chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Lumbar puncture, Muscular weakness, Nerve conduction studies abnormal, Vision blurred
Clinical narrative: The patient developed severe headache 13 days after vaccine administration, followed by right-sided facial palsy, then progressive bilateral lower extremity weakness and some intermittent blurred vision.  He was first seen 16 days after vaccine administration, at which time his right facial palsy was the prominent symptom, and was put on acyclovir, prednisone, and artificial tears.  His lower extremity weakness then progressed, and he was re-evaluated 2 days later.  He still had a right facial nerve palsy and sigificant weakness of his bilateral hip flexion, knee extension and flexion, and great toe dorsiflexion and plantar flexion.  Neurology was consulted by phone, the patient was transferred to an ER, and then admitted to Hospital for 4 days, where he underwent a normal brain MRI, an LP that showed 3-4 wbc's, protein of 373, and glucose of 59.  His nerve conduction studies showed absent F waves in median, ulnar, common peroneal, and tibial nerves; normal conduction velocities, but slightly prolonged distal latencies.  He was transferred to another Hospital where he could undergo better monitoring while getting IVIG. 9/17/08-records received for DOS 9/10-9/13/08-DC DX: Guillain-Barre. Treated with IVIG. Presented to ED with C/O right-sided facial weakness and bilateral lower extremity weakness 7 days prior to admission. Symptoms began one week ago with headache with aura on 9/3/08. Next day weakenss on right side of face and face was droopy followed one day later with lower extremity weakness with some difficulty in walking. Diagnosed with Bell's palsy. Two days later developed blurry vision, unable to focus on schoolwork.  Elevated systolic blood pressure.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Live birth, Oral contraception, Ultrasound scan
Clinical narrative: Information has been received from a nurse through a Merck pregnancy registry concerning a 26 year old female patient with a history of 4 pregnancies and 2 live births who was on oral contraceptives in the first trimester, with gestational diabetes and insulin dependency, who on 31-MAY-2007 was vaccinated with the first dose of GARDASIL (lot# 657737/0522U). The patient was pregnant with a LMP of 09-Apr-2007. Follow up information indicated that on 09-Jan-2008 the patient delivered a normal liveborn male infant weeks from LMP 37 2/7 with a Apgar score 8/9. Follow up information has been received in the form of medical records. On 09-JAN-2008, the baby was born with hyperbilirubinemia and bilateral cephalohematomas. The weight was 8 lbs, the length 21 inches, head circumference 13.8 inch. On 12-JAN-2008 and 13-JAN-2008, the patient was admitted for phototherapy. Saturday, 12-JAN-2008, the patient's bilirubin was 19 and Sunday, 13-JAN-2008, rebound bilirubin was 11 (5 hours off phototherapy). A total bilirubin measurement with a heel stick was performed. The lab results were reported as: -12-JAN-2008: 18.0 mg /dl 19.2 mg /dl. -13-JAN-2008: 12.3 mg/dl 10.8 mg/dl 11.2 mg/dl 16.1 mg/dl. On 14-JAN-2008, the baby had a sick visit to the doctor and still had jaundice and cephalohematoma, with icteric sclera and hyperbilirubinemia. Some lab test was performed, which included a measurement of Total bilirubin with a heel stick. The results was : 12.2 mg/dl. On 18-JAN-2008, the baby had a sick visit date, and it was noted that the baby had jaundice from chest to upper abdomen (seedy yellow) and hyperbilirubinemia. The pediatrician was concerned about the baby's head swollen. The baby still had cephalohematoma. On examination on 25-JAN-2008, it was noted that the baby still had bilateral cephalohematoma; the left side greater the right side. It was also noticed that the baby had urine frequently, had jaundice in the face, and diaper rash. The baby was 15 days. A lab test was performed which included a PKU (result not reported). On examination on 08-FEB-2008, it was noted small cephalohematoma right. The baby was 1 month of age. On 07-MAR-2008, the baby's cephalohematomas was resolved. On an unspecified date, the baby recovered from diaper rash. The outcome of the baby's hyperbilirubinemia and frequent urination was unknown. No additional information is expected. It was also reported that the infant developed adverse experiences after vaccination with ROTATEQ (WAES # 809USA01659). All medical records will be provided upon request.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Asthma, Blood pressure, Body temperature, Burning sensation
