chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Hot flush, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Localized pain/swelling at injection site. Complained of pain with lifting arm at injection site (right). Patient also complained of numbness infect/hot flashes/weakness. Temp 100 deg F after injection (next day).
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Localized pain/swelling at injection site. Complained of pain with lifting arm at injection site (right). Patient also complained of numbness infect/hot flashes/weakness. Temp 100 deg F after injection (next day).
Age: 0.2
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Apnoea, Basophil count increased, Blood culture negative, C-reactive protein increased, Culture urine negative
Clinical narrative: Increasing apneas requiring septic work-up/antibiotics. Symptom started about25 hours after DTaP/IPV. Blood//urine cultures negative.  4/4/08 Reviewed hospital medical records of 11/8-12/04/2007.  Patient transferred to outlying birth hospital on 12/4/07 w/interim d/c summary dated 3/14/08. FINAL DX: cardiac arrest 11/8; extreme prematurity; RDS; chronic lung disease; PDA; pulmonary interstitial emphysema; seizures; IVH; ROP; anemia; thrombocytopenia, adrenal insufficiency; hypotension,hyperbilirubinemia, electrolyte instability, coagulopathy, metabolic acidosis, all resolved; coag-neg staph bacteremia, resolving. Records reveal patient had been transferred from outlying birth hospital at 10 days of age for PDA ligation on 11/9.  Patient experienced multiple problems associated w/extreme prematurity.  Transfused w/multiple blood products.  Stabilized & returned to birth hospital on 12/4/2007.  Records from birth hospital that accompanied VAERS report reveal patient experienced hyponatremia at time of vaccination on 12/28 & 12/29.  Dx w/newborn sepsis on 12/30.  4/18/08 Reviewed hospital medical records for 12/4/07-03/19/2008. FINAL DX: 23 wk preemie, anemia of prematurity, ROP, SGA, at risk RSV.                          4/29/08 Reviewed hospital records for 12/28/2007-1/5/2008 including vax record for 12/28 & 12/29/2007. Records reveal patient continued on CPAP & caffiene for apnea since 11/22, last apnea noted 12/27, mostly self resolved.  Was on Pb for seizures, last seizure noted 11/26.  Had increased apneas overnight 12/29-30.  Caffiene & high flow nasal cannula increased.  Started IV antibiotics on 12/31 for increased CRP of 2.6  & presumed sepsis.  Transfused 12/31.  CRP 0.94 on 1/2/08.  6 apnea spells 1/3-1/4/2008 w/probable reflux.  CRP 1/4 0.23.
Age: 0.2
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Lymphocyte percentage decreased, White blood cell count
Clinical narrative: Increasing apneas requiring septic work-up/antibiotics. Symptom started about25 hours after DTaP/IPV. Blood//urine cultures negative.  4/4/08 Reviewed hospital medical records of 11/8-12/04/2007.  Patient transferred to outlying birth hospital on 12/4/07 w/interim d/c summary dated 3/14/08. FINAL DX: cardiac arrest 11/8; extreme prematurity; RDS; chronic lung disease; PDA; pulmonary interstitial emphysema; seizures; IVH; ROP; anemia; thrombocytopenia, adrenal insufficiency; hypotension,hyperbilirubinemia, electrolyte instability, coagulopathy, metabolic acidosis, all resolved; coag-neg staph bacteremia, resolving. Records reveal patient had been transferred from outlying birth hospital at 10 days of age for PDA ligation on 11/9.  Patient experienced multiple problems associated w/extreme prematurity.  Transfused w/multiple blood products.  Stabilized & returned to birth hospital on 12/4/2007.  Records from birth hospital that accompanied VAERS report reveal patient experienced hyponatremia at time of vaccination on 12/28 & 12/29.  Dx w/newborn sepsis on 12/30.  4/18/08 Reviewed hospital medical records for 12/4/07-03/19/2008. FINAL DX: 23 wk preemie, anemia of prematurity, ROP, SGA, at risk RSV.                          4/29/08 Reviewed hospital records for 12/28/2007-1/5/2008 including vax record for 12/28 & 12/29/2007. Records reveal patient continued on CPAP & caffiene for apnea since 11/22, last apnea noted 12/27, mostly self resolved.  Was on Pb for seizures, last seizure noted 11/26.  Had increased apneas overnight 12/29-30.  Caffiene & high flow nasal cannula increased.  Started IV antibiotics on 12/31 for increased CRP of 2.6  & presumed sepsis.  Transfused 12/31.  CRP 0.94 on 1/2/08.  6 apnea spells 1/3-1/4/2008 w/probable reflux.  CRP 1/4 0.23.
