chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 7 cm area of erythema + A heat & tender.  No lymphangitis.
Age: 72.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth, Pruritus
Clinical narrative: 4/29 & 4/30 injection site warm, painful.  5/1 hives around injection site, itchy.  Rx'd Benadryl, Tylenol or Advil.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Inflammation
Clinical narrative: Redness, inflammation of right arm, afebrile.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Red swelling 6-8 hrs post vaccination 4" x 2" at injection site R upper arm.  Developed to 8x8" flaming red swollen area with red streaks to R forearm as described by attending health aid in village and picture via AFHCAN.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Patient complained of headache and dizziness for approximately 14 hours after receiving the vaccine. Patient was observed for 4 hours in the emergency department that evening, but no intervention except ibuprofen was given. Symptoms resolved subsequently.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blepharospasm, Dyskinesia, Muscle twitching, Pyrexia, Somnolence
Clinical narrative: Patient had episode of unusual movements on day of vaccination.  Movements involved brief twitching of arms and fluttering of eyelids.  Duration only 15 seconds.  Pt then noted to have fever temp 101.6.  After this seemed unusually somnolent for 1 hour.  After this returned to nl activity.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Child was brought in by mother for fever and raised redden area on right tricep, mother stated she (child) received immunization Thursday 5/1/08 at school by Public Health nurse, fevers, and redness started 5/2/08. See by doctor in Emergency room on 5/4/08.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Appendicectomy, Appendicitis
Clinical narrative: Subject participated in a non-company sponsored clinical trial at a college.  Report was sent to an agency by one of the investigators, but as the company is not involved in this trial, the report was databased as spontaneous report.  A 16-year-old young man, born on 24 OCT 1991, was vaccinated for the first time with FLUVIRIN, batch-no. 0080685, i.m. into the right deltoid muscle on 17 NOV 2007.  An acute episode of severe abdominal pain localized to the right lower quadrant was reported on 24 DEC 2007.  He was seen in the emergency room where he was afebrile (oral temperature 98.7F), his white blood cell count was normal at 9.500 cells and a CAT scan of the abdomen revealed a possible appendicolith with mild thickening of the appendix.  The patient was taken to the operating room for an appendectomy on 24 DEC 2007.  Histology of specimen revealed mild acute appendicitis.  The subject had an uneventful hospital course and was discharged home on 25 DEC 2007.  The investigator did not see a causal relationship to vaccination with FLUVIRIN.  Medical history: asthma.  Seriousness criterion: hospitalisation.  Causality: unrelated.  Appendicitis was caused by appendicolith and subsequent infection.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: On 5/1/08 pt felt hard, hot area on L upper arm.  After observing area she noticed it was red.  On 5/3/08 pt states "all cleared up without medical treatment, ointments, etc."
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Caesarean section, Delayed delivery, Drug exposure during pregnancy, Protein total
Clinical narrative: Initial and follow up information has been received from Pregnancy Registry for Gardasil from a Nurse Practitioner (N.P.) and with a follow up telephone call concerning a 18 year old (previously reported as 20 year old) female patient with abnormal PAP test. She was obese and was a smoker who had cervical condyloma and "SAA". It was reported that patient was vaccinated around December, 2006 with a first dose of Gardasil. On 05-FEB-2007 she was vaccinated with the second dose of Gardasil (lot # 654510/0962F). Concomitant therapy included "birth control patch", Tylenol as needed for headache and she was treated with prenatal vitamins for pregnancy. The reporter reported that patient received her first injection and was pregnant. She had routine obstetrics labs done. No further information was available. In follow up it was reported that her last menstrual period (LMP) was on 03-JUN-2007 and expected delivery date was 09-MAR-2008. There was no information about delivery or outcome of the delivery. In follow up information from the doctor's office it was reported that on 27-SEP-2007 routine serum maternal alpha-fetoprotein test was done. Patient had ultrasound on 25-JUL-2007, 22-AUG-2007, 10-OCT-2007 and in 09-JAN-2008 for confirmation dates and screening of pregnancy. On 22-AUG-2007 pregnancy associated plasma protein test and on 27-SEP-2007 maternal serum alphafeto protein (MSAFP) was done. No information for the results are available. It was reported that on 13-MAR-2008 at 40.4/7 weeks from LMP patient delivered a female normal baby by cesarean section delivery. The indication for C/S delivery was not reported at this time. The baby weighed 8 lb 12 oz and her apgar score was 8.9. No complication was reported with the baby. Upon internal review patient's failure to progress (delayed delivery and) required a cesesaren section delivery. The event was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Initial and follow up information has been received from Pregnancy Registry for Gardasil from a Nurse Practitioner (N.P.) and with a follow up telephone call concerning a 18 year old (previously reported as 20 year old) female patient with abnormal PAP test. She was obese and was a smoker who had cervical condyloma and "SAA". It was reported that patient was vaccinated around December, 2006 with a first dose of Gardasil. On 05-FEB-2007 she was vaccinated with the second dose of Gardasil (lot # 654510/0962F). Concomitant therapy included "birth control patch", Tylenol as needed for headache and she was treated with prenatal vitamins for pregnancy. The reporter reported that patient received her first injection and was pregnant. She had routine obstetrics labs done. No further information was