Clinical narrative: Vaccine administered at approx 10am on 8/20/08 in right deltoid. No side effects were noted. By report from this individual she stated that she was cooking supper around 5:30pm and she had a nosebleed then she started feeling achy and tired. She took TYLENOL P.O. She stated she made Potato Salad but though she must have put too much vinegar in it because it burned when she swallowed it. She stated the vision in her left eye became blurred (blind in right eye). She stated that when she laid down it was harder to breathe so she remained elevated on pillows but could not sleep. She presented with no wheezing in lung sounds but had dyspnea/asthma-like symptoms. She stated that by morning the vision in left eye was double and blurred. All her joints were stiff very hard to bend and had difficulty getting her breath. Stated that she continued to feel nauseated but did not vomit. Upon examination vital signs were: T 97.4, P 74, BP 117/77, R 24 SpO2 93%. (VS on 8/4/08 were T 98.9, P 85, R 16, B/P 135/95, SpO2 95%). Presented with difficulty with ROM of all extremities and digits r/t stiffness and pains in joints, red and swollen and warm to touch. Skin cool and moist. Vesicular lesions behind Right ear with clear drainage from ear apparent. Complaint of tinnitus in Left ear. Examination of oral cavity revealed stomatitis. Was transported to ER for direct admit. 9/22/08-records received for DOS 8/21-8/25/08-DC DX: Possible reaction to hepatitis A & B vaccines. Arthralgias. Urticaria. Presented to ED with C/O arthralgias in both knees and right elbow, shakes and weakness in arms and legs. Nose bleeds. Sores on tongue and behind ear. Pain when ambulating, difficulty swallowing.  Difficulty getting enough air in.  Returned to ED on 8/26/08- with C/O confusion. Ambien prescription of 10 dispensed on 8/25/28 now shows 3 remaining and Lortab 30 dispensed only 21 left. Neurological exam non-focal.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Diplopia, Dyspnoea, Epistaxis, Erythema, Fatigue
Clinical narrative: Vaccine administered at approx 10am on 8/20/08 in right deltoid. No side effects were noted. By report from this individual she stated that she was cooking supper around 5:30pm and she had a nosebleed then she started feeling achy and tired. She took TYLENOL P.O. She stated she made Potato Salad but though she must have put too much vinegar in it because it burned when she swallowed it. She stated the vision in her left eye became blurred (blind in right eye). She stated that when she laid down it was harder to breathe so she remained elevated on pillows but could not sleep. She presented with no wheezing in lung sounds but had dyspnea/asthma-like symptoms. She stated that by morning the vision in left eye was double and blurred. All her joints were stiff very hard to bend and had difficulty getting her breath. Stated that she continued to feel nauseated but did not vomit. Upon examination vital signs were: T 97.4, P 74, BP 117/77, R 24 SpO2 93%. (VS on 8/4/08 were T 98.9, P 85, R 16, B/P 135/95, SpO2 95%). Presented with difficulty with ROM of all extremities and digits r/t stiffness and pains in joints, red and swollen and warm to touch. Skin cool and moist. Vesicular lesions behind Right ear with clear drainage from ear apparent. Complaint of tinnitus in Left ear. Examination of oral cavity revealed stomatitis. Was transported to ER for direct admit. 9/22/08-records received for DOS 8/21-8/25/08-DC DX: Possible reaction to hepatitis A & B vaccines. Arthralgias. Urticaria. Presented to ED with C/O arthralgias in both knees and right elbow, shakes and weakness in arms and legs. Nose bleeds. Sores on tongue and behind ear. Pain when ambulating, difficulty swallowing.  Difficulty getting enough air in.  Returned to ED on 8/26/08- with C/O confusion. Ambien prescription of 10 dispensed on 8/25/28 now shows 3 remaining and Lortab 30 dispensed only 21 left. Neurological exam non-focal.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Insomnia, Joint range of motion decreased, Joint stiffness, Joint swelling, Joint warmth
Clinical narrative: Vaccine administered at approx 10am on 8/20/08 in right deltoid. No side effects were noted. By report from this individual she stated that she was cooking supper around 5:30pm and she had a nosebleed then she started feeling achy and tired. She took TYLENOL P.O. She stated she made Potato Salad but though she must have put too much vinegar in it because it burned when she swallowed it. She stated the vision in her left eye became blurred (blind in right eye). She stated that when she laid down it was harder to breathe so she remained elevated on pillows but could not sleep. She presented with no wheezing in lung sounds but had dyspnea/asthma-like symptoms. She stated that by morning the vision in left eye was double and blurred. All her joints were stiff very hard to bend and had difficulty getting her breath. Stated that she continued to feel nauseated but did not vomit. Upon examination vital signs were: T 97.4, P 74, BP 117/77, R 24 SpO2 93%. (VS on 8/4/08 were T 98.9, P 85, R 16, B/P 135/95, SpO2 95%). Presented with difficulty with ROM of all extremities and digits r/t stiffness and pains in joints, red and swollen and warm to touch. Skin cool and moist. Vesicular lesions behind Right ear with clear drainage from ear apparent. Complaint of tinnitus in Left ear. Examination of oral cavity revealed stomatitis. Was transported to ER for direct admit. 9/22/08-records received for DOS 8/21-8/25/08-DC DX: Possible reaction to hepatitis A & B vaccines. Arthralgias. Urticaria. Presented to ED with C/O arthralgias in both knees and right elbow, shakes and weakness in arms and legs. Nose bleeds. Sores on tongue and behind ear. Pain when ambulating, difficulty swallowing.  Difficulty getting enough air in.  Returned to ED on 8/26/08- with C/O confusion. Ambien prescription of 10 dispensed on 8/25/28 now shows 3 remaining and Lortab 30 dispensed only 21 left. Neurological exam non-focal.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Nausea, Otorrhoea, Oxygen saturation decreased, Pain, Rash vesicular
