chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site induration
Clinical narrative: Induration of 60 cm at DT booster site within 24 hours after receiving booster. Benadryal OTC. Woke up next morning noticing reaction.
Age: 4.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: DIFFUSE LEFT THIGH SWELLING.  LEFT THIGH RED AND SWOLLEN
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Woke at 1 am 06-25-03 with temp of 101 continued for 1 1/2 days with motrin given every 6 hours. 1 dose motrin given prior to injections.
Age: 2.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: RIGHT UPPER LATERAL THIGH WITH APPROXIMATELY 8 CM AREA OF INDURATION, ERYTHEMA AND CENTRAL VESICLES
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, OPV
Symptoms: Convulsion, Mental retardation severity unspecified, Status epilepticus
Clinical narrative: less than one month after receiving DTaP, Hib2,OPV my child experienced a 20-30 minute long afebrile seizure event. Another episode (shorter in duration) was then witnessed in ER. Three day hospital stay resulted. Did not medicate at that point, but was urged to do so after the child then experienced many more seizures in the ensuing months. The 60 day follow up received on 9/17/03 states pt continues to have recurrent seizures which are very poorly controlled. She carries a concurrent dx of autism, has a poorly functioning immune system (IgA def, IgG sub 2/4 are just about null) x GST MI is null.  Discharge Summary received on 8/06/2003 states status epilepticus.
Age: 0.3
Sex: M
Vaccine: HIBV
Symptoms: Crying, Irritability, Screaming
Clinical narrative: From 7:00 PM to 7:30 PM, resisted attempts to breastfeed or received very little in between constant bouts of screaming and crying.  From 7:30 PM to 8:30 PM, he slept.  At 8:30 PM, awoke with constant, hysterical, doubled-over screaming and crying.  Finally slept from 9:15 PM until 9:50 PM.  At 9:50 PM, awoke with more of same--screaming, crying and moaning, constantly until 12:00 midnight.  From 12:00 midnight until 12:30 AM, was finally able to breastfeed, with crying in between.  Finally went to sleep at 12:45 AM.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Gait disturbance, Injection site swelling
Clinical narrative: After 5th dose of DTaP, my son's entire leg swelled up where the shot was given - the day after shot was given - this effect lasted 1 day - he did limp all day
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Cyanosis, Hypotonia, Stupor
Clinical narrative: From faxed correspondence received on 4/22/02, it was reported: This report concerns a 2 month old who on 1/8/02 was vaccinated IM in the right thigh with a first dose of haemophilus B conjugate vaccine (+) hepatitis B vaccines recombinant (yeast) (lot # 638581/1668k). Concomitant vaccination the same day included a first dose of Poliovirus vaccine given SC in the left thigh, a first dose of diphtheria toxoid + pertussis vaccine (+) tetanus toxoid given IM in the left thigh and a first dose of Streptococcus pneumoniae vaccine given IM in the left thigh. Other concomitant medication included Ibuprofen. Post vaccination on 1/9/02, the patient cried substantially and became hypotonic/hyporesponsive and dusky in color for a period of 1-5 minutes. He was brought to the hospital by EMS. The patient was hospitalized for three days. The symptoms resolved spontaneously. Lab data included a CBC and chemistry panel with normal limits: urinalysis 3 WBC's; and blood and urine with negative results. The patient's sleep study was normal. No further information is available. From faxed correspondence received on 5/24/02: No further information is available. From faxed correspondence received on 6/17/02 the number of days required for hospitalization and the sleep study lab data was provided. From additional correspondence received on 6/24/03 through a telephone conversation with the reporter, it was reported that they had not received any additional information for this case and do not anticipate any, therefore, this case will be closed. From additional info received on 7/2/03 through telephone contact, it was requested by them to amend previous paragraph. Exclude them as the source reporter of this case as stated in the previous paragraph. No further info is anticipated, this case is considered closed.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Cyanosis, Erythema, Pruritus, Wheezing
Clinical narrative: Received MMR vaccine 2nd dose. Started coughing, wheezing, severe itching, and marked erythema of Sleining cincum and oral cyanosis. Given Epinephrine SC injection, albuterol and inhalation of oxygen.  Sent to ER.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Paraesthesia
Clinical narrative: Left arm (site) swelling, redness with distal paresthesia. Antihistamine, ice, monitoring. Continue naproxen.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 6/28/03 headache, nausea, dizziness, chills, cold sweats, temp 100 deg F. Seen by PMD 7/1/03 sxs resolved. Pt also had appetite decrease, fatigue. Groin tenderness.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Tenderness
Clinical narrative: 6/28/03 headache, nausea, dizziness, chills, cold sweats, temp 100 deg F. Seen by PMD 7/1/03 sxs resolved. Pt also had appetite decrease, fatigue. Groin tenderness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt developed redness, slight swollenness with warm to the touch to the upper right arm.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Diarrhoea, Gastrointestinal disorder, Vomiting
