chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Day after vaccine administered pt developed large firm palpable hematoma under injection site and had flushing to face in the early am.  Towards evening pt developed flu-like symptoms such as body aches, chills, nausea, and headache.  Symptoms persisted 3 days.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Asthenia, CSF protein increased, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Pt presented to the hospital with progressive weakness and the inability to walk. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyporeflexia, Lumbar puncture abnormal
Clinical narrative: Pt presented to the hospital with progressive weakness and the inability to walk. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU(H1N1), FLU3, HIBV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The night of the vaccines, the patient started to tell her mom that her arm hurt. Overnight, she had a small fever to touch, though mom didn't take it with a thermometer. The following morning 1/22/10, the arm was swollen, red and warm and the child was grabbing it saying it hurt. In the office, there was a warm, tender, erythematous area 10cmx8cm over the L deltoid with no fluctuance and unclear borders. It did not look like a hive and I put the patient on Keflex to cover for a cellulitis. 2 days later, 1/23/10 the erythema spread quickly per mom's report and in 4 hours extended down to the elbow. There were no further fevers. Mom called our service and was advised to go to the Emergency room. The child was admitted to hospital and placed on IV antibiotics overnight. She was discharged on Cleocin. And was seen on 1/25/10 in our office, fully improved with a pea-sized lymph node in the L axilla.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU(H1N1), FLU3, HIBV
Symptoms: Lymphadenopathy, Skin warm
Clinical narrative: The night of the vaccines, the patient started to tell her mom that her arm hurt. Overnight, she had a small fever to touch, though mom didn't take it with a thermometer. The following morning 1/22/10, the arm was swollen, red and warm and the child was grabbing it saying it hurt. In the office, there was a warm, tender, erythematous area 10cmx8cm over the L deltoid with no fluctuance and unclear borders. It did not look like a hive and I put the patient on Keflex to cover for a cellulitis. 2 days later, 1/23/10 the erythema spread quickly per mom's report and in 4 hours extended down to the elbow. There were no further fevers. Mom called our service and was advised to go to the Emergency room. The child was admitted to hospital and placed on IV antibiotics overnight. She was discharged on Cleocin. And was seen on 1/25/10 in our office, fully improved with a pea-sized lymph node in the L axilla.
Age: 65.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Bronchitis, Cough, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Started cough that night, arm very sore and kept her awake at night, cough got worse and she went to walk in clinic and treated for bronchitis, never got better, went to her MD and they put her in the hospital with pneumonia, she was there for a week, and is now home but patient says the shot is to blame.  Patient states she still has tenderness and redness at injection site.
Age: 65.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pneumonia, Sleep disorder
Clinical narrative: Started cough that night, arm very sore and kept her awake at night, cough got worse and she went to walk in clinic and treated for bronchitis, never got better, went to her MD and they put her in the hospital with pneumonia, she was there for a week, and is now home but patient says the shot is to blame.  Patient states she still has tenderness and redness at injection site.
Age: 65.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Arthralgia, Asthenia, Cough, Dyspnoea, Headache
Clinical narrative: Started cough that night, arm very sore and kept her awake at night, cough got worse and she went to walk in clinic and treated for bronchitis, never got better, went to her MD and they put her in the hospital with pneumonia, she was there for a week, and is now home but patient says the shot is to blame.  Patient states she still has tenderness and redness at injection site.
Age: 65.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site rash, Musculoskeletal pain, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: Started cough that night, arm very sore and kept her awake at night, cough got worse and she went to walk in clinic and treated for bronchitis, never got better, went to her MD and they put her in the hospital with pneumonia, she was there for a week, and is now home but patient says the shot is to blame.  Patient states she still has tenderness and redness at injection site.