available. In follow up it was reported that her last menstrual period (LMP) was on 03-JUN-2007 and expected delivery date was 09-MAR-2008. There was no information about delivery or outcome of the delivery. In follow up information from the doctor's office it was reported that on 27-SEP-2007 routine serum maternal alpha-fetoprotein test was done. Patient had ultrasound on 25-JUL-2007, 22-AUG-2007, 10-OCT-2007 and in 09-JAN-2008 for confirmation dates and screening of pregnancy. On 22-AUG-2007 pregnancy associated plasma protein test and on 27-SEP-2007 maternal serum alphafeto protein (MSAFP) was done. No information for the results are available. It was reported that on 13-MAR-2008 at 40.4/7 weeks from LMP patient delivered a female normal baby by cesarean section delivery. The indication for C/S delivery was not reported at this time. The baby weighed 8 lb 12 oz and her apgar score was 8.9. No complication was reported with the baby. Upon internal review patient's failure to progress (delayed delivery and) required a cesesaren section delivery. The event was determined to be an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Caesarean section, Drug exposure during pregnancy, Laboratory test normal
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for Gardasil, concerning a 25 year old female with a history of one previous pregnancy and a miscarriage and a history of childhood epilepsy who on 12-JUN-2007 was vaccinated with a first dose of Gardasil (Lot # 657868/0523U) 0.5 mL IM. Concomitant medications included prenatal vitamins daily (unspecified) as a supplement and ZANTAC daily for reflux. The patient received her first dose of Gardasil IM and since found out that she is pregnant. The nurse practitioner mentioned the pregnancy is normal to date. Medical attention was sought. No additional information is available. The last menstrual period (LMP) was 16-MAY-2007 and the estimated time of delivery is 07-FEB-2008. Follow-up information was received. Medical history and dates of LMP and estimated date of delivery was updated. Follow-up information was received from the physician's office. On 10-SEP-2007 there was a quad screen performed and was within normal limits. On 30-JAN-2008 the patient had a normal healthy baby girl weighing 8 pounds 1 ounce. The apgar score was 9/9. The patient was 38 and 6/7 weeks from LMP. During labor/delivery the baby was in a frank breech presentation and c-section was done. Upon internal review c-section for breech presentation was considered to be an other medical event. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blindness transient, Colposcopy, Nausea
Clinical narrative: Information has been received from a 22 year old female patient who is allergic to amoxicillin and had human papilloma viral infection.  On 25-APR-2008 she was vaccinated with a first dose of Gardasil.  She reported that approximately twenty minutes after vaccination she began to feel nauseous.  In addition, her vision was adversely affected.  She began to see black dots and then "everything went black" and she had a temporary total loss of vision for ten to fifteen seconds.  She reported that she laid down for ten minutes and she seemed fine after that.  The only other symptom she had been experiencing was abdominal cramping as of 26-APR-2008.  She had a colposcopy of the cervix on the same day she received the injection.  The patient reported to be recovering.  Upon internal review temporary total loss of vision was determined to be an other important medical event.  No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Allergy test negative, Cellulitis, Cough, Dyspnoea, Erythema
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with allergy to influenza vaccine and a history of Fallot's tetralogy with subsequent surgery in 2003 who on 10-APR-2008 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) 0.5 ml SQ (Lot # 658033/0986U).  Concomitant therapy included DTaP, poliovirus vaccine and PPD TINE TEST.  Later that night, the patient experienced injection site reaction with redness and hardness at site.  On 11-APR-2008, the patient was coughing with difficulty breathing, turned red all over and went to the emergency room.  The patient was treated with BENADRYL, prednisone, breathing treatment and epinephrine.  Later the patient went home with an EPI-PEN for emergency use.  The patient's mother stated that the child has been to an allergist.  An allergy panel was negative, including eggs, and the doctor is unsure of the cause of symptoms.  This test did not include neomycin and gelatin.  By 14-APR-2008, the child was feeling better but her whole arm was red and swollen up and down with a pimple like spot in the center.  The patient was treated with amoxicillin for cellulitis.  It was reported that the patient also had an injection site reaction after the flu vaccine but not this extensive.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with allergy to influenza vaccine and a history of Fallot's tetralogy with subsequent surgery in 2003 who on 10-APR-2008 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) 0.5 ml SQ (Lot # 658033/0986U).  Concomitant therapy included DTaP, poliovirus vaccine and PPD TINE TEST.  Later that night, the patient experienced injection site reaction with redness and hardness at site.  On 11-APR-2008, the patient was coughing with difficulty breathing, turned red all over and went to the emergency room.  The patient was treated with BENADRYL, prednisone, breathing treatment and epinephrine.  Later the patient went home with an EPI-PEN for emergency use.  The patient's mother stated that the child has been to an allergist.  An allergy panel was negative, including eggs, and the doctor is unsure of the cause of symptoms.  This test did not include neomycin and gelatin.  By 14-APR-2008, the child was feeling better but her whole arm was red and swollen up and down with a pimple like spot in the center.  The patient was treated with amoxicillin for cellulitis.  It was reported that the patient also had an injection site reaction after the flu vaccine but not this extensive.  Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Pneumonia
