chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood creatinine increased, Dehydration, Fatigue, Infection
Clinical narrative: Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06.  11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome.  Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit.  Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics.  ID & resp consults done.  No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion.  WBC 12.2, plts 40.  Rapid influenza test was neg.  Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nausea, Ocular hyperaemia, Pain, Pneumonia, Pyrexia
Clinical narrative: Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06.  11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome.  Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit.  Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics.  ID & resp consults done.  No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion.  WBC 12.2, plts 40.  Rapid influenza test was neg.  Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Renal failure acute, Sepsis, Weight decreased
Clinical narrative: Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06.  11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome.  Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit.  Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics.  ID & resp consults done.  No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion.  WBC 12.2, plts 40.  Rapid influenza test was neg.  Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.
Sex: U
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a physician and described the occurrence of death unspecified in a subject of unspecified age and gender who was vaccinated with Dtap, Manufacturer unspecified, for prophylaxis. On an unspecified date approximately a year before 11/7/06, the subject received a dose of Dtap (dose number and lot number not provided). Approx one month after vaccination with Dtap, the subject died. Report received via manufacturer.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema
Clinical narrative: Redness and swelling in left axilla, injection given right deltoid opposite arm.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Erythema
Clinical narrative: 20 minutes after injections pt developed three 1cm area of erythema on both feet and right lower leg, at about 500 pm mom called from home resolved. Dr will examine pt in office.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: Pt telephoned the office on 11/9/06 one day after receiving the vaccine, stating that she was having joint pain in her legs markly both knees. States that it hurt to straighten her legs. Pt stated that her arm was not sore, red, or swollen. Advised her to come in to the office or at least see her physician for check up and she refused. Instructed pt that this is probably not a reaction to flu vaccine.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Lt arm red, warm to touch, swollen from mid upper arm to anticubital area. C/O discomfort when touch. Physician notified.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Stomach discomfort
Clinical narrative: 10/18 has mosquito bites on each arm after injection site on upper arm, No temp noted scratching eased after 10/23, still has upset stomach.
Age: 7.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Nausea, Vomiting
Clinical narrative: Site swollen, red, nausea, vomiting, headaches.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperpyrexia, Neutropenia, Pyrexia
Clinical narrative: High fever 104 and Neutropenia. Pt presented with hyperpyrexia up to 104. Which began 24 hours after influenza vaccine. Noted to have decreased 1,700 5 days later.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Pyrexia
Clinical narrative: Fever, chills, joint pain and weakness started evening of Flu shot.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: B/P 160/110 11/09, 140/90 11/10 at private physician and office extremely tired, had diarrhea 11/04 et felt ill, Sunday 11/05 felt fine 11/06 feet and legs throbbing, no temp, still has frontal headache, left arm sore, achy, throbbing x 4 days
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: B/P 160/110 11/09, 140/90 11/10 at private physician and office extremely tired, had diarrhea 11/04 et felt ill, Sunday 11/05 felt fine 11/06 feet and legs throbbing, no temp, still has frontal headache, left arm sore, achy, throbbing x 4 days
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Discomfort, Fatigue, Headache
Clinical narrative: Developed headache 10/18/06 worsened 10/19/06. Developed achy joints and low back discomfort felt tired for 1 week.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea, Respiratory distress, Stridor, Wheezing
Clinical narrative: Significant shortness of breath and stridor moderate distress and wheezing. Xopenex 0.63 mg nebulizer was administered which improved pts condition stridor resolved completely.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Skin discolouration
Clinical narrative: Flu vaccine given 11/7/06 approx 3pm, next morning pink rash (with itching) over trunk and extremities.
Age: 11.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Large, red, swelling at site. Treatment Benadryl, cool packs, observation.
