chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Blood culture negative, Culture urine negative, Lumbar puncture normal, Pyrexia, Viral infection
Clinical narrative: Initial report received on 31 January 2007, from other manufacturer. A two month old female patient was enrolled in the prophylactic study that was conducted by the other manufacturer. On 11 July 2006, she received ActHib intra muscular, into the thigh (lot number UE864AA which corresponds to lot number Z0404-2), the first dose rotavirus vaccine  (lot number AROTA033A), and Prevnar, intra muscular into the thigh (lot number AZ5969K). The patients medical history included gastrointestinal reflux disease, since 29 June 2006. She was treated with lansoprazole, 15 mg, orally, from 29 June 2006 to 30 June 2006. On 20 July 2006, nine days post vaccinations and 21 days post first dose of lansoprazole, the patient developed viral syndrome. She had fever (of 3839 Celsius degrees) and was hospitalized. The patient was treated with paracetamol and ceftriaxone sodium (3 doses). Relevant tests on 20 July 2006 included negative lumbar puncture and also negative blood and urine cultures (after 40 hours). No details of relevant assessments were available. On 21 July 2006, she received the second dose of ceftriaxone sodium. The patient was discharged from the hospital on 22 July 2006 after the third dose of ceftriaxone sodium. The event resolved on 22 July 2006. The investigator considered that there was a reasonably possibility that the viral syndrome may have been caused by rotavirus vaccine, Pediarix, Act Hib and Prevnar and that the event was possibly due to the medication lansoprazole and the patients medical condition of the gastrointestinal reflux disease. The investigator also replied that although it was possible that the patient's fever was due to the rotavirus vaccine, he believed that the possibility was quite small and more likely attribute to a viral syndrome. The reporting other manufacturer was requesting more information.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No symptoms, died within 30 days of recieving vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received Pediarix #3. Swollen and red today with elevated pain
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Erythema, Swelling
Clinical narrative: Received Pediarix #3. Swollen and red today with elevated pain
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Dose #3 administered at 2-3pm on 05/22/06.  Onset of symptoms at 8-9pm.  Soreness at injection site, nausea, headache.  Called MD.  MD did not address symptoms.  Contacted Public Health and Env Services.  Advised pt to again contact MD and ask them to report adverse event.  Other details related to vaccine administration unknown.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia
Clinical narrative: Dose #3 administered at 5-5:30pm.  Pt woke up in the middle of the night complaining of bilateral shoulder numbness.  The numbness was gone by morning.  Pt reported info to MD.  MD advised him to report symptoms to Public Health and Env Services.  Advised pt again to ask MD to report symptoms since additional information regarding vaccine administration is unknown.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site pain, Nausea, Pain
Clinical narrative: Dose #3 administered at 2:30-3pm.  Soreness at injection site and then body aches, nausea, and headache at 6am on 05/23/06.  Event reported to MD administering vaccine.  MD advised pt to report to Public Health and Env Services.  Pt again advised to have MD report event since additional details unknown to health department.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Allergy test, Rash
Clinical narrative: 12 mo infant female with history of egg allergy. Confirmed by immunocap testing, received MMRV (ProQuad) and within 20 min developed a non pruritic, blanching rash on lower extremities more on the left leg.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site scab
Clinical narrative: 3 months after getting shot, patients injection site is still scabbing up. It will scab, and the scab will fall off and scab again. Patient reports no fever, no redness, no swelling just the tiny scab, recurring again and again.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Foetal non-stress test, Gestational diabetes, Normal delivery, Pregnancy
Clinical narrative: Initial report received on 11/Jul/2006 from a health care professional. A 31 year old female patient with a past medical history that includes the current pregnancy, allergy to Penicillin, and two previous pregnancies that resulted in the delivery of one normal/viable infant per pregnancy had received a 0.5ml intra muscular dose of Adacel, lot number C2340AA, in the left deltoid, on 11/Jul/2006. The patient had been vaccinated with Adacel for an injury she received to her toe. Her last menstrual period was on 14/Dec/2005. Her expected date of delivery was not provided. Per the reporter, the subject has not experienced any adverse events since the vaccination with Adacel on 11/Jul/2006. Follow up information received on 06 November 2006. The completed Pregnancy report form was received. The patient had the following significant medical conditions. Diabetes Mellitus II, Ovarian cancer and obesity. The date of her last menstrual period was 04 Dec 2005 and her estimated date of delivery was 26 Sept 2006. She had 3 previous pregnancies, 2 of which resulted in live births, with no congenital anomalies and 1 of which resulted in a spontaneous abortion prior to 20 weeks gestation. The patient also exposed to the following drugs. Prenatal vitamins with Iron for an intrauterine pregnancy indication-taken per os at the start of the pregnancy and Zyrtec for an allergy indication taken per os at 20 weeks of the pregnancy. Her current pregnancy history consisted of Group B strep and gestational diabetes mellitus at 34 weeks with normal results. The patient gave birth vaginally on 18 Sept 2006, at 39 gestational weeks, to one female, live child with no congenital anomaly. The child's weight was 5 lbs, 10.8 oz and her length was 18 1/2 inches. Her apgar scores were 8 at 1 minute and 9 at 5 minutes. Follow up information received on 05 January 2007. The baby continues to do well. Follow up information received on 29 January 2007. After internal review, case upgraded to serious status. The patient had 3 ultrasounds and they were all normal. She had gestational diabetes prior to receiving Adacel. Her blood sugar at the time of injection was 81. She is not obese and dose not have ovarian cancer.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan normal
