chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Scratch, Skin burning sensation, Throat tightness
Clinical narrative: Thursday, Feb 17/11 - Flu vaccine administered in the afternoon, approximately 1430 or 1500 hrs by RN. Associate reports feeling pain from injection site to her elbow initially following. Thursday, Feb 17/11-Associate developed s/s hives and lip swelling after supper that evening. Associate reports she did not eat anything different than she has eaten before and the only new event was receiving the flu vaccine that afternoon. Friday, Feb 18/11- Associate reports continued hives, with lip and hand swelling. Associate states she took BENADRYL 25 mg orally at 1330hrs. Associate into Hospital-Occupational Health Services to see work comp provider, given KENALOG 40 mg IM at 1525hrs for continued lip swelling and hives. Friday, Feb 18/11-Associate reports she developed increased swelling to lips and hands at 1730 hrs and took BENADRYL 2 tabs. She also report feeling like she had a tight airway and a cough and took her Albuterol Inhaler. She described her palms of hands feeling like "they were on fire" and had painful wrists. Saturday, Feb 19/11-Associate states she woke up at 0000 hrs, feeling like she was on fire, had blotch-like hives to arms, eyes, ears, face, neck under breasts, stomach, low back and also to pubic area and knees. She continued taking BENADRYL 2 tabs every 4 hours on Saturday. She reported feeling an ear ache with swollen ear canals, however, later in the evening felt like the symptoms were starting to resolve. Sunday, Feb 20/11-Associate reports she continued BENADRYL 2 tabs every 6 hours. She states her hands started to decrease in swelling, but continued to itch. Thursday, Feb 24/11-Associate reports single, occasional hive eruption with itchy palms, is able to wear her wedding ring again and overall feels much improved. She states she notices that skin redness remains for 10 minutes after scratching itchy areas. Work Comp provider reviewed case and determined probable allergic reaction to influenza vaccine. Seen in office for follow up visit 4/15/11. All symptoms resolved.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Thursday, Feb 17/11 - Flu vaccine administered in the afternoon, approximately 1430 or 1500 hrs by RN. Associate reports feeling pain from injection site to her elbow initially following. Thursday, Feb 17/11-Associate developed s/s hives and lip swelling after supper that evening. Associate reports she did not eat anything different than she has eaten before and the only new event was receiving the flu vaccine that afternoon. Friday, Feb 18/11- Associate reports continued hives, with lip and hand swelling. Associate states she took BENADRYL 25 mg orally at 1330hrs. Associate into Hospital-Occupational Health Services to see work comp provider, given KENALOG 40 mg IM at 1525hrs for continued lip swelling and hives. Friday, Feb 18/11-Associate reports she developed increased swelling to lips and hands at 1730 hrs and took BENADRYL 2 tabs. She also report feeling like she had a tight airway and a cough and took her Albuterol Inhaler. She described her palms of hands feeling like "they were on fire" and had painful wrists. Saturday, Feb 19/11-Associate states she woke up at 0000 hrs, feeling like she was on fire, had blotch-like hives to arms, eyes, ears, face, neck under breasts, stomach, low back and also to pubic area and knees. She continued taking BENADRYL 2 tabs every 4 hours on Saturday. She reported feeling an ear ache with swollen ear canals, however, later in the evening felt like the symptoms were starting to resolve. Sunday, Feb 20/11-Associate reports she continued BENADRYL 2 tabs every 6 hours. She states her hands started to decrease in swelling, but continued to itch. Thursday, Feb 24/11-Associate reports single, occasional hive eruption with itchy palms, is able to wear her wedding ring again and overall feels much improved. She states she notices that skin redness remains for 10 minutes after scratching itchy areas. Work Comp provider reviewed case and determined probable allergic reaction to influenza vaccine. Seen in office for follow up visit 4/15/11. All symptoms resolved.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Rash papular
Clinical narrative: Pt. given VARIVAX 3/22/10. Presented to office today with rash (papulovesicular) in dermatomal distribution consistent with shingles. No known exposure to wild-type varicella.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chills, Dysphonia, Dyspnoea
Clinical narrative: Hoarse, difficulty breathing, fever, nasal congestion - blood from nose, sore throat, coughing and blood from lungs, headache, chills, weak (could not stand long). I was hoarse 4 weeks. I was like this over 6 weeks.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Epistaxis, Haemoptysis, Headache, Nasal congestion
Clinical narrative: Hoarse, difficulty breathing, fever, nasal congestion - blood from nose, sore throat, coughing and blood from lungs, headache, chills, weak (could not stand long). I was hoarse 4 weeks. I was like this over 6 weeks.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Hoarse, difficulty breathing, fever, nasal congestion - blood from nose, sore throat, coughing and blood from lungs, headache, chills, weak (could not stand long). I was hoarse 4 weeks. I was like this over 6 weeks.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: Awoke Monday (4/11/11) with achy flu-like symptoms, came home from MD office - nauseated and vomiting. MD attributed his S/S to the ZOSTAVAX injection given Saturday 4/9/2011 s/s duration 8-12 hrs.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: Cellulitis at injection site vs reaction.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: Cellulitis vs reaction at injection site.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.52
Sex: F
Vaccine: HEPA, MMR
Symptoms: Irritability, Pallor, Pyrexia, Rash
Clinical narrative: Fever 4/15; peaked 4/16 at 104-105; 101 4/17 & 4/18. Fussy. Rash on trunk - blanched.