Clinical narrative: Pt had negative reactions to previous vaccines, but the reaction to the MMR was immediate and severe. He experienced chronic (daily) vomiting, diarrhea, and gastrointestinal distress. The gastrointestinal problems continue and are unresolved other than vomiting.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema
Clinical narrative: 7/3/03: Red area on left thigh 8 x 6 cm non tender and non fluctuant. Tx:  Augmentin 400/5 tsp bid
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site induration, Injection site swelling, Pain
Clinical narrative: Significant left upper extremity pain, 5 cm raised area warm, firm, tender lasted about 7 days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and swelling of right thigh 11 x 5.5 cm.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Blister, Infection, Rash
Clinical narrative: Pt brought to office by his mother 6/30/03 with a rash. He was diagnosed by MD with chicken pox. He had approximately 25 vesicles.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt was seen on 6/25/03 for well child exam. At that time pt was given DTaP in right thigh. Seen again on 6/27/03 for cellulitis and immunization reaction to DTaP. Had a 24.5 cm x 16.5 cm warm and pink area where shot was given.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Patient came in on 06/25/2003 for well child exam and was given DTaP in the right thigh IM.  Seen again 06/27/2003 due to complication of DTaP symptoms include swelling and a 8 x 7.5 cm redness and warm area on thigh.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: DTaP given 06/17/2003: Patient present to clinic on 06/20/2003 with erythema left anterior thigh 2 hours after immunizations.  Was started on Keflex 200mg per mouth every 8 hours x 10 days
Age: 14.0
Sex: F
Vaccine: TD, TD
Symptoms: Facial palsy, Hypoaesthesia, Pain
Clinical narrative: Received Td vaccine at approximately 18:30 06/19/2003.  That evening started having soreness in left shoulder-extending up into neck.  By next day had numbness in face and tongue.  Left side of face.  Saw MD-Diagnosis: Bells Palsy on prednisone 25mg.
Age: 1.8
Sex: F
Vaccine: PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever and possible seizure.  Seen at ER same night as vaccine.
Age: 4.8
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: 10 cm x 8 cm erythematous warm, indurated, non-tender right upper arm developed in the 48 hours after DTaP immunization treated with Keflex for possible cellulitis.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site oedema, Skin burning sensation
Clinical narrative: Burning and swelling at injection site.  Localized reaction-erythema and swelling measuring 10 cm x 5 cm.  No ecchymosis.  Prescribed: Atarax 25mg94hr as occasion requires.
Age: 73.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Aches and pains low grade fever day after injection 06/14/2003.  On 06/16/2003 midnight-deep muscle pain-very painful-chills, fever 104, lasted 36 hours.
Sex: F
Vaccine: HIBV, PNC
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Right thigh swollen "the whole thigh" per mom.  Very red and sore to touch. HIB vaccine.  No reaction with the Prevnar.
Age: 4.11
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Ecchymosis, Erythema
Clinical narrative: complained of quarter sized erythema 06/25/2003 AM.  Progressively larger area of erythema 14:40 06/27/2003.  12.5 cm x 16 cm with some ecchymosis.  On upper right thigh.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: 13 days after patient presented with measles like exavithem, no respiratory symptoms. Follow up on 08/04/02: "Manufacturer vaccine # and Lot # not available at this time."
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Generalized varicella rash (11 vesicles) vesicle on torso, face and extremities
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Pain
Clinical narrative: Right arm with erythema, warm and tender
Age: 59.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt reports large reddened, swollen area about 1.5" below Td injection site which appeared 1 day after after injections. She was seen by her primary physician who ordered oral antihistamines.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site oedema
Clinical narrative: Localized redness and edema with discomfort.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Localized redness and edema and fever (101 degrees) with discomfort. Given prednisone treatment.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Left tricep swelling, soreness, erythema
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Oedema
Clinical narrative: Pt's upper lip and right arm and both thighs swelled up on Tuesday afternoon 7-1-03 has improved by 7-3-03 @ 1030 AM pt treated herself with ice packs.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Febrile convulsion, Musculoskeletal stiffness, Pyrexia, Rhinorrhoea, Somnolence
Clinical narrative: Pt brought to Emergency Room by EMS. Was just waking up when "tensed up and jerked two times and eyes got big" . Noted to be sleepy afterwards. EMS noted patient to be alert and not postictal in appearance or activity. Pt also noted in ER to have rhinorrhea and to be tugging at both ears.  Mother complaints child has been running fever on and off for two days and they medicated only when child had fever. Pt was admitted to hospital for observation  with dx of febrile seizure, febrile illness, and bandemia. Test performed were chest x ray negative, blood cultures negative, and CBC showing hematocrit of 35.7L, RDW 32.9L, Neut 23L, and Bands 51H CBC was otherwise all with in normal limits. Patient was treated with Rocephin 300 mg IM Q 12hrs (mixed with lidocaine) and motrin suspension 120mg p.o. q 8 hours prn temp above 101.
