chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Shot was given the MCV4 on 7-14-06; Foster mother did call md; pt. almost went to the ER but was monitored at home. Mom did inform her pediatrician.  Pt. had shortness of breath, sore throat, paleness, stomach cramps, weakness, dizziness, fast heartbeat,and a fever per foster mother. Foster mother reported this information to us on her next visit 4-27-07. She gave me permission to fill out this form. Mom believes it was the MCV4, not the Tdap that caused the symptoms.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pallor, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Shot was given the MCV4 on 7-14-06; Foster mother did call md; pt. almost went to the ER but was monitored at home. Mom did inform her pediatrician.  Pt. had shortness of breath, sore throat, paleness, stomach cramps, weakness, dizziness, fast heartbeat,and a fever per foster mother. Foster mother reported this information to us on her next visit 4-27-07. She gave me permission to fill out this form. Mom believes it was the MCV4, not the Tdap that caused the symptoms.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Bone pain, Cardiac flutter, Dizziness, Fatigue
Clinical narrative: 22 hours after after vaccine was given- child felt dizzy and said heart was fluttering. She also experienced flu like symptoms: aching bones, tired, sleepiness, lack of appetite, raised red (warm) patch size of baseball at site of injection.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Influenza like illness, Injection site erythema, Injection site rash, Injection site warmth, Somnolence
Clinical narrative: 22 hours after after vaccine was given- child felt dizzy and said heart was fluttering. She also experienced flu like symptoms: aching bones, tired, sleepiness, lack of appetite, raised red (warm) patch size of baseball at site of injection.
Age: 0.64
Sex: M
Vaccine: FLU3, HEP
Symptoms: Rash generalised, Vaccination complication, Vaccine positive rechallenge, Vomiting
Clinical narrative: T/C from parent on 5/8/07 reporting rash all over infants body, head to feet. Denies fever, reports some GI vomiting of formula. Had child evaluated by Dr. who dx. rash as reaction to flu#2 vaccine received on 5/1/07. Parent recalls that a mild rash followed the first flu shot administered back in March, but at that time was much less and she thought it was probably a heat rash and did not relate rash to vaccines received on 3-20-07 (Flu#1, Dtap#3, IPV#3, Prevnar#3)
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Bursitis, Musculoskeletal pain, Vaccine positive rechallenge
Clinical narrative: Employee told me this morning that she is having pain in the left shoulder which radiates to her upper chest. This pain is similar to the same complaint she had after receiving her first injection of Hep B Vaccine. She saw her private doctor after she had these complaints and was told that she had bursitis in her right shoulder. I gave her injection yesterday in her left deltoid.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: High-pitched crying
Clinical narrative: baby had high pitched shrill cry during the first 24 hours after vaccine administration.  consolable after tylenol but remained crying off and on with shrill cry.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: PT DEVELOPED ON DAY 21 FROM VACCINE A ZOSTER RASH ON THE T 12 DERMATOME ON THE CONTRALATERAL SIDE OF THE BODY FROM THE VACCINE SITE
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: May 3rd mother states she noticed daughters Rt. leg being reddened,warm to touch,&painfulwith hardened area in middle . States she had been giving child tylenol since shot on Apr.26th .Took daughter to M.D. on 5/8/07 at which time he started her on Amoxil 200mg/5ml 1tsp. daily for 10 days to return to Doctor on 5/15/07 .
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red, Raised approx. 6 inches. area to left upper arm. Donor C/O Soreness and itching, area warm to touch
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cellulitis, Local reaction
Clinical narrative: The patient is a 25 y/o male.  He was given a smallpox vaccination which developed a local cellulitis after he had applied double band aids to the vaccination site.  He followed up at the MTF when an infection had developed.  He was seen by the Doctor who prescribed TRIMOXAZOLE for 10 days and cellulitis cleared, but patient developed a local reaction to the band aids.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: mother noted facial "breaking out." No itching/redness. Pt stated she can "feel it."
