chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: Initial report received from the CDCP (VAERS numbers 247225) on 30/Nov/2005. A 15 year old female patient with a history of seizures and nephrotic syndrome had received an administration (route and site not reported) of Menactra, lot number U1677AA on 09/Aug/2005. She also received Hepatitis B vaccine from another manufacturer (route, site and lot number not reported) and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix, route, site and lot number not reported). The dates of administration were not specified for these vaccinations. One day later, on 10/Aug/2005, the patient developed seizures. She has had several seizures since her vaccination. She had not had any seizures for two years prior to her vaccination. The event was reported in a patient with a previous history of seizures. This patient also had received other vaccines in addition to Menactra conjugate vaccine. Information regarding ESG, complete blood cell count, drug screen, CT scan of the head, brain MRI, blood sugar, blood chemistry, liver function tests, kidney function tests, and lumbar puncture, were not provided. It also was not reported if the patient received any antiepileptic drugs at the time of the event. Unexplained recurrent seizures way occur in any epileptic patients and there are numerous and various factors, endogamous or expressions, that may affect the clearance of antiepileptic drugs and require dose adjustments (OMIC).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Papilloedema
Clinical narrative: Initial report received from the CDCP (VAERS numbers 247764) on 30/Nov/2005. A 17 year old female had received an administration (routine and site not reported) of Menactra, lot number U1766AA, on 22/Aug/2005. Approximately 16-18 days later, she developed bilateral papilledema. Recover status was not reported. Papilledema is an optic disk swelling that is secondary to an underlying elevation in intracranial pressure. Very limited information is available in this case. Further information including but not limited to the patient's history and physical, any concomitant medication, the results of the laboratory studies/diagnostics, procedures and consults, is needed in order to complete the medical assessment (OMIC).
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Facial palsy
Clinical narrative: Initial report received from the CDCP (VAERS numbers 247933) on 30/Nov/2005. A 16 year old male with no pre-existing medical conditions had received an administration (route and site not reported) of Menactra, lot number 41812AA, and another manufacturer's vaccine, Boostrix T-Dap (route, site and lot number not reported), on 10/Nov/2005. Six days later, on 06/Nov/2005, the patient developed Bell's Palsy. The patient's recovery status was unknown. Bell's palsy is the most common form of facial paralysis. Incidence of Bell's palsy in the US is approximately 23 cases per 100,000 persons and this condition affects approximately 1 person in 65 in a lifetime. The cause remains unknown, but it is thought to be viral. Herpes simplex virus infection has been isolated in many patients with Bell's palsy. Bell's palsy also has been associated with systemic disease, inflammatory or vascular disorders and trauma. In this report there were no laboratory studies/diagnostics reported, including serology testing for an infectious cause (OMIC).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Cough, Influenza like illness, Pain, Pharyngolaryngeal pain
Clinical narrative: Initial report received on 01/06/2006.  A 17 year old female patient received an injection of Menactra, on 12/01/2005.  Route and site of administration were not reported.  6 days later, she experienced body aches, sore throat, cough and weakness of her lower extremities.  Per the report, the event did not require hospitalization, and as of 12/12/2005, the patient had fully recovered.  The patient's mother said it may have been a flu-like illness.
Age: 15.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received from the Food and Drug Administration, VAERS report number 251634, on 22/Feb/2006. From information received from an intensive Guillain Barre syndrome case finding search conducted in the state for the time period from 01 March 2005 to 15 October 2005, it was reported that a 15 year old male patient had received an injection of Menactra vaccine, lot number not reported, on 05/Jul/2005. Route and site of administration were not reported. Thirty-five days post-vaccination, the patient experienced sensations of tingling and numbness in both feet. The patient was examined in an emergency room and diagnosed with mild Guillain Barre Syndrome. The patient had no weakness and was not hospitalized. Per this VAERS line list report, the case was considered "not serious." The patient received an outpatient neurology consult for evaluation of tingling and numbness sensation in both feet. The assessment indicated "tingling sensation in both feet was most likely secondary to parainfectious pol." Recovery status was not reported. The report (source) of this case is the same as cases 2006-00420 and 2006-00421. Follow-up information received on 02/Mar/2006 from the centers for Disease control and prevention with  a VAERS number of 251634. Per reporter, no hospitalization was required for these events. It was reported that this did not meet the clinical cas definition of Guillain-BArre syndrome. The patient most likely had parainfectious polneuropathy the mildest form os CBS. Per the reporter, the patient did recover from these events. Date of recovery was not reported.