Clinical narrative: Initial report received on 11/Jul/2006 from a health care professional. A 31 year old female patient with a past medical history that includes the current pregnancy, allergy to Penicillin, and two previous pregnancies that resulted in the delivery of one normal/viable infant per pregnancy had received a 0.5ml intra muscular dose of Adacel, lot number C2340AA, in the left deltoid, on 11/Jul/2006. The patient had been vaccinated with Adacel for an injury she received to her toe. Her last menstrual period was on 14/Dec/2005. Her expected date of delivery was not provided. Per the reporter, the subject has not experienced any adverse events since the vaccination with Adacel on 11/Jul/2006. Follow up information received on 06 November 2006. The completed Pregnancy report form was received. The patient had the following significant medical conditions. Diabetes Mellitus II, Ovarian cancer and obesity. The date of her last menstrual period was 04 Dec 2005 and her estimated date of delivery was 26 Sept 2006. She had 3 previous pregnancies, 2 of which resulted in live births, with no congenital anomalies and 1 of which resulted in a spontaneous abortion prior to 20 weeks gestation. The patient also exposed to the following drugs. Prenatal vitamins with Iron for an intrauterine pregnancy indication-taken per os at the start of the pregnancy and Zyrtec for an allergy indication taken per os at 20 weeks of the pregnancy. Her current pregnancy history consisted of Group B strep and gestational diabetes mellitus at 34 weeks with normal results. The patient gave birth vaginally on 18 Sept 2006, at 39 gestational weeks, to one female, live child with no congenital anomaly. The child's weight was 5 lbs, 10.8 oz and her length was 18 1/2 inches. Her apgar scores were 8 at 1 minute and 9 at 5 minutes. Follow up information received on 05 January 2007. The baby continues to do well. Follow up information received on 29 January 2007. After internal review, case upgraded to serious status. The patient had 3 ultrasounds and they were all normal. She had gestational diabetes prior to receiving Adacel. Her blood sugar at the time of injection was 81. She is not obese and dose not have ovarian cancer.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Brain oedema, Headache, Inflammation, Influenza like illness, Leukoencephalomyelitis
Clinical narrative: Progressive flu-like SX. DX with ADEM at Hospital. Significant swelling in brain optic nerve inflamed. Tremors up and down body, Vertigo. (Onset SX end of Dec Cold like SX sinus infection and HA's. MRI, Spinal Tap. Steroids in Hosp x 5 days, still taking Med, will continue x 4 more wk. (Prednisone tapes 30mg to 0).  3/20/07 Received medical records from hospital which reveal patient experienced ataxia & tremor beginning 12/10 w/HA.  Saw PCP & dx w/sinusitis & started antibiotics.  Developed vomiting, dizziness & continued HA & was taken to outlying hospital on 12/24.  CT revealed sinus infection.  On 1/5/07 continued to be dizzy, had tremor & was leaning to right on ambulation.  Readmitted to outlying hospital.  Repeat CT scan showed sinusitis resolved.  D/C to f/u w/PCP.   Saw PCP on 1/8 & had stiff legged walk & was instructed to take to higher level of care hospital if no improvement.  Admitted 1/9/07-1/15/07.  Consults by neuro, optham & ID.  Treated w/high dose steroids.  Improved & d/c to home on tapering steroids to be f/u in neuro & opth clinics. FINAL DX: ADEM & optic neuritis of left eye.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Nasopharyngitis, Nuclear magnetic resonance imaging, Optic nerve disorder, Sinusitis
Clinical narrative: Progressive flu-like SX. DX with ADEM at Hospital. Significant swelling in brain optic nerve inflamed. Tremors up and down body, Vertigo. (Onset SX end of Dec Cold like SX sinus infection and HA's. MRI, Spinal Tap. Steroids in Hosp x 5 days, still taking Med, will continue x 4 more wk. (Prednisone tapes 30mg to 0).  3/20/07 Received medical records from hospital which reveal patient experienced ataxia & tremor beginning 12/10 w/HA.  Saw PCP & dx w/sinusitis & started antibiotics.  Developed vomiting, dizziness & continued HA & was taken to outlying hospital on 12/24.  CT revealed sinus infection.  On 1/5/07 continued to be dizzy, had tremor & was leaning to right on ambulation.  Readmitted to outlying hospital.  Repeat CT scan showed sinusitis resolved.  D/C to f/u w/PCP.   Saw PCP on 1/8 & had stiff legged walk & was instructed to take to higher level of care hospital if no improvement.  Admitted 1/9/07-1/15/07.  Consults by neuro, optham & ID.  Treated w/high dose steroids.  Improved & d/c to home on tapering steroids to be f/u in neuro & opth clinics. FINAL DX: ADEM & optic neuritis of left eye.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Vertigo
Clinical narrative: Progressive flu-like SX. DX with ADEM at Hospital. Significant swelling in brain optic nerve inflamed. Tremors up and down body, Vertigo. (Onset SX end of Dec Cold like SX sinus infection and HA's. MRI, Spinal Tap. Steroids in Hosp x 5 days, still taking Med, will continue x 4 more wk. (Prednisone tapes 30mg to 0).  3/20/07 Received medical records from hospital which reveal patient experienced ataxia & tremor beginning 12/10 w/HA.  Saw PCP & dx w/sinusitis & started antibiotics.  Developed vomiting, dizziness & continued HA & was taken to outlying hospital on 12/24.  CT revealed sinus infection.  On 1/5/07 continued to be dizzy, had tremor & was leaning to right on ambulation.  Readmitted to outlying hospital.  Repeat CT scan showed sinusitis resolved.  D/C to f/u w/PCP.   Saw PCP on 1/8 & had stiff legged walk & was instructed to take to higher level of care hospital if no improvement.  Admitted 1/9/07-1/15/07.  Consults by neuro, optham & ID.  Treated w/high dose steroids.  Improved & d/c to home on tapering steroids to be f/u in neuro & opth clinics. FINAL DX: ADEM & optic neuritis of left eye.