Age: 73.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Eyelid oedema, Herpes zoster, Local swelling, Pain
Clinical narrative: break through shingle lesion Lt temple area with pain, swelling extending to Lt eyelid and neck area
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Urticaria
Clinical narrative: generalized urticaria, appeared within 48 hrs of receicing vaccine.  Slight fever 100.2.  Treated with Prednisolone 5mL
Age: 0.33
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Mom stated that infant had cried for more than 3 hours after administration of 2 mon IZ.(prevnar, HIB, pediarix and RV5 - unable to list all the IZ given at 2m visit #21.) Crying started 4 hours after shots given.  At 4 month visit split IZ at mom's request.  gave HIB and prevnar, 4 hours after IZ cried for 4 hours with redness at site that was knee to hip on side of injection. swell/redness gone after 24 hours.  not seen at clinic, verbal report from mom 5/8/07
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Mother brought child into the clinic for PPD reading.  Stated that the school called her on Monday, 7 May 07, that the left upper arm was red and swollen, from the shoulder to the elbow.  Mother stated child complained of minimal pain but that the arm was warm to touch and itchy.  Child was seen by doctor and prescribed cool compresses to area and may use hydrocortisone for itchy as needed.  Follow up appointment made for 10 May 07 to observe site for increased swelling.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Mother brought child into the clinic for PPD reading.  Stated that the school called her on Monday, 7 May 07, that the left upper arm was red and swollen, from the shoulder to the elbow.  Mother stated child complained of minimal pain but that the arm was warm to touch and itchy.  Child was seen by doctor and prescribed cool compresses to area and may use hydrocortisone for itchy as needed.  Follow up appointment made for 10 May 07 to observe site for increased swelling.
Age: 1.58
Sex: F
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMRV, PNC
Symptoms: Blood lactate dehydrogenase, Blood uric acid, Full blood count, Induration, Laboratory test
Clinical narrative: Within 3 minutes of receiving vaccines, pt developed red rash, right eye, cheek, right leg, right foot with urticarial lesions plus indurations. Zero drooling, zero resp distress. Benadryl given and within 20 min decreased erythema and itching.
Age: 1.58
Sex: F
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMRV, PNC
Symptoms: Pruritus, Rash erythematous, Red blood cell sedimentation rate, Skin lesion, Urticaria
Clinical narrative: Within 3 minutes of receiving vaccines, pt developed red rash, right eye, cheek, right leg, right foot with urticarial lesions plus indurations. Zero drooling, zero resp distress. Benadryl given and within 20 min decreased erythema and itching.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PPV
Symptoms: Blister, Pyrexia, Varicella
Clinical narrative: My 1 year old son received the MMRV on 4/25/07. He appears to have gotten chicken pox from the vaccine. He had had fevers and is broken out in blisters from head to toe!
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic, Necrotising retinitis, Vision blurred
Clinical narrative: Patient presented to eye doctor with blurred vision in right eye. Patient admitted to hospital with acute retinal necrosis with herpes zoster in right eye. Patient was hospitalized short-term while receiving acyclovir IV therapy. Patient was discharged to home with home health services to continue acyclovir therapy. Situation was not resolved upon hospital discharge.  5/18/07 Received medical records from hospital which reveal patient experienced pain & decreased vision of right eye & saw opthal who noted retinal abnormalities.  Vision worsened to blindness of right eye & acute retinal necrosis.  Admitted 4/6-4/9/07. ID consult done.  Treated w/IV antiviral.  PICC line placed for continued IV antiviral as outpatient for total of 14 days then to begin oral antivirals. FINAL DX: acute retinal necrosis, right side, likely secondary to herpes zoster s/p vaccine. Patient's condition (necrotizing retinitis) was noted to be improving per physician.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: MMRV given in (L) leg. Pt noted scratch leg after bandaid applied. Paper work completed. Checked leg prior to leaving. Pt states no linger itching, area red in arm swelling, ice pack applied. Swelling decreased. Pt denied any other itching.