Age: 15.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received from the Food and Drug Administration, VAERS report number 251634, on 22/Feb/2006. From information received from an intensive Guillain Barre syndrome case finding search conducted in the state for the time period from 01 March 2005 to 15 October 2005, it was reported that a 15 year old male patient had received an injection of Menactra vaccine, lot number not reported, on 05/Jul/2005. Route and site of administration were not reported. Thirty-five days post-vaccination, the patient experienced sensations of tingling and numbness in both feet. The patient was examined in an emergency room and diagnosed with mild Guillain Barre Syndrome. The patient had no weakness and was not hospitalized. Per this VAERS line list report, the case was considered "not serious." The patient received an outpatient neurology consult for evaluation of tingling and numbness sensation in both feet. The assessment indicated "tingling sensation in both feet was most likely secondary to parainfectious pol." Recovery status was not reported. The report (source) of this case is the same as cases 2006-00420 and 2006-00421. Follow-up information received on 02/Mar/2006 from the centers for Disease control and prevention with  a VAERS number of 251634. Per reporter, no hospitalization was required for these events. It was reported that this did not meet the clinical cas definition of Guillain-BArre syndrome. The patient most likely had parainfectious polneuropathy the mildest form os CBS. Per the reporter, the patient did recover from these events. Date of recovery was not reported.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site hypersensitivity
Clinical narrative: 1 days after injection, redness, cellulitis around the injection. Discharge summary states reddness, warm. msv
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: 3-6-06 Pt had Hep A #1, Dtap #4 right thigh, PCV #4 L thigh. On 3-7-06 Pt was seen by Dr, Dx allergic reaction (to vaccine) Rx; Augmentin 600 ES and Motrin 100mg,5cc). Sx: redness and swollen. 3-8-06 was also seen.
Age: 1.22
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Diffuse hives about five minutes after vaccine administration. Patient received Benadryl and Zyrtec and was observed for 30 minutes. At that time patient had faint rash with a few isolated hives.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration 11 cm x 9 cm Lt thigh area.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure; parents took child to ER at Medical Center and followed up with Dr. on 3-9-06; labs done, treat fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Contusion, Swelling
Clinical narrative: Swelling in left arm, bruising, and blisters. Gave Benadryl
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever, Convulsion X2
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Pain
Clinical narrative: Left arm discomfort 3 days after injection. Pain radiating from lt arm to lt forearm. Ibuprofen 200mg started 3/2/2006 with decrease intensity of symptom.
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Varicella Vaccine local reaction.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Radiculitis brachial
Clinical narrative: Brachial Neuritis
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Anorexia, Crying, Depressed level of consciousness, Eye movement disorder
Clinical narrative: 3/3/06 baby started to scream and could not be consoled. would not eat, approx 8pm baby vomited once profusely, then again smaller amount, child arrested, very hypotonic eyes rolled to back of head, no fever, transported to hospital via ambulance. 6/20/06 Medical records received from hospital which reveal patient experienced altered mental status, vomiting & lethargy same day as vaccination received and was admitted to hospital for overnight observation.  W/U results were WNL & was d/c to be followed by PCP/ss
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Hepatic enzyme abnormal, Hypotonia, Lethargy, Pallor, Screaming
Clinical narrative: 3/3/06 baby started to scream and could not be consoled. would not eat, approx 8pm baby vomited once profusely, then again smaller amount, child arrested, very hypotonic eyes rolled to back of head, no fever, transported to hospital via ambulance. 6/20/06 Medical records received from hospital which reveal patient experienced altered mental status, vomiting & lethargy same day as vaccination received and was admitted to hospital for overnight observation.  W/U results were WNL & was d/c to be followed by PCP/ss
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: 3/3/06 baby started to scream and could not be consoled. would not eat, approx 8pm baby vomited once profusely, then again smaller amount, child arrested, very hypotonic eyes rolled to back of head, no fever, transported to hospital via ambulance. 6/20/06 Medical records received from hospital which reveal patient experienced altered mental status, vomiting & lethargy same day as vaccination received and was admitted to hospital for overnight observation.  W/U results were WNL & was d/c to be followed by PCP/ss
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Alanine aminotransferase increased, Anorexia, Blood alkaline phosphatase increased, Blood calcium increased, Blood potassium increased
Clinical narrative: 3/3/06 baby started to scream and could not be consoled. would not eat, approx 8pm baby vomited once profusely, then again smaller amount, child arrested, very hypotonic eyes rolled to back of head, no fever, transported to hospital via ambulance. 6/20/06 Medical records received from hospital which reveal patient experienced altered mental status, vomiting & lethargy same day as vaccination received and was admitted to hospital for overnight observation.  W/U results were WNL & was d/c to be followed by PCP/ss