Age: 65.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pyrexia, Sneezing
Clinical narrative: Started cough that night, arm very sore and kept her awake at night, cough got worse and she went to walk in clinic and treated for bronchitis, never got better, went to her MD and they put her in the hospital with pneumonia, she was there for a week, and is now home but patient says the shot is to blame.  Patient states she still has tenderness and redness at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dysstasia, Fatigue
Clinical narrative: Started on 01/22/2010 covered in itchy red rash & still exists on both lower extremities (below the knees). Hands swollen & has red itchy rash. Few spots of red rash on upper body & elbows. On 01/22/2010 vomited twice & had diarrhea & still have loose bowels.  Starting 01/22/2010 have had no appetite & have eaten nothing more than a couple pieces of fruit (tried once to eat a hamburger but it upset my stomach). Always tired & listless. On 01/24/2010 started with weakness in all joints & was difficult to stand up, walk or grip anything with hands. Ran slight fevers off & on starting 01/22/2010 with 101.8 being the highest on 01/24/2010. On 01/25/2010 went to walk in clinic. Diagnosis: Rash Pruritus Allergic Reaction to Shingles Vaccine. Received one injection at clinic of Solumedrol 125 mg IM single dose, a prescription for Cimetidine 800 mg (1 at bedtime), Methylprednisolone 4 mg (6 day supply) & up to 50 mg of Benadryl every 4 hr.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Oedema peripheral, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Started on 01/22/2010 covered in itchy red rash & still exists on both lower extremities (below the knees). Hands swollen & has red itchy rash. Few spots of red rash on upper body & elbows. On 01/22/2010 vomited twice & had diarrhea & still have loose bowels.  Starting 01/22/2010 have had no appetite & have eaten nothing more than a couple pieces of fruit (tried once to eat a hamburger but it upset my stomach). Always tired & listless. On 01/24/2010 started with weakness in all joints & was difficult to stand up, walk or grip anything with hands. Ran slight fevers off & on starting 01/22/2010 with 101.8 being the highest on 01/24/2010. On 01/25/2010 went to walk in clinic. Diagnosis: Rash Pruritus Allergic Reaction to Shingles Vaccine. Received one injection at clinic of Solumedrol 125 mg IM single dose, a prescription for Cimetidine 800 mg (1 at bedtime), Methylprednisolone 4 mg (6 day supply) & up to 50 mg of Benadryl every 4 hr.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Vomiting
Clinical narrative: Started on 01/22/2010 covered in itchy red rash & still exists on both lower extremities (below the knees). Hands swollen & has red itchy rash. Few spots of red rash on upper body & elbows. On 01/22/2010 vomited twice & had diarrhea & still have loose bowels.  Starting 01/22/2010 have had no appetite & have eaten nothing more than a couple pieces of fruit (tried once to eat a hamburger but it upset my stomach). Always tired & listless. On 01/24/2010 started with weakness in all joints & was difficult to stand up, walk or grip anything with hands. Ran slight fevers off & on starting 01/22/2010 with 101.8 being the highest on 01/24/2010. On 01/25/2010 went to walk in clinic. Diagnosis: Rash Pruritus Allergic Reaction to Shingles Vaccine. Received one injection at clinic of Solumedrol 125 mg IM single dose, a prescription for Cimetidine 800 mg (1 at bedtime), Methylprednisolone 4 mg (6 day supply) & up to 50 mg of Benadryl every 4 hr.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Almost immediately following injection started itching at injection site down to elbow.  Injection site swollen with redness on arm, right side of chest, spreading to right leg.  Mom called pediatrician, gave Benadryl, took her to Urgent Care. They gave her Benadryl and steroid shots.  Released after about 3 hours.
