chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, PNC
Symptoms: Induration, Nodule on extremity, Oedema peripheral
Clinical narrative: Right thigh swelling within 2-4 hours after injections.  Swelling peaked at 2 days.  As swelling decreased, mom noticed hard, dime sized lumps in thigh.  Lump has lasted for more than 6 weeks.  Swelling gone.  No treatment.  Using leg normally.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, PNC
Symptoms: Induration, Nodule on extremity, Oedema peripheral
Clinical narrative: Right thigh swelling within 2-4 hours after vaccines.  Swelling peaked at 2 days.  As swelling decreased, mom noted hard, dime sized lumps in thigh.  Lump has lasted for more than 6 weeks.  Swelling gone.  No treatment.  Using legs normally.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: Injection site - left deltoid within 2" upper arm became very hard and swollen, warm to touch, extremely painful with minimal relief from Motrin or Tylenol. Left axilla and lymph nodes also very red, swollen, warm, and painful. Sx lasted five days, before beginning to subside.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Skin warm
Clinical narrative: Injection site - left deltoid within 2" upper arm became very hard and swollen, warm to touch, extremely painful with minimal relief from Motrin or Tylenol. Left axilla and lymph nodes also very red, swollen, warm, and painful. Sx lasted five days, before beginning to subside.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Pallor
Clinical narrative: After first shot - exhausted 24 hrs - per donor/friends.  s/s that occurred after this shot: dizzy/nausea/pale/faint feeling/weakness.  Elevated legs, monitored vs, 10 oz H2O and 5 oz yogurt given.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Syncope
Clinical narrative: After first shot - exhausted 24 hrs - per donor/friends.  s/s that occurred after this shot: dizzy/nausea/pale/faint feeling/weakness.  Elevated legs, monitored vs, 10 oz H2O and 5 oz yogurt given.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Musculoskeletal discomfort, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Patient reported of swollen, red shoulder after receiving what appears to be an IM injection 2 days ago.  Joint pain in shoulder.  Patient states it feels as if his shoulder has been pulled out of socket.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: 2 days after injection of Varivax into left arm, developed local reaction: swelling, redness, and itching about size of orange - did not measure.  When seen in office symptoms had decreased.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Urine analysis abnormal, Urticaria
Clinical narrative: Severe urticarial rash started on the 3rd day after injection.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: 3 days s/p injection c/o severe pain.
Age: 40.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Headache
Clinical narrative: c/o headache beginning 1/2 hr after shots - still has today 2-11-08.
Age: 7.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Wheezing
Clinical narrative: Wheezing and redness of face shortly after vaccines given.  Treatment - Epi-Pen, Benadryl, Prednisone.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Soreness at injection site on same day as vaccination.  Then by 2/2/08 symptoms increased.  Headache, mild stomach ache, arm achy, unable to lift higher than 90 degree angle.  No fever, no swelling or redness at site.  Symptoms lasted 2 wks.  Relieved slightly with Naprosyn every 12 hours for 2 days.
Age: 0.3
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood bilirubin increased, Blood bilirubin increased
Clinical narrative: 2/4/08 - Seen by patient's pediatrician at office for stools with no color (acholic stools).  Liver function panel: mild elevation of total bilirubin, direct bilirubin, and ALT/AST enzymes.  2/11/08 - Abdominal ultrasound showed multiple gallstones. 02/11/2010 Follow-up information from a physician conceringin a 21 week old male with no pre-existing medical conditions or allergies who on 15-JAN-2008 at 11:49 was vaccinated PO with his second dose of GARDASIL (lot# 657985/1244U). There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 11:48 included the second dose of TRIPEDIA (lot# U2354BA) in the right anterolateral thigh, the second dose IPOL (lot# Z08732) in the left anterolateral thigh and the second dose PREVENAR (lot# 70145A) in the left anterolateral thigh. On 04-FEB-2008 at 14:19 the patient was seen by the reporting pediatirician for complaint of stools with ono color. The patient had a normal physical examination with no signs of jaundice. Lab diagnostic studies performed included a liver function panel which showed mild elevation of tatl bilirubin 2.0 direct bilirubin 0.8 and AST=79 ALT=140 enzymes. Oh 11-FEB 2008 an abdominal ultrasound showed multiple gall stones. On 21-FEB-2008 with repeat abdominal ultrasound showed interval improvement with fever gall scones, no bile duct dilatation and questionable sludge in gall bladder. On that same day that same day the patient recovered.  Additional information  has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Cholelithiasis, Faeces pale, Ultrasound abdomen abnormal
