chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV, TD
Symptoms: Serum sickness, White blood cell count increased
Clinical narrative: Serum sickness, arthralgia/fever 5/3/06 Review of 16-page discharge summary indicates final diagnosis of serum sickness.  Additional symptom of polyarthralgia was noted. Sent home on Avapro, Bactrim, and prednisone along with routine meds.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: erythematous reaction to left deltoid swelling, pain and warmth, tender/firm to touch.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: erythematous reaction to left deltoid swelling, pain and warmth, tender/firm to touch.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: No reactions.  Patient was inadvertently given varivax instead of Prevnar.  Mother notified on 03/23/2006 when mistake was discovered. Follow-up Information 19-APR-2006: To date, there has been no adverse reaction. There was an error in vaccine administration. Pt. inadvertently received Varivax at age 4 months.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Mother called:  child had temperature 101.2 last pm, night after shots administered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MM
Symptoms: Urticaria
Clinical narrative: 20 hours post 4 year vaccine a 4.0 x 7.5cm area upper left thigh was noticed.  There is a hive or pustule about 2mm in center.
Age: 1.06
Sex: F
Vaccine: HBHEPB, MMR, PNC
Symptoms: Rash
Clinical narrative: Rash, treated with Benadryl.
Age: 1.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Child received varicella vaccine 11/08/2002.  Diagnosed with disease 04/04/2006.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Swelling face, Throat tightness
Clinical narrative: 10 minutes after administering flu shot, patient complained of swelling in eyelids, lips and throat getting tight.  Administered Benadryl and epinephrine.  Stabilized.  911 called and responded, patient taken to ED.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Arm sore within minutes tingling in fingers of right hand within 3 days.  Continues today with numbness right hand.  Bruising at injection site.  No fever.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Pain
Clinical narrative: Sore arm, seizure, 1 month after flu shot, 12/19/2005.  Went to hospital.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, MNQ
Symptoms: Convulsion
Clinical narrative: 10:10 received 3 immunizations and PPD, at 10:15 child leaned over and fell out of the chair, hitting his head on the floor.  He then had what appeared to be a seizure lasting 5 seconds.  He was non responsive for about 30 seconds.  He then became alert to self and place.  Vitals within normal limits.  Referred to doctor.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Left arm swollen - baseball size, hot to touch, red, tender to touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Nausea, Oedema, Pain
Clinical narrative: Moderate upper arm swelling, redness, and pain, nausea, myalgias.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pallor
Clinical narrative: Patient developed poor color tone immediately following DTap, IPV, Hib, Prevenar immunization. P, RR, Pulse ox NL. Although still subdued. Patient recovered within several mins, slept for several hours, and then was back to normal.
Age: 15.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient developed mild case chicken pox.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea
Clinical narrative: Rec'd telephone call from, father of child @ 5pm stating son Rec'd immunizations from health dept approximately 1 hr ago, complaining of difficulty breathing. Advised parent to talk to ER for evaluation ASAP. 11/15/05 TC no answer, left message on answering mach, for parent to call. 11/16/05 father states they went to ER and a nurse listened to his lungs and stated those were the best lungs she had heard all day. There was no congestion or wheezing. They waited on doctor for a while. Pt got to feeling OK so they left ER before he was seen by MD. Father states he is fine now.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Eye oedema, Hypersensitivity, Pyrexia, Rash, Urticaria
Clinical narrative: Mother states she had noticed fever all day on 12/01/2005 but at about 3:00PM it appeared to her the baby's left eye was swollen and then the right eye. She also noticed hives. She called the health dept. and was told to take baby to ER. Infant had fever of 101 in ER and was given Tylenol. After fever came down rash appeared to resolved left leg where Prevnar was given was extremely swollen. DR in ER told mom this was allergic reaction and Health Dept needed to give vaccines one at a time next time.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dizziness, Erythema, Swelling
Clinical narrative: Swelling erythema, dark pink area to site of immunization, dizziness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Infection
Clinical narrative: Mother reports doctor visit on 03/09/2006 due to redness of upper left arm.  Also several knots in this area.  Noticed this 03/08/2006 at 8PM.  Reports doctor said this was infection from the shot - not a reaction.  Gave him Omnicef.  Spoke with mother this AM, 03/13/2006, states child is fine, redness almost gone.