Age: 82.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Pt. c/o tingling in Left arm and papitations. Blood pressure and Heart rate taken and ambulance called. Pt. left clinic at 11:20am.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Uticaria. Patient is an employee and employee health review is confidential.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: No reaction on previous exposure to drug, Pruritus, Rash generalised, Reaction to preservatives
Clinical narrative: On 1/21/10 at 2:30pm, patient called stating that on 1/21/10 at approx 10:30am she noticed severe itching and a rash developing on entire body (except face).  No respiratory distress.  On 1/22/10 patient went to her primary doctor due to continued severe itching and worsening rash.  She states the MD ruled out all other causes except possible reaction to the preservatives in the H1N1 swine flu shot she received on 1/20/10.  He prescribed Benadryl and steroids.  She had full resolution on 1/25/10.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Patient returns to clinic after 2 days with report of redness/swelling at Zostavax injection site (noted area - right upper posterior arm).  Otherwise, asymptomatic.  Instructed to take Tylenol/Motrin for pain/fever.  Antihistamine as requested as directed.  Follow up with PCP/ER if symptoms worsen or persist.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Pain in the injection site radiating to the shoulder lower arm and fingers up to behind the ear, started 2 days after pt. received Seasonal influenza vaccine on his Right arm. Also c/o tingling in the same extremity on and off. Pain also worsens with movement of arm.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Hearing impaired, Myalgia, Nasal congestion, Pyrexia, Respiratory tract congestion
Clinical narrative: Woke up with a fever and was achy, sluggish.  I had until 10:15pm. On 1/20/10 I still felt achy, sluggish until Thurs 1/21/10. Woke up feeling better.  By the end of the day 1/21 I was very ill again.  I developed a low grade fever, chest, nasal and head congestion, with congestion imparing the hearing in my left ear. Treated with Mucinex, Allegra D. This lasted until 1/25/10.  Today 1/26 I woke up feeling better with more energy, but still a little sluggish.  Still have some congestion.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Sluggishness
Clinical narrative: Woke up with a fever and was achy, sluggish.  I had until 10:15pm. On 1/20/10 I still felt achy, sluggish until Thurs 1/21/10. Woke up feeling better.  By the end of the day 1/21 I was very ill again.  I developed a low grade fever, chest, nasal and head congestion, with congestion imparing the hearing in my left ear. Treated with Mucinex, Allegra D. This lasted until 1/25/10.  Today 1/26 I woke up feeling better with more energy, but still a little sluggish.  Still have some congestion.
Age: 23.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Swelling of tongue and throat
Age: 1.51
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion
Clinical narrative: Child had a seizure while in fathers car, short duration, went to hospital and had another one shortyly after.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Feeling hot, Pruritus, Scab, Skin burning sensation
Clinical narrative: Existing areas of psoriasis became hot and red around and in and itched and burned. Sunday, there were itchy bumps and the psoriasis was oozing clear liquid that scabbed over. Monday, went to doctor and was put on Methylprednisolone tablets for the acute reaction.
Age: 20.0
Sex: M
Vaccine: FLU(H1N1), MMR
Symptoms: Presyncope
Clinical narrative: Near syncope episode after second vaccine administered.  Never lost vital signs or consciousness.  Recovered quickly with recumbent position.  Sent home after brief period of rest.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Headache, Malaise, Pruritus, Rash macular
Clinical narrative: Complained of not feeling "well" day after vaccine.  C/o headache, feeling itchy inside, and red splotchy skin to the face, neck, and arms.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hyporeflexia, Lumbar puncture abnormal
Clinical narrative: Pt presented to Hospital on 10/31/2009. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dizziness, Fatigue, Heart rate increased, Laboratory test
Clinical narrative: Fatigue and body aches for 48 hours, followed by rapid heart beat, dizziness/lightheadedness, tightness in the chest.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Fatigue and body aches for 48 hours, followed by rapid heart beat, dizziness/lightheadedness, tightness in the chest.