Age: 3.5
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash started one day after receiving flu vaccine. Benadryl was used x 1 day. Rash resolved after 2 days.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2/1/07 Mother reported arm red, hot and swollen at injection site warm compresses applied, office visit-script for Amoxil given.  2/2/07 Office visit for recheck-Benadryl taken. 2/2/07-evening-ER visit-Augmentin and Prednisone started. 2/3/07-Office visit-improvement noted
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Left arm swollen and red, hot to touch, fever of 101. 1/24/07 13x16 cm area of redness, slightly swollen but 1355 not tense. Left upper arm
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abnormal sleep-related event, Barium swallow, Chest X-ray, Dyskinesia, Electroencephalogram
Clinical narrative: Gardasil and Menactra given 1/11/07 beginning 1/22/07 jerking, tremors, shaking episodes occurring only during sleep
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Full blood count, Tremor
Clinical narrative: Gardasil and Menactra given 1/11/07 beginning 1/22/07 jerking, tremors, shaking episodes occurring only during sleep
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Erythema, Feeling hot, Swelling
Clinical narrative: swelling, hot, red
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Tremor
Clinical narrative: 1515-pt presented with complaints of being shaky after having blood drawn in the lab. I administered the flu vaccine im and pt reported he was fine but then experienced syncope so we had him recline with knees up until he had recovered.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1/26/07 redness, swelling at site of injection. Cold-ice pack applied. 1/27/07 larger area of redness, swelling, possible infection-patient went to emergency room
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: 30mmx20mm redness, bruising at the injection site, soreness
Age: 1.0
Sex: M
Vaccine: FLUX, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Incorrect dose administered, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Pt was getting the flu shot and the nurse giving him the injection gave him an adult dose instead of a pediatric dose. The days following the injection he ran high fevers, was irritable and showed swelling in his thigh where the injection was given, also was red and raised
Age: 1.0
Sex: M
Vaccine: FLUX, HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Pt was getting the flu shot and the nurse giving him the injection gave him an adult dose instead of a pediatric dose. The days following the injection he ran high fevers, was irritable and showed swelling in his thigh where the injection was given, also was red and raised
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Local reaction, 2x2 cm of erythematous, tender, warm rash on R arm. Symptomatic treatment.
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Convulsion
Clinical narrative: 8 yo female with history of seizure disorder; seizure free on trileptal for 2 years, had seizure 2 days after receiving Hep A and Influenza
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Lethargy
Clinical narrative: Lethargy
Age: 1.01
Sex: F
Vaccine: MMRV, PNC
Symptoms: Cyanosis, Peripheral coldness, Pyrexia, Rash, Viral myocarditis
Clinical narrative: Information has been received from a physician concerning a 12-month-old female with no pre-existing allergies, birth defects, or medical conditions who on 28-AUG-2006 was vaccinated in the right leg with her first dose of ProQuad vaccine (upgrade process) (lot#654471/0821F). Concomitant therapy that day included Prevnar vaccine (lot# B086S2K). There was no illness at the time of vaccination. There were no adverse reports following prior vaccinations for the patient or siblings. On 11-SEP-2006, the patient developed a fever which lasted for five days and vomited three times. It was reported that the patient developed a three elevated molluscum rashes on the left deltoid and shoulder. The patient turned blue with cold mouth, feet, and hands, and was rushed to the emergency room. On 16-SEP-2006, the patient was pronounced dead. An autopsy was performed and the cause of death was viral myocarditis (life threatening). Additional information has been requested. 2/20/07 Received medical records & autopsy report from provider which reveal patient experienced few molluscum lesions & viral macules on day of vax but was otherwise well.  Seen on 9/16 for fever, rash, vomiting & ear pain for approx 5 days.  Dx w/gastroenteritis & tx symptomatically.  Autopsy Report reveals COD as myocarditis, most likely viral; however, micro studies did not detect virus.  It was felt that the molluscum contagiosum rash was not related to the myocarditis. 3/20/07 Received cardiac path report which reveals lymphocytic myocarditis.  No congenital anomalies or structural damage noted.
