chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site warmth, Oedema
Clinical narrative: From initial information received from a health care professional, regarding an adverse event occurring in the USA, it was reported that a 5 year old female patient received Daptacel vaccination, lot number C1698AA, administered intra muscularly in the right thigh on 08/11/2004. Some time after the vaccination, onset date illegible on source document, it was reported that the patient developed a swollen, red, indurated area over her right anterior thigh that was warm to the touch. The patient was placed on antibiotics for Cellulitis with allergic reaction to DTaP. Reportedly the patient also developed a temperature. Reportedly the patient recovered from this experience. From additional information received on 10/11/2004 from a health care professional,  the patients full name,address and telephone number were provided. Reportedly the patient received her fourth dose of IPOL, lot number 409030, administered intramuscularly in the left thigh as well as her second dose of MMR, lot number 0101N, manufactured by Merck, administered intramuscularly in the right thigh in addition to Daptacel on 08/11/2004. The patient experienced the above mentioned symptoms the next day, on 08/12/2004. Symptoms resolved with Keflex regimen on 08/16/2004. The reporter of this case is the same reporteer for cases 200402938, 200402947, 200402948, 2004002949, and 200402950. From additional information received on 11/12/2004 from the initial reporter, the IPOL lot number was confirmed as 904030, which is not an Aventis lot number. No further information is anticipitated, this case is considered closed.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Musculoskeletal stiffness
Clinical narrative: From initial information received on 09/03/2004 from a health care professional, regarding an adverse event occurring in the USA, it was reported that a two month old female patinet received her first dose of IPOL vaccine, lot number X1040 administered in the right leg, her first dose of  Daptacel vaccine, administered in the left leg, her first dose of Prevnar, manufacturer Lederle, administered in the right leg and her first dose of Comvax, manufacturer Merck, administered i/n the left leg on 09/02/2004. Reportedly after the fourth injection the patient became quiet and her leg stiffened, no other adverse events reported. The father of the patient picked her up and the patient was acting "normal" The patients recovery status is currently unknown. From additional information recevied on 11/01/2004 from the initial reporter it was reported that the patient received the vaccinations between ten and eleven on the morning of 09/02/2004. The patient was vaccinated at a private doctors office and the vaccine purchased with private funds.
Age: 1.72
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Oedema
Clinical narrative: From initial information recieved on 10/01/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 20 month old male patient received a dose of Daptacel, lot number C1663AA, administered in the left leg on 09/21/2004 at 9:30 am. Route of administration was not reported. The following day, the patient develoeped a lumb under skin at hte site of injection measuring approximately five to six millimeters in diameter with secondary inflammatory reaction. The patient was seen by a physician on 09/30/2004 and was also noted to have a cold. Physical examination revealed a small firm pen dot, most likely non-tender just distal to the spot representing the site of injection. Physicians impression was that of an upper respiratory infection with a lump likely due to the shot with secondary inflammatory reaction. Pediacare was predscribed for upper respiatoratory infection and cough as needed. No treatment was provided for the lump. Reportedly, the patinet recovered from these events. From additional information received on 11/29/2004 from a health care professional, it was reported , "Reviewed, no additional information at this time" No further information is anticipated, this case is considered closed.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Oedema
Clinical narrative: From initial information received on 11/19/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a six month old female patient received her third dose of Daptacel, lot number C1700AA, administered in the right thigh, a dose of IPOL, lot number X1212, administered in the left thigh, a dose of Comvax (haemophilus B conjugate + Hep B) lot number 0567P, manufacturer Merck, administered in the right thigh and a dose of Prevnar, lot number A57562A, Manufacturer Lederle, administered in the left thigh on 11/16/2004. Routes of administration were not reported. Two days later, the patient developed redness and edema on bilateral thighs, but primarily on her right thigh, as reported by patients mother. The patient has no known allergies. It is unknown if whether she recovered from these events. The reporter of this case is the same reporter as cases 200403769, 200403770, 200403771, 200403772, and 200403773.
