chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Dyskinesia, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of jerking in a 5 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. There were no concurrent medications. On 6/9/06 at 09:00 AM, the subject received 1st dose of Pediarix in the left leg (lot AC21B051AA). On 6/9/06, the subject also received the 1st dose of Haemophilus influenzae tetanus conjugate vaccine (lot UB472AA) and 7-valent pneumococcal conjugate vaccine (lot B08633C) at unspecified sites of injection. On 6/9/06 at 3:00 PM, 6 hours after vaccination with Pediarix, the subject experienced jerking, a fever of 101 degrees F, inconsolable pain and crying. The healthcare professional reported that there was, no loss of consciousness associated with the jerking. The subject was treated with paracetamol which had no effect on the symptoms. The healthcare professional considered the events were disabling. On 6/12/06 the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Pediarix.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Insomnia, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of jerking in a 5 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. There were no concurrent medications. On 6/9/06 at 09:00 AM, the subject received 1st dose of Pediarix in the left leg (lot AC21B051AA). On 6/9/06, the subject also received the 1st dose of Haemophilus influenzae tetanus conjugate vaccine (lot UB472AA) and 7-valent pneumococcal conjugate vaccine (lot B08633C) at unspecified sites of injection. On 6/9/06 at 3:00 PM, 6 hours after vaccination with Pediarix, the subject experienced jerking, a fever of 101 degrees F, inconsolable pain and crying. The healthcare professional reported that there was, no loss of consciousness associated with the jerking. The subject was treated with paracetamol which had no effect on the symptoms. The healthcare professional considered the events were disabling. On 6/12/06 the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Pediarix.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Neurodevelopmental disorder, Pyrexia, Tenderness, Trismus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of jerking in a 5 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. There were no concurrent medications. On 6/9/06 at 09:00 AM, the subject received 1st dose of Pediarix in the left leg (lot AC21B051AA). On 6/9/06, the subject also received the 1st dose of Haemophilus influenzae tetanus conjugate vaccine (lot UB472AA) and 7-valent pneumococcal conjugate vaccine (lot B08633C) at unspecified sites of injection. On 6/9/06 at 3:00 PM, 6 hours after vaccination with Pediarix, the subject experienced jerking, a fever of 101 degrees F, inconsolable pain and crying. The healthcare professional reported that there was, no loss of consciousness associated with the jerking. The subject was treated with paracetamol which had no effect on the symptoms. The healthcare professional considered the events were disabling. On 6/12/06 the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Pediarix.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Bacterial infection, Crying, Muscle rigidity, Muscle twitching
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of jerking in a 5 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. There were no concurrent medications. On 6/9/06 at 09:00 AM, the subject received 1st dose of Pediarix in the left leg (lot AC21B051AA). On 6/9/06, the subject also received the 1st dose of Haemophilus influenzae tetanus conjugate vaccine (lot UB472AA) and 7-valent pneumococcal conjugate vaccine (lot B08633C) at unspecified sites of injection. On 6/9/06 at 3:00 PM, 6 hours after vaccination with Pediarix, the subject experienced jerking, a fever of 101 degrees F, inconsolable pain and crying. The healthcare professional reported that there was, no loss of consciousness associated with the jerking. The subject was treated with paracetamol which had no effect on the symptoms. The healthcare professional considered the events were disabling. On 6/12/06 the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Pediarix.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of jerking in a 5 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. There were no concurrent medications. On 6/9/06 at 09:00 AM, the subject received 1st dose of Pediarix in the left leg (lot AC21B051AA). On 6/9/06, the subject also received the 1st dose of Haemophilus influenzae tetanus conjugate vaccine (lot UB472AA) and 7-valent pneumococcal conjugate vaccine (lot B08633C) at unspecified sites of injection. On 6/9/06 at 3:00 PM, 6 hours after vaccination with Pediarix, the subject experienced jerking, a fever of 101 degrees F, inconsolable pain and crying. The healthcare professional reported that there was, no loss of consciousness associated with the jerking. The subject was treated with paracetamol which had no effect on the symptoms. The healthcare professional considered the events were disabling. On 6/12/06 the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Pediarix.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hypersensitivity, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 12 hrs had pain in arm, subsequently had pain, swelling. Pain helped by muscle relaxants. Now had redness, blanching, has probable arthous type III hypersensitivity reaction.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: Received Adacel 6/19 and began with side effects on 6/20. Reports headache, vomiting, muscle aches, fever, swollen neck gland, site red, tender and swollen. Fever 100.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Tenderness, Vomiting
Clinical narrative: Received Adacel 6/19 and began with side effects on 6/20. Reports headache, vomiting, muscle aches, fever, swollen neck gland, site red, tender and swollen. Fever 100.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Nasal congestion, Urticaria
Clinical narrative: Pt returned to our office 20-25 mins after receiving vaccines with urticaria on head/face, legs and slightly on torso. Stuffy nose. Pt was given Benadryl orally and Orapred orally. Initial O2 sat 94%. Within 10 mins, O2 sat 98-100% on RA. Pt remained stable in office for 40 mins.
