chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Complained of symptoms - 48 hrs after Adacel - worse left arm pain, distress, left side ache, extremely fatigue, mild HA, nausea, diarrhea, no rashes left forearm 21 x 40 mm erythema) mild swelling under skin induration 50x60mm, tender, sl. warm. Complained of pain mid clav -> mid shoulder
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pain of skin, Skin induration
Clinical narrative: Complained of symptoms - 48 hrs after Adacel - worse left arm pain, distress, left side ache, extremely fatigue, mild HA, nausea, diarrhea, no rashes left forearm 21 x 40 mm erythema) mild swelling under skin induration 50x60mm, tender, sl. warm. Complained of pain mid clav -> mid shoulder
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Complained of symptoms - 48 hrs after Adacel - worse left arm pain, distress, left side ache, extremely fatigue, mild HA, nausea, diarrhea, no rashes left forearm 21 x 40 mm erythema) mild swelling under skin induration 50x60mm, tender, sl. warm. Complained of pain mid clav -> mid shoulder
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Vaccine administered on 3/28/08.  Significant pain and swelling began on 3/29/08.  Swelling extended to under the arm and below the elbow.  Treatment: ice, heat, Tylenol, Benadryl.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site warmth
Clinical narrative: One week after getting injection pt is still complaining of itching and irritated sensation at site (R delt) 4 x 9 cm area with very faint erythema and increased temp to touch (may be due to scratching/rubbing).  Does not appear cellulitic.  No systemic reaction.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Dermatitis atopic, Injection site pruritus, Local reaction, Skin exfoliation, Skin hyperpigmentation
Clinical narrative: Local reaction due to atopic dermatitis with hyperpigmentation and slight scaling/itch in are 4x6cm surrounding injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Ocular hyperaemia, Pain of skin, Rash
Clinical narrative: Pain L side of scalp & eye area, rash & redness of L eye.  Shingles +.  Treatment Valtrex 1 gm 1 >/= 1.  Dr (ophthalmology) exam - no evidence of ophthalmic involvement.
Age: 1.2
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, HEPA, MMR, PNC
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: None Stated
Age: 29.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Injected limb mobility decreased, Injection site pain, Oedema
Clinical narrative: 08:30 on 3/16/08 with c/o severe pain in L arm delt injection site radiating down arm.  Some edema & shoulder ROM.  Neuro Intact NON & sensation.
Age: 0.3
Sex: M
Vaccine: HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Hypoaesthesia oral, Pain
Clinical narrative: Imms of Hep A and HPV given at 830 AM. Patient waited 20 minutes and left to return to school . Called at 1015 AM that tongue was numb, (L) side hurt, was dizzy. Brought back to clinic - observed with VS q 15 mins x 1 1/2 hours. All symptoms except numb tongue resolved.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient received Zostavax on 4/15/08, subcutaneously developed a "light rash extending all around abdomen" that was "Not painful, but a little itchy." Patient then called Dr and the nurse (No name given) said it was "nothing to be concerned about."
Age: 76.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Electromyogram normal, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Pain subsequent to injection in right upper extremity in area of lower deltoid "Dull to severe ache" worse with use. 1st reported on 10-23-07. Unresponsive to Advil, Tylenol, Lipoderm patch, Neurontin and Capsaicin cream.
Age: 76.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Pain in extremity, Red blood cell sedimentation rate decreased
Clinical narrative: Pain subsequent to injection in right upper extremity in area of lower deltoid "Dull to severe ache" worse with use. 1st reported on 10-23-07. Unresponsive to Advil, Tylenol, Lipoderm patch, Neurontin and Capsaicin cream.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Skin induration, Vomiting
Clinical narrative: Patient has 5cm induration other symptoms are vomiting and weakness in arm.
