chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.61
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Injection site warmth, Lymphocyte count increased, Neutrophil percentage increased, Pyrexia, Urinary system X-ray
Clinical narrative: Pt is a 19 mon old little boy who was in the office for wcc and vaccination on 8-29-2008; One day after vaccination (8-30-08), pt began to have vomiting nbnb, ~7times; On the second day (8-31-08) pt had red warm area on Left thigh > right thigh and it felt firm and pt felt like he had a subjective fever; pt went to urgent care for eval that night after fever increased to 102.7. Parents were told that pt had possible cellulitis at site of the injections on the left and was told to take po clindamycin and sent home. Pt continued to vomit and was unable to consistently take po antibiotic; also temp increased to 103. So pt returned to ER on 9-1-08 and was given 1 dose of IV clindamycin for possible cellulitis coverage in Left thigh and had blood testing (cbc/bld cx)  and urine testing and a KUB - all of which parents were told was nl; pt was sent home again. Pt was seen in the PCP office for f/u on 9-2-08.  Pt had a red area on Left thigh-mildly pink area medial area ~3x3 cm and small 8mm nodule in center. no fluctuance; not hot to touch; not consistent with cellulitis.  Pt was not taking po and seemed ill appearing. Pt was still having fevers as well at home (day 4-5 of fevers) so pt was sent for inpatient admission at hospital to try to determine fever origin as leg lesion did not seem to represent cellulitis.  Per parents, inpatient doctors did further testing and gave IV fluids and they diagnosed probable viral syndrome, fat necrosis in thigh, and sent him home as fever had resolved (await inpatient hosp records and final outpt cultures.) 9/9/08-records received for DOS 9/2-9/3/08-DC DX: Fever and abdominal pain now resolved. Fat necrosis with possible cellulitis, status post vaccine now resolved. Most likely viral syndrome gastroenteritis with some dysphagia and feeding difficulty now resolved. The afternoon of August 29, 2008 developed emesis and following day fever up to 102.7, rhinitis. On August 30, 2008 developed erythema around vaccine site on left leg. Unable to keep oral antibiotic down. Developed intermittent abdominal pain, decreased oral intake, did not want to swallow seemed to choke with attempts to eat solids. Urine output decreased. Listless, mild dehydration.
Age: 1.61
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Viral infection, Vomiting, White blood cell count normal, X-ray normal
Clinical narrative: Pt is a 19 mon old little boy who was in the office for wcc and vaccination on 8-29-2008; One day after vaccination (8-30-08), pt began to have vomiting nbnb, ~7times; On the second day (8-31-08) pt had red warm area on Left thigh > right thigh and it felt firm and pt felt like he had a subjective fever; pt went to urgent care for eval that night after fever increased to 102.7. Parents were told that pt had possible cellulitis at site of the injections on the left and was told to take po clindamycin and sent home. Pt continued to vomit and was unable to consistently take po antibiotic; also temp increased to 103. So pt returned to ER on 9-1-08 and was given 1 dose of IV clindamycin for possible cellulitis coverage in Left thigh and had blood testing (cbc/bld cx)  and urine testing and a KUB - all of which parents were told was nl; pt was sent home again. Pt was seen in the PCP office for f/u on 9-2-08.  Pt had a red area on Left thigh-mildly pink area medial area ~3x3 cm and small 8mm nodule in center. no fluctuance; not hot to touch; not consistent with cellulitis.  Pt was not taking po and seemed ill appearing. Pt was still having fevers as well at home (day 4-5 of fevers) so pt was sent for inpatient admission at hospital to try to determine fever origin as leg lesion did not seem to represent cellulitis.  Per parents, inpatient doctors did further testing and gave IV fluids and they diagnosed probable viral syndrome, fat necrosis in thigh, and sent him home as fever had resolved (await inpatient hosp records and final outpt cultures.) 9/9/08-records received for DOS 9/2-9/3/08-DC DX: Fever and abdominal pain now resolved. Fat necrosis with possible cellulitis, status post vaccine now resolved. Most likely viral syndrome gastroenteritis with some dysphagia and feeding difficulty now resolved. The afternoon of August 29, 2008 developed emesis and following day fever up to 102.7, rhinitis. On August 30, 2008 developed erythema around vaccine site on left leg. Unable to keep oral antibiotic down. Developed intermittent abdominal pain, decreased oral intake, did not want to swallow seemed to choke with attempts to eat solids. Urine output decreased. Listless, mild dehydration.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Discomfort, Erythema, Hypoaesthesia, Induration, Paraesthesia
Clinical narrative: Pt has 100mm area of slight erythema and induration that is slightly uncomfortable. Pt describes numbness and tingling in area.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood immunoglobulin M abnormal, Hepatic enzyme increased, Malaise