Age: 40.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 37.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Dizziness, Headache
Clinical narrative: Woke up dizzy, getting headaches from it. Started prednisone on 1/22/10, got steroid shot 1/25/10
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nasal discomfort, Sinus headache
Clinical narrative: Nose sore, sinus, sinus pressure between the breath. Pt got H1N1 shot on 1-20-10 Wed 9-12 noon. Called for the symptoms on 1-25-10 at 8:00pm. Called her DR.MD gave her CLARITIN 10mg and MEDROL DOSE PAK. Pt was contacted on 1-26-10 at 2pm she is  fine. Did not finish MEDROL DOSE PAK still soreness but better than first nite
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cold sweat, Pallor, Vomiting
Clinical narrative: child became pale after IM injection, clammy skin, vomited x 1. Pt assisted to floor. Legs elevated, cool compress to forehead. Observed 20 mins. Child placed in chair. Drinking feeling better - gait steady.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fall
Clinical narrative: Child fell to floor after receiving H1N1 shot. Parent at site. Pt has hx of passing out. Pt supine, legs elevated. Cool compress applied to forehead, sat in chair. Drinking fluids. Felt better. Gait steady.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Convulsion
Clinical narrative: Pt had a seizure at home and was taken to the ER.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Itching, swelling and redness induration 5cm.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Hyperhidrosis, Vision blurred
Clinical narrative: Blurred vision, headache, sweating
Age: 69.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blister, Injection site erythema, Injection site rash, Pruritus
Clinical narrative: Redness to Rt deltoid area on 1/25/10 at 5 P.M. and rash < itch to both lower legs above ankles. Vesicle like lesions-was seen here 1/26/10 at 9:30, was given BENADRYL OTC and MEDROL dose pack. 7 days after H1N1 given.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Student got the H1N1 vaccine in one arm at 8:57. Was told he would need a second dose and got back in line at 9:01. Nurse did not realize he was already vaccinated until she went to sign form.
Age: 86.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chronic obstructive pulmonary disease, Dizziness, Dyspnoea
Clinical narrative: Pt took H1N1 shot at 3:29 pm on Jan. 25, 2010. After about 10 mins. pt started feeling dizziness and SOB. Pt sent to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU(H1N1), FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Right deltoid swelling, at injection site and below injection site. Red, hot to the touch.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Lightheaded and nauseous. Pounding Headache and Chills. Pt stated she was very tired pale and diaphoretic.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Nausea, Pallor
Clinical narrative: Lightheaded and nauseous. Pounding Headache and Chills. Pt stated she was very tired pale and diaphoretic.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Convulsion, Dyspnoea, Endotracheal intubation, Iron deficiency anaemia
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Oxygen saturation decreased, Paralysis, Resuscitation
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abscess drainage, Blood test, Chest pain, Computerised tomogram, Condition aggravated
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Conversion disorder, Convulsion, Cyanosis, Electrocardiogram, Electroencephalogram
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gaze palsy, Haemoglobin decreased, Head injury, Hypoaesthesia facial, Hypoaesthesia oral
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incisional drainage, Incontinence, Iron deficiency anaemia, Laboratory test abnormal, Loss of consciousness
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Paralysis, Respiratory arrest, Rhinoplasty
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Subcutaneous abscess, Tremor, Trismus, Urine analysis abnormal, Urine iron increased
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: 9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Rash
Clinical narrative: 16 DAYS POST VACCINATION OF H1N1 VACCINE. PT STILL HAS SIGNIFICANT POINT TENDERNESS AT INJECTION SITE, NO BRUISING OR OTHER ABNORMALITIES. ALSO C/O RAISED NONCOLORED RASHED ON STOMACH AND BACK SINCE VACCINATION.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Depressed level of consciousness, Emotional distress, Hyperhidrosis, Pallor, Screaming
Clinical narrative: Child distressed and screaming during vaccination process. Post vaccination pallor, sweating, and slow to respond. VS B/P 94/60 P 78 R 18.  Spontaneous recovery without treatment.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient complained of arm being really sore, itchy, red and warm to the touch. No complaints of respiratory difficulty. Patient's wife placed hydrocortisone cream on the area on 01/24/2010 which helped the redness, warmth and itchiness disappear.