Age: 38.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Hives/rash - generalized over body (back, Rt leg, both arms, butt, head). Unsure of actual start date (week of 4-11-11). BENADRYL by mouth & cream for itchy rash -> no relief -> going to prompt care.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Electrocardiogram normal, Full blood count normal, Hypopnoea, Hypotonia
Clinical narrative: Per Parents; Fever, pale, limp, not responding and shallow breathing.  Was instructed to call 911.  Parents did not want to wait and drove pt. to Hospital themselves while on the phone with one of our nurses.  Per ER: Uncertain to  the cause of the spell.  Would consider a seizure as a possibility or possibly a fainting type of episode.  X-ray normal.  EKG difficult to interpret due to crying and movement, but rhythm appears normal.  CBC, Urine and Chemistry panel all essentially normal.  Rash developed, red raised bumps.  Pt. also had whelps at injection sites.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Laboratory test normal, Pallor, Pyrexia, Rash erythematous
Clinical narrative: Per Parents; Fever, pale, limp, not responding and shallow breathing.  Was instructed to call 911.  Parents did not want to wait and drove pt. to Hospital themselves while on the phone with one of our nurses.  Per ER: Uncertain to  the cause of the spell.  Would consider a seizure as a possibility or possibly a fainting type of episode.  X-ray normal.  EKG difficult to interpret due to crying and movement, but rhythm appears normal.  CBC, Urine and Chemistry panel all essentially normal.  Rash developed, red raised bumps.  Pt. also had whelps at injection sites.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Unresponsive to stimuli, Urine analysis normal, Urticaria, X-ray normal
Clinical narrative: Per Parents; Fever, pale, limp, not responding and shallow breathing.  Was instructed to call 911.  Parents did not want to wait and drove pt. to Hospital themselves while on the phone with one of our nurses.  Per ER: Uncertain to  the cause of the spell.  Would consider a seizure as a possibility or possibly a fainting type of episode.  X-ray normal.  EKG difficult to interpret due to crying and movement, but rhythm appears normal.  CBC, Urine and Chemistry panel all essentially normal.  Rash developed, red raised bumps.  Pt. also had whelps at injection sites.
Age: 0.76
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient developed vomiting in the morning.  Had one episode and was sent to daycare where she developed a fever and had a second episode of vomiting.
Age: 1.51
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Decreased appetite, Oedema peripheral, Pyrexia
Clinical narrative: Swollen Arm (whole arm)- Low grade Fever - poor appetite -
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Induration, Oedema
Clinical narrative: Vaccine Thursday. Reaction noted Fri PM - erythema, edema, induration. Mom an LVN, gave MOTRIN & TYLENOL as syx persisted thru Sunday. Today no pain - mild erythema diffuse with .5cm induration.
Age: 4.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Injection site pain, Nausea, Weight bearing difficulty
Clinical narrative: Patient developed leg pain and was not able to walk on his right leg the next day. He complained of nausea and stomach pain.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine administered.  DTaP instead of Tdap.  I (patient) discovered error when filing paperwork for insurance.  I returned to Clinic to ask and they told me vaccines were interchageable.  I showed them the VIS I had downloaded (they never provided it to me prior to vaccinating me) and pointed out that "DTap is not licensed for adolescents, adults, or children 7 years of age and older."  They offered to write me a note stating it was OK and I said that was unacceptable.  I insisted they call the manufacturer, who confirmed what I said.  At that point, they said it was fine, I had received more of the diphtheria and pertussis components, but I would be fine and did not need to be re-vaccinated.  They don't seem to think they did anything wrong.  I do.