Age: 0.2
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Apnoea, C-reactive protein increased, Condition aggravated, Culture urine negative, Urine analysis normal
Clinical narrative: Increased apneas (severe needing bagging) led to rule out sepsis and antibiotics. Occurred within 24 hours of immunizations. Was near time of discharge.  3/21/08 Reviewed hospital medical records for 01/04-2/22/2008.  Transferred from outlying hospital after birth and transferred from this hospital to another at d/c for continued care. FINAL DX: ex 28 wk preemie twin #1, birth weight 969 gms; recent weight 1680 gms; PMA approx 36 wks; apnea of prematurity; resolved surfactant deficient respiratory distress syndrome; resolved enterobacter pneumonia; immature retins ophthalmology f/u required Records reveal patient experienced presumed sepsis for premature prolonged rupture of membranes.  Developed:retinopathy of prematurity; enterobacter pneumonia; intubated/extubated; continued periods of apnea on caffeine.   4/11/08 Reviewed hospital medical records for 2/22-3/27/2008. FINAL DX: preemie as noted in prior records, anemia, apnea, GERD, PDA ROP, RSV.  Increased severity & frequency of apnea;increased CRP w/n 24 hrs of immunizations & likely due to immunizations in preemies at 2 mo shots. Experienced several apnea spells s/p immunizations, last one 3/19.  Progressed well overall & D/C home on RA, d/c weight 2475 gms, only med iron, taking nipple feeds well on reflux precautions.
Age: 0.2
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Apnoea, Band neutrophil count, Blood culture negative, Culture urine negative, Neutrophil count
Clinical narrative: Increased apneas - severity and frequency - led to rule out sepsis and antibiotics.  Occurred 24 hours after immunizations.  See attached notes.  Was near time of discharge.  3/21/08 Reviewed hospital medical records of 01/04/2008-2/22/2008. FINAL DX: resolved distress of prematurity; apnea of prematurity requiring caffeine; anemia of prematurity on iron. Medical records reveal patient experienced multiple complications of prematurity.  Initially received TPN & gradually transitioned to oral feeds.  D/C weight 1915 gms.  Developed sepsis & received IV antibiotics.  Possible ROP to f/u at d/c.  Transferred to neonatal unit more convenient for parents when stablized.                      4/11/08 Reviewed hospital medical records for 2/22-3/27/2008. FINAL DX: preemie as noted in prior records, anemia, apnea, GERD, ROP, RSV Records reveal increased severity & frequency of apnea;increased CRP w/n 24 hrs of immunizations & likely due to immunizations in preemies at 2 mo shots. Experienced several apnea spells s/p immunizations, last one 3/20.  Progressed well overall & D/C home on RA, d/c weight 3240 gms, only med iron, taking nipple feeds well on reflux precautions.
Age: 0.2
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: White blood cell count normal
Clinical narrative: Increased apneas - severity and frequency - led to rule out sepsis and antibiotics.  Occurred 24 hours after immunizations.  See attached notes.  Was near time of discharge.  3/21/08 Reviewed hospital medical records of 01/04/2008-2/22/2008. FINAL DX: resolved distress of prematurity; apnea of prematurity requiring caffeine; anemia of prematurity on iron. Medical records reveal patient experienced multiple complications of prematurity.  Initially received TPN & gradually transitioned to oral feeds.  D/C weight 1915 gms.  Developed sepsis & received IV antibiotics.  Possible ROP to f/u at d/c.  Transferred to neonatal unit more convenient for parents when stablized.                      4/11/08 Reviewed hospital medical records for 2/22-3/27/2008. FINAL DX: preemie as noted in prior records, anemia, apnea, GERD, ROP, RSV Records reveal increased severity & frequency of apnea;increased CRP w/n 24 hrs of immunizations & likely due to immunizations in preemies at 2 mo shots. Experienced several apnea spells s/p immunizations, last one 3/20.  Progressed well overall & D/C home on RA, d/c weight 3240 gms, only med iron, taking nipple feeds well on reflux precautions.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister, Rash
Clinical narrative: This is a rash on (R) upper arm and middle arm measured 120 mm in width and 95 mm in length with blister in middle of rash measuring 20 mm in length and 30 mm in width. Pt put some ice wrapped in towel 03/14/08, blister appeared after ice application. Rx Benadryl 12.5 mg and HC cream 2.5%. Prescribed by physician.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injury, Syncope
Clinical narrative: Pt. had syncopal episode after receiving vaccines. Pt fainted after receiving immunization when getting into car to leave clinic. Suffered small bump. No visual disturbance. Vitals stable. After observation released home.