Age: 1.53
Sex: F
Vaccine: DTAP, OPV
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Developed chickenpox even though vaccinated 7/11/97.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Pronounced morbilliform rash 9-10 days s/p MMR.
Age: 0.49
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Gaze palsy, Tremor
Clinical narrative: When pt came in for CPE on 6/16/06, grandmother reported reaction to vaccines given 1/10/06. States that evening she witnessed a mild convulsion with pt shaking all over and eyes rolled back. States she doesn't think he lost consciousness. She did not report incident at that time or have pt seen because it didn't last long and he was fine afterwards. States maternal aunt had seizure after DTP. Pt was afebrile at time of seizure
Age: 57.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Swelling
Clinical narrative: Swelling under right axilla. No temp. Tx: Antihistamines
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever for 2 - 3 days starting day of vaccine; developed hives 6-14-06 - still present.
Age: 1.51
Sex: F
Vaccine: DTAP, MMR
Symptoms: Skin ulcer
Clinical narrative: Lesions on trunk of body and scalp for 3 weeks. No treatment.
Age: 7.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Had vaccines listed in box 13 on 6/5/06. Was brought in on morning of 6/7/06 with "swollen arm" on the left. On exam, he had slight swelling of upper arm with some redness. On applying pressure complained of some pain/itch. Dr felt this was a local reaction to the pertussis component.
Age: 1.02
Sex: F
Vaccine: HBPV, MMR, VARCEL
Symptoms: Blister
Clinical narrative: Multiple facial vesicles for 2 days
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Rash developed 6/12/2006. Less than 50 "spots" per parent. Never blistered. Physician exam stating varicella. No lab work done.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Child immunized 6/13/06 - Received phone call from "Grandmother 6/15 approx 8:00 AM". States noticed redness (diameter tennis ball and swelling diameter golf ball, hot to touch left deltoid area) on 6/14 about 2 PM. States gave Tylenol, child had mild temp. States looks better today (deltoid left) never had difficulty using arm, never complained of discomfort. Advised continue administer Tylenol prn and may also apply topical Benadryl PM, and cool compresses. Advised seek medical attention if notices anything abnormal - drainage, increased swelling, wheezing, inability to use arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis right thigh. Given Keflex antibiotic.
Age: 1.61
Sex: F
Vaccine: DTAP, HEPA, IPV, PNC
Symptoms: Febrile convulsion
Clinical narrative: Immunizations 06/16/06 - Seen in another clinic 06/17/06 with febrile seizures.
Age: 0.37
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever with generalized seizure lasting 17 minutes; Taken by paramedics to emergency department. Evaluation with blood, urine, CSF. Temp in ED 104.1
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Area both arms red/swollen and itchy per mom.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Itchy, red hive at injection site followed by spreading of hives to all extremities.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received on 02/22/2006, from the patient who is a health care professional. A 55 year old male patient with no reported significant medical history, had received a second administration (route not reported of Adacel, lot number C2454AA), in the left deltoid on 02/10/2006. The next day he experienced entire upper arm swelling, redness, warmth,pain and the area was the size of a baseball. He also had nausea and headache resulting from the intensity of the pain. The duration of the symptoms lasted approximately ten days then the area measured 1 x 1/2 in size. The patient was seen by a physician. He had not recovered from these events at the time of this report. Follow up information received on 03/29/2006 from the patient. The patient was treated with Tylenol and heat. The patient recovered from the event.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Initial report received on 02/22/2006, from the patient who is a health care professional. A 55 year old male patient with no reported significant medical history, had received a second administration (route not reported of Adacel, lot number C2454AA), in the left deltoid on 02/10/2006. The next day he experienced entire upper arm swelling, redness, warmth,pain and the area was the size of a baseball. He also had nausea and headache resulting from the intensity of the pain. The duration of the symptoms lasted approximately ten days then the area measured 1 x 1/2 in size. The patient was seen by a physician. He had not recovered from these events at the time of this report. Follow up information received on 03/29/2006 from the patient. The patient was treated with Tylenol and heat. The patient recovered from the event.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: A 39 year old female patient with an unknown medical history had received an administration (route and site not reported) of Adacel (lot number not reported) on an unspecified date. 24 hours post vaccination, the patient developed swelling, hardness, redness from the shoulder to the wrist and shooting pains in the lower arm. The signs and symptoms are persisting. There were no reports of fever. At the time of this report the patient had not recovered from these events.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Malaise, Musculoskeletal stiffness
Clinical narrative: Initial report received on 03/24/2006, from a health care provider. A 51 year old female patient with allergies to Demerol and Toradol had received an administration (route not reported) of Adacel (lot number C2454AA) in the left deltoid on 03/17/2006. 24 hours later, she complained of have pain and swelling at the injection site, general malaise and stiffness in the arm up to her neck, that required a physician visit on 03/22/2006. At the time of this report it was unknown if the patient had recovered from these events. Follow up information received on 05/01/2006: The patient had a history of allergic rhinitis. Treatment included ice and over the counter Benadryl. At the time of this report the patient had recovered.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Face oedema, Hypoaesthesia, Injection site oedema, Vomiting