Age: 11.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Red, swollen right deltoid, warm to touch, not hot.  Patient denies any pain/discomfort at site of injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pharyngeal oedema
Clinical narrative: 2:30pm mother called and stated that their child's throat was swelling and she is making a funny noise. She was in the car almost to the ER. I advised her to go to the ER and call us back later.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Received call stating patient is having reaction from PPR (Rabies) vaccine.  Called patient for more information and stated early this AM numbness in hand, arm, and tongue, lasted 5-10 minutes.  No numbness now.  Severe headache started this AM within normal limits.  Stated took BC Pill dose missed and regular dose late last night.  Advised to see doctor or urgent care.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Cough, Injection site swelling, Lacrimation increased, Pyrexia
Clinical narrative: Mom reports fever 101.4 degrees at 6:30PM on 12/14/2005.  Also had a little swelling at injection site.  On 12/15/2005 had cough, watery eyes, and temperature 100.2 degrees.  Saw doctor on 12/19/2005.  Patient declined hospitalization and treated at home with steady improvement.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Sleep disorder
Clinical narrative: Extreme pain by late afternoon - could not sleep because of pain- took Tylenol.  Saw doctor on 12/15/2005, was given anti-inflammatory medicine- doctor stated immunization possibly given too high and in joint - arm fine as of today.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Diagnosed with varicella, received varivax on 08/17/1999.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Left thigh red, swollen, hard, hot fever.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Irritability
Clinical narrative: Cranky, thigh red, hot, swollen, left more then right.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Rec'd DTap and IPV in left arm. On 3/27/2006 woke up 3/28/2006 with red, swollen arm. DX with Cellulitis immunization treated with Keflex.
Age: 1.49
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site hypersensitivity
Clinical narrative: Rec'd DTap and Ipol in left arm in 3/27/2006 woke 3/28/2006 with some redness. Worsen by 3/29/2006 came in for office visit DX with left are cellulitis immunizations.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Mom called office 3/28/2006 stated child's left arm with red bump, warm, tender to touch.
Age: 35.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Oedema, Pain
Clinical narrative: 1 1/2 hours after injection client called to report severe pain in left arm with edema and erythema, also stated had TD and Hepatitis in same arm on 1/17/2006. No problem breathing instructed to Tylenol or Advil for pain, 25mg Benadryl and apply ice see PCP if not improvement.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Vaccination in late a.m. 10/27/06. patient well. That evening, some myalgias, fever, fatigue, headache. Same symptoms worse next morning plus difficulty breathing, dizziness, injection site red, hot, swollen painful. Patient confined to bed x1 week due to symptoms.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Vaccination in late a.m. 10/27/06. patient well. That evening, some myalgias, fever, fatigue, headache. Same symptoms worse next morning plus difficulty breathing, dizziness, injection site red, hot, swollen painful. Patient confined to bed x1 week due to symptoms.
Age: 58.0
Sex: M
Vaccine: DTAP
Symptoms: Abscess, Injection site abscess, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: DTaP vaccination given 1-24-06 in right upper arm. 2-5-06 patient noticed lump in the area of the injection. 3-1-06 patient noticed lump was red and tender. 3-16-06 he sought further medical evaluation. Round mass in right upper arm area 2cm diameter palpable, 1 cm area of erythema overlying mass. Warm compresses and antibiotic ointment administered daily. Rechecked 3-22-06 mass was 3cm and erythema 2 cm. Afebrile. Started on Duricef 500mg bid for 10 days. Incision and drainage of mass was done 3-22-06. Purulent material expressed and sent for culture. Cyst like capsule also removed. 3-30-06 well healed incised area right upper arm. Asymptomatic.
Age: 58.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: DTaP vaccination given 1-24-06 in right upper arm. 2-5-06 patient noticed lump in the area of the injection. 3-1-06 patient noticed lump was red and tender. 3-16-06 he sought further medical evaluation. Round mass in right upper arm area 2cm diameter palpable, 1 cm area of erythema overlying mass. Warm compresses and antibiotic ointment administered daily. Rechecked 3-22-06 mass was 3cm and erythema 2 cm. Afebrile. Started on Duricef 500mg bid for 10 days. Incision and drainage of mass was done 3-22-06. Purulent material expressed and sent for culture. Cyst like capsule also removed. 3-30-06 well healed incised area right upper arm. Asymptomatic.