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Lymphadenopathy
Clinical narrative: From initial infomation received on 11/22/2004
Sex: M
Vaccine: DTAP
Symptoms: Injection site vesicles
Clinical narrative: From initial information received on 08/14/2004 from the patients mother regarding an adverse event occurring in the U.S.A., it was reported that a 17 month old male patient received his fourth dose of Daptacel administered on an unspecified date. The lot number, route, and site of administration were not reported. Sometime after the administration the patient developed blisters around the injection site. The patient's mother states she's not concerned as the event has resolved. The child was not seen by a physician. She has requested that the facility that administered the product not be contacted.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Bacterial infection, Drug ineffective, Immunoglobulins decreased
Clinical narrative: From initial information received on 3/9/05 from a licensed practical nurse regarding an adverse event occurring in the USA, it was reported that a six month old female received her third dose of DAPTACEL, lot number C1625AA, administered on 3/18/04. The route and site of administration were not reported. 315 days later, at 15 months of age, the patient was diagnosed with no IgG and pertussis. Previous Daptacel vaccination dates reported included 11/5/03 and 12/20/03 with no reactions reported. The patient also has a 13 year old brother, who was diagnosed with pertussis on 1/4/05. It was not reported whether the patient recovered from this event. The reporter of this case is the same reporter as case 200500532. (OMIC)
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Bacterial infection, Drug ineffective
Clinical narrative: From initial information received on 3/9/05 from a licensed practical nurse regarding an adverse event occurring in the USA, it was reported that a five year old patient (gender not reported) received a dose of DAPTACEL, lot number C1625AA, administered on 3/15/04 as a five year booster dose. The route and site of administration were not reported. Nine months later, in December of 2004, the patient was diagnosed with pertussis. The patient previously received a booster dose of DTaP, lot number 467674, at 15-18 months of age with no reactions reported. It is unknown how many doses the patient received in the past as the child was not a patient at the reporting facility. It is unknown whether the patient recovered from this event. The reporter of this case is the same reporter as case 200500531. (OMIC)
Age: 1.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site rash, Pruritus, Rash vesicular
Clinical narrative: Vesicular rash to right wrist and both knees. Itching, no fever, no sign of pain, no breathing difficulty. Slight rash to both thighs near vaccine administration site.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash, treated with Benadryl as needed.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Breast pain, Influenza like illness, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Same day of vaccination: pain and swelling Next day: more pain and swelling, body aches, hives, runny nose, arm pit swelling and severe pain, left breast swelling and pain,  Day three: fever, pain, body pain and feeling of flu Day four: Less swelling, still pain and low fever  On day two: seen in ER given vicoden and naproxen, told to use hot packs,,told the vaccine seeped into left lymph node..follow up with Doctor. I could not receive ordinarily given RX due to my comprimised immune system...
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Rhinorrhoea, Urticaria
Clinical narrative: Same day of vaccination: pain and swelling Next day: more pain and swelling, body aches, hives, runny nose, arm pit swelling and severe pain, left breast swelling and pain,  Day three: fever, pain, body pain and feeling of flu Day four: Less swelling, still pain and low fever  On day two: seen in ER given vicoden and naproxen, told to use hot packs,,told the vaccine seeped into left lymph node..follow up with Doctor. I could not receive ordinarily given RX due to my comprimised immune system...
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Bradycardia, Hypotension, Stupor, Syncope
Clinical narrative: Patient received her 4 year old vaccinations during her well child visit on 3-11-05 and had a hypotensive, hyporesponsive, bradycardic syncopal event 10 minutes after receiving the vaccinations.  Patient was transported to the ED.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient recieved vaccine in right hip on 3/14/05.  Within the next 24 hours she developed erythema, tenderness, just below the site.  This area grew to about 5 inches in diameter and has hard.  Within 96 hours the hardness and tenderness was relieved and the erythema was shrinking
Age: 1.5
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Lethargy, Pneumonia, Pyrexia, Rash, Rash morbilliform
Clinical narrative: 3/9/05  Receives vaccinations for MMR, DaTP, and Varicella. She has an ear infection without fever and Dr assures it is ok for vaccination. 3/10/05  starts antibiotics for ear (amoxicillan) 3/13/05  becomes very lethargic and feels feverish. 3/14/05 -  has 103 degree fever underarm.  Very unhappy.  Motrin helps for a little while. 3/15/05 - breaks out with a rash near her hair line and spreads down her torso.  Red & raised bumps.  Last day with a fever 3/16/05 - Rash worse. Take her to Dr. who diagnoses her with a measles rash and pneumonia They change antibiotics to Zithromax.  Ear looks better, but a little fluid remains. 3/17/05 - is still very ill and unhappy.  Rash is no longer raised, but still present as flattened discoloration. 3/21/05 - is finally well enough for daycare.
Age: 1.5
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Skin discolouration
Clinical narrative: 3/9/05  Receives vaccinations for MMR, DaTP, and Varicella. She has an ear infection without fever and Dr assures it is ok for vaccination. 3/10/05  starts antibiotics for ear (amoxicillan) 3/13/05  becomes very lethargic and feels feverish. 3/14/05 -  has 103 degree fever underarm.  Very unhappy.  Motrin helps for a little while. 3/15/05 - breaks out with a rash near her hair line and spreads down her torso.  Red & raised bumps.  Last day with a fever 3/16/05 - Rash worse. Take her to Dr. who diagnoses her with a measles rash and pneumonia They change antibiotics to Zithromax.  Ear looks better, but a little fluid remains. 3/17/05 - is still very ill and unhappy.  Rash is no longer raised, but still present as flattened discoloration. 3/21/05 - is finally well enough for daycare.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site induration, Skin nodule, Swelling
Clinical narrative: 03/09/05:  Received 6 month shots on Tuesday, March 8, 2005 at 10:45am.  Mother of child noticed child's leg (left thigh) swollen with palpable nodule under skin at 8:00 pm.  Leg remains swollen with induration today.