Age: 18.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling at site of injection (50mm x 50mm), hardness. Symptoms still resolving. Treating with Motrin for pain, observation.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Angioneurotic oedema, Face oedema
Clinical narrative: Angioedema lips for one month by history from pt.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Muscle spasms, Musculoskeletal stiffness, Pain
Clinical narrative: Erythema left arm, pt reported Tues evening 10/24 pain arm, stiffness and pain left side body cramping left leg Tues with increased difficulty breathing.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Arthritis, Hyperhidrosis, Lymphadenopathy, Nausea
Clinical narrative: PT reported on 10/27/06 that within 10 minutes after receiving vaccine she felt glands in neck felt hugh and later joints ached and felt like hot burning needles in them. Joints felt like on pins and needles. Then night of 10/26/06 had fever of 99 with spike of 103 with nausea. Reported had hugh sweat during night and woke up feeling better. 10/27/06 14:45 at time of report pt reported feeling fine.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia
Clinical narrative: PT reported on 10/27/06 that within 10 minutes after receiving vaccine she felt glands in neck felt hugh and later joints ached and felt like hot burning needles in them. Joints felt like on pins and needles. Then night of 10/26/06 had fever of 99 with spike of 103 with nausea. Reported had hugh sweat during night and woke up feeling better. 10/27/06 14:45 at time of report pt reported feeling fine.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: PT reported on 10/27/06 that within 10 minutes after receiving vaccine she felt glands in neck felt hugh and later joints ached and felt like hot burning needles in them. Joints felt like on pins and needles. Then night of 10/26/06 had fever of 99 with spike of 103 with nausea. Reported had hugh sweat during night and woke up feeling better. 10/27/06 14:45 at time of report pt reported feeling fine.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Respiratory distress
Clinical narrative: Pt admitted to medical center 10/24/2006 for SOB and resp distress. No documented fever. Long standing H/O COPD. Pt expired 11/2/06 no autopsy done.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Chills, Fatigue, Hand-foot-and-mouth disease, Heart rate increased
Clinical narrative: 10/25/06 am school nurse called to take child to Doctor. Rash hives on feet morning of 10/26/06 I reported to school nurse. Evening of 10/26/06 rash spread through body. Got appt 9:00am. 10/27/06 rash appeared to turn to blisters in certain areas of body spreading through out. Treated with Bacitracin zinc ointment. Prescription by Dr. Child did not have high fever. He experienced chills and sweating. Loss of appetite. Sores in mouth and nose, underneath tongue discoloration. Fast heart beat, tiredness. Also treated with Children's Benadryl and appears to have recovered today.  12/14/06 Received medical records which included Lot number.  Reveal patient seen on 10/25 with cold s/s of sore throat, nasal congestion & dry cough for approx 1 day.  Afebrile.  Exam revealed purulent nasal discharge & erythematous pharynx.  Received flu shot.  Developed rash which started on feet following day & spread to extremities.  Exam on 10/27 revealed gen macular erythematous rash with several erythematous, papular & occasionally umbilicated lesions on dorsal & ventral aspect of feet, palms, buttocks belly, chin & mouth.  Patient was out of school until 11/6/06. Final Dx: Hand, foot & mouth disease.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Injection site vesicles, Mouth ulceration, Rash, Tongue discolouration
Clinical narrative: 10/25/06 am school nurse called to take child to Doctor. Rash hives on feet morning of 10/26/06 I reported to school nurse. Evening of 10/26/06 rash spread through body. Got appt 9:00am. 10/27/06 rash appeared to turn to blisters in certain areas of body spreading through out. Treated with Bacitracin zinc ointment. Prescription by Dr. Child did not have high fever. He experienced chills and sweating. Loss of appetite. Sores in mouth and nose, underneath tongue discoloration. Fast heart beat, tiredness. Also treated with Children's Benadryl and appears to have recovered today.  12/14/06 Received medical records which included Lot number.  Reveal patient seen on 10/25 with cold s/s of sore throat, nasal congestion & dry cough for approx 1 day.  Afebrile.  Exam revealed purulent nasal discharge & erythematous pharynx.  Received flu shot.  Developed rash which started on feet following day & spread to extremities.  Exam on 10/27 revealed gen macular erythematous rash with several erythematous, papular & occasionally umbilicated lesions on dorsal & ventral aspect of feet, palms, buttocks belly, chin & mouth.  Patient was out of school until 11/6/06. Final Dx: Hand, foot & mouth disease.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 10/25/06 am school nurse called to take child to Doctor. Rash hives on feet morning of 10/26/06 I reported to school nurse. Evening of 10/26/06 rash spread through body. Got appt 9:00am. 10/27/06 rash appeared to turn to blisters in certain areas of body spreading through out. Treated with Bacitracin zinc ointment. Prescription by Dr. Child did not have high fever. He experienced chills and sweating. Loss of appetite. Sores in mouth and nose, underneath tongue discoloration. Fast heart beat, tiredness. Also treated with Children's Benadryl and appears to have recovered today.  12/14/06 Received medical records which included Lot number.  Reveal patient seen on 10/25 with cold s/s of sore throat, nasal congestion & dry cough for approx 1 day.  Afebrile.  Exam revealed purulent nasal discharge & erythematous pharynx.  Received flu shot.  Developed rash which started on feet following day & spread to extremities.  Exam on 10/27 revealed gen macular erythematous rash with several erythematous, papular & occasionally umbilicated lesions on dorsal & ventral aspect of feet, palms, buttocks belly, chin & mouth.  Patient was out of school until 11/6/06. Final Dx: Hand, foot & mouth disease.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Oedema, Pyrexia, Somnolence