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated liver enzymes in a 10-year-old female subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline).  Concurrent vaccinations given on 29 July 2008 included the 3rd dose of VARIVAX; Merck; unknown.  On 29 July 2008, the subject received the 1st dose of HAVRIX pediatric (unknown, left arm).  During the same office visit, on 29 July 2008, blood work was taken by the physician.  On 07 August 2008, results of the blood work showed that the subject had elevated alanine aminotransferase (ALT) of 308 (units unspecified, laboratory normal range reported to be between 2 and 40); and elevated aspartate aminotransferase (AST) of 175 (units unspecified, laboratory normal range reported to be between 4 and 35).  Due to the elevated liver enzymes, a hepatic panel was taken on an unspecified date for further evaluation.  On 26 August 2008, the results of the hepatic panel showed that the ALT level of 29 (units unspecified) and AST level of 27 (units unspecified) had returned to normal.  The hepatic panel also showed immunoglobulin M reactivity.  Per the reporting nurse, the mother of the subject stated that the child did not feel well and had been vomiting in mid August (date unspecified).  No treatment has been required for any of these events at the time of reporting.  The subject's mother also provided information that the child had possibly been exposed to the hepatitis a virus via commercial contact at a restaurant, either a couple of days before or after the vaccination with HAVRIX.  Thus, the causality for HAVRIX is not known at the time of this report due to the confounding factor of the possible hepatitis A exposure.  This case was assessed as medically serious by GSK.  At the time of reporting, the outcome of the elevated liver enzymes (ALT and AST) were resolved; the outcome of the vomiting and not feeling well was unknown; and the abnormal blood immunoglobulin M was unresolved.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated liver enzymes in a 10-year-old female subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline).  Concurrent vaccinations given on 29 July 2008 included the 3rd dose of VARIVAX; Merck; unknown.  On 29 July 2008, the subject received the 1st dose of HAVRIX pediatric (unknown, left arm).  During the same office visit, on 29 July 2008, blood work was taken by the physician.  On 07 August 2008, results of the blood work showed that the subject had elevated alanine aminotransferase (ALT) of 308 (units unspecified, laboratory normal range reported to be between 2 and 40); and elevated aspartate aminotransferase (AST) of 175 (units unspecified, laboratory normal range reported to be between 4 and 35).  Due to the elevated liver enzymes, a hepatic panel was taken on an unspecified date for further evaluation.  On 26 August 2008, the results of the hepatic panel showed that the ALT level of 29 (units unspecified) and AST level of 27 (units unspecified) had returned to normal.  The hepatic panel also showed immunoglobulin M reactivity.  Per the reporting nurse, the mother of the subject stated that the child did not feel well and had been vomiting in mid August (date unspecified).  No treatment has been required for any of these events at the time of reporting.  The subject's mother also provided information that the child had possibly been exposed to the hepatitis a virus via commercial contact at a restaurant, either a couple of days before or after the vaccination with HAVRIX.  Thus, the causality for HAVRIX is not known at the time of this report due to the confounding factor of the possible hepatitis A exposure.  This case was assessed as medically serious by GSK.  At the time of reporting, the outcome of the elevated liver enzymes (ALT and AST) were resolved; the outcome of the vomiting and not feeling well was unknown; and the abnormal blood immunoglobulin M was unresolved.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Vomiting
Clinical narrative: Intussusception - reduced by air contrast enema (did not require surgery). Had vomiting/blood in stool - sent to hospital for treatment.  11/7/08 Reviewed hospital medical records of 9/2-9/3/2008. FINAL DX: Intussusception Records reveal patient experienced vomiting & bloody stools x 1 day.  Seen by PCP & was to be sleepy & lethargic. Admitted for observation s/p reduction of IS.  Progressed well & d/c to home.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood culture, Culture wound
Clinical narrative: Patient returned to office with redness and swelling near vaccination site. Patient was given 1 gram of Rocephin DM in the office. Patient went home, was given Benadryl, and returned to office on 9/4/08 for a follow up. Patient was seen on 9/4/2008. Redness increased, and three red abscess were noted in vaccination site. Patient was admitted to hospital to culture abscess for MRSA.   9/19/08 Reviewed hospital records of 9/4-9/5/2008. FINAL DX: cellulitis right leg Records reveal patient experienced right leg injection site warmth, pain, swelling, erythema, difficult to walk.  Similar reaction to past vaccinations.  Improved w/antibiotics & d/c to home on continued oral antibiotics.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blood product transfusion, Platelet count decreased
Clinical narrative: Thrombocytopenia treated with IVIG 10/6/08-records received for DOS 10/1-10/2/08-DC DX: Idiopathic thrombocytopenic purpura. Few days prior to admission developed fever and diagnosed with viral syndrome. Clear rhinorrhea. Night prior to admission developed rash with small red dots and bruising noted. PE: positive petechial rash on face, trunk and extremities with ecchymosis.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Computerised tomogram abnormal, Culture wound negative, Debridement, Injected limb mobility decreased