Age: 1.37
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Nausea, Vomiting
Clinical narrative: Patient developed a severe case of shingles on the left side of the stomach. Had nausea, vomiting and severe pain. This happened when we were visiting relatives. She was diagnosed and treated by some doctor up there. She was sick for about two weeks.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Cough, Irritability, Oral intake reduced, Rash
Clinical narrative: Chicken pox vaccine given 2/23/05, child sick (cranky and unwilling to eat) 2/25/05 PM.  2/26/05 AM - runny nose and cough started, still unwilling to eat.  Runny nose, cough and poor appetite continued and she started with a rash that appeared to be chicken pox 3/1/05 (2 or 3 spots), she continued to get more blisters (40 or more total) under her diaper, on her belly and on her face over the next 2 weeks. She was started on Augmentin 3/7/05 for an ear infection and changed to Zithromax 3/14/05.  There have been no new blisters seen since ~3/16/05 and the blisters she still has appear to finally be going away.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Chicken pox vaccine given 2/23/05, child sick (cranky and unwilling to eat) 2/25/05 PM.  2/26/05 AM - runny nose and cough started, still unwilling to eat.  Runny nose, cough and poor appetite continued and she started with a rash that appeared to be chicken pox 3/1/05 (2 or 3 spots), she continued to get more blisters (40 or more total) under her diaper, on her belly and on her face over the next 2 weeks. She was started on Augmentin 3/7/05 for an ear infection and changed to Zithromax 3/14/05.  There have been no new blisters seen since ~3/16/05 and the blisters she still has appear to finally be going away.
Age: 28.0
Sex: M
Vaccine: TTOX
Symptoms: Dyspnoea, Rash, Swelling
Clinical narrative: The patient was administered the tetanus toxoid vaccine as a part of routine immunization care.  Whithin 2 hours after administration of the vaccine the patient displayed difficulty breathing, swelling, and a rash subsequently developed.  The patient was rushed to a local emergency room for treatment in which the patient received treatment with corticosteroids, antihistamines, albuterol inh., and calamine lotion.
Age: 0.74
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Vaccine administered at 3 p.m., hives started showing up that evening.  Remained the same over the next 24 hours, worsened 48 hours later to cover entire trunk, face, and neck.  No improvement noted 10 days later.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Vomiting
Clinical narrative: VACCINES ABOUT 2:30PM. BABY STARTED CRYING "NON-STOP" ABOUT 3PM - NOT NORMAL CRYING. VOMITED A FEEDING AT ABOUT 6:45PM, STILL CRYING. MOM PHONES DOCTOR AND ADVISED TO HAVE BABY EVALUATED IN E.D. TONIGHT. CRIED TOTAL 4-5 HOURS WAS FINE WHEN E.D. PHYSICIAN SAW HER.  1 5YR OLD BROTHER, NEVER ANY PROBLEMS W/ VACCINE.
Age: 1.23
Sex: M
Vaccine: DTAP, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Spiked fever on 3-4-05 to 102.6 degrees - seized x 2, each one lasting 20-25 minutes.  Additional siezure on 3-6-05 lasting 5 minutes.  Seen in the ER each time - Tylenol and Motrin were given.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Aspartate aminotransferase increased, Bacterial infection, Blood bilirubin increased, Cough, Drug ineffective
Clinical narrative: Patient was administered 4 doses of Prevnar vaccine between 4/8/02 and 1/31/03. Unfortunately, he acquired a severe streptococcal pneumonia with empyema (serotype 19). He was hospitalized for 3 weeks. Required artificial ventilation and chest tube placement. Disease acquired 2/8/05; vaccine failure. 3/24/05-Reviewed d/c summary and the principal diagnosis was listed as respiratory failure/pneumonia. Secondary diagnoses were listed as empyema in lungs, acute renal failure, sepsis, and narcotic withdrawal (due to prolonged use of Fentanyl patches).  Four days prior to admission, he went to the emergency room with a temperature of 103. He had significant cough, congestion and some emesis typically following his cough. He had decreased urine output over the two days prior to admission, decreased appetite and was very fussy and tired. Mom had recently had the flu.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Hypoxia, Immunoglobulins decreased, Laboratory test abnormal, Pleural effusion, Pneumonia
Clinical narrative: Patient was administered 4 doses of Prevnar vaccine between 4/8/02 and 1/31/03. Unfortunately, he acquired a severe streptococcal pneumonia with empyema (serotype 19). He was hospitalized for 3 weeks. Required artificial ventilation and chest tube placement. Disease acquired 2/8/05; vaccine failure. 3/24/05-Reviewed d/c summary and the principal diagnosis was listed as respiratory failure/pneumonia. Secondary diagnoses were listed as empyema in lungs, acute renal failure, sepsis, and narcotic withdrawal (due to prolonged use of Fentanyl patches).  Four days prior to admission, he went to the emergency room with a temperature of 103. He had significant cough, congestion and some emesis typically following his cough. He had decreased urine output over the two days prior to admission, decreased appetite and was very fussy and tired. Mom had recently had the flu.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Renal failure acute, Respiratory failure, Sepsis