Age: 50.0
Sex: F
Vaccine: JEV, TDAP
Symptoms: Cellulitis, Hypersensitivity, Local swelling, Oedema peripheral
Clinical narrative: Patient returned 5 days after vaccines were administered with very large local swelling to the deltoid area spreading towards the arm pit.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5
Symptoms: Mass, Swelling
Clinical narrative: Lump 1/2 cent. swollen in lump area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Erythema, Immediate post-injection reaction, Oedema peripheral
Clinical narrative: Within 10 minutes of injection - light headed, very pale - near fainting lasting over 1 hr; 36 hrs later red hot swollen quarter sized swelling - 4 days later 2 silver dollar size with bruising same size underneath with pain and itching - 6 days later minimal itching, swelling, bruising
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pallor, Presyncope, Pruritus, Skin warm
Clinical narrative: Within 10 minutes of injection - light headed, very pale - near fainting lasting over 1 hr; 36 hrs later red hot swollen quarter sized swelling - 4 days later 2 silver dollar size with bruising same size underneath with pain and itching - 6 days later minimal itching, swelling, bruising
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Fatigue, Headache, Nausea
Clinical narrative: H/A, fatigue, nausea, T 100.8 <24 after adm
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Redness, swelling, cellulitis to the right arm.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Adacel approved for ages 11-64yrs; was given 2 months before turning 11 years. No adverse reaction.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Computerised tomogram normal, Confusional state, Dizziness, Dysstasia, Erythema
Clinical narrative: One day after vaccination pt had (L) arm redness and then severe dizziness, confusion, unable to stand, hypertension requiring hospital observation. 4/23/08-records received for DOS 4/15-4/16/08-DC DX: Constellation of nausea and vomiting with vertigo and confusion. Etiologies include viral syndrome, versus vaccination reaction. Presented with 4 day history arm aching and redness, dizziness, fevers and chills vertigo and confusion and trouble functioning. Nauseated.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hypertension, Scan brain
Clinical narrative: One day after vaccination pt had (L) arm redness and then severe dizziness, confusion, unable to stand, hypertension requiring hospital observation. 4/23/08-records received for DOS 4/15-4/16/08-DC DX: Constellation of nausea and vomiting with vertigo and confusion. Etiologies include viral syndrome, versus vaccination reaction. Presented with 4 day history arm aching and redness, dizziness, fevers and chills vertigo and confusion and trouble functioning. Nauseated.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood glucose decreased, Hepatic enzyme increased, Hypoglycaemia
Clinical narrative: Baby brought to ER for lethargy 8 days after MMR vaccination.  Lab work revealed hypoglycemia and elevated liver enzymes. 5/15/08-records received for DOS 4/11/08-Admitted with acute hepatitis, symptoms began 2 days ago with cough and rhinorrhea, decreased oral intake. this morning woke with lethargy difficult to keep awake, refused all oral intake. Admitted for observation.  Possible EBV.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Lethargy
Clinical narrative: Baby brought to ER for lethargy 8 days after MMR vaccination.  Lab work revealed hypoglycemia and elevated liver enzymes. 5/15/08-records received for DOS 4/11/08-Admitted with acute hepatitis, symptoms began 2 days ago with cough and rhinorrhea, decreased oral intake. this morning woke with lethargy difficult to keep awake, refused all oral intake. Admitted for observation.  Possible EBV.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Apnoea, Diarrhoea, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Patient developed vomiting episodes for days and irritable. Followed by watery black stools. Evaluated at "hospital - Pediatric (3-18-08) ED. KUB done (consisted with intussusception) ileocolic intussusception reduced with pneumatic reduction. Apnea episode (brief, did not require O2/stimulation only). EKG, UGI, echo and EEG were normal limits. Apnea episode occurred after reduction and when sleep; IV infiltrated. Discharged home in 2 days.  04/28/2008 MR received for DOS 3/18-20/2008 with D/C DX: Intussusception s/p reduction, apnea spell x1. Pt presented to ER with 3 day hx of vomiting after every meal, irritability, crying, and dark watery stool.  PE WNL. Ileocolic Intussusception noted on and reduced by Barium Enema. Pt had an episode of cyanosis s/p reduction.  W/u WNL.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Enema administration, Faeces discoloured, Intussusception, Irritability, Urinary system X-ray
Clinical narrative: Patient developed vomiting episodes for days and irritable. Followed by watery black stools. Evaluated at "hospital - Pediatric (3-18-08) ED. KUB done (consisted with intussusception) ileocolic intussusception reduced with pneumatic reduction. Apnea episode (brief, did not require O2/stimulation only). EKG, UGI, echo and EEG were normal limits. Apnea episode occurred after reduction and when sleep; IV infiltrated. Discharged home in 2 days.  04/28/2008 MR received for DOS 3/18-20/2008 with D/C DX: Intussusception s/p reduction, apnea spell x1. Pt presented to ER with 3 day hx of vomiting after every meal, irritability, crying, and dark watery stool.  PE WNL. Ileocolic Intussusception noted on and reduced by Barium Enema. Pt had an episode of cyanosis s/p reduction.  W/u WNL.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Patient developed vomiting episodes for days and irritable. Followed by watery black stools. Evaluated at "hospital - Pediatric (3-18-08) ED. KUB done (consisted with intussusception) ileocolic intussusception reduced with pneumatic reduction. Apnea episode (brief, did not require O2/stimulation only). EKG, UGI, echo and EEG were normal limits. Apnea episode occurred after reduction and when sleep; IV infiltrated. Discharged home in 2 days.  04/28/2008 MR received for DOS 3/18-20/2008 with D/C DX: Intussusception s/p reduction, apnea spell x1. Pt presented to ER with 3 day hx of vomiting after every meal, irritability, crying, and dark watery stool.  PE WNL. Ileocolic Intussusception noted on and reduced by Barium Enema. Pt had an episode of cyanosis s/p reduction.  W/u WNL.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Rec'd vaccine 4/14/08.  Mom reports today red, edema at Varivax site on L arm.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain of skin, Rash erythematous, Skin warm