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Eye movement disorder, Hypotonia, Respiratory arrest, Screaming
Clinical narrative: 3/3/06 baby started to scream and could not be consoled. would not eat, approx 8pm baby vomited once profusely, then again smaller amount, child arrested, very hypotonic eyes rolled to back of head, no fever, transported to hospital via ambulance. 6/20/06 Medical records received from hospital which reveal patient experienced altered mental status, vomiting & lethargy same day as vaccination received and was admitted to hospital for overnight observation.  W/U results were WNL & was d/c to be followed by PCP/ss
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Anorexia, Crying, Depressed level of consciousness, Eye movement disorder
Clinical narrative: This case was reported by a physician and described the occurrence of arrest in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject had no known drug allergies. there were no concurrent medications. On 3/3/2006 at 11:00am, the subject received 1st dosed of Pediarix (lot AC21B011BA). On 3/3/2006, the subject also received 7 valent pneumococcal conjugate vaccine (Prevnar, lot B0B642K) and Haemophilus influenzae type b conjugate vaccine (PedvaxHib, lot 0656R). On 3/3/2006 at 3:00 pm, 4 hours after vaccination with Pediarix, the subject experienced uncontrollable screaming and would not eat. At 8:00pm on 3/3/2006, the subject vomited profusely. At an unspecified time on 3/3/2006, the subject was hypotonic, her eyes rolled back in her head and she arrested. The subject was taken to an emergency room and was hospitalized. The events were considered to jeopardize the subject. At the hospital, on 3/3/2006. Laboratory evaluation revealed elevated alanine aminotransferase at 66, elevated alkaline phosphatase at 417, elevated potassium at 5.3 and elevated calcium at 10.3. On 3/5/2006, the events resolved and the subject was discharged from the hospital. The vaccination course with Pediarix was discontinued. the physician considered the events to probably be related to vaccination with Pediarix.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Hepatic enzyme abnormal, Hypotonia, Lethargy, Pallor, Screaming
Clinical narrative: This case was reported by a physician and described the occurrence of arrest in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject had no known drug allergies. there were no concurrent medications. On 3/3/2006 at 11:00am, the subject received 1st dosed of Pediarix (lot AC21B011BA). On 3/3/2006, the subject also received 7 valent pneumococcal conjugate vaccine (Prevnar, lot B0B642K) and Haemophilus influenzae type b conjugate vaccine (PedvaxHib, lot 0656R). On 3/3/2006 at 3:00 pm, 4 hours after vaccination with Pediarix, the subject experienced uncontrollable screaming and would not eat. At 8:00pm on 3/3/2006, the subject vomited profusely. At an unspecified time on 3/3/2006, the subject was hypotonic, her eyes rolled back in her head and she arrested. The subject was taken to an emergency room and was hospitalized. The events were considered to jeopardize the subject. At the hospital, on 3/3/2006. Laboratory evaluation revealed elevated alanine aminotransferase at 66, elevated alkaline phosphatase at 417, elevated potassium at 5.3 and elevated calcium at 10.3. On 3/5/2006, the events resolved and the subject was discharged from the hospital. The vaccination course with Pediarix was discontinued. the physician considered the events to probably be related to vaccination with Pediarix.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of arrest in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject had no known drug allergies. there were no concurrent medications. On 3/3/2006 at 11:00am, the subject received 1st dosed of Pediarix (lot AC21B011BA). On 3/3/2006, the subject also received 7 valent pneumococcal conjugate vaccine (Prevnar, lot B0B642K) and Haemophilus influenzae type b conjugate vaccine (PedvaxHib, lot 0656R). On 3/3/2006 at 3:00 pm, 4 hours after vaccination with Pediarix, the subject experienced uncontrollable screaming and would not eat. At 8:00pm on 3/3/2006, the subject vomited profusely. At an unspecified time on 3/3/2006, the subject was hypotonic, her eyes rolled back in her head and she arrested. The subject was taken to an emergency room and was hospitalized. The events were considered to jeopardize the subject. At the hospital, on 3/3/2006. Laboratory evaluation revealed elevated alanine aminotransferase at 66, elevated alkaline phosphatase at 417, elevated potassium at 5.3 and elevated calcium at 10.3. On 3/5/2006, the events resolved and the subject was discharged from the hospital. The vaccination course with Pediarix was discontinued. the physician considered the events to probably be related to vaccination with Pediarix.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Alanine aminotransferase increased, Anorexia, Blood alkaline phosphatase increased, Blood calcium increased, Blood potassium increased