Age: 13.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTaP instead of TdaP. He is 13 years old. Per CDC, it does count as valid dose. May have more of a injection site reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Lt. upper thigh 11 1/2 x 11 cm well defined erythema warm/edematous
Age: 0.9
Sex: F
Vaccine: PNC
Symptoms: Immediate post-injection reaction, Rash erythematous, Rash macular
Clinical narrative: Developed pinkish to erythematous macular rashes on the face, arms and scalp a few minutes after receiving first dose of Prevnar; did not have any respiratory symptoms; given a dose of Benadryl; mom says rashes resolved after 5 hours.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Autism, Pyrexia
Clinical narrative: Patient quit talking for 6 months after the 5 shots.  Then 7-07 was diagnosed with autism.  He had a fever and just didn't seem the same.  Like he was just not there anymore.  6/27/08 Reviewed PCP office records 12/13/04 pt w/cough, sneeze, thick green nasal drainage x 7 days & dx w/URI.  Otherwise developmentally appropriate.  Speech unintelligible 4/17/07.  8/5/08 Reviewed psychological evaluation of 9/18/2007. FINAL DX: autistic disorder; PDD; & mental retardation Records reveal patient experienced difficulty interacting w/others; avoiding eye contact; failure to make friends; difficulty communicating; stereotypical repetitive behaviors; difficulty adapting to changes in environment or routine; & delayed self-help skills.  Was receiving counseling; was in developmental disabilities program; & ST/OT & behavioral therapy were recommended.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, elevated area measuring approximately 5cm in diameter. Warm to touch. No fever from the patient. Patient was instructed to use cold compress and Benadryl. Reaction noted 24 hours after administration of vaccine to the left arm.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red, swollen, raised area to left leg.  Patient's mom phoned in reaction to the left leg 24 hours after vaccine was administered.  She was instructed to use cold compresses, Tylenol and Benadryl.  Return to clinic if no changes.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site mass, Oedema peripheral
Clinical narrative: Red, swollen, area with hard limp to both legs at injection site. Patient's parent called and reported reaction 24 hours after vaccine injection.
Age: 1.7
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Red, swollen area with hard knot to both legs at injection site.  Patient's parent called and reported reaction 24 hours after vaccine was administered.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red, swollen area approximately 1.5cm in diameter, multiple areas on left and right legs.  Patient's mom called in adverse reaction 7 days after vaccines were administered.  Cold compresses and use Tylenol and Benadryl were instructed for treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: 2" x 2 1/2" cellulitis at vaccine site, right deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: About 2 inch erythema slightly raised to left thigh. Advice to apply warm compress and give Tylenol for pain. Advice mother to return to clinic if signs and symptoms get worse. Mother verbalized understanding.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Area very red, warm to touch and raised.  Dermatologic patterns: Consistent with urticaria (large local reaction measuring 3cm diameters on anterior right thigh where vaccines were administered.  Per doctor certainly from vaccine.  Subcutaneous involvement only.  Plan to treat symptomatically.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Rash pruritic
Clinical narrative: Rash red itchy from back then all over forehead to legs; started 3/13/07
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given 1st Hep B 3/9/08 and given another Hep B 3/14/08 - mother did not have paperwork that stated she had vaccines and was unsure if received any vaccines.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: 7x7cm swelling right thigh with fever on swollen area. Mom brought child today for us to see the injection site. 25.1in Needle was used.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Skin lesion
Clinical narrative: Errhymatic vascular eruption at site of Varivax injection with induration. Found right thigh (lateral) 7-8 vesicular lesion
Age: 43.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting lasting 10-15 minutes, 8 hours after vaccination.
Age: 7.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: A 7 year old child was inadvertently given an adult Hep B dose.  Vital sign remain stable after the injection.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Extreme pain and swelling around injection site. Extreme pain spreading from neck to the fingers. Numbness occurred the 1st day after the shot. Nausea and vomiting occurred the 1st day after the shot.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Extreme pain and swelling around injection site. Extreme pain spreading from neck to the fingers. Numbness occurred the 1st day after the shot. Nausea and vomiting occurred the 1st day after the shot.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Ear pain, Erythema, Induration, Injection site pain