Age: 33.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Anosmia
Clinical narrative: Anosmia. Total loss of sense of smell, going on 5 days now.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom reports redness, itching, and swelling at site 24 hours after vaccine. Upon presenting to the Health Department, nurse observed left arm was red and slightly swollen. Capillary refill in less than 1 second. Peripheral pulse left wrist intact.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: She had  little rash on her neck but more on her lower back and it just kept getting worse. It wasn't on her face at all around 10:30 that night but then it spread to her face and ears by 7:00 AM. We have been fighting fevers of over 102 for over 3 days now and it is still continuing so we are taking her in again today.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Death, Intensive care, Meningitis, Respiratory disorder
Clinical narrative: upper respiratory complaints - admitted to ICU.
Age: 25.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Fatigue, Headache, Influenza serology positive, Myalgia
Clinical narrative: FEVER, SORE THROAT, CONGESTION, COUGH, MUSCLE ACHES, FATIGUE, HEADACHE
Age: 25.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Oropharyngeal pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: FEVER, SORE THROAT, CONGESTION, COUGH, MUSCLE ACHES, FATIGUE, HEADACHE
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: UPON ENTERING IN THE VACCINES THAT WERE ADMINISTERED TODAY, I DISCOVERED THAT THE HPV WAS GIVEN BACK IN DECEMBER OF 2009, WHICH WAS A LITTLE OVER A MONTH AGO, WHICH WAS NOT ENTERED INTO SHOTS, THEREFORE THE VACCINE GIVEN TODAY WAS GIVEN IN ERROR.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: RAISED AREA, HOT TO TOUCH MEASURING APPROX. 3" BY 2.5"  APPEARS TO RESEMBLE 1/2 A BALL AS REPORTED BY CAREGIVER.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dysgeusia, Pain in extremity, Pallor, Palpitations
Clinical narrative: C/o of strange metal taste in mouth, lightheadedness, pale color, heart racing throat feeling tight pain in Left arm. Treatment 0.3cc epinephrine to Right arm where H1N1 shot was given 911 called sent to Medical Center by paramedics.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Throat tightness
Clinical narrative: C/o of strange metal taste in mouth, lightheadedness, pale color, heart racing throat feeling tight pain in Left arm. Treatment 0.3cc epinephrine to Right arm where H1N1 shot was given 911 called sent to Medical Center by paramedics.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Rash macular
Clinical narrative: Face became very red and splotchy... lasting more than 6 hours.  Called family doctor and was advised to come to office.  Doctor confirmed as vaccine reaction and advised Benadryl.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Back pain, Headache, Rash, Urticaria
Clinical narrative: Rash and hives localized to chest (sternum) only.  Headached.  Lower Back Pain.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1), IPV, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Administered TdaP, MCV-4, and H1N1 in RD.  IPV and varicella administered in LD.  Ten minutes after administration, pt developed a raised wheal-like area at the site of the IPV injection.  He was given oral Benadryl 25 mg and observed for 20 minutes.  There was no further reaction observed at that time.  The pt left with instructions to continue Benadryl q 4-6 hrs throughout the night and next day given by Dr.  Mother contacted by phone the next day, she stated that pt was doing better, the wheal was gone and there was only some redness at the site.  Pt had no pruritis or other reaction.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chromaturia, Erythema, Injection site induration, Injection site mass, Pain in extremity
Clinical narrative: Pain in arm of injection. Swelling, redness, fever of 103.4 F. Later orange colored urine. 103 fever for two days, 102 for 1 day. Pain in arm for two weeks, hard bump at point of injection still.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Pain in arm of injection. Swelling, redness, fever of 103.4 F. Later orange colored urine. 103 fever for two days, 102 for 1 day. Pain in arm for two weeks, hard bump at point of injection still.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Diarrhoea, Electrocardiogram, Nausea, Physical examination
Clinical narrative: Stomach cramps, nausea, dry heaves, and loose bowel movements.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Retching
Clinical narrative: Stomach cramps, nausea, dry heaves, and loose bowel movements.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Arthralgia, Fall, Guillain-Barre syndrome, Walking aid user
Clinical narrative: started with pain in left hip around 10/10/08.Went to hospital on 10/16/08. Was dismissed. By 10/20/08 he could not walk.  Was admitted to nursing care on 10/21/08. Diagnosed GBS 11/05/08 in hospital again, was dismissed to nursing care, remains there today, recovered from GBS, but can walk only with a walker, has fallen 12-15 times in the past year with multiple trips to the ER.  Before the GBS he was walking with the aid of a cane 2-3 miles every day.