Age: 12.0
Sex: F
Vaccine: FLU3, MEN, TDAP
Symptoms: Erythema, Fatigue, Feeling hot, Somnolence
Clinical narrative: LEFT DELTOID AREA RED AND HOT TO TOUCH HAS NO FEVER MOTHER STATES ON DAY CHILD WAS VACCINATED CHILD WAS VERY TIRED AND SLEEPY.  OTHER WISE CHILD FINE.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: RIGHT DELTOID QARM , RED, SWOLLEN.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling hot, Injection site induration, Pain, Swelling
Clinical narrative: Patient developed pain, swelling, and warmth < 24 hours after the vaccine was given. Induration of 9.5cm x 12 cm at 24 hours. No evidence of cellulitis.
Age: 0.4
Sex: F
Vaccine: DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Cardio-respiratory arrest
Clinical narrative: Child presented with cardiopulmonary arrest per parents previously health with negative PMH. Found apneic and unresponsive, medics called and child intubated and resuscitation attempted in route. Child apneic and unresponsive upon arrival at ED. Resuscitation was not successful. Per parents child received vaccine, 1 day DTP.   5/8/06 Received ER medical records which indicate patient arrived at ER in full arrest & was unable to be resuscitated.  5/19/08 Autopsy states COD as sudden death associaated with a hypotonic-hyporesponsive episode due to recent vaccinations.  Autopsy states patient & twin well on day of vaccination.  Then developed fever, vomited & developed severe diarrhea.  Became limp with diaper change, caregiver started CPR & was transported to ER.
Age: 0.4
Sex: F
Vaccine: DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Child presented with cardiopulmonary arrest per parents previously health with negative PMH. Found apneic and unresponsive, medics called and child intubated and resuscitation attempted in route. Child apneic and unresponsive upon arrival at ED. Resuscitation was not successful. Per parents child received vaccine, 1 day DTP.   5/8/06 Received ER medical records which indicate patient arrived at ER in full arrest & was unable to be resuscitated.  5/19/08 Autopsy states COD as sudden death associaated with a hypotonic-hyporesponsive episode due to recent vaccinations.  Autopsy states patient & twin well on day of vaccination.  Then developed fever, vomited & developed severe diarrhea.  Became limp with diaper change, caregiver started CPR & was transported to ER.
Sex: U
Vaccine: HEPA
Symptoms: Liver function test abnormal, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of elevated liver function test in a subject of unspecified age and gender who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. On an unspecified date in either 2000 or 2001, the subject received a dose of Havrix, (dose number and lot number not provided. At an unspecified time after vaccination with Havrix, on an unspecified date in either 2000 or 2001, the subject was hospitalised for 5 days. The outcome of the events was not reported. Report received via manufacturer.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain, Diarrhoea, Dyspnoea, Feeling hot, Hypokinesia
Clinical narrative: This case was reported in a literature article and described the occurrence of injection site edema in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (manf unspecified) for prophylaxis. Previous and/or concurrent vaccination included combined measles, mumps and rubella vaccine, live attenuated (new strain) (manf unspecified) left thigh given on the same day than the DTPa vaccine. On an unspecified date the subject received booster dose of Dtpa (unk right thigh). The child had missed his previous DTaP booster vaccination at 12-18 months of age and was this receiving the fourth dose of Dtap. Twelve hrs after vaccination with Dtpa, the subject was admitted to the emergency ward with diffuse swelling and erythema of the right thigh. Erythema and swelling progressed to involve the entire right thigh with mild main noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination at the emergency ward revealed a well appearing child in no acute distress. Rectal temp was 97.2deg F, blood pressure 102/44 mmHg, pulse rate 106/min and resp rate 24/min. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the DTaP vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3, a platelet count of 118000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin sodium (oxacillin) was initiated. Over the course of several hours, the area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive oedema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm, and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of deep venous thrombosis. During the hospitalization. The child remained afebrile and playful, with normal appetite and normal leg mobility. The subject was hospitalized for 2 days. The subject was treated with oxacillin sodium and diphenhydramine. By the end of the 2nd hospital day, the events were resolved. The author considered the events were related to vaccination with Dtpa.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Nausea, Oedema