Clinical narrative: On 3-11-08 patient presented in office with c/o ear ache and sore throat.  Her ears were WNL and rapid strep screen was negative for strep. Temp was 99.1. She received # 2 VZV vaccine into her right upper arm.  On 3-13-08 she presented in office with a circular 10 cm area of erythema and firm induration.  The site was warm and slighty painful to touch. Temp was 98.5.   Ibuprofen and cold compresses were recommended, with follow up as needed.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pharyngolaryngeal pain
Clinical narrative: On 3-11-08 patient presented in office with c/o ear ache and sore throat.  Her ears were WNL and rapid strep screen was negative for strep. Temp was 99.1. She received # 2 VZV vaccine into her right upper arm.  On 3-13-08 she presented in office with a circular 10 cm area of erythema and firm induration.  The site was warm and slighty painful to touch. Temp was 98.5.   Ibuprofen and cold compresses were recommended, with follow up as needed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling and heat surrounding injection site of DTaP approximately 2 inches across. Full range of motion of arm.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Oedema, Swelling, Tenderness
Clinical narrative: Patient presented in office 2-27-08 for ADHD visit with concerns about weight loss.  He was healthy and afebrile.  He received # 2 VZV vaccine into his right upper arm.  On 2-28-08 he presented in office with moderate edema and localized area of puffy erythema, 3 x 5 cm, with mild tenderness. His temp was 97, orally.  Ibuprofen and cool compresses were recommended with follow up if not improving.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Acute tonsillitis, Bronchial hyperreactivity, Inflammation, Lymphadenopathy, Pyrexia
Clinical narrative: Returned to clinic, 3/6/08 with complaint of rash and fever. Hx of spots within 24 hours of vaccination. Spots started resolving 2 days ago. Swollen glands since yesterday and fever last night, 102 degrees. Seen by Dr.--dx tonsillitis, rash, possible epiglottitis, fever, emesis, ?immunization reaction, RAD; referred to ER for evaluation, dx with Acute exudative tonsillitis. Seen in ER 3/8/08, dx viral exanthem.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Skin discolouration, Viral rash, Vomiting
Clinical narrative: Returned to clinic, 3/6/08 with complaint of rash and fever. Hx of spots within 24 hours of vaccination. Spots started resolving 2 days ago. Swollen glands since yesterday and fever last night, 102 degrees. Seen by Dr.--dx tonsillitis, rash, possible epiglottitis, fever, emesis, ?immunization reaction, RAD; referred to ER for evaluation, dx with Acute exudative tonsillitis. Seen in ER 3/8/08, dx viral exanthem.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site cellulitis, Injection site discharge, Injection site pain, Injection site swelling
Clinical narrative: (This report may have already been submitted by this nurse, but a copy can not be found so it is either being submitted for the first time or this is the second time.)  On 2-12-08 patient received #2 dose of VZV vaccine into the left upper arm. On 2-14-08 patient's mother called to report that he had significant swelling at the injection site.  Mom described the injection site as if "someone inserted a softball under his skin."  She reported that the area was "bruised, swollen, painful, hot to touch and that there was watery pus coming out of it, fever of 101.9." Mom took patient to a facility 2-14-08 where he was diagnosed with cellulitis at the injection site and placed on Augmentin and a "steroid". On 2-15-08 his temp was 100.5 and mom had given him 2 doses of the medications prescribed from the facility and she declined a follow up appointment to our office.  Patient presented to the office 2-18-08 to status his injection site.  The site had returned to normal, temp was 97.6, non-tender, with free movement of the left arm.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: (This report may have already been submitted by this nurse, but a copy can not be found so it is either being submitted for the first time or this is the second time.)  On 2-12-08 patient received #2 dose of VZV vaccine into the left upper arm. On 2-14-08 patient's mother called to report that he had significant swelling at the injection site.  Mom described the injection site as if "someone inserted a softball under his skin."  She reported that the area was "bruised, swollen, painful, hot to touch and that there was watery pus coming out of it, fever of 101.9." Mom took patient to a facility 2-14-08 where he was diagnosed with cellulitis at the injection site and placed on Augmentin and a "steroid". On 2-15-08 his temp was 100.5 and mom had given him 2 doses of the medications prescribed from the facility and she declined a follow up appointment to our office.  Patient presented to the office 2-18-08 to status his injection site.  The site had returned to normal, temp was 97.6, non-tender, with free movement of the left arm.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Nausea
Clinical narrative: Employee was seen by M.D. for nausea and diarrhea. Viremia of MMR.
Age: 15.0
Sex: F
Vaccine: HPV4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Swelling, redness, rash, pain, tenderness in L delt. area.
Age: 1.69
Sex: M
Vaccine: FLU3, PNC
Symptoms: Blood test normal, Body temperature increased, Chest X-ray normal, Convulsion, Culture negative
Clinical narrative: Influenza/Prevnar shot given 3/5/08; prt reported temp of 104.8 and seizures next day- taken to ER. F/u with pediatrician on 3/7/08.