Age: 1.01
Sex: F
Vaccine: MMRV, PNC
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 12-month-old female with no pre-existing allergies, birth defects, or medical conditions who on 28-AUG-2006 was vaccinated in the right leg with her first dose of ProQuad vaccine (upgrade process) (lot#654471/0821F). Concomitant therapy that day included Prevnar vaccine (lot# B086S2K). There was no illness at the time of vaccination. There were no adverse reports following prior vaccinations for the patient or siblings. On 11-SEP-2006, the patient developed a fever which lasted for five days and vomited three times. It was reported that the patient developed a three elevated molluscum rashes on the left deltoid and shoulder. The patient turned blue with cold mouth, feet, and hands, and was rushed to the emergency room. On 16-SEP-2006, the patient was pronounced dead. An autopsy was performed and the cause of death was viral myocarditis (life threatening). Additional information has been requested. 2/20/07 Received medical records & autopsy report from provider which reveal patient experienced few molluscum lesions & viral macules on day of vax but was otherwise well.  Seen on 9/16 for fever, rash, vomiting & ear pain for approx 5 days.  Dx w/gastroenteritis & tx symptomatically.  Autopsy Report reveals COD as myocarditis, most likely viral; however, micro studies did not detect virus.  It was felt that the molluscum contagiosum rash was not related to the myocarditis. 3/20/07 Received cardiac path report which reveals lymphocytic myocarditis.  No congenital anomalies or structural damage noted.
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Dizziness, Nausea, Vertigo
Clinical narrative: Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast). The day after vaccination, the patient felt dizzy and lightheaded and experienced nausea. The patient was admitted to the hospital for 2 days. A CT scan performed at the hospital revealed vertigo. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Anaemia haemolytic autoimmune, Blood bilirubin increased, Blood pressure decreased, Coombs direct test negative, Coombs direct test positive
Clinical narrative: It was reported in a published article, title as stated above, that a 12 month old female was vaccinated with a first dose of Varivax vaccine. Suspect vaccination at the same time included a third dose of Pneumovax 23 vaccine (manufacturer unknown). The previously healthy girl presented with an 18-day history of increasing irritability, somnolence, and fever that began shortly after receiving the two vaccinations. Her past medical history included no previous vaccine reactions, surgeries, hospitalizations, or serious illnesses. A physical exam revealed a temperature of 97.8 degrees Fahrenheit, pulse 154, respiration 26, and blood pressure 126/59. She was a pale but playful girl with clear rhinorrhea, normal tympanic membranes, clear lungs, 2/6 lungs, 2/6 systolic ejection murmur, no organomegaly, and no edema. Laboratory tests revealed WBC 10.3, HGB 5.8, retics 4.3 corrected, Tbili 1.5, normal transaminases, direct Coombs' 3+ with warm autoantibodies present. The patient was admitted to the hospital and treated with IV steroids, IVIG, and one transfusion. Eleven days later she was discharged with a HGB of 9.7. Serology three months later revealed adequate IgG antibodies to varicella and a negative direct Coombs' test. She was tapered off steroids over four months, and there have been no relapses of hemolytic anemia in over three years despite subsequent vaccines.  No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Haemoglobin decreased, Haemoglobin increased, Haemoglobin normal, Heart rate increased, Irritability
Clinical narrative: It was reported in a published article, title as stated above, that a 12 month old female was vaccinated with a first dose of Varivax vaccine. Suspect vaccination at the same time included a third dose of Pneumovax 23 vaccine (manufacturer unknown). The previously healthy girl presented with an 18-day history of increasing irritability, somnolence, and fever that began shortly after receiving the two vaccinations. Her past medical history included no previous vaccine reactions, surgeries, hospitalizations, or serious illnesses. A physical exam revealed a temperature of 97.8 degrees Fahrenheit, pulse 154, respiration 26, and blood pressure 126/59. She was a pale but playful girl with clear rhinorrhea, normal tympanic membranes, clear lungs, 2/6 lungs, 2/6 systolic ejection murmur, no organomegaly, and no edema. Laboratory tests revealed WBC 10.3, HGB 5.8, retics 4.3 corrected, Tbili 1.5, normal transaminases, direct Coombs' 3+ with warm autoantibodies present. The patient was admitted to the hospital and treated with IV steroids, IVIG, and one transfusion. Eleven days later she was discharged with a HGB of 9.7. Serology three months later revealed adequate IgG antibodies to varicella and a negative direct Coombs' test. She was tapered off steroids over four months, and there have been no relapses of hemolytic anemia in over three years despite subsequent vaccines.  No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Pallor, Pyrexia, Reticulocyte count increased, Rhinorrhoea, Somnolence