Age: 1.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Increasing redness, swelling, hotness to (R) leg
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMRV, PNC
Symptoms: Erythema, Gait disturbance, Oedema peripheral
Clinical narrative: Mother says child developed swelling the day after his shot was given. Given on 4/26/07. Swelling and redness from knee to groin. Child had difficulty walking until today.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Swelling induration at injection site <24 hr after injection. Swelling and erythema approx 15-20 cm in diameter. Mild 101 deg fever
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: One day after receiving vaccines, mother notice that the child's "whole body shook" for 7-10 seconds, while being breast fed. Mother said his name, but said child didn't respond. His eyes were closed while shaking, He was ok after that incident. No other incidents have happened since then.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R upper arm swollen with redness at inj site
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Inappropriate schedule of drug administration, Local reaction, Swelling, Tenderness
Clinical narrative: Severe local reaction-(L) thigh swollen, mild diffuse erythema and tenderness
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis
Clinical narrative: Leg cellulitis ? abx given / pt. recovered just fine.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Flushing
Clinical narrative: Shot was given around 12:15 pm. Around 2:00 pm I began to feel dizzy and flushed. (I had patients tell me that I was white)
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Arthropod bite, Cellulitis, Erythema, Induration
Clinical narrative: mild erythema and induration/ left thigh cellulitis-oro more likely a mosquito bite (per Dr.). Septra Pediatric susp.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, HEPA
Symptoms: Convulsion, Full blood count, Pyrexia
Clinical narrative: fever to 103.6 2 brief generalized seizures
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Muscular weakness, Myalgia, Nausea, Vomiting
Clinical narrative: did fine 1st day, next day had leg muscle weakness and that night had nausea and vomiting. 3rd day-all muscle hurt but not as intense. Had a headache but relieved with pain me. 4/19-much better.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Mother reports child's arm got swollen and itching in area of shot - noticed 6 hours after shot given. Nothing has helped itching
Sex: U
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: PT was not seen by the facility that administered the vaccine, was seen at Urgent Care for a large area of swelling
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Inflammation, Scab, Skin exfoliation, Skin warm
Clinical narrative: Desquamating red skim, central area of scab. Not redness that is spreading too much, warm, tender, most likely inflammation, worsened from 2-6 days after the shot.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Tenderness
Clinical narrative: Desquamating red skim, central area of scab. Not redness that is spreading too much, warm, tender, most likely inflammation, worsened from 2-6 days after the shot.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Local reaction about 10cm diameter redness and swelling at injection site. Mildly pruritic and mildly tender.
Age: 66.0
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Erythema, Injection site induration, Oedema peripheral, Pruritus
Clinical narrative: Swelling left arm felt hot to touch, redness 2 inch red below injection, itching severe site hard to touch with 3 red spots. Low grade temp.
Age: 66.0
Sex: F
Vaccine: DTAP
Symptoms: Skin warm
Clinical narrative: Swelling left arm felt hot to touch, redness 2 inch red below injection, itching severe site hard to touch with 3 red spots. Low grade temp.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Inappropriate schedule of drug administration, Injection site bruising, Nausea
Clinical narrative: Bruising at injection site-bluish/purple in color. Nausea with severe headaches.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Vomiting, dizziness, headaches
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Injection site pain, Neck pain, Pain
Clinical narrative: aching, chills, pain from injection site radiation to left side neck. dry hacking cough
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypersensitivity, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on approximately 15-JAN-2007 was vaccinated with Gardasil. On 28-MAR-2007, the patient was vaccinated with a second dose of Gardasil. On 02-APR-2007 the patient experienced itchiness and red spots on whole body. After seven days of itchiness, the patient received an injection to reduce the allergic response on the whole body. On approximately 28-APR-2007 the patient still experienced itchy palms and feet. Additionally the patient experienced aching and numbness in both hands and feet. She complained that it was hard to complete the housework due to aching and numbness. On approximately 01-MAY-2007 the patient experienced red spots and itchiness on face. Subsequently, the patient recovered from itchiness and red spots on whole body. However, the patient's itchy palms and feet as well as aching and numbness persisted. The red spots and itchiness on face also persisted. The reporter felt that itchiness and red spots on whole body, itchy palms and feet, aching, numbness, red spots and itchiness on face were related to therapy with Gardasil. Aching and numbness were considered to be disabling. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from a physician concerning a female who on approximately 15-JAN-2007 was vaccinated with Gardasil. On 28-MAR-2007, the patient was vaccinated with a second dose of Gardasil. On 02-APR-2007 the patient experienced itchiness and red spots on whole body. After seven days of itchiness, the patient received an injection to reduce the allergic response on the whole body. On approximately 28-APR-2007 the patient still experienced itchy palms and feet. Additionally the patient experienced aching and numbness in both hands and feet. She complained that it was hard to complete the housework due to aching and numbness. On approximately 01-MAY-2007 the patient experienced red spots and itchiness on face. Subsequently, the patient recovered from itchiness and red spots on whole body. However, the patient's itchy palms and feet as well as aching and numbness persisted. The red spots and itchiness on face also persisted. The reporter felt that itchiness and red spots on whole body, itchy palms and feet, aching, numbness, red spots and itchiness on face were related to therapy with Gardasil. Aching and numbness were considered to be disabling. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Asthenia, Dizziness, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Information has been received from a health professional concerning a 26 year old female with sulfonamide allergy who on 22-FEB-2007 was vaccinated, in the left arm, with a first dose of Gardasil (lot # 655849/0263U). There was no concomitant medication. There were no adverse symptoms reported after the first dose. On 24-APR-2007 the patient was vaccinated with Gardasil a second dose. Immediately after the vaccination, the patient experienced left arm pain, nausea, dizziness and loss of appetite. On 25-APR-2007 the patient experienced a lot of pain in her left arm that radiated down to her hand. Her fingers were weak and she was unable to use her hand. Also on that same day the pain radiated to the patient's left leg for a half an hour. Patient was treated with ice and ibuprofen. On 26-APR-2007 the patient recovered. The reporting registered nurse considered unable to use her hand, nausea, loss of appetite, dizziness, fingers were weak, pain in left arm that radiated down her hand, and left leg pain to be disabling.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 26 year old female with sulfonamide allergy who on 22-FEB-2007 was vaccinated, in the left arm, with a first dose of Gardasil (lot # 655849/0263U). There was no concomitant medication. There were no adverse symptoms reported after the first dose. On 24-APR-2007 the patient was vaccinated with Gardasil a second dose. Immediately after the vaccination, the patient experienced left arm pain, nausea, dizziness and loss of appetite. On 25-APR-2007 the patient experienced a lot of pain in her left arm that radiated down to her hand. Her fingers were weak and she was unable to use her hand. Also on that same day the pain radiated to the patient's left leg for a half an hour. Patient was treated with ice and ibuprofen. On 26-APR-2007 the patient recovered. The reporting registered nurse considered unable to use her hand, nausea, loss of appetite, dizziness, fingers were weak, pain in left arm that radiated down her hand, and left leg pain to be disabling.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Groin pain, Headache, Herpes zoster, Laboratory test normal, Meningitis viral
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested.  5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea.  Opthal exam prior to admit was WNL.  Admitted 5/3-5/6/07.  ID consult obtained.  Treated w/IV antibiotics & antivirals.  Symptoms resolved day after treatment started & patient continued to progress well.  D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected.  6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg.  Also included name of admitting physician at hospital where PCP does not have privileges.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested.  5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea.  Opthal exam prior to admit was WNL.  Admitted 5/3-5/6/07.  ID consult obtained.  Treated w/IV antibiotics & antivirals.  Symptoms resolved day after treatment started & patient continued to progress well.  D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected.  6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg.  Also included name of admitting physician at hospital where PCP does not have privileges.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: CSF lymphocyte count, Feeling abnormal, Headache, Herpes zoster, Lumbar puncture
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested.  5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea.  Opthal exam prior to admit was WNL.  Admitted 5/3-5/6/07.  ID consult obtained.  Treated w/IV antibiotics & antivirals.  Symptoms resolved day after treatment started & patient continued to progress well.  D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected.  6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg.  Also included name of admitting physician at hospital where PCP does not have privileges.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Meningitis viral, Pain, Polymerase chain reaction