Clinical narrative: Patient was administered 4 doses of Prevnar vaccine between 4/8/02 and 1/31/03. Unfortunately, he acquired a severe streptococcal pneumonia with empyema (serotype 19). He was hospitalized for 3 weeks. Required artificial ventilation and chest tube placement. Disease acquired 2/8/05; vaccine failure. 3/24/05-Reviewed d/c summary and the principal diagnosis was listed as respiratory failure/pneumonia. Secondary diagnoses were listed as empyema in lungs, acute renal failure, sepsis, and narcotic withdrawal (due to prolonged use of Fentanyl patches).  Four days prior to admission, he went to the emergency room with a temperature of 103. He had significant cough, congestion and some emesis typically following his cough. He had decreased urine output over the two days prior to admission, decreased appetite and was very fussy and tired. Mom had recently had the flu.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Anorexia, Bacterial infection, Chills, Constipation, Disorientation
Clinical narrative: Loss of bladder control, dizziness, mild fever, disorientation, loss of appetite, constantly fatigued, uncontrolled shaking, chills, loss of muscle control. Per follow up report received on 06/01/2005:  Patient was hospitalized for 5 days and had to continue antibiotic another 10 days.  Patient also developed urosepsis, but did recoverd. Information from discharge summary states constipation, bacterial infection, urinary tract infection. msv. Information from medical records states hypovolemia, hypokalemia
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Fatigue, Hypokalaemia, Hypovolaemia, Laboratory test abnormal
Clinical narrative: Loss of bladder control, dizziness, mild fever, disorientation, loss of appetite, constantly fatigued, uncontrolled shaking, chills, loss of muscle control. Per follow up report received on 06/01/2005:  Patient was hospitalized for 5 days and had to continue antibiotic another 10 days.  Patient also developed urosepsis, but did recoverd. Information from discharge summary states constipation, bacterial infection, urinary tract infection. msv. Information from medical records states hypovolemia, hypokalemia
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Leukocytosis, Myopathy, Pyrexia, Tremor, Urinary incontinence
Clinical narrative: Loss of bladder control, dizziness, mild fever, disorientation, loss of appetite, constantly fatigued, uncontrolled shaking, chills, loss of muscle control. Per follow up report received on 06/01/2005:  Patient was hospitalized for 5 days and had to continue antibiotic another 10 days.  Patient also developed urosepsis, but did recoverd. Information from discharge summary states constipation, bacterial infection, urinary tract infection. msv. Information from medical records states hypovolemia, hypokalemia
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Urinary tract infection
Clinical narrative: Loss of bladder control, dizziness, mild fever, disorientation, loss of appetite, constantly fatigued, uncontrolled shaking, chills, loss of muscle control. Per follow up report received on 06/01/2005:  Patient was hospitalized for 5 days and had to continue antibiotic another 10 days.  Patient also developed urosepsis, but did recoverd. Information from discharge summary states constipation, bacterial infection, urinary tract infection. msv. Information from medical records states hypovolemia, hypokalemia
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Hypokinesia, Laboratory test abnormal, Overdose
Clinical narrative: Information has been received from a consumer concerning her daughter who has no known drug reactions/allergies and a history of high mercury levels who was vaccinated IM with a dose of MMR. It was reported that the patient had a similar vaccination schedule (exact vaccinations not provided) as her brother which included HIB conjugate vaccine, diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid, HIB conjugate vaccine, poliovirus vaccine live oral, diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid, varicella virus vaccine live and hepatitis B vaccine. It was reported that the vaccines were thimerosal free. Subsequently, the patient developed autism with motor and behavioral problems and was hospitalized. Lab diagnostic studies included: baby teeth analyzed for mercury content the result of which was 240 ppb, and chelating therapy to measure urine levels of mercury, results not reported. It was reported that the patient's mother's family has a genetic abnormality that prevents them from removing mercury from the body. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. The patient's autism was considered to be disabling. The patient's brother (WAES0503USA01200) had a similar experience after vaccination with MMR. Additional information is not expected.