Clinical narrative: Left arm with deeply erythematous 8cm circular, edematous rash surrounded by less erythematous, 4cm none edematous rash, (+) tender, (+) warm to touch per MH note.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Tdap given dose #5 - not DTaP.  Mother stated no side effects noted.  Mother informed not to received Tdap at in 6th grade entry.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Received Below immunizations - left arm developed mild redness the evening, post injection at injection site; next day with increased erythema.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient's R arm had redness & swelling from shoulder to elbow.  Fever of 100.  Duricef.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Fatigue, Rash
Clinical narrative: Next day had rash on neck then progress to area between scapula - lasted over a week.  Pt also had LLR started next day - 10x12 cm.  Seen in ER for tests 16Apr07.  Pt on 12Apr had "inefficient breathing"/fatigue while running 3 miles outside during allergy season.  Seen in ER, 16Apr07 - Tx with Benadryl, steroid 1 x3d, and Xopenex MDI.  Not had to use Xopenex MDI.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Erythema, Skin discolouration
Clinical narrative: Within seconds of receiving vaccines, noticed skin mottled and then bright red on back, face spreading to extremities.  Benadryl and Tylenol given per J tube per order.  Pt observed and D/c to home per Dr. order.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: Pt c/o rash - neck, arms 1-2 wks after all six anthrax shots, lasting 2-3 wks.  c/o bumps on his skin, flesh colored, reddish after scratch - pruritic but not hives.  Reports only after Anthrax shots - he gets this rash - 6-7 times, not only 1-2 wks after Anthrax shots.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema
Clinical narrative: 10 x 11cm area erythema
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash + swelling at L upper arm.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Oedema peripheral
Clinical narrative: Swelling left non-dominant arm persistent 6 months after vaccination. Objective measurements up to 4.5 cm larger than dominant arm
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash papular, Urticaria
Clinical narrative: papular urticaria developed 5 days after immunizations.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Chest discomfort, Dizziness, Stomach discomfort
Clinical narrative: Light headed, stomach upset, 5- 10 min after. Chest, tightness 10 min epi and Zyrtec given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red area with warmth to left upper arm, (+) itch treated with Clindamycin- change Augmentin ES
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Dizziness, Electrocardiogram normal, Full blood count normal
Clinical narrative: Received vaccine 6:30pm 4/8/08. At around 9:30 patient states she noted rapid heartbeat then following day felt weak, lightheaded and intermitted to nausea. Symptoms have been on and off for past week. Called 4/15 to report symptoms. Seen 4/16-
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Metabolic function test abnormal, Nausea, Red blood cell sedimentation rate normal
Clinical narrative: Received vaccine 6:30pm 4/8/08. At around 9:30 patient states she noted rapid heartbeat then following day felt weak, lightheaded and intermitted to nausea. Symptoms have been on and off for past week. Called 4/15 to report symptoms. Seen 4/16-
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Patient was exposed to Varicella 10 days ago.  Now has acute mild varicella.  Eruption on chest and proximal extremities.  Sister has same rash.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Patient was exposed to Varicella 10 days ago.  Now has acute mild varicella.  Eruption on chest and face.  Sister has same rash.
Age: 1.1
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Measles antibody, Oral disorder, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Fever (103 F)-started Friday 4/18/08; Rash (diffuse, but more concentrated around ears and forehead at hairline)-started Sunday 4/20/08 Oral lesions Runny nose *ODH recommends to report event to VAERS
Age: 1.1
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Saturday 4/19/08 low grade temperature 99.  Tylenol given 1/day Saturday.  Saturday night temperature 100.  Sunday am 99 at 3:30 pm red spot noted on left side, small of back and arch of foot.  Rash had spread to crest and feet.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at site, redness, swelling and hot to touch. Vaccine and reaction to the right arm.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: cellulitis, redness, swelling, hot to touch to left arm
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Left upper thigh swollen and red.  C/o itching after 48 hours of receiving shot.  Patient was put on Keflex 250mg.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 50 mm red, swollen, hard area, very hot to touch on left deltoid, also c/o itching on site.  Recommended cool wash cloth, ibu, Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 50 mm red, swollen, hard area, very hot to touch on left deltoid, Also c/o itching at site.  Recommended cool wash cloth, ibuprofen and Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 50mm reddened, swollen, hard area on arm, very hot to the touch right arm.  Also itching at site.  Recommended cool wash cloth, ibuprofen and Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 4-15-08 p.m. right arm became red, swoolen and warm (approx 4 inch long) around whole upper arm.  Gave Motrin.  4-15-08 p.m. Saw Dr.  4-16-08 a.m. advised cold pack, given allergy and cream.  Advised her to mark area with pen so can evaluate if condition worsens/improves.  Call Dr. if worsens.  When next Td due, advise Dr. of reaction.
Age: 0.58
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Erythema, Rash
Clinical narrative: Mother presents in clinic on 4/22/08 and reports that 2 days after receiving immunizations on 03/21/08 client developed red rash all over her face.  Denies any changes at time in diet, skin applications, soaps, medications, etc.  Mother states she applied cool water and the rash lessened, resolved in 1-2 weeks without further problem.  Denies any other concurrent problems.  Did not seek medical care.  Later stated it may have been due to herbs used in cooking.