Clinical narrative: 2/4/08 - Seen by patient's pediatrician at office for stools with no color (acholic stools).  Liver function panel: mild elevation of total bilirubin, direct bilirubin, and ALT/AST enzymes.  2/11/08 - Abdominal ultrasound showed multiple gallstones. 02/11/2010 Follow-up information from a physician conceringin a 21 week old male with no pre-existing medical conditions or allergies who on 15-JAN-2008 at 11:49 was vaccinated PO with his second dose of GARDASIL (lot# 657985/1244U). There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 11:48 included the second dose of TRIPEDIA (lot# U2354BA) in the right anterolateral thigh, the second dose IPOL (lot# Z08732) in the left anterolateral thigh and the second dose PREVENAR (lot# 70145A) in the left anterolateral thigh. On 04-FEB-2008 at 14:19 the patient was seen by the reporting pediatirician for complaint of stools with ono color. The patient had a normal physical examination with no signs of jaundice. Lab diagnostic studies performed included a liver function panel which showed mild elevation of tatl bilirubin 2.0 direct bilirubin 0.8 and AST=79 ALT=140 enzymes. Oh 11-FEB 2008 an abdominal ultrasound showed multiple gall stones. On 21-FEB-2008 with repeat abdominal ultrasound showed interval improvement with fever gall scones, no bile duct dilatation and questionable sludge in gall bladder. On that same day that same day the patient recovered.  Additional information  has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received pneumonia shot on 12/28/06. That same day my left arm from the injection site to my elbow became swollen, red and hot to the touch.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Itching right after shot.  Swelling & redness.  Rt upper arm.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Left arm with large, erythemazation area, warmth, tender.  Diagnosis Cellulitis.  Augmentin 400mg b.i.d. for 10 days.
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Dizziness, Shock, Syncope, Syncope vasovagal
Clinical narrative: Individual states felt dizzy and fainted for a quick second and recovered.  Individual states first time to have vasovagal reaction.  No injury resulted from reaction.  Individual treated for shock and monitored closely until felt better.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Patient received flu shot 10-29-07.  On 2-6-08 patient called me to complain her arm was still sore.  She has noticed loss of strength.  She said she tried both IBU and APAP.  She said she does not have PCP to follow up with, even though I referred her to her MD.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: After receiving MMR vaccination, child's arm became red and swollen from shoulder to elbow.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Vision blurred
Clinical narrative: Five minutes post injection pt c/o dizziness and blurred vision.  BP decreased.  Symptoms started subsiding after 5 minutes.  Discharged to home with no further complaints 20 min post injection.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Joint dislocation
Clinical narrative: Donor states hip pain since 2nd rabies vaccine on 210/08. States onset approx 3 hours after injection and today (2/11/08) feels hips are popping out of place. Reaction marked yes by medical receptionist and referred. While general aches and muscle pain are known reactions to vaccinations, localized pain is not a recognized reaction after vaccines.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received redness and swelling at injection site.  Instructed to use cold compress and f/u w/ doctor if worsens.
Age: 29.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Pts LA swelled up, turned red and was warm to touch at injection site.  Instructed pt to put cold compress on site.
Age: 55.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Erythema, Mass, Skin irritation, Skin warm, Swelling
Clinical narrative: Red and swollen, warm to touch with lump about 50+ mm.  Individual just complain of minor irritation.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Syncope
Clinical narrative: Pt stated he felt dizzy and lightheaded. Pt fainted, laid pt down and elevated feet.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HBHEPB, PNC
Symptoms: No adverse reaction
Clinical narrative: No adverse events. Pt received 2 doses hep B.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse reaction
Clinical narrative: None.  Patient given extra dose of Hep A.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Erythema, Skin nodule, Skin warm
Clinical narrative: Immunizations: Pediarix and Prevnar given in (R) thigh on 1/30/08. On 2/2/08 2 firm lumps noted in thigh with erythema - warm to touch. Advised cool compresses and Tylenol.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: 1/29/08 - sore inj. site.  1/29-1/30 - fever 99.8 - body aches.  1/31 - fever gone & body aches gone.  2/1 - better, recovered.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy, nausea
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Hot, swollen, sl tender - Lt deltoid area. 5cm x 6cm area of erythema - no fever, Rx - Benadryl and Duricef.