Sex: U
Vaccine: FLUX
Symptoms: Spinal cord disorder
Clinical narrative: Case number PHHY2011US32369 is an initial report from a non-health care professional received on 06 Apr 2011: This patient received seasonal influenza virus vaccine (manufacturer and batch number unknown) on an unspecified date. She presented with spinal cord problems after getting the flu shot. No further information was available at the time of this report.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection for TDAP given 4/11/11. On 4/18/11 patient reports swelling, redness, itching at injection site. Advised ER by Dr., Dx reaction to Tdap, given BACTRIM, Prednisone and CLARITIN. D/C to home.
Age: 41.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Back pain, Injected limb mobility decreased, Injury, Musculoskeletal pain
Clinical narrative: Left shoulder became increasingly painful.  By morning of 10/16, my left shoulder was immobilized, excruciating pain, could not move/lift left arm.  Pain radiates into back scapula/shoulder.
Age: 0.13
Sex: M
Vaccine: PNC13, RV1
Symptoms: Infantile spitting up, Vomiting
Clinical narrative: Significant increase in spitup/vomit - treated with an increase in Rantidine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection was hot, erythematous, painful, itchy and swollen.  Patient went to PMD and received a cortisone injection.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Biopsy kidney abnormal, Blood creatinine increased, Glomerulonephritis membranous, Hypertension, Nephrotic syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of membranous nephropathy in a 60-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). Parent's medical history included Guillain-Barre after influenza vaccination (her father). He died from it. On an unspecified date, the subject received an unspecified dose of Flu vaccine (administration site and route unknown, batch number not provided). 5 days after vaccination with Flu vaccine, the subject experienced abrupt onset of lower extremity pitting edema and hypertension. This case was assessed as medically serious by GSK. Her laboratory data revealed acute kidney injury with serum creatinine of 10.2. Her spot urine total protein to creatinine ratio was 23. Serological workup was negative. She underwent kidney biopsy which was showed stage 1 membranous nephropathy with acute interstitial nephritis. She was started on daily oral prednisone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalized (Serum creatinine-0.9) five weeks after initiation of oral prednisone. Her spot urine total protein to creatinine ratio decreased to 1.3. After one week of completion of therapy, patient was found to have elevated Serum creatinine of 2.3. Her spot urine total protein to creatinine ratio increased to 28. At this time, patient underwent repeat kidney biopsy which showed membranous nephropathy with resolution of acute interstitial nephritis. Patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her serum creatinine decreased to 0.9. Her spot urine total protein to creatinine ratio decreased to 0.2 upon completion of therapy. She continued to be in remission, six months after completion of oral corticosteroid therapy. The abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Oedema, Renal failure acute, Tubulointerstitial nephritis, Urine protein/creatinine ratio increased
Clinical narrative: This case was reported in a literature article and described the occurrence of membranous nephropathy in a 60-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). Parent's medical history included Guillain-Barre after influenza vaccination (her father). He died from it. On an unspecified date, the subject received an unspecified dose of Flu vaccine (administration site and route unknown, batch number not provided). 5 days after vaccination with Flu vaccine, the subject experienced abrupt onset of lower extremity pitting edema and hypertension. This case was assessed as medically serious by GSK. Her laboratory data revealed acute kidney injury with serum creatinine of 10.2. Her spot urine total protein to creatinine ratio was 23. Serological workup was negative. She underwent kidney biopsy which was showed stage 1 membranous nephropathy with acute interstitial nephritis. She was started on daily oral prednisone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalized (Serum creatinine-0.9) five weeks after initiation of oral prednisone. Her spot urine total protein to creatinine ratio decreased to 1.3. After one week of completion of therapy, patient was found to have elevated Serum creatinine of 2.3. Her spot urine total protein to creatinine ratio increased to 28. At this time, patient underwent repeat kidney biopsy which showed membranous nephropathy with resolution of acute interstitial nephritis. Patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her serum creatinine decreased to 0.9. Her spot urine total protein to creatinine ratio decreased to 0.2 upon completion of therapy. She continued to be in remission, six months after completion of oral corticosteroid therapy. The abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Oedema, Oedema peripheral, Renal failure acute, Renal impairment, Serology negative
