chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: TD, TTOX
Symptoms: Urinary tract infection, Vaccination complication
Clinical narrative: The evening of 9/26/06 patient felt very weak and sick. Patient had a UT infection and was given medication for that, so patient assumed that was a problem. Felt worse next day, and on 3rd day patient thought would die. After 2 trips back to doctor, and only medications changed, my daughter discovered that I had symptoms of reaction to tetanus. Too much has happened to write here, but patient is still having many problems. No treatment.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Decreased appetite, Dehydration, Diarrhoea haemorrhagic, Intestinal obstruction
Clinical narrative: Initial report received on 07 November 2006 from another manufacturer, report number WAES0611USA00928, who received the original report from the agency. A nine-week-old male patient , with no medical history, and no current illnesses, had received a first dose, left leg, intra-muscular injection of ActHIB, lot number 0E84AA, a first dose, right leg, intra-muscular injection of Pediarix, manufacturer reported, lot number AC21B073AA, a first dose, left leg, intra-muscular injection of Prevnar, manufacturer reported, lot number B0862D, and a first oral dose of Rotateq, manufacturer reported, lot number 653755/0319F, on 25 October 2006.  The patient had two days with reported fever that improved by day three.  On 29 October 2006, at 22:00 pm, the patient's parents noticed irritability, decreased appetite, and also reported two episodes of emesis, and one episode of diarrhea with blood and mucous.  The patient presented to the physician's office where he was noted to be sick looking, lethargic, and mildly dehydrated.  On physical examination, he had abdominal pain, and abdominal x-rays revealed several air-fluid levels, and distention. The patient was subsequently admitted to the hospital.  While hospitalized, an abdominal CT was suggestive of intussusception which was confirmed with gastrografin enema. The gastrografin enema also reduced the intussusception.  After intervention, the patient did well and was discharged from the hospital after two days.  The patient recovered. Per the other manufacturer, no further information is available. Follow-up information received on 22 November 2006 from another manufacturer, report number WAES0611USA00928.  Per the reporter, the records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of the Center for Biologics and Research (CBER) and was released by the regulatory agency.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Lethargy, Leukocytosis, Pyrexia
Clinical narrative: Initial report received on 07 November 2006 from another manufacturer, report number WAES0611USA00928, who received the original report from the agency. A nine-week-old male patient , with no medical history, and no current illnesses, had received a first dose, left leg, intra-muscular injection of ActHIB, lot number 0E84AA, a first dose, right leg, intra-muscular injection of Pediarix, manufacturer reported, lot number AC21B073AA, a first dose, left leg, intra-muscular injection of Prevnar, manufacturer reported, lot number B0862D, and a first oral dose of Rotateq, manufacturer reported, lot number 653755/0319F, on 25 October 2006.  The patient had two days with reported fever that improved by day three.  On 29 October 2006, at 22:00 pm, the patient's parents noticed irritability, decreased appetite, and also reported two episodes of emesis, and one episode of diarrhea with blood and mucous.  The patient presented to the physician's office where he was noted to be sick looking, lethargic, and mildly dehydrated.  On physical examination, he had abdominal pain, and abdominal x-rays revealed several air-fluid levels, and distention. The patient was subsequently admitted to the hospital.  While hospitalized, an abdominal CT was suggestive of intussusception which was confirmed with gastrografin enema. The gastrografin enema also reduced the intussusception.  After intervention, the patient did well and was discharged from the hospital after two days.  The patient recovered. Per the other manufacturer, no further information is available. Follow-up information received on 22 November 2006 from another manufacturer, report number WAES0611USA00928.  Per the reporter, the records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of the Center for Biologics and Research (CBER) and was released by the regulatory agency.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial report received on 07 November 2006 from another manufacturer, report number WAES0611USA00928, who received the original report from the agency. A nine-week-old male patient , with no medical history, and no current illnesses, had received a first dose, left leg, intra-muscular injection of ActHIB, lot number 0E84AA, a first dose, right leg, intra-muscular injection of Pediarix, manufacturer reported, lot number AC21B073AA, a first dose, left leg, intra-muscular injection of Prevnar, manufacturer reported, lot number B0862D, and a first oral dose of Rotateq, manufacturer reported, lot number 653755/0319F, on 25 October 2006.  The patient had two days with reported fever that improved by day three.  On 29 October 2006, at 22:00 pm, the patient's parents noticed irritability, decreased appetite, and also reported two episodes of emesis, and one episode of diarrhea with blood and mucous.  The patient presented to the physician's office where he was noted to be sick looking, lethargic, and mildly dehydrated.  On physical examination, he had abdominal pain, and abdominal x-rays revealed several air-fluid levels, and distention. The patient was subsequently admitted to the hospital.  While hospitalized, an abdominal CT was suggestive of intussusception which was confirmed with gastrografin enema. The gastrografin enema also reduced the intussusception.  