Clinical narrative: This case was reported by a physician and described the occurrence of arrest in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject had no known drug allergies. there were no concurrent medications. On 3/3/2006 at 11:00am, the subject received 1st dosed of Pediarix (lot AC21B011BA). On 3/3/2006, the subject also received 7 valent pneumococcal conjugate vaccine (Prevnar, lot B0B642K) and Haemophilus influenzae type b conjugate vaccine (PedvaxHib, lot 0656R). On 3/3/2006 at 3:00 pm, 4 hours after vaccination with Pediarix, the subject experienced uncontrollable screaming and would not eat. At 8:00pm on 3/3/2006, the subject vomited profusely. At an unspecified time on 3/3/2006, the subject was hypotonic, her eyes rolled back in her head and she arrested. The subject was taken to an emergency room and was hospitalized. The events were considered to jeopardize the subject. At the hospital, on 3/3/2006. Laboratory evaluation revealed elevated alanine aminotransferase at 66, elevated alkaline phosphatase at 417, elevated potassium at 5.3 and elevated calcium at 10.3. On 3/5/2006, the events resolved and the subject was discharged from the hospital. The vaccination course with Pediarix was discontinued. the physician considered the events to probably be related to vaccination with Pediarix.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Eye movement disorder, Hypotonia, Respiratory arrest, Screaming
Clinical narrative: This case was reported by a physician and described the occurrence of arrest in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject had no known drug allergies. there were no concurrent medications. On 3/3/2006 at 11:00am, the subject received 1st dosed of Pediarix (lot AC21B011BA). On 3/3/2006, the subject also received 7 valent pneumococcal conjugate vaccine (Prevnar, lot B0B642K) and Haemophilus influenzae type b conjugate vaccine (PedvaxHib, lot 0656R). On 3/3/2006 at 3:00 pm, 4 hours after vaccination with Pediarix, the subject experienced uncontrollable screaming and would not eat. At 8:00pm on 3/3/2006, the subject vomited profusely. At an unspecified time on 3/3/2006, the subject was hypotonic, her eyes rolled back in her head and she arrested. The subject was taken to an emergency room and was hospitalized. The events were considered to jeopardize the subject. At the hospital, on 3/3/2006. Laboratory evaluation revealed elevated alanine aminotransferase at 66, elevated alkaline phosphatase at 417, elevated potassium at 5.3 and elevated calcium at 10.3. On 3/5/2006, the events resolved and the subject was discharged from the hospital. The vaccination course with Pediarix was discontinued. the physician considered the events to probably be related to vaccination with Pediarix.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Feeling hot, Injection site erythema, Local reaction, Vomiting
Clinical narrative: Vomiting, redness, and warmth at site - patient returned for follow up next day.  No treatment required. Per follow-up: Pt had local reactin to DTaP of flu shot. Reaction 2 1/2 x 2 1/2 inch L thigh. Area warm to touch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash papular
Clinical narrative: Fine papular rash with scattered urticarial lesions on neck and trunk.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Local dermatologic reaction at injection site right upper arm, redness, warmth.
Age: 1.26
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Had febrile convulsion.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: States developed fine itchy rash - generalized on 03/05/2006.  Was taking Benadryl when presented on 03/08/2006.  Given prescription for Zyrtec as needed.  Still has rash.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: Developed 8 x 10 cm area of induration, erythema, pruritic surrounding injection site.
Age: 1.02
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella vaccine breakthrough.  Diagnosed with Varicella on 03/03/2006.  Rash started on 03/01/2006.  Had 11 spots, some with vesicles spread over body.  No fever.
Age: 0.9
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Varicella vaccine breakthrough.  Mother called to report chickenpox.  Exposed at school.  Had 25-30 lesions on face, trunk, and legs, some fluid-filled.  No fever.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Musculoskeletal stiffness
Clinical narrative: Complaint of feeling dizzy, chills, difficulty breathing through nose, weakness.  Took Benadryl, felt relief afterwards.  One day later patient felt stiff and lightheaded, then symptoms subsided.
Age: 1.33
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site mass
Clinical narrative: Local reaction, legs with lumps at site of injection.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Swelling
Clinical narrative: Left arm swollen, approximately 14 1/2, inflamed area on inner aspect approximately 2x2, entire arm painful.
Age: 0.82
Sex: F
Vaccine: HEP, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Patient had seizure, high fever, and went to emergency room.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: Achy upper arms - worse in left.  Feels like arms weigh more.  Went to doctor to rule out heart problems.  No heart problem found.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: 2 1/2 x 3 cm reddened area surrounding site of injection of varicella vaccine given 02/23/2006.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Local reaction to pneumovax.  Erythema/induration of skin left deltoid region, moving down to just above elbow.  Started 6 hours after injection.  Prescribed medrol pack, keflex, and lortab.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: 18 hours after receiving vaccines, patient had a febrile seizure lasting less than 3 minutes.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Pain in jaw, Pyrexia, Swelling, Tongue disorder
Clinical narrative: 02/28/2006 Started to feel bad, 03/01/2006 lips began to swell, had fever, tongue feeling thick.  03/03/2006 woke up with swelling on views with tenderness under jaw line.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe pain, swelling, redness - same evening.  Went to ER - given pain meds and antibiotic.