Clinical narrative: Information has been received from a nurse practitioner concerning an 83 year old female consumer who on 14-FEB-2008 was vaccinated SQ with a 0.65ml of ZOSTAVAX.  Concomitant therapy included acyclovir (ZOVIRAX) and clorazepate dipotassium.  Subsequently, on 20-FEB-2008, the patient developed shingles.  Unspecified medical attention was sought.  It was unspecified if lab studies were performed.  It was reported that the patient was treated for shingles (treatment regimen not reported) and made a full recovery.  It was also reported that the patient went on vacation and when she returned from vacation she developed pneumonia and died on 12-APR-2008.  There was no product quality complaint involved.  The cause of death was pneumonia.  The nurse practitioner considered the event to be disabling.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Body temperature increased, Loss of consciousness, Pain, Rash vesicular
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 77 year old female consumer with rectal polyps, benign hypertension, vertigo, rhinitis, hyperthyroidism, rheumatoid arthritis, megaloblastic anemia, allergies to LESCOL, RELAFEN, ZOLOFT and TAGAMET, and a history of shingles, chickenpox, diverticulitis, diverticulosis, complete colectomy in 1978 and hysterectomy who on 17-APR-2008 was vaccinated in the left upper arm with a first dose of Zostavax (Oka/Merck) (lot # 659323/0164X).  Concomitant therapy included folic acid, SYNTHROID, BENICAR and CLARINEX.  On 18-APR-2008, the day after vaccination the patient developed zoster-like blisters under her breast and around her back.  The patient experienced mild tenderness.  On 25-APR-2008 the patient was examined by the physician.  There were no lab studies performed.  The patient had a generalized, very sore, blister-like rash.  The rash was on her groin area, her chest, her neck, and her arms.  It was reported that the patient experienced syncope while in the waiting room.  When she regained consciousness she vomited.  The patient was sent to the hospital to be admitted.  At the time of the report the patient had not recovered.  there was no product quality complaint involved.  Additional information from the physician indicated that the patient also developed lesions in her groin and on her buttocks.  The lesions looked like shingles.  The patient was prescribed VALTREX.  Follow-up information from the physician confirmed that the patient was admitted to the hospital and they were "working her up."  The physician reported that the patient's rash was a bilateral rash with a dermatomal distribution.  The rash was now also in her pelvic area and on her arms.  Initially the rash was not painful, however there is now tenderness in the areas.  The rash is vesicular in type with lesions crusted.  Follow-up information from the physician indicated that the patient developed more than 20 lesions on her neck, thighs, genitalia, and arms.  The patient also developed pain (rated 10 on a scale of 0 to 10).  It was also noted that there was no recent exposure to chickenpox or herpes zoster.  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain.  The sample of the lesions was collected on 25-APR-2008 and sent to the laboratory on 29-APR-2008.  The sample was taken from a papular lesion.  The physician considered the events to be disabling.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Syncope, Tenderness, Viral test, Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 77 year old female consumer with rectal polyps, benign hypertension, vertigo, rhinitis, hyperthyroidism, rheumatoid arthritis, megaloblastic anemia, allergies to LESCOL, RELAFEN, ZOLOFT and TAGAMET, and a history of shingles, chickenpox, diverticulitis, diverticulosis, complete colectomy in 1978 and hysterectomy who on 17-APR-2008 was vaccinated in the left upper arm with a first dose of Zostavax (Oka/Merck) (lot # 659323/0164X).  Concomitant therapy included folic acid, SYNTHROID, BENICAR and CLARINEX.  On 18-APR-2008, the day after vaccination the patient developed zoster-like blisters under her breast and around her back.  The patient experienced mild tenderness.  On 25-APR-2008 the patient was examined by the physician.  There were no lab studies performed.  The patient had a generalized, very sore, blister-like rash.  The rash was on her groin area, her chest, her neck, and her arms.  It was reported that the patient experienced syncope while in the waiting room.  When she regained consciousness she vomited.  The patient was sent to the hospital to be admitted.  At the time of the report the patient had not recovered.  there was no product quality complaint involved.  Additional information from the physician indicated that the patient also developed lesions in her groin and on her buttocks.  The lesions looked like shingles.  The patient was prescribed VALTREX.  Follow-up information from the physician confirmed that the patient was admitted to the hospital and they were "working her up."  The physician reported that the patient's rash was a bilateral rash with a dermatomal distribution.  The rash was now also in her pelvic area and on her arms.  Initially the rash was not painful, however there is now tenderness in the areas.  The rash is vesicular in type with lesions crusted.  Follow-up information from the physician indicated that the patient developed more than 20 lesions on her neck, thighs, genitalia, and arms.  The patient also developed pain (rated 10 on a scale of 0 to 10).  It was also noted that there was no recent exposure to chickenpox or herpes zoster.  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain.  The sample of the lesions was collected on 25-APR-2008 and sent to the laboratory on 29-APR-2008.  The sample was taken from a papular lesion.  The physician considered the events to be disabling.  Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: 20-30 red papules- (L) axilla, biceps, groin, thigh- 4-6 more erupted in the following 2 days.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Hypertension, Vomiting
Clinical narrative: Rec'd 2nd Rabies vaccine on 4/26/08. Went to ER on 4/27/08 w/reports of high blood pressure and constant vomiting.
