chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough
Clinical narrative: Patient states he started coughing up thick mucus.  Patient was given Keflex 500mg 1 cap QID for 7 days, and Predinsone 20mg 1 tab BID for 10 days.  Patient states he is still having symptoms.  Patient advised to follow up again with his physician.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Full blood count, Human chorionic gonadotropin, Injection site erythema, Injection site urticaria
Clinical narrative: Local reaction at site; redness, warmth, large wheal; Fever 101F; URI sx; Rx was 1000 ml NS, CXR; 650 mg Tylenol and 25 mg IV Benadryl.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth, Local reaction, Metabolic function test, Pyrexia, Upper respiratory tract infection
Clinical narrative: Local reaction at site; redness, warmth, large wheal; Fever 101F; URI sx; Rx was 1000 ml NS, CXR; 650 mg Tylenol and 25 mg IV Benadryl.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: Local reaction at site; redness, warmth, large wheal; Fever 101F; URI sx; Rx was 1000 ml NS, CXR; 650 mg Tylenol and 25 mg IV Benadryl.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Childhood disintegrative disorder, Convulsion, Crying, Electroencephalogram, Hemiparesis
Clinical narrative: Our son received his 2 month vaccinations and all was well.  Then 3 days later I was awaken out of my sleep and saw my son shaking in his basinette. I picked him up and he continue to shake both arms and legs.  I grabbed his legs only to notice that the shaking will not stop.  Then I looked at his face I called his name him seem to be in another world a blank stare.  I just watched in disbelief he stop shaking after a min or two.  I picked him up and he begin to cried.  From that point I called the doctor for the next available appointment. I stated my suspicion to the doctor and she said that she did not think it was the shot.  She said that she would send him to neurology but in the mean time take him home.  She was not the only doctor I told about my suspicion about the shot but I was told that there was evidence pointing to that and it was inconclusive, but in my heart I knew to stick with this top.  In the following days he showed the same behavior. He had seizures over time short episodes that lasted a minute. We finally just made up in our mind we would not leave until something was done.   Made arrangements for him to go to hospital.  Where we stayed for four days and all kind of test were ran but could not be pin pointed to why the onset of seizures.  Dr. diagnosed him with Keppra.  My husband and I discussed the conculsion about vaccines and it was again dismissed.  There is not enough evidence to conclude that.  Our son was put on give 50 mg orally every twelve hours of Levetiracetam to be increased to 40 mg/kg over two weeks.  He was stable and sent home at five months we noticed that he was not gaining weight as he should, he could not sit up or crawl, he was five months and his left side was weak at that point he was put in intense phyiscally therapy and occupational therapy, over time he was making ground but still behind.  On his 1st birthday he started walking and he continue to progress with help.  He was to see ot/pt with infant development specialist as well.  He has recently been cleared to be taken off his Keppra after his two years of seizures free but than the question has come should we give him pertussis.  We as his parent do not agree or think that it is a good ideal that is why we are filing this.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inability to crawl, Nuclear magnetic resonance imaging, Posture abnormal, Sleep study, Staring
Clinical narrative: Our son received his 2 month vaccinations and all was well.  Then 3 days later I was awaken out of my sleep and saw my son shaking in his basinette. I picked him up and he continue to shake both arms and legs.  I grabbed his legs only to notice that the shaking will not stop.  Then I looked at his face I called his name him seem to be in another world a blank stare.  I just watched in disbelief he stop shaking after a min or two.  I picked him up and he begin to cried.  From that point I called the doctor for the next available appointment. I stated my suspicion to the doctor and she said that she did not think it was the shot.  