Age: 1.51
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Abasia, Body temperature increased, Fatigue, Feeding disorder, Pyrexia
Clinical narrative: Within 24 hours of administration of DTaP and Hep A patient began temperatures exceeding 101. Extreme fatigue, Prolonged screaming, grabbing head, unable to walk or feed self. Rash developed by day 4 and staring of into space events were noted. 4/29/08-DC Summary received for DOS 4/15-4/16/08-DX: Cerebellitis. Presented with fever to 101, beginning on 4/8/08. Developed ataxia and fevers persisted. Erythematous rash developed on torso and extremities. Two days prior to admission noted to have difficulty walking and fell. Twin sisiter also became ill with high fevers and rash. 1/26/2010 Follow up: Still has problems with fine motor skills and coordination.
Age: 1.51
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Screaming, Staring
Clinical narrative: Within 24 hours of administration of DTaP and Hep A patient began temperatures exceeding 101. Extreme fatigue, Prolonged screaming, grabbing head, unable to walk or feed self. Rash developed by day 4 and staring of into space events were noted. 4/29/08-DC Summary received for DOS 4/15-4/16/08-DX: Cerebellitis. Presented with fever to 101, beginning on 4/8/08. Developed ataxia and fevers persisted. Erythematous rash developed on torso and extremities. Two days prior to admission noted to have difficulty walking and fell. Twin sisiter also became ill with high fevers and rash. 1/26/2010 Follow up: Still has problems with fine motor skills and coordination.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea, abdominal pain mild.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Patient started to feel weakness, fatigue, light headed, nausea, diarrhea, headache, and Dizziness after receiving an anthrax shot, Friday April 18th 2008.  The patient was told to take Tylenol, drink fluids, and rest.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea
Clinical narrative: Patient started to feel weakness, fatigue, light headed, nausea, diarrhea, headache, and Dizziness after receiving an anthrax shot, Friday April 18th 2008.  The patient was told to take Tylenol, drink fluids, and rest.
Age: 11.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Injection site urticaria
Clinical narrative: Softball sized, raised, hive at the site of injection.  Per parent.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction, Induration, Pruritus
Clinical narrative: Red immediately after immunization, hard to touch, itchy. Patient applied rubbing alcohol. Now still red, slightly indurated 5.5 x 10 cm. Patient prescribed Claritin 10 mg QD and Westcort Cream to be applied TID.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Full blood count normal, Oedema peripheral, Red blood cell sedimentation rate normal, Urticaria
Clinical narrative: Urticarial rash. Erythematous, edematous hands and feet. Onset 4/9/08 and persisting through 4/22/08. Treated with prednisone.  3/30/09 Link w/342857.  4/16/09 Received hospital medical records of 10/15-10/17/2008. FINAL DX: arthritis, pain improved. Records reveal patient experienced arthritis from possible serum sickness w/increasing joint pain x 2 days, N/V, abdominal pain, increased fatigue x 3-4 days.  GI, Pain, PT/OT consults done.  Improved & d/c to home on steroids & antiarthritis meds  Rheum Clinic records of 6/26-11/3/2008 FINAL DX: slowly resolving serum sickness.  ER records 4/23/2008. FINAL DX:Serum sickness Records reveal patient experienced hives & joint pain x 2 wks, starting approx 2 days s/p vaccination #2.  Had been tx w/steroids but recurred.  Developed weakness & abdominal pain, decreased appetite, decreased UOP.  Rheum & GI consult done.  D/c to home.  ER records 9/3/2008. FINAL DX: flare of rheumatologis disease REcords reveal patient experienced leg pain x 1 day w/joint pain, heat, swelling.  Had received IV solumedrol one day prior & was on oral steroids.  Vomitedx 2 days.  Alopecia 2 wks prior. Rheum & GI consult done.  Pain med given & d/c to home.   4/21/09 Received ER & GI consult medical records.  ER records 12/7/2008. FINAL DX: abdominal pain, LUQ Records reveal patient w/LUQ pain x 3 hrs w/nausea, constipation.  Tx w/meds, improved & d/c to home w/Rheum & GI f/u.  ER records 1/11/2009. FINAL DX: abdominal pain, unspecified site Records reveal patient had colonscopy 2 days prior & ad acute onset abdominal pain x 1 day.  W/U neg & d/c to home w/pain meds & referred for further GI w/u.  GI Clinic records 12/15/08-3/5/2009. FINAL DX: irritable bowel syndrome Records reveal patient w/abdominal pain, fatigue, N/V & hematochezia s/p serum sickness & being tx w/multiple meds.  Rheum s/s were improving but GI symptoms increased w/daily vomiting. Had missed approx 1 mo of school.  Tx s/p colonscopy included Bentyl, high fiber diet & avoidance of caffeine.  Improved on this regimen.  Had rheum relapse when steroids tapered & dose had to be increased.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: TC from patient 2:30 pm 4/17/08.  Received HPV, Menactra, and Tdap while in clinic.  Also received 1 gram Zithromax and 500 mg Cipro--client on no meds.  No chronic illness. No allergies.  No problem with childhood vaccines. C/o no rash, but tiching on upper abdomen, arms and neck since om 4/15/08. Also c.o nausea ans "stomachache"' No vomiting.