Age: 1.67
Sex: M
Vaccine: DTAP
Symptoms: Coma, Febrile convulsion
Clinical narrative: 40 second episode of unresponsiveness and eyes rolling up.  Seen in emergency room.  Diagnosed probable febrile seizure.  No prescription given.  patient had a fever for 2 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Redness/swelling in left deltoid area in AM 03/03/2006.  Treated with Cephalexin.
Age: 31.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Rash
Clinical narrative: Completed oral typhoid vaccine 2 days prior.  Presented with fine red rash under arms, trunk, lasted 2 days.  No other symptoms.  Treated with Zyrtec, and over the counter hydrocortisone.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: DTAP was administered to a 7 year old child  in error.
Age: 1.01
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Injection site mass, Tenderness
Clinical narrative: Induration 10 x 5 cm on right thigh redness pulp tender mass noticed on 3/5/06 Sunday
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Moderate erythema/warmth left bicep region no fever Tx rice PRK, frequent ROM, FU PRN
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Gait disturbance, Inflammation, Rash
Clinical narrative: From superior imm in left ant thigh sig inflamnation spread //// all the way to his knee. Rash overlying. Limp. Did not treat for bacterial infection. Probably DPT.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Anorexia, Stomach discomfort, Vomiting
Clinical narrative: No appetite, upset stomach, and vomiting. Pt had an abdominal U/S and phenergan inj.
Age: 30.0
Sex: F
Vaccine: TTOX
Symptoms: Chest discomfort, Chills, Headache, Nausea, Pain
Clinical narrative: Headache, Nausea, Chills, Body Aches, Paleness, Tightness in Chest, Pain.
Age: 30.0
Sex: F
Vaccine: TTOX
Symptoms: Pallor
Clinical narrative: Headache, Nausea, Chills, Body Aches, Paleness, Tightness in Chest, Pain.
Age: 18.0
Sex: F
Vaccine: DTAP, MNQ, DTAP, MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Distal parasthesias and numbness - worse in lower extremities occuring 3 days after immunization of Menactra.  On the 4th day patient went to the emergency room and had lab work and a CT scan to rule out Guillain-Barre Syndrome.  On the fifth day patient presented to Internal Medicine specialist who in turn consulted Neurology.  It was determined not to be Guillain-Barre syndrome because the patient still had all reflexes present.  The symptoms have slowly gone away.
Age: 18.0
Sex: F
Vaccine: DTAP, MNQ, DTAP, MNQ
Symptoms: Medication error, Paraesthesia
Clinical narrative: Distal parasthesias and numbness - worse in lower extremities occuring 3 days after immunization of Menactra.  On the 4th day patient went to the emergency room and had lab work and a CT scan to rule out Guillain-Barre Syndrome.  On the fifth day patient presented to Internal Medicine specialist who in turn consulted Neurology.  It was determined not to be Guillain-Barre syndrome because the patient still had all reflexes present.  The symptoms have slowly gone away.
Age: 1.28
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Varicella, fever.
Age: 48.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Urticaria
Clinical narrative: Pt received vaccine at approx 8:30am.  At approx 7:30pm she noticed hives on her lower torso.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Memory impairment, Paraesthesia, Speech disorder
Clinical narrative: This case was reported by a medical student and described the occurrence of electrical shock in a 45 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The subjects medical history included neurofibromatosis type 1. There were no concurrent medications. On 10/9/2002 the subject received 3rd dose of Engerix B lot ENG5285A6. At an unspecified time after vaccination with 3rd dose of Engerix B, on 10/09/2002, the subject experienced electrical shocks, tingling sensation, delayed verbal response time and forgetfulness. The medical student considered the events to be disabling and to jeopardize the subject. At the time of follow up reporting. on 3/1/2006, the events were ongoing. The medical student considered the events to possibly be related to vaccination with Engerix B.