Clinical narrative: Initial report received from a health care professional on 04/11/2006. A 33 year old female patient with a significant history of allergies developed swelling of her left upper arm, swelling of her face, left cheek and jaw, numbness and vomiting nine hours after receiving the intramuscular injection of Adacel, lot number C2454AA (expiry date 06/28/2008) in the left deltoid on 04/10/2006. The patient received in concomitant the intramuscular injection of Hepatitis B vaccination (lot number D040F). Site of administration not reported. Per reporter the patient had no illness at the time of vaccination. She was seen by a physician and treated with Motrin. At the time of this report the patient had not recovered.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Cough
Clinical narrative: Initial report received from a health care professional on 04/11/2006. A 44 year old female patient developed constant coughing the same day she received the intramuscular injection of Adacel, lot number C2384AA (sit of administration not reported) on 04/10/2006.  Per reporter, the patient will be seeing her primary care physician. Treatment was not reported. At the time of this report the patient had not recovered.
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Skin ulcer, Tenderness
Clinical narrative: A female patient (age and date of birth not reported) developed a lesion/nodule which was tender and firm, 1 cm in size after receiving the injection of Adacel (lot number unknown) one month ago. It was reported the vaccine was administered intradermally in the forearm. The exact date of administration was not reported. Per reporter the patient was seen by a physician. No treatment was reported. At the time of this report the patient had not recovered. Per reporter, who is the responsible physician, he will fax additional patient information via completed VAERS form.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site nodule, Injection site oedema, Injection site pain
Clinical narrative: Initial report received 05/15/2006, from a health care professional. A 48 year old female patient with a medical history of hypertension, anxiety and hyperthyroidism had received and administration of Adacel, lot number C2455AA, in the right deltoid (route not reported) on 04/27/2006. Within 24 hours post immunization, the patient's right arm became swollen from the shoulder to her elbow and was red, warm and painful. The patient contacted the physician's office and her symptoms were treated as cellulitis, but no confirmation of the diagnosis was provided. She was prescribed a ten day regimen of Keflex. On 05/12/2006, the patient was evaluated by the physician for a persisting nodule. The patient had not recovered from these adverse events at the time of this report.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Initial report received 05/15/2006, from a health care professional. A 48 year old female patient with a medical history of hypertension, anxiety and hyperthyroidism had received and administration of Adacel, lot number C2455AA, in the right deltoid (route not reported) on 04/27/2006. Within 24 hours post immunization, the patient's right arm became swollen from the shoulder to her elbow and was red, warm and painful. The patient contacted the physician's office and her symptoms were treated as cellulitis, but no confirmation of the diagnosis was provided. She was prescribed a ten day regimen of Keflex. On 05/12/2006, the patient was evaluated by the physician for a persisting nodule. The patient had not recovered from these adverse events at the time of this report.
Age: 18.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Muscular weakness
Clinical narrative: An 18 year old male patient presented to the physician's office on 05/15/2006 and prior to his vaccination with Adacel and Menomune he was found to have a fever of 102 degrees Fahrenheit, a red sore throat and throat ulcers. He was diagnosed with viral infection. He subsequently received his first intramuscular does of Adacel, lot number C2341AA, in the deltoid muscle and his first intramuscular dose of Menomune A/C/Y/W-135, lot number UE266AA in the deltoid muscle on 05/15/2006. The exact site of administration was not reported for either vaccine. Later that day, at an unspecified time, the patient developed abdominal wall weakness and weakness in his upper and lower extremities. It was reported that no diagnostic laboratory testing was completed. The next day the patient was evaluated by the physician and his symptoms had resolved. Follow-up information received on 15/Aug/2006 from a physician. The symptoms cleared on approximately 14/Aug/2006.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Unintended pregnancy
Clinical narrative: Initial report was received on 03/19/2006 and 05/23/06 from the patient. This is a 30 year old pregnant female with a history of asthma, seasonal allergies and one previous pregnancy that resulted in delivery of a normal, viable full term baby. The patient had received her last diphtheria tetanus vaccination some time in 1998 or 1999 (patient could not remember). She had been on progesterone fertility treatment for two weeks, between 04/17/2006 and 05/01/2006. The patient had received intramuscular dose of Adacel, lot number C2456AA, in the left deltoid muscle on 05/15/2006. The patient was not aware of the pregnancy at the time of the vaccination. Subsequent blood work confirmed the pregnancy. The expected date of delivery was reported as sometime in January or February 2007. The date of her last menstrual period was 04/14/2006. Forty eight hours post immunization, the patient developed soreness at the injection site. It was not reported if any treatment was received for this. At the time of this report, it was not reported if the patient had recovered from the injection site soreness.