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Confusional state, Disorientation, Dizziness, Facial palsy
Clinical narrative: Symptoms/signs: Joint Pain/Swelling, Flu-like symptoms, Fatigue and Malaise, 3 Skin Rashes, Headaches - Migraines, Eye/Sight problems, Tingling - Face, Numbness - Face, Dizziness, Confusion / Disorientation, Short-term Memory Deficit, Pain in left Clavicle and Shoulder - recurrent, Neck Pain with Fatigue with Headache, Aggravated Sleep Disturbance, Arthalgia, Myalgia, Diagnosed Lyme Disease, Bells Palsy, Possible Cardiac problem, Aggravated Major Depressive Disorder?, Aggravated Anxiety and Panic Disorder? Vagus Nerve Implant (VNS)? Time Course: Diagnosed 6/24/2003 - I became disabled 4/1/2001 via.  Treatment:  Zithromax 500/mg daily, Rocephin 2 grams Shot, Electrocardiogram. Initial Consult with Neuro-Ophthalmology - need to schedule visual field test
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Hypoaesthesia, Influenza like illness, Joint swelling
Clinical narrative: Symptoms/signs: Joint Pain/Swelling, Flu-like symptoms, Fatigue and Malaise, 3 Skin Rashes, Headaches - Migraines, Eye/Sight problems, Tingling - Face, Numbness - Face, Dizziness, Confusion / Disorientation, Short-term Memory Deficit, Pain in left Clavicle and Shoulder - recurrent, Neck Pain with Fatigue with Headache, Aggravated Sleep Disturbance, Arthalgia, Myalgia, Diagnosed Lyme Disease, Bells Palsy, Possible Cardiac problem, Aggravated Major Depressive Disorder?, Aggravated Anxiety and Panic Disorder? Vagus Nerve Implant (VNS)? Time Course: Diagnosed 6/24/2003 - I became disabled 4/1/2001 via.  Treatment:  Zithromax 500/mg daily, Rocephin 2 grams Shot, Electrocardiogram. Initial Consult with Neuro-Ophthalmology - need to schedule visual field test
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Laboratory test abnormal, Malaise, Memory impairment, Myalgia, Neck pain
Clinical narrative: Symptoms/signs: Joint Pain/Swelling, Flu-like symptoms, Fatigue and Malaise, 3 Skin Rashes, Headaches - Migraines, Eye/Sight problems, Tingling - Face, Numbness - Face, Dizziness, Confusion / Disorientation, Short-term Memory Deficit, Pain in left Clavicle and Shoulder - recurrent, Neck Pain with Fatigue with Headache, Aggravated Sleep Disturbance, Arthalgia, Myalgia, Diagnosed Lyme Disease, Bells Palsy, Possible Cardiac problem, Aggravated Major Depressive Disorder?, Aggravated Anxiety and Panic Disorder? Vagus Nerve Implant (VNS)? Time Course: Diagnosed 6/24/2003 - I became disabled 4/1/2001 via.  Treatment:  Zithromax 500/mg daily, Rocephin 2 grams Shot, Electrocardiogram. Initial Consult with Neuro-Ophthalmology - need to schedule visual field test
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Paraesthesia, Rash, Sleep disorder, Visual disturbance
Clinical narrative: Symptoms/signs: Joint Pain/Swelling, Flu-like symptoms, Fatigue and Malaise, 3 Skin Rashes, Headaches - Migraines, Eye/Sight problems, Tingling - Face, Numbness - Face, Dizziness, Confusion / Disorientation, Short-term Memory Deficit, Pain in left Clavicle and Shoulder - recurrent, Neck Pain with Fatigue with Headache, Aggravated Sleep Disturbance, Arthalgia, Myalgia, Diagnosed Lyme Disease, Bells Palsy, Possible Cardiac problem, Aggravated Major Depressive Disorder?, Aggravated Anxiety and Panic Disorder? Vagus Nerve Implant (VNS)? Time Course: Diagnosed 6/24/2003 - I became disabled 4/1/2001 via.  Treatment:  Zithromax 500/mg daily, Rocephin 2 grams Shot, Electrocardiogram. Initial Consult with Neuro-Ophthalmology - need to schedule visual field test
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: The day of the vaccination's administration the site was red and irritating.  Patient was scratching at it and saying it hurt.  The next morning it was swollen, red and hot and he continued to scratch at it.  Throughout the morning it got worse, to the point it was about 3 inches in radius from the injection site, raised and swollen, and still hot and itchy.  We called the dr.  They had us come in, saying it was probably an allergic reaction.  Upon examining it, they confirmed that it was an allergic reaction and told us to give him benedryl.  We gave him the benedryl and by the next morning the size of the red patch was noticeably reduced and he had stopped scratching.  The area remained discolored for a few weeks afterward.  It faded to a brownish-purple color, like that of a liver spot, then eventually disapeared.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Skin discolouration, Skin irritation
Clinical narrative: The day of the vaccination's administration the site was red and irritating.  Patient was scratching at it and saying it hurt.  The next morning it was swollen, red and hot and he continued to scratch at it.  Throughout the morning it got worse, to the point it was about 3 inches in radius from the injection site, raised and swollen, and still hot and itchy.  We called the dr.  They had us come in, saying it was probably an allergic reaction.  Upon examining it, they confirmed that it was an allergic reaction and told us to give him benedryl.  We gave him the benedryl and by the next morning the size of the red patch was noticeably reduced and he had stopped scratching.  The area remained discolored for a few weeks afterward.  It faded to a brownish-purple color, like that of a liver spot, then eventually disapeared.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dizziness, Dyspnoea, Flushing
Clinical narrative: Almost immediately after receiving pneumococcal vaccine IM patient complained of difficulty breathing. She appeared flushed, and had a slight cough. She also complained of feeling light headed. Before treatment could be administered, patient started to look better, color improved, and she stated she was breathing better. The pulse oximeter showed a Sp02 of 92% when first applied, it quickly went to 95-98%. No medication or oxygen was provided. Vitals signs and Sp02 was monitored for approximately 45 minutes, they remained stable. Her temp was 97.3. Patient was sent home in her parents care.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea
Clinical narrative: From fax correspondence received on 2/1/02 regarding a report describing an event occurring in the US. A 2 month old male received his first dose of Prevnar, Infanrix, Comvax, and IPV vaccine on 6/13/01. Approximately 1 hour after being put to bed that evening, he was found not breathing. He died. From faxed correspondence on 7/22/02 the identification number was provided. From additional information received on 6/30/03, it was reported that this case came as part of the pilot program for Prevnar in which we received limited data back from VAERS. Unfortunately, due to confidentially laws, these reports did not provide any reporter information making follow up impossible. No further information is anticipated, this case is considered closed. Follow up on 03/24/04: "From faxed correspondence received on 02/01/02 from the manufacturer regarding a report from another manufacturer describing an event occurring in the US.  "This report was received from the Center for Biologics Evaluation and Research (VAERS Ref. No. [illegible].  A 2 month old male received his first dose of Prevnar, Infanrix, Comvax, and IPV vaccine on 06/13/01.  Approximately 1 hour after being put to bed that evening, he was found not breathing.  He died". From faxed correspondence received at manufacturer on 07/22/02, the manufacturer identification number (WAES0202USA00433) was provided. From additional information received on 06/30/03 from another manufacturer (HQ9747603JAN2002), it was reported that "this case came to the manufacturer as part of the pilot program for Prevnar in which we received limited data back from VAERS.  Unfortunately, due to confidentially laws, these reports did not provide any reporter information making follow-up impossible".  No further information is anticipated, this case is considered closed.  Additional information received 03/18/04: A different lot number for the Comvax product was provided as 1522K rather than the previously reported 1533K.  No further information is anticipated, this case is still considered closed.  From additional information received on 03/29/04, the VAERS reference number for this case has been reported as 178822.  Additionally, a lot number for the IPOL product was provided as R14372.  The lot number for Prevnar was also reported as 477-450, which had previously been reported as 477-490.  No other new information was provided.  No further information is anticipated, this case is considered closed.
Age: 1.2
Sex: F
Vaccine: HBHEPB, IPV, MMR, PNC
Symptoms: Convulsion, Cyanosis, Dyskinesia, Pyrexia
Clinical narrative: From faxed correspondence received on 4/22/02, it was reported: This report concerns a 14 month old female who on 12/26/01 was vaccinated with the third dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) IM in the right leg (lot # 640931/0951L). Concomitant vaccinations that same day included the first dose of MMR SC in the left leg (lot # 639985/0905L), the third dose of poliovirus vaccine (IPOL) SC in the right (lot # T1464) and the fourth dose of Streptococcus pneumoniae vaccine (IM) in the let leg (lot #484133). One and a half hours later, the patient developed two episodes of jerking and cyanosis. She as taken to the emergency room and her temperature was noted to be 102 degrees F. A computed axial tomography of her head was normal, complete blood cell count was normal, urinalysis was negative and blood cultures were negative. A chest x-ray revealed a questionable infiltrate. A diagnosis of seizure was made. It was noted that prior to the vaccination, the patient had received a short examination and was noted to be afebrile with no cough. The patient's seizure was considered to be medically important (OMIC). No further information is available. From additional information received on 6/30/03 from a telephone call, it was reported that there is no additional information for this case and no new information is anticipated. This case is considered closed.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Convulsion, Dyskinesia, Grunting, Hypotonia
Clinical narrative: From faxed correspondence received on 4/22/02, it was reported: This report was received for Streptococcus pneumoniae vaccine. this was originally reported by a health professional concerning a 3 month old male patient who on 1/18/02 was vaccinated IM in the left leg with the second dose (lot number 641319/1366L) of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant suspect therapy on 1/18/02 included the second dose (lot number U0426) SC in the right leg of poliovirus vaccine (IPOL), the second dose (lot number U0540CA) IM in the right leg of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) and the first dose (lot number 484203) IM in the left leg of Streptococcus pneumoniae vaccine. There were no other concomitant therapies. ON 1/19/02 at 02:30 the patient's parents heard a grunting noise and the patient was jerking his arms and legs rhythmically while staring straight ahead. The parents reported that the seizure lasted at least 15 minutes, possibly up to 30 minutes. The patient seemed flaccid and unresponsive for 10 minutes. He was then reportedly back to his normal self, smiling and nursing. He was taken to the emergency room via ambulance where his temperature was 99.9 degrees F. He experienced another seizure on the way home. His eyes focused to the right side and he was unresponsive. He was taken to the hospital and was admitted for 24 hours. A computerized tomogram was normal and a metabolic panel was performed; however, the results were not provided. It was unknown if the patient had a past medical history. No further information is available. From additional information received on 6/30/03 from a telephone call, it was reported that there is no additional information for this case and no new information is anticipated. This case is considered closed.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Staring