Age: 49.0
Sex: M
Vaccine: RAB
Symptoms: Herpes zoster
Clinical narrative: Rash (L) side of thorax. Classic "shingles" outbreak of vesicles along dermatomal distribution over (L) ribs (9th or 10th rib) in a narrow band per doctor.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Sneezing, Swelling face, Urticaria
Clinical narrative: Facial swelling, sneezing, generalized urticaria within 5 minutes of Varivax #2. Resolved by 24 hours later.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: 1st injection on 2-5-08 donor stated about 8 hrs later after the injection experienced nausea and had emesis x2, the nausea lasted 36 hrs and then resolved. 2nd injection on 2-8-08 had nausea 8 hrs after injection and had emesis x 1, the nausea lasted 20 hrs then resolved. No treatment given.
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Skin nodule, Urticaria
Clinical narrative: Pt received Twinrix vaccine on 1/30/08. About 3 days after receiving vaccine he developed bumps on his neck bilaterally which were somewhat itchy. Bumps were somewhat "hive like" on (L) side of neck but less prominent on (R) side.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: No adverse event. Pt received 2 varicella vaccines - now with active chicken pox.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: One day after vaccine pt had red, itchy rash in axilla, abdomen and groin - pt also takes many medications but none were new at that time. Patient treated with oral steroids and rash resolved.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Induration, Pain, Pruritus
Clinical narrative: Erythema, swelling, induration, pain and itching. Onset in evening after vaccine administration. Treated with antihistamines and antibiotics for secondary cellulitis.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: Erythema, swelling, induration, pain and itching. Onset in evening after vaccine administration. Treated with antihistamines and antibiotics for secondary cellulitis.
Age: 33.0
Sex: M
Vaccine: ANTH, HEP, MMRV, UNK, ANTH, HEP, TYP
Symptoms: Cough, Dizziness, Fatigue, Sinus headache, Sinusitis
Clinical narrative: Persistent generalized joint pains x2 weeks, since receipt of vaccines on 24 JAN 2008.  Service member received AVA #1 (left arm) and HepB #2, typhoid booster (right arm) on 24 JAN 2008.  About 1.5-2 hours following vaccine receipt, he experienced onset of a "sinus headache", fatigue, light-headedness, and generalized joint pains - he treated this with OTC Vanquish and sleep.  Within 24 hours later, he noted local injection site pain in arms, itching and swelling around the left arm injection site - "golf-ball size".  He denied fever/chills, skin eruptions, angio-edema, cardio-respiratory or other systemic symptoms.  He was treated for a sinus infection by his civilian PCM last week.  At the time of interview, SM reported resolution of all symptoms except for persistent generalized joint pain and fatigue.  He left arm swelling had decreased to "marble size".  SM denied previous vaccine reactions; he has hd both HepB and typhoid vaccines in past without reaction.  He reported filing his own VAERS report.  Symptom: Joint Pain, multiple joints.  Start: 01/24/2008.  Symptom: Swelling.  Start: 01/24/2008.  Comment: left arm at injection site, size of 'golf ball'.  Symptom: Fatigue, Malaise >60 Days.  Start: 01/24/2008.
Age: 33.0
Sex: M
Vaccine: ANTH, HEP, MMRV, UNK, ANTH, HEP, TYP
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Injection site pruritus
Clinical narrative: Persistent generalized joint pains x2 weeks, since receipt of vaccines on 24 JAN 2008.  Service member received AVA #1 (left arm) and HepB #2, typhoid booster (right arm) on 24 JAN 2008.  About 1.5-2 hours following vaccine receipt, he experienced onset of a "sinus headache", fatigue, light-headedness, and generalized joint pains - he treated this with OTC Vanquish and sleep.  Within 24 hours later, he noted local injection site pain in arms, itching and swelling around the left arm injection site - "golf-ball size".  He denied fever/chills, skin eruptions, angio-edema, cardio-respiratory or other systemic symptoms.  He was treated for a sinus infection by his civilian PCM last week.  At the time of interview, SM reported resolution of all symptoms except for persistent generalized joint pain and fatigue.  He left arm swelling had decreased to "marble size".  SM denied previous vaccine reactions; he has hd both HepB and typhoid vaccines in past without reaction.  He reported filing his own VAERS report.  Symptom: Joint Pain, multiple joints.  Start: 01/24/2008.  Symptom: Swelling.  Start: 01/24/2008.  Comment: left arm at injection site, size of 'golf ball'.  Symptom: Fatigue, Malaise >60 Days.  Start: 01/24/2008.