Clinical narrative: 9/19 PNEUMOVAX IM - R delt.  9/20 - Pt developed severe pain/blister -> adm to hosp -> necrotizing fasciitis -> surgical debridement -> 9/24 wound closure -> persistent pain, decreased ROM.  11/14/08 Reviewed hospital medical records of 9/20-9/25/2007 & 11/2-11/7/2007. FINAL DX: RUE soft tissue infection; surgical debridement & wound closure; complex regional pain syndrome Records reveal patient experienced painful blistering reaction over right deltoid after vaccination.  Taken to OR for debridement or right deltoid/shoulder in 9/2007.  Returned to hospital for increased pain & weakness of right shoulder into the neck, chest & down the arm, fever, chills.  Neuro, rheum & pain consults done.  Improved pain mgt, strength & ROM at d/c to home on continued PT & to f/u w/neuro, rheum & pain clinics. 1/27/2010 Persistent arm pain.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Necrotising fasciitis, Pain, Surgery
Clinical narrative: 9/19 PNEUMOVAX IM - R delt.  9/20 - Pt developed severe pain/blister -> adm to hosp -> necrotizing fasciitis -> surgical debridement -> 9/24 wound closure -> persistent pain, decreased ROM.  11/14/08 Reviewed hospital medical records of 9/20-9/25/2007 & 11/2-11/7/2007. FINAL DX: RUE soft tissue infection; surgical debridement & wound closure; complex regional pain syndrome Records reveal patient experienced painful blistering reaction over right deltoid after vaccination.  Taken to OR for debridement or right deltoid/shoulder in 9/2007.  Returned to hospital for increased pain & weakness of right shoulder into the neck, chest & down the arm, fever, chills.  Neuro, rheum & pain consults done.  Improved pain mgt, strength & ROM at d/c to home on continued PT & to f/u w/neuro, rheum & pain clinics. 1/27/2010 Persistent arm pain.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Child received Tdap Boostrix, Lot #C2770AA instead of Dtap Infanrix Lot #AC14B060AB.  Mother was notified on 09/03/08.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Child received Tdap Boostrix Lot #C2770AA instead of Dtap Infanrix Lot #AC14B060AB.  Mother was notified 09/04/2008.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Child received Tdap-Boostrix lot # C2770AA instead of DTaP Infanrix Lot # AC14B060AB. Mother was notified 09/04/08.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Child received Tdap - BOOSTRIX Lot# C2770AA; Instead of Dtap INFANRIX Lot# AC14B060AB; Mother was notified on 09/08/08
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Child received Tdap-Boostrix Lot # C2770AA instead of DTaP Infanrix Lot # AC14B060AB. Mother was notified on 09/03/2008.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dizziness, Headache, Intensive care, Laboratory test
Clinical narrative: Headache, seizures, fever, dizziness, lupus like syndrome; Started - approximately 4 months after last injection, patient hospitalized several times placed in intensive care unit 11/17/08 records received-for DOS 7/27/08-admitted via ED for C/O abdominal pain for 5 days, no bowel movement in 5 days. Seen by PCP on 7/24/08 with no diagnosis. Seen 2 days prior in ED with negative workup. Signed out AMA. Notes for DOS 8/18/08-DX-Drug-induced lupus, questionable. Possible underlying systemic lupus. Viral syndrome, questionable viral encephalitis. Inflammatory renal disease. Myalgias with possible peripheral neuropathy. Possible reaction to vaccination. Anemia. Elevated erythrocyte sedimentation rate suggesting underlying inflammatory disease. Abdominal pain possibly secondary to renal inflammation. Presented with C/O abdominal pain, intermittent joint and neck pain and headache.Records for 8/30-9/02/08 DC DX: new-onset seizure activity. Possible benign vasculitis to inflammatory vasculitis. Possible cerebral infarct evolving nature with edema involving multiple areas of brain as per MRI. History of lupus positivity possibly drug induced lupus. Questionable viral meningitis with negative CSF. Generalized pain and fatigue. Peripheral neuropathy. Possible meningitis inflammatory nature. Renal failure with reversal. Normal creatinine. Transferred.12/8/08-records received for DOS 9/2-9/12/08-DC DX:PRES. Hypertensive Disorder. Presented with 2 month history of headahces, joint pains, and abdominal pain. Presented to ED 3 days prior with severe headache, vomiting and multiple generalized tonic clonic seizures. Headaches began end of June and diagnosed with sinusitis. Subsequently developed leg aches, wrist aches, joint stiffness and mild rash on legs. Extreme headache, double vision vomiting. Symptoms improved but developed severe stomach pains and constipation.  Improved with Prednisone but symptoms began after Prednisone taper. Rheumatology thinks this is a vasculitis secondary to OCPs. Ophthalmology mild esophoria visible with alternating cover tear. Malignant HTN. Anxiety. Photosensitivity,
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lupus-like syndrome, Pyrexia