Age: 0.17
Sex: F
Vaccine: DTP, HIBV, IPV, PNC, RV5
Symptoms: Gastroenteritis, Mucous stools, Screaming
Clinical narrative: Within the week of receiving the vaccine, the baby developed mucousy bowel movements which contunued and then progressed.  About three weeks later the child presented to the office with mucousy stools and 'screaming fits' which prompted an ER evaluation for intussusception.  From there she was discharged and seen by a pediatric GI specialist who called it 'gastroenteritis' with no change in intake or treatment.  The symptoms gradually spontaneously resolved. No second rotovirus vaccine was given at the four month check up.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Patient lethargic with high fever (102 after Tylenol it would come down, but not normal), decreased appetite.
Age: 27.0
Sex: F
Vaccine: HEP, SMALL, TYP
Symptoms: Chills, Discomfort, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Chills; Swelling Lymphnodes in both arm pits with associated discomfort; Headaches.
Age: 37.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Headache
Clinical narrative: Constant headache with two episodes of Migraine.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site swelling
Clinical narrative: Swollen area to Left thigh area, now 12 days post vaccination with DTAP #4, Flu #1 to that leg.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: ON 04/18/04 PT RECEIVED FOUR (4) VACCINES:  MMR, VARIVAX, DTAP AND IPOL. PARENTS CALLED ADVICE LINE @1218 ON 04/20/08 REGARDING SWELLING OF (L) UPPER ARM AT VACCINATION SITES.  PT TAKEN FOR APT AN HR LATER. EXAMINING MD DR NOTED (L) ARM TO BE ERYTHROMATOUS; ARM NON-TENDER, NO INDURATION. PT TREATED W/BENADRYL AND PREDNISONE WHICH TOOK FOR LESS THAN 24HRS (DIDN'T LIKE TASTE).
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site streaking, Injection site warmth, Pyrexia
Clinical narrative: Patient had a large 3 inch by 3 inch welt at vaccination site that was hot and tender and lasted for a week.  Patient had a 101 degree fever that lasted 3 days.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Diarrhoea, Rash generalised, Rash papular, Vomiting
Clinical narrative: Patient had MMR vaccine on 04/08/2008. Had vomiting, diarrhea on 04/15/2008. Developed a generalized rash (papular). No fever.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site swelling, X-ray
Clinical narrative: Patient had received 3 prior DTaP shots, but was not caught up on them at 2 years, so a DTaP shot was given 3 days after DTaP shot, leg was greatly swollen, about twice the size of normal thigh.  Was not hard, but still fleshy feeling and did not have fever.  More noteworthy, 10 days afer shot, he started limping in the opposite leg that shot was administered.  14 days after he is still limping, intermittenly, but has gotten worse.  Xrays came out normal.  Are still proceeding with diagnosis.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: 21 yo female with fever 100.8, vomiting and diarrhea about 4-5 hours after administration of first HPV (Gardasil) shot. Patient recovered within 24 hours.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: WENT TO CHECK PATIENT AFTER 15 MINUTES-BLOODY NOSE IN PROCESS-WAS SEEN BY CPNP-PLAPICAL & RADIAL=80   EPISTAXIS SLOWING AFTER 5 MINUTES DENIES DIZZINESS, ANY OTHER S/S PER MOM PT HAS EPISTAXIS ? ALLERGIES INCREASE INCIDENCE SPRING & FALL-  B/P 100/64 WAS TOLD OK TO GO HOME, TRY CLARITIN 1 TAB QTTS
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Gaze palsy, Pyrexia
Clinical narrative: ARMS RHYTHMICALLY MOVING AND EYES ROLLING BACK; FEVER TO 103
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular, Respiratory tract congestion
Clinical narrative: Pt developed rash on face and subsequently spread to trunk.  Some of rash was vesicular and in various stages.  The rash started one wk after the vaccine also asso with fever (101) and congestion and coryza.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Febrile convulsion, Tremor
Clinical narrative: Presumed febrile seizure ~  15 hours after Pediarix, hib, Prevnar administration, mom states fever to 106 & shaking activity for 10 minutes, resolved with cool bath and Tylenol.
Age: 44.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, TYP
Symptoms: Tinnitus
Clinical narrative: Patient states that several hours after receiving her travel immunizations on 3-11-08 she began to notice ringing in her ears. After 2 weeks she sought medical care. Various tests were run and diagnosis of "tinnitis" was given. She presented herself again in our clinic today to state these facts and to say that the ringing ended this week. She believes the vaccines caused this reaction especially the typhoid vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient was in office on 4/17 for visit and was noted to need Menactra vaccine. Patient given vaccine 4/17 and per parent report on Friday the 18th she noted swelling to the left arm. Saturday the 19th of April parent took child to ER to be evaluated for swelling. Swelling approx 2 inches and redness from elbow to shoulder of left arm. Seemed to improve after Benadryl given. Then given Benadryl Q 4 hours X 24+ hours.  Was seen for follow up appointment on 4/22 and was recovered.