Age: 1.23
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Child developed fever 103F within 24 hours of TIV vaccine. Dehydrated, vomiting and diarrhea. Hospitalized rehydrated and medicated. Rotavirus rule out.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Coma, Drooling, Dysarthria, Loss of consciousness
Clinical narrative: She received immunizations and was fine. Riding home with Mom talking/laughing. Approx 20 minutes after injections she started slurring speech, not responsive, passed out and started drooling. Mom called office and was sent to Hospital ER. By the time she got to ER was acting more normal. Exam normal at time.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: redness, swelling, warm induration 12 cm x 6 cm  Rt upper outer arm Tx: keflex 500 mg tid x 10 days Ice and elevate
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, IPV
Symptoms: Convulsion
Clinical narrative: Patient had unprovored seizure within 12 hours of receiving vaccine. (brief, < 2 min, no sequella, evaluation pending)
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Abdominal pain upper, Headache, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Initial report received from a patient's parent on 03/Feb/2006. An 11 year old male patient with no pre-existing medical history received a right arm injection of Menactra, lot number and route of administration not reported; a right arm injection of Adacel, lot number and route of administration not reported; and a left arm injection of Measles, Mumps and Rubella Vaccine manufacturer not reported, lot number and route of administration not reported, on 20/Jan/2006. On 21/Jan/2006, one day post-vaccination, the patient developed a four to five inch area of swelling at the injection site of the right arm. He also experienced nausea, stomach pain, headache and a slight rash on his shoulders. The nausea resolved after 1.5 days. Two days post-vaccination, he was not able to eat a normal diet and was eating a diet consisting of toast, waffles and crackers. He was examined by his physician on 25/Jan/2006; and, per the parent, the physician thought the events "may by a reaction to the vaccinations." On 28/Jan/2006, the patient was examined in an emergency room where unspecified x-rays and lab tests were completed. All diagnostic tests were negative. He was re-examined by his personal physician on 31/Jan/2006 and had a fever. He was treated with Aciphex, Tums and Tylenol. At the time of this report, the patient continues with the stomach pain and had not recovered.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Initial report received from a patient's parent on 03/Feb/2006. An 11 year old male patient with no pre-existing medical history received a right arm injection of Menactra, lot number and route of administration not reported; a right arm injection of Adacel, lot number and route of administration not reported; and a left arm injection of Measles, Mumps and Rubella Vaccine manufacturer not reported, lot number and route of administration not reported, on 20/Jan/2006. On 21/Jan/2006, one day post-vaccination, the patient developed a four to five inch area of swelling at the injection site of the right arm. He also experienced nausea, stomach pain, headache and a slight rash on his shoulders. The nausea resolved after 1.5 days. Two days post-vaccination, he was not able to eat a normal diet and was eating a diet consisting of toast, waffles and crackers. He was examined by his physician on 25/Jan/2006; and, per the parent, the physician thought the events "may by a reaction to the vaccinations." On 28/Jan/2006, the patient was examined in an emergency room where unspecified x-rays and lab tests were completed. All diagnostic tests were negative. He was re-examined by his personal physician on 31/Jan/2006 and had a fever. He was treated with Aciphex, Tums and Tylenol. At the time of this report, the patient continues with the stomach pain and had not recovered.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Initial report received on 14/Feb/2006 from a physician. A 17 year old female patient with a concurrent viral illness with cough had received an administration (route and site not reported) of Menactra, lot number U18592AA on 09/Feb/2006. Two days later, she developed a low grade fever, headache, local reaction and rash. She was treated with Zyrtec and Tagamet. The patient had not recovered from these events at the time of this report.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Initial report received on 24/Feb/2006 from a study site participating in the above mentioned trial in the USA under the reference number MTA30. A 32 year old male subject received an injection of Menactra, manufacturer, lot number not reported, on 11/Jan/2006. On that day, he experienced dizziness, shortness of breath, myalgia, chills, fever and headache. One day later, he was examined in an emergency room and complained of continuous headache, body aches, tightness around his chest, mild photophobia, dizziness and warmth, mild swelling and tenderness at the injection site. He also complained of a "sore throat swelling sensation." He denied shortness of breath during examination, and his pulse ox on room air was 96-97%. His temperature was 101.5 degrees Fahrenheit. He denied focal weakness or numbness. He had no history of previous upper respiratory infection symptoms, cough or runny nose. The subject has a history of vasovagal syncope, rectal bleeding and an allergy to penicillin. He was treated with Tylenol per os and intravenous fluids. Per the emergency record, a creatinine was ordered. However, additional laboratory test, an EKG or chest x-ray were not ordered. He was subsequently discharged from the emergency room with the diagnosis of a "vaccine reaction." The subject had no dizziness or pain at the time of discharge. Recovery status of additional events was not reported. Per the investigator, this is a non-serious adverse event that was related to the study vaccine.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pain, Pharyngolaryngeal pain
