccine on 9/23/08 and was taken to Emergency Room on 10/20/08 and was diagnosed with intussception 12/11/08-records received for DOS 10/20-10/21/08-DC DX: Acute intussusception. Presented to ED with projectile vomiting, no passage of bloody or mucous stool.
Age: 0.31
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Patient developed intussusception 12 days after receiving Rotateq. Reduction required surgery. 12/29/08-records received for DOS 11/16-11/19/08-DC DX: Intussusception, status post open reduction.  Presented with intermittent severe episodes of abdominal pain. DC Summary for DOS 11/16-11/19/08-DC DX: Intussusception status post open reduction. Presented with C/O abdominal pain, lethargy.
Age: 0.31
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Gastrointestinal surgery, Intussusception
Clinical narrative: Patient developed intussusception 12 days after receiving Rotateq. Reduction required surgery. 12/29/08-records received for DOS 11/16-11/19/08-DC DX: Intussusception, status post open reduction.  Presented with intermittent severe episodes of abdominal pain. DC Summary for DOS 11/16-11/19/08-DC DX: Intussusception status post open reduction. Presented with C/O abdominal pain, lethargy.