Clinical narrative: Left axilla very swollen, left arm pain x 8 days severe per pt, high fevers subj x 4 days, excess fatigue, sleepiness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Laboratory test abnormal
Clinical narrative: 8-10 episodes of diarrhea s/p rotavirus PO vaccine. Lasted 12-14 days. RX with Pedialyte, formula D.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema, Pyrexia
Clinical narrative: About 24 hour immunization developed erythema with fever, left lateral thigh which increased within over 24 hours to 8cm diameter when seen in over 11/9/06 TX Keflex.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red, hot, swollen, around injection site, treatment Benadryl, Tylenol, cool compresses, observation.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Headache, Myalgia, Nausea
Clinical narrative: pain muscular, headache, nausea, heat muscular.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Rash papular
Clinical narrative: Papular rash partially circling arm near site where immunization given. Rash progressed to chest, abdomen, inner thighs, anterior neck, and face. Started approximately 7 hours after receiving immunization. Took Benadryl with no relief, Claritin with some relief. Notified HD 3 days after event began.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema, Injection site pain, Pain, Pyrexia
Clinical narrative: On 11/02/06 pt wife called to say pt running fever and c/o sore arm at site and injection and aching all over body. Pt taking Advil for pain and fever, Presented to clinic at 11/03/06. Temp 99.4 with pain and swelling in left arm.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Listless, Pyrexia
Clinical narrative: Parents brought child to clinic for fever (102.1 on arrival) and "listless".  Fever since early this morning (about 10 hours).  had not given any remedy for fever.  Was seen by MD and given tylenol suppository for fever and parents advised of fever control.  no other symptoms voiced.  child received flu vaccine 2 days ago.
Age: 14.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Urticaria
Clinical narrative: The day following administration of Nasal Flumist, developed mild urticarial rash on nose and cheeks.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: One day after flu shot mother noted 3x2 cm swelling and redness on left thigh where injection had been given.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Injection site pain, Nasal congestion
Clinical narrative: I had the flu shot on Friday and by Sunday, felt still very tired and started to get congested and coughing. I have continued to be congested (yellow) and coughing and it's more than a week later. When I had the shot the nurse drew blood so site was sore.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Developed high fever and severe body ache within 18 hours.  Attempted control with 1 gm acetaminophen every four hours.  After thre (3) doses changed to 400 mg ibuprofen every six (6) hours.  Fever subsided in 24 hours. Aches persisted for two (2) sufficient to warrant continued medication.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Received vaccination on 10/28/06.  On 10/29/06, noticed area around injection was very red, warm to touch, swollen (hard lump), and sore.  Noticed red area around injection site was spreading.  Returned to doctor on 10/31.  Took prescribed antibiotics (ceflix 250 BID 3 days).  Returned to doctor for follow-up on 11/7/06...injection site was healed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Received vaccination on 10/28/06.  On 10/29/06, noticed area around injection was very red, warm to touch, swollen (hard lump), and sore.  Noticed red area around injection site was spreading.  Returned to doctor on 10/31.  Took prescribed antibiotics (ceflix 250 BID 3 days).  Returned to doctor for follow-up on 11/7/06...injection site was healed.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Oedema peripheral, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: I had a severe reaction to the flu shot.  In addition to feeling like I have the flu, I have hives on most every part of my body-solid raised and large hives on the inside and outside of my legs, behind, arms and chest.  My nose is runny.  I continue to have major hives and swelling of the legs, feet and hands and it is 5 days later.  I still feel very ill.  My hives burn and itch.    There have been no changes in diet, creams or my environment.  I am not allergic to eggs.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Wheezing
Clinical narrative: Chest congestion with slight wheezing beginning about three hours after injection and lasting for about 48 hours.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction: left deltoid region.
Age: 18.0
Sex: M
Vaccine: MNQ, MEN, MEN
Symptoms: Back pain, Cough, Dyspnoea, Eye disorder, Muscle twitching
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from the pts parent. An 18 year old male pt, with no concurrent illnesses, had received a left arm injection of Menomune, lot number UE356AA, on 8/5/06 at 9:00 am for entrance into college. The route of administration was not reported. The product lot number provided has an expiration date of 7/28/06. The pt has past medical history of asthma for 18 years but has not taken any medication for this in the last three years. He is allergic to mold, dust, and pollen and receives weekly allergy shots. That evening after receiving the vaccination on  8/5/06, the pt developed a swollen tight throat and lung inflammation that progressed to constant throat tightness and lung congestion. 82 days later, he developed complete facial paralysis, and semi paralysis to his legs bilaterally. The pt required ER visit (date not reported) for these adverse events. The pt was treated with Prednisone, and amoxicillin, and reportedly experienced episodes of swollen throat with those treatments. At the time of this report, the pt was still having leg weakness but the facial symptoms had resolved. it is unknown if the pt has full recovered form these adverse events.