Clinical narrative: This case was reported in a literature article and described the occurrence of membranous nephropathy in a 60-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). Parent's medical history included Guillain-Barre after influenza vaccination (her father). He died from it. On an unspecified date, the subject received an unspecified dose of Flu vaccine (administration site and route unknown, batch number not provided). 5 days after vaccination with Flu vaccine, the subject experienced abrupt onset of lower extremity pitting edema and hypertension. This case was assessed as medically serious by GSK. Her laboratory data revealed acute kidney injury with serum creatinine of 10.2. Her spot urine total protein to creatinine ratio was 23. Serological workup was negative. She underwent kidney biopsy which was showed stage 1 membranous nephropathy with acute interstitial nephritis. She was started on daily oral prednisone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalized (Serum creatinine-0.9) five weeks after initiation of oral prednisone. Her spot urine total protein to creatinine ratio decreased to 1.3. After one week of completion of therapy, patient was found to have elevated Serum creatinine of 2.3. Her spot urine total protein to creatinine ratio increased to 28. At this time, patient underwent repeat kidney biopsy which showed membranous nephropathy with resolution of acute interstitial nephritis. Patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her serum creatinine decreased to 0.9. Her spot urine total protein to creatinine ratio decreased to 0.2 upon completion of therapy. She continued to be in remission, six months after completion of oral corticosteroid therapy. The abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tubulointerstitial nephritis, Urine protein/creatinine ratio increased
Clinical narrative: This case was reported in a literature article and described the occurrence of membranous nephropathy in a 60-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). Parent's medical history included Guillain-Barre after influenza vaccination (her father). He died from it. On an unspecified date, the subject received an unspecified dose of Flu vaccine (administration site and route unknown, batch number not provided). 5 days after vaccination with Flu vaccine, the subject experienced abrupt onset of lower extremity pitting edema and hypertension. This case was assessed as medically serious by GSK. Her laboratory data revealed acute kidney injury with serum creatinine of 10.2. Her spot urine total protein to creatinine ratio was 23. Serological workup was negative. She underwent kidney biopsy which was showed stage 1 membranous nephropathy with acute interstitial nephritis. She was started on daily oral prednisone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalized (Serum creatinine-0.9) five weeks after initiation of oral prednisone. Her spot urine total protein to creatinine ratio decreased to 1.3. After one week of completion of therapy, patient was found to have elevated Serum creatinine of 2.3. Her spot urine total protein to creatinine ratio increased to 28. At this time, patient underwent repeat kidney biopsy which showed membranous nephropathy with resolution of acute interstitial nephritis. Patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her serum creatinine decreased to 0.9. Her spot urine total protein to creatinine ratio decreased to 0.2 upon completion of therapy. She continued to be in remission, six months after completion of oral corticosteroid therapy. The abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever and hives. Given Benadryl for hives for 2 days, stopped the Benadryl and the hives came back.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Drug dispensing error, Drug exposure during pregnancy, Laboratory test normal, Pregnancy with contraceptive device
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included gestational diabetes and gestational hypertension. Concurrent medications included Prenatal vitamins. On 27 September 2010 the subject received a dose of BOOSTRIX (.5 ml, unknown, left arm). Her last menstrual period was on an unspecified date and estimated date of delivery was on 30 January 2011. The subject was exposed to BOOSTRIX during an unknown trimester. On 27 September 2010, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy and prescription dispensing error. The healthcare professional reported that a pregnant subject received a BOOSTRIX inadvertently. The subject received this vaccination in error due to it not being prescribed for her (prescription dispensing error). At the time of the report, no other adverse events occurred. The outcome of the pregnancy was unknown. Follow-up information was received via the patient's physician on 26 October 2010. It was reported that the patient's date of last menstrual period was 25 April 2010 and that conception was normal. She receives prenatal vitamins with DHA. The subject's gestational age at the time of vaccination was 22 weeks. The pregnancy was an intrauterine pregnancy with an intrauterine device (IUD) in place. The IUD was removed on 23 June 2010. Follow-up information was received via a nurse on 13 April 2011. It was reported that conception was normal. The subject experienced a premature delivery on 28 November 2010, at 31 weeks gestation. The male neonate was delivered via cesarean section and weighed 4 pounds and 2 ounces. APGAR scores at 1 and 5 minutes were 08 and 09. No defect were noted, however, the neonate was sent to the neonatal intensive care unit due to the pre-term delivery. The event was not considered to be serious although premature delivery is considered medically serious by GSK.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Premature delivery