Age: 9.0
Sex: F
Vaccine: HEPA, TD, VARCEL
Symptoms: Condition aggravated, Tic
Clinical narrative: Has history of tics-after the vaccines were given-within a few hours was having increased tics, tics almost were constant.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 5 1/2 in. x 5 in. Red, hot, swollen area
Age: 29.0
Sex: F
Vaccine: DTP
Symptoms: Diarrhoea, Headache, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: pain in (L) deltoid area with tingling in fingers, (+) fever, vomiting diarrhea and headache, ice compresses and Motrin 600 mg tid
Age: 29.0
Sex: F
Vaccine: DTP
Symptoms: Vomiting
Clinical narrative: pain in (L) deltoid area with tingling in fingers, (+) fever, vomiting diarrhea and headache, ice compresses and Motrin 600 mg tid
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt returned to the clinic 48 hours post-vaccine with 2.5 x 3 cm area of red, hot, very tender induration with 3x4 cm surrounding erythema, LUE at injection site
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Ten vesicular & papular rash both arms & chest wall on 4/26/08.  ? post vaccination dermatitis.  ? chicken pox.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: Was contacted by pt's mother afternoon of injection who informed office that pt had called her during her lunch hour and reported a rash on her thigh and some nausea. Pt was contacted. Denied use of new soap, detergent, fragrances, contact with chemicals, etc. On 3/26 pt was contacted again she stated rash went away on 3/25 but reappeared on 3/26/08, arms were itching but no rash presented. Pt stated she did not use the Benadryl 25 mg or 1% Hydrocortisone cream. Was told to contact office if no improvement.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 05/01/2008 10:30 AM student c/o "high fever", took temp 101 degrees. Called mother and she came to get him.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Influenza like illness, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Patient began to experience flu-like sx shortly after receiving the vaccine. She went to see her physician about 48 hrs after vaccine. Her arm was warm, painful, & swollen. She had a fever of 102. MD gave Rocephin IV Sunday, M, T, & Th. Oral Keflex 500 mg QID x 2 weeks.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient began to experience flu-like sx shortly after receiving the vaccine. She went to see her physician about 48 hrs after vaccine. Her arm was warm, painful, & swollen. She had a fever of 102. MD gave Rocephin IV Sunday, M, T, & Th. Oral Keflex 500 mg QID x 2 weeks.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Influenza, Injected limb mobility decreased, Malaise, Pain
Clinical narrative: Pt reports soreness in (L) arm on Fri eve which progressed to cold sweats, generalized body aches, felt like "he had the flu". No redness, swelling, cont cold packs per Dr on Mon "Flu symptoms" gone. Taking 600 mg Advil 3x daily. Pain from (L) shoulder to elbow w/movement & sleep disturbed.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pt reports soreness in (L) arm on Fri eve which progressed to cold sweats, generalized body aches, felt like "he had the flu". No redness, swelling, cont cold packs per Dr on Mon "Flu symptoms" gone. Taking 600 mg Advil 3x daily. Pain from (L) shoulder to elbow w/movement & sleep disturbed.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Bacterial culture positive, Polymerase chain reaction, Rash erythematous, Rash pustular, Skin lesion
Clinical narrative: Developed a large pustule on an erythematous base on rt dorsal proximal 5th digit approx 2 wks post spv. Did not wear gloves while changing dsg. Symptom: Lesions, Pustule Start: 04/01/2008 Comment: Rt 5th digit
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Virus culture negative
Clinical narrative: Developed a large pustule on an erythematous base on rt dorsal proximal 5th digit approx 2 wks post spv. Did not wear gloves while changing dsg. Symptom: Lesions, Pustule Start: 04/01/2008 Comment: Rt 5th digit
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood test, Body temperature increased, Chest X-ray, Crying, Diarrhoea
Clinical narrative: Vomiting, persistent diarrhea started 4-30-08 at midnight. temp 101.4 degrees, Listless; High pitched crying. Pedialyte given. To ER on May 2. Vomiting, diarrhea ended May 3 at noon.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Listless, Stool analysis, Urine analysis, Vomiting
Clinical narrative: Vomiting, persistent diarrhea started 4-30-08 at midnight. temp 101.4 degrees, Listless; High pitched crying. Pedialyte given. To ER on May 2. Vomiting, diarrhea ended May 3 at noon.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Pt states L arm became red and swollen at 6 pm. Soreness and aching later on in evening. Pt applied ice pack and Darvocet, w/some relief. 5/7/08 Redness and induration > 120mm. Warm to touch with > redness increasing (per patient). Pt was seen by MD and tx'd w/celedrex 300 mg and pogel and OTC Benadryl.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Pt states L arm became red and swollen at 6 pm. Soreness and aching later on in evening. Pt applied ice pack and Darvocet, w/some relief. 5/7/08 Redness and induration > 120mm. Warm to touch with > redness increasing (per patient). Pt was seen by MD and tx'd w/celedrex 300 mg and pogel and OTC Benadryl.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: L arm with 8x8cm erythema. Ibuprofen, heat