After intervention, the patient did well and was discharged from the hospital after two days.  The patient recovered. Per the other manufacturer, no further information is available. Follow-up information received on 22 November 2006 from another manufacturer, report number WAES0611USA00928.  Per the reporter, the records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of the Center for Biologics and Research (CBER) and was released by the regulatory agency.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal distension, Abdominal pain, Decreased appetite, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: Initial report received on 07 November 2006 from another manufacturer, report number WAES0611USA00928, who received the original report from the agency. A nine-week-old male patient , with no medical history, and no current illnesses, had received a first dose, left leg, intra-muscular injection of ActHIB, lot number 0E84AA, a first dose, right leg, intra-muscular injection of Pediarix, manufacturer reported, lot number AC21B073AA, a first dose, left leg, intra-muscular injection of Prevnar, manufacturer reported, lot number B0862D, and a first oral dose of Rotateq, manufacturer reported, lot number 653755/0319F, on 25 October 2006.  The patient had two days with reported fever that improved by day three.  On 29 October 2006, at 22:00 pm, the patient's parents noticed irritability, decreased appetite, and also reported two episodes of emesis, and one episode of diarrhea with blood and mucous.  The patient presented to the physician's office where he was noted to be sick looking, lethargic, and mildly dehydrated.  On physical examination, he had abdominal pain, and abdominal x-rays revealed several air-fluid levels, and distention. The patient was subsequently admitted to the hospital.  While hospitalized, an abdominal CT was suggestive of intussusception which was confirmed with gastrografin enema. The gastrografin enema also reduced the intussusception.  After intervention, the patient did well and was discharged from the hospital after two days.  The patient recovered. Per the other manufacturer, no further information is available. Follow-up information received on 22 November 2006 from another manufacturer, report number WAES0611USA00928.  Per the reporter, the records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of the Center for Biologics and Research (CBER) and was released by the regulatory agency.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Lethargy, Vomiting
Clinical narrative: Initial report received on 07 November 2006 from another manufacturer, report number WAES0611USA00928, who received the original report from the agency. A nine-week-old male patient , with no medical history, and no current illnesses, had received a first dose, left leg, intra-muscular injection of ActHIB, lot number 0E84AA, a first dose, right leg, intra-muscular injection of Pediarix, manufacturer reported, lot number AC21B073AA, a first dose, left leg, intra-muscular injection of Prevnar, manufacturer reported, lot number B0862D, and a first oral dose of Rotateq, manufacturer reported, lot number 653755/0319F, on 25 October 2006.  The patient had two days with reported fever that improved by day three.  On 29 October 2006, at 22:00 pm, the patient's parents noticed irritability, decreased appetite, and also reported two episodes of emesis, and one episode of diarrhea with blood and mucous.  The patient presented to the physician's office where he was noted to be sick looking, lethargic, and mildly dehydrated.  On physical examination, he had abdominal pain, and abdominal x-rays revealed several air-fluid levels, and distention. The patient was subsequently admitted to the hospital.  While hospitalized, an abdominal CT was suggestive of intussusception which was confirmed with gastrografin enema. The gastrografin enema also reduced the intussusception.  After intervention, the patient did well and was discharged from the hospital after two days.  The patient recovered. Per the other manufacturer, no further information is available. Follow-up information received on 22 November 2006 from another manufacturer, report number WAES0611USA00928.  Per the reporter, the records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of the Center for Biologics and Research (CBER) and was released by the regulatory agency.
Age: 0.93
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test abnormal, Leukocytosis, Oedema peripheral, Pericardial effusion, Pyrexia
Clinical narrative: Initial case received on 11/28/06 from the pts parent. An 11 month old female pt had received in injection of Fluzone SV (specific product not reported), lot number not reported, route and site of administration not reported, on 11/15/06. Seven days post vaccination, the pt experienced a low grade fever, irritability, and change in sleep pattern. Four additional days later, she developed swelling of the feet and  hands. The pt was examined in an emergency room and subsequently admitted to the hospital. A sedimentation rate elevated (results not provided). At the time of this report, the pt had not recovered.
Age: 0.93
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Spherocytic anaemia, Systemic lupus erythematosus, Vasculitis
Clinical narrative: Initial case received on 11/28/06 from the pts parent. An 11 month old female pt had received in injection of Fluzone SV (specific product not reported), lot number not reported, route and site of administration not reported, on 11/15/06. Seven days post vaccination, the pt experienced a low grade fever, irritability, and change in sleep pattern. Four additional days later, she developed swelling of the feet and  hands. The pt was examined in an emergency room and subsequently admitted to the hospital. A sedimentation rate elevated (results not provided). At the time of this report, the pt had not recovered.