Age: 47.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Tinnitus
Clinical narrative: Patient states that 4 days after receiving travel vaccines 3-11-08, he began to have ringing in the ears. Significant other (previously reported through VAERS) also had same reaction of ringing in ears but several hours after vaccines. The only difference between the two were that Patient received the oral typhoid and significant other received the injectable typhoid. Significant other sought medical treatment whereas patient did not. Unsure as to when patient no longer had symptoms. They both presented themselves in our clinic again today with this information. Significant other and patient are sure the "tinnitis" was caused by the vaccines especially the typhoid vaccines.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is extremely swollen, red, hot, painful, and itchy. The nurse at my work suggested I have the problem noted in my record in case I am asked to get another shot in the future. Condition has worsened in the four days since I got the shot.
Age: 0.71
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site mass
Clinical narrative: "Knots the size of marbles where the shots were given" shots given 4/14.  Reported by mother 4/22/08.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Lip swelling, Tachycardia, Urticaria, Vomiting
Clinical narrative: LIP SWELLING, HIVES, ERYTHEMA OF TRUNK, EMESIS WITHIN 15 MIN. OF VACCINATION.  GIVEN EPINEPHRINE SUBCUTANEOUS, SOLUMEDROL AND BENADRYL IM, ALBUTEROL NEB TREATMENT.  WENT TO ER AFTER 30 MIN. OF REACTION.  GOOD PULSE OX. MONITORING AND STABLE VITALS.  TACHYCARDIA RESOLVED.  ALL ABOVE SX. RESOLVED.  GIVEN IV FLUID HYDRATION ONLY IN THE ER.
Age: 70.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint effusion, Lyme disease, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of right knee pain in a 70-year-old male subject who was vaccinated with LYMERIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  The subject's medical history included thyroidectomy.  Concurrent medications included Thyroxine sodium (Synthroid).  On 12 April 2001, 1 May 2000 and 29 March 2000 the subject received 3rd dose, 2nd dose and 1st dose of LYMERIX (all injections in the right arm).  In November 2007, a little over 6 years after the 3rd vaccination with LYMERIX, the subject experienced right knee pain with fluid on the right knee.  This was considered to be a systemic reaction.  The events were considered to be disabling.  At the time of reporting, the subject was being tested for Lyme disease.  Developing Lyme disease following vaccination series with LYMERIX is considered to be a vaccination failure.  At the time of reporting, the knee pain was unresolved.  The outcome of the other events was not known.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count, Hypotonic-hyporesponsive episode
Clinical narrative: 24 hours OBV-HOLD-IV fluids.  Hypotonic hyporesponsive episode. 05/09/2008 MR received for DOS 4/15-16/2008 with D/C DX: Adverse Reaction to Immunizations. Within hours of receiving vaccines pt became pale, lethargic and could not be roused to feed.  PE (+) for lethargy and tachycardia (182 bpm). Improvement noted with IVF bolus.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and hot at injection site whole arm swollen and tender up to top of shoulder. 4/20/08 Fever 012 which has not ameliorated with Tylenol 36 hrs. 0900 am shortness of breath for 36 hrs. Better 4-21-08 9:00 PM.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Redness and hot at injection site whole arm swollen and tender up to top of shoulder. 4/20/08 Fever 012 which has not ameliorated with Tylenol 36 hrs. 0900 am shortness of breath for 36 hrs. Better 4-21-08 9:00 PM.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Erythema, Flushing
Clinical narrative: Flushing, redness of face and neck, shortness of breath. Patient given epinephrine and solumedrol for allergic reaction in ER.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting x3, afebrile- no previous illness, no family illness-discussed re-hydration and signs and symptoms of dehydration.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash generalised, Urticaria
Clinical narrative: Hive-like lesions developed after the patient's 3rd Gardasil injection. She states that the lesions began around her injection site on her (R) arm and spread out throughout her body
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Pharyngolaryngeal pain, Pruritus, Throat irritation
Clinical narrative: ~10 minutes after injection of Zostavax, Pt stated that she had an itchy throat and that her ears felt itchy.  Administered diphenhydramine.  After observing pt for ~20 min, she stated that she felt better and left pharmacy.  Called pt ~3 hours later, only had sore throat.  Called again ~1 hour later, no sore throat only hoarseness.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cough, Dyspnoea, Oral pruritus, Pain, Rhinorrhoea
Clinical narrative: 30 min after getting shot mouth began itchy and runny nose.  Woke up next day terrible body aches and had trouble breathing.  Bad cough also.  Took Benadryl, Zyrtec, Advil.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Adverse drug reaction, Erythema, Injection site irritation, Injection site swelling
Clinical narrative: Swelling and burning at the site of injection. Over 24 hrs. erythematic area worsened - ER visit
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: Swelling/burning at injection site - over 24 hours got nurse.  Went to ER.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Local reaction
Clinical narrative: Burning for about 90 sec after injection. Lump at injection site now, slight burning following morning with redness surrounding lump.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis left thigh moderate erythema, tender, warm to touch.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Asthenia, Rash, Screaming, Tremor
Clinical narrative: Screaming immediately after vaccine administered.  Body shaking, child expressed need to have "poo" "poo" and brought her knees to her chest for 30 minutes from 10 AM until 11 AM.  1:20 AM developed rash over legs.  Noted blisters on hands and feet.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: developed Varicella post-vaccination- 3 months