Clinical narrative: From faxed correspondence received on 4/22/02, it was reported: This report was received for Streptococcus pneumoniae vaccine. this was originally reported by a health professional concerning a 3 month old male patient who on 1/18/02 was vaccinated IM in the left leg with the second dose (lot number 641319/1366L) of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant suspect therapy on 1/18/02 included the second dose (lot number U0426) SC in the right leg of poliovirus vaccine (IPOL), the second dose (lot number U0540CA) IM in the right leg of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) and the first dose (lot number 484203) IM in the left leg of Streptococcus pneumoniae vaccine. There were no other concomitant therapies. ON 1/19/02 at 02:30 the patient's parents heard a grunting noise and the patient was jerking his arms and legs rhythmically while staring straight ahead. The parents reported that the seizure lasted at least 15 minutes, possibly up to 30 minutes. The patient seemed flaccid and unresponsive for 10 minutes. He was then reportedly back to his normal self, smiling and nursing. He was taken to the emergency room via ambulance where his temperature was 99.9 degrees F. He experienced another seizure on the way home. His eyes focused to the right side and he was unresponsive. He was taken to the hospital and was admitted for 24 hours. A computerized tomogram was normal and a metabolic panel was performed; however, the results were not provided. It was unknown if the patient had a past medical history. No further information is available. From additional information received on 6/30/03 from a telephone call, it was reported that there is no additional information for this case and no new information is anticipated. This case is considered closed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Skin ulcer
Clinical narrative: Right shoulder indurated, non-fluctulant, red area 5 cm diameter 48 hours after immunization. Tx Keflex 250 mg/tsp 1 1/2 tsp QID for 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right shoulder indurated, non-fluctulant, red area 5 cm diameter 48 hours after immunization. Tx Keflex 250 mg/tsp 1 1/2 tsp QID for 10 days.
Age: 39.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Impaired healing, Influenza like illness, Lymphadenopathy, Oedema
Clinical narrative: It was reported that a 39 year old female pt received TD ADS ADULT, administered in the left deltoid in the AM on 6/10/03. Later the same day the pt experienced an injection site reaction being red, hot and swollen with severe pain, and no range of motion due to intense pain. She had swollen neck and axillary glands, and a fever of 103 F for three days. The pt also experienced chest congestion that evening. The pt took Tylenol and Motrin and her physician prescribed prednisone and Augmentin. Keflex was administered in the ER due to wound prophylaxis. The local reaction resolved within 24 hrs. The pt also reported loss of hearing in her left ear the same evening. It began as ringing and then went to muffled sound. The hearing loss still persists and the pt has an appointment with an audiologist to determine the extent of the loss. A 15-day follow up report received 10/20/2003 adds: From additional info received on 07/25/2003, it was reported that the pt experienced a fever of 103 F for 3 days, left arm paralysis for one day, swelling and redness for 4 days, loss of hearing in left ear, flu symptoms, extreme pain in the left arm and swelling of lymph glands. The pt has recovered from all symptoms, except the hearing loss and a wound on her foot frmo a steel crow bar. It was also reported that the pt had past flu-like reactions from TD vaccinations at the ages of 17 and 27. From additional info received from a hospital staff member, it was reported that the responsible physician "is no longer employed at this facility". No further info is anticipated, this case is considered closed.
Age: 39.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain, Paralysis, Pyrexia
Clinical narrative: It was reported that a 39 year old female pt received TD ADS ADULT, administered in the left deltoid in the AM on 6/10/03. Later the same day the pt experienced an injection site reaction being red, hot and swollen with severe pain, and no range of motion due to intense pain. She had swollen neck and axillary glands, and a fever of 103 F for three days. The pt also experienced chest congestion that evening. The pt took Tylenol and Motrin and her physician prescribed prednisone and Augmentin. Keflex was administered in the ER due to wound prophylaxis. The local reaction resolved within 24 hrs. The pt also reported loss of hearing in her left ear the same evening. It began as ringing and then went to muffled sound. The hearing loss still persists and the pt has an appointment with an audiologist to determine the extent of the loss. A 15-day follow up report received 10/20/2003 adds: From additional info received on 07/25/2003, it was reported that the pt experienced a fever of 103 F for 3 days, left arm paralysis for one day, swelling and redness for 4 days, loss of hearing in left ear, flu symptoms, extreme pain in the left arm and swelling of lymph glands. The pt has recovered from all symptoms, except the hearing loss and a wound on her foot frmo a steel crow bar. It was also reported that the pt had past flu-like reactions from TD vaccinations at the ages of 17 and 27. From additional info received from a hospital staff member, it was reported that the responsible physician "is no longer employed at this facility". No further info is anticipated, this case is considered closed.