Sex: M
Vaccine: DTAP, HEP, HIBV, HIBV, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Drug toxicity, Hypokinesia, Laboratory test abnormal
Clinical narrative: Information has been received from a consumer concerning her son who has no known drug reactions/allergies and a history of high mercury levels, suicide attempt at 7 years old, numbness in extremities and motor control issues who was vaccinated IM with a dose of MMR. Concomitant vaccination included HIB conjugate vaccine, diphtheria toxoid (+) pertussis acellular 4 component vaccine (+) tetanus toxoid, HIB conjugate vaccine, poliovirus vaccine live oral, diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid, varicella virus vaccine live and hepatitis B vaccine. It was reported that some vaccines were thimerosal free. Subsequently, the patient developed autism with motor and behavioral problems and was hospitalized. Lab diagnostic studies included: baby teeth analyzed for mercury content the result of which was 3040 PPB, and chelating therapy to measure urine levels of mercury, results not reported. It was reported that the patient's mother's family has a genetic abnormality that prevents them from removing mercury from the body. At the time of the report, the patient had not yet recovered. There was no product quality complaint involved. The patient's autism was considered to be disabling. The patient's sister (WAES0503USA01574) had a similar experience after vaccination with MMR. Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Hypokinesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a licensed visiting nurse and a 47 year old Hispanic male physician with no allergies or medical conditions, concerning his own experience, who on 12/3/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). There was no illness at the time of vaccination. On 12/4/04, the physician developed cellulitis with redness, swelling and tenderness of left arm from upper deltoid injection site and around to armpit. The nurse reported that the physician was treated with cool compresses and recovered the morning of 12/6/04. There was no product quality complaint involved. Follow up information from the physician indicated that he had cellulitis of the left arm with a 3cm diameter of induration, paresthesia of the left hand, left shoulder pain, decreased left arm mobility and pain with the decreased function. Amoxicillin (+) clavulanate potassium antibiotic was started and there was resolution of the cellulitis in 5 days. It was reported that the patient was recovered. The physician considered the experienced an other important medical event (OMIC). Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Pain, Paraesthesia, Shoulder pain
Clinical narrative: Information has been received from a licensed visiting nurse and a 47 year old Hispanic male physician with no allergies or medical conditions, concerning his own experience, who on 12/3/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). There was no illness at the time of vaccination. On 12/4/04, the physician developed cellulitis with redness, swelling and tenderness of left arm from upper deltoid injection site and around to armpit. The nurse reported that the physician was treated with cool compresses and recovered the morning of 12/6/04. There was no product quality complaint involved. Follow up information from the physician indicated that he had cellulitis of the left arm with a 3cm diameter of induration, paresthesia of the left hand, left shoulder pain, decreased left arm mobility and pain with the decreased function. Amoxicillin (+) clavulanate potassium antibiotic was started and there was resolution of the cellulitis in 5 days. It was reported that the patient was recovered. The physician considered the experienced an other important medical event (OMIC). Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Abortion, Dysmenorrhoea, Laboratory test abnormal, Medication error, Unintended pregnancy
Clinical narrative: This 15 year old female subject was enrolled in a blinded study for the prophylaxis of genital herpes disease and herpes simplex virus type 2 infection in healthy pre-teen and adolescent females. The subject received single dose IM injection of blinded study vaccine in the left deltoid on 8/4/04, 8/30/04, and on 1/10/05. Lot numbers were not provided. The subject had been randomized to receive the active control in this study, a marketed formulation of Havrix vaccine containing 320 ELISA units of hepatitis A antigen + 0.25mg aluminum in 0.5ml. On 2/16/05, this 15 year old female presented to the emergency room reporting symptoms of a possible sexually transmitted disease. All tests for STD's were negative. A urine pregnancy test was positive. Subject's last menstrual period was on 1/20/05 and the estimated date of delivery was 10/28/05. On 2/26/05, 47 days after the third investigational product, the subject experienced bad cramping and vaginal bleeding. She was taken to a nearby clinic where spontaneous abortion was diagnosed. The spontaneous abortion was considered to be medically significant (OMIC). A dilatation and curettage was performed under anesthesia. The gestation age at the time of the spontaneous abortion was four weeks. She was discharged home with prescriptions for unspecified antibiotics, pain medication, and a laxative. The events resolved on 2/26/05 after 1 day. On 3/7/05, subject had follow up visit at clinic and underwent dilatation and curettage. Subject's mother reported she was fully recovered. The investigator considered there was reasonable possibility that the spontaneous abortion may have been caused by investigational product. The investigator also considered the event to be possibly associated with a natural history of early pregnancies.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Vaginal haemorrhage
Clinical narrative: This 15 year old female subject was enrolled in a blinded study for the prophylaxis of genital herpes disease and herpes simplex virus type 2 infection in healthy pre-teen and adolescent females. The subject received single dose IM injection of blinded study vaccine in the left deltoid on 8/4/04, 8/30/04, and on 1/10/05. Lot numbers were not provided. The subject had been randomized to receive the active control in this study, a marketed formulation of Havrix vaccine containing 320 ELISA units of hepatitis A antigen + 0.25mg aluminum in 0.5ml. On 2/16/05, this 15 year old female presented to the emergency room reporting symptoms of a possible sexually transmitted disease. All tests for STD's were negative. A urine pregnancy test was positive. Subject's last menstrual period was on 1/20/05 and the estimated date of delivery was 10/28/05. On 2/26/05, 47 days after the third investigational product, the subject experienced bad cramping and vaginal bleeding. She was taken to a nearby clinic where spontaneous abortion was diagnosed. The spontaneous abortion was considered to be medically significant (OMIC). A dilatation and curettage was performed under anesthesia. The gestation age at the time of the spontaneous abortion was four weeks. She was discharged home with prescriptions for unspecified antibiotics, pain medication, and a laxative. The events resolved on 2/26/05 after 1 day. On 3/7/05, subject had follow up visit at clinic and underwent dilatation and curettage. Subject's mother reported she was fully recovered. The investigator considered there was reasonable possibility that the spontaneous abortion may have been caused by investigational product. The investigator also considered the event to be possibly associated with a natural history of early pregnancies.