Clinical narrative: Headache, seizures, fever, dizziness, lupus like syndrome; Started - approximately 4 months after last injection, patient hospitalized several times placed in intensive care unit 11/17/08 records received-for DOS 7/27/08-admitted via ED for C/O abdominal pain for 5 days, no bowel movement in 5 days. Seen by PCP on 7/24/08 with no diagnosis. Seen 2 days prior in ED with negative workup. Signed out AMA. Notes for DOS 8/18/08-DX-Drug-induced lupus, questionable. Possible underlying systemic lupus. Viral syndrome, questionable viral encephalitis. Inflammatory renal disease. Myalgias with possible peripheral neuropathy. Possible reaction to vaccination. Anemia. Elevated erythrocyte sedimentation rate suggesting underlying inflammatory disease. Abdominal pain possibly secondary to renal inflammation. Presented with C/O abdominal pain, intermittent joint and neck pain and headache.Records for 8/30-9/02/08 DC DX: new-onset seizure activity. Possible benign vasculitis to inflammatory vasculitis. Possible cerebral infarct evolving nature with edema involving multiple areas of brain as per MRI. History of lupus positivity possibly drug induced lupus. Questionable viral meningitis with negative CSF. Generalized pain and fatigue. Peripheral neuropathy. Possible meningitis inflammatory nature. Renal failure with reversal. Normal creatinine. Transferred.12/8/08-records received for DOS 9/2-9/12/08-DC DX:PRES. Hypertensive Disorder. Presented with 2 month history of headahces, joint pains, and abdominal pain. Presented to ED 3 days prior with severe headache, vomiting and multiple generalized tonic clonic seizures. Headaches began end of June and diagnosed with sinusitis. Subsequently developed leg aches, wrist aches, joint stiffness and mild rash on legs. Extreme headache, double vision vomiting. Symptoms improved but developed severe stomach pains and constipation.  Improved with Prednisone but symptoms began after Prednisone taper. Rheumatology thinks this is a vasculitis secondary to OCPs. Ophthalmology mild esophoria visible with alternating cover tear. Malignant HTN. Anxiety. Photosensitivity,
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion, Dizziness, Headache, Laboratory test
Clinical narrative: Headache, seizures, fever, dizziness, lupus like syndrome; Started - approximately 4 months after last injection, patient hospitalized several times placed in intensive care unit 11/17/08 records received-for DOS 7/27/08-admitted via ED for C/O abdominal pain for 5 days, no bowel movement in 5 days. Seen by PCP on 7/24/08 with no diagnosis. Seen 2 days prior in ED with negative workup. Signed out AMA. Notes for DOS 8/18/08-DX-Drug-induced lupus, questionable. Possible underlying systemic lupus. Viral syndrome, questionable viral encephalitis. Inflammatory renal disease. Myalgias with possible peripheral neuropathy. Possible reaction to vaccination. Anemia. Elevated erythrocyte sedimentation rate suggesting underlying inflammatory disease. Abdominal pain possibly secondary to renal inflammation. Presented with C/O abdominal pain, intermittent joint and neck pain and headache.Records for 8/30-9/02/08 DC DX: new-onset seizure activity. Possible benign vasculitis to inflammatory vasculitis. Possible cerebral infarct evolving nature with edema involving multiple areas of brain as per MRI. History of lupus positivity possibly drug induced lupus. Questionable viral meningitis with negative CSF. Generalized pain and fatigue. Peripheral neuropathy. Possible meningitis inflammatory nature. Renal failure with reversal. Normal creatinine. Transferred.12/8/08-records received for DOS 9/2-9/12/08-DC DX:PRES. Hypertensive Disorder. Presented with 2 month history of headahces, joint pains, and abdominal pain. Presented to ED 3 days prior with severe headache, vomiting and multiple generalized tonic clonic seizures. Headaches began end of June and diagnosed with sinusitis. Subsequently developed leg aches, wrist aches, joint stiffness and mild rash on legs. Extreme headache, double vision vomiting. Symptoms improved but developed severe stomach pains and constipation.  Improved with Prednisone but symptoms began after Prednisone taper. Rheumatology thinks this is a vasculitis secondary to OCPs. Ophthalmology mild esophoria visible with alternating cover tear. Malignant HTN. Anxiety. Photosensitivity,
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Breath holding, Syncope
Clinical narrative: 6 month female experienced breath holding spell and syncope.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Erythema, Headache, Local reaction
Clinical narrative: Symptoms - fever, chills, nausea, dizziness, localized, swelling, redness and pain and myalgia, headache. Developed in 22 hours. After vaccination administered; Treatment - supportive treatment - antipyretics (Motrin and Tylenol)
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Symptoms - fever, chills, nausea, dizziness, localized, swelling, redness and pain and myalgia, headache. Developed in 22 hours. After vaccination administered; Treatment - supportive treatment - antipyretics (Motrin and Tylenol)
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Pt fainted after injections.
Age: 13.0
Sex: F
Vaccine: HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood pressure, Dizziness, Feeling hot, Haemoglobin normal, Immediate post-injection reaction
Clinical narrative: The above patient was given vaccines on 8/28/08. After receiving the vaccine the patient began feeling warm and dizziness. The patient was carried to examine room. Patient was noted to be drowsy but responsive. No resuscitation given. Patient awake alert, communicative <5 minutes after returning to area.