Age: 39.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypoacusis, Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: It was reported that a 39 year old female pt received TD ADS ADULT, administered in the left deltoid in the AM on 6/10/03. Later the same day the pt experienced an injection site reaction being red, hot and swollen with severe pain, and no range of motion due to intense pain. She had swollen neck and axillary glands, and a fever of 103 F for three days. The pt also experienced chest congestion that evening. The pt took Tylenol and Motrin and her physician prescribed prednisone and Augmentin. Keflex was administered in the ER due to wound prophylaxis. The local reaction resolved within 24 hrs. The pt also reported loss of hearing in her left ear the same evening. It began as ringing and then went to muffled sound. The hearing loss still persists and the pt has an appointment with an audiologist to determine the extent of the loss. A 15-day follow up report received 10/20/2003 adds: From additional info received on 07/25/2003, it was reported that the pt experienced a fever of 103 F for 3 days, left arm paralysis for one day, swelling and redness for 4 days, loss of hearing in left ear, flu symptoms, extreme pain in the left arm and swelling of lymph glands. The pt has recovered from all symptoms, except the hearing loss and a wound on her foot frmo a steel crow bar. It was also reported that the pt had past flu-like reactions from TD vaccinations at the ages of 17 and 27. From additional info received from a hospital staff member, it was reported that the responsible physician "is no longer employed at this facility". No further info is anticipated, this case is considered closed.
Age: 39.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site warmth, Lymphadenopathy, Oedema, Pain, Pulmonary congestion
Clinical narrative: It was reported that a 39 year old female pt received TD ADS ADULT, administered in the left deltoid in the AM on 6/10/03. Later the same day the pt experienced an injection site reaction being red, hot and swollen with severe pain, and no range of motion due to intense pain. She had swollen neck and axillary glands, and a fever of 103 F for three days. The pt also experienced chest congestion that evening. The pt took Tylenol and Motrin and her physician prescribed prednisone and Augmentin. Keflex was administered in the ER due to wound prophylaxis. The local reaction resolved within 24 hrs. The pt also reported loss of hearing in her left ear the same evening. It began as ringing and then went to muffled sound. The hearing loss still persists and the pt has an appointment with an audiologist to determine the extent of the loss. A 15-day follow up report received 10/20/2003 adds: From additional info received on 07/25/2003, it was reported that the pt experienced a fever of 103 F for 3 days, left arm paralysis for one day, swelling and redness for 4 days, loss of hearing in left ear, flu symptoms, extreme pain in the left arm and swelling of lymph glands. The pt has recovered from all symptoms, except the hearing loss and a wound on her foot frmo a steel crow bar. It was also reported that the pt had past flu-like reactions from TD vaccinations at the ages of 17 and 27. From additional info received from a hospital staff member, it was reported that the responsible physician "is no longer employed at this facility". No further info is anticipated, this case is considered closed.
Age: 39.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia, Tinnitus
Clinical narrative: It was reported that a 39 year old female pt received TD ADS ADULT, administered in the left deltoid in the AM on 6/10/03. Later the same day the pt experienced an injection site reaction being red, hot and swollen with severe pain, and no range of motion due to intense pain. She had swollen neck and axillary glands, and a fever of 103 F for three days. The pt also experienced chest congestion that evening. The pt took Tylenol and Motrin and her physician prescribed prednisone and Augmentin. Keflex was administered in the ER due to wound prophylaxis. The local reaction resolved within 24 hrs. The pt also reported loss of hearing in her left ear the same evening. It began as ringing and then went to muffled sound. The hearing loss still persists and the pt has an appointment with an audiologist to determine the extent of the loss. A 15-day follow up report received 10/20/2003 adds: From additional info received on 07/25/2003, it was reported that the pt experienced a fever of 103 F for 3 days, left arm paralysis for one day, swelling and redness for 4 days, loss of hearing in left ear, flu symptoms, extreme pain in the left arm and swelling of lymph glands. The pt has recovered from all symptoms, except the hearing loss and a wound on her foot frmo a steel crow bar. It was also reported that the pt had past flu-like reactions from TD vaccinations at the ages of 17 and 27. From additional info received from a hospital staff member, it was reported that the responsible physician "is no longer employed at this facility". No further info is anticipated, this case is considered closed.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Autism
Clinical narrative: It was reported that a 2 year old male pt received an IPOL vaccination on 7/12/00, 9/6/00 and 11/6/00. In September 2002, the pt developed autism. No specifics were provided and the pt's current recovery status is unknown. Further info is expected. From additional info received on 6/30/03, "This case came to us via a consumer. Follow up attempts have been unsuccessful in obtaining any additional info. No further info is anticipated, this case is considered closed. Seriousness criteria: other medically significant (OMIC).
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Dyskinesia, Hyperhidrosis, Irritability, Medication error
Clinical narrative: A mother reported that her 4 month old daughter received a dose of Prevnar along with Engerix B, DTaP, Hib, and IPOL vaccines on 4/16/03. (The mother noted that the infant's third dose of Engerix B was inadvertently administered 4 months after the second dose instead of at the recommended 6 months interval because the second dose was not recorded in the infant's hospital records.) Reportedly, the infant had no relevant medical history. On 4/17/03, the infant became sleepy and cranky. She developed a slight fever, a cold sweat, and was jerky-twitching. She reportedly was not talking baby talk, and she was not herself, wouldn't play. Her pupils were small--just dots. According to the mother, she had to hold the infant for 3 days post-vaccination. On 4/20/03, the infant's symptoms reportedly resolved. Jerkiness and twitching were considered medically important (OMIC).