She said that she would send him to neurology but in the mean time take him home.  She was not the only doctor I told about my suspicion about the shot but I was told that there was evidence pointing to that and it was inconclusive, but in my heart I knew to stick with this top.  In the following days he showed the same behavior. He had seizures over time short episodes that lasted a minute. We finally just made up in our mind we would not leave until something was done.   Made arrangements for him to go to hospital.  Where we stayed for four days and all kind of test were ran but could not be pin pointed to why the onset of seizures.  Dr. diagnosed him with Keppra.  My husband and I discussed the conculsion about vaccines and it was again dismissed.  There is not enough evidence to conclude that.  Our son was put on give 50 mg orally every twelve hours of Levetiracetam to be increased to 40 mg/kg over two weeks.  He was stable and sent home at five months we noticed that he was not gaining weight as he should, he could not sit up or crawl, he was five months and his left side was weak at that point he was put in intense phyiscally therapy and occupational therapy, over time he was making ground but still behind.  On his 1st birthday he started walking and he continue to progress with help.  He was to see ot/pt with infant development specialist as well.  He has recently been cleared to be taken off his Keppra after his two years of seizures free but than the question has come should we give him pertussis.  We as his parent do not agree or think that it is a good ideal that is why we are filing this.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Tremor, Unresponsive to stimuli, Weight gain poor
Clinical narrative: Our son received his 2 month vaccinations and all was well.  Then 3 days later I was awaken out of my sleep and saw my son shaking in his basinette. I picked him up and he continue to shake both arms and legs.  I grabbed his legs only to notice that the shaking will not stop.  Then I looked at his face I called his name him seem to be in another world a blank stare.  I just watched in disbelief he stop shaking after a min or two.  I picked him up and he begin to cried.  From that point I called the doctor for the next available appointment. I stated my suspicion to the doctor and she said that she did not think it was the shot.  She said that she would send him to neurology but in the mean time take him home.  She was not the only doctor I told about my suspicion about the shot but I was told that there was evidence pointing to that and it was inconclusive, but in my heart I knew to stick with this top.  In the following days he showed the same behavior. He had seizures over time short episodes that lasted a minute. We finally just made up in our mind we would not leave until something was done.   Made arrangements for him to go to hospital.  Where we stayed for four days and all kind of test were ran but could not be pin pointed to why the onset of seizures.  Dr. diagnosed him with Keppra.  My husband and I discussed the conculsion about vaccines and it was again dismissed.  There is not enough evidence to conclude that.  Our son was put on give 50 mg orally every twelve hours of Levetiracetam to be increased to 40 mg/kg over two weeks.  He was stable and sent home at five months we noticed that he was not gaining weight as he should, he could not sit up or crawl, he was five months and his left side was weak at that point he was put in intense phyiscally therapy and occupational therapy, over time he was making ground but still behind.  On his 1st birthday he started walking and he continue to progress with help.  He was to see ot/pt with infant development specialist as well.  He has recently been cleared to be taken off his Keppra after his two years of seizures free but than the question has come should we give him pertussis.  We as his parent do not agree or think that it is a good ideal that is why we are filing this.
Age: 1.32
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site reaction, Rash, Rash macular
Clinical narrative: DAY AFTER VACCINES GIVEN MOTHER NOTED RASH. ON EXAM 11/4/11 PT HAD RIGHT THIGH AT INJECTION SITE 11X14CM MACULAR ERYTHEMA; LEFT THIGH AT INJECTION SITE 4.5X3 CM ERYTHEMA AND LEFT THIGH 12X4CM ERYTHEMA. HAD 10X4CM URTICARIAL LESION ON ABDOMEN AND SMALLER ONE ON BACK. TEMP 100.