Age: 1.41
Sex: F
Vaccine: MMR, PNC
Symptoms: Fatigue, Irritability, Pyrexia, Rash
Clinical narrative: fever, irritability, fatigue, rash over diaper area
Age: 22.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Heart rate increased, Urticaria
Clinical narrative: HIVES, AND FAST HEART BEAT, ON GOING THROUGH OUT THE DAY, TREATMENT: HAVE TO MAKE A DOCTORS APPT.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Anaphylactic reaction, Diarrhoea, Urticaria, Vomiting
Clinical narrative: Abdominal pain, diarrhea, vomiting, hives.
Age: 3.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nausea
Clinical narrative: Nausea
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pamphlet given at time of Vaccine stated if mild problems report and I had Redness, soreness, swelling and itchiness for 4 days.
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Balance disorder, Headache, Hyperaesthesia, Hypoaesthesia, Laboratory test
Clinical narrative: 30Y/O male c/o numbness/sensitivity in both hands and feet, loss of balance and increased weakness in both arms, Headache and neck pain
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Lumbar puncture, Muscular weakness, Neck pain
Clinical narrative: 30Y/O male c/o numbness/sensitivity in both hands and feet, loss of balance and increased weakness in both arms, Headache and neck pain
Age: 68.0
Sex: F
Vaccine: HEP, PPV, TYP
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: The day after her vaccinations (3) she developed a sore, red, warm lump on her left deltoid and upper arm. Clinic started KEFLEX for cellulitis. It worsened over night. She was admitted to the hospital for IV antibiotics.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Choking, Loss of consciousness
Clinical narrative: Pt. lost consciousness and made choking, snorting sounds.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain
Clinical narrative: Continuous aching L arm - shoulder to elbow. Accompanied by extreme episodes of pain lasting up to 30 min. Episodes of electrical shock type pain shooting up arm pain scale 2-3 episodes 7-8
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Continuous aching L arm - shoulder to elbow. Accompanied by extreme episodes of pain lasting up to 30 min. Episodes of electrical shock type pain shooting up arm pain scale 2-3 episodes 7-8
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Laboratory test, Nausea, Syncope
Clinical narrative: Patient received vaccine 1/25/2010 during physical around 9:30 AM - About 12 hrs later while in shower began feeling dizzy & fainted. Has mild nausea & headache now but no dizziness still.
Age: 1.2
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Injection site cellulitis, Injection site rash, Varicella
Clinical narrative: Cellulitis R thigh and rash which seemed consistent varicella rash  14 days after varicella vaccine. Treated with CEPHALEXIN 250/5ml 1 tsp BID x 5 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Scratch
Clinical narrative: Mother reports patient's left arm was red half way down arm and up to shoulder with swelling present. Reports no change in child's behavior. Redness resolved by 01/24/10, mother reports has scratches on arm from itching it during time of reaction. Mother took child to hospital 01/16/10, but was not seen by doctor. No medications other than TYLENOL and MOTRIN were given.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Right deltoid muscle sore, especially when moving arm. Soreness has continued since vaccination in November.
Age: 18.0
Sex: F
Vaccine: HPVX
Symptoms: Hypersensitivity, Laboratory test, Leukocytoclastic vasculitis
Clinical narrative: Hypersensitivity or Leukocytoclastic Vasculitis
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site vesicles
Clinical narrative: Woke up the day after getting the Tdap and her left deltoid was red, swollen, a hard knot was present. Later that day dry looking blisters appeared. She came back to the office on 1/25/10 and an area of induration and erythema 11x10 cm was noted by her PCP. The RN called and there is light improvement in the arm today.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Epistaxis, Loss of consciousness, Nausea
Clinical narrative: Patient waited 15 minutes after injection. Pt felt nausous. Got up to go to bathroom, passed out, landed on face, stomach. Had bloody nose. Had seizure-like activity. Taken to hospital for evaluation.