Clinical narrative: Vaccine administered at approx 10am on 8/20/08 in right deltoid. No side effects were noted. By report from this individual she stated that she was cooking supper around 5:30pm and she had a nosebleed then she started feeling achy and tired. She took TYLENOL P.O. She stated she made Potato Salad but though she must have put too much vinegar in it because it burned when she swallowed it. She stated the vision in her left eye became blurred (blind in right eye). She stated that when she laid down it was harder to breathe so she remained elevated on pillows but could not sleep. She presented with no wheezing in lung sounds but had dyspnea/asthma-like symptoms. She stated that by morning the vision in left eye was double and blurred. All her joints were stiff very hard to bend and had difficulty getting her breath. Stated that she continued to feel nauseated but did not vomit. Upon examination vital signs were: T 97.4, P 74, BP 117/77, R 24 SpO2 93%. (VS on 8/4/08 were T 98.9, P 85, R 16, B/P 135/95, SpO2 95%). Presented with difficulty with ROM of all extremities and digits r/t stiffness and pains in joints, red and swollen and warm to touch. Skin cool and moist. Vesicular lesions behind Right ear with clear drainage from ear apparent. Complaint of tinnitus in Left ear. Examination of oral cavity revealed stomatitis. Was transported to ER for direct admit. 9/22/08-records received for DOS 8/21-8/25/08-DC DX: Possible reaction to hepatitis A & B vaccines. Arthralgias. Urticaria. Presented to ED with C/O arthralgias in both knees and right elbow, shakes and weakness in arms and legs. Nose bleeds. Sores on tongue and behind ear. Pain when ambulating, difficulty swallowing.  Difficulty getting enough air in.  Returned to ED on 8/26/08- with C/O confusion. Ambien prescription of 10 dispensed on 8/25/28 now shows 3 remaining and Lortab 30 dispensed only 21 left. Neurological exam non-focal.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Respiratory rate increased, Stomatitis, Tinnitus, Vision blurred
Clinical narrative: Vaccine administered at approx 10am on 8/20/08 in right deltoid. No side effects were noted. By report from this individual she stated that she was cooking supper around 5:30pm and she had a nosebleed then she started feeling achy and tired. She took TYLENOL P.O. She stated she made Potato Salad but though she must have put too much vinegar in it because it burned when she swallowed it. She stated the vision in her left eye became blurred (blind in right eye). She stated that when she laid down it was harder to breathe so she remained elevated on pillows but could not sleep. She presented with no wheezing in lung sounds but had dyspnea/asthma-like symptoms. She stated that by morning the vision in left eye was double and blurred. All her joints were stiff very hard to bend and had difficulty getting her breath. Stated that she continued to feel nauseated but did not vomit. Upon examination vital signs were: T 97.4, P 74, BP 117/77, R 24 SpO2 93%. (VS on 8/4/08 were T 98.9, P 85, R 16, B/P 135/95, SpO2 95%). Presented with difficulty with ROM of all extremities and digits r/t stiffness and pains in joints, red and swollen and warm to touch. Skin cool and moist. Vesicular lesions behind Right ear with clear drainage from ear apparent. Complaint of tinnitus in Left ear. Examination of oral cavity revealed stomatitis. Was transported to ER for direct admit. 9/22/08-records received for DOS 8/21-8/25/08-DC DX: Possible reaction to hepatitis A & B vaccines. Arthralgias. Urticaria. Presented to ED with C/O arthralgias in both knees and right elbow, shakes and weakness in arms and legs. Nose bleeds. Sores on tongue and behind ear. Pain when ambulating, difficulty swallowing.  Difficulty getting enough air in.  Returned to ED on 8/26/08- with C/O confusion. Ambien prescription of 10 dispensed on 8/25/28 now shows 3 remaining and Lortab 30 dispensed only 21 left. Neurological exam non-focal.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase increased, Muscular weakness, Myalgia, Myositis
Clinical narrative: muscle pain and weakness starting 1 day after flu vaccine- Leg/Arms with development of reactive disorders. CK increased 30003, Dx Myositis 9/19/08 Reviewed hospital medical records of 9/9-9/11/2008. FINAL DX: Myositis Records reveal patient experienced progressively worsening muscle pain, weakness, throat soreness & arms tingling.  Tx w/IVF.  Improved & d/c to home.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia, Rash
Clinical narrative: Fever, rash on stomach, legs, arms.  Dizzy, headache.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2.5 cm area of redness and induration at left arm injection site.  (Varicella site)
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Dizziness, Heart rate normal
Clinical narrative: Pt given Tdap, GARDASIL, varicella, Hep A => dizzy x few seconds.  VSS (T=97.8, P=76, RR=20, BP=106/60) => Pt observed for 1 1/2 hours => VSS repeated T=97.9, P=76, RR=20, 108/60 s/p 1 1/2 hr.