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Nystagmus, Oxygen saturation normal, Vertigo, Vomiting
Clinical narrative: 1 hour after getting vaccine felt hot, developed vertigo and threw up.  Lateral gaze nystagmus demonstrated.  3 days later symptoms had cleared.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Vaccination complication, Weight bearing difficulty
Clinical narrative: R leg still very sore & unable to bear weight since shots per 4-21-08 visit.  Dad states he carried child out of office (five) that day 4-14-08.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Varicella received 5/1.  On 5/2 developed pain/erythema/swelling at injection site.  Tactile temp.  Rxn site improved on
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: May 4, developed rash to head and trunk, spreading to extremeties. May 5, temp. 100.0 rectally. May 6, seen in office for evaluation; advised observation, no treatment. May 7 phone call to mother: child acts well, rash persists.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Scab, Vaccination failure, Varicella
Clinical narrative: Breakthrough Chickenpox diagnosed 5/1/2008: pink, papulo-vesicular rash on face, chest, back; few with crusts.
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A 3 day old infant inadvertently received the 2 month shots on 5/5/08. On 5/7/08, was seen by pediatrician and had a normal exam. No adverse reactions. The child was born at 38 weeks gestation. Infant did NOT receive birth dose of hepatitis B vaccine.
Age: 10.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Burning sensation, Chills, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 18 hours later patient woke up feeling stiffness in legs, shivering profusely, burning in head and neck. Fever went from 100 to 103 degrees in twenty minutes treatment included blankets, cold compresses, ice chips in mouth and Advil. Patient better 10 hours later.
Age: 1.58
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Pt's mother reported hives, progressing from the time they got home and worsening by bed time.  States the child had received Hib before but never Hep A.  No other changes in routine noted.  Advised by our MD to give benadryl.  Did relieve sx.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Pruritus, Vasoconstriction
Clinical narrative: Itching and Burning, 20 seconds after Tdap administered. Vaso constriction.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: About 10:00 PM Father noticed baby's rt. leg was swollen and red and painful to touch. Mother states upper and lower leg were swollen. Emergency Room report diagnosis was Local Allergic Reaction Right thigh.  Was given Benadryl and Motrin at 10:30 PM and discharged home with instructions to return if symptoms increased and to follow up with Physician.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure, Dizziness, Heart rate, Hyperhidrosis, Pallor
Clinical narrative: 6:45 pm Received two injections today.  Within 1 minute, complained of feeling dizzy.  Had not eaten since morning.  Color slightly pale, slightly diaphoretic. Reclined in reclining chair, given a sucker and juice to sip. VS checked at 6:50 and 6:55 pm (BP 108/76 p.92,BP 106/76 p.88).  At 6:55 pm color was pink, skin warm and dry, "felt better".  Assisted to sitting position. Tolerated well.  7 pm Ambulated to lobby with assistance, tol. well.  Discharged with Mom.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Fatigue, Hyperhidrosis, Influenza like illness, Pain, Upper respiratory tract congestion
Clinical narrative: flu like symptoms 36+ hours after dose.  Described as sweating, chest congestion, mild fatique, body aches.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Blood test, Enema administration, Laboratory test, Pyrexia
Clinical narrative: Around 11:00pm night of immunizations, child with 103 temp, after alternating Tylenol and Motrin.  Morning of 2/1/08, child given Tylenol and Motrin simulatneously for fever of 104.  Fever did not decrease, taken to Medical Center.  Blood work, and many other tests ran.  Everything negative.  Pt. given Enema, 3 hours later fever broke.  Pt. dc'd to home.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception, X-ray abnormal
Clinical narrative: Patient developed intussusception on 2/25/08.  Reduced with air contrast b.e. same day. 7/30/08-records received for DOS  2/26/08 DX:Intussusception. Presented with colicky abdominal pain. Heme positive stools, 15-20 episodes of emesis last one streaked with blood and yellow color bilious emesis. Normal BM earlier in day then loose BM at 1700.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception, X-ray abnormal
Clinical narrative: Patient developed intussusception on 2/25/08.  Reduced with air contrast b.e. same day. 7/30/08-records received for DOS  2/26/08 DX:Intussusception. Presented with colicky abdominal pain. Heme positive stools, 15-20 episodes of emesis last one streaked with blood and yellow color bilious emesis. Normal BM earlier in day then loose BM at 1700.