Age: 0.93
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Irritability, Oedema peripheral, Pyrexia, Red blood cell sedimentation rate increased, Sleep disorder
Clinical narrative: Initial case received on 11/28/06 from the pts parent. An 11 month old female pt had received in injection of Fluzone SV (specific product not reported), lot number not reported, route and site of administration not reported, on 11/15/06. Seven days post vaccination, the pt experienced a low grade fever, irritability, and change in sleep pattern. Four additional days later, she developed swelling of the feet and  hands. The pt was examined in an emergency room and subsequently admitted to the hospital. A sedimentation rate elevated (results not provided). At the time of this report, the pt had not recovered.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF test abnormal, Difficulty in walking, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: Onset of leg pain, 2 days after influenza vaccine on 11/11/2006, weakness with walking on about 11/13/06, increased difficulty walking starting about 11/24/06. Hospitalized 1/27/06 and diagnosed with Guillian Barre Syndrome.  12/12/06 Received medical records from hosptial which reveal patient admitted 11/27/06 after developing acute progressive distal to proximal weakness over a 2 wk period prior to admit.  Difficulty climbing stairs & walking funny, complaining that whole body hurt.  Symptoms began 2 days s/p flu vax.  Also had URI symptoms with low grade fever & was seen in ER approx 2 wks prior to admit & was placed on antibiotics & inhaler for wheezing.  Tx w/IVIG & responded very well.  Consults by Neuro & ID.  Noted to have tremors of upper extremities. DTRs absent in LEs.  Gait was wide based & slow.  Continued to improve & was d/c to home on 12/1/06. Final DX: Guillain Barre syndrome.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Onset of leg pain, 2 days after influenza vaccine on 11/11/2006, weakness with walking on about 11/13/06, increased difficulty walking starting about 11/24/06. Hospitalized 1/27/06 and diagnosed with Guillian Barre Syndrome.  12/12/06 Received medical records from hosptial which reveal patient admitted 11/27/06 after developing acute progressive distal to proximal weakness over a 2 wk period prior to admit.  Difficulty climbing stairs & walking funny, complaining that whole body hurt.  Symptoms began 2 days s/p flu vax.  Also had URI symptoms with low grade fever & was seen in ER approx 2 wks prior to admit & was placed on antibiotics & inhaler for wheezing.  Tx w/IVIG & responded very well.  Consults by Neuro & ID.  Noted to have tremors of upper extremities. DTRs absent in LEs.  Gait was wide based & slow.  Continued to improve & was d/c to home on 12/1/06. Final DX: Guillain Barre syndrome.
Age: 1.08
Sex: M
Vaccine: FLU3, HEP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: L5 distribution VZV immunization related shingles. Acychovse for 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Eye swelling, Swelling, Urticaria
Clinical narrative: Received DTap/IPV/MMR-Varivax (ProQuad) within 5 minutes child back with swelling both lower eyelids and 1 hive below Left eye. Mild lower lip swelling not short breath wheezing-CTA 100% given Benadryl 12.5mg per tube with 10 ml. Water flush. Re-evaluated two more time over next 30 min with stable. Lung fine and resolving swelling/hives. No respiratory distress. Zyrtec every 10hours for 3days. no further swelling or wheezing.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Gait disturbance, Headache, Muscular weakness, Pyrexia
Clinical narrative: Information has been received from an investigator concerning a 12 year old male with migraine headaches who entered a study. On approx 6/16/06 and 8/16/06 and on 11/16/06 at 16:15 the pt was vaccinated with a first, second and third dose of HPV vaccine. On 11/17/06 the pt woke up at 6:40 and went to the  bathroom and he reported that he had trouble walking. He returned to bed. The pts father woke him up at 7:45 and noted that he had a fever of 101.3F. the pt stated that his arms and legs were heavy feeling and he didn't think he could walk. the pt experienced muscle weakness. The pts parents call the physician and were advised to take the pt to the ER. The pt went to the ER via ambulance. When the pt arrived the ER his temp was 99.5F (Pt was treated with Advil at home. It was noted that the pts neurosigns were normal and the pt reported to have a headache but refused Imetrex. the pt was discharged and no further tests were done. On 11/17/06 the pt recovered. The reporting investigator felt that muscle weakness was related to study therapy. Muscle weakness was considered to be an other important medical event (OMIC).