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested.  5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea.  Opthal exam prior to admit was WNL.  Admitted 5/3-5/6/07.  ID consult obtained.  Treated w/IV antibiotics & antivirals.  Symptoms resolved day after treatment started & patient continued to progress well.  D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected.  6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg.  Also included name of admitting physician at hospital where PCP does not have privileges.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Meningitis viral, Myalgia, Pain, Rash
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested.  5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea.  Opthal exam prior to admit was WNL.  Admitted 5/3-5/6/07.  ID consult obtained.  Treated w/IV antibiotics & antivirals.  Symptoms resolved day after treatment started & patient continued to progress well.  D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected.  6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg.  Also included name of admitting physician at hospital where PCP does not have privileges.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood glucose decreased, Blood pressure decreased, Computerised tomogram normal, Convulsion, Urinary incontinence
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female who is cross sighted with estopia and who fainted previously with no other known allergies or medical history who on 02-APR-2007 in the AM was vaccinated SC in the right arm with 0.5 ML second dose of Varivax (Lot # 647532/0637R). At the time of vaccination, the patient was noted to have allergic rhinitis. There was no concomitant medication. On 02-APR-2007 the patient experienced seizure about 15 minutes after vaccination while she was sitting in the waiting room. The seizure lasted about 4 minutes. The patient hit her head on the wall without apparent injury. She was taken to the emergency room and the patient's blood glucose was42 when she was evaluated by a physician. It was reported that she only ate a small amount of "fruit loops" cereal that day. During the seizure, the patient had vomited and urinated. She had fainted on a previous occasion. As of 04-Apr-2007, the patient had recovered. Follow up information received from a physician indicated that on 02-APR-2007 in the AM the patient developed a generalized seizure in the waiting room after receiving the second dose of Varivax. The patient has head on the wall, vomiting once, and voided. The blood pressure was 60/48. The patient was awake by the time EMS transported her to the hospital. A CT of the head was normal. The patient recovered on 02-APR-2007. The reporter considered the events to be other important medical events. No additional information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female who is cross sighted with estopia and who fainted previously with no other known allergies or medical history who on 02-APR-2007 in the AM was vaccinated SC in the right arm with 0.5 ML second dose of Varivax (Lot # 647532/0637R). At the time of vaccination, the patient was noted to have allergic rhinitis. There was no concomitant medication. On 02-APR-2007 the patient experienced seizure about 15 minutes after vaccination while she was sitting in the waiting room. The seizure lasted about 4 minutes. The patient hit her head on the wall without apparent injury. She was taken to the emergency room and the patient's blood glucose was42 when she was evaluated by a physician. It was reported that she only ate a small amount of "fruit loops" cereal that day. During the seizure, the patient had vomited and urinated. She had fainted on a previous occasion. As of 04-Apr-2007, the patient had recovered. Follow up information received from a physician indicated that on 02-APR-2007 in the AM the patient developed a generalized seizure in the waiting room after receiving the second dose of Varivax. The patient has head on the wall, vomiting once, and voided. The blood pressure was 60/48. The patient was awake by the time EMS transported her to the hospital. A CT of the head was normal. The patient recovered on 02-APR-2007. The reporter considered the events to be other important medical events. No additional information is expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Death, Erythema, Pneumonia, Rash generalised
Clinical narrative: Broke out in red rash all over body called Dr office to report it -2 days later was told it wasn't caused by vaccine, no treatment recommended. Had pneumonia 3 wks later.  5/15/07 Received medical records from pulmonologist which reveal patient experienced dyspnea, cough, night sweats & dysphagia for approx 6 mos when initially evaluated on 3/15/06. He also complained of occasional HA, daytime hypersomnolence, occasional constipation.  Exam revealed velcro type rales in bases & clubbing of extremities.  Patient referred for open lung biopsy but deferred.  Started on supplemental O2.  Spirometry done 8/06 & 10/06 revealed worsening restrictive disease. FINAL DX of pulmonologist: idiopathic pulmonary fibrosis.  6/12/07 Received hospital medical records which reveal patient experienced acute flare of interstitial fibrosis; acute renal failure; pneumonia; idiopathic pulmonary fibrosis; prostrate cancer; & GERD.  Had increasing SOB, fever/chills, HA & productive cough x 15 days.  Admitted 11/20-12/4/06.  Treated w/high dose steroids, IV antibiotics & high flow O2.  Pulmonary & ID consults done.  Very gradually stabilized & was d/c to home on continued oral antibiotics & steroids w/hospice care for poor prognosis. FINAL DX: Acute flare of interstitial fibrosis; acute renal failure; pneumonia; idiopathic pulmonary fibrosis; prostrate cancer; & GERD. 7/17/07 Received Death Certificate which reveals COD as pulmonary fibrosis.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Induration