Age: 21.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, TYP
Symptoms: Lip swelling, Periorbital oedema, Urticaria
Clinical narrative: Came to facility for travel consult 4/15/08; Went to Travel clinic 4/17 for Yellow Fever, Came to facility 4/29/08 had started Oral Typhoid 4/28/08 c/o right periorbital edema, no hives, no SOB. Advised to continue Oral Typhoid. Came to facility 5/5 c/o of Left peri-orbital edema, hives on right arm and left hip, with lip swelling. Denied SOB,wheezing, difficulty swallowing. Received 50 mg of IM benadryl, Epi-Pen, and started tappering dose of prednisone at 60 mg.Advised not to take last dose of Typhoid. Returned to facility 5/6 symptoms resolved
Age: 48.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 4-26-08 Patient states that her right upper arm was swollen,red,itchy and warm at the injection site. Area about 3" in diameter. Treated the site with ice and Motrin per patient. The reddened area increased to 7" and she went to the ER on 4-27-08. There she was treated with hydrocortisone cream and Atarax. Went to PCP on 4-28-08 and per patient was given "steroid shot in the hip". Telephone call to patient on 05-07-08. She states that the injection site only has occasional itching, but the swelling is gone. Also said she is having complications to the steroids she received and is still having follow-up with her doctors.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Immunization given in am.  Mom called and reported generalized hives and a temp of 102 in the evening.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash erythematous
Clinical narrative: Patient developed a rash 4 days after recieving the Zoster vaccine.  She described it as itchy, red bumps on her upper arm. She also developed a few blisters around this area.  This rash then spread to her forearm.  I recommended she use Benedryl cream to help with the itching.  She later informed me she had used the Benedryl cream as well as Eucerin cream which provided releif from the pruritis.  She stated that the rash resolved after 6 days.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast, Crying, Enema administration
Clinical narrative: on 5/5/08, patient seen in the ER with worsening intermittent abdominal pain for 1 day.  Child would bring knees to his chest and cry inconsolably for up to 20 minutes.  AXR showed intussuception, and patient was seen by surgery who successfully performed an air-contrast enema.  Patient was admitted to the hospital.  6/3/08 Reviewed hospital medical records for 5/5-5/7/2008. FINAL DX: intussusception, enema reduced. Records reveal patient experiencec worsening abdominal pain, crying inconsolably, vomiting, reduced oral intake, lethargy, irritability.  Admitted for observation s/p enema reduction of IS.  Improved & d/c to home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, X-ray abnormal
Clinical narrative: on 5/5/08, patient seen in the ER with worsening intermittent abdominal pain for 1 day.  Child would bring knees to his chest and cry inconsolably for up to 20 minutes.  AXR showed intussuception, and patient was seen by surgery who successfully performed an air-contrast enema.  Patient was admitted to the hospital.  6/3/08 Reviewed hospital medical records for 5/5-5/7/2008. FINAL DX: intussusception, enema reduced. Records reveal patient experiencec worsening abdominal pain, crying inconsolably, vomiting, reduced oral intake, lethargy, irritability.  Admitted for observation s/p enema reduction of IS.  Improved & d/c to home.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness, swelling to l deltoid. ice pack on the site
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Cough, Injection site swelling, Nasal congestion
Clinical narrative: cough, mother also stated that patient's right arm sweeling on 4/29 after the shot on 4/28, didn't check on 4/30, but worsed today   no runy nose, + mild stuffy nose
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Lethargy, Vomiting
Clinical narrative: Pt began vomiting, severe h/a and lethargy less than 24 hours after injection.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Neck pain
Clinical narrative: Generalized Headache began 4 hours after vaccination.  Lasted 5 days.  Additional complaint of right sided neck pain (vaccine administered R deltoid.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood product transfusion, CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Headache
Clinical narrative: Onset of headache and bilateral upper extremity weakness within 24 hours of receiving vaccine. Progressed to lower extremities, requiring hospitalization.  Working diagnosis is transverse myelitis versus Guillain-Barre Syndrome. Diagnostic work-up still in progress. Treatment course has been acyclovir and IVIG.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Immunoglobulins, Muscular weakness, Polymerase chain reaction, Red blood cells CSF positive, Viral DNA test negative