Age: 1.0
Sex: F
Vaccine: FLU3, HEP, HEPA, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: fever, febrile seizure
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness unilateral, Eye pain, Headache, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: One hour after awaking on 9/10, left eye became blurry, right eye painful, then left side of face felt numb, lasted 5-6 minutes. Then left hand felt numb and heavy for 50 minutes. Headache developed over right side of head, could not see out of left eye. Headache through the day; Tx:Advil  9/17/08 MR received from PCP. Returned to office 1 day after HPV #3 with c/o tingling to L side of face and L hand.  Loss of sensation began near the mouth and spread toward the L side of face. Developed blurry vision eye which lasted ~5 minutes. L hand numbness lasted 30 minutes- unable to grab things. Developed severe R sided H/A and vomited 5x. Has become photopobic. PE WNL. Assessment:  Migraine headache. No further f/u at this time.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of heaviness, Vision blurred
Clinical narrative: One hour after awaking on 9/10, left eye became blurry, right eye painful, then left side of face felt numb, lasted 5-6 minutes. Then left hand felt numb and heavy for 50 minutes. Headache developed over right side of head, could not see out of left eye. Headache through the day; Tx:Advil  9/17/08 MR received from PCP. Returned to office 1 day after HPV #3 with c/o tingling to L side of face and L hand.  Loss of sensation began near the mouth and spread toward the L side of face. Developed blurry vision eye which lasted ~5 minutes. L hand numbness lasted 30 minutes- unable to grab things. Developed severe R sided H/A and vomited 5x. Has become photopobic. PE WNL. Assessment:  Migraine headache. No further f/u at this time.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Pt. presented with itchy, red, raised rash that continued to spread.  Calamine lotion, AVEENO bath and BENADRYL advised.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Next AM headache.  Swelling at site next day- L arm 7cm x 9cm raised swollen tender area with 5cm oval area of erythema.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4cm area of redness and induration at left arm injection site. (Varicella Site)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 24-36 hr after fever 99 red swollen hot injection site.
Age: 16.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 9/11/08 1545 client came to clinic was given TWINRIX under 18 yrs of age, this is his 1st dose.
Age: 1.2
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site induration
Clinical narrative: Erythema (Induration at injection site)
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Body temperature, Lethargy, Oedema peripheral
Clinical narrative: Swollen feet & hands, lethargy T 98.7 aching joints.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Pt received Hep B vaccine on 9/4/08 and rash all over on 9/5/08. Pt did not report rash to us until 9/11/08. Pt states she has been taking Benadryl and rash is almost gone. Pt states she is also allergic to latex. Blood drawn for immune status. Pt states she had Hep B shot years ago with no problems.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Night sweats, Pain in extremity, Swelling
Clinical narrative: Right arm pain, swelling, redness and night sweats. No treatment required. Given instructions to return to clinic or ER if symptoms worsen.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Antibody test positive, Arthralgia, Fibula fracture, Laboratory test abnormal, Peripheral coldness
Clinical narrative: Several medications PLAQUENIL methotrexate, folic acid. My daughter was very healthy up until the HPV shots symptoms are ache bones, fatigue, hands turn purple then numb is being seen by rheumatologist at hospital every 2 months.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Raynaud's phenomenon, Systemic lupus erythematosus
Clinical narrative: Several medications PLAQUENIL methotrexate, folic acid. My daughter was very healthy up until the HPV shots symptoms are ache bones, fatigue, hands turn purple then numb is being seen by rheumatologist at hospital every 2 months.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Hypoaesthesia, Peripheral coldness, Raynaud's phenomenon
Clinical narrative: Several medications PLAQUENIL methotrexate, folic acid. My daughter was very healthy up until the HPV shots symptoms are ache bones, fatigue, hands turn purple then numb is being seen by rheumatologist at hospital every 2 months.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: Several medications PLAQUENIL methotrexate, folic acid. My daughter was very healthy up until the HPV shots symptoms are ache bones, fatigue, hands turn purple then numb is being seen by rheumatologist at hospital every 2 months.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Bone pain, Fatigue, Hypoaesthesia, Raynaud's phenomenon, Rheumatoid arthritis
Clinical narrative: Several medications PLAQUENIL methotrexate, folic acid. My daughter was very healthy up until the HPV shots symptoms are ache bones, fatigue, hands turn purple then numb is being seen by rheumatologist at hospital every 2 months.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Skin discolouration, Systemic lupus erythematosus
Clinical narrative: Several medications PLAQUENIL methotrexate, folic acid. My daughter was very healthy up until the HPV shots symptoms are ache bones, fatigue, hands turn purple then numb is being seen by rheumatologist at hospital every 2 months.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: 4 Apr 08 - Shingles shot suggested by doctor even though I had shingles in 2001.  Received shot, rash broke out on wrist and ring finger first.  Self medicated until 7 May 08 - went back to doctor.  He said he didn't know what it was, but gave me Zyrtec and cortisone cream.  Did not work, so went to dermatologist - not to base.  She said it was no itching, but scabs.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, RV5