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Sensation of heaviness
Clinical narrative: Information has been received from an investigator concerning a 12 year old male with migraine headaches who entered a study. On approx 6/16/06 and 8/16/06 and on 11/16/06 at 16:15 the pt was vaccinated with a first, second and third dose of HPV vaccine. On 11/17/06 the pt woke up at 6:40 and went to the  bathroom and he reported that he had trouble walking. He returned to bed. The pts father woke him up at 7:45 and noted that he had a fever of 101.3F. the pt stated that his arms and legs were heavy feeling and he didn't think he could walk. the pt experienced muscle weakness. The pts parents call the physician and were advised to take the pt to the ER. The pt went to the ER via ambulance. When the pt arrived the ER his temp was 99.5F (Pt was treated with Advil at home. It was noted that the pts neurosigns were normal and the pt reported to have a headache but refused Imetrex. the pt was discharged and no further tests were done. On 11/17/06 the pt recovered. The reporting investigator felt that muscle weakness was related to study therapy. Muscle weakness was considered to be an other important medical event (OMIC).
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Gastroschisis, Unintended pregnancy
Clinical narrative: Information has been received through the pregnancy registry from a nurse practitioner concerning a 15 year old female who was vaccinated with a dose of varicella virus vaccine live when she was approx 4-5 weeks pregnant. An ultrasound showed a gastroschisis. A repeat ultrasound was scheduled. At the time of the report, the pt was 18 weeks gestation. The vaccine was given at another physician, and she does not have any other information on the administration. Gastroschisis was noted to be a congenital anomaly. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fluid retention, Injection site infection, Injection site oedema, Injection site warmth, Skin discolouration
Clinical narrative: Received PP23 vaccine 11/15/2006. right arm became swollen, warm to touch 11/15/2006pm, on am 11/16 client observed swelling from shoulder to below elbow, dark discoloration and fluid under skin to wrist, deltoid hot to touch, came into clinic to advise, referred to PP seen 11/16/06 per PP. states given Keflex, Bactrim for infected arm, arm continued to swell. Fri  11/17/06 hospitalized for IV antibiotics, released 11/19/06 on oral antibiotics Augmentin. RTC to PP in 1 week.  MR received from hospital stay of 11/17-18/2006 for c/o redness, swelling, and pain in the right deltoid following Pneumovax, which had not responded to oral antibiotics.  HPI: The evening of her Pneumovax pt. began to notice redness and swelling of the right deltoid area.  OV to PCP the following day where Keflex and Bactrim were prescribed.  Redness, swelling, and pain were increasing and spreading to the lower arm despite antibiotics.  Pt. developed chills and nausea on day 2 s/p vax. She was then refered to the ER by her PCP for IV antibiotics.  Impression:  Spreading erythema, swelling, and pain 2' to right upper extremity cellulitis, not responding to outpatient antibiotics.  COPD-stable. Hx. of Rectal carcinoma.  Peripheral Vascular Disease.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest pain, Laboratory test abnormal, Myocarditis
Clinical narrative: Healthy special operations officer developed chest pain on day 9 post small pox vaccine. Admitted to civilian hospital on 28 Nov 06. Diagnoses with post vaccinial myocarditis. 12/27/06-records received and reviewed for DOS 11/28-11/29/06 DC DX: Pericarditis, mild myopericarditis with EKG suggestive of pericarditis.  HX of present illness, developed severe reaction on the dorsum below left deltoid encompassing most of lateral left upper arm. Lymph node on right mandible and axille, tender. Two nights of night sweats. Retrosternal chest pain. Lesions on neck and face, Infectious Disease Assessment: skin reaction to small pox and myocarditis manifestations.   Follow-up received on Mar 28 2007 states - Pt recovered from the adverse events that were reported for this vaccination. No signs of myocarditis on residual cardiac involvement.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Pericarditis, Troponin I increased
Clinical narrative: Healthy special operations officer developed chest pain on day 9 post small pox vaccine. Admitted to civilian hospital on 28 Nov 06. Diagnoses with post vaccinial myocarditis. 12/27/06-records received and reviewed for DOS 11/28-11/29/06 DC DX: Pericarditis, mild myopericarditis with EKG suggestive of pericarditis.  HX of present illness, developed severe reaction on the dorsum below left deltoid encompassing most of lateral left upper arm. Lymph node on right mandible and axille, tender. Two nights of night sweats. Retrosternal chest pain. Lesions on neck and face, Infectious Disease Assessment: skin reaction to small pox and myocarditis manifestations.   Follow-up received on Mar 28 2007 states - Pt recovered from the adverse events that were reported for this vaccination. No signs of myocarditis on residual cardiac involvement.