Age: 1.32
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Urticaria
Clinical narrative: DAY AFTER VACCINES GIVEN MOTHER NOTED RASH. ON EXAM 11/4/11 PT HAD RIGHT THIGH AT INJECTION SITE 11X14CM MACULAR ERYTHEMA; LEFT THIGH AT INJECTION SITE 4.5X3 CM ERYTHEMA AND LEFT THIGH 12X4CM ERYTHEMA. HAD 10X4CM URTICARIAL LESION ON ABDOMEN AND SMALLER ONE ON BACK. TEMP 100.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Decreased appetite, Headache
Clinical narrative: Intense headache (no photophobia or otophobia) Motrin helped some. Decreased appetite. No Know fever. On 11/28/2011 headache was a little better so went to school.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Left upper arm with pale nickle sized area where shot was given. On either side if that there is a sm blister at the edges of where the bandaid would have been. Distal to that area there is redness, tense swelling and the area is hot to touch.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Hypoaesthesia oral
Clinical narrative: Within 5 minutes of receiving flu shot, dizzy, short of breath, heart pounding, tunnel vision, numb lips, tremors. Symptoms continued to worsen over the next several days, requiring 3 trips to the emergency room for chest pain, chest pressure, dizziness, tunnel vision.  Misdiagnosed as anxiety attacks, later confirmed as adverse reaction by primary care provider. Symptoms of chest pain and pressure still occurring 3 weeks post vaccine.  Taking Mobic for possible pleurisy d/t vaccine.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations, Tremor, Tunnel vision, Vaccination complication
Clinical narrative: Within 5 minutes of receiving flu shot, dizzy, short of breath, heart pounding, tunnel vision, numb lips, tremors. Symptoms continued to worsen over the next several days, requiring 3 trips to the emergency room for chest pain, chest pressure, dizziness, tunnel vision.  Misdiagnosed as anxiety attacks, later confirmed as adverse reaction by primary care provider. Symptoms of chest pain and pressure still occurring 3 weeks post vaccine.  Taking Mobic for possible pleurisy d/t vaccine.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Burning sensation, Electrocardiogram, Hypoaesthesia, Injection site pain
Clinical narrative: WHEN I WOKE UP NEXT MORNING I HAD SEVERE PAIN IN ARM WHERE I GOT FLU SHOT, SEVERE CRAMPS IN ENTIRE ARM SHOULDER BLADE HAND PINS AND NEEDLES IN FINGERS WEAKNESS IN ARM IT HAS BEEN 13 DAYS AND STILL FINGERS ARE NUMB SHOOTING PAINS DOWN ARM FOREARM FEELS LIKE IT IS BURNING.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Muscular weakness, Pain, Paraesthesia, X-ray
Clinical narrative: WHEN I WOKE UP NEXT MORNING I HAD SEVERE PAIN IN ARM WHERE I GOT FLU SHOT, SEVERE CRAMPS IN ENTIRE ARM SHOULDER BLADE HAND PINS AND NEEDLES IN FINGERS WEAKNESS IN ARM IT HAS BEEN 13 DAYS AND STILL FINGERS ARE NUMB SHOOTING PAINS DOWN ARM FOREARM FEELS LIKE IT IS BURNING.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Child had a rash along her thigh where she got the Varicella Immunization.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Blood pressure decreased, Chest pain, Nausea, Pain, Pain in extremity
Clinical narrative: Patient reported decreasing Blood pressure, pain in arm, radiating across chest, achy, nausea.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram, Posture abnormal
Clinical narrative: Sudden head and shoulder jerks and head drops.  Lucid look for a couple of seconds after head drop.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Abdominal pain upper, Chills, Headache, Lymphadenopathy, Nasal congestion
Clinical narrative: Fever of 105, Chills off and on, swollen glands, stomach ache, vomiting, stuffy nasal cavity, head ache, foul smelling urine.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Urine odour abnormal, Vomiting
Clinical narrative: Fever of 105, Chills off and on, swollen glands, stomach ache, vomiting, stuffy nasal cavity, head ache, foul smelling urine.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Started getting dizzy at various times during the day and while doing normal activities. Had not had this problem befor getting the shot. Has not went to a health care provider. But is still having dizziness off and on during the day it is not severe enough to seek medical care at this time.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Borrelia test, Dizziness, Fatigue
Clinical narrative: Fatigue, extreme aches in joints, nausea, severe headaches, tingling in toes, heart racing, light headedness.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Laboratory test, Meningitis, Nausea, Palpitations
Clinical narrative: Fatigue, extreme aches in joints, nausea, severe headaches, tingling in toes, heart racing, light headedness.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Fatigue, extreme aches in joints, nausea, severe headaches, tingling in toes, heart racing, light headedness.
Age: 23.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Dyspnoea, Pruritus, Throat irritation
Clinical narrative: Scratchy throat, restricted breathing, itchy inner ear - 1 hr 15 min after immunization. BENADRYL shot administered - observed two hours - symptoms went away. Released 3 hrs 35 min after vaccine administered.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Asthenia, Nausea, Syncope, Tremor
Clinical narrative: Shaking; weak; fainting; stomach cramps; nausea. (Merck case # 1-4696507599).