Age: 18.0
Sex: M
Vaccine: MNQ, MEN, MEN
Symptoms: Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from the pts parent. An 18 year old male pt, with no concurrent illnesses, had received a left arm injection of Menomune, lot number UE356AA, on 8/5/06 at 9:00 am for entrance into college. The route of administration was not reported. The product lot number provided has an expiration date of 7/28/06. The pt has past medical history of asthma for 18 years but has not taken any medication for this in the last three years. He is allergic to mold, dust, and pollen and receives weekly allergy shots. That evening after receiving the vaccination on  8/5/06, the pt developed a swollen tight throat and lung inflammation that progressed to constant throat tightness and lung congestion. 82 days later, he developed complete facial paralysis, and semi paralysis to his legs bilaterally. The pt required ER visit (date not reported) for these adverse events. The pt was treated with Prednisone, and amoxicillin, and reportedly experienced episodes of swollen throat with those treatments. At the time of this report, the pt was still having leg weakness but the facial symptoms had resolved. it is unknown if the pt has full recovered form these adverse events.
Age: 18.0
Sex: M
Vaccine: MNQ, MEN, MEN
Symptoms: Asthenia, Facial palsy, Inflammation, Lung disorder, Nasal congestion
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from the pts parent. An 18 year old male pt, with no concurrent illnesses, had received a left arm injection of Menomune, lot number UE356AA, on 8/5/06 at 9:00 am for entrance into college. The route of administration was not reported. The product lot number provided has an expiration date of 7/28/06. The pt has past medical history of asthma for 18 years but has not taken any medication for this in the last three years. He is allergic to mold, dust, and pollen and receives weekly allergy shots. That evening after receiving the vaccination on  8/5/06, the pt developed a swollen tight throat and lung inflammation that progressed to constant throat tightness and lung congestion. 82 days later, he developed complete facial paralysis, and semi paralysis to his legs bilaterally. The pt required ER visit (date not reported) for these adverse events. The pt was treated with Prednisone, and amoxicillin, and reportedly experienced episodes of swollen throat with those treatments. At the time of this report, the pt was still having leg weakness but the facial symptoms had resolved. it is unknown if the pt has full recovered form these adverse events.
Age: 18.0
Sex: M
Vaccine: MNQ, MEN, MEN
Symptoms: Paralysis, Pharyngeal oedema, Throat tightness
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from the pts parent. An 18 year old male pt, with no concurrent illnesses, had received a left arm injection of Menomune, lot number UE356AA, on 8/5/06 at 9:00 am for entrance into college. The route of administration was not reported. The product lot number provided has an expiration date of 7/28/06. The pt has past medical history of asthma for 18 years but has not taken any medication for this in the last three years. He is allergic to mold, dust, and pollen and receives weekly allergy shots. That evening after receiving the vaccination on  8/5/06, the pt developed a swollen tight throat and lung inflammation that progressed to constant throat tightness and lung congestion. 82 days later, he developed complete facial paralysis, and semi paralysis to his legs bilaterally. The pt required ER visit (date not reported) for these adverse events. The pt was treated with Prednisone, and amoxicillin, and reportedly experienced episodes of swollen throat with those treatments. At the time of this report, the pt was still having leg weakness but the facial symptoms had resolved. it is unknown if the pt has full recovered form these adverse events.
Age: 18.0
Sex: M
Vaccine: MNQ, MEN, MEN
Symptoms: Chest discomfort, Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia, Medication error
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from the pts parent. An 18 year old male pt, with no concurrent illnesses, had received a left arm injection of Menomune, lot number UE356AA, on 8/5/06 at 9:00 am for entrance into college. The route of administration was not reported. The product lot number provided has an expiration date of 7/28/06. The pt has past medical history of asthma for 18 years but has not taken any medication for this in the last three years. He is allergic to mold, dust, and pollen and receives weekly allergy shots. That evening after receiving the vaccination on  8/5/06, the pt developed a swollen tight throat and lung inflammation that progressed to constant throat tightness and lung congestion. 82 days later, he developed complete facial paralysis, and semi paralysis to his legs bilaterally. The pt required ER visit (date not reported) for these adverse events. The pt was treated with Prednisone, and amoxicillin, and reportedly experienced episodes of swollen throat with those treatments. At the time of this report, the pt was still having leg weakness but the facial symptoms had resolved. it is unknown if the pt has full recovered form these adverse events.