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Infection
Clinical narrative: Bruising at site of injection. Possible minor infection at site. Treatment: Neosporin topical-covered with bandage for 2-3 days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Swelling face, Throat tightness, Visual disturbance
Clinical narrative: Has history of allergic reaction to wine and wine vinegar. Reported puffiness of face, tightness in throat and visual changes. Came to occupational health service area immediately. Benadryl given (25mg) with response. Returned to work. Shot given at 12:55; symptoms began at 2:15pm.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Injection site reaction, Wheezing
Clinical narrative: Large local reaction L arm deltoid to middle of upper arm, raised, hot, also wheezed. Has had flu shot before with no significant problems. No egg allergy.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Patient given Tdap, HAV, MMR when 2 wks pregnant. Patient informed to discuss with her OB doctor. Pt had a positive HCG (Pregnancy test on 10/30/06.  MMR was given 10/12/06.  Pt may have been pregnant at the time MMR was given.  Pt's OB Dr. was informed. RN.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash, patches on body, chest, back, abdomen and legs.  Patient went to primary care physician who gave patient an injection of cortisone and Clarinex 5mg pills for the rash and itching.
Age: 90.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Entire right arm site of pneumovax was edematous/erythematous, no other rashes ore edema (had flu vaccine in left arm). Resolved when seen 1 week later.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus, Rash erythematous, Urticaria
Clinical narrative: On 11/22/06 client developed hives on left cheek red raised area, very itchy, she had stated she was very stressed at her job, on 11/23/06. Woke up to find approx 10-12 water blisters that broke open and oozed. Cleansed area with Bactine and applied Benadryl cream and antibiotic ointment. 11/27/06 areas are drying up and fading client did not see doctor.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness upon rising 7am Nov 4, 2am Nov 5, 8am Nov 5, 7am Nov 6, Dizziness lying down 10am Nov 7
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Pain
Clinical narrative: Pt stated swelling in the left supra clavicular ore, a small amount of pain noticed as well, the symptoms lasted five days, no treatment was needed.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: My husband  had flu shot, 9 hours later we had severe vomiting and Diarrhea that lasted into the early morning hours.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: I had flu shot, 9 hours later I had severe vomiting and diarrhea that lasted into the early morning hours.
Age: 1.73
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Injection site induration
Clinical narrative: Induration over vaccine site, (site of Dtap and Prevnar on right thigh.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Redness, swelling from just above elbow to shoulder. Site was hot to the touch. From injection site to below left ear ached. Lasted approx 3 days for aching, redness, and heat stayed over 10 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Area around injection was red and itched. Lasted for 4 days. Itching started about 10 min after injection was given.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, warm, sore area around the shot. About 4in x 3in.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: My arm was red, and puffy where the vaccine was given. My arm itched also.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Large red area surrounding location of vaccine, swollen, hot to touch, soreness, lasted about 4 days.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Swollen, red, hard at injection site on left arm.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Very red 1" diameter hot to touch very sore. Lasted 5-6 days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: Slight itching after injection (shortly after), next day redness and soreness about size of silver dollar. Itching, mild, continued for about 10 days. Redness lasted 5-7 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Local Swelling 2" diameter local fever, arm sore, ache.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: The area around the injection at 1/4" in diameter became sore and hot to touch on 11/14/06 and the same area itched on 11/15/06.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: No signs of fever, rash, chills HA or muscle aches no bruising or redness to injection site. Influenza 0.5cc given instead of 0.25CC.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt noted redness and warmth to injection site day after injection and some swelling ice applied.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: After second dose of a 3 dose series, pt blood pressure increased from normal baseline of 100/60 to 185/135 approx 15-20 minutes after receiving the Gardasil. Pt had near syncopal episode. PT recovered very quickly after ward.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Arm red and itchy.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See attached
Age: 4.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Medication error
Clinical narrative: Pt inadvertently given MMR 3 instead of Varivax 2, no physical signs symptoms.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Eye inflammation, Oedema
Clinical narrative: Burning eyes, swelling, difficulty breathing.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Sneezing
Clinical narrative: Began sneezing (near constant) early am day after vaccine received, continued until 10/29/06, gone by evening of 10/29/06. Evening of 10/29/06 onset of dry coughing last 2 days. No other symptoms. Now well with complete resolution of symptoms. no medical provider visit.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Constipation, Injection site erythema, Injection site pain, Tenderness, Wheezing