Age: 13.0
Sex: F
Vaccine: HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Somnolence
Clinical narrative: The above patient was given vaccines on 8/28/08. After receiving the vaccine the patient began feeling warm and dizziness. The patient was carried to examine room. Patient was noted to be drowsy but responsive. No resuscitation given. Patient awake alert, communicative <5 minutes after returning to area.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Stomatitis
Clinical narrative: Red band encircling arm 2cm above and below site of injection, severe tenderness and area of 1 by 1 cm hardness at site. Pt also developed oral sores resembling canker sores at same time - but sure if related vs a viral illness.
Age: 1.3
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Blister
Clinical narrative: Multiple Vesicles
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood urine present, Body temperature, Full blood count, Granulocyte count decreased, Haemoglobin normal
Clinical narrative: 9/4/08 - arrived in office. Complained of vomiting 2 hours after shot yesterday. And x1 today; nausea, T98.1
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Lymphocyte percentage increased, Monocyte percentage, Nausea, Protein urine present, Specific gravity urine increased
Clinical narrative: 9/4/08 - arrived in office. Complained of vomiting 2 hours after shot yesterday. And x1 today; nausea, T98.1
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urine analysis, Vomiting, White blood cell count normal, pH urine normal
Clinical narrative: 9/4/08 - arrived in office. Complained of vomiting 2 hours after shot yesterday. And x1 today; nausea, T98.1
Age: 9.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Inappropriate schedule of drug administration, Pain, Pyrexia, Rash
Clinical narrative: 9/3/08 - TC c/o low grade fever, rash to face, arms, upper chest, back, body aches x 3 days.  F/u with MD.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Vomiting
Clinical narrative: Pt vomited, pt felt fatigued.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 4 year old male with right arm swelling, itch and pain after receiving vaccines.  Right arm with 11 x 12 cm redness and induration.  Right arm 1.5cm larger than left.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Feeling hot
Clinical narrative: Hot sensation to entire body one hour after last rabies injection. Symptoms lasted two hours.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 3 inch area of erythema, induration and pruritus at site of injection.  Vaccine booster given 32. after initial.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R thigh swelling and redness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Came into clinic for PPD reading.  Patient states left upper arm red, swollen and hot to touch.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Fatigue, Hypotonia, Tremor
Clinical narrative: Head began to shake, spread to body, then became limp and was tired afterward - lasted about 1 min; referred to neurologist.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 2.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 48 hours post vaccination chills with fever 102 degrees (fever lasted 24 hours/and red rash covering entire neck (rash lasted 24 hours).  Child recovered after 24 hours.  Mom did not bring child for Dr to see rash.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient returned to clinic on 08/25/2008 complaining of tenderness on the right upper arm.  The wound was 2 x 3 inches, round, warm, red.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Rt deltoid swollen, red, tender, unable to move arm x2-3 months, used sling at home to prevent pain with movement - reported event/symptoms 9/2/08.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypokinesia, Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial and follow-up information has been received from a healthcare worker and a VAERS form concerning a 76 year old male patient with hyperlipidemia and coronary artery disease (CAD) with no illness at the time of vaccination who on 10-MAR-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 659150/1384U) IM in the left deltoid muscle at 2PM in the afternoon.  Secondary suspect therapy included hydrochlorothiazide (manufacturer unknown).  Concomitant therapy included NIASPAN and K-TAB.  At 5:00 PM on 10-MAR-2008 the patient stated that from the time he received the injection the area started to hurt and by that evening his arm started to swell from his elbow to the top of this shoulder and painful.  It kept him up all night, he also stated he had body aches with it.  The symptoms lasted 2 days.  He did not report it until the third day by then the area was much better but an outline of where the redness had been can be seen.  Three of the physician's staff had seen his arm.  The patient used ice to the site to relieve the swelling and pain. On an unspecified date the patient had recovered.  This is one of 2 reports from the same source. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Insomnia, Pain
Clinical narrative: Initial and follow-up information has been received from a healthcare worker and a VAERS form concerning a 76 year old male patient with hyperlipidemia and coronary artery disease (CAD) with no illness at the time of vaccination who on 10-MAR-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 659150/1384U) IM in the left deltoid muscle at 2PM in the afternoon.  Secondary suspect therapy included hydrochlorothiazide (manufacturer unknown).  Concomitant therapy included NIASPAN and K-TAB.  At 5:00 PM on 10-MAR-2008 the patient stated that from the time he received the injection the area started to hurt and by that evening his arm started to swell from his elbow to the top of this shoulder and painful.  It kept him up all night, he also stated he had body aches with it.  The symptoms lasted 2 days.  He did not report it until the third day by then the area was much better but an outline of where the redness had been can be seen.  Three of the physician's staff had seen his arm.  The patient used ice to the site to relieve the swelling and pain. On an unspecified date the patient had recovered.  This is one of 2 reports from the same source. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, MMR