Age: 33.0
Sex: M
Vaccine: ANTH, HEP, MMRV, UNK, ANTH, HEP, TYP
Symptoms: Injection site swelling, Malaise, Oedema peripheral, Sinus headache
Clinical narrative: Persistent generalized joint pains x2 weeks, since receipt of vaccines on 24 JAN 2008.  Service member received AVA #1 (left arm) and HepB #2, typhoid booster (right arm) on 24 JAN 2008.  About 1.5-2 hours following vaccine receipt, he experienced onset of a "sinus headache", fatigue, light-headedness, and generalized joint pains - he treated this with OTC Vanquish and sleep.  Within 24 hours later, he noted local injection site pain in arms, itching and swelling around the left arm injection site - "golf-ball size".  He denied fever/chills, skin eruptions, angio-edema, cardio-respiratory or other systemic symptoms.  He was treated for a sinus infection by his civilian PCM last week.  At the time of interview, SM reported resolution of all symptoms except for persistent generalized joint pain and fatigue.  He left arm swelling had decreased to "marble size".  SM denied previous vaccine reactions; he has hd both HepB and typhoid vaccines in past without reaction.  He reported filing his own VAERS report.  Symptom: Joint Pain, multiple joints.  Start: 01/24/2008.  Symptom: Swelling.  Start: 01/24/2008.  Comment: left arm at injection site, size of 'golf ball'.  Symptom: Fatigue, Malaise >60 Days.  Start: 01/24/2008.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Activated partial thromboplastin time shortened, Blood urine present, Contusion, Haematochezia, Idiopathic thrombocytopenic purpura
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Intensive care, International normalised ratio, Petechiae, Platelet count decreased, Urine analysis abnormal
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count increased
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Contusion, Epistaxis, Haematochezia, Idiopathic thrombocytopenic purpura, Immunoglobulins
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Intensive care, Petechiae, Platelet count decreased, Transfusion
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Contusion, Epistaxis, Haematochezia, Idiopathic thrombocytopenic purpura, Petechiae
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Platelet count decreased
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Blood urine present, Contusion, Haematocrit, Haemoglobin, Idiopathic thrombocytopenic purpura
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Immunoglobulins, Intensive care, International normalised ratio, Petechiae, Platelet count decreased
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Prothrombin time, Red blood cells urine positive, Respiratory tract congestion, Transfusion, Urine analysis abnormal
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count
Clinical narrative: Initial report received on 08 February 2008 from a health care professional.  A three-month-old female patient, with a runny nose and mild congestion at the time of vaccination, had received a second dose, gluteus maximus, intramuscular injection of Act-HIB, lot number UF213AA (sanofi pasteur ltd. lot number A0317-2); a second dose, left leg, intramuscular injection of Pediarix, manufacturer GSK, lot number AC21B125CB; and a second dose, gluteus maximus, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B70145K; on 18 January 2008.  The patient was on no other medications.  Three days post-vaccination, the patient developed streaks of blood in her diaper.  The next day, the blood streaking was worse, and the patient was taken to an emergency room for evaluation.  Petechiae and bruising were noted in the emergency room, and the patient's platelet count was zero.  The patient was subsequently admitted to a pediatric intensive care unit with the diagnosis of idiopathic thrombocytopenic purpura.  Additional diagnostic testing included: WBC 12.5, Hgb. 12.1, Hct. 35.0, PT 10.7, INR 1.05, PTT 25.5, and urinalysis with trace of blood and 5 RBCs on microscopic evaluation.  The patient was treated with IVIG, steroids, and a platelet transfusion.  The reporter also considered the event to be a life threatening illness.  The patient was hospitalized for four days and subsequently recovered from the event.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Blindness, Headache, Optic neuritis
Clinical narrative: Information has been received from a physician concerning an 18 year old male with obesity and no drug allergies who in approximately 2004 and 07-JAN-2008 was vaccinated IM with his first and second 0.5 ml doses of Vaqta.  Concomitant vaccinations administered on 07-JAN-2008 included a dose of FluMist and a dose of MENACTRA.  In January 2008, the patient was having symptoms of blindness.  On approximately 14-JAN-2008 a week after administration the patient began to experience headaches and a few days later, the patient could not see.  The patient sought medical attention through an ophthalmologist and a neurologist.  At recent appointments the patient could not read the largest letter on the reading chart and prior to this point the patient had 20/20 vision.  It was noted that the patient was believed to have optic neuritis.  The patient was treated with a course of steroids and his headaches have gotten better since initiating treatment, but his vision has not.  The patient was under the care of a neuro-ophthalmologist at the time of this report and was not recovered.  There was no product quality complaint.  The events were considered to be disabling by the reporting physician.  Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Blindness, Headache, Ophthalmological examination abnormal, Optic neuritis