Clinical narrative: Onset of headache and bilateral upper extremity weakness within 24 hours of receiving vaccine. Progressed to lower extremities, requiring hospitalization.  Working diagnosis is transverse myelitis versus Guillain-Barre Syndrome. Diagnostic work-up still in progress. Treatment course has been acyclovir and IVIG.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, CSF cell count, CSF glucose, CSF test abnormal, CSF white blood cell count
Clinical narrative: Onset of headache and bilateral upper extremity weakness within 24 hours of receiving vaccine. Progressed to lower extremities, requiring hospitalization.  Working diagnosis is transverse myelitis versus Guillain-Barre Syndrome. Diagnostic work-up still in progress. Treatment course has been acyclovir and IVIG.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscular weakness
Clinical narrative: Onset of headache and bilateral upper extremity weakness within 24 hours of receiving vaccine. Progressed to lower extremities, requiring hospitalization.  Working diagnosis is transverse myelitis versus Guillain-Barre Syndrome. Diagnostic work-up still in progress. Treatment course has been acyclovir and IVIG.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, CSF oligoclonal band absent, CSF protein increased, Electromyogram abnormal, Mobility decreased
Clinical narrative: Onset of headache and bilateral upper extremity weakness within 24 hours of receiving vaccine. Progressed to lower extremities, requiring hospitalization.  Working diagnosis is transverse myelitis versus Guillain-Barre Syndrome. Diagnostic work-up still in progress. Treatment course has been acyclovir and IVIG.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscular weakness, Polymerase chain reaction, Viral DNA test negative
Clinical narrative: Onset of headache and bilateral upper extremity weakness within 24 hours of receiving vaccine. Progressed to lower extremities, requiring hospitalization.  Working diagnosis is transverse myelitis versus Guillain-Barre Syndrome. Diagnostic work-up still in progress. Treatment course has been acyclovir and IVIG.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV
Symptoms: Crying
Clinical narrative: After receiving 2 mo imm. baby cried while taking bottles for the 1st day.  Then OK next day then cried while bottling for next 2-3 weejs,
Age: 2.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Abasia, Abnormal behaviour, Communication disorder, Crying, Fatigue
Clinical narrative: Following the vaccination she developed a small fever just below 100 degrees.  Her legs were extremely sore to the degree that she did not do any walking for about 6 hrs after the soreness began 1 1/2 hrs after the vaccination.  This was not concerning to us because we expected some local inflamation.  About 28 hours after her vaccination she was inconsolable and was screaming "NO" repeatiably.  She was tired and we thought that this was extremely unusual behavior for her so we tried to lay her down.  She screamed herself to sleep.  She awoke after 1hr screaming and then fell back asleep after about 10 minutes.  She then slept about 1-2 more hours more and woke up completely inconsolable and unreachable with communication.  This began concerning us because this was extremely unusual behavior for her.  No communication, food, treats, or anything we could think of would bring her out of this state.  When picked up she kicked and screamed even more.  After about an hour of this she appeared worn out and finally stropped screaming.  She laid on her moms shoulders again and started to calm down.  Her behavior and communication were extremely poor the rest of the night until we laid her back down for bed.  The next morning (today)she appeared much better and was communicating and responding much better.  She still does not seem to be quite herself.
Age: 2.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Inflammation, Pain in extremity, Pyrexia, Screaming, Unresponsive to stimuli
Clinical narrative: Following the vaccination she developed a small fever just below 100 degrees.  Her legs were extremely sore to the degree that she did not do any walking for about 6 hrs after the soreness began 1 1/2 hrs after the vaccination.  This was not concerning to us because we expected some local inflamation.  About 28 hours after her vaccination she was inconsolable and was screaming "NO" repeatiably.  She was tired and we thought that this was extremely unusual behavior for her so we tried to lay her down.  She screamed herself to sleep.  She awoke after 1hr screaming and then fell back asleep after about 10 minutes.  She then slept about 1-2 more hours more and woke up completely inconsolable and unreachable with communication.  This began concerning us because this was extremely unusual behavior for her.  No communication, food, treats, or anything we could think of would bring her out of this state.  When picked up she kicked and screamed even more.  After about an hour of this she appeared worn out and finally stropped screaming.  She laid on her moms shoulders again and started to calm down.  Her behavior and communication were extremely poor the rest of the night until we laid her back down for bed.  The next morning (today)she appeared much better and was communicating and responding much better.  She still does not seem to be quite herself.