Age: 44.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, MMR, MNQ, TYP, YF, FLUX, HEPAB, IPV, MNQ, TYP, YF
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Movement disorder
Clinical narrative: June 13, 2006 felt like mass in throat, then numbness in fingers and toes. Started having difficulty in gait followed by weakness in gym (unable to lift weights). Treated by IVIG and dose Prednisolone. Admitted 6/20/06.
Age: 44.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, MMR, MNQ, TYP, YF, FLUX, HEPAB, IPV, MNQ, TYP, YF
Symptoms: Throat tightness
Clinical narrative: June 13, 2006 felt like mass in throat, then numbness in fingers and toes. Started having difficulty in gait followed by weakness in gym (unable to lift weights). Treated by IVIG and dose Prednisolone. Admitted 6/20/06.
Age: 44.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, MMR, MNQ, TYP, YF, FLUX, HEPAB, IPV, MNQ, TYP, YF
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Throat tightness
Clinical narrative: June 13, 2006 felt like mass in throat, then numbness in fingers and toes. Started having difficulty in gait followed by weakness in gym (unable to lift weights). Treated by IVIG and dose Prednisolone. Admitted 6/20/06.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: "Bad" headache, fever 99.6, fatigue, severe chills for approximately 1 hour, pain @site.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure, fever 102.6 (R) 15-20 minute seizure, before postictal period had normal exam in ER No h/o febrile seizure in past
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: As soon as Varivax was given there was an immediate wheal formation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Local reaction, swollen redness induration at DTAP site extended from upper arm to elbow
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis
Age: 24.0
Sex: F
Vaccine: HEPA, RAB
Symptoms: Convulsion, Loss of consciousness, Syncope
Clinical narrative: PCT developed syncope, tonic and clonic achirhesl/seizures lost consciousness approximately 40-50 seconds. Treatment oxygen mask, Benadryl IM 50mg.
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: High fever with red mark @ sight of his shot.
Age: 34.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Bacterial infection, CSF test abnormal, Erythema, Headache, Injection site abscess
Clinical narrative: Hospitalized on 9/24/05 due to possible meningitis. Headache, general Start: 9/20/05 10 days post vaccination. Fever 9/20/05. Erythema 9/20/05, end 9/30/05, drainage at SPV site. Follow up 6/06: patient states he fully recovered with no residual effects. Discharge summary states pharyngitis. msv Medical records state photophobia, bacterial infection. msv
Age: 34.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Laboratory test abnormal, Leukocytosis, Lymphadenopathy, Meningitis, Pharyngitis
Clinical narrative: Hospitalized on 9/24/05 due to possible meningitis. Headache, general Start: 9/20/05 10 days post vaccination. Fever 9/20/05. Erythema 9/20/05, end 9/30/05, drainage at SPV site. Follow up 6/06: patient states he fully recovered with no residual effects. Discharge summary states pharyngitis. msv Medical records state photophobia, bacterial infection. msv
Age: 34.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Photophobia, Pyrexia
Clinical narrative: Hospitalized on 9/24/05 due to possible meningitis. Headache, general Start: 9/20/05 10 days post vaccination. Fever 9/20/05. Erythema 9/20/05, end 9/30/05, drainage at SPV site. Follow up 6/06: patient states he fully recovered with no residual effects. Discharge summary states pharyngitis. msv Medical records state photophobia, bacterial infection. msv
Age: 0.21
Sex: F
Vaccine: DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Dehydration, Diarrhoea, Enteritis, Immunoglobulins increased, Otitis media
Clinical narrative: Initial report received on 08May06 from an investigator participating in the above mentioned trial. A six month old female subject experienced failure to thrive and chronic diarrhea, 112 days after receiving an IM, right thigh, second dose injection of Influenza virus vaccine No preservative Trival A and B Subvirion U. Lot number UD07402. Sixteen days later, she was hospitalized for the event. At the time of this report the event was considered ongoing. According to investigator, the events were not related to the study vaccine. Follow up information received on 26May06. The subject's final diagnosis was autoimmune enteropathy assumed to be protein allergy. Follow up information received on 09Jun06. Per the reporter, 105 days post immunization, the subject developed otitis media, chronic diarrhea, mild dehydration and failure to thrive that lead to hospitalization on 06May06. On admission to the hospital the subject weighed 13 pounds 6 oz. A RAST test was completed and was negative for whey, wheat, soybean, peanut and egg. A barium contrast enema of the colon was normal with no