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Hypoaesthesia, Pruritus, Swelling, Urticaria
Clinical narrative: Hives - wrists, elbows, ankles, knees, waistband, hands - swelling, redness, itch approximately 24-72 hours after vaccine.  Swelling and numbness of lips, tongue, cheeks approximately 24-48 hours after vaccine.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate decreased, Hypoaesthesia, Pain in extremity, Pharyngolaryngeal pain
Clinical narrative: Within 5min of injection. She complained of pain numbness down right arm. Also complained of right throat pain. denied sob. diaphoretic; Ice pack given, rest. pulse 82
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Diarrhoea, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Signs and symptoms: moody, grumpy, short tempered, red and swollen injection site, diarrhea, rash.  Treatment: Tylenol, fluids, observe, cold pack to injection site.  4/22/08: mom reports only signs and symptoms now is slight redness injection site.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Loss of consciousness, Nausea
Clinical narrative: as soon as the injection was given patient c/o nausea and bent forward in the chair, then slipped forward onto floor and had LOC approximately 5 seconds. Assisted onto the bed, cold packs applied legs elevated, water given. Felt better after approximately 10 minutes and was ok to leave.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood culture negative, Neutrophil percentage, Platelet count increased, Red blood cell count normal, Streptococcal identification test
Clinical narrative: Information regarding PREVNAR was received from a nurse regarding a 4-month-old female patient who received the second dose on 02-Mar-2007 along with the second dose of ROTATEQ (Merck & Co Inc) (rotavirus vaccine, oral, pentavalent), the second dose of COMVAX (Merck Sharp & Dome) (haemophilus B conjugate vaccine/hepatitis B vaccine), the second dose of Poliomyelitis Vaccine Inactivated (manufacturer unknown) and the second dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (manufacturer unknown) (diphtheria/tetanus toxoid/acellular pertussis vaccine). On 03-Mar-2007, the child developed hives. The patient's concurrent illness include otitis media and dry skin. No changes to soaps. Formula fed only (no changes). Indication for Prevnar was immunization. Product was administered on 02-Mar-2007. Dose regimen was 0.5 mL 1 time per day (intramuscular). Concomitant therapy included Hydrocortisone and Amoxicillin. On 02-Mar-2007, the patient received the second dose of PREVNAR along with other childhood vaccines. On 03-Mar-2007, the child developed hives (urticaria). The patient was brought to the emergency room where treatment with BENADRYL cream was recommended. The child was afebrile. As of 05-Mar-2007, the patient had not recovered from the event. On 03-Mar-2007 test results were: red blood cell count (results: 4.7); platelet count (results: 568); culture throat (results: Rapid strep test: negative); mean platelet volume (results: 6.3); neutrophil percentage (results: 52 %); and blood culture (results: negative). No additional information was available at the time of this report.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Information regarding PREVNAR was received from a nurse regarding a 4-month-old female patient who received the second dose on 02-Mar-2007 along with the second dose of ROTATEQ (Merck & Co Inc) (rotavirus vaccine, oral, pentavalent), the second dose of COMVAX (Merck Sharp & Dome) (haemophilus B conjugate vaccine/hepatitis B vaccine), the second dose of Poliomyelitis Vaccine Inactivated (manufacturer unknown) and the second dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (manufacturer unknown) (diphtheria/tetanus toxoid/acellular pertussis vaccine). On 03-Mar-2007, the child developed hives. The patient's concurrent illness include otitis media and dry skin. No changes to soaps. Formula fed only (no changes). Indication for Prevnar was immunization. Product was administered on 02-Mar-2007. Dose regimen was 0.5 mL 1 time per day (intramuscular). Concomitant therapy included Hydrocortisone and Amoxicillin. On 02-Mar-2007, the patient received the second dose of PREVNAR along with other childhood vaccines. On 03-Mar-2007, the child developed hives (urticaria). The patient was brought to the emergency room where treatment with BENADRYL cream was recommended. The child was afebrile. As of 05-Mar-2007, the patient had not recovered from the event. On 03-Mar-2007 test results were: red blood cell count (results: 4.7); platelet count (results: 568); culture throat (results: Rapid strep test: negative); mean platelet volume (results: 6.3); neutrophil percentage (results: 52 %); and blood culture (results: negative). No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site reaction, Injection site swelling, Rash macular, Urticaria
Clinical narrative: Additional information was provided from a follow-up visit with an allergist, who recommended further vaccinations be done at the clinic under close supervision.  Information regarding PREVNAR was received from a healthcare professional regarding a 15-month-old male patient who experienced large welts and blotches at injection sites and back, top of scalp, neck, and cheek.  At 15 months of age, the patient received the fourth dose on 22-Jun-2007.  The patient also received the fourth dose of ACT-HIB (Aventis) and the fourth dose of TRIPEDIA (Aventis) on 22-Jun-2007.  The patient's concurrent illness includes torticollis (No known drug allergies) with a past history of urticaria (after vaccine (hepatitis B/Flu shot) administered on 12-Nov-2007).  Product was administered on 22-Jun-2007.  Concomitant therapy included TYLENOL.  On 22-Jun-2007, approximately 5-10 post-vaccinations, the patient developed large welts and blotches at both injection sites, back, top of scalp, neck, and cheek.  After 15 minutes post-injection, he developed increases swelling of the left thigh (injection site of DTP/HIB injection).  Treatment included oral BENADRYL.  Within 20 minutes, the welts were fading.  The baby was reported as active.  There was no evidence of respiratory distress.  The child recovered on an unspecified date.  Follow-up with an allergist was planned.  No additional information was available at the time of this report.