Symptoms: Blood culture positive, Body temperature increased, CSF culture positive, Death, Drug ineffective
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 15-week-old male patient who experienced Pneumococcal meningitis. At 15 weeks of age, the patient received the first dose on 15-Jul-2008. He also received the first doses of HIB (manufacturer unknown), Poliomyelitis Vaccine Inactivated (manufacturer unknown), DTaP and ROTATEQ (Merck & Co Inc) on 15-Jul-2008. Relevant medical history was not provided. Concomitant therapy included Hepatitis B Vaccine, HIB, ROTATEQ, DTaP and Poliomyelitis Vaccine Inactivated. On 25-Aug-2008, the patient presented with nystagmus, irritability and fever. He was hospitalized and diagnostic tests were performed (see test results), however serotyping was not performed. The blood culture and cerebral spinal fluid culture were positive for Pneumococcus. The patient was diagnosed as having Pneumococcal meningitis drug ineffective on 25-Aug-2008. Treatments were not reported. The patient died on 28-Aug-2008. The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease. No further information was available at the time of this report. The cause of death was reported as meningitis Pneumococcal. On 25-Aug-2008 test results were: blood culture (results: positive for Pneumococcus); body temperature (results: fever); CSF culture (results: positive for Pneumococcus). 9/16/08-office notes received-8/12/08-well visit normal exam. C/O fussy and will not take bottle. Daycare provider was ill day prior to office visit. 8/25/08-fever and seizure.  9/25/08-records received-urgent care center visit 8/12/08-C/O irritability and vomiting without fever. Sent to ED. Presented to ED with vomiting and screaming. Large projectile emesis times 3, decreased oral intake. Admitted overnight. Returned to ED on 8/25/08-fever began day prior of 103.3. In ED pulse oximeter decreased to mid 80's. Transferred to another facility. 10/16/08-records received for DOS 8/25-8/28/08-Expired 8/28/08 06:35. Fever, eyes deviating from neutral position. Right pupil dilated, right side of face droopy. Symptoms began on 8/24/08 with temperature of 100.6. Respiratory difficulty and perioral cyanosis. Irritable, agitated.  11/06/08-records received-Cause of death:meningitis due to pneumoccal meningitis.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, RV5
Symptoms: Irritability, Meningitis pneumococcal, Nystagmus, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 15-week-old male patient who experienced Pneumococcal meningitis. At 15 weeks of age, the patient received the first dose on 15-Jul-2008. He also received the first doses of HIB (manufacturer unknown), Poliomyelitis Vaccine Inactivated (manufacturer unknown), DTaP and ROTATEQ (Merck & Co Inc) on 15-Jul-2008. Relevant medical history was not provided. Concomitant therapy included Hepatitis B Vaccine, HIB, ROTATEQ, DTaP and Poliomyelitis Vaccine Inactivated. On 25-Aug-2008, the patient presented with nystagmus, irritability and fever. He was hospitalized and diagnostic tests were performed (see test results), however serotyping was not performed. The blood culture and cerebral spinal fluid culture were positive for Pneumococcus. The patient was diagnosed as having Pneumococcal meningitis drug ineffective on 25-Aug-2008. Treatments were not reported. The patient died on 28-Aug-2008. The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease. No further information was available at the time of this report. The cause of death was reported as meningitis Pneumococcal. On 25-Aug-2008 test results were: blood culture (results: positive for Pneumococcus); body temperature (results: fever); CSF culture (results: positive for Pneumococcus). 9/16/08-office notes received-8/12/08-well visit normal exam. C/O fussy and will not take bottle. Daycare provider was ill day prior to office visit. 8/25/08-fever and seizure.  9/25/08-records received-urgent care center visit 8/12/08-C/O irritability and vomiting without fever. Sent to ED. Presented to ED with vomiting and screaming. Large projectile emesis times 3, decreased oral intake. Admitted overnight. Returned to ED on 8/25/08-fever began day prior of 103.3. In ED pulse oximeter decreased to mid 80's. Transferred to another facility. 10/16/08-records received for DOS 8/25-8/28/08-Expired 8/28/08 06:35. Fever, eyes deviating from neutral position. Right pupil dilated, right side of face droopy. Symptoms began on 8/24/08 with temperature of 100.6. Respiratory difficulty and perioral cyanosis. Irritable, agitated.  11/06/08-records received-Cause of death:meningitis due to pneumoccal meningitis.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, RV5
Symptoms: Blood culture positive, CSF culture positive, Febrile infection, Gram stain positive, Meningitis pneumococcal
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 15-week-old male patient who experienced Pneumococcal meningitis. At 15 weeks of age, the patient received the first dose on 15-Jul-2008. He also received the first doses of HIB (manufacturer unknown), Poliomyelitis Vaccine Inactivated (manufacturer unknown), DTaP and ROTATEQ (Merck & Co Inc) on 15-Jul-2008. Relevant medical history was not provided. Concomitant therapy included Hepatitis B Vaccine, HIB, ROTATEQ, DTaP and Poliomyelitis Vaccine Inactivated. On 25-Aug-2008, the patient presented with nystagmus, irritability and fever. He was hospitalized and diagnostic tests were performed (see test results), however serotyping was not performed. The blood culture and cerebral spinal fluid culture were positive for Pneumococcus. The patient was diagnosed as having Pneumococcal meningitis drug ineffective on 25-Aug-2008. Treatments were not reported. The patient died on 28-Aug-2008. The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease. No further information was available at the time of this report. The cause of death was reported as meningitis Pneumococcal. On 25-Aug-2008 test results were: blood culture (results: positive for Pneumococcus); body temperature (results: fever); CSF culture (results: positive for Pneumococcus). 