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included gestational diabetes and gestational hypertension. Concurrent medications included Prenatal vitamins. On 27 September 2010 the subject received a dose of BOOSTRIX (.5 ml, unknown, left arm). Her last menstrual period was on an unspecified date and estimated date of delivery was on 30 January 2011. The subject was exposed to BOOSTRIX during an unknown trimester. On 27 September 2010, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy and prescription dispensing error. The healthcare professional reported that a pregnant subject received a BOOSTRIX inadvertently. The subject received this vaccination in error due to it not being prescribed for her (prescription dispensing error). At the time of the report, no other adverse events occurred. The outcome of the pregnancy was unknown. Follow-up information was received via the patient's physician on 26 October 2010. It was reported that the patient's date of last menstrual period was 25 April 2010 and that conception was normal. She receives prenatal vitamins with DHA. The subject's gestational age at the time of vaccination was 22 weeks. The pregnancy was an intrauterine pregnancy with an intrauterine device (IUD) in place. The IUD was removed on 23 June 2010. Follow-up information was received via a nurse on 13 April 2011. It was reported that conception was normal. The subject experienced a premature delivery on 28 November 2010, at 31 weeks gestation. The male neonate was delivered via cesarean section and weighed 4 pounds and 2 ounces. APGAR scores at 1 and 5 minutes were 08 and 09. No defect were noted, however, the neonate was sent to the neonatal intensive care unit due to the pre-term delivery. The event was not considered to be serious although premature delivery is considered medically serious by GSK.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Mother reported that approximately 2 hrs after injection, developed a quarter sized welt with bumps at injection site that was very red. It continued to increase in size, up to the size of a softball, was very red and warm to touch. The swelling subsided 4 days later but remained red and warm, as well as arm soreness. on 4/11/11 complained of a sore throat. On 4/12/11 awoke with difficulty breathing, and the back of the tongue was swollen and noticed that evening noticed two large pus pockets to the back of the throat. No temp. Saw Dr. on 4/13/11 and was diagnosed with Strep throat and put on antibiotic.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Oral pustule, Oropharyngeal pain, Pain in extremity, Pharyngitis streptococcal
Clinical narrative: Mother reported that approximately 2 hrs after injection, developed a quarter sized welt with bumps at injection site that was very red. It continued to increase in size, up to the size of a softball, was very red and warm to touch. The swelling subsided 4 days later but remained red and warm, as well as arm soreness. on 4/11/11 complained of a sore throat. On 4/12/11 awoke with difficulty breathing, and the back of the tongue was swollen and noticed that evening noticed two large pus pockets to the back of the throat. No temp. Saw Dr. on 4/13/11 and was diagnosed with Strep throat and put on antibiotic.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Swollen tongue
Clinical narrative: Mother reported that approximately 2 hrs after injection, developed a quarter sized welt with bumps at injection site that was very red. It continued to increase in size, up to the size of a softball, was very red and warm to touch. The swelling subsided 4 days later but remained red and warm, as well as arm soreness. on 4/11/11 complained of a sore throat. On 4/12/11 awoke with difficulty breathing, and the back of the tongue was swollen and noticed that evening noticed two large pus pockets to the back of the throat. No temp. Saw Dr. on 4/13/11 and was diagnosed with Strep throat and put on antibiotic.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Convulsion, Heart rate increased, Pyrexia, Respiratory rate increased, Screaming
Clinical narrative: Convulsions, screaming as if scared or in pain, increased heart rate, quick breathing and fever.  The symptoms lasted an hour except the fever, which lasted 2 more days.
Age: 12.0
Sex: M
Vaccine: FLU3, MEN, VARCEL
Symptoms: Fall, Feeling cold, Head injury, Pallor, Syncope
Clinical narrative: APPROXIMATELY 15 MIN AFTER VACCINE ADMINSTERED AND BLOOD DRAWN, PATIENT GOT UP FROM CHAIR TO LEAVE AND WAS STANDING WAITING FOR MOTHER WHEN SUDDENLY FELL/FAINTING TO THE FLOOR. PATIENT HIT HIS HEAD ON FLOOR. NURSE ASSESSED PATIENT IMMEDIATELY ON IMPACT AND PATIENT RESPONDED SLOWLY TO VERBAL COMMANDS, ORIENTED X 3. PATIENT INITIALLY PALE AND COLD TO TOUCH. V/S:  B/P @ 100/60, HR @ 87, RR @ 24, O2 SAT @ 100%. HOSPITAL RESPONSE PROCESS INITIATED AND PATIENT SENT TO THE EMERGENCY ROOM OF THE HOSPITAL WITHIN 10 MINUTES WITH MOTHER ACCOMPANYING PATIENT. UPON FOLLOW-UP, PATIENT DISCHARGED FROM ER AND NO FURTHER ADVERSE EVENT/OUTCOME.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Adverse reaction, Chills, Hyperhidrosis, Injection site erythema, Injection site urticaria
Clinical narrative: Chills began.  Within an hour of the chills sweating started. By the evening a low grade fever.  Muscle aches since the onset of the adverse reaction. By day two the shot site formed a pink welt about 2-3 inches in diameter.  20 April the welt is 5-6 inches in diameter and the low grade fever continues. Muscle aches since.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Chills began.  Within an hour of the chills sweating started. By the evening a low grade fever.  Muscle aches since the onset of the adverse reaction. By day two the shot site formed a pink welt about 2-3 inches in diameter.  20 April the welt is 5-6 inches in diameter and the low grade fever continues. Muscle aches since.