Age: 19.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.66
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Fever > 103, fatigue, headache  - within 4 hrs of receiving vaccine symptoms persisted for 2 days. Pt appeared very ill but was always responsive. Without s/s rhinorrhea/cough/rash.
Age: 1.5
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures x 2 in 2ys. Sx Rx.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: Had vaccines in AM and had cellulitis reaction at night.
Age: 17.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Loss of consciousness
Clinical narrative: After receiving vaccines patient passed out. No LOC, dizzy, cool clammy. Responsive alert & oriented.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysgeusia, Oedema peripheral
Clinical narrative: Swelling on (R) arm, metallic taste on tongue.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: 11/15/2011 - Injection given. 11/17/2011 - Pt called to report increase in arthritic pain & stiffness. No change in regular regimen.
Age: 0.43
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Dehydration, Diarrhoea, Ultrasound scan abnormal, Vomiting, White blood cell count increased
Clinical narrative: Pt rec'd ROTATEQ on 10/24/11. On 10/27 developed severe vomiting, seen in ER 10/28 w. increased WBC, dehydration & U.S. questionable for intussusception. Improved w. IV hydration & diarrhea developed for 4-5 more days.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eyelid oedema, Lip swelling, Oedema mouth
Clinical narrative: 4 hours after the flu shot, her voice was hoarse, 5th hr; her eyelids began to swell & become puffy (wears contacts). At 6 hrs lips became puffy & inside of mouth began to swell. Went to ER at hour #6. Rec'd IV BENADRYL & prednisone IM. 2 hr ER observation vs normal on discharge get symptoms gone. Now taking 40 mg prednisone QD x 5 days. To see allergist.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt was given the varicella vaccination on 11/23/11 & on 11/29/11 pt was seen for the dx of chicken pox.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Musculoskeletal pain, Neck pain, Swelling
Clinical narrative: ZOSTAVAX given 4/26, pt called 4/30 - arm red, hot, swollen under arm (axilla) given ADVIL, resolved in few days. But she also had pain back of shoulder up neck - that has recurred evy 2-3 wk for about 3 days. Last episode 3 wk ago.
Sex: F
Vaccine: VARZOS
Symptoms: Epistaxis
Clinical narrative: Pt received ZOSTAVAX on 11/16/11, called on 11/22/11 to report a nosebleed. Pt said she did not change her routine other than receiving this vaccine. She is not sure whether this is related to the vaccine or not. She has not contacted her PCP regarding this.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Was in pain 5 week. Top elbow to shoulder.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Heart rate increased, Vomiting
Clinical narrative: Also on 11/24 on top of or along lips chills, diarrhea, headache, vomiting, fast heart beat. Time course  - from 9pm on 11/23/11 - 3 am 11/24/11.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Patient reported blistering at injection site the day after which persisted for several days.
Age: 29.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported pain in her (L) arm with limited range of motion first reported within 24 hours of vaccine. Was evaluated by primary care provider. Pain & limited range of motion persisting.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Dyskinesia, Mydriasis, Staring, Unresponsive to stimuli
Clinical narrative: 11/11/11 at about 830am. Pt for healthy visit. BP prior to vaccination 124/64. Pt rec'd GARDASIL in (LT) upper arm and then within 1 1/2 mins rec'd flu vaccine in (RT) arm. As soon as second vac completed; pt eyes dilated, had fixed gaze to the left, would not respond to verbal command & then feel to right side with assistance, eyes closed sl. jerking of upper extremities & then 45 secs came around.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: Vaccine given 11/9/11, developed pain, redness, swelling and hives to left arm on 11/10/11. Pt seen 11/11/11 and is resolving.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Went to ER with severe vomiting. Ultrasound found intussusception.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Erythema and swelling in localized area of right arm day after administration. Secondary to PNEUMOVAX injection.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing
Clinical narrative: Pt experienced flushing. Patient waited 30 min then we took BP -> 175/90. Pt say his BP runs high as I talked to him he started feeling better. I called him at home 1 1/2 hr later & he was ok.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Slightly elevated, warm to touch, itchy, red - suggested to call MD.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Skin infection, Vaccination site reaction
Clinical narrative: Post vaccination patient diagnosed w/ skin infection at vaccination site.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site vesicles, Rash papular
Clinical narrative: Yellowish blister to (L) upper arm 24 hour after immunization, lasted for 5 days. Papular rash noted to site.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash morbilliform, Urticaria