Age: 34.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Diarrhoea, Facial palsy, Hypoaesthesia, Vomiting
Clinical narrative: Vomiting and Diarrhea for 1-2 weeks:  October 14, 2004 and February 8, 2005.  Facial paralysis and numbness on left side/prednisone and valtrex.
Age: 34.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Diarrhoea, Fatigue, Mood swings, Nausea, Somnolence
Clinical narrative: Vomiting and Diarrhea for 1-2 weeks:  October 14, 2004 and February 8, 2005.  Facial paralysis and numbness on left side/prednisone and valtrex.
Age: 34.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Vomiting
Clinical narrative: Vomiting and Diarrhea for 1-2 weeks:  October 14, 2004 and February 8, 2005.  Facial paralysis and numbness on left side/prednisone and valtrex.
Age: 1.34
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Erythema, Pruritus, Skin ulcer
Clinical narrative: Generalized Erythematous Papular lesions with crusting in different stages of healing.  Varivax administered 17 days ago on clinic visit on 02/28/2004.  Treatment:  Calamine lotion and Benadryl 12.5mg every 6 hours as needed for itching.
Age: 1.03
Sex: F
Vaccine: DTAP, FLU3, MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Approximately 9 PM on 02/22 had possible seizure (unconscious, eyes rolled back, generalized jerking, lasted 3-4 minutes) went to ER when found to be febrile without specific site of infection.  Influenza screen, CBC, Electrolytes, Glucose, BUN, Creatine, Ca, all normal, UA Urine and Blood Cultures negative; diagnosis was acute febrile illness with febrile seizure.  Released home without specific treatment except antipyretics.
Age: 1.13
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Dysphagia, Irritability, Rash papular, Urticaria
Clinical narrative: On 02/25/2005 infant had hives around DTAP site- right leg and also on face.  Also, had some difficulty swallowing and had non-stop fussing and crying, per Mom.  Taken to ER that same evening, he was given a dose of Tylenol and a dose of Atarax in the ER for what was described as a vesiculopapular rash and discharged that same evening with no acute distress.
Age: 1.1
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth
Clinical narrative: Received PCV7, HIB in left thigh, and flu shot in right thigh.  MMR in right arm subcutaneously, and VAR in left arm subcutaneously.  Immediately after vaccines given, nurse noticed a dollar sized reddened area at injection site.  Two inches in size on both arms extending to elbow, warm to touch on both arms.  Baby had no signs of Physical assessment done in ER.  Vital signs normal, pulse ox 98%.  No treatment needed.  Diagnosis:  Allergic reaction resolved.  Referred to Pediatrician.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Paraesthesia, Pruritus, Tachycardia, Throat tightness
Clinical narrative: Tachycardia, parasthesia (up and down the line) 10 minutes after injection.  Heart rate 112 and irregular, 3 minutes later patient complained of tightness in her throat.  Patient refused ambulance transfer to ER. Medical records state warm, itching, reaction aggreviated. msv
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vasodilatation
Clinical narrative: Tachycardia, parasthesia (up and down the line) 10 minutes after injection.  Heart rate 112 and irregular, 3 minutes later patient complained of tightness in her throat.  Patient refused ambulance transfer to ER. Medical records state warm, itching, reaction aggreviated. msv
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Erythema, warmth, swelling.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis left arm, given keflex for 5 days.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Depressed level of consciousness, Pyrexia, Tremor
Clinical narrative: Severe shaking spell with decreased responsiveness. No loss of consciousness.   Given 6 month immunizations earlier that day at noon, including DTAP #3, HIB #3, PCV #3, Hep B #2.  Episode occurred same evening, went to ER, had fever.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR
Symptoms: Convulsion
Clinical narrative: Mother reported seizure like episode in PM on 03/10/2005, duration approximately 2-3 minutes.  Recovered without incident, 03/11/2005.  Better no problems, no temperature.  (Reported 03/11/2005)
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Influenza like illness, Muscular weakness
Clinical narrative: 02/23/2005-Next day headache, dizzyness, weak grip, flu-like symptoms. 02/24/2005- Saw Dr., says better but still had flu-like symptoms.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: Immunizations given. 2-3 hours after shots, began inconsolable crying for 5-6 hours then stopped.