Age: 1.12
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Rash erythematous, Rash maculo-papular, Skin warm
Clinical narrative: Developed a head to toe maculopapular erythematous exanthem on 4/19/11.  Felt warm to mom on 4/19/11.  Mild fussiness on 4/19/11.  Evaluted in clinic on 4/20/11 and reassurance given.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Starting in evening pain at injection site. Also including pain in elbow & shoulder joints. VICODIN needed to reduce pain level. Injection site is not hot or discolored. VICODIN only taking the edge off the pain. Patients major complaint elbow joint pain.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, PNC13, VARCEL
Symptoms: Dry skin, Oedema peripheral, Skin exfoliation
Clinical narrative: Pt's mother & grandmother brought child to PH office to show nursing staff dried, cracked hands & feet (peeling). They had been to provider week before to show very swollen extremities which occurred approximately 1 wk after receiving 6 shots at their office. Pt's MD said it was likely a reaction to Varicella vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Local swelling and redness on area where HPV vaccine was administered.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood lactate dehydrogenase, Body temperature increased
Clinical narrative: One day after the vaccine was injected, low grade temperature from 99 degrees-101 degrees & lasted for 3 weeks. Medical attention sought after 1 week and abnormal liver function found by labs and ultrasound showed enlarged liver. No treatment as M.D. unable to find cause or exact diagnosis levels returned to normal 2/22/11.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Hepatomegaly, Liver function test abnormal, Ultrasound liver abnormal
Clinical narrative: One day after the vaccine was injected, low grade temperature from 99 degrees-101 degrees & lasted for 3 weeks. Medical attention sought after 1 week and abnormal liver function found by labs and ultrasound showed enlarged liver. No treatment as M.D. unable to find cause or exact diagnosis levels returned to normal 2/22/11.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination site inflammation, Vaccination site reaction
Clinical narrative: Localized reaction at vaccination site. Dx: Post vaccination inflammation. Tx: cold/warm compress 4x a day TYLENOL 500 mg every 4 hours (MOTRIN) ibuprofen 400 mg every 6 hours for ache.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Oropharyngeal pain, Stomatitis, Viral infection
Clinical narrative: Patient reported sores blisters on roof of mouth and under tongue and a sore throat 2 days after having shingles shot. Patient was seen at Dr's office and released on day 3 with diagnosis of viral infection in mouth/unrelated to ZOSTAVAX.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral pain, Stomatitis
Clinical narrative: Patient reported sores blisters on roof of mouth and under tongue and a sore throat 2 days after having shingles shot. Patient was seen at Dr's office and released on day 3 with diagnosis of viral infection in mouth/unrelated to ZOSTAVAX.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: 10-14-10 Merck 1483Y.
Age: 1.06
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at the administration site.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Pain
Clinical narrative: Intense chest pain one hour after vaccine. Ache lasted a few days.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, VIIth nerve paralysis
Clinical narrative: Pt developed HA 2 days after Tdap given. In 4 days she developed right facial paralysis.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Syncope, Tremor
Clinical narrative: Dizzy, shook, fainted. Laid patient down, raised feet, cool cloth patient recovered and patient reevaluated by doctor.