abnormalities. Stool cultures for parasite, ova and bacteria were negative. Immunology/serology testing was completed and showed the immunology IGG=875 (range 211-741 mg/dl), IGG 1-750 (range 205-409), IgA 169 (range 10-50), IgM 104 (range 20-100), Celiac disease antibodies showed Gliadin ABS, IgG 74.9 (range 0.0-24.9EU) and Gliadin ABS, IGA34.9 (range 0.0-24.9EU). The HIV antibody was non reactive. Treatment for the event was not provided. The subject was started on Neocate 32-35 oz a day, with no other foods until good weight gain is obtained. The subject was discharged from the hospital on 19May06 with a discharge weight of 12 pounds 10.5 oz. The subject was discontinued from the study on 26May06. At the time of this report, the subject had not recovered from these events. The events in this case were previously reported as not related to the study vaccine, but according to the investigator, the causality has changed and is now being reported as related to the study vaccine.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Benign intracranial hypertension
Clinical narrative: Initial information received on 13Jun06 and 16Jun06 from a health care professional. A 17 yr old female pt had received a dose of Adacel, lot number C2341AA, in the arm on 07Dec05. The route and site of administration was not reported. One day later, the pt developed orbital pseudotumor. The pt was treated with high doses of corticosteroids and recovered. She again developed another orbital pseudotumor on 05Jun06 after receiving Tubersol on 24Apr06, and Menactra on 18Apr06, that event is reported in case 2006-01513.
Sex: U
Vaccine: FLUN3
Symptoms: Convulsion
Clinical narrative: A nurse reported that a child (gender and age unspecified) with unknown medical history had an episode of seizure following receipt of FluMist vaccine and was hospitalized. Information regarding hospitalization, treatment and event outcome were not provided at the time of this report. The reporter causality was not reported.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Rash macular
Clinical narrative: Rash that is red dots with raised white centers
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Lethargy, Pain, Pyrexia
Clinical narrative: Fever of 102.8 (A), pain, lethargy, diarrhea.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site induration
Clinical narrative: Local erythema. Induration
Age: 1.53
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: Right arm swollen. Patient placed on antibiotics due to Dtap vaccine reaction.
Age: 50.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient report left upper arm pain and soreness 4 weeks post injection.  She has tenderness to touch but no loss of left arm range of motion.  She report this persistant problem to employee health on 6/21/2006, when symptoms persisted.
Age: 50.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Tenderness
Clinical narrative: Patient report left upper arm pain and soreness 4 weeks post injection.  She has tenderness to touch but no loss of left arm range of motion.  She report this persistant problem to employee health on 6/21/2006, when symptoms persisted.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pt. experienced a fever of 101.7, severe body and muscle aching.  Nausea and vomiting that lasted approx. 8 hours.  She is still nauseated.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Injection site erythema, Injection site induration, Irritability
Clinical narrative: Pt. was extremely fussy with persistant crying for nearly 72 hours and left leg was red and indurated but resolved 4 days after the vaccination administration. The fussiness was most prominent the day after vaccination.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Amyotrophic lateral sclerosis, Balance disorder, Blood creatine phosphokinase increased, Fall, Hyporeflexia
Clinical narrative: 2 weeks after receiving flu shot I started falling and have been in a wheelchair since Feb 2005. Medical records state decreased reflexes, ALS. 60 day Follow-up Information 29-SEP-2006: I am still in a wheel chair. I am gradually regaining strength in my arms and legs and am crawling. I am getting oriental-accupuncture which is helping remove toxins.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Multiple sclerosis, Wheelchair user
Clinical narrative: 2 weeks after receiving flu shot I started falling and have been in a wheelchair since Feb 2005. Medical records state decreased reflexes, ALS. 60 day Follow-up Information 29-SEP-2006: I am still in a wheel chair. I am gradually regaining strength in my arms and legs and am crawling. I am getting oriental-accupuncture which is helping remove toxins.
Age: 18.0
Sex: F
Vaccine: MEN, PPV, MNQ, PPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Within 30 minutes of administration, pt developed localized swelling, erythema, ecchymosis and pain at administration site.   (Vaccine was given SQ/IM due to her diagnisis of ITP.)