Age: 0.77
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Fever to 103 degrees Fahrenheit starting 48 hours after vaccine administation.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Decreased appetite, Somnolence
Clinical narrative: Very sleepy decreased eating for approximately 20 hours.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Dyskinesia, Screaming, Staring
Clinical narrative: Mother called the health dept because  was to bring infant for accelerated schedule stated that child had a reaction form last vaccines a month ago. Stated child cried for more than 3 hours, but thought it was because the child was teething. Stated she finally took a bottle and fell asleep during the night, but when the child awaken she had a blank stare and did not respond to verbal stimuli and had jerky movements of hands and feet. Took infant to the emergency room and was given Motrin. Stay there and the child was better. The ER physician stated that the reaction was from the vaccines. Is to see own physician per request.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Pain
Clinical narrative: This was a difficult give-she felt tight but it was the fully accessible correct site. She was due for her routine 10 year Td booster. She tolerated injection well though she said it hurt like "the dickens" Good comfort measures. Spoke with EE about other issues 02/28 and 03/01 she made no mention on 03/03 she came in c/o severe pain and unable to move arm well. No visible irritation to site-Referred for medical follow up. In Process?
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oedema, Oedema peripheral
Clinical narrative: 2days later, left arm and shoulder were swollen, erythematous, warm and painful.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Abasia, Neck pain, Pain
Clinical narrative: After receiving tetanus on 02/28/2005, child woke up on morning of 03/01/2005 with complaints of neck pain, generalized pain, unable to walk, has been to ER and Dr office with no definate diagnosis.
Age: 36.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Back pain, Hypokinesia, Neck pain, Shoulder pain
Clinical narrative: Patient c/o cervical neck pain- on right side of spine 1 1/2 days after receiving Twinrix. Pain starts at base of skull and radiates down to shoulder blades. Pain agitated by raising right arm or turning head. Pain persisted 2-3 weeks.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness, erythema, below injection site, fever, given Keflex for Cellulitis.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: On 02/009/05, eleven days after vaccination client noted a quarter sized red, raised, warm tender lump at the back of left arm at about the the injection site, which subsided slowly over the next week. On 02/15/05, another lesion cropped up on the opposite arm, described as dime size but the same. No vesicules noted.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccinations on 05/23/05 at 9:42 am. She received a DTaP and IPV vaccine IM in her left deltoid and one MMR SQ above the left elbow. The next afternoon (5:00 PM) her mother said she noticed the arm was becoming hard, swollen, red and hot, especially in the area of the DTaP vaccination. She did not contact a doctor because she said it takes too long to get an appointment but treated her with Mortin. Monday morning, she brought the child back to the clinic. By Monday, the redness, swelling and warmth had moved down to the top surface of her forearm and Mom stated that it was much better than it had been on Friday and Saturday, when there was a larger painful, red, swollen area on the deltoid. Mom said this was the first time patient has had a reaction and none of her two siblings have experienced one. She has no other known allergies. Mom said she has not received any more vaccines than the ones listed on the card: the recommended four DTaP ( the last in April 2001), three IPV (the last in October 2000) and one MMR (April 2001). We told her to watch patient and call her doctor if she had any more concerns or problems.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Pain, Pruritus
Clinical narrative: Mother noticed reaction 20 minutes after vaccination. Itchy area, hot and  pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain
Clinical narrative: Patient had erythema, pain, swelling of 8" diameter on the right upper extremity, after right deltoid injection. Apparent cellulitis.
Age: 25.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Abortion spontaneous, Unintended pregnancy
Clinical narrative: Patient did not know she was pregnant when she received her second MMR. She miscarried at 7.5 weeks.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, erythema, near injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Rash erythematous
Clinical narrative: 5cm x 7cm well circumferenced erythematous rash.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left deltoid red, hard and swollen. Began to turn red 4 to 5 hours after injection. Was seen in office arm swollen and red from shoulder to elbow. Place on Keflex 250 mg PO for 10 days. Also given Clarinex.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Developed cellulitis on right deltoid.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema induratum
Clinical narrative: Developed large area of erythema and induration of right thigh within 24 hours of receiving DTaP #5.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Photosensitivity reaction
Clinical narrative: Rash. Was on a field trip when rash started, only where his skin was exposed. Benadryl was given.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Diagnosed with Varicella. Received Varivax 08/18/2000.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Diagnosed with varicella, recevied Varivax 04/12/1996
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth
Clinical narrative: Red, warm, swollen left deltoid. 10cm. cool compress.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis left arm from elbow to shoulder. Heat, itching, and erythema.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Nonspecific reaction
Clinical narrative: Pt had moderate to DTaP. About 10x12mm
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Nonspecific reaction
Clinical narrative: Pt has large reaction DTaP about 12x12cm.