Clinical narrative: Whelps & measle-like rash over most of body (legs, chest, arms, hips) with itching started 11-18-11, has cleared some since, may go to the dr in the morning.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Bordetella test positive, Choking, Cough, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of pertussis in a 25-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), dtpa vaccine (non-gsk). Concurrent vaccination included PEDVAXHIB (non-gsk); Merck; unknown; unknown given on 14 December 2010; MMR II (non-gsk); Merck; unknown; unknown given on 14 December 2010. On 14 December 2010 the subject received INFANRIX as the 4th dose in series (unknown route, right thigh). On an unspecified dates, prior to receiving INFANRIX, the subject received 1st dose, 2nd dose and 3rd of DTPa vaccine (Non-GSK) (details unknwon. In October 2011, at an unspecified time after vaccination with DTPa vaccine (Non-GSK), 10 months after vaccination with INFANRIX, the subject experienced choking and cough. On 01 November 2011 pertussis and vaccination failure were confirmed with positive test result. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included pertussis identification test positive on 01 November 2011. The subject was treated with "respiratory" inhaler (Inhalers). At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with INFANRIX HEXA and DTPa vaccine (Non-GSK). This is two of three cases from this reporter. The office has noticed a recent outbreak of pertussis in their area. See A0955333A and A0955537A for details regarding other two cases.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, swelling, left upper arm. Using BENADRYL - effective in reducing sx.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Bordetella test positive, Cough, Pertussis, Respiratory tract congestion, Throat irritation
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of pertussis in a 5-year-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease. Concurrent vaccination included PEDVAXHIB (non-gsk); Merck; unknown; unknown given on 15 September 2006 and 20 November 2006; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on 15 September 2006, 20 November 2006 and 30 January 2007. Concurrent medications included ZANTAC. On 15 September 2006 at 15:45, 20 November 2006 at 15:45 and 30 January 2007 at 11:00 the subject received 1st dose, 2nd dose and 3rd dose of PEDIARIX (unknown route, left thigh). In October 2011, 5 years after vaccination with PEDIARIX, the subject experienced pertussis cough, chest congestion unspecified, needing to clear throat and vaccination failure. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included pertussis identification test positive on 26 October 2011. The subject was treated with ZITHROMAX and codeine. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. This is three of three cases from this reporter. The office has noticed a recent outbreak of pertussis in their area. See A0955333A and A0955529A for details regarding other two cases.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of pertussis in a 5-year-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease. Concurrent vaccination included PEDVAXHIB (non-gsk); Merck; unknown; unknown given on 15 September 2006 and 20 November 2006; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on 15 September 2006, 20 November 2006 and 30 January 2007. Concurrent medications included ZANTAC. On 15 September 2006 at 15:45, 20 November 2006 at 15:45 and 30 January 2007 at 11:00 the subject received 1st dose, 2nd dose and 3rd dose of PEDIARIX (unknown route, left thigh). In October 2011, 5 years after vaccination with PEDIARIX, the subject experienced pertussis cough, chest congestion unspecified, needing to clear throat and vaccination failure. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included pertussis identification test positive on 26 October 2011. The subject was treated with ZITHROMAX and codeine. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. This is three of three cases from this reporter. The office has noticed a recent outbreak of pertussis in their area. See A0955333A and A0955529A for details regarding other two cases.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Body temperature increased, Injection site reaction, Local reaction, Rash
Clinical narrative: Rash on face and trunk, temp 99.4 TA. Local reaction (R) leg 2 x 3 cm.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Bordetella test positive, Cough, Pertussis, Upper respiratory tract infection, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of pertussis in a 14-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PEDVAXHIB (non-gsk); Merck; unknown; unknown given on 15 November 2010 and 14 January 2011; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on 15 November 2010 and 14 January 2011; ROTATEQ (non-gsk); Merck; unknown given on 15 November 2010 and 14 January 2011. Concurrent medications included TYLENOL. On 15 November 2010, 14 January 2011 and 23 March 2011 at approximately 17:00 the subject received 1st dose, 2nd dose and 3rd dose of PEDIARIX (unknown route, left thigh). In November 2011, 8 months after vaccination with 1st dose of PEDIARIX, 10 months after vaccination with 2nd dose of PEDIARIX, 12 months after vaccination with 3rd dose of PEDIARIX, the subject experienced pertussis, upper respiratory infection, cough and vaccination failure. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included pertussis identification test positive on 14 November 2011. The subject was treated with ZITHROMAX. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. This is one of three cases from this reporter. The office has noticed a recent outbreak of pertussis in their area. See A0955529A and A0955537A for details regarding other two cases.