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Miosis, Muscle twitching, Pyrexia, Somnolence
Clinical narrative: A mother reported that her 4 month old daughter received a dose of Prevnar along with Engerix B, DTaP, Hib, and IPOL vaccines on 4/16/03. (The mother noted that the infant's third dose of Engerix B was inadvertently administered 4 months after the second dose instead of at the recommended 6 months interval because the second dose was not recorded in the infant's hospital records.) Reportedly, the infant had no relevant medical history. On 4/17/03, the infant became sleepy and cranky. She developed a slight fever, a cold sweat, and was jerky-twitching. She reportedly was not talking baby talk, and she was not herself, wouldn't play. Her pupils were small--just dots. According to the mother, she had to hold the infant for 3 days post-vaccination. On 4/20/03, the infant's symptoms reportedly resolved. Jerkiness and twitching were considered medically important (OMIC).
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain, Arthralgia, Dizziness, Eclampsia, Haemolytic anaemia
Clinical narrative: At time of vaccine, headache, watery eyes, fever, severe stomach cramps, pain in muschle and joints, blisters on lips, mouth and nose (symptomatic of actual anthrax). I was 8 weeks pregnant at time of vaccine. Severe unexplained liver and renal failure at 30 weeks gestation; emergency c-section live birth. Continued medical care; outcome unknown so far. A 60-day follow up report received 11/24/03 adds :Due to the fact that this may have complicated the pregnancy, resulting in HELLP syndrome, there may be long term liver and kidney damage. Additional pregnancy's are highly discouraged. Recovery still marked "Unknown". Change of name (divorce) noted. Sweats, stomach cramps, dizziness, aches in knees and hips. Later led to complications in pregnancy causing HELLP syndrome (renal failure, liver damage, high blood pressure). Discharge summary states pre-eclamsia, ileus, renal failure, edema. msv
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Hepatic enzyme abnormal, Hepatic failure, Hyperhidrosis, Hypertension
Clinical narrative: At time of vaccine, headache, watery eyes, fever, severe stomach cramps, pain in muschle and joints, blisters on lips, mouth and nose (symptomatic of actual anthrax). I was 8 weeks pregnant at time of vaccine. Severe unexplained liver and renal failure at 30 weeks gestation; emergency c-section live birth. Continued medical care; outcome unknown so far. A 60-day follow up report received 11/24/03 adds :Due to the fact that this may have complicated the pregnancy, resulting in HELLP syndrome, there may be long term liver and kidney damage. Additional pregnancy's are highly discouraged. Recovery still marked "Unknown". Change of name (divorce) noted. Sweats, stomach cramps, dizziness, aches in knees and hips. Later led to complications in pregnancy causing HELLP syndrome (renal failure, liver damage, high blood pressure). Discharge summary states pre-eclamsia, ileus, renal failure, edema. msv
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Ileus, Lacrimation increased, Liver function test abnormal, Myalgia, Oedema
Clinical narrative: At time of vaccine, headache, watery eyes, fever, severe stomach cramps, pain in muschle and joints, blisters on lips, mouth and nose (symptomatic of actual anthrax). I was 8 weeks pregnant at time of vaccine. Severe unexplained liver and renal failure at 30 weeks gestation; emergency c-section live birth. Continued medical care; outcome unknown so far. A 60-day follow up report received 11/24/03 adds :Due to the fact that this may have complicated the pregnancy, resulting in HELLP syndrome, there may be long term liver and kidney damage. Additional pregnancy's are highly discouraged. Recovery still marked "Unknown". Change of name (divorce) noted. Sweats, stomach cramps, dizziness, aches in knees and hips. Later led to complications in pregnancy causing HELLP syndrome (renal failure, liver damage, high blood pressure). Discharge summary states pre-eclamsia, ileus, renal failure, edema. msv
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Oral mucosal blistering, Pain, Platelet count decreased, Pyrexia, Renal failure
Clinical narrative: At time of vaccine, headache, watery eyes, fever, severe stomach cramps, pain in muschle and joints, blisters on lips, mouth and nose (symptomatic of actual anthrax). I was 8 weeks pregnant at time of vaccine. Severe unexplained liver and renal failure at 30 weeks gestation; emergency c-section live birth. Continued medical care; outcome unknown so far. A 60-day follow up report received 11/24/03 adds :Due to the fact that this may have complicated the pregnancy, resulting in HELLP syndrome, there may be long term liver and kidney damage. Additional pregnancy's are highly discouraged. Recovery still marked "Unknown". Change of name (divorce) noted. Sweats, stomach cramps, dizziness, aches in knees and hips. Later led to complications in pregnancy causing HELLP syndrome (renal failure, liver damage, high blood pressure). Discharge summary states pre-eclamsia, ileus, renal failure, edema. msv
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Unintended pregnancy
Clinical narrative: At time of vaccine, headache, watery eyes, fever, severe stomach cramps, pain in muschle and joints, blisters on lips, mouth and nose (symptomatic of actual anthrax). I was 8 weeks pregnant at time of vaccine. Severe unexplained liver and renal failure at 30 weeks gestation; emergency c-section live birth. Continued medical care; outcome unknown so far. A 60-day follow up report received 11/24/03 adds :Due to the fact that this may have complicated the pregnancy, resulting in HELLP syndrome, there may be long term liver and kidney damage. Additional pregnancy's are highly discouraged. Recovery still marked "Unknown". Change of name (divorce) noted. Sweats, stomach cramps, dizziness, aches in knees and hips. Later led to complications in pregnancy causing HELLP syndrome (renal failure, liver damage, high blood pressure). Discharge summary states pre-eclamsia, ileus, renal failure, edema. msv
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever, questionable seizure.