Clinical narrative: Localized reaction on left upper arm sore redness, tenderness, bronchial reaction, constipation, wheezing, resolved with Epi Pen and Albuterol inhalation.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Feeling hot
Clinical narrative: Pt was given flu shot at 15:07 and was asked to wait so after that, after 30 minutes she left and returned approx 15 minutes after and said she was feeling warmness on left arm at chest. BP 200/104. She was monitored for 20 mins and B/P was rechecked and reading 150/102, advised to call her Dr and notify of reaction. She called DR office and office nurse told her to take Benadryl. Pt stated she was feeling better, was also checked by school nurse.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Convulsion
Clinical narrative: Pt had a seizure (generalized) lasting 5-6 minutes occurred less than 24 hours after influenza vaccine administration. First time pt received this vaccine.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Oedema
Clinical narrative: Approx 1 hour after flu vaccine was given her mother noticed her face and neck were swollen although she herself did not notice this. Reports she slept about 3 hours after wards. Denies throat swelling, difficulty swallowing or breathing. Claims swelling was gone after 3 hour nap.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Contusion, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Received Flu vaccine 11/3/06. Pt states on 11/6/06 around 4:30pm started having left arm pain at chest pain. States she called RN yesterday et was instructed to apply ice to shot site and take Tylenol. States she applied ice et took Aleve. Also took Lusonex for allergies left upper arm, red, swollen and area size of quarter having bruise. Red and swollen left upper approx 4-6" long et 2" wide. Warm to touch.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Received Flu vaccine 11/3/06. Pt states on 11/6/06 around 4:30pm started having left arm pain at chest pain. States she called RN yesterday et was instructed to apply ice to shot site and take Tylenol. States she applied ice et took Aleve. Also took Lusonex for allergies left upper arm, red, swollen and area size of quarter having bruise. Red and swollen left upper approx 4-6" long et 2" wide. Warm to touch.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Left thigh red, swollen and itchy site 5in x 4in no abscess, reaction began 24 hours prior to recheck in our office.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Rash macular, Skin discolouration
Clinical narrative: Local reaction 1cm diameter of warm, erythematous, swelling and blotchy red/white rash below injection site on thigh to knee.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Vaccine given in thigh area red and swollen. No pain noted. Pt was seen in our office for visit and no adverse reaction noted.
Age: 42.0
Sex: M
Vaccine: FLU3
Clinical narrative: Left acute brachial plexus neuritis, evaluated by neurologist.   12/14/06 Received medical records from neurologist which reveal patient eval showed decreased strength & grip in left arm/hand.  Tx w/steroids & pain meds & scheduled for EMG on 12/4.  No EMG report included.  T/C to neuro office to request EMG report.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema and soreness left arm.
Age: 63.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Joint range of motion decreased, Pain, Shoulder pain
Clinical narrative: Deep, aching pain in upper right arm and shoulder developed on 10/30/2006. I took Naproxen and TRAMADOL.  I reported this to PCP through fax and telephone message.  I saw PA name reported on 11/4/2006.  She prescribed Ibuprofen and Lido Derm Patches and ordered blood work.  These medications did not help.  PA name reported prescribed MEDROL Pak after blood work results and ordered referral to neurologist.  MEDROL Pak gave me TY-relief only, after 6 days of use pain became acute, I am now using 2nd Dose Pak and seeing neurologist on 12/07. I am unable to lift anything with this arm.  I feel severe pain when I move this arm or while I am in bed.  12/14/06 Received medical records from provider which reveal patient seen 10/28/06 with dyspnea & + TB skin test, gastritis, DJD, carpal tunnel & high cholesterol.  Records included Lot numbers missing from report.  Next seen on 11/4/06 with pain on palpation over right shoulder, no swelling or redness noted but ROM & grip strength of right arm/hand was decreased.  Referred to neuro & given steroids to start after labs done. 1/16/07 Received records from neurologist which reveal patient seen 12/7/06 for pain of right shoulder & arm subsequent to tetanus vax 10/28/06.  Neuro exam was WNL with some mild difficulty raising arm above head.  It was felt that the problem was frozen shoulder or adhesive capsulitis due to the pain rather than any true muscle or nerve involvement.  She was referred for intensive PT to be continued for 4-6 weeks then was to return for further evaluation.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures.
Age: 1.02
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 1.07
Sex: F
Vaccine: MMR, PNC
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 1.01
Sex: F
Vaccine: HIBV, IPV, MMR, PNC
Symptoms: Decreased appetite, Erythema, Irritability, Pyrexia, Rash macular
Clinical narrative: Erythematous, raised, macules (rash); low grade fever; fussy; slightly decreased appetite; not sleep well. Treatment- Ibuprofen and Prelone syrup 1/2 tsp every day for 6 days.
Age: 1.01
Sex: F
Vaccine: HIBV, IPV, MMR, PNC
Symptoms: Sleep disorder
Clinical narrative: Erythematous, raised, macules (rash); low grade fever; fussy; slightly decreased appetite; not sleep well. Treatment- Ibuprofen and Prelone syrup 1/2 tsp every day for 6 days.
Age: 0.37
Sex: M
Vaccine: DTAP, IPV
Symptoms: Convulsion
Clinical narrative: Focal seizures X 2 approximately 12 hours after DTaP each lasting only a few seconds.  No previous history.  No family history.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Malaise, Myalgia, Pyrexia
Clinical narrative: Varivax #2 admin 11/7/06. Onset fever of 102F, myalgia, malaise, non-productive cough on 11/22/06. Recent viral Upper respiratory infection last of week of October.