Clinical narrative: Initial report received on 24/Feb/2006 from a study site participating in the above mentioned trial in the USA under the reference number MTA30. A 32 year old male subject received an injection of Menactra, manufacturer, lot number not reported, on 11/Jan/2006. On that day, he experienced dizziness, shortness of breath, myalgia, chills, fever and headache. One day later, he was examined in an emergency room and complained of continuous headache, body aches, tightness around his chest, mild photophobia, dizziness and warmth, mild swelling and tenderness at the injection site. He also complained of a "sore throat swelling sensation." He denied shortness of breath during examination, and his pulse ox on room air was 96-97%. His temperature was 101.5 degrees Fahrenheit. He denied focal weakness or numbness. He had no history of previous upper respiratory infection symptoms, cough or runny nose. The subject has a history of vasovagal syncope, rectal bleeding and an allergy to penicillin. He was treated with Tylenol per os and intravenous fluids. Per the emergency record, a creatinine was ordered. However, additional laboratory test, an EKG or chest x-ray were not ordered. He was subsequently discharged from the emergency room with the diagnosis of a "vaccine reaction." The subject had no dizziness or pain at the time of discharge. Recovery status of additional events was not reported. Per the investigator, this is a non-serious adverse event that was related to the study vaccine.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Photophobia, Pyrexia, Tenderness
Clinical narrative: Initial report received on 24/Feb/2006 from a study site participating in the above mentioned trial in the USA under the reference number MTA30. A 32 year old male subject received an injection of Menactra, manufacturer, lot number not reported, on 11/Jan/2006. On that day, he experienced dizziness, shortness of breath, myalgia, chills, fever and headache. One day later, he was examined in an emergency room and complained of continuous headache, body aches, tightness around his chest, mild photophobia, dizziness and warmth, mild swelling and tenderness at the injection site. He also complained of a "sore throat swelling sensation." He denied shortness of breath during examination, and his pulse ox on room air was 96-97%. His temperature was 101.5 degrees Fahrenheit. He denied focal weakness or numbness. He had no history of previous upper respiratory infection symptoms, cough or runny nose. The subject has a history of vasovagal syncope, rectal bleeding and an allergy to penicillin. He was treated with Tylenol per os and intravenous fluids. Per the emergency record, a creatinine was ordered. However, additional laboratory test, an EKG or chest x-ray were not ordered. He was subsequently discharged from the emergency room with the diagnosis of a "vaccine reaction." The subject had no dizziness or pain at the time of discharge. Recovery status of additional events was not reported. Per the investigator, this is a non-serious adverse event that was related to the study vaccine.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MNQ
Symptoms: Feeling hot, Irritability, Pyrexia, Swelling, Wrong drug administered
Clinical narrative: Initial report received from the patient's parent on 17/Nov/2005. A two month old male patient received an injection of Menactra, lot number unknown, on 15/Nov/2005. This product is not licensed for administration in this age group. The route and site of administration were unknown. In the evening on the date of vaccination, the patient experienced a fever of 101 degrees Fahrenheit, was irritable, and his thigh was swollen and warm. Per the reporter, the symptoms still persist, but the fever had decreased to 100 degrees Fahrenheit. At the time of this report, the patient had not recovered. Follow-up information received on 14/Feb/2006 from a health care provider. At the time of vaccination, the patient was using hydrocortisone cream for eczema. Prior to being vaccinated on that day, he was diagnosed with oral candidiasis and prescribed Diflucan. It was unknown whether the patient started this medication. The Menactra vaccination was administered intramuscularly in the left thigh (although PCV-7 was ordered). Concomitant vaccinations received on that day included an intramuscular, right thigh, first dose injection of Dtap/IPV/HBV (Pediarix), lot number AC21801211BA and an intramuscular, left thigh, first dose injection of HIB vaccine, lot number 0209R. The reporter indicates that attempts to contact the parents concerning recovery status have been unsuccessful.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: Initial report received on 21/Nov/2005 from a health care professional. An 18 year old female patient with no significant medical history had received an administration (route/site not reported) of Menactra, lot number U1860AA on 17/Nov/2005. Approximately ten hours later she developed severe headache and dizziness. She described her dizziness as "feeling like the room was spinning." The headaches and dizziness continue to come and go at times. At the time of this report the patient had not recovered from these events. Follow-up information received on 10/Feb/2006 from a health care provider. The case was reviewed and there is no additional information at this time. Follow-up information received on 21/Mar/2006 from a health care provider. Per the reporter, the patient had a normal exam. No additional information was provided.