Age: 1.67
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Lethargy
Clinical narrative: Patient became lethargic with flu like symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Lymph node pain
Clinical narrative: Lg localized area of erythema (L) upper outer thigh with warmth in induration, no fluc mass x 1 very small tender (L) inguinal node area 6" by 3"
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Acute disseminated encephalomyelitis, Coma, Confusional state, Death, Lumbar puncture
Clinical narrative: 4 days after immunization, patient went to another facility for an MRI and lumbar puncture with general anesthesia. Per phone messages from family, on the way home, patient developed fever with hallucinations. From that point forward, experienced cognitive decline and deterioration of neurological status. Admitted to another hospital on 11/24/2010. Per letter from family, patient was comatose as of 11/26/2010 was discharged home on hospice care on 12/7/2010 and patient expired 1/2/2011.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Subacute sclerosing panencephalitis
Clinical narrative: 4 days after immunization, patient went to another facility for an MRI and lumbar puncture with general anesthesia. Per phone messages from family, on the way home, patient developed fever with hallucinations. From that point forward, experienced cognitive decline and deterioration of neurological status. Admitted to another hospital on 11/24/2010. Per letter from family, patient was comatose as of 11/26/2010 was discharged home on hospice care on 12/7/2010 and patient expired 1/2/2011.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Acute disseminated encephalomyelitis, Confusional state, Death, Dementia, Headache
Clinical narrative: 4 days after immunization, patient went to another facility for an MRI and lumbar puncture with general anesthesia. Per phone messages from family, on the way home, patient developed fever with hallucinations. From that point forward, experienced cognitive decline and deterioration of neurological status. Admitted to another hospital on 11/24/2010. Per letter from family, patient was comatose as of 11/26/2010 was discharged home on hospice care on 12/7/2010 and patient expired 1/2/2011.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: 4 days after immunization, patient went to another facility for an MRI and lumbar puncture with general anesthesia. Per phone messages from family, on the way home, patient developed fever with hallucinations. From that point forward, experienced cognitive decline and deterioration of neurological status. Admitted to another hospital on 11/24/2010. Per letter from family, patient was comatose as of 11/26/2010 was discharged home on hospice care on 12/7/2010 and patient expired 1/2/2011.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Cognitive disorder, Coma, Death, Hallucination, Lumbar puncture
Clinical narrative: 4 days after immunization, patient went to another facility for an MRI and lumbar puncture with general anesthesia. Per phone messages from family, on the way home, patient developed fever with hallucinations. From that point forward, experienced cognitive decline and deterioration of neurological status. Admitted to another hospital on 11/24/2010. Per letter from family, patient was comatose as of 11/26/2010 was discharged home on hospice care on 12/7/2010 and patient expired 1/2/2011.
Age: 7.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Neurological decompensation, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: 4 days after immunization, patient went to another facility for an MRI and lumbar puncture with general anesthesia. Per phone messages from family, on the way home, patient developed fever with hallucinations. From that point forward, experienced cognitive decline and deterioration of neurological status. Admitted to another hospital on 11/24/2010. Per letter from family, patient was comatose as of 11/26/2010 was discharged home on hospice care on 12/7/2010 and patient expired 1/2/2011.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and tenderness at injection site.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF test normal, Chest X-ray abnormal, Feeding disorder of infancy or early childhood, Irritability, Pyrexia
Clinical narrative: Fever, irritability, vomiting, poor feeding. Symptoms had onset the day of immunization and have now lasted for 9 days. Required 2 emergency department visits, IV fluids, septic workup and now hospitalization.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Fever, irritability, vomiting, poor feeding. Symptoms had onset the day of immunization and have now lasted for 9 days. Required 2 emergency department visits, IV fluids, septic workup and now hospitalization.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Abasia, Arthralgia, Joint swelling, Ultrasound scan, X-ray
Clinical narrative: Information has been received from a pharmacy technician concerning her 18 month old son who was vaccinated SC with MMR II (lot # not reported). Subsequently the patient began experiencing swelling in his hip and joint pain. Also he could not walk for two months after receiving MMR II. The reporter thought the status of the patient improved but she was "not positive". The patient saw a rheumatologist. X-rays and ultrasounds were performed, results not provided. Swelling in hip, joint pain and can not walk for two months were considered to be disabling by the reporter ("sounds like it"). Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Feeling abnormal, Haematochezia, Occult blood positive
Clinical narrative: Information has been received from a licensed visiting nurse and a medical assistant concerning an 8 week old male with reflux and no known drug allergy who on 11-APR-2011 was vaccinated orally with his first dose of 2 ml ROTATEQ (lot # 668964/1200Z). Secondary suspect therapy included a dose of RECOMBIVAX HB (lot # 669600/0230AA, thimerosal-free) on 11-APR-2011. Concomitant therapy included nizatidine, PENTACEL (lot # C382AA) and PREVNAR (lot # E89951). On 13-APR-2011 the patient experienced bloody stool, diarrhea, fever and fuzziness after receiving the vaccine. The patient was rushed to the hospital emergency room and was kept overnight. The patient was released from the hospital on 14-APR-2011. No discharge summary was available. Results of stool culture performed while hospitalized were not received. Stool heme was tested in the office which showed positive. It was unspecified what treatment was given to the patient. At the time of reporting, the patient's bloody stool persisted and the outcome of diarrhea, fever and fuzziness was unknown. It was unknown if the events were disabling or life threatening. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse and a medical assistant concerning an 8 week old male with reflux and no known drug allergy who on 11-APR-2011 was vaccinated orally with his first dose of 2 ml ROTATEQ (lot # 668964/1200Z). Secondary suspect therapy included a dose of RECOMBIVAX HB (lot # 669600/0230AA, thimerosal-free) on 11-APR-2011. Concomitant therapy included nizatidine, PENTACEL (lot # C382AA) and PREVNAR (lot # E89951). On 13-APR-2011 the patient experienced bloody stool, diarrhea, fever and fuzziness after receiving the vaccine. The patient was rushed to the hospital emergency room and was kept overnight. The patient was released from the hospital on 14-APR-2011. No discharge summary was available. Results of stool culture performed while hospitalized were not received. Stool heme was tested in the office which showed positive. It was unspecified what treatment was given to the patient. At the time of reporting, the patient's bloody stool persisted and the outcome of diarrhea, fever and fuzziness was unknown. It was unknown if the events were disabling or life threatening. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red, painful left thigh occurred on 4/17/11 next day. TYLENOL 1 1/2 tsp every 4 hrs as needed for pain.