Age: 42.0
Sex: F
Vaccine: RUB, VARCEL
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: Rubeola and varicella vaccines given at around 0715. Patient back in office around 0815 feeling overwhelming fatigue, mild shortness of breath and was diaphoretic and was taken to the emergency room.
Age: 1.26
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Patient developed several lesions on torso and face.  Follow-up information received 3/23/07 - This vaccine wa not given in our office. I do not have that information. Patient started in our office @ 3 yrs old and that info was not provided.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Temp 100F- 2nd day broke out in fine red dotted rash over entire body. No other problems.  Over the counter medicine for 1 day-rash was gone. Referred to primary doctor.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin ulcer, Swelling
Clinical narrative: Pain, redness, swelling and lesions at the injection site and now developed skin lesions in other areas.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Received flu shot 11/17/06 in office-started within 20 min. Elbow down to 1st and 2nd fingers. Pain and very weak "could still bend fingertips, couldn't lift a plate)". No numbness. Self limiting resolved in 15 minutes-held arm above heart and kept moving.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site hypersensitivity, Pruritus
Clinical narrative: 1 cm raised itchy annular plaque at injection site.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Shoulder pain
Clinical narrative: Patient describes soreness to right deltoid area after receiving flu vaccine on 11/3/06. Patient describes whole arm sore. Examined by MD on 12/1/06. DX- rt shoulder pain following flu vaccine. Tx- continue NDAIDS. F/u in 1 month if pain continues.
Age: 0.83
Sex: M
Vaccine: FLU3
Symptoms: Skin discolouration, Swelling
Clinical narrative: Significant swelling and purple discoloration of distal left lower extremity with moderate swelling of distal right lower extremity and b/l distal upper extremities.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Pt developed swollen glands 9 days after with fatigue and low grade fever. Full body rash 13 days later. pt had body aches. Pt states 14 days later symptoms are resolving.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Pt c/o arm soreness that travels down the arm continuing for time following vaccine. Worsenes over time.
Age: 1.07
Sex: F
Vaccine: HBPV, MMR, VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Attenuated breakthrough case of chicken pox clinically diagnosed 11-28-06. Child vaccinated with varivax on 06-07-02. 15-20 lesions.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Coma, Eye movement disorder, Hypotonia, Stupor
Clinical narrative: Eyes rolled to back of head and paitent became unresponsive. "hypotonic / hyposponsive reaction"
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Redness, induration at injection site, 8cm, Left upper arm, localized site inflammation, possible infection vs. allergic reaction.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Chest discomfort, Fatigue, Pain, Respiratory distress
Clinical narrative: Pt reported "significant respiratory distress" that awakened him from sleep 8-10 hours after getting his flu shot.  He describes his symptoms as similar to past asthma attacks with wheezing, but had an unusual sensation of chest tightness  ..."almost like someone was standing on my chest."  Used albuterol inhaler - 2 puffs - and felt his symptoms improved enough to return to sleep.  Upon awakening in the morning, he had some remaining chest tightness and he was fatigued from disturbed sleep. He also minor body aches that improved.  + hx of childhood asthma that now is related to seasonal allergies, worse in spring.  Received allergy shots for 3 years, now on monthly maintenance.  Takes no meds except vitamin, fexofenadine prn for seasonal allergies, and albuterol inhaler prn.  Denies current allergy or asthma symptoms, hx of heart disease or a reaction to past immunizations of any kind. Does not get a flu shot every year, but has never had a reaction of any kind in the past.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Sleep disorder, Wheezing
Clinical narrative: Pt reported "significant respiratory distress" that awakened him from sleep 8-10 hours after getting his flu shot.  He describes his symptoms as similar to past asthma attacks with wheezing, but had an unusual sensation of chest tightness  ..."almost like someone was standing on my chest."  Used albuterol inhaler - 2 puffs - and felt his symptoms improved enough to return to sleep.  Upon awakening in the morning, he had some remaining chest tightness and he was fatigued from disturbed sleep. He also minor body aches that improved.  + hx of childhood asthma that now is related to seasonal allergies, worse in spring.  Received allergy shots for 3 years, now on monthly maintenance.  Takes no meds except vitamin, fexofenadine prn for seasonal allergies, and albuterol inhaler prn.  Denies current allergy or asthma symptoms, hx of heart disease or a reaction to past immunizations of any kind. Does not get a flu shot every year, but has never had a reaction of any kind in the past.