Symptoms: Aphasia, Eye rolling, Pyrexia, Regressive behaviour
Clinical narrative: Information has been received from a physician concerning a 18 month old female with no pre-existing allergies, birth defects or medical conditions who on 24-MAR-2008 was vaccinated with the first dose of MMR (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 656669/0425U), in the right leg.  On 24-MAR-2008 the patient experienced developmental regression, loss of speech, eye tics and fever, that lasted 1-2 weeks and then the patient resumed with normal developmental milestones.  It was reported that there were no laboratory tests performed.  There was no illness at time of vaccination and no history of adverse events following prior vaccination.  Upon internal review, loss of speech was considered an other important medical event.  Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, MMR
Symptoms: Aphasia, Developmental delay, Pyrexia, Regressive behaviour, Tic
Clinical narrative: Information has been received from a physician concerning a 18 month old female with no pre-existing allergies, birth defects or medical conditions who on 24-MAR-2008 was vaccinated with the first dose of MMR (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 656669/0425U), in the right leg.  On 24-MAR-2008 the patient experienced developmental regression, loss of speech, eye tics and fever, that lasted 1-2 weeks and then the patient resumed with normal developmental milestones.  It was reported that there were no laboratory tests performed.  There was no illness at time of vaccination and no history of adverse events following prior vaccination.  Upon internal review, loss of speech was considered an other important medical event.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Oedema peripheral
Clinical narrative: L arm swollen & decrease sensation.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a patient who had received the 3 dose series of ROTATEQ.  Subsequently the patient developed rotavirus infection and was hospitalized.  It is reported that the patient has not recovered from the event.  No product quality complaint involved.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a pediatrician concerning a 9 week old patient who was vaccinated with the first dose of ROTATEQ.  The patient experienced hematochezia seven days post vaccination with the first dose of ROTATEQ.  "As far as the patient recovering, being hospitalized the Doctor also considered that it could be a milk allergy and had the mother switch the formula so no hospitalizations were reported and no repeat visit to the Doctor's office."  Upon internal review, hematochezia was considered to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with ROTATEQ.  The patient developed intussusception 9 days after the second dose of ROTATEQ and was hospitalized.  It was reported that the patient has recovered (date unknown). No product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Monoplegia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient's injection arm was paralyzed.  The patient was seeing a neurologist.  The outcome of the patient was unspecified.  Upon internal review, the injection arm paralyzed is determined to be an other important medical events.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Immediate post-injection reaction, Tuberculin test
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced seizure right after received the vaccine. Dosing schedule will be discontinued due to the patient's reaction. The had patient recovered. Upon internal review, seizure was determined to be an other important medical event. The test was performed (results not provided). Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: YF
Symptoms: Haemoptysis, Oral disorder, Petechiae, Platelet count decreased, White blood cell count decreased
Clinical narrative: SERIOUSNESS CRITERIA: OTHER- MEDICALLY SIGNIFICANT.  Initial report was received 26 August 2008 from the patient's child, who is also a physician.  A 77-year-old female patient with an unknown medical history had received an injection of Yellow Fever vaccine, lot number VF307AB (lot number invalid) on 11 August 2008 and 11 days later, developed oral lesions and petachia.  Three days later on 25 August 2008, the patient developed hemoptysis and was evaluated at the emergency room.  Laboratory test results revealed her WBC and platelet counts decreased since 11 August 2008.  The patient was not hospitalized.  It was unknown if the patient had any illness at the time of vaccination.  At the time of the report, the patient had not recovered from the event.
Age: 23.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Pregnancy test urine positive, Ultrasound scan abnormal