Clinical narrative: It was reported in a published article, title as stated above, that a 12 month old female was vaccinated with a first dose of Varivax vaccine. Suspect vaccination at the same time included a third dose of Pneumovax 23 vaccine (manufacturer unknown). The previously healthy girl presented with an 18-day history of increasing irritability, somnolence, and fever that began shortly after receiving the two vaccinations. Her past medical history included no previous vaccine reactions, surgeries, hospitalizations, or serious illnesses. A physical exam revealed a temperature of 97.8 degrees Fahrenheit, pulse 154, respiration 26, and blood pressure 126/59. She was a pale but playful girl with clear rhinorrhea, normal tympanic membranes, clear lungs, 2/6 lungs, 2/6 systolic ejection murmur, no organomegaly, and no edema. Laboratory tests revealed WBC 10.3, HGB 5.8, retics 4.3 corrected, Tbili 1.5, normal transaminases, direct Coombs' 3+ with warm autoantibodies present. The patient was admitted to the hospital and treated with IV steroids, IVIG, and one transfusion. Eleven days later she was discharged with a HGB of 9.7. Serology three months later revealed adequate IgG antibodies to varicella and a negative direct Coombs' test. She was tapered off steroids over four months, and there have been no relapses of hemolytic anemia in over three years despite subsequent vaccines.  No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Transaminases, Transfusion, White blood cell count increased, White blood cell count normal
Clinical narrative: It was reported in a published article, title as stated above, that a 12 month old female was vaccinated with a first dose of Varivax vaccine. Suspect vaccination at the same time included a third dose of Pneumovax 23 vaccine (manufacturer unknown). The previously healthy girl presented with an 18-day history of increasing irritability, somnolence, and fever that began shortly after receiving the two vaccinations. Her past medical history included no previous vaccine reactions, surgeries, hospitalizations, or serious illnesses. A physical exam revealed a temperature of 97.8 degrees Fahrenheit, pulse 154, respiration 26, and blood pressure 126/59. She was a pale but playful girl with clear rhinorrhea, normal tympanic membranes, clear lungs, 2/6 lungs, 2/6 systolic ejection murmur, no organomegaly, and no edema. Laboratory tests revealed WBC 10.3, HGB 5.8, retics 4.3 corrected, Tbili 1.5, normal transaminases, direct Coombs' 3+ with warm autoantibodies present. The patient was admitted to the hospital and treated with IV steroids, IVIG, and one transfusion. Eleven days later she was discharged with a HGB of 9.7. Serology three months later revealed adequate IgG antibodies to varicella and a negative direct Coombs' test. She was tapered off steroids over four months, and there have been no relapses of hemolytic anemia in over three years despite subsequent vaccines.  No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Swelling face
Clinical narrative: Information has been received from a physician concerning a 5 year old male, with no medical history and no allergies, who in January 2003, was vaccinated with a first 0.5 ml SQ dose of Varivax vaccine (lot#654128/1147F). There was no concomitant medication. It was reported that the patient received a first dose of Havrix vaccine in January 2007. On 27-JAN-2007 the patient developed facial swelling and difficulty breathing. The physician administered epinephrine, Benadryl, and two breathing treatments in the office. The patient was prescribed a course of steroids and fully recovered after two days of treatment, on 29-JAN-2007. No product quality complain was involved. No other information was provided. The reporter considered the patient's experiences to be immediately life-threatening, disabling and an other important medical event. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Decreased appetite, Haematochezia, Mucous stools, Rotavirus test positive, Stool analysis
Clinical narrative: Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who on 18-SEP-2006 was vaccinated with a first 2 ml oral dose of Rotateq vaccine (human-bovine) (lot#"B08682H"). Concomitant vaccinations administered on the same day included a first dose of Pediarix, a first dose of Hib conj vaccine and a first dose of Prevnar. On 17-NOV-2006 the patient was vaccinated with a second 2 ml oral dose of Rotateq (human-bovine) (lot#654352/0410F). Concomitant vaccinations administered on that included a second dose of Pediarix, a second dose of Hib conj vaccine and a second dose of Prevnar. The patient presented to the office on 24-JAN-2007 with bloody stools, decreased appetite, and mucus in her stools. A stool analysis was performed, which was positive for rotavirus. The reporter did not know the patient's status at the time of the report. The patient was not hospitalized. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's bloody stool was considered to be an other important medical event. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site urticaria, Local reaction
Clinical narrative: Large red local reaction and urticaria within 48 hrs of Dtap and HIB vaccines, right leg.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Patient received pneumococcal vaccine on 02/01/2007 im in left upper arm.  On 02/03/2007 receives and warmth at site were noted.  On 02/04/2007 area of redness is enlarged to 10cm wide and 6cm long with a large fluid filled blister present measuring 5cm wide x2.5cm long seeping serous fluid.  Prednisone ordered on 2/4/07.  Neosporin dressings ordered bid to arm on 02/05/2007.