Age: 1.2
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at inj site; requiring evaluation and medication.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Patient recieved TDAP vaccine on January 19, 2010. Mother called January 22, 2010 report severe swelling and inflammation in Right arm, patient was seen the same day as a sick visit.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Hypersensitivity, Injection site erythema
Clinical narrative: Extensive warmth, erythema, redness at the injection site. ? allergic reaction vs cellulitis. Rx: Ice, DARVOCET for pain, KEFLEX 500 TID.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Hypokinesia, Injection site anaesthesia, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: A 20-year-old female received the following vaccinations on 23  March 2006: TYHIM VI, lot number not reported,  DRYVAX, Wyeth, lot number not reported, and BIOTHRAX, Emergent Biosolutions, lot number not reported. The BIOTHRAX vaccine was administered in the left deltoid; administration site for other vaccines were unknown (the patient thought she may have received at least one of the other vaccines in the right deltoid, but was not certain). Immediately following vaccination, the patient noted an aching pain at the BIOTHRAX injection site, which intensified that afternoon and was accompanied by numbness. The pain was described as muscle pain. She developed redness and swelling "the size of a nickel" at the BIOTHRAX injection site, in addition to a subcutaneous nodule smaller than the size of a pea. The pain and numbness limited arm movement and function, and pain was described as 6/10 using pain scale of 0 (no pain) to 10 (worst pain ever experienced). She took ibuprofen, and the pain slightly decreased. The symptoms resolved after three to four days. She received a second BIOTHRAX vaccine on 12 April 2006 and experienced a similar reaction. The patient denied unusual prolonged, or systemic symptoms.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site swelling, Myalgia
Clinical narrative: A 20-year-old female received the following vaccinations on 23  March 2006: TYHIM VI, lot number not reported,  DRYVAX, Wyeth, lot number not reported, and BIOTHRAX, Emergent Biosolutions, lot number not reported. The BIOTHRAX vaccine was administered in the left deltoid; administration site for other vaccines were unknown (the patient thought she may have received at least one of the other vaccines in the right deltoid, but was not certain). Immediately following vaccination, the patient noted an aching pain at the BIOTHRAX injection site, which intensified that afternoon and was accompanied by numbness. The pain was described as muscle pain. She developed redness and swelling "the size of a nickel" at the BIOTHRAX injection site, in addition to a subcutaneous nodule smaller than the size of a pea. The pain and numbness limited arm movement and function, and pain was described as 6/10 using pain scale of 0 (no pain) to 10 (worst pain ever experienced). She took ibuprofen, and the pain slightly decreased. The symptoms resolved after three to four days. She received a second BIOTHRAX vaccine on 12 April 2006 and experienced a similar reaction. The patient denied unusual prolonged, or systemic symptoms.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Unevaluable event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with RECOMBIVAX B (Merck), ENGERIX B. The subject's medical history included skin problem. Concurrent medications included RAPTIVA. On 2 November 2006, the subject received 1st dose of Hepatitis B vaccine (unknown, left deltoid). On 5 December 2006, 3 April 2007, the subject received 2nd dose and 3rd dose of Engerix B (1ml, unknown, left deltoid) and experienced not responding to therapy and drug dose administration interval too short. On 19 March 2008, 8 May 2008 and 17 July 2008 the subject received 1st dose, 2nd dose, and 3rd dose of Engerix B (1ml, unknown, right deltoid) and experienced not responding to therapy and drug dose administration interval too short. Relevant test results included negative titers. The healthcare professional reported the subject received two separate series of Hepatitis B vaccine and still has a negative titer. The first series was a mixture of GSK and Merck product. The subject told the nurse on 08 May 2007, that he had a negative titer. The second series of hepatitis B vaccine were all GSK products. The reporting healthcare professional did not know when the titer was drawn. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 15 December 2008. The subject's skin problem was further described as small blisters on hands and feet. Additional concomitant mediations included Atenolol, Tricor and Nexium. The reporter stated Raptiva was preventing the subject from building titers with the Hepatitis B vaccine. The subject started therapy with Raptiva in 2007, 125mL per week and continues. At the time of the report, the events were unresolved. Follow-up information was received on 26 October 2009, via healthcare professional. The health clinic where the subject is employed reported to the healthcare professional, that the subject discontinued Raptiva for one month and then received the Hepatitis vaccine series and has now developed "resistance" to hepatitis B. The original report indicated that he had not developed "resistance" after receiving Engerix B. Since Raptiva had now been discontinued, the subject will not receive the drug again.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an adult male subject (a physician) not responding to therapy following vaccination with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date the subject completed his hepatitis B series (20 mcg doses administered). At an unspecified time after completion of the hepatitis B vaccine series, the subject was found to have not responded to therapy. At the time of reporting the outcome of the event was unspecified. This event occurred in two subjects (two physicians) with case A0734383A serving as the master and linked to A0734385A (active) and A0734386A (created in error-void). Follow-up received from reporting pharmacist on 6 June 2009: The subject received the complete hepatitis B vaccination series during 1996 and 1997. No titers were drawn. The subject subsequently received a repeat hepatitis B vaccine series with ENGERIX B (GlaxoSmithKline, intramuscular, AHBVB584AA, expiry 6 November 2010) on 23 September 2008, 24 October 2008 and 23 March 2009. Titer on 29 May 2009 was greater than 100 (units not specified). No adverse events were reported.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an adult male subject (a physician) not responding to therapy following vaccination with HEPATITIS B (manufacturer unspecified).  On an unspecified date the subject completed his HEPATITIS B series (20 mcg doses administered).  At an unspecified time after completion of the HEPATITIS B vaccine series, the subject was found to have not responded to therapy.  At the time of reporting the outcome of the event was unspecified.  This event occurred in two subjects (two physicians) with this case, A0734383A serving as the master and linked to A0734385A (active) and A0734386A (created in error-void).  Follow-up was received on 8 June 2009 from reporting pharmacist:  The subject received the complete HEPATITIS B vaccination series during 1985.  No titers were obtained.  The subject subsequently received a repeat HEPATITIS B vaccine series with ENGERIX B (GlaxoSmithKline, intramuscular, AHBVB448AA, expiry 24 January 2010) on 3 June 2008, 15 December 2008 and 24 January 2009.  Titer on 2 March 2009 was 0.18 (units not specified).  No adverse events were reported.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site erythema, Injection site warmth, Product quality issue, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 16-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included ZANTAC and NEXIUM.  The subject had received ENGERIX B before as childhood immunizations. On 16 July 2009 the subject received ENGERIX B (20 mcg, unknown, left arm). On 16 July 2009, 2 hours after vaccination with ENGERIX B, the subject's arm became red and warm from the immunization site down to her hand. A product complaint was associated with this report. The reporter was concerned if this particular lot of vaccine could complaint was associated with this report. The reporter was concerned if this particular lot of vaccine could result in the same reaction as the reported events. The reporter did not have a specific complaint associated wit hthe vial, components or appearance of the vaccine. At the time of reporting the events were resolved. Follow-up information received on 17 August 2009 indicated that the events began on the day of vaccination, 16 July 2009 and resolved one day later on 17 July 2009.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Cough, Erythema, Immediate post-injection reaction, Injection site rash, Wheezing
Clinical narrative: Rash on left arm, cough, wheezing and mild erythema immediately following HIB administration at child's pediatrician's office. Mother administered Epi-pen and brought the child to the emergency room. Child was given Decadron 6 mg and Benadryl.