Sex: F
Vaccine: HEP
Symptoms: Medication error, Rash erythematous, Unintended pregnancy
Clinical narrative: Information has been received from a physician concerning an adult female employee who "sometime last week" on approximately 05-Jan-2005 may have been vaccinated with an intradermal dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot #646996/1093N) while 7 months pregnant. It was reported the patient developed a red, indurated area about 35 mm in diameter. The patient's status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Crying, Medication error
Clinical narrative: Information has been received from a physician concerning a "healthy" 5 month old male who on 14-Jan-2005 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #643389/0534M). The patient was vaccinated earlier on the same day with a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (Pediarix). The child had no reaction at the time of vaccination but was crying. Unspecified medical attention was sought. A product quality complaint was not involved.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Ear pain, Influenza like illness, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN nurse concerning a 22 year old white male with an allergy to beef who on 07Dec04 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 644389/0035N). Two to three days later, on approx 09Dec04, the pt developed a fever and redness and swelling at the injection site. On 10Feb05 at 15:00PM, the pt was vaccinated IM in the left deltoid with a second dose of hep B virus vaccine rHBsAg (yeast) (lot 648211/0864P). There was no illness at the time of vaccination. The pt again developed fever, redness and that time a persistent cough several days after the vaccination, on approx 14Feb05. Unspecified medical attention was sought and the pt recovered both times. The nurse was unsure whether the pt would be given the next dose. A product quality complaint was not involved. Follow up information was received from the RN who reported that the pt stated that he started having flu symptoms, a temp and was achy on 12Feb05, approx two days after receiving the second dose of hep B virus vaccine rHBsAg (yeast). The pt saw a nurse practitioner on 23Feb05 for ear pain, clear sinus drainage, and a sore throat. The diagnosis was seasonal allergies with allergic rhinitis. No diagnostic lab tests were performed. Subsequently, on an unspecified date, the pt recovered. No further information is expected.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Pain, Pharyngolaryngeal pain, Pyrexia, Rhinitis allergic, Sinusitis
Clinical narrative: Information has been received from a RN nurse concerning a 22 year old white male with an allergy to beef who on 07Dec04 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 644389/0035N). Two to three days later, on approx 09Dec04, the pt developed a fever and redness and swelling at the injection site. On 10Feb05 at 15:00PM, the pt was vaccinated IM in the left deltoid with a second dose of hep B virus vaccine rHBsAg (yeast) (lot 648211/0864P). There was no illness at the time of vaccination. The pt again developed fever, redness and that time a persistent cough several days after the vaccination, on approx 14Feb05. Unspecified medical attention was sought and the pt recovered both times. The nurse was unsure whether the pt would be given the next dose. A product quality complaint was not involved. Follow up information was received from the RN who reported that the pt stated that he started having flu symptoms, a temp and was achy on 12Feb05, approx two days after receiving the second dose of hep B virus vaccine rHBsAg (yeast). The pt saw a nurse practitioner on 23Feb05 for ear pain, clear sinus drainage, and a sore throat. The diagnosis was seasonal allergies with allergic rhinitis. No diagnostic lab tests were performed. Subsequently, on an unspecified date, the pt recovered. No further information is expected.
Age: 14.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Syncope, Urticaria
Clinical narrative: Information has been received from a RN concerning a 14 year old male with no known drug reactions/allergies and whose mother is allergic to latex who on 15Dec04 was vaccinated IM with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 643399/0367P). Suspect vaccination that day included diphtheria toxoid/tetanus toxoid (manf unk). On 15Dec04 the pt developed itchiness and raised areas like hives on his inner thighs, the back of both knees and his groin area. It was reported that the pt was afebrile. The pt was treated with diphenhydramine hydrochloride (Benadryl) capsules and cream. On 21Dec04 the pt was seen in the office with what was described as faint areas of redness but no raised areas noted. No further treatment was required. No lab diagnostic studies were performed. At the time of the report the pt had recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Psoriasis
Clinical narrative: 43 year old female with pre-existing psoriasis who on 03/22/2005 was vaccinated with a dose of Hepatitis B virus vaccine.  Concomitant therapy included therapy with methotrexate.  On 03/23/2005 the patient experienced a flare up of her pre-existing psoriasis.  Unspecified medical attention was sought.  The physician reported that she had not recovered.  No product quality complaint was involved.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Hypoaesthesia
Clinical narrative: 44 year old female, with no pertinent medical history, who on 02/16/1995 was vaccinated with a first 10 mcg, intramuscular dose in the outer arm of hepatitis B virus vaccine.  It was noted that the vaccination series was completed elsewhere.  The reporter stated that not right away, but within the last couple of years, in approximately 2003 the patient experienced headaches, dizzy spells and some numbness.  It was reported that the diagnosis was unknown.  It was noted that the patient is still being treated.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: 14 year old white female with exercised induced asthma and a bactrim allergy and a history of depression, acne, premenstrual syndrome, and headaches, who presented to the office on 04/05/2005 for a well child visit and was vaccinated intramuscularly in the left arm at 15:00 with a first dose of Hepatitis B virus vaccine.  There was no concomitant medication.  However, the report indicates the patient has taken fluoxetine hydrochloride in the past.  On 04/06/2005 the patient experienced vomiting, 3 to 4 times, bad headache, lightheadedness and slight fever.  The patient is reported as recovered.  Unspecified medical attention was sought.  No product quality complaint was involved. No additional information is expected.