Clinical narrative: This case was reported in a literature article and described the occurrence of injection site edema in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (manf unspecified) for prophylaxis. Previous and/or concurrent vaccination included combined measles, mumps and rubella vaccine, live attenuated (new strain) (manf unspecified) left thigh given on the same day than the DTPa vaccine. On an unspecified date the subject received booster dose of Dtpa (unk right thigh). The child had missed his previous DTaP booster vaccination at 12-18 months of age and was this receiving the fourth dose of Dtap. Twelve hrs after vaccination with Dtpa, the subject was admitted to the emergency ward with diffuse swelling and erythema of the right thigh. Erythema and swelling progressed to involve the entire right thigh with mild main noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination at the emergency ward revealed a well appearing child in no acute distress. Rectal temp was 97.2deg F, blood pressure 102/44 mmHg, pulse rate 106/min and resp rate 24/min. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the DTaP vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3, a platelet count of 118000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin sodium (oxacillin) was initiated. Over the course of several hours, the area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive oedema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm, and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of deep venous thrombosis. During the hospitalization. The child remained afebrile and playful, with normal appetite and normal leg mobility. The subject was hospitalized for 2 days. The subject was treated with oxacillin sodium and diphenhydramine. By the end of the 2nd hospital day, the events were resolved. The author considered the events were related to vaccination with Dtpa.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Pallor, Pruritus, Pyrexia, Rash papular
Clinical narrative: This case was reported in a literature article and described the occurrence of injection site edema in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (manf unspecified) for prophylaxis. Previous and/or concurrent vaccination included combined measles, mumps and rubella vaccine, live attenuated (new strain) (manf unspecified) left thigh given on the same day than the DTPa vaccine. On an unspecified date the subject received booster dose of Dtpa (unk right thigh). The child had missed his previous DTaP booster vaccination at 12-18 months of age and was this receiving the fourth dose of Dtap. Twelve hrs after vaccination with Dtpa, the subject was admitted to the emergency ward with diffuse swelling and erythema of the right thigh. Erythema and swelling progressed to involve the entire right thigh with mild main noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination at the emergency ward revealed a well appearing child in no acute distress. Rectal temp was 97.2deg F, blood pressure 102/44 mmHg, pulse rate 106/min and resp rate 24/min. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the DTaP vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3, a platelet count of 118000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin sodium (oxacillin) was initiated. Over the course of several hours, the area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive oedema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm, and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of deep venous thrombosis. During the hospitalization. The child remained afebrile and playful, with normal appetite and normal leg mobility. The subject was hospitalized for 2 days. The subject was treated with oxacillin sodium and diphenhydramine. By the end of the 2nd hospital day, the events were resolved. The author considered the events were related to vaccination with Dtpa.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of injection site edema in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (manf unspecified) for prophylaxis. Previous and/or concurrent vaccination included combined measles, mumps and rubella vaccine, live attenuated (new strain) (manf unspecified) left thigh given on the same day than the DTPa vaccine. On an unspecified date the subject received booster dose of Dtpa (unk right thigh). The child had missed his previous DTaP booster vaccination at 12-18 months of age and was this receiving the fourth dose of Dtap. Twelve hrs after vaccination with Dtpa, the subject was admitted to the emergency ward with diffuse swelling and erythema of the right thigh. Erythema and swelling progressed to involve the entire right thigh with mild main noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination at the emergency ward revealed a well appearing child in no acute distress. Rectal temp was 97.2deg F, blood pressure 102/44 mmHg, pulse rate 106/min and resp rate 24/min. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the DTaP vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3, a platelet count of 118000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin sodium (oxacillin) was initiated. Over the course of several hours, the area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive oedema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm, and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of deep venous thrombosis. During the hospitalization. The child remained afebrile and playful, with normal appetite and normal leg mobility. The subject was hospitalized for 2 days. The subject was treated with oxacillin sodium and diphenhydramine. By the end of the 2nd hospital day, the events were resolved. The author considered the events were related to vaccination with Dtpa.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Confusional state, Heart rate decreased, Hyperhidrosis, Mydriasis, Pallor
Clinical narrative: Seriousness criteria Other medically significant (OMIC). Initial report received on 3/30/2006 from a physician. A 16 year old male patient injection (site not reported) of Menactra, lot number U1638AA, on 3/28/2006 at 16:00. Five minutes later, he turned pale, began sweating, became confused, his pupils were dilated and his pulse was weak. He was given 0.3 cc of Epinephrine (1:1000) SQ and was taken to the emergency room. Per the reporter, the patient recovered from these events.
Age: 1.25
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Rash erythematous
Clinical narrative: 3/22 pt had multiple red spots on both thighs. Advised to apply cool compress and may use Benadryl but should come in to be seen by doc, mom declined. 3/23 rash all over body. Dx by doc as reaction.