Clinical narrative: Based upon follow-up information received 29 August 2008, this case was upgraded to serious.  Initial report received on 21 April 2008 from a health care professional.  A 23 year old female patient received on 11 April 2008 an intramuscular left deltoid 0.5 ml injection of ADACEL (lot# C2889AA), and intradermal left forearm 0.1 ml injection of TUBERSOL (lot# C2805AA), a subcutaneous right arm 0.5 ml injection of MMR (Merck, lot# 08656), and an intramuscular right deltoid 0.5 ml injection of ENGERIX (GSK, lot # AHBVB438AA).  It was determined that the patient was pregnant at the time of vaccination.  Her last menstrual period was 04 March 2008 and her expected date of confinement was 09 December 2008.  No prenatal testing was reported.  The patient's past obstetric history included one live full-term birth with no congenital anomalies.  No medical history or current medications were reported.  No adverse event was reported.  Follow-up information was received on 29 August 2008 from a health care professional.  The patient's obstetric history included four prior pregnancies, of which one had been a full term live birth with no congenital anomalies.  It was unknown if the patient had any elective or spontaneous abortions, prior to, or greater than 20 weeks gestation, other than the pregnancy pertaining to the reported event which occurred on 20 April 2008.  The patient had a positive urine pregnancy test on 18 April 2008.  She presented to the emergency room on 20 April 2008 at which time an ultrasound showed an empty uterus - spontaneous miscarriage.  At that time, her HCG was 2857; and had previously been 3071 on 18 April 2008.  According to medical records received, her ultrasound showed no embryonic pole, but there was a positive yolk sac, and the patient was sent home with precautions.  She had significant bleeding when she passed "a lot of stuff" that looked like it may have been tissue.  She had a follow-up evaluation on 08 May 2008 at which time she discussed an interest in birth control.  Her quantitative HCG had been less than 2 at that visit.  Additional test results had been negative for Chlamydia and gonorrhea.  The patient was scheduled to follow-up in two weeks to have an IUD placed.  The patient's recovery status was not reported.  On 09 May 2008, the patient received a second dose subcutaneous injection of MMR, lot number 0040X which was received after the reported event.  The patient has since become pregnant again, and her last menstrual period had been 21 June 2008.  No further information was provided.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Cardiac arrest, Pulse absent, Resuscitation, Unresponsive to stimuli
Clinical narrative: Baby brought to ED by squad.  Found unresponsive at home with no pulse.  Remained in asystole throughout resuscitation attempt.  10/24/2008 Autopsy report states COD as Undetermined, not c/w SIDS; manner of death undetermined.  Report also states pathological diagnoses: pulmonary edema, mild; minor skin injuries to face; small for developmental age by weight & head circumference; and terminal aspiration of gastric contents.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Arthralgia, Headache, Immediate post-injection reaction, Lethargy, Malaise
Clinical narrative: Severe headaches (immed. after 1st course) continuing almost daily.  Joint aches, extreme malaise and lethargy.  (2 visits to eye specialist - reported to physician).  9/23/08 Reviewed PCP medical records & vaccine records.  PCP office called parent for status check as they were unaware of any problems patient had.  Office states patient had severe HA after 1st & 3rd HPV vaccines.  Parent reports patient is completely asymptomatic now.  Eye exam of 12/31/07 reveals clear vision & no pain. 1/26/2010 Headaches have lessend but still occurring.
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Agitation, Attention deficit/hyperactivity disorder, Oppositional defiant disorder, Restlessness, Speech disorder developmental
Clinical narrative: After receiving the vaccines listed below in #13, my son seemed more agitated and less restful, i.e. difficult to get to bed at night or nap. He has currently been diagnosed with symbolic language disorder, ADHD, oppositional defiance. He is currently undergoing speech therapy, behavior therapy, music therapy, early childhood at school, in addition to taking supplements.  9/12/08 Reviewed PCP medical & vaccination records of 8/12/2006-8/21/2008. FINAL DX: Language disorder Records reveal patient experienced speech concerns on day of vaccination using approx 3 words.  Also had patchy eczema at that time.  Ear, uro & allergy consults done prior to vaccination date.  PE tubes placed.  Currently being evaluated for ASD/PDD.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Global amnesia
Clinical narrative: Approximately 24 hrs after rec. the vaccine, an 8 hr period of transient global amnesia occurred.  10/21/08 Reviewed hospital medical records of 8/12-8/14/2008. FINAL DX: no d/c summary available. Records reveal patient experienced dizziness, memory changes & witnessed amnesia.  Neuro consult done which revealed impaired short/long term memory deficits.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Malaise, Pyrexia, Vomiting
Clinical narrative: Fever of 102 degrees F, vomiting, severe headache, malaise.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: One hour after receiving vaccine patient felt sweaty, lightheaded & faint.  Did not pass out.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient developed redness and warmth at site of injections.  No pain, no pruritis.  Patient received Keflex PO x 10 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: ZOSTAVAX administered Monday 8/25/08 1:30pm.  Tuesday had a large welt, 2 1/2"x4 1/2" - red, hot, itchy - Sunday morning faded; today, Mon 9/1/08, have a bruise 1"x2 1/2".  Used 10% cortisone cream, morning + night to alleviate itching.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test urine
Clinical narrative: 15 y/o female clinic visit for update in vaccines received MENACTRA/Hep A/varicella vaccines before (+) pregnancy test.  Date of visit was 8/26/08.