Age: 1.69
Sex: M
Vaccine: FLU3, PNC
Symptoms: Streptococcal identification test negative, Virus culture negative
Clinical narrative: Influenza/Prevnar shot given 3/5/08; prt reported temp of 104.8 and seizures next day- taken to ER. F/u with pediatrician on 3/7/08.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Patient RECIEVED T-DAP VACCINE 2/29/2008, WAS IN 3/5/2008 AND SAID SHE HAD DEVELOPED FEVER AND CHILLS FOR TWO DAYS AFTER RECIEVED VACCINE.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: CSF glucose abnormal, CSF lymphocyte count abnormal, CSF monocyte count decreased, CSF protein increased, CSF white blood cell count increased
Clinical narrative: Guillain-Barre Syndrome  4/25/08 Reviewed hospital medical records of 3/11-3/20/2008. FINAL DX: Guillain Barre syndrome. Records reveal patient experienced fatigue, pallor, urinary urgency, progressive difficulty walking w/pain & heaviness in his legs, penis & back x 2 weeks resulting in several falls.  Immediately s/p vaccine, experienced flu-like symptoms which resolved w/n 24 hours.  While hospitalized developed increased LE weakness, areflexia.  Neuro consult done.  Tx w/IVIG x 5 days.  D/C to inpatient rehab facility for continued PT.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Guillain-Barre Syndrome  4/25/08 Reviewed hospital medical records of 3/11-3/20/2008. FINAL DX: Guillain Barre syndrome. Records reveal patient experienced fatigue, pallor, urinary urgency, progressive difficulty walking w/pain & heaviness in his legs, penis & back x 2 weeks resulting in several falls.  Immediately s/p vaccine, experienced flu-like symptoms which resolved w/n 24 hours.  While hospitalized developed increased LE weakness, areflexia.  Neuro consult done.  Tx w/IVIG x 5 days.  D/C to inpatient rehab facility for continued PT.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Blood product transfusion, CSF glucose normal, CSF lymphocyte count normal, CSF protein increased, CSF white blood cell count
Clinical narrative: Guillain-Barre Syndrome  4/25/08 Reviewed hospital medical records of 3/11-3/20/2008. FINAL DX: Guillain Barre syndrome. Records reveal patient experienced fatigue, pallor, urinary urgency, progressive difficulty walking w/pain & heaviness in his legs, penis & back x 2 weeks resulting in several falls.  Immediately s/p vaccine, experienced flu-like symptoms which resolved w/n 24 hours.  While hospitalized developed increased LE weakness, areflexia.  Neuro consult done.  Tx w/IVIG x 5 days.  D/C to inpatient rehab facility for continued PT.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Gait disturbance, Guillain-Barre syndrome, Lumbar puncture abnormal, Monocyte count decreased, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Guillain-Barre Syndrome  4/25/08 Reviewed hospital medical records of 3/11-3/20/2008. FINAL DX: Guillain Barre syndrome. Records reveal patient experienced fatigue, pallor, urinary urgency, progressive difficulty walking w/pain & heaviness in his legs, penis & back x 2 weeks resulting in several falls.  Immediately s/p vaccine, experienced flu-like symptoms which resolved w/n 24 hours.  While hospitalized developed increased LE weakness, areflexia.  Neuro consult done.  Tx w/IVIG x 5 days.  D/C to inpatient rehab facility for continued PT.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Red blood cell count normal
Clinical narrative: Guillain-Barre Syndrome  4/25/08 Reviewed hospital medical records of 3/11-3/20/2008. FINAL DX: Guillain Barre syndrome. Records reveal patient experienced fatigue, pallor, urinary urgency, progressive difficulty walking w/pain & heaviness in his legs, penis & back x 2 weeks resulting in several falls.  Immediately s/p vaccine, experienced flu-like symptoms which resolved w/n 24 hours.  While hospitalized developed increased LE weakness, areflexia.  Neuro consult done.  Tx w/IVIG x 5 days.  D/C to inpatient rehab facility for continued PT.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus
Clinical narrative: On 03/13/2008 @ 250pm I administered the second HBV vaccine injection to patient. At 254pm she started to experience itchiness and redness to (L) forearm; at 257pm noted small red, itchy area near injection site; at 300pm noted itchy redness to (L) upper chest and neck; at 316pm Benadryl 25mg given by mouth bp 120/56; at 320pm Benadryl 25mg given by mouth.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Approximately 48 hours after receiving the Zostavax vaccine, the patient developed a red, itchy, hard lump the size of a fist at the site of injection.  While the entire lump was red and itchy, symptoms were most severe at the actual size of needle penetration.  Patient has been treating with Benadryl and hot compresses.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Dyspnoea, Lip swelling, Pruritus, Rash, Swelling face