Age: 1.04
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Eyelid oedema, Face oedema, Medication error
Clinical narrative: Eyelids and lips swelling within 6 hrs of receiving vaccines. Seen at hospital, received 2 tsp of Benadryl and referred to return if problems.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site oedema, Injection site pain
Clinical narrative: Right upper arm swelling, pain warmth.  Rx: cool compresses/ibuprofen.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: No reaction to medication. Possible injection to wrong site. Subacromial space. Causing lt shoulder and neck pain, moderate pain.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: 2 month old given standard 2 month vaccines 3/30/06, developed a rash over face, neck and thighs with temps to 99-100 within 24 hrs of vaccination. Prescribed Tylenol, infant Benadryl. At 48 hrs, rash was worse urticarial, generalized and fevers up to 103. Prescribed Motrin, which improved rash/fevers. Continued to interact to feed well throughout the course of rash/fevers. Had complete blood count at 48 hrs post vaccination in ER. Labs normal except for viral shift. Infant discharged from ER 4/1/06 with instructions to use Tylenol/Motrin to keep fevers down. Per mothers verbal request 4/3/06 infant completely recovered by 72 hrs post vaccination with resolution of rash/fevers and normal activity.
Age: 0.23
Sex: F
Vaccine: HEP, HIBV, IPV, TDAP, HEP, HIBV, IPV, TDAP
Symptoms: Hypoxia, Medication error, Tachycardia
Clinical narrative: Seriousness criteria other medically significant (OMIC) Initial report received on 3/28/2006 from a health care provider. A two month old female patient, with a medical history of premature birth at 26 weeks gestation and bronchopulmonary dysplasia, had received on 2/25/2006, a dose one, left thigh injection of Adacel, lot number C2340AA, a dose one site unknown injection of IPOL, lot number unknown, a dose one, right thigh injection of Hib vaccine, lot number 0717R, and a dose one, right thigh injection of Hepatitis B vaccine, lot number 0143R. The patient had been hospitalized since birth (birth weight 580 grams) in the Neonatal intensive care unit. Per the reporter, the patient was administered Adacel in error. At an unspecified amount of time post immunization, the patient experienced an episode of tachycardia and decreased oxygen saturations. At the time of the events, the patient was already receiving oxygen, and secondary to the event, her oxygen administration was increased. There was no separate hospitalization for this event. The patient subsequently recovered from the event.
Age: 0.23
Sex: F
Vaccine: HEP, HIBV, IPV, TDAP, HEP, HIBV, IPV, TDAP
Symptoms: Hypoxia, Tachycardia
Clinical narrative: Seriousness criteria other medically significant (OMIC) Initial report received on 3/28/2006 from a health care provider. A two month old female patient, with a medical history of premature birth at 26 weeks gestation and bronchopulmonary dysplasia, had received on 2/25/2006, a dose one, left thigh injection of Adacel, lot number C2340AA, a dose one site unknown injection of IPOL, lot number unknown, a dose one, right thigh injection of Hib vaccine, lot number 0717R, and a dose one, right thigh injection of Hepatitis B vaccine, lot number 0143R. The patient had been hospitalized since birth (birth weight 580 grams) in the Neonatal intensive care unit. Per the reporter, the patient was administered Adacel in error. At an unspecified amount of time post immunization, the patient experienced an episode of tachycardia and decreased oxygen saturations. At the time of the events, the patient was already receiving oxygen, and secondary to the event, her oxygen administration was increased. There was no separate hospitalization for this event. The patient subsequently recovered from the event.
Sex: F
Vaccine: DTAP, PNC
Symptoms: Accidental overdose, Autism, Condition aggravated, Medication error
Clinical narrative: This case was considered medically important for the event of autism. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer via a regulatory authority regarding a 21 month old female autistic pt who accidentally received a 5th dose of Prevnar which reportedly made the child's autism worse. The pt received the fifth dose on an unspecified date. The pt's concurrent illness includes autism (age of onset 1). Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Daptacel (diphtheria and tetanus toxoids/acellular pertussis vaccine adsorbed). Concomitant medications were not reported. A nurse reported that she received a call from the mother of an autistic child who accidentally was given a 5th dose of Prevnar (accidental overdose) (incorrect dose administered) on an unspecified date. The mother stated that 2-3 days after vaccination, the child's autism got worse (autism) (condition aggravated). The child is now about 3 yrs of age. The mother declined further information.