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Bronchitis, Injection site pain, Sinusitis, Upper respiratory tract infection
Clinical narrative: Tdap given IM left deltoid (non-dominant arm) on 11/29/06. On 12/3/06 pt noticed sore arm at injection site, tender left armpit. URI symptoms also present w/acute bronchitis and sinusitis diagnosed. For injection site discomfort recommended Tylenol. Given abx, steroid inhaler and beta-2 agonist inhaler for bronchitis in a smoker with pending dental work.  Influenza shot given IM right deltoid without any discomfort. URI symptoms as noted above.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: 11/30/06 Called PDDH to report he started at noon today feeling nauseated, dizzy.  No fever. Sx came on suddenly. Instructed to call MD.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site induration, Injection site mass, Paraesthesia
Clinical narrative: Vaccine injected into left deltoid on Wednesday 11-29-06 @ 8:30 am.  During and immediately after injection, she said she felt it run down her arm to fingertips.  It felt tingly and numb.  She was told to move her fingers and let me know if she felt short of breath or had any chest pains, etc. On 11-30-06 she felt a small knot (nickel size) approx 1-2 inches under injection site.  It felt hard but was not red or sore.  Then on Monday 12-4-06, she said that her left fingers were still tingly and numb.  Not all the time but off and on every day since 11/29.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Dyspnoea, Laryngeal oedema, Pharyngeal oedema
Clinical narrative: 11:30 am single injection in right deltoid 3:30 pm patient's voice begins to get hoarse 4:30 pm patient completely loses voice and feel throat start to swell 5:00 pm arrive at ER, no voice and throat very swolen, patient is light headed and having difficulty breathing 5:30 pm Adreniliane is administered as single injection, Antihistimine is given via IV and breathing treatment of albutorol (or equivalent) given at hospital.  X-ray taken of throat 6:00 pm Patient starts to get voice back and swelling starts to go down. 7:30 pm Patient discharged from ER and given Rx for Steroids, antihistamine and anti-anxiety.
Age: 22.0
Sex: M
Vaccine: FLUN3, HEPAB, IPV, MEN, MMR, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillaine Barre Syndrome 12/21/06-records received and reviewed from reporter. GBS-with ascending peripheral hyposensation. CXR revealed pulmonary edema. Transferred to hospital.  01/16/07-records received and reviewed for DOS 12/3-12/14/06 DC DX: GBS- trach for pneumonia, transferred to ECF for rehab. numbness began in feet then tingling in hands extending to knee and elbows. Difficulty keeping right eye opened and difficultly swallowing. On 12/3/06 ataxic gait.  Decreased grip and strength in lower extremities.  Annual follow up information indications status of recipent recovery still unknown. Recipient of the letter is no longer stationd in the same area with this soldier.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Within 24 hours of injection had fairly intense headache lasting about 36 hours. Associated with Nausea. No vomiting. Unresponsive to Motrin 800mg taken three times during course of headache.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Lymphadenopathy, Neck pain, Parotid gland enlargement, Swelling
Clinical narrative: The Patient was given the vaccine on 11/28/06 and his mother says that he started to have neck swelling and neck pain 11/30/06.  They presented for medical care on 12/1/06 and the patient was noted to have bilateral parotid swelling, right greater than left.  The also had enlargement of the anterior cervical lymph nodes in his neck and submandibular nodes.  We were unable to express any secretions from his parotid gland, and he did not have parotid tenderness.  There was no fever.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Apnoea, Pyrexia, Respiratory tract infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of respiratory infection in a 32-year-old male subject who was vaccinated with Influenza virus vaccine trivalent (FluLaval) for prophylaxis.  The subject had no pre-existing medical conditions.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Glycopyrronium bromide (Robinul), Fexofenadine hydrochloride (Allegra), Atenolol (Tenormin), Calcium carbonate (Oscal), Eflornithine (Vaniqa) and Risefronic acid (Actonel).  On 15 November 2006 the subject received a dose of FluLaval.  The reporting healthcare professional follow-up with the subject approximately one week later and the subject had " no side effects to report".   On 26 November 2006, 11 days after vaccination with FluLaval, the subject experienced a fever of 102 degrees Fahrenheit and a respiratory infection.  On 28 November 2006 the subject was taken to the emergency room.  The healthcare professional reported that on 28 November 2006 the subject had "stopped breathing and they (the emergency room) were unable to resuscitate".  The subject died on 28 November 2006.  It was unknown whether an autopsy was performed.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC
Symptoms: Eye swelling, Swelling face, Wheezing
Clinical narrative: Swelling to eyes and lips and wheezing. He received Albuterol Neb treatment x 2, IV Benadryl and IV Solumedrol. Admitted for 23 hours observation.  1/16/07 Received medical records from hospital which reveal patient admitted 11/30/06 angioneurotic edema, SOB & wheezing following vax.  Treated w/nebs, IV Benadryl & steroids w/improvement.  Admitted for 23 hour observation. FINAL DX: anaphylactic reaction s/p immunizations.