Age: 3.0
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Raised, painful red bump on Lt thigh. Back into office 9 days after immunization given.  Follow-up states raised red wheal on left outer thigh at site of DTaP vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling left deltoid 5x7 cm with redness.  Had swelling right deltoid also-now normal
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: DTap given 8/30/06. 9/1/06 marked swelling, warmth and erythema at injection site-13 cm x 10 cm swelling-treated as bad reaction with Benadryl and Motrin. Started on Keflex 9/2/06
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Loss of consciousness, Nausea, Oedema peripheral, X-ray
Clinical narrative: 16 hrs after administration, very nauseated, passed out in bathroom.  Awoke with lump on head, broken tooth, hematoma on cut lip, chin, bruises on neck, chin, face, breast. Arm was red, swollen.  Lasted about a week.  Dentist had to repair tooth.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Sensation of foreign body, Swelling, Swelling face
Clinical narrative: 1/23/07 Rash-tues-thursday 1/23-1/25 with aching shoulder right arm joint symptoms gone 1/29/07. 1/25/07 joint pain, swelling-shoulders, hands, toes, fingers, knees. (puffiness left side of face.  Feeling a lump in throat when swallowing-gone 1/26/07)
Sex: U
Vaccine: DTAP, HIBV, MMR
Symptoms: Full blood count, Injection site cellulitis, White blood cell count
Clinical narrative: Left thigh cellutlitis r/o abscess, on antibiotics
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: local erythema, entire deltoid
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash generalised
Clinical narrative: Client reports itching on bottom, then entire body approximately 15-30 minutes after receiving rabies pre-exposure vaccine #3. Client reports also to having a rash over body.
Age: 8.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pruritus, Rash papular, Rash vesicular, Varicella
Clinical narrative: Vesicular lesions, mildly itchy 10-15 papular lesions, scalp, face, trunk, buttock. Diagnose: Post vaccine Varicella.
Age: 1.08
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Varicella 20 to 40 lesions, afebrile.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: varicella-approx 45 lesions, afebrile
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Dry skin, Erythema, Pruritus
Clinical narrative: Red spots dry skin itching on arms legs and chest. Monitor.
Age: 46.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Oedema, Pain, Rash, Rash generalised
Clinical narrative: given Rubella booster 1/22/07. c/o Lymphaedema on 1/26/07. 1/29/07-body aches.  2/4/07 noted rash on face.  2/5/07 rash back/abd/arms/legs.  2/6 and 2/7 joint pain (swelling of hands-2/7) 2/9/07-sore, rash gone, swelling gone.  Continue with slight joint pain
Age: 46.0
Sex: F
Vaccine: RUB
Symptoms: Swelling
Clinical narrative: given Rubella booster 1/22/07. c/o Lymphaedema on 1/26/07. 1/29/07-body aches.  2/4/07 noted rash on face.  2/5/07 rash back/abd/arms/legs.  2/6 and 2/7 joint pain (swelling of hands-2/7) 2/9/07-sore, rash gone, swelling gone.  Continue with slight joint pain
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Injection site pain, Skin lesion
Clinical narrative: According to patient, within 12 hours of vaccine adminstration, she began feeling some pain on/around injection site.  Patient examined site and found blistering type of lesion.  Patient presneted back to me 2 days after vaccination was given.  Approx. 10mm blister type lesion noticed lateral to site of injection (approx 25-30cm away from injection site)  Patient states pain was not that bad any more ( 2 days later )  No other signs or sx present.  NKA/NKDA.  No tx given.  Do not know if lesion has resolved yet.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Rash, Rash pruritic
Clinical narrative: client stated that on Wednesday (vaccination done on Monday) rash noticed on forearms, legs (behind knees), and groin.  "Tiny, little rashed spots similar to poison ivy"  Stated had not been outside and had not changed detergent/household cleaning products.  Denies food allergies.  Rash is itchy and has been applying Caladryl lotion--which helps. No other symptoms.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Anaemia, Biopsy bone marrow, Blood test, Blood test abnormal, Chills
Clinical narrative: One Day after receiving Flu shot, my father experienced extreme pain throughout his entire body along with fatigue. Soon after, fevers began with night sweats and chills.  He returned to Dr. who prescribed several antibiotics over the course of weeks with no relief.  Symptoms continued and he was hospitalized at a hospital on 12/20/06 - 12/22/06.  Fevers continued to come and go, mostly at night with sweats and chills.  He continued to loose weight and was anemic.  He changed doctors and began seeing another Dr. who noted there was infection but could not determine the cause.  My father was hospitalized again on 01/17/07 - 01/23/07 and was seen by several doctors and administered several tests but doctors have yet to determine the cause of the infection.  On 02/08/07, he visited with a Dr.  who requested I contact CDC b/c he believes the symptoms are related to his Flu Shot of 11/14/06. His blood work continues to be very abnormal and the muscle fatigue/pain, anemia, and fevers continue. My father has been unable to work since this began and had to unwillingly retire due to above events. He has trouble climbing steps and walking even a small distance.  Prior to this he was very active and completely different.  