Clinical narrative: Induration quarter size armed area within 1st minute.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Crying, Insomnia, Rash, Temporal arteritis
Clinical narrative: Patient received above immunizations on 5/8/07 mother stated he developed palpable rash which started on legs, then chest and abdomen this morning. He had approx temperature this AM. Could not sleep well last night and was crying.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, chills
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 8 1/2 year old child developed erythematous, warm about 6x8 cm area on extensor surface of left upper arm where Varivax was given. Area itchy and painful to child.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Left arm cellulitis, 6x6 area of erythema noted to L elbow and upper arm.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: LEFT ARM WITH LOCAL REACTION- 5 1/2CM X 5 1/2CM AREA OF REDNESS AND INDURATION; WARM TO TOUCH, LOW GRADE FEVER
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: BI LATERAL LEG SWELLING AND FEVER. TREAT WITH ICE AND TYLENOL AND FOLLOW UP WITH DR. IF SYMPTOMS CONTINUE
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cold compress therapy, Pyrexia, Tenderness, Testicular swelling
Clinical narrative: pt developed  low grade fever and swelling of both testes after the MMRV immunization.Pt was given the immunization on 4/30 2007. Mom tried cold compresses and  the swelling came down. He was brought in for a check up on 5/2/2007. Pt denied h/o trauma  to the groin area. he said he had mild tenderness on examination
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cold compress therapy, Discomfort, Erythema, Swelling, Tenderness
Clinical narrative: uncomfortable tenderness, swelling, redness, which extended to the axillary area, has been treated with ice packs.  5/11/07 Received medical records from hospital which reveal patient experienced recurrent chest discomfort , pallor, starring & left arm numbness followed by passing out while in church.  Admitted 5/6/07- 5/10/07.  Vax given 5/7/07 while hospitalized.  Patient had hx of extensive cardiac w/u which was neg.  Multiple consults done while in hospital.  No D/C Summary included.  Will call hospital for d/c date. Admit DX: syncopal episode, chest pain, r/o MI, dyslipidemia, hx of tachycardia & HTN FINAL DX: None given. 5/11/07 T/C to med recs.  D/C on 5/10/07.  No D/C summary dictated.  No final dx available.
Age: 14.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Child received a DTaP vs a Tdap.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Disorientation, Dizziness, Hearing impaired, Heart rate decreased
Clinical narrative: Vagal reaction: immediately after injection, I felt my heart palpitating, I felt light-headed, and I heard distorted noises.  I became disoriented for a moment or two, then heard clearly again.  The nurse helped me lay down for about 5 minutes and gave me water and juice to drink.  She said I looked pale; my blood pressure was lower than my normal reading, and my heart rate was 50.  After resting for a few moments, I felt fine, and I have not felt any faintness or pain at the injection site since.  The nurse did not report this reaction, because in her judgment it was simply a vagal reaction and unrelated to the vaccine.  I shared this information with two employees of Merck; one of them asked me to report this reaction anyway, and the other may have reported it separately.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Palpitations, Syncope vasovagal
Clinical narrative: Vagal reaction: immediately after injection, I felt my heart palpitating, I felt light-headed, and I heard distorted noises.  I became disoriented for a moment or two, then heard clearly again.  The nurse helped me lay down for about 5 minutes and gave me water and juice to drink.  She said I looked pale; my blood pressure was lower than my normal reading, and my heart rate was 50.  After resting for a few moments, I felt fine, and I have not felt any faintness or pain at the injection site since.  The nurse did not report this reaction, because in her judgment it was simply a vagal reaction and unrelated to the vaccine.  I shared this information with two employees of Merck; one of them asked me to report this reaction anyway, and the other may have reported it separately.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, CSF test normal, Chest X-ray normal, Headache, Malaise