Age: 1.29
Sex: F
Vaccine: DTAPH, MMRV, DTAP, HIBV, MMRV
Symptoms: Crying, Infection, Pain, Skin disorder, Skin ulcer
Clinical narrative: (OMIC) Information has been received from a physician concerning a 16 month old female with no medical history or allergies who on 2/21/2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live + varicella virus vaccine live (upgrade process) (lot 652232/0772R). Concomitant therapy that day included a dose of diphtheria toxoid (+) Hib conj vaccine (tet toxoid) (+) pertussis acellular Biken vaccine (+) tetanus toxoid (TRIHIBIT). On 3/20/2006 the patient developed painful weeping lesions that crusted over along one dermatome. The lesions were on her right leg, upper thigh. The skin was denuded and showed evidence of a skin infection. There were less than 50 lesions. Unspecified medical attention was sought. No laboratory diagnostic test were performed. The patient was treated with amoxicillin + clavulanate potassium Augmentin. At the time of the report the patient was recovering, but had not yet been seen for a follow up visit. There was no product quality complaint involved. It was noted that therapy had been discontinued. Additional information has been requested.
Age: 1.29
Sex: F
Vaccine: DTAPH, MMRV, DTAP, HIBV, MMRV
Symptoms: Crying, Infection, Skin disorder, Skin ulcer
Clinical narrative: (OMIC) Information has been received from a physician concerning a 16 month old female with no medical history or allergies who on 2/21/2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live + varicella virus vaccine live (upgrade process) (lot 652232/0772R). Concomitant therapy that day included a dose of diphtheria toxoid (+) Hib conj vaccine (tet toxoid) (+) pertussis acellular Biken vaccine (+) tetanus toxoid (TRIHIBIT). On 3/20/2006 the patient developed painful weeping lesions that crusted over along one dermatome. The lesions were on her right leg, upper thigh. The skin was denuded and showed evidence of a skin infection. There were less than 50 lesions. Unspecified medical attention was sought. No laboratory diagnostic test were performed. The patient was treated with amoxicillin + clavulanate potassium Augmentin. At the time of the report the patient was recovering, but had not yet been seen for a follow up visit. There was no product quality complaint involved. It was noted that therapy had been discontinued. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Asperger's disorder, Autism, Bacterial infection, Blood immunoglobulin E increased
Clinical narrative: After receiving MMR vaccine at 15 month check up began exhibiting sever changes in behavior, severe meltdowns, would run away from teachers, would not participate in class activities, loss of eye contact with parents/teacher, family members, began walking on tip-toes.  He could not transition during any type of change in activity at home or school, would run around house with a high pitched scream.  He would line up his toys or tear them up and play with them in an inappropriate manner.  He also would want to watch the same movie over and over - in an obsessive manner.  He also would flap his hands.  We observed all of these characteristics at age 3, I had him formally diagnosed by a doctor with Asperger's Syndrome, an autism spectrum disorder, February 2004. 5/8/06 Received medical records from PCP which indicate patient experienced allergies to peanuts, eggs, cats & oak trees, frequent cough, eczema, hives, OM & bronchitis & multiple episodes of staph/strep skin infections. Tx by allergist, neuropsychologist (for toe walking) who dx w/Aspergers 4/04 and GI doctor who dx w/diarrhea & feeding difficulties despite eliminating dairy, gluten & soy.  Unable to obtain records from neuropsychologist despite multiple requests/ss. 60 Day Follow-up Information 16-JUN-2006: He still has a diagnosis of Asberger's Syndrome but has much less severe O.C.D. behaviors as when he was 1 1/2 - 2 yrs of age and socially acts appropriately now. Patient has improved drastically in all areas due to a specialized preschool for the past 2 years, sensory integration, gluten-free/casein-free diet, vitamin supplementation, etc, but some times he has some unruly behavior but it may be due to him being 5 and 1/2 years old, and not Asberger's Syndrome.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Bronchitis, Diarrhoea, Eczema, Gait disturbance, Hypersensitivity