Age: 16.0
Sex: F
Vaccine: DT, IPV, VARCEL
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site warmth
Clinical narrative: Large erythematous circular macule surrounding administration site. Warm and tender to touch. Area extends 3 inch. in diameter with regular borders.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Muscle contractions involuntary
Clinical narrative: 7 days after INFLUENZA vaccine developed progressive fasciculations and numbness over last 2 months. Is being followed by neurology for same.
Age: 18.0
Sex: F
Vaccine: HEPAB, MEN, HEPAB, MEN
Symptoms: Activities of daily living impaired, Asthenia, Blood potassium decreased, Blood pressure increased, Blood test normal
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of dizziness in a 18-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included latex allergy. Concurrent vaccination included meningitis vaccine, strain not specified (manufacturer unspecified) given in the right arm on 28 January 2011. There were no concurrent medications. On the morning of 28 January 2011 the subject received 1st dose of TWINRIX in the left arm. On the evening of 28 January 2011, less than one day after vaccination with TWINRIX, the subject experienced dizziness, lightheadedness and tachycardia. At the time of reporting the events were unresolved. It was additionally noted that the subject went to the emergency room on 07 February 2011. She had a follow-up with a cardiologist on an unknown date. It was not known if the TWINRIX injection was from a vial or a prefilled syringe. The mother planned to continue follow-up with her daughter's (the subject) pediatrician on an unknown date. Follow-up information received via the mother of the consumer later on 14 February 2011 reported that the subject will return in 6 months for an additional TWINRIX vaccine. Follow-up information was received on 03 March 2011 via consumer, who reported the lot number as NDC number 581-60-815-46. Follow-up information was received on 22 March 2011 with no additional information provided.
Age: 18.0
Sex: F
Vaccine: HEPAB, MEN, HEPAB, MEN
Symptoms: Chest X-ray normal, Dehydration, Dizziness, Electrocardiogram normal, Feeling abnormal
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of dizziness in a 18-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included latex allergy. Concurrent vaccination included meningitis vaccine, strain not specified (manufacturer unspecified) given in the right arm on 28 January 2011. There were no concurrent medications. On the morning of 28 January 2011 the subject received 1st dose of TWINRIX in the left arm. On the evening of 28 January 2011, less than one day after vaccination with TWINRIX, the subject experienced dizziness, lightheadedness and tachycardia. At the time of reporting the events were unresolved. It was additionally noted that the subject went to the emergency room on 07 February 2011. She had a follow-up with a cardiologist on an unknown date. It was not known if the TWINRIX injection was from a vial or a prefilled syringe. The mother planned to continue follow-up with her daughter's (the subject) pediatrician on an unknown date. Follow-up information received via the mother of the consumer later on 14 February 2011 reported that the subject will return in 6 months for an additional TWINRIX vaccine. Follow-up information was received on 03 March 2011 via consumer, who reported the lot number as NDC number 581-60-815-46. Follow-up information was received on 22 March 2011 with no additional information provided.