Age: 18.0
Sex: F
Vaccine: MEN, PPV, MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Within 30 minutes of administration, pt developed localized swelling, erythema, ecchymosis and pain at administration site.   (Vaccine was given SQ/IM due to her diagnisis of ITP.)
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: ARTHUS REACTION DAY 3 AFTER INJECTION ABX
Age: 1.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Pyrexia, Rash morbilliform, Vomiting
Clinical narrative: On the 8th day my daughter developed a fever, which spiked to 104.2F with vomiting; on the 10th day she developed a measle-like rash one her entire body and face.  Made several calls to the doctor's office and after-hours care, but they could not confirm if the reaction was due to the vaccines.  Upon further investigation, I suspect these symptoms are a result of the ProQuad.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site nodule
Clinical narrative: Patient had nodules at each injection site (total of 3 sites) for 2 months.  No cellulitis, erythema, or signs of infection.
Age: 1.01
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure, temp 104 at ER and admission to hospital.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Mother states child cried inconsolable for 4 hours after receiving Dtap, IVP, HIB and Prevnar on 3/31/06. Slight fever x 24 hours (not taken per mother). Vomited x1 that same pm after crying.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Rash macular, Swelling
Clinical narrative: Seen 5/19/06. Skin upper third of left arm swollen and warm to touch, not firm, macular.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 5/17 mom called same day, very red hurt, swollen. 5/18 mom called left arm from shoulder to elbow is huge, swelling under arm, very hard.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Swelling
Clinical narrative: Temp 100.6, red are hot, swollen (arm in note)
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Erythema, heat, tenderness right upper thigh. Treated: Keflex 250mg 3/4 tsp PO QID for 7 days. Benadryl 12.5 mg/dl every 6 hours. OTC Ibuprofen as directed, ice.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Woke up with itching/burning between toes and top of feet; noted several 1cm fluid filled, red wheals between toes, on feet and heal. Some on lower leg and thigh; few on labia. Denies shortness of breath, chest tightness, or throat changes. At 5 PM, itching and redness decreased. By next day nearly gone. Benadryl 50mg every 4-6 hours. Caladryl lotion and oatmeal bath.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Papular lesions noted on trunk, extremities, and face; started 4 days ago (6/19/06). PE sparse about 7 papulovesicular lesions noted all over possibly from varicella shot.
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Erythematous rash on face.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous, Swelling
Clinical narrative: red, raised rash and splotches over entire body. Had antihistamine and steroid for swelling and itching Tuesday night (ER). Thursday more antihistamine given. Today 2/23  rash much worse - even over ears and neck as well as body.
Age: 26.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site erythema, Latex allergy, Pruritus
Clinical narrative: Immediate redness at injection site. Within 30 minutes, had developed a rash and had difficulty breathing (anaphylactic reaction). Within 1 hour, skin over majority of body (head, neck, torso, limbs) was itchy, red, and covered in hives (utricaria). Medical records state allergic reaction to vaccine. msv. Follow-up: Allergist suspects Latex, Neomycin Reaction.
Age: 26.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Rash, Urticaria, Vaccination complication
Clinical narrative: Immediate redness at injection site. Within 30 minutes, had developed a rash and had difficulty breathing (anaphylactic reaction). Within 1 hour, skin over majority of body (head, neck, torso, limbs) was itchy, red, and covered in hives (utricaria). Medical records state allergic reaction to vaccine. msv. Follow-up: Allergist suspects Latex, Neomycin Reaction.
Age: 26.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Dyspnoea, Rash
Clinical narrative: Immediate redness at injection site. Within 30 minutes, had developed a rash and had difficulty breathing (anaphylactic reaction). Within 1 hour, skin over majority of body (head, neck, torso, limbs) was itchy, red, and covered in hives (utricaria). Medical records state allergic reaction to vaccine. msv. Follow-up: Allergist suspects Latex, Neomycin Reaction.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site mass, Pyrexia, Rash, Swelling
Clinical narrative: Started running a mild fever on 6-13-06. It spiked in the middle of the night reaching at least 104 degrees.  We took her to the ER and were told that her ears and throat looked good so they wanted to test her for a UTI.  We chose to go with the bag method since we did not want them to put a catheter in her.  The bag was not put on correctly so the urine went in her diaper instead of the bag.  We followed up with her regular doctor later that day.  Again we were told that her ears and throat looked good.  We also got a clean urine sample in the bag at this visit.  We asked the doctor if she could be having a reaction to her shots.  She stated, "No, that would have happened within one to two days".  We were told that she had a fever of unknown origin and that if she still had it after two weeks we should come back to have her tested for an infectious disease.  We were not comfortable accepting that our daughter had an unusually high fever for no reason, so we utilized other resources (health lines, internet, etc.) and found out that her symptoms could indeed be due to her immunizations.  She ran this high temp until 6-16-06.  At that time she was still running a fever but it was lower, around 100 to 101 degrees.  Her fever finally broke in the middle of that night.  Tylenol and Motrin were only cutting her fever for half of the time so we had to give her tepid baths, etc. to keep her temp down until she could have more medicine. After her fever broke on 6-17-06, she developed a rash which started on her face and head and then spread all over her torso.  The rash finally cleared up on 6-21-06.  For the past couple of days, she has had a red swollen bump on her right thigh.  We are not sure if this is from her injection site or not.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Lethargy, Nausea, Pyrexia
Clinical narrative: Fever 102.5 F 12 hours, nausea 8-9 hours, lethargy 8-9 hours.