My father had had prior Flu shots in the past but hadn't had the vaccine in about 4 years. He never experienced any reaction like this.  03/05/2007 MR received from PCP. Multiple OVs from 12/08/2006 to 01/03/2007 for c/o fever. Temp 101.8 on 12/15/06 and 101.1 on 12/29/06.  Fatigue and malaise noted on 12/29/06. DX: FUO.  04/27/2007 MR received for 2 hospital admits 12/20-22/2006 and 1/17-23/2007. Initial admit for c/o cough, generalized aches and weakness. PE: WNL. Prinicipal Dx:  1) Acute Bronchitis. 2)  Malaise/Fatigue.  2nd Admission for c/o fever on and off x 2 months. C/O chills, generalized aches and fatigue. PE: WNL. Principal DX: 1)  Fever of Unknown Origin. 2) Anemia with Thromobocytosis, mild colitis.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Colonoscopy, Computerised tomogram, Fatigue, Gait disturbance, Infection
Clinical narrative: One Day after receiving Flu shot, my father experienced extreme pain throughout his entire body along with fatigue. Soon after, fevers began with night sweats and chills.  He returned to Dr. who prescribed several antibiotics over the course of weeks with no relief.  Symptoms continued and he was hospitalized at a hospital on 12/20/06 - 12/22/06.  Fevers continued to come and go, mostly at night with sweats and chills.  He continued to loose weight and was anemic.  He changed doctors and began seeing another Dr. who noted there was infection but could not determine the cause.  My father was hospitalized again on 01/17/07 - 01/23/07 and was seen by several doctors and administered several tests but doctors have yet to determine the cause of the infection.  On 02/08/07, he visited with a Dr.  who requested I contact CDC b/c he believes the symptoms are related to his Flu Shot of 11/14/06. His blood work continues to be very abnormal and the muscle fatigue/pain, anemia, and fevers continue. My father has been unable to work since this began and had to unwillingly retire due to above events. He has trouble climbing steps and walking even a small distance.  Prior to this he was very active and completely different.  My father had had prior Flu shots in the past but hadn't had the vaccine in about 4 years. He never experienced any reaction like this.  03/05/2007 MR received from PCP. Multiple OVs from 12/08/2006 to 01/03/2007 for c/o fever. Temp 101.8 on 12/15/06 and 101.1 on 12/29/06.  Fatigue and malaise noted on 12/29/06. DX: FUO.  04/27/2007 MR received for 2 hospital admits 12/20-22/2006 and 1/17-23/2007. Initial admit for c/o cough, generalized aches and weakness. PE: WNL. Prinicipal Dx:  1) Acute Bronchitis. 2)  Malaise/Fatigue.  2nd Admission for c/o fever on and off x 2 months. C/O chills, generalized aches and fatigue. PE: WNL. Principal DX: 1)  Fever of Unknown Origin. 2) Anemia with Thromobocytosis, mild colitis.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle fatigue, Night sweats, Pain, Pyrexia, Weight decreased
Clinical narrative: One Day after receiving Flu shot, my father experienced extreme pain throughout his entire body along with fatigue. Soon after, fevers began with night sweats and chills.  He returned to Dr. who prescribed several antibiotics over the course of weeks with no relief.  Symptoms continued and he was hospitalized at a hospital on 12/20/06 - 12/22/06.  Fevers continued to come and go, mostly at night with sweats and chills.  He continued to loose weight and was anemic.  He changed doctors and began seeing another Dr. who noted there was infection but could not determine the cause.  My father was hospitalized again on 01/17/07 - 01/23/07 and was seen by several doctors and administered several tests but doctors have yet to determine the cause of the infection.  On 02/08/07, he visited with a Dr.  who requested I contact CDC b/c he believes the symptoms are related to his Flu Shot of 11/14/06. His blood work continues to be very abnormal and the muscle fatigue/pain, anemia, and fevers continue. My father has been unable to work since this began and had to unwillingly retire due to above events. He has trouble climbing steps and walking even a small distance.  Prior to this he was very active and completely different.  My father had had prior Flu shots in the past but hadn't had the vaccine in about 4 years. He never experienced any reaction like this.  03/05/2007 MR received from PCP. Multiple OVs from 12/08/2006 to 01/03/2007 for c/o fever. Temp 101.8 on 12/15/06 and 101.1 on 12/29/06.  Fatigue and malaise noted on 12/29/06. DX: FUO.  04/27/2007 MR received for 2 hospital admits 12/20-22/2006 and 1/17-23/2007. Initial admit for c/o cough, generalized aches and weakness. PE: WNL. Prinicipal Dx:  1) Acute Bronchitis. 2)  Malaise/Fatigue.  2nd Admission for c/o fever on and off x 2 months. C/O chills, generalized aches and fatigue. PE: WNL. Principal DX: 1)  Fever of Unknown Origin. 2) Anemia with Thromobocytosis, mild colitis.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: One Day after receiving Flu shot, my father experienced extreme pain throughout his entire body along with fatigue. Soon after, fevers began with night sweats and chills.  He returned to Dr. who prescribed several antibiotics over the course of weeks with no relief.  Symptoms continued and he was hospitalized at a hospital on 12/20/06 - 12/22/06.  Fevers continued to come and go, mostly at night with sweats and chills.  He continued to loose weight and was anemic.  He changed doctors and began seeing another Dr. who noted there was infection but could not determine the cause.  