Age: 1.2
Sex: F
Vaccine: HIBV, PNC
Symptoms: Gait disturbance, Irritability, Mobility decreased
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old female patient who experienced unable to move her left leg and irritability.  At 12 months of age, the patient received the fourth dose on 29-Jun-2007.  Relevant medical history was not provided.  Product was administered on 29-Jun-2007.  Additional suspect medication included Act-Hib.  Concomitant medications were not reported.  The patient was unable to move her left leg and was irritable on 29-Jun-2007.  Patient's mother took her to the ER where she was instructed to apply warm compresses and give her MOTRIN.  As of 02-Jul-2007, patient was still irritable and was still limping.
Age: 0.3
Sex: F
Vaccine: HBHEPB, IPV, PNC
Symptoms: Haemoglobin decreased, Injection site rash, Petechiae, Platelet count increased
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who experienced petechial rash localized from the injection site down and petechial rash localized from the injection site down.  At 4 months of age, the patient received the second dose on 20-Apr-2007.  The patient also received the second dose of TRIPACEL, the second dose of IPOL, and the second dose of COMVAX on 20-Apr-2007.  Relevant medical history was not provided.  Mother has systemic lupus erythematosus.  Product was administered on 20-Apr-2007.  Dose regimen was 1 dose (intramuscular).  Concomitant medications were not reported.  The patient experienced petechial rash (purplish/reddish) localized from the injection site down on 22-Apr-2007.  The rash faded over 7 to 10 days.  The patient fully recovered (2007).
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: New information was received in medical history, and event details. Information regarding PREVNAR was received from a physician regarding a 4-months-old female patient who experienced possible SIDS - crib death. At 4 months of age, the patient received the second dose on 05-Sep-2007 and the first dose on 11-Jul-2007. The patient also received the second dose of DAPTACEL (Aventis-Pasteur), the second of ACT-HIB (Aventis) and the second dose of IPOL Aventis-Pasteur on 05-Sep-2007. The patient's concurrent illness includes gastrooesophageal reflux disease (mild physiologic). Mother had no complications with pregnancy. Infant was full term healthy vaginal delivery. No smokers in the family. Infant was bottle- fed. The infant had no adverse events from first set of vaccinations. Indication for PREVNAR was immunisation. The dose regimen was 0.5 mL 1 time per day (intramuscular) on 11-Jul-2007 and then was 0.5 mL 1 time per day (intramuscular) on 05-Sep-2007. Concomitant therapy included PREVNAR, DAPTACEL, IPOL and ACT-HIB. The baby was seen for a routine physical on 05-Sep-2007, and the physician pronounced her to be healthy. Routine vaccinations of PREVNAR, DAPTACEL, IPOL, and ACT-HIB were administered at around 11 A.M. The doctor's office was notified that the baby died suddenly that night. The time of death was reported as 9 P.M. The nurse reported that the patient experienced possible SIDS - crib death (sudden infant death syndrome) on 05-Sep-2007. A note in the patient's chart, based on information from the father, indicated crib death, and stated that the baby had been placed on her stomach to sleep. The father stated that there was no emesis noted at death scene. The doctor reported that the baby was in the crib, on her stomach at the time of death. No additional information was available at the time of this report. The cause of death was reported as sudden infant death syndrome and the autopsy cause of death was not reported.
Age: 0.2
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site discolouration
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who experienced brownish discoloration at both injection sites.  At 2 months of age, the patient received the first dose on 02-Mar-2007.  Relevant medical history was not provided.  Product was administered on 02-Mar-2007.  Concomitant therapy included TRIPACEL.  The patient experienced brownish discoloration at both injection sites on 02-Mar-2007.  The reporting healthcare professional stated that the discoloration is about 1/2 inch long and not wide at all.  She further stated that it looks like two birthmarks.  Outcome was reported as not recovered.  No additional information was available at the time of this report.