9/16/08-office notes received-8/12/08-well visit normal exam. C/O fussy and will not take bottle. Daycare provider was ill day prior to office visit. 8/25/08-fever and seizure.  9/25/08-records received-urgent care center visit 8/12/08-C/O irritability and vomiting without fever. Sent to ED. Presented to ED with vomiting and screaming. Large projectile emesis times 3, decreased oral intake. Admitted overnight. Returned to ED on 8/25/08-fever began day prior of 103.3. In ED pulse oximeter decreased to mid 80's. Transferred to another facility. 10/16/08-records received for DOS 8/25-8/28/08-Expired 8/28/08 06:35. Fever, eyes deviating from neutral position. Right pupil dilated, right side of face droopy. Symptoms began on 8/24/08 with temperature of 100.6. Respiratory difficulty and perioral cyanosis. Irritable, agitated.  11/06/08-records received-Cause of death:meningitis due to pneumoccal meningitis.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, RV5
Symptoms: Nystagmus
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 15-week-old male patient who experienced Pneumococcal meningitis. At 15 weeks of age, the patient received the first dose on 15-Jul-2008. He also received the first doses of HIB (manufacturer unknown), Poliomyelitis Vaccine Inactivated (manufacturer unknown), DTaP and ROTATEQ (Merck & Co Inc) on 15-Jul-2008. Relevant medical history was not provided. Concomitant therapy included Hepatitis B Vaccine, HIB, ROTATEQ, DTaP and Poliomyelitis Vaccine Inactivated. On 25-Aug-2008, the patient presented with nystagmus, irritability and fever. He was hospitalized and diagnostic tests were performed (see test results), however serotyping was not performed. The blood culture and cerebral spinal fluid culture were positive for Pneumococcus. The patient was diagnosed as having Pneumococcal meningitis drug ineffective on 25-Aug-2008. Treatments were not reported. The patient died on 28-Aug-2008. The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease. No further information was available at the time of this report. The cause of death was reported as meningitis Pneumococcal. On 25-Aug-2008 test results were: blood culture (results: positive for Pneumococcus); body temperature (results: fever); CSF culture (results: positive for Pneumococcus). 9/16/08-office notes received-8/12/08-well visit normal exam. C/O fussy and will not take bottle. Daycare provider was ill day prior to office visit. 8/25/08-fever and seizure.  9/25/08-records received-urgent care center visit 8/12/08-C/O irritability and vomiting without fever. Sent to ED. Presented to ED with vomiting and screaming. Large projectile emesis times 3, decreased oral intake. Admitted overnight. Returned to ED on 8/25/08-fever began day prior of 103.3. In ED pulse oximeter decreased to mid 80's. Transferred to another facility. 10/16/08-records received for DOS 8/25-8/28/08-Expired 8/28/08 06:35. Fever, eyes deviating from neutral position. Right pupil dilated, right side of face droopy. Symptoms began on 8/24/08 with temperature of 100.6. Respiratory difficulty and perioral cyanosis. Irritable, agitated.  11/06/08-records received-Cause of death:meningitis due to pneumoccal meningitis.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Blindness, Blood culture positive, Body temperature increased, CSF culture positive, Drug ineffective
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 61-day-old male patient who experienced pneumococcal meningitis - drug ineffective and became blind.  The patient received the first dose on 12-Oct-2007.  The patient also received the first doses of DTaP (manufacturer unknown), IPV, ROTATEQ (Merck & Co Inc) and Hib (Sanofi) on 12-Oct-2007.  The second dose of Hep B (manufacturer unknown) was also administered on 12-Oct-2007.  Relevant medical history was not provided.  Concomitant therapy included DTaP, Polio-Vaccine, HIB (Sanofi), ROTATEQ and Hep B.  The patient was admitted to the hospital on 14-Oct-2007 with a fever of 103 degrees C.  Diagnostic tests were performed (see test results), however serotyping was not performed.  The blood culture and culture of cerebral spinal fluid were both positive for Pneumococcus.  The patient was diagnosed as having Pneumococcal meningitis - drug ineffective.  The infant became blind on an unknown date in Oct-2007.  The infant survived but remained blind.  The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease.  No further information was available at the time of this report.  On 14-Oct-2007 test results were: body temperature (results: 103 deg. F.); CSF culture (results: positive for Pneumococcus); and blood culture (results: positive for Pneumococcus).  12/2/08 Reviewed hospital medical records of 10/15-10/31/2008. FINAL DX: pneumococcal meningitis, seizures, diabetes insipidus. Records reveal patient experienced fever, irritability, reduced oral intake.  Seen in outlying hospital, admitted to PICU, intubated, tx/IV antibiotics & then transferred for higher level of care. Had seizure en route.  Neuro, endocrine consults done.  Tx w/IV antibiotics, anticonvulsants, DDAVP, tube feeds.  Weaned to RA by 10/22.  Transfused PRBCs.    9/26/08 Reviewed Hospital medical records of 10/14-10/15/2007. FINAL DX: sepsis, presumed pneumococcal; meningitis, probable pneumococcal; leukppenia & bandemia; grunting Records reveal patient experienced fever 103.2.  Tx w/IV antibiotics.  Admitted to ICU overnight, began grunting in AM & became lethargic.  Intubated & transferred to higher level of care. 9/16/08 Reviewed PCP office records of 10/12/07-11/8/07. FINAL DX: Records reveal patient experienced thrush on day of vaccination otherwise in good health.  