Age: 17.0
Sex: U
Vaccine: HPV4, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Per phone call - sx appeared 7d after injection - mom describes.  Rash that looked like large whelps resembling "ring-worm" - faded away after 5-7d with meds - rash was on back arms - hips.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Chest pain, Dyspnoea, Heart rate normal, Injection site swelling, Local reaction
Clinical narrative: Given both injections ~3:30 P.M 8/18/08.  Left office and mom called about 10 min. later from cell phone to say child c/o chest pain and difficulty breathing.  Came right back to office.  See office notes (attached).  Pt just had NV for immunizations.  Was in the car about to leave the parking lot (not 5-10 minutes later), developed CP associated w/ breathing, mom brought him immediately back to our office.  Never happened b/f - did have a h/o allergies though, and +fam h/o asthma.  On arrival, we brought him to the exam room.  He c/o subjective central CP (not reproducible) but assoc w/ deep breaths.  NO SOB, dizziness, vomiting, tongue swelling, dyspnea.  Appeared comfortable/non-toxic.  On initial exam, he had scant faint exp wheezing but good air movement, no Rtx's or intercostal muscle use.  Good cap refill, pulse 80's-90's & regular, no oroph erythema or swelling.  We gave him a neb tx; he felt much better & remained comfortable throughout.  Lung exam was improved (almost normal to begin with).  We also gave 25 mg po BENADRYL & 40 mg po prednisone in the office.  He stayed here X20-30 minutes for observation & did fine.  Caller: parent called at 2000 on 7;19;2008.  Concerns/Comments: see prior notes on immunization reaction.  Tonight he noted swelling of the arm locally where the injection was given without redness and minimal itching and no pain with use of the arm no CP/SOB.  Probably large local reaction.  Will use ice and TYLENOL and have them call in the AM if not better.  Doctor responded at 20:05 on 7/19/2008.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Given both injections ~3:30 P.M 8/18/08.  Left office and mom called about 10 min. later from cell phone to say child c/o chest pain and difficulty breathing.  Came right back to office.  See office notes (attached).  Pt just had NV for immunizations.  Was in the car about to leave the parking lot (not 5-10 minutes later), developed CP associated w/ breathing, mom brought him immediately back to our office.  Never happened b/f - did have a h/o allergies though, and +fam h/o asthma.  On arrival, we brought him to the exam room.  He c/o subjective central CP (not reproducible) but assoc w/ deep breaths.  NO SOB, dizziness, vomiting, tongue swelling, dyspnea.  Appeared comfortable/non-toxic.  On initial exam, he had scant faint exp wheezing but good air movement, no Rtx's or intercostal muscle use.  Good cap refill, pulse 80's-90's & regular, no oroph erythema or swelling.  We gave him a neb tx; he felt much better & remained comfortable throughout.  Lung exam was improved (almost normal to begin with).  We also gave 25 mg po BENADRYL & 40 mg po prednisone in the office.  He stayed here X20-30 minutes for observation & did fine.  Caller: parent called at 2000 on 7;19;2008.  Concerns/Comments: see prior notes on immunization reaction.  Tonight he noted swelling of the arm locally where the injection was given without redness and minimal itching and no pain with use of the arm no CP/SOB.  Probably large local reaction.  Will use ice and TYLENOL and have them call in the AM if not better.  Doctor responded at 20:05 on 7/19/2008.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever started 1/2 after receiving vaccines 105 at 600pm despite Tylenol. 104.2 When seen office Motrin 50mg given 800pm and wet towel with fan. Temp 103.5
Age: 0.4
Sex: F
Vaccine: PNC
Symptoms: Abnormal behaviour, Cough, Irritability
Clinical narrative: Patient received Prevnar vaccine on 8/1/08.  Within 24 hours, patient stopped all usual babbling and "talking".  Patient was extremely irritable: no sounds, other than coughing, were made until 8/15/08.  On that day, patient's behavior appeared totally normal and has been since.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 12x6cm area redness and swelling with 3x3cm central area erythema.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Swelling
Clinical narrative: 3x3cm area of redness and swelling with 1x1cm area erythema at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had red, warm, swelling over deltoid area where DTAP given.
Age: 80.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Bitten by a bat - Believed to be rabid. Initial shots given at hospital. Received right deltoid shots on 8-13-08 - Additional shots on 8-16-08, 8-20-08 and 8-27-08 - Broke out in hives after taking shot on 8-27-08 - Left arm between elbow and wrist covered in hives described as red circular wheals, near location of the bat bite. Told to take Benadryl.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Local reaction
Clinical narrative: Local erythema right thigh only.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Convulsion, Fatigue, Full blood count, Metabolic function test, Tremor
Clinical narrative: 8/30/2008 Awoke from nap and appeared fatigue, whole body began shaking and convulsing lasted 5 min total. POC took to ED. ED course IV NS Bolus, CBC and BMP drawn, more alert after fluid bolus and patient discharged home with parents.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Bacterial culture, Differential white blood cell count, Full blood count, Nausea, Pyrexia
Clinical narrative: Fever, nausea.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Streptococcal identification test
Clinical narrative: Fever, nausea.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Oedema peripheral, Pruritus, Vomiting
Clinical narrative: Within 10-20 minutes of receiving vaccines, patient complained of itching of both hands.  Hands became so swollen, could not close.  Vomited x2, complained of headache approximately 10 hours later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh warm, sl. swollen, medially red
Age: 1.16
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Abdominal pain upper, Anorexia, Diarrhoea, Fatigue, Immediate post-injection reaction
Clinical narrative: Fussy immediately after immunization, screaming, not sleeping well, diarrhea off and on, off and on fever, stomach pain; Lasted 12-13 days, was tired all the time. Rash in day 13. Loss of appetite.
Age: 1.16
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Screaming, Sleep disorder
Clinical narrative: Fussy immediately after immunization, screaming, not sleeping well, diarrhea off and on, off and on fever, stomach pain; Lasted 12-13 days, was tired all the time. Rash in day 13. Loss of appetite.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Fever 100.2, marked swelling, redness, induration right thigh.  Seen in ER given antibiotics.