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Anthrax (4086) & Typhoid given in left arm. Within 24 hrs arm swollen from upper bicep to below elbow. Skin red & hot to touch. Symptoms present after 72 hrs.
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: Lip swelling, Throat irritation, Urticaria
Clinical narrative: Swollen lips, itchy throat, hives.  Received treatment in ER as he had already left our office.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Hypersensitivity, Inflammation
Clinical narrative: This case is a cluster of 3 or 4 unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a health care professional on 12 April 2011. A group of 3 or 4 unidentified patients' received (dates not reported) an injection (route and site not reported) of ADACEL, sanofi pasteur lot number C3828AA. The patient's had moderate cellulitis after receiving ADACEL. A different individual gave the injection to each of the patients who reacted. Two patients had inflammatory reactions in the left upper arm and had received Td in the office within the last 5 days. It was unclear if they were allergic reactions or cellulitis. Both patients were put on antibiotics. The TDap that was administered to these patients had the same lot number (C3828AA) but were different vials as these were unit dose vials. The outcome was not reported. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: I received a ZOSTAVAX injection on 4/12/2011. On 4/13/2011 I experienced a red, bumpy, itching rash at the injection site that appears at this time to be a mild form of shingles.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Skin:  Left central/medial upper thigh with 6 cm round, erythematous, warm and indurated area with central injection; right central upper thigh with faint erythema noted around injection site
Age: 1.72
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Lip swelling
Clinical narrative: Temp of 39.9 degrees C and swelling of lips. Occurred approx. 5hrs after immun. Taken to ED. Given acetamophen, BENADRYL. Symptoms resolved. No tongue swelling or trouble breathing.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Cough, Feeling hot, Headache
Clinical narrative: Coughing, feeling very weak, chills, slight headache, feeling very hot/heated.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Pain
Clinical narrative: Patient received ZOSTAVAX on 3/29/11. She said she noticed pain on day of administration. On the next day she hit the area of the injection site and that is when she noticed a red area extending about 1-2 inches. On 4/13/11, it remained the same and felt lumpy. She was advised to have medical doctor look at it.
Age: 1.28
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Convulsion, Dyskinesia, Neurological examination normal, Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Approximately 15 hours after receiving vaccines she had an episode at home where she began shaking and having jerking movements. Lasted approximately 2 minutes - was taken by ambulance to emergency room. Felt to be a seizure. Was afebrile. Has since had evaluation by neurologist who felt it was a seizure.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous, Skin discolouration
Clinical narrative: Symptoms started 4/17/11 - he broke out on arms legs, tummy and neck with red pussy bumps w/ white rings around them. Today 4/20/11 is the first day they look better.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling noted to left upper arm.
Age: 65.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke up with redness in the area of the injection, also heat to the site, swelling, and pain in the injection site area. Pt stated that she took Benadryl and put and ice pack on the area. Pt reported that some symptoms had gotten better on Sunday (4/17/2011), and continued to get better thru Monday morning all had pretty much completely resolved on soreness to the arm by Wednesday (4/20/2011). Pt did still have some marked "pink" area around the injection site on Wednesday afternoon, but swelling and pain had resolved.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Extensive urticaric rash - body wide.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: On the afternoon of the immunizations (4/14/11) mom noted "egg" at injection site on (R) thigh - was red, swollen, and firm. Fussy baby with 100.2 fever. Had office visit next day (4/15/11) Dx with localized reaction to PENTACEL vaccine.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Local reaction, Pyrexia
Clinical narrative: On the afternoon of the immunizations (4/14/11) mom noted "egg" at injection site on (R) thigh - was red, swollen, and firm. Fussy baby with 100.2 fever. Had office visit next day (4/15/11) Dx with localized reaction to PENTACEL vaccine.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site reaction
Clinical narrative: persistent soreness and stiffness in ext of vaccine administration