Age: 18.0
Sex: M
Vaccine: MNQ, MEN, MEN
Symptoms: Paraesthesia, Paralysis, Throat tightness, Vomiting, Weight decreased
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from the pts parent. An 18 year old male pt, with no concurrent illnesses, had received a left arm injection of Menomune, lot number UE356AA, on 8/5/06 at 9:00 am for entrance into college. The route of administration was not reported. The product lot number provided has an expiration date of 7/28/06. The pt has past medical history of asthma for 18 years but has not taken any medication for this in the last three years. He is allergic to mold, dust, and pollen and receives weekly allergy shots. That evening after receiving the vaccination on  8/5/06, the pt developed a swollen tight throat and lung inflammation that progressed to constant throat tightness and lung congestion. 82 days later, he developed complete facial paralysis, and semi paralysis to his legs bilaterally. The pt required ER visit (date not reported) for these adverse events. The pt was treated with Prednisone, and amoxicillin, and reportedly experienced episodes of swollen throat with those treatments. At the time of this report, the pt was still having leg weakness but the facial symptoms had resolved. it is unknown if the pt has full recovered form these adverse events.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Back pain, Decreased appetite, Ear disorder, Feeling hot, Headache
Clinical narrative: An 18 year old male patient with a history of severe migraine headaches, and ears popping had received a first, intra-muscular, right deltoid dose of Menactra on 05/Oct/2006 at 10:00 am.  Fifteen minutes post-immunization at 10:15am the father reported that the paint "looked funny and face looked blotchy". The patient only ate one half of his lunch.  Two hours and forty-five minutes later, the patient had a headache, felt warm, and felt like he was going to be sick.  One hour and twenty minutes later, the mother called the facility were the patient had received the Menactra vaccine stating the patient still had a headache, but denied any other symptoms.  The family reported that the patient had a problem with his ears popping during the summer and had just finished his antibiotics one to two weeks ago.  He was to have an appointment with and ENT on 09/Oct/2006.  The mother had advised to have the patient follow-up with the health center at school, or have him see a physician.  The following day, the reporter contacted the family by telephone and the family stated the patient had complained of back pain and was soon at the school health center on 09/Oct/2006, and because of the back pain he was told "he had a cold in his kidney".  The patient's temperature at the health center was 99.0 degrees.  The family reported that the patient was feeling better on 06/Oct/2006 but still complained of back discomfort but was attending school.  Per the reported, it was unknown if any diagnostic tests/laboratory data were performed.  Treatment received was not reported. At the time of this report, the patient had not fully recovered from these adverse events.  Follow-up information received on 30 October 2006.  Per the reporter, the case was reviewed and the Menactra was administered in the left deltoid; no additional information is available at this time.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Malaise, Migraine, Musculoskeletal discomfort, Pyrexia, Rash macular
Clinical narrative: An 18 year old male patient with a history of severe migraine headaches, and ears popping had received a first, intra-muscular, right deltoid dose of Menactra on 05/Oct/2006 at 10:00 am.  Fifteen minutes post-immunization at 10:15am the father reported that the paint "looked funny and face looked blotchy". The patient only ate one half of his lunch.  Two hours and forty-five minutes later, the patient had a headache, felt warm, and felt like he was going to be sick.  One hour and twenty minutes later, the mother called the facility were the patient had received the Menactra vaccine stating the patient still had a headache, but denied any other symptoms.  The family reported that the patient had a problem with his ears popping during the summer and had just finished his antibiotics one to two weeks ago.  He was to have an appointment with and ENT on 09/Oct/2006.  The mother had advised to have the patient follow-up with the health center at school, or have him see a physician.  The following day, the reporter contacted the family by telephone and the family stated the patient had complained of back pain and was soon at the school health center on 09/Oct/2006, and because of the back pain he was told "he had a cold in his kidney".  The patient's temperature at the health center was 99.0 degrees.  The family reported that the patient was feeling better on 06/Oct/2006 but still complained of back discomfort but was attending school.  Per the reported, it was unknown if any diagnostic tests/laboratory data were performed.  Treatment received was not reported. At the time of this report, the patient had not fully recovered from these adverse events.  Follow-up information received on 30 October 2006.  Per the reporter, the case was reviewed and the Menactra was administered in the left deltoid; no additional information is available at this time.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Renal disorder