Age: 1.4
Sex: U
Vaccine: HBHEPB, IPV, PNC, VARCEL
Symptoms: Swelling
Clinical narrative: Pt reports to primary care clinic complaining of loss of tissue at injection site for wellbaby vaccines. Mother states last set of vaccines was Feb/Mar and 4 were received - IPOL, Comvax, Prevnar and Varivax. The loss of tissue has been progressive per patient. Patient info not available, only age.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: On 7/1/03 pt had varicella vaccine and Prevnar. Mother called 7/4/03. Rash/fever ? related to vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Edema and erythema with indurated area covering most of anterior thigh (left thigh).
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling
Clinical narrative: Approx 20-30 minutes after immunization, developed swelling and chemosis left eye. Benadryl 2 tsp given, Patomol 2 drops bid; Rx-Atarax 10 mg bid given.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Pain, Synovitis
Clinical narrative: Pt complained of hip pain on 6/21/03 - seen by MD on 6/23/03 - Dx with ?toxic synoitis - Motrin was prescribed - spoke with pt's mother 6/25/03. Child is "doing a lot better".
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Flushing, Headache, Lethargy, Pallor, Somnolence
Clinical narrative: About 5-10 minutes after vaccine, pt was flushed and appeared tremulous for a few seconds. Resp WNL 21, pulse 90, BP 92/58 responsive. Drowsy, "lethargic, pale, bad headache", ambulatory, went to MD after injection, having a "brainn fx test" on Wednesday.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Tremor
Clinical narrative: About 5-10 minutes after vaccine, pt was flushed and appeared tremulous for a few seconds. Resp WNL 21, pulse 90, BP 92/58 responsive. Drowsy, "lethargic, pale, bad headache", ambulatory, went to MD after injection, having a "brainn fx test" on Wednesday.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Large (10cm x 10cm) deeply pink, almost urticarial swelling over the left deltoid, extending to the shoulder.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis
Clinical narrative: Cellulitis on left anterior thigh 5.2 x 5.5 cm - Keflex for 7 days and warm soaks.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: DTaP, IPOL vaccines given on 6/30/03. On 7/3/03 patient has temp to 101.5 and grand mal seizure. Pt is autistic. Pt had 1 previous febrile seizure on 5/4/01.
Age: 1.5
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Oedema
Clinical narrative: Extreme swelling upper leg and knee - not warm or tender, mild, patchy erythema.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Local redness. Swelling, warm to touch. Benadryl 1 1/4 tsp given 6/30/03. Orapred 1 1/4 tsp given 6/30/03. Cefzil 200 mg.
Age: 11.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site mass, Pain
Clinical narrative: Within 8 hours he had a hard lump about 1/4" away from site of injection which was tender and red. Also some swelling under his arm by mother's account. Lump was the size of a puppy's ball - that resolved but redness persists 3 days after immunization.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Injection site induration, Injection site oedema, Pruritus
Clinical narrative: Left deltoid swollen-firm to touch. Blistered at site - weeping, warm to touch. Tx Benadryl po triple antibiotic ointment and Ibuprofen. Full ROM left arm. Pt complained of itching, no fever. 10 cm x 8 cm induration of tricep left , 6mm uncovered vesicle.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: Swelling at left shoulder and possible cellulitis. Keflex x 3 plus cortisone. Received treatment at clinic.
Age: 38.0
Sex: M
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: The area of injection left deltoid pt reported his arm became red, itchy and swollen on the 7th day after the shot; it remained that way for 3-4 days and disappeared completely.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash face to toes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 4 cm redness, erythema, swelling
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Injection site erythema, Rash papular
Clinical narrative: 2 1/2-3 week after injection developed papular rash with erythematous base at about dertatome T 6-7. Fever blisters at first but these never broke open or crusted. No scratching, pain behaviors or change in activity or eating.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Injection site oedema, Pain, Pyrexia, Rash
Clinical narrative: DTaP IM left thigh about 9:30 AM on 6/25/03. Severe pain left thigh 6/27/03 evening. Fever and headache 6/27/03. Lower leg pain. Rash and swelling shot site 6/27/03.
Age: 0.7
Sex: F
Vaccine: IPV
Symptoms: Wheezing
Clinical narrative: Mom claims that child had wheezing after the 3/24/03 DTaP, IPV, Hib, Hep B at age 5 1/2 months.