Clinical narrative: Client states around 9:30 that evening she had an outbreak of rash, itching starting on her hands & then all over body.  Stated had swollen lips & had a hard time breathing when lying down.  Used inhaler & Benadryl.  Had swollen chin this am.  Also states she ate shrimp last night.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Computerised tomogram abnormal, White blood cell count increased
Clinical narrative: Apparent cellulitis after 7-25-06 vaccination.  Received antibiotics.  3/21/08 Reviewed hospital medical records of 07/15/2006-07/27/2006. FINAL DX: prostate cancer. Records reveal patient experienced laparoscopic radial prostatectomy.  Received Pneumovax prior to d/c home.  Records also reveal patient was re-admitted 7/27/2006-08/01/2006. FINAL DX: cellulitis Patient experienced nausea, abdominal pain & fever of 101.8.  Returned to hospital on day of d/c s/p prostatectomy.  Developed swelling & erythema of LUE next day s/p pneumovax c/w cellulitis.  Tx w/IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Delirium, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, delirium, redness, pain and swelling at site of vaccine.  Received antibiotics.  4/1/08 Reviewed hospital medical records for 11/13/2006.   FINAL DX: left shoulder cellulitis s/p vaccination; pathologic lesion right proximal femur; right femur intermedullary nailing.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Differential white blood cell count abnormal, Injection site erythema, Injection site pain, Myofascitis
Clinical narrative: Onset redness, exquisite pain over site of vaccination.  Fever, chills, WBC 25 with bandemia.  5/1/08 Reviewed hospital medical records for 3/11-3/12/2008. FINAL DX: cellulitis right deltoid s/p immunization Records indicate patient experienced fever, nausea, chills, soaking night sweats, reduced oral intake, rigors, pounding HA & arm pain after multiple vaccinations in preparation for foreign travel.  No reaction to prior vaccinations.  Had sore throat x 1 week prior to vaccinations w/tonsillar exudate.  Seen in ID clinic on day of admission.  Improved & d/c to home on continued oral antibiotics.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Pyrexia, White blood cell count increased
Clinical narrative: Onset redness, exquisite pain over site of vaccination.  Fever, chills, WBC 25 with bandemia.  5/1/08 Reviewed hospital medical records for 3/11-3/12/2008. FINAL DX: cellulitis right deltoid s/p immunization Records indicate patient experienced fever, nausea, chills, soaking night sweats, reduced oral intake, rigors, pounding HA & arm pain after multiple vaccinations in preparation for foreign travel.  No reaction to prior vaccinations.  Had sore throat x 1 week prior to vaccinations w/tonsillar exudate.  Seen in ID clinic on day of admission.  Improved & d/c to home on continued oral antibiotics.
Age: 43.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Diarrhoea, Dyspepsia, Laboratory test, Pyrexia
Clinical narrative: Began with fever, then noted diarrhea, dyspepsia. Symptoms onset after vaccine and persisted today. Seen and labs sent for evaluation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Tenderness
Clinical narrative: Pt was given a DTaP vaccination in his right deltoid.  When the patient arrived home his right upper arm was hot, hard, red and swollen.  On 3/8/08 his mother took him the ER (because it was a Saturday) to be checked because the swelling and redness was not subsiding.  ER provided no treatment on their visit stating it was a normal reaction to a vaccine.  I phoned the mother on 3/10/08 to follow up and was told that his arm was still swollen and uncomfortable.  We recommended hot packs to the arm to help encourage absorption of fluid in his arm.  He was seen today 3/14/08 in our office.  His arm is still somewhat red and warm.  Pt complains of itchiness and slight tenderness.  There were no systemic reactions reported.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Skin lesion, Skin warm
Clinical narrative: 2 hours after immunization broke out in rash each lesion approx size of a quarter. Skin hot to touch but no fever. Seen in ER @ 6PM. Gave Benadryl po, Albuterol 2mg tab & Loratidine.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient has possible local reaction to vaccine; redness, swelling.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injected limb mobility decreased, Injection site mass, Pain in extremity
Clinical narrative: Sore Arm since influenza vaccine on 11-1-07. Has been seen by her HCP and was told she has a "lump under muscle" at injection site. She states that she cannot raise arm above shoulder or take her arm out of coat sleeve. Reports arm was fine prior to flu shot. Did not remark about any other symptoms except arm soreness during next 1-2 days.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient had possible local reaction to vaccine; redness and swelling.