Clinical narrative: An 18 year old male patient with a history of severe migraine headaches, and ears popping had received a first, intra-muscular, right deltoid dose of Menactra on 05/Oct/2006 at 10:00 am.  Fifteen minutes post-immunization at 10:15am the father reported that the paint "looked funny and face looked blotchy". The patient only ate one half of his lunch.  Two hours and forty-five minutes later, the patient had a headache, felt warm, and felt like he was going to be sick.  One hour and twenty minutes later, the mother called the facility were the patient had received the Menactra vaccine stating the patient still had a headache, but denied any other symptoms.  The family reported that the patient had a problem with his ears popping during the summer and had just finished his antibiotics one to two weeks ago.  He was to have an appointment with and ENT on 09/Oct/2006.  The mother had advised to have the patient follow-up with the health center at school, or have him see a physician.  The following day, the reporter contacted the family by telephone and the family stated the patient had complained of back pain and was soon at the school health center on 09/Oct/2006, and because of the back pain he was told "he had a cold in his kidney".  The patient's temperature at the health center was 99.0 degrees.  The family reported that the patient was feeling better on 06/Oct/2006 but still complained of back discomfort but was attending school.  Per the reported, it was unknown if any diagnostic tests/laboratory data were performed.  Treatment received was not reported. At the time of this report, the patient had not fully recovered from these adverse events.  Follow-up information received on 30 October 2006.  Per the reporter, the case was reviewed and the Menactra was administered in the left deltoid; no additional information is available at this time.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Back pain, Decreased appetite, Feeling hot, Headache, Nausea
Clinical narrative: An 18 year old male patient with a history of severe migraine headaches, and ears popping had received a first, intra-muscular, right deltoid dose of Menactra on 05/Oct/2006 at 10:00 am.  Fifteen minutes post-immunization at 10:15am the father reported that the paint "looked funny and face looked blotchy". The patient only ate one half of his lunch.  Two hours and forty-five minutes later, the patient had a headache, felt warm, and felt like he was going to be sick.  One hour and twenty minutes later, the mother called the facility were the patient had received the Menactra vaccine stating the patient still had a headache, but denied any other symptoms.  The family reported that the patient had a problem with his ears popping during the summer and had just finished his antibiotics one to two weeks ago.  He was to have an appointment with and ENT on 09/Oct/2006.  The mother had advised to have the patient follow-up with the health center at school, or have him see a physician.  The following day, the reporter contacted the family by telephone and the family stated the patient had complained of back pain and was soon at the school health center on 09/Oct/2006, and because of the back pain he was told "he had a cold in his kidney".  The patient's temperature at the health center was 99.0 degrees.  The family reported that the patient was feeling better on 06/Oct/2006 but still complained of back discomfort but was attending school.  Per the reported, it was unknown if any diagnostic tests/laboratory data were performed.  Treatment received was not reported. At the time of this report, the patient had not fully recovered from these adverse events.  Follow-up information received on 30 October 2006.  Per the reporter, the case was reviewed and the Menactra was administered in the left deltoid; no additional information is available at this time.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Rash macular
Clinical narrative: An 18 year old male patient with a history of severe migraine headaches, and ears popping had received a first, intra-muscular, right deltoid dose of Menactra on 05/Oct/2006 at 10:00 am.  Fifteen minutes post-immunization at 10:15am the father reported that the paint "looked funny and face looked blotchy". The patient only ate one half of his lunch.  Two hours and forty-five minutes later, the patient had a headache, felt warm, and felt like he was going to be sick.  One hour and twenty minutes later, the mother called the facility were the patient had received the Menactra vaccine stating the patient still had a headache, but denied any other symptoms.  The family reported that the patient had a problem with his ears popping during the summer and had just finished his antibiotics one to two weeks ago.  He was to have an appointment with and ENT on 09/Oct/2006.  The mother had advised to have the patient follow-up with the health center at school, or have him see a physician.  The following day, the reporter contacted the family by telephone and the family stated the patient had complained of back pain and was soon at the school health center on 09/Oct/2006, and because of the back pain he was told "he had a cold in his kidney".  The patient's temperature at the health center was 99.0 degrees.  The family reported that the patient was feeling better on 06/Oct/2006 but still complained of back discomfort but was attending school.  Per the reported, it was unknown if any diagnostic tests/laboratory data were performed.  Treatment received was not reported. At the time of this report, the patient had not fully recovered from these adverse events.  Follow-up information received on 30 October 2006.  Per the reporter, the case was reviewed and the Menactra was administered in the left deltoid; no additional information is available at this time.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Initial report received on 06 November 2006 from a health care professional.  