Age: 1.03
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Rash all over body, Erythema.
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia
Clinical narrative: 02/11/2005-9:30 am Received p/c from mom child running temperature after receiving immunizations on 02/08/2005. Temp checked today at 9:25 am 104 degrees Fahrenheit rectally. Mom started giving 0.8ml Tylenol T.I.D. Ms Wanjohi givning reduced dosage. Mom to give 1-2ml per protocal. Give fluids. Re-check temp in 1 hour if still increased to to MD and notify clinic. 02/11/2005-t/c from mom said temp decreased to 101.0 fahrenheit and child is playing.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site atrophy
Clinical narrative: Bruising followed by atrophic changes injection site. Referral to ped neurologist following consult with pediatrician. Changes included SC and muscle tissue. No strength ROM or Reflex changes.
Age: 23.0
Sex: M
Vaccine: MEN, TYP, VARCEL
Symptoms: Hypertension, Oedema, Pruritus
Clinical narrative: Had been given typhoid, meningococcal and chicken pox. About 16 mins later. Pt c/o swelling hands and itching. No redness, no hives, no bruising sores. BP 140/90, HR 80 RR18, Watch for next 2hrs, pt better no issues.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Cellulitis, Erythema, Oedema
Clinical narrative: Right upper thigh mild erythema with swelling and streaking extending to knee, cellulitis.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Left upper arm red, itchy and raised wheal after injection. Mom took child to clinic for evaluation by MD. States left clinic after 1/2 hour, all s/s disappeared resolved called 03/07/05 no concerns.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Pt received Varivax 4/29/04 and had break through of 5 lesions after exposure.
Age: 1.04
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt received Varicella vaccine 5/22/03. Pt has developed chicken pox lesions as of 3/05.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Swelling and erythema covering the entire left deltoid, mild point tenderness.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Malaise, Pyrexia
Clinical narrative: On 02/03/05 mother informed me that infant had a fever and was very sick about one week after I had given immunizations. Mom also stated that infant was coughing for 6 weeks but is finally better. Infant was seen by Dr. and he did some tests and put her on medications. She stated Dr had said something about if a test was positive but it was negative. Mom apologized for not calling me sooner. I told her I would contact Dr regarding pt and further immunizations. I telephoned clinic and spoke with Dr's nurse. She check pt's chart and told me infant was another Dr's pt and referred it to another nurse. I told her I was concerned about what mom had told me and wanted to know if it was safe to give next immunizations if mom called to make an appt for the next ones or if I should refer her back to Dr. Nurse said she spoke with Dr and had tried to reach mom on phone but was unable to do so. She said she would keep trying though. Nurse advised me that Dr wanted parents to bring infant in for a well baby check. I told nurse that if mom called us we would advise her to take pt to see Dr.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Pt's left arm had red, warm spot size of a 50 cent piece at area where IPV given, this happened on the 2nd day after imms given. Mother took child to doctor where he was prescribed Keflex.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Feeling hot, Hypersensitivity, Oedema, Pruritus
Clinical narrative: HAV #1 given at Health Div 1/28/05 at 10AM. By 12PM that day, ct felt hot, face became red and slightly swollen; itching started 1/29/05 morning. Redness, itchiness, slight swelling has remained constant (increasing in evening) through today. Today skin peeling. No difficulty breathing. Used Desitin x 1 with improvement. 2/8/05 TC Pt who visited PP 2/4/05 was diagnosed allergic reaction; not to receive HAV #2.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Skin exfoliation
Clinical narrative: HAV #1 given at Health Div 1/28/05 at 10AM. By 12PM that day, ct felt hot, face became red and slightly swollen; itching started 1/29/05 morning. Redness, itchiness, slight swelling has remained constant (increasing in evening) through today. Today skin peeling. No difficulty breathing. Used Desitin x 1 with improvement. 2/8/05 TC Pt who visited PP 2/4/05 was diagnosed allergic reaction; not to receive HAV #2.
Age: 1.11
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash papular
Clinical narrative: Papular spots generalized over body since 3/15/05.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Lethargy, Oedema, Pain
Clinical narrative: Left arm swollen twice the size as normal lethargic pain, no documentation all per mom, brought to ER, treated w/ Benadryl reported per Dr.
Age: 1.02
Sex: F
Vaccine: MMR, PNC
Symptoms: Viral infection
Clinical narrative: Varivax vaccine on 2/15/05, chicken pox on 3/14/05.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Right arm swelling, redness and warmth. Motrin 150mg q6h prn, Benadryl 12.5mg q6h prn.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Received on 03/07/05 Pediatrix, Hib, PCV 7. Developed pink pimply rash 3/8/05. 3/11/05 reported rash worse-brighter red spread to back, stomach, neck. Tx: Hydrocortisone cream 1%, Benadryl PRN, F/U MD.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left deltoid erythema, slight swelling, localized reaction