Age: 7.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling and fever.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Fatigue, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Shaky; swollen parotid glands. Continued observation. No other treatment.
Age: 18.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Parotid gland enlargement, Tremor
Clinical narrative: Shaky; swollen parotid glands. Continued observation. No other treatment.
Age: 60.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Medication error, Pyrexia, Rash morbilliform, Viral infection
Clinical narrative: 5-19-06 102 degrees,aches, sore eyes, 5-20 103 degrees, sore eyes, 5-21-06 102 - 103 degrees lethargic, 5-22 AM 99.1 degree feel better - PM 102 degree rash on forehead and temples, 5-23-06 102 degree wake up covered in measles 5-24 102 - 103 degrees rash, 5-25 101.5 rash, 5-26 99 degree rash, 5-27 98.6 rash, 5-28 rash, 5-29 light rash, 5-30 returned to work
Age: 60.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Drug ineffective, Eye pain, Lethargy, Pyrexia, Rash
Clinical narrative: 5-19-06 102 degrees,aches, sore eyes, 5-20 103 degrees, sore eyes, 5-21-06 102 - 103 degrees lethargic, 5-22 AM 99.1 degree feel better - PM 102 degree rash on forehead and temples, 5-23-06 102 degree wake up covered in measles 5-24 102 - 103 degrees rash, 5-25 101.5 rash, 5-26 99 degree rash, 5-27 98.6 rash, 5-28 rash, 5-29 light rash, 5-30 returned to work
Age: 60.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash morbilliform, Viral infection
Clinical narrative: 5-19-06 102 degrees,aches, sore eyes, 5-20 103 degrees, sore eyes, 5-21-06 102 - 103 degrees lethargic, 5-22 AM 99.1 degree feel better - PM 102 degree rash on forehead and temples, 5-23-06 102 degree wake up covered in measles 5-24 102 - 103 degrees rash, 5-25 101.5 rash, 5-26 99 degree rash, 5-27 98.6 rash, 5-28 rash, 5-29 light rash, 5-30 returned to work
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Cardiac enzymes, Catheterisation cardiac, Chest pain, Echocardiogram abnormal
Clinical narrative: Substernal pain 6-10 increasing, sharp and radiating into both arms. Diaphoretic. Pt given Dilaudid for pain and stat labs and testing were completed. Dx: Myocarditis, elevated Troponin, Aortic root dilation.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Laboratory test abnormal, Troponin
Clinical narrative: Substernal pain 6-10 increasing, sharp and radiating into both arms. Diaphoretic. Pt given Dilaudid for pain and stat labs and testing were completed. Dx: Myocarditis, elevated Troponin, Aortic root dilation.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Hyperhidrosis, Laboratory test abnormal, Myocarditis
Clinical narrative: Substernal pain 6-10 increasing, sharp and radiating into both arms. Diaphoretic. Pt given Dilaudid for pain and stat labs and testing were completed. Dx: Myocarditis, elevated Troponin, Aortic root dilation.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cerebral haematoma, Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: Substernal pain 6-10 increasing, sharp and radiating into both arms. Diaphoretic. Pt given Dilaudid for pain and stat labs and testing were completed. Dx: Myocarditis, elevated Troponin, Aortic root dilation.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Influenza like illness, Laboratory test abnormal, Myocarditis, Pain
Clinical narrative: Substernal pain 6-10 increasing, sharp and radiating into both arms. Diaphoretic. Pt given Dilaudid for pain and stat labs and testing were completed. Dx: Myocarditis, elevated Troponin, Aortic root dilation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Skin nodule, Swelling
Clinical narrative: 8 x 8 inch swollen red firm mass not hard and not hot to the touch.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Developed "softball size" lump under arm (arm pit) vaccine was given IM. Lymph node swelling.