Age: 40.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Fatigue, Feeling cold
Clinical narrative: Extremely tired and  Very cold and shivering off and on for 48 hours (so far)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV
Symptoms: Injection site swelling
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 30 April 2008 from another manufacturer, report number A0723454A.  The original reporter to the other manufacturer was a sales representative who received the report from a physician.  The other manufacturer reported this case as a 15-day report.  A 4-year-old male patient, with unknown medical history had received a third dose of IPOL (Lot # A0342), and a fifth left arm dose of Infanrix (manufacturer GlaxoSmithKline, Lot # AC14606999) on 12 March 2008 at approximately 12:30 PM.  The routes and sites of administration for both vaccines were not provided.  Two days post-vaccination, the patient experienced severe swelling in the left upper arm that involved the elbow.  The patient was evaluated in the physician's office and treated with "antibiotics" (type not provided).  It was "unknown" if any relevant diagnostic tests or laboratory data were performed.  The physician considered the extensive swelling of the vaccinated limb as clinically significant.  The physician retained the vials of vaccine to return to the other manufacturer if necessary. At the time of the report, the patient's severe arm swelling had resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV
Symptoms: Oedema peripheral
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 30 April 2008 from another manufacturer, report number A0723454A.  The original reporter to the other manufacturer was a sales representative who received the report from a physician.  The other manufacturer reported this case as a 15-day report.  A 4-year-old male patient, with unknown medical history had received a third dose of IPOL (Lot # A0342), and a fifth left arm dose of Infanrix (manufacturer GlaxoSmithKline, Lot # AC14606999) on 12 March 2008 at approximately 12:30 PM.  The routes and sites of administration for both vaccines were not provided.  Two days post-vaccination, the patient experienced severe swelling in the left upper arm that involved the elbow.  The patient was evaluated in the physician's office and treated with "antibiotics" (type not provided).  It was "unknown" if any relevant diagnostic tests or laboratory data were performed.  The physician considered the extensive swelling of the vaccinated limb as clinically significant.  The physician retained the vials of vaccine to return to the other manufacturer if necessary. At the time of the report, the patient's severe arm swelling had resolved.
Age: 0.13
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Intestinal obstruction, Intussusception, Surgery, Ultrasound scan abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a healthy 9 week old male who on 17-APR-2008 was vaccinated PO with a dose of ROTATEQ (lot# 657518/1192U). On 30-APR-2008 the patient experienced intussusception. The patient was admitted to the hospital ICU and was in septic shock. The patient underwent surgery on that same day. The patient was in recovery in the ICU at the time of this report. There was no product quality complaint. Intussusception and septic shock were also considered to be disabling, immediately life-threatening and other important medical events (surgery) by the physician. Additional information has been requested
Age: 0.13
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a physician concerning a healthy 9 week old male who on 17-APR-2008 was vaccinated PO with a dose of ROTATEQ (lot# 657518/1192U). On 30-APR-2008 the patient experienced intussusception. The patient was admitted to the hospital ICU and was in septic shock. The patient underwent surgery on that same day. The patient was in recovery in the ICU at the time of this report. There was no product quality complaint. Intussusception and septic shock were also considered to be disabling, immediately life-threatening and other important medical events (surgery) by the physician. Additional information has been requested
Age: 0.13
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Intensive care, Intussusception, Septic shock, Surgery
Clinical narrative: Information has been received from a physician concerning a healthy 9 week old male who on 17-APR-2008 was vaccinated PO with a dose of ROTATEQ (lot# 657518/1192U). On 30-APR-2008 the patient experienced intussusception. The patient was admitted to the hospital ICU and was in septic shock. The patient underwent surgery on that same day. The patient was in recovery in the ICU at the time of this report. There was no product quality complaint. Intussusception and septic shock were also considered to be disabling, immediately life-threatening and other important medical events (surgery) by the physician. Additional information has been requested
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Electrocardiogram normal, Hyperhidrosis, Immediate post-injection reaction, Malaise
Clinical narrative: Pt given pneumococcal vaccine in clinic on 12/19/08. He had ill sensation after receiving pneumococcal vaccine with diaphoresis and abdominal discomfort. Almost immediate begun after administration of pneumococcal vaccine. No skin lesions noted and no breathing difficulty. Wonder if this is more of a vaso-vagal response in an anxious recipient of vaccine than true reaction to vaccination components (especially given the immediate onset). He was transported to the ED for further evaluation. No EKG changes were noted. Pt was found to be stable with no signs of anaphylaxis. He was given fluids and a meal and left with no complications.