Clinical narrative: Information has been received from a physician concerning an 18 year old male with obesity and no drug allergies who in approximately 2004 and 07-JAN-2008 was vaccinated IM with his first and second 0.5 ml doses of Vaqta.  Concomitant vaccinations administered on 07-JAN-2008 included a dose of FluMist and a dose of MENACTRA.  In January 2008, the patient was having symptoms of blindness.  On approximately 14-JAN-2008 a week after administration the patient began to experience headaches and a few days later, the patient could not see.  The patient sought medical attention through an ophthalmologist and a neurologist.  At recent appointments the patient could not read the largest letter on the reading chart and prior to this point the patient had 20/20 vision.  It was noted that the patient was believed to have optic neuritis.  The patient was treated with a course of steroids and his headaches have gotten better since initiating treatment, but his vision has not.  The patient was under the care of a neuro-ophthalmologist at the time of this report and was not recovered.  There was no product quality complaint.  The events were considered to be disabling by the reporting physician.  Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Blindness, Headache, Lumbar puncture, Nuclear magnetic resonance imaging normal, Optic neuritis
Clinical narrative: Information has been received from a physician concerning an 18 year old male with obesity and no drug allergies who in approximately 2004 and 07-JAN-2008 was vaccinated IM with his first and second 0.5 ml doses of Vaqta.  Concomitant vaccinations administered on 07-JAN-2008 included a dose of FluMist and a dose of MENACTRA.  In January 2008, the patient was having symptoms of blindness.  On approximately 14-JAN-2008 a week after administration the patient began to experience headaches and a few days later, the patient could not see.  The patient sought medical attention through an ophthalmologist and a neurologist.  At recent appointments the patient could not read the largest letter on the reading chart and prior to this point the patient had 20/20 vision.  It was noted that the patient was believed to have optic neuritis.  The patient was treated with a course of steroids and his headaches have gotten better since initiating treatment, but his vision has not.  The patient was under the care of a neuro-ophthalmologist at the time of this report and was not recovered.  There was no product quality complaint.  The events were considered to be disabling by the reporting physician.  Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Vision blurred
Clinical narrative: Information has been received from a physician concerning an 18 year old male with obesity and no drug allergies who in approximately 2004 and 07-JAN-2008 was vaccinated IM with his first and second 0.5 ml doses of Vaqta.  Concomitant vaccinations administered on 07-JAN-2008 included a dose of FluMist and a dose of MENACTRA.  In January 2008, the patient was having symptoms of blindness.  On approximately 14-JAN-2008 a week after administration the patient began to experience headaches and a few days later, the patient could not see.  The patient sought medical attention through an ophthalmologist and a neurologist.  At recent appointments the patient could not read the largest letter on the reading chart and prior to this point the patient had 20/20 vision.  It was noted that the patient was believed to have optic neuritis.  The patient was treated with a course of steroids and his headaches have gotten better since initiating treatment, but his vision has not.  The patient was under the care of a neuro-ophthalmologist at the time of this report and was not recovered.  There was no product quality complaint.  The events were considered to be disabling by the reporting physician.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ear pain, Facial pain, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of guillain-barre syndrome with an electromyogram abnormal from 3 years ago who on 04-FEB-2008 was vaccinated with the first dose of Gardasil IM. On 04-FEB-2008 the physician reported that the patient developed face, jaw and leg pain. The patient also felt lethargic and experienced muscle weakness. The patient was admitted in the hospital but the length and dates of hospitalization is unknown. On an unspecified date the patient had a spinal magnetic resonance imaging (MRI) performed and was negative. The patient is not currently in the hospital and has "improved 95%". The patient still has some pain, muscle weakness and numbness in her face, jaw and legs. No further information was available. The events required hospitalization and were considered to be other medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of guillain-barre syndrome with an electromyogram abnormal from 3 years ago who on 04-FEB-2008 was vaccinated with the first dose of Gardasil IM. On 