Tx w/antibiotics.  Next is t/c from parent of fever 103.2.  Referred to hospital.  Admitted w/(+) s. pneumon in CSF & tx IV antibiotics. Transferred 10/15 to higher level of care PICU & d/c to home 11/1/07.  Became less responsive at home & readmitted to hsopital w/swelling of hands/feet.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Meningitis pneumococcal, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 61-day-old male patient who experienced pneumococcal meningitis - drug ineffective and became blind.  The patient received the first dose on 12-Oct-2007.  The patient also received the first doses of DTaP (manufacturer unknown), IPV, ROTATEQ (Merck & Co Inc) and Hib (Sanofi) on 12-Oct-2007.  The second dose of Hep B (manufacturer unknown) was also administered on 12-Oct-2007.  Relevant medical history was not provided.  Concomitant therapy included DTaP, Polio-Vaccine, HIB (Sanofi), ROTATEQ and Hep B.  The patient was admitted to the hospital on 14-Oct-2007 with a fever of 103 degrees C.  Diagnostic tests were performed (see test results), however serotyping was not performed.  The blood culture and culture of cerebral spinal fluid were both positive for Pneumococcus.  The patient was diagnosed as having Pneumococcal meningitis - drug ineffective.  The infant became blind on an unknown date in Oct-2007.  The infant survived but remained blind.  The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease.  No further information was available at the time of this report.  On 14-Oct-2007 test results were: body temperature (results: 103 deg. F.); CSF culture (results: positive for Pneumococcus); and blood culture (results: positive for Pneumococcus).  12/2/08 Reviewed hospital medical records of 10/15-10/31/2008. FINAL DX: pneumococcal meningitis, seizures, diabetes insipidus. Records reveal patient experienced fever, irritability, reduced oral intake.  Seen in outlying hospital, admitted to PICU, intubated, tx/IV antibiotics & then transferred for higher level of care. Had seizure en route.  Neuro, endocrine consults done.  Tx w/IV antibiotics, anticonvulsants, DDAVP, tube feeds.  Weaned to RA by 10/22.  Transfused PRBCs.    9/26/08 Reviewed Hospital medical records of 10/14-10/15/2007. FINAL DX: sepsis, presumed pneumococcal; meningitis, probable pneumococcal; leukppenia & bandemia; grunting Records reveal patient experienced fever 103.2.  Tx w/IV antibiotics.  Admitted to ICU overnight, began grunting in AM & became lethargic.  Intubated & transferred to higher level of care. 9/16/08 Reviewed PCP office records of 10/12/07-11/8/07. FINAL DX: Records reveal patient experienced thrush on day of vaccination otherwise in good health.  Tx w/antibiotics.  Next is t/c from parent of fever 103.2.  Referred to hospital.  Admitted w/(+) s. pneumon in CSF & tx IV antibiotics. Transferred 10/15 to higher level of care PICU & d/c to home 11/1/07.  Became less responsive at home & readmitted to hsopital w/swelling of hands/feet.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 64 year old male, weight 154lb, height 66 inches, with no pre-existing allergies or medical conditions, who on 04-JUN-2008 at 09:52 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 659406/0298X) SQ into the left arm. On 06-JUN-2008 at 08:28 the patient developed shingles.  The outcome of the shingles was not reported.  The patient sought medical attention with a physician office visit.  The reporter considered shingles to be disabling.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Flushing, Hypoxia
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient with no known allergies who on 03-JUN-2008 was vaccinated with a dose of PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and had an anaphylactic reaction immediately after vaccination.  Before the patient left the pediatrician's office he experienced tightness in the chest, shortness of breath, tightness in the throat, urticaria, and flushing.  The patient was administered epinephrine, BENADRYL, 30 mg prednisone PO, and XOPENIX via nebulizer.  The adverse experience improved after treatment.  The physician may have filled an adverse experience dermatology report for this case.  The physician will most likely be performing skin sensitivity testing in the future.  No additional information was provided.  No product quality complaint was involved.  The adverse experience was considered an important medical event upon internal review.  Additional information was received from the physician who indicated that the patient had also developed rapid breathing.  The patient was treated with ORAPRED.  He did not have any redness at the injection site.  He has not had any prior reactions to vaccines.  Follow up information was received from the physician who reported that the patient had a prior episode of RAD requiring nebulizer treatment with XOPENEX (date unknown).  The patient received a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (rHA) Lot # 658165/0040X) in the right arm and a second dose of VARIVAX (Lot # 660658/0173X) (previously reported as PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck)) in the left arm at 1:20 pm on 03-JUN-2008.  On 03-JUN-2008 (also reported as 02-JUN-2008) shortly (less than 10 minutes) after the vaccines were administered, the patient developed anaphylactic reaction with stridor, urticaria, expiratory wheezing and hypoxia (pulse ox 92%).  Medical attention was sought while in the physicians office.  The patient required subcutaneous epinephrine and nebulized XOPENEX.  The patient recovered on 03-JUN-2008 (also reported as 02-JUN-2008).  Anaphylactic reaction was considered to be immediately life threatening.  A lot check has been requested.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, No reaction on previous exposure to drug, Oxygen saturation, Respiratory rate increased, Stridor