Age: 22.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Erythema, Swelling
Clinical narrative: Later the same day noticed some redness and swelling. Over the next 2 - 3 days redness, swelling and general discomfort continued. Client took Benadryl for 2 days. No medical intervention by physician.
Age: 25.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Ear pain, Headache, Heart rate irregular
Clinical narrative: Started on May 29th with severe headache, and up until last Monday, 6/12/06 went to doctor with headache and earache. Was also told that he had irregular heartbeat. Was referred to cardiologist who did EKG and Echocardiogram which were found to be normal. Headache free since 6/15/2006 when started prescription for headache.
Age: 38.0
Sex: M
Vaccine: YF
Symptoms: Chest pain, Pericarditis
Clinical narrative: Chest pain for 2 weeks. Evaluated by cardiologist. Pericarditis confirmed by Echocardiogram.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Apnoea, Cardio-respiratory arrest, Hypoxia, Sudden infant death syndrome
Clinical narrative: Patient stopped breathing about 7:00 AM 5/10/2006. CPR began by rescue personnel and continued in ER. Pt intubated and resuscitative effort continued for 45 minutes. Pronounced dead at 8:09 AM 5/10/2006. 6/30/06 Received ER medical records which reveal patient arrived febrile & in full arrest.  History of URI for approx 1 mon prior to death & wa co-sleeping with adult.  Resuscitation unsuccessful. 6/30/06 Received medical records from PCP with no new info. 7/18/06 Received autopsy report which stated COD as Sudden Death in infant cosleeping with adult/ss
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Upper respiratory tract infection
Clinical narrative: Patient stopped breathing about 7:00 AM 5/10/2006. CPR began by rescue personnel and continued in ER. Pt intubated and resuscitative effort continued for 45 minutes. Pronounced dead at 8:09 AM 5/10/2006. 6/30/06 Received ER medical records which reveal patient arrived febrile & in full arrest.  History of URI for approx 1 mon prior to death & wa co-sleeping with adult.  Resuscitation unsuccessful. 6/30/06 Received medical records from PCP with no new info. 7/18/06 Received autopsy report which stated COD as Sudden Death in infant cosleeping with adult/ss
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, Pseudo lymphoma, Similar reaction on previous exposure to drug
Clinical narrative: Initial report received on 6/15/06 from a health care professional. This is a 17 year old female patient who has a past medical history of orbital pseudotumor on 12/07/05 that resolved. The patient received a SC injection of Tubersol on 4/24/06 and a SC injection of Menactra on 4/18/06. The lot numbers and sites of administration were not reported for either products. It is not recommended that Menactra or Tubersol be administered SC. The patient developed an orbital pseudotumor 42 days after receiving Tubersol. She was subsequently treated with high doses of corticosteroids. Relevant tests and laboratory data were reported as normal. At the time of this report, the patient had recovered from these events. The patient experienced a previous orbital pseudotumor on 12/08/050 after vaccination with Adacel on 12/7/05. The patient recovered. This event is reported in case 200601477. (OMIC)
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Contusion, Metrorrhagia, Petechiae, Pharyngitis, Platelet disorder
Clinical narrative: He developed ITP on 5/30/06 and was admitted to hospital. He was given IVIG. He was discharged on 5/31/06. He first developed petechiae and bruising on 5/26/06per mom. He developed bleeding on 5/30/06. 07/05/2006-hospital report received from Hospital-DC DX idiopathic thrombocytopenia purpura, strep pharyngitis. RX in hospital included IVIG, amoxicillin. Platelets 2000.  Temp on admission 36.9. PE documented petechial rash on neck, antecubital fossas (B) dorsum of feet, bruising on scalp, arms, legs, chest, spinous processes. Dried bleeding on inner aspect of lower lip. Throat mild erythema positive palatal petechiae. Behavior normal eating well. PMH includes bilateral myringotomy 5/10/06. FH includes sister with Wilm's tumor 2/05.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Thrombocytopenic purpura
Clinical narrative: He developed ITP on 5/30/06 and was admitted to hospital. He was given IVIG. He was discharged on 5/31/06. He first developed petechiae and bruising on 5/26/06per mom. He developed bleeding on 5/30/06. 07/05/2006-hospital report received from Hospital-DC DX idiopathic thrombocytopenia purpura, strep pharyngitis. RX in hospital included IVIG, amoxicillin. Platelets 2000.  Temp on admission 36.9. PE documented petechial rash on neck, antecubital fossas (B) dorsum of feet, bruising on scalp, arms, legs, chest, spinous processes. Dried bleeding on inner aspect of lower lip. Throat mild erythema positive palatal petechiae. Behavior normal eating well. PMH includes bilateral myringotomy 5/10/06. FH includes sister with Wilm's tumor 2/05.