My father was hospitalized again on 01/17/07 - 01/23/07 and was seen by several doctors and administered several tests but doctors have yet to determine the cause of the infection.  On 02/08/07, he visited with a Dr.  who requested I contact CDC b/c he believes the symptoms are related to his Flu Shot of 11/14/06. His blood work continues to be very abnormal and the muscle fatigue/pain, anemia, and fevers continue. My father has been unable to work since this began and had to unwillingly retire due to above events. He has trouble climbing steps and walking even a small distance.  Prior to this he was very active and completely different.  My father had had prior Flu shots in the past but hadn't had the vaccine in about 4 years. He never experienced any reaction like this.  03/05/2007 MR received from PCP. Multiple OVs from 12/08/2006 to 01/03/2007 for c/o fever. Temp 101.8 on 12/15/06 and 101.1 on 12/29/06.  Fatigue and malaise noted on 12/29/06. DX: FUO.  04/27/2007 MR received for 2 hospital admits 12/20-22/2006 and 1/17-23/2007. Initial admit for c/o cough, generalized aches and weakness. PE: WNL. Prinicipal Dx:  1) Acute Bronchitis. 2)  Malaise/Fatigue.  2nd Admission for c/o fever on and off x 2 months. C/O chills, generalized aches and fatigue. PE: WNL. Principal DX: 1)  Fever of Unknown Origin. 2) Anemia with Thromobocytosis, mild colitis.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Eczema, Herpes simplex, Oral mucosal blistering
Clinical narrative: Shingles vaccine 12/04/06.  Developed pain in breast an back end of 06; horrible and severe chafe like and shooting pain under arm on 01/10/07.  Dermatologist Asadi dx excema, prescribed Elidil, no help.  Internist who ordered vaccine seen on 01/31/07, couldn't rule out.  Prescribed Valtrex-but too late for Valtrex.  Dermatologist Pyring who conducted study on shingles seen 02/09/07 prescribed Lidocaine patch.  Unable to wear bra. Developed fever blister on mouth 02/07.  Pain continues.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin irritation
Clinical narrative: Shingles vaccine 12/04/06.  Developed pain in breast an back end of 06; horrible and severe chafe like and shooting pain under arm on 01/10/07.  Dermatologist Asadi dx excema, prescribed Elidil, no help.  Internist who ordered vaccine seen on 01/31/07, couldn't rule out.  Prescribed Valtrex-but too late for Valtrex.  Dermatologist Pyring who conducted study on shingles seen 02/09/07 prescribed Lidocaine patch.  Unable to wear bra. Developed fever blister on mouth 02/07.  Pain continues.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Fatigue, Oedema peripheral, Pyrexia, Screaming
Clinical narrative: fever above 103, repeated high pitched screaming for hours followed by extreme sleepiness for 2.5 days loss in appetite, swollen leg, tired, not interested in playing for 5 days
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Somnolence
Clinical narrative: fever above 103, repeated high pitched screaming for hours followed by extreme sleepiness for 2.5 days loss in appetite, swollen leg, tired, not interested in playing for 5 days
Age: 0.0
Sex: M
Vaccine: MMRV
Symptoms: Headache, Infection, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: MOTHER NOTIFYED NURSE AT IHS CLINIC OF THURSDAY 02/07/2007 THAT CHILD HAD A HARD,RED HOT SILVER DOLLAR SIZE LUMP WITH RED STICKS EXTENDING DOWN TO ELBOW AT INJECTION SITE, ALSO C/O HA. UNABLE TO GET TO IHS CLINIC IN LAMME DEER,MT. SO TAKEN TO CLINIC IN COLSTRIP MT. MOTHER INFORMED NURSE AT LAME DEER CLINIC THAT CHILD HAD AN INFECTION AND WAS PUT ON CLYDAMYCIN.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Petechiae
Clinical narrative: 14 y/o girl had distal swelling of both hands with erythema and some petechiae within one day of receiving 1st dose of gardasil.  No other symptoms.  Mother gave benadryl
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration
Clinical narrative: 7 cm x 7 cm reddened area slightly indurated on Rt. deltoid
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed hives all over his body and was very itchy within 48 hours.  Benadryl given, itching subsided, hives resolved.  Slept next am, had few residual hives on abdomen and back.  Around 8-9 pm next night, developed hives again which were worse, Benadryl given, same occurance the following night.  No shortness of breath or difficulty breathing, MD notified.
Age: 13.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site warmth, Swelling
Clinical narrative: L arm red swollen and warm. 1.5 x 1.5
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: R deltoid red swollen and warm 3x3.5 cm  L deltoid red swollen warm 1.5 x 2
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Redness, swelling pain L arm 3 in x 2 in length
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Screaming
Clinical narrative: Inconsolable crying and screaming for hours (don't remember exactly how many, but all afternoon and evening) after receiving 2 month vaccinations.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, MMR, PPV
Symptoms: Measles, Pruritus, Pyrexia, Rash
Clinical narrative: He received the MMR Vaccine on January 29th. On Tuesday, February 6th he developed a 101 degree fever which did not let up until middle of the night on Thursday February 8th. Then on the morning of February 8th, he developed a rash that has now covered his entire body. It started out light and has gotten worse. They are measle like bumps all over. I did speak to our doctor and he did reassure us that this was a side effect. I am not sure how long this will take to subside but hopefully not long. His behavior for the most part is normal, he is just itchy.