Clinical narrative: After receiving MMR vaccine at 15 month check up began exhibiting sever changes in behavior, severe meltdowns, would run away from teachers, would not participate in class activities, loss of eye contact with parents/teacher, family members, began walking on tip-toes.  He could not transition during any type of change in activity at home or school, would run around house with a high pitched scream.  He would line up his toys or tear them up and play with them in an inappropriate manner.  He also would want to watch the same movie over and over - in an obsessive manner.  He also would flap his hands.  We observed all of these characteristics at age 3, I had him formally diagnosed by a doctor with Asperger's Syndrome, an autism spectrum disorder, February 2004. 5/8/06 Received medical records from PCP which indicate patient experienced allergies to peanuts, eggs, cats & oak trees, frequent cough, eczema, hives, OM & bronchitis & multiple episodes of staph/strep skin infections. Tx by allergist, neuropsychologist (for toe walking) who dx w/Aspergers 4/04 and GI doctor who dx w/diarrhea & feeding difficulties despite eliminating dairy, gluten & soy.  Unable to obtain records from neuropsychologist despite multiple requests/ss. 60 Day Follow-up Information 16-JUN-2006: He still has a diagnosis of Asberger's Syndrome but has much less severe O.C.D. behaviors as when he was 1 1/2 - 2 yrs of age and socially acts appropriately now. Patient has improved drastically in all areas due to a specialized preschool for the past 2 years, sensory integration, gluten-free/casein-free diet, vitamin supplementation, etc, but some times he has some unruly behavior but it may be due to him being 5 and 1/2 years old, and not Asberger's Syndrome.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Laboratory test abnormal, Otitis media, Sensory integrative dysfunction, Social avoidant behaviour, Urticaria
Clinical narrative: After receiving MMR vaccine at 15 month check up began exhibiting sever changes in behavior, severe meltdowns, would run away from teachers, would not participate in class activities, loss of eye contact with parents/teacher, family members, began walking on tip-toes.  He could not transition during any type of change in activity at home or school, would run around house with a high pitched scream.  He would line up his toys or tear them up and play with them in an inappropriate manner.  He also would want to watch the same movie over and over - in an obsessive manner.  He also would flap his hands.  We observed all of these characteristics at age 3, I had him formally diagnosed by a doctor with Asperger's Syndrome, an autism spectrum disorder, February 2004. 5/8/06 Received medical records from PCP which indicate patient experienced allergies to peanuts, eggs, cats & oak trees, frequent cough, eczema, hives, OM & bronchitis & multiple episodes of staph/strep skin infections. Tx by allergist, neuropsychologist (for toe walking) who dx w/Aspergers 4/04 and GI doctor who dx w/diarrhea & feeding difficulties despite eliminating dairy, gluten & soy.  Unable to obtain records from neuropsychologist despite multiple requests/ss. 60 Day Follow-up Information 16-JUN-2006: He still has a diagnosis of Asberger's Syndrome but has much less severe O.C.D. behaviors as when he was 1 1/2 - 2 yrs of age and socially acts appropriately now. Patient has improved drastically in all areas due to a specialized preschool for the past 2 years, sensory integration, gluten-free/casein-free diet, vitamin supplementation, etc, but some times he has some unruly behavior but it may be due to him being 5 and 1/2 years old, and not Asberger's Syndrome.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Cyst, Depression, Hypertension, Insomnia
Clinical narrative: High blood pressure, insomnia, cyst, depression, anxiety, vision problems. 10/11/06-ophthalmology note for DOS 10/3/06 received: Senile type cataracts OU, ametropia, conjunctival nevi. Psychiatry note for DOS 10/05/06 received: major depression with psychotic features severely decompensated
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Visual disturbance
Clinical narrative: High blood pressure, insomnia, cyst, depression, anxiety, vision problems. 10/11/06-ophthalmology note for DOS 10/3/06 received: Senile type cataracts OU, ametropia, conjunctival nevi. Psychiatry note for DOS 10/05/06 received: major depression with psychotic features severely decompensated
Age: 1.02
Sex: F
Vaccine: HBHEPB, MMRV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever started 03/24/2006 approximately 5 hours after injection, 102 degrees continued until Monday, 03/27/2006, when it went to 104 degrees and has continued- no other symptoms.  No local reaction.  Does have loose stools.
Age: 1.47
Sex: M
Vaccine: DTAP, IPV
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Exposed to chicken pox 3 weeks ago, has a rash.  Diagnosed with chickenpox 03/31/2006.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Multiple spots with erythema, multiple vesicles more than 20 face/chest/head.