Age: 1.49
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Possible local reaction; redness and swelling.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A non-serious report of influenza was received from a consumer concerning a child of unknown age and gender.  This case is submitted in accordance with a companies post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No relevant medical or drug history information was reported.  The child was given FluMist in November 2007.  The patient developed influenza infection in February 2008.  No outcome for the event was provided by the reporter.  Rechallenge is not applicable.  The reporter did not provide a statement of causality to FluMist.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A nonserious report of expired dose of vaccine administered has been received from a physician concerning a four-year-old male patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on an unknown date. The FluMist had expired on an unknown date. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable to this adverse event. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A nonserious report of expired dose of vaccine administered has been received from a physician concerning a two-and-a-half year old female patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on an unknown date. The FluMist had expired on an unknown date. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable to this adverse event. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of expired dose of FluMist administered was received from a physician concerning a three-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FluMist. No medical history nor concomitant medications were reported. The patient received FluMist vaccine on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. A follow-up call to the reporter four weeks later on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving the expired FluMist vaccine. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This is in follow-up to report(s) previously submitted on 02/05/08. A non-serious spontaneous report of expired dose of FLUMIST administered was received from a physician concerning a 40-month-old female. No medical history was reported. There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 21-Nov-2008: No adverse event occurred as a result of the medication error.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Body temperature increased, Bronchitis, Convulsion, Dyskinesia, Eosinophil count normal
Clinical narrative: Patient went in for a well-check on 1-21-08, we did not know he had a Temp of 100.1 at the time of the Varicella shot. Facility said his temp was normal. We got the records from the office and that is when we saw he had temp of 100.1. After he got the shot we left and went to get a pair of shoes. He said he did not feel good and did not want to get a movie. So we came home that was around 3:30 he went to his room and laid down. I asked him if he wanted to watch a movie and he said no. He fell asleep and I checked on him he felt warm. I got him up to take his temperature and he threw up and he had a temp of 102.3 so I gave him Tylenol and he fell back to sleep. I checked on him at 8:30 he was burning up his temp was 104.8 I called the ER and she told me to put him in a tepid bath and give him Tylenol and Motrin alternate every 4 hours. I got his Temp down to 102 and it stated at 102 and 101.6 I could not get a an appointment with Dr. he was booked so I took him to the ER on 1-24-08 Dr. saw him, I told her that he had a chickenpox Vaccine on the 1-21-08 she was not concerned about that she said he had Acute Bronchitis. She gave him a Z-Pack 200mg. We gave him the pills crushed up in applesauce. He seemed ok for a few days and then he started jerking his head and he had neck pain. On 2-7-08 he got up around 7:30 and he was jerking out of his skin he could not talk to me and he was staring out into space. I ran him To The ER and Dr. could not find the reason for the Seizure he took a Video of patient, I don't know what he did with it. I told him patient had a chickenpox shot on 1-21-08 he was concerned about that, and he ran all kinds of tests on him. He finally said patient needed to go to Hospital he was taken by ambulance, Dr. gave him a dose of penicillin before he left. It took 3 1/2 hours to get to hospital in another city when he got there the jerking and twitching had slowed down. The neurologist did no tests no EEG on patient. We were there 22 hours we did not see a Doctor until 8am 2-8-08 when he did come in he looked at patient and said he has a TIC. He gave him Topmaz 25mg and told us to go home and try to live with it. Patient has seen 3 neurologist he has been in 3 hospitals. We found a neurologist in another city he has put patient on Penicillin 250mg and Clonidine 0.1mg. Patient went into Dr. office a happy little boy on 1-21-08 he is now suffering and jerking all over his body he is having severe neurological problems. One 1-20-08 he made the HONOR ROLL at school, that is why he was going to get a new pair of SHOES.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Feeling hot, Haematocrit normal, Lymphocyte count increased, Malaise, Mean platelet volume decreased
Clinical narrative: Patient went in for a well-check on 1-21-08, we did not know he had a Temp of 100.1 at the time of the Varicella shot. Facility said his temp was normal. We got the records from the office and that is when we saw he had temp of 100.1. After he got the shot we left and went to get a pair of shoes. He said he did not feel good and did not want to get a movie. So we came home that was around 3:30 he went to his room and laid down. I asked him if he wanted to watch a movie and he said no. He fell asleep and I checked on him he felt warm. I got him up to take his temperature and he threw up and he had a temp of 102.3 so I gave him Tylenol and he fell back to sleep. I checked on him at 8:30 he was burning up his temp was 104.8 I called the ER and she told me to put him in a tepid bath and give him Tylenol and Motrin alternate every 4 hours. I got his Temp down to 102 and it stated at 102 and 101.6 I could not get a an appointment with Dr. he was booked so I took him to the ER on 1-24-08 Dr. saw him, I told her that he had a chickenpox Vaccine on the 1-21-08 she was not concerned about that she said he had Acute Bronchitis. She gave him a Z-Pack 200mg. We gave him the pills crushed up in applesauce. He seemed ok for a few days and then he started jerking his head and he had neck pain. On 2-7-08 he got up around 7:30 and he was jerking out of his skin he could not talk to me