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient with no known allergies who on 03-JUN-2008 was vaccinated with a dose of PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and had an anaphylactic reaction immediately after vaccination.  Before the patient left the pediatrician's office he experienced tightness in the chest, shortness of breath, tightness in the throat, urticaria, and flushing.  The patient was administered epinephrine, BENADRYL, 30 mg prednisone PO, and XOPENIX via nebulizer.  The adverse experience improved after treatment.  The physician may have filled an adverse experience dermatology report for this case.  The physician will most likely be performing skin sensitivity testing in the future.  No additional information was provided.  No product quality complaint was involved.  The adverse experience was considered an important medical event upon internal review.  Additional information was received from the physician who indicated that the patient had also developed rapid breathing.  The patient was treated with ORAPRED.  He did not have any redness at the injection site.  He has not had any prior reactions to vaccines.  Follow up information was received from the physician who reported that the patient had a prior episode of RAD requiring nebulizer treatment with XOPENEX (date unknown).  The patient received a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (rHA) Lot # 658165/0040X) in the right arm and a second dose of VARIVAX (Lot # 660658/0173X) (previously reported as PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck)) in the left arm at 1:20 pm on 03-JUN-2008.  On 03-JUN-2008 (also reported as 02-JUN-2008) shortly (less than 10 minutes) after the vaccines were administered, the patient developed anaphylactic reaction with stridor, urticaria, expiratory wheezing and hypoxia (pulse ox 92%).  Medical attention was sought while in the physicians office.  The patient required subcutaneous epinephrine and nebulized XOPENEX.  The patient recovered on 03-JUN-2008 (also reported as 02-JUN-2008).  Anaphylactic reaction was considered to be immediately life threatening.  A lot check has been requested.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient with no known allergies who on 03-JUN-2008 was vaccinated with a dose of PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and had an anaphylactic reaction immediately after vaccination.  Before the patient left the pediatrician's office he experienced tightness in the chest, shortness of breath, tightness in the throat, urticaria, and flushing.  The patient was administered epinephrine, BENADRYL, 30 mg prednisone PO, and XOPENIX via nebulizer.  The adverse experience improved after treatment.  The physician may have filled an adverse experience dermatology report for this case.  The physician will most likely be performing skin sensitivity testing in the future.  No additional information was provided.  No product quality complaint was involved.  The adverse experience was considered an important medical event upon internal review.  Additional information was received from the physician who indicated that the patient had also developed rapid breathing.  The patient was treated with ORAPRED.  He did not have any redness at the injection site.  He has not had any prior reactions to vaccines.  Follow up information was received from the physician who reported that the patient had a prior episode of RAD requiring nebulizer treatment with XOPENEX (date unknown).  The patient received a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (rHA) Lot # 658165/0040X) in the right arm and a second dose of VARIVAX (Lot # 660658/0173X) (previously reported as PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck)) in the left arm at 1:20 pm on 03-JUN-2008.  On 03-JUN-2008 (also reported as 02-JUN-2008) shortly (less than 10 minutes) after the vaccines were administered, the patient developed anaphylactic reaction with stridor, urticaria, expiratory wheezing and hypoxia (pulse ox 92%).  Medical attention was sought while in the physicians office.  The patient required subcutaneous epinephrine and nebulized XOPENEX.  The patient recovered on 03-JUN-2008 (also reported as 02-JUN-2008).  Anaphylactic reaction was considered to be immediately life threatening.  A lot check has been requested.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 16 year old female who in September 2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL.  On the same day, the patient developed cellulitis at the injection site, on her arm.  The patient was evaluated in an emergency room and admitted to the hospital overnight for IV antibiotic treatment.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Cellulitis at the injection site, on her arm was also considered to be disabling and a other important medical event (IV antibiotics) by the NP.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Dry skin, Eczema, Injection site eczema, Injection site rash
Clinical narrative: Initial report was received 03 September 2008 from a health care professional.  A nine-week-old male patient with no medical history, received a first dose, intramuscular left thigh injection of PENTACEL, lot number C3175AA and a first dose of "ROTOTECH", lot number 0301X orally, on 13 August 2008 and two days later, developed an "excema" like rash on his left leg at the injection site which spread to his left ankle and left arm.  The patient was evaluated by their physician on 18 August 2008 at which the patient was afebrile however, the eczema like rash described was noted to be slightly dry and waxy.  Corrective treatments included cortisone and "UCERIN" cream which were ineffective.  The rash subsequently spread to the patient's right left and persisted on all areas described at the time of the report.  The patient's mother had been taking clonazepam while breastfeeding.  No further information was provided.