Age: 1.87
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right upper arm (DTaP) 20cm circumference compared to left arm 17cm. Erythematous diam 10cm x 7cm, warm to touch. No fever uses arm freely.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Mom states child started with uncontrollable crying at 4pm on 6/22/2005 and cried until 8pm, cried herself to sleep for 1/2 hrs woke with 1/2 hrs during night with crying episodes. Cont this until 11am on 6/23/2005. Temp on 6/23 was 9930 Axillary.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Cellulitis, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Left deltoid red, swollen, stomach ache, RX'd Keflex could not exclude cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: 10cm x 10cm area of redness, swelling and induration around injection site of DTap.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Erythema, edema, warmth at site of DTap #5. Estimate 8 diam onset with 30 hours after injection. NO systemic DX. Pt Rec'd MMR  adm arm posteriorly.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 16 x 8.5 cm area of erythema, slight induration, slight warmth, no streaks.
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site mass, Rash macular
Clinical narrative: Seen for acute visit on 3/27/06. Pt noted to have indurated approx 3mm and 1 mm around each after 2 vaccine sites on left thigh, slight erythema, macular rash area, no signs of cellulitis.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: As per Dr's note on 3/8/06 8x8 cm red warm area on left upper outer arm, mild induration over central portion with fluctuance. Recommended cool compresses to arm at home, gave RX for Benadryl 12.5 mg/5ml, 7.5ml PO q 6 hrs. prn. Redness or swelling of arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Upper left leg is red, swollen and warm to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site induration, Lymphadenopathy, Swelling
Clinical narrative: Left arm will swelling, redness, warm to the touch; there is a 3 1/2 by  1/2 area inflamed, induration, tender to touch with axillary nodes.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Haematocrit decreased, Hypersensitivity, Swelling, Tenderness
Clinical narrative: Patient recieved in the left deltoid-IPV 0.5ml and DTAP 0.5ml.  In the right deltoid-MMR 0.5 and Varicella 0.5ml.  This was on 2/9/06.  On 2/11/06 mother presented child to hospital.  Child's complaints at time were left arm swelling and tenderness.  Pediatric History & Physical in assessment physician entry of Cellulitis arm left? allergic reation.  Plan: IV antibiotics, compresses warm.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Difficulty in walking, Joint swelling, Pyrexia
Clinical narrative: Approximately 2 wks following vaccination of MMR, patient developed fever and pain and swelling in both knees.  She is using crutches to walk at present and waiting referral to orthopedic.
Age: 0.43
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Face oedema, Pyrexia
Clinical narrative: Facial swelling. Temp. 102F. Child received shots at health dept. Was seen by doctor on 4-5-06.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema multiforme, Pyrexia, Rash
Clinical narrative: Fever to 102 started 3/25 and continued through 4/5. Rash started 3/29, rapidly progressed, erythema multiforme, trunk extremities, face. 3/31 was completely covered. 4/6 rash improved healing and scarring.Treated with ibuprofen for fever 3/25-3/31.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR
Symptoms: Rash
Clinical narrative: PATIENT DEVELOPED RASH ON BACK AND STOMACH AREA.  MOTHER STATES CHILD HAS BEEN FINE OTHERWISE.  HAS HAD NO FEVER NO LOSS OF APPETITE NOR SLEEP.  CHILD VERY ALERT, VERY HIMSELF.  VACCINE ADMINISTERED AT THIS TIME WERE MMR, PEDIARIX AND HEP-A. NO ILLNESS AT TIME OF VISIT.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Upon admission, patient reported erythema and warm to touch at the pneumococcal vaccine injection site. She received the vaccine as an outpatient.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Asthma, Balance disorder, Cognitive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of pain, swelling and burning of the joints in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced pain, swelling and burning in her joints, fatigue, flu like symptoms, coordination and balance problems, asthma, allergies, cognitive problems, sleep disturbances, gastrointestinal problems, hypothyroidism, possible neurological injuries, possible autoimmune disease and decreased activities of daily life. This case was assesses as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Coordination abnormal, Fatigue, Gastrointestinal disorder, Hypersensitivity, Hypothyroidism
Clinical narrative: This case was reported by a lawyer and described the occurrence of pain, swelling and burning of the joints in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced pain, swelling and burning in her joints, fatigue, flu like symptoms, coordination and balance problems, asthma, allergies, cognitive problems, sleep disturbances, gastrointestinal problems, hypothyroidism, possible neurological injuries, possible autoimmune disease and decreased activities of daily life. This case was assesses as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.