04-FEB-2008 the physician reported that the patient developed face, jaw and leg pain. The patient also felt lethargic and experienced muscle weakness. The patient was admitted in the hospital but the length and dates of hospitalization is unknown. On an unspecified date the patient had a spinal magnetic resonance imaging (MRI) performed and was negative. The patient is not currently in the hospital and has "improved 95%". The patient still has some pain, muscle weakness and numbness in her face, jaw and legs. No further information was available. The events required hospitalization and were considered to be other medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Facial pain, Hypoaesthesia, Hypoaesthesia facial, Lethargy, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of guillain-barre syndrome with an electromyogram abnormal from 3 years ago who on 04-FEB-2008 was vaccinated with the first dose of Gardasil IM. On 04-FEB-2008 the physician reported that the patient developed face, jaw and leg pain. The patient also felt lethargic and experienced muscle weakness. The patient was admitted in the hospital but the length and dates of hospitalization is unknown. On an unspecified date the patient had a spinal magnetic resonance imaging (MRI) performed and was negative. The patient is not currently in the hospital and has "improved 95%". The patient still has some pain, muscle weakness and numbness in her face, jaw and legs. No further information was available. The events required hospitalization and were considered to be other medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Pain in jaw
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of guillain-barre syndrome with an electromyogram abnormal from 3 years ago who on 04-FEB-2008 was vaccinated with the first dose of Gardasil IM. On 04-FEB-2008 the physician reported that the patient developed face, jaw and leg pain. The patient also felt lethargic and experienced muscle weakness. The patient was admitted in the hospital but the length and dates of hospitalization is unknown. On an unspecified date the patient had a spinal magnetic resonance imaging (MRI) performed and was negative. The patient is not currently in the hospital and has "improved 95%". The patient still has some pain, muscle weakness and numbness in her face, jaw and legs. No further information was available. The events required hospitalization and were considered to be other medical events. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Developed diarrhea 2 days after receiving the Rotateq.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Soreness at site, red, hot to touch, hard around site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Headache, Visual disturbance
Clinical narrative: Immediately after vaccines were given (Adacel, Menactra, and HPV 1/3) pt. c/o dizziness and weakness.  After lying down for 15 min, pt. ambulated out of office.  Next morning, mom phoned and reported that pt. c/o dizziness while in the shower, "saw stars" and black.  Pt. climbed out of shower and sat on floor.  All day, main complaint of headache.
Age: 0.8
Sex: M
Vaccine: FLU3, HEP
Symptoms: Body temperature increased
Clinical narrative: Mother states that baby was fine with no fever after immunizations until midnight 11/2/07.  Had been giving Tylenol q 4 hrs since immunization.  Baby woke up for a bottle and temp was 105 axillary.  Took child to ER.  According to ER record temp was 100.1 rectally on arrival.  Was told to continue Tylenol & follow-up with PMD next day.  Was ok next day.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Local reaction, Pain, Rash
Clinical narrative: ER visit on 10-14-07 with local redness, swelling & rash.  Dx. was cellulitis, pt. given Benadryl 25 mg & Keflex 500 mg.  In today with (10-16-07) redness & swelling c/o pain, did not advise nurse she had reaction 25 yr. ago with TD before getting Tdap on 10-12-07.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Similar reaction on previous exposure to drug, Swelling
Clinical narrative: ER visit on 10-14-07 with local redness, swelling & rash.  Dx. was cellulitis, pt. given Benadryl 25 mg & Keflex 500 mg.  In today with (10-16-07) redness & swelling c/o pain, did not advise nurse she had reaction 25 yr. ago with TD before getting Tdap on 10-12-07.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Anorexia, Chromaturia, Cough, Dizziness, Heart rate increased
Clinical narrative: 3 day 6"x6" swollen at site.  Very itchy.  Scattered red spots on back looked like solid red mass.  5th day redness decreased injection swollen/no itch.  10th day nausea, dizziness, no hunger.  13th day better.  14th day 2/19/08 still dizzy, no nausea.  No fever, had dry cough.  Rapid heart beat (3rd day) 151/90.  Hydrated throughout time.  Urine smelled like tomato plant.  Darker.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Mass, Nausea, Rash
Clinical narrative: 3 day 6"x6" swollen at site.  Very itchy.  Scattered red spots on back looked like solid red mass.  5th day redness decreased injection swollen/no itch.  10th day nausea, dizziness, no hunger.  13th day better.  14th day 2/19/08 still dizzy, no nausea.  No fever, had dry cough.  Rapid heart beat (3rd day) 151/90.  Hydrated throughout time.  Urine smelled like tomato plant.  Darker.