Clinical narrative: Patient received vaccine at his high school in preparation for college dorm life.  Four hours after vaccine administration headache began.  Two hours later, patient had subjective fever and malaise.  Took ibuprofen 800mg then slept through the night.  Awoke with severe headache, fever (38.6 in ED), muscle stiffness so was brought to emergency department by his mother. Patient stated he did not receive VIS with vaccine administration. In the ED, again had fever as above, headache, and neck stiffness, therefore had lumbar puncture to rule out meningitis (results below). Later discharged from emergency department to home.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient received vaccine at his high school in preparation for college dorm life.  Four hours after vaccine administration headache began.  Two hours later, patient had subjective fever and malaise.  Took ibuprofen 800mg then slept through the night.  Awoke with severe headache, fever (38.6 in ED), muscle stiffness so was brought to emergency department by his mother. Patient stated he did not receive VIS with vaccine administration. In the ED, again had fever as above, headache, and neck stiffness, therefore had lumbar puncture to rule out meningitis (results below). Later discharged from emergency department to home.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 55mm x 55mm area of induration, erythema, and slight warmth, noted 36 hours after varivax dose #2 at site of injection.  First dose of Varivax was given on 6/15/1995.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: APPROX 24 HRS FOLLOWING FIRST VACCINATION,(GIVEN SC IN THE RT DELT REGION) PT'S RT HAND DEVELOPED EXTREME SORENESS TO THE TOUCH AND LOSS OF GRIP. SYMPTOMS LASTED >24HRS. HE ALSO EXPERIANCED BODY ACHES.  BODY ACHES HAVE NOT SUBSIDED FOR THREE WEEKS. APPROX 24HRS FOLLOWING THE SECOND VACCINATION (GIVEN SC IN THE L DELT REGION) PT STILL EXPERIANCING "ALL OVER" BODY ACHES.  ALSO EXTREME TENDERNESS TO THE PECTORAL MUSCLES.  "VERY TENDER TO THE TOUCH" EVEN DIFFICULT TO TAKE DEEP BREATHS.  TENDERNESS IS "SLOWLY GOING AWAY" BUT THE BODY ACHES REMAIN.  PT DOES NOT C/O ANY FEVER.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site warmth, Stomach discomfort
Clinical narrative: Tdap administered approximately 10:00 am at school clinic. As reported per school nurse, reddness and warmth were noted at the injection site almost immediately. Patient awoke the next morning with a fever of 102 degrees F and he complained of headache and an upset stomach. He was absent from school. The child returned to school in 48 hours with continued redness and swelling, but afebrile.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Rash generalised, Rash papular, Skin reaction
Clinical narrative: Topical reaction confirmed by MD as head to toe whole body papular rash 4 hours after recieving immunizations.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope, two minutes after Gardisil vaccine.Our office has given about 50 vaccines, and two people have had syncope after the injection. I don't think that is good.
Age: 56.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Abdominal pain, Laboratory test
Clinical narrative: Severe abd pain occured during the evening and pt went to CPMC ER
Age: 27.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Anthrax-wrong route-ID, redness to area-ice applied to area, zyrtec given,return to clinic 5/11 for a recheck,per M.D.   vaccine unknown was tuberculin ppd.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Myalgia, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Sore throat, runny nose, fatigue, muscle aches.  Patient was in superb health until onset of symptoms resulting from the vaccine.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Booster Varicella given May 7, 2007.  One day later developed swelling and erythema, warm to touch.  No fevers, no red streaks.  Seen in clinic on May 9 afternoon.  Swelling was 8cm x 8cm, erythema was 5cm x 5 cm, warm to touch.  No evidence of infection.  MOC stated that swelling was resolving by May 9.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Explorative laparotomy, Intussusception, Laparotomy
Clinical narrative: Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and had surgery. Follow up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot # AC21B069AA), a third dose of ACTHIB (Lot # UF021AB), and a third dose of PREVNAR (Lot # B08678K). The patient was vaccinated with the first dose of Rotateq (Lot # 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and bloody mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/laborotomy showed intussusception to rectosigmoid only reducible to hepatic flexure. Abdominal ultrasound confirmed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 4-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. A standard lot check investigation was performed for Lot # 655050/0778F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. A standard lot check investigation was performed for Lot # 655082/0779F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Barium enema, Colectomy, Haematochezia, Intussusception
Clinical narrative: Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and had surgery. Follow up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot # AC21B069AA), a third dose of ACTHIB (Lot # UF021AB), and a third dose of PREVNAR (Lot # B08678K). The patient was vaccinated with the first dose of Rotateq (Lot # 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and bloody mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/laborotomy showed intussusception to rectosigmoid only reducible to hepatic flexure. Abdominal ultrasound confirmed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 4-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. A standard lot check investigation was performed for Lot # 655050/0778F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. A standard lot check investigation was performed for Lot # 655082/0779F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.