and he was staring out into space. I ran him To The ER and Dr. could not find the reason for the Seizure he took a Video of patient, I don't know what he did with it. I told him patient had a chickenpox shot on 1-21-08 he was concerned about that, and he ran all kinds of tests on him. He finally said patient needed to go to Hospital he was taken by ambulance, Dr. gave him a dose of penicillin before he left. It took 3 1/2 hours to get to hospital in another city when he got there the jerking and twitching had slowed down. The neurologist did no tests no EEG on patient. We were there 22 hours we did not see a Doctor until 8am 2-8-08 when he did come in he looked at patient and said he has a TIC. He gave him Topmaz 25mg and told us to go home and try to live with it. Patient has seen 3 neurologist he has been in 3 hospitals. We found a neurologist in another city he has put patient on Penicillin 250mg and Clonidine 0.1mg. Patient went into Dr. office a happy little boy on 1-21-08 he is now suffering and jerking all over his body he is having severe neurological problems. One 1-20-08 he made the HONOR ROLL at school, that is why he was going to get a new pair of SHOES.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Muscle twitching, Neck pain, Nervous system disorder, Neutrophil percentage decreased, Platelet count increased
Clinical narrative: Patient went in for a well-check on 1-21-08, we did not know he had a Temp of 100.1 at the time of the Varicella shot. Facility said his temp was normal. We got the records from the office and that is when we saw he had temp of 100.1. After he got the shot we left and went to get a pair of shoes. He said he did not feel good and did not want to get a movie. So we came home that was around 3:30 he went to his room and laid down. I asked him if he wanted to watch a movie and he said no. He fell asleep and I checked on him he felt warm. I got him up to take his temperature and he threw up and he had a temp of 102.3 so I gave him Tylenol and he fell back to sleep. I checked on him at 8:30 he was burning up his temp was 104.8 I called the ER and she told me to put him in a tepid bath and give him Tylenol and Motrin alternate every 4 hours. I got his Temp down to 102 and it stated at 102 and 101.6 I could not get a an appointment with Dr. he was booked so I took him to the ER on 1-24-08 Dr. saw him, I told her that he had a chickenpox Vaccine on the 1-21-08 she was not concerned about that she said he had Acute Bronchitis. She gave him a Z-Pack 200mg. We gave him the pills crushed up in applesauce. He seemed ok for a few days and then he started jerking his head and he had neck pain. On 2-7-08 he got up around 7:30 and he was jerking out of his skin he could not talk to me and he was staring out into space. I ran him To The ER and Dr. could not find the reason for the Seizure he took a Video of patient, I don't know what he did with it. I told him patient had a chickenpox shot on 1-21-08 he was concerned about that, and he ran all kinds of tests on him. He finally said patient needed to go to Hospital he was taken by ambulance, Dr. gave him a dose of penicillin before he left. It took 3 1/2 hours to get to hospital in another city when he got there the jerking and twitching had slowed down. The neurologist did no tests no EEG on patient. We were there 22 hours we did not see a Doctor until 8am 2-8-08 when he did come in he looked at patient and said he has a TIC. He gave him Topmaz 25mg and told us to go home and try to live with it. Patient has seen 3 neurologist he has been in 3 hospitals. We found a neurologist in another city he has put patient on Penicillin 250mg and Clonidine 0.1mg. Patient went into Dr. office a happy little boy on 1-21-08 he is now suffering and jerking all over his body he is having severe neurological problems. One 1-20-08 he made the HONOR ROLL at school, that is why he was going to get a new pair of SHOES.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Red cell distribution width decreased, Speech disorder, Staring, Streptococcal identification test positive
Clinical narrative: Patient went in for a well-check on 1-21-08, we did not know he had a Temp of 100.1 at the time of the Varicella shot. Facility said his temp was normal. We got the records from the office and that is when we saw he had temp of 100.1. After he got the shot we left and went to get a pair of shoes. He said he did not feel good and did not want to get a movie. So we came home that was around 3:30 he went to his room and laid down. I asked him if he wanted to watch a movie and he said no. He fell asleep and I checked on him he felt warm. I got him up to take his temperature and he threw up and he had a temp of 102.3 so I gave him Tylenol and he fell back to sleep. I checked on him at 8:30 he was burning up his temp was 104.8 I called the ER and she told me to put him in a tepid bath and give him Tylenol and Motrin alternate every 4 hours. I got his Temp down to 102 and it stated at 102 and 101.6 I could not get a an appointment with Dr. he was booked so I took him to the ER on 1-24-08 Dr. saw him, I told her that he had a chickenpox Vaccine on the 1-21-08 she was not concerned about that she said he had Acute Bronchitis. She gave him a Z-Pack 200mg. We gave him the pills crushed up in applesauce. He seemed ok for a few days and then he started jerking his head and he had neck pain. On 2-7-08 he got up around 7:30 and he was jerking out of his skin he could not talk to me and he was staring out into space. I ran him To The ER and Dr. could not find the reason for the Seizure he took a Video of patient, I don't know what he did with it. I told him patient had a chickenpox shot on 1-21-08 he was concerned about that, and he ran all kinds of tests on him. He finally said patient needed to go to Hospital he was taken by ambulance, Dr. gave him a dose of penicillin before he left. It took 3 1/2 hours to get to hospital in another city when he got there the jerking and twitching had slowed down. The neurologist did no tests no EEG on patient. We were there 22 hours we did not see a Doctor until 8am 2-8-08 when he did come in he looked at patient and said he has a TIC. He gave him Topmaz 25mg and told us to go home and try to live with it. Patient has seen 3 neurologist he has been in 3 hospitals. We found a neurologist in another city he has put patient on Penicillin 250mg and Clonidine 0.1mg. Patient went into Dr. office a happy little boy on 1-21-08 he is now suffering and jerking all over his body he is having severe neurological problems. One 1-20-08 he made the HONOR ROLL at school, that is why he was going to get a new pair of SHOES.