A two-month-old male patient had received an injection of ActHIB, lot number UF009AB (lot number Z0815-2); an injection of Prevnar, manufacturer reported, lot number B08653K; an injection of Pediarix, manufacturer reported, lot number AC21B065AA; and an administration of Rotateq, manufacturer reported, lot number 0776F; on 17 October 2006.  Route and sites of administration were not provided.  There was no illness at the time of vaccination.  Five days post-vaccination, on 22 October 2006, the patient was transported to an emergency room and was dead on arrival.  Additional medically relevant information was not provided.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Initial report received on 06 November 2006 from a health care professional.  A two-month-old male patient had received an injection of ActHIB, lot number UF009AB (lot number Z0815-2); an injection of Prevnar, manufacturer reported, lot number B08653K; an injection of Pediarix, manufacturer reported, lot number AC21B065AA; and an administration of Rotateq, manufacturer reported, lot number 0776F; on 17 October 2006.  Route and sites of administration were not provided.  There was no illness at the time of vaccination.  Five days post-vaccination, on 22 October 2006, the patient was transported to an emergency room and was dead on arrival.  Additional medically relevant information was not provided.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Initial report received on 06 November 2006 from a health care professional.  A two-month-old male patient had received an injection of ActHIB, lot number UF009AB (lot number Z0815-2); an injection of Prevnar, manufacturer reported, lot number B08653K; an injection of Pediarix, manufacturer reported, lot number AC21B065AA; and an administration of Rotateq, manufacturer reported, lot number 0776F; on 17 October 2006.  Route and sites of administration were not provided.  There was no illness at the time of vaccination.  Five days post-vaccination, on 22 October 2006, the patient was transported to an emergency room and was dead on arrival.  Additional medically relevant information was not provided.
Age: 60.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 days post vaccination, developed large erythematous area which was hot to touch and very hard in the center; + painful.
Age: 60.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 2 days post vaccination, developed large erythematous area which was hot to touch and very hard in the center; + painful.
Age: 13.0
Sex: F
Vaccine: FLUN3, PPV, TD
Symptoms: Dizziness, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Marked redness, swelling and pain at site of PPV 23, Headache, nausea, dizziness, neck pain.
Age: 13.0
Sex: F
Vaccine: FLUN3, PPV, TD
Symptoms: Nausea, Neck pain
Clinical narrative: Marked redness, swelling and pain at site of PPV 23, Headache, nausea, dizziness, neck pain.
Age: 81.0
Sex: F
Vaccine: VARCEL
Symptoms: Gait disturbance, Hypoacusis, Tinnitus
Clinical narrative: Sudden onset gait instability, tinnitus and decreased hearing left ear at 4PM 11/09/06.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Flu vaccine leaked out the side of the syringe (BD integra) where the needle attaches. Vaccine dripped down her arm and got on her face. 0.3 ml (adjusted dose) was then readministered.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Nausea, Panic reaction
Clinical narrative: Nausea, Dizziness, flushed feeling. Person suffers from panic attacks, low BP 92/58.
Age: 0.77
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Wheezing
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Agitation, Bradycardia, Crying, Hypoxia, Neonatal apnoeic attack
Clinical narrative: Screaming uncontrollably. Vomiting in the mornings, looks like he's cramping up. 11/27/06 Received medical records from hospital which reveal patient was admitted from birth on 8/26/06 to 9/3/06. Developed grunting respirations & episodes of apnea & bradycardia.  Tx with IVF & antibiotics & caffiene for suspected apnea of preemie.  Then continued to improve.  D/c home on apnea monitor & oral caffiene.  D/C weight 4 lbs 9 oz. Birth hx: 36 wks, NSVD, small for gest age.  Apgars 7 & 8.  Some concern about maternal infection, Mom had fever s/p delivery & placenta was malodorous. Final Dx: 36 wk gestational age infant w/initial respiratory distress, hypoxia & suspected sepsis, all resolved; hypospadias; apnea of preemie/ss
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Neonatal respiratory distress syndrome, Sepsis, Vomiting
Clinical narrative: Screaming uncontrollably. Vomiting in the mornings, looks like he's cramping up. 11/27/06 Received medical records from hospital which reveal patient was admitted from birth on 8/26/06 to 9/3/06. Developed grunting respirations & episodes of apnea & bradycardia.  Tx with IVF & antibiotics & caffiene for suspected apnea of preemie.  Then continued to improve.  D/c home on apnea monitor & oral caffiene.  D/C weight 4 lbs 9 oz. Birth hx: 36 wks, NSVD, small for gest age.  Apgars 7 & 8.  Some concern about maternal infection, Mom had fever s/p delivery & placenta was malodorous. Final Dx: 36 wk gestational age infant w/initial respiratory distress, hypoxia & suspected sepsis, all resolved; hypospadias; apnea of preemie/ss
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Erythema, Myalgia, Nausea, Swelling
Clinical narrative: Left arm swelling, redness, warm to touch, soreness (describes as "caked-feeling" (hardness) under the redness).  Gave shot 11/07/2006 approximately 2 pm-adverse effects started next morning on 11/08/2006 (area effected starts about 3 inches below shot area and goes down arm another 4 to 5 inches) as of 11/10/2006, still experiencing side effects but still have lessened due to BENADRYL. Patient also states diarrhea and nauseated starting next morning.
Age: 1.27
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Anaphylactic reaction, Flushing, Swelling face, Urticaria
Clinical narrative: Patient was administered DTap/IPV/Flu vaccine within 5 minutes or less after vaccines given, patient developed generalized flushing and urticaria and swelling of lips noted, anaphylaxis.  Patient given Epinephrine SC and Decadron IM with with good response.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: Patient received Flumist at age 3 instead of after age 5.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling, Urticaria, Vomiting
Clinical narrative: Approximately 2 hours after vaccine, patient complain of increased hives on back of legs.  Then became painful.  Patient exercised at gym for 1 hour and then noticed swelling of both hands/wrists.  Vomited at 2100.  Took BENADRYL,  by mouth at 2300, as per phone order by private medical doctor.  Next am, patient woke up with increased hives and feet swelling.  Then went to hospital emergency room.
Age: 48.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Fatigue, Pruritus, Rash macular, Urticaria
Clinical narrative: States day of vaccines very fatigued by next patient treated generalized itching.  Had hive on side of face again with fatigue enough to sleep during the day. The following day states ears "burning with blotches" on her face extreme fatigue-on 4th day post vaccine patient state felt normal.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Rash pruritic, Swelling, Swelling face
Clinical narrative: Patient experienced periorbital swelling, swelling lips and papular pruritic rash face (temporal region) approximately 20 hours after receiving yellow fever in left deltoid.  Patient treated with Benadryl and Pepcid by mouth.
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Abdominal pain, Agitation, Crying, Gastrooesophageal reflux disease
Clinical narrative: Uncontrollable screaming mid afternoon on 11/4.  Seen at local ER, given TYLENOL suppository and examination.  No testing.  Discharged home and seemed fine.  Began uncontrollable screaming again approximately 1/2 hour after emergency room visit.  Taken to different hospital emergency room, then transferred to another hospital as rule out intussusception.  Admitted, stayed 2 days.  Kidney, Ureter, Bladder and Abdomen ultrasound negative.  No surgery.  11/27/06 Received records from PCP which included hospital diagnostic records & reveals patient admitted to hospital 11/5 with abdominal pain.  Abdominal xray could not r/o intussusception (IS).  US of abdomen/scrotum was found to be WNL & w/o evidence of IS but positive for small left hydrocele. PCP records indicate patient at birth had hypospadius, fractured left clavicle & elevated bilirubin (resolved).  Patient was irritable & fussy but developing well.  Dx w/GERD./ss  12/4/06 Received medical records from hospital which reveal patient admitted overnight, 11/5-11/6/06.  US was WNL & tol oral feedings.   Final Dx: Abdominal pain./ss
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Crying, Screaming
Clinical narrative: Uncontrollable screaming mid afternoon on 11/4.  Seen at local ER, given TYLENOL suppository and examination.  No testing.  Discharged home and seemed fine.  Began uncontrollable screaming again approximately 1/2 hour after emergency room visit.  Taken to different hospital emergency room, then transferred to another hospital as rule out intussusception.  Admitted, stayed 2 days.  Kidney, Ureter, Bladder and Abdomen ultrasound negative.  No surgery.  11/27/06 Received records from PCP which included hospital diagnostic records & reveals patient admitted to hospital 11/5 with abdominal pain.  Abdominal xray could not r/o intussusception (IS).  US of abdomen/scrotum was found to be WNL & w/o evidence of IS but positive for small left hydrocele. PCP records indicate patient at birth had hypospadius, fractured left clavicle & elevated bilirubin (resolved).  Patient was irritable & fussy but developing well.  Dx w/GERD./ss  12/4/06 Received medical records from hospital which reveal patient admitted overnight, 11/5-11/6/06.  US was WNL & tol oral feedings.   Final Dx: Abdominal pain./ss