Age: 18.0
Sex: F
Vaccine: HEPAB, MEN, HEPAB, MEN
Symptoms: Heart rate increased, Hypoaesthesia, Neurological examination normal, Postural orthostatic tachycardia syndrome, Urine analysis normal
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of dizziness in a 18-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included latex allergy. Concurrent vaccination included meningitis vaccine, strain not specified (manufacturer unspecified) given in the right arm on 28 January 2011. There were no concurrent medications. On the morning of 28 January 2011 the subject received 1st dose of TWINRIX in the left arm. On the evening of 28 January 2011, less than one day after vaccination with TWINRIX, the subject experienced dizziness, lightheadedness and tachycardia. At the time of reporting the events were unresolved. It was additionally noted that the subject went to the emergency room on 07 February 2011. She had a follow-up with a cardiologist on an unknown date. It was not known if the TWINRIX injection was from a vial or a prefilled syringe. The mother planned to continue follow-up with her daughter's (the subject) pediatrician on an unknown date. Follow-up information received via the mother of the consumer later on 14 February 2011 reported that the subject will return in 6 months for an additional TWINRIX vaccine. Follow-up information was received on 03 March 2011 via consumer, who reported the lot number as NDC number 581-60-815-46. Follow-up information was received on 22 March 2011 with no additional information provided.
Age: 18.0
Sex: F
Vaccine: HEPAB, MEN, HEPAB, MEN
Symptoms: Vision blurred
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of dizziness in a 18-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included latex allergy. Concurrent vaccination included meningitis vaccine, strain not specified (manufacturer unspecified) given in the right arm on 28 January 2011. There were no concurrent medications. On the morning of 28 January 2011 the subject received 1st dose of TWINRIX in the left arm. On the evening of 28 January 2011, less than one day after vaccination with TWINRIX, the subject experienced dizziness, lightheadedness and tachycardia. At the time of reporting the events were unresolved. It was additionally noted that the subject went to the emergency room on 07 February 2011. She had a follow-up with a cardiologist on an unknown date. It was not known if the TWINRIX injection was from a vial or a prefilled syringe. The mother planned to continue follow-up with her daughter's (the subject) pediatrician on an unknown date. Follow-up information received via the mother of the consumer later on 14 February 2011 reported that the subject will return in 6 months for an additional TWINRIX vaccine. Follow-up information was received on 03 March 2011 via consumer, who reported the lot number as NDC number 581-60-815-46. Follow-up information was received on 22 March 2011 with no additional information provided.
Age: 18.0
Sex: F
Vaccine: HEPAB, MEN, HEPAB, MEN
Symptoms: Dizziness, Tachycardia
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of dizziness in a 18-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included latex allergy. Concurrent vaccination included meningitis vaccine, strain not specified (manufacturer unspecified) given in the right arm on 28 January 2011. There were no concurrent medications. On the morning of 28 January 2011 the subject received 1st dose of TWINRIX in the left arm. On the evening of 28 January 2011, less than one day after vaccination with TWINRIX, the subject experienced dizziness, lightheadedness and tachycardia. At the time of reporting the events were unresolved. It was additionally noted that the subject went to the emergency room on 07 February 2011. She had a follow-up with a cardiologist on an unknown date. It was not known if the TWINRIX injection was from a vial or a prefilled syringe. The mother planned to continue follow-up with her daughter's (the subject) pediatrician on an unknown date. Follow-up information received via the mother of the consumer later on 14 February 2011 reported that the subject will return in 6 months for an additional TWINRIX vaccine. Follow-up information was received on 03 March 2011 via consumer, who reported the lot number as NDC number 581-60-815-46. Follow-up information was received on 22 March 2011 with no additional information provided.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt. states immediately after receiving flu vaccine, she experienced near-syncopal event. Lightheaded, dizziness, incoherent, loss of hearing, "saw stars". Nurse called EMS, who assessed patient and released her. No further treatment needed and pt. followed up with her primary doctor.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Deafness, Dizziness, Immediate post-injection reaction, Incoherent, Presyncope
Clinical narrative: Pt. states immediately after receiving flu vaccine, she experienced near-syncopal event. Lightheaded, dizziness, incoherent, loss of hearing, "saw stars". Nurse called EMS, who assessed patient and released her. No further treatment needed and pt. followed up with her primary doctor.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Visual impairment
Clinical narrative: Pt. states immediately after receiving flu vaccine, she experienced near-syncopal event. Lightheaded, dizziness, incoherent, loss of hearing, "saw stars". Nurse called EMS, who assessed patient and released her. No further treatment needed and pt. followed up with her primary doctor.
Age: 1.28
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Decreased appetite, Delusional perception, Dizziness, Irritability, Somnolence
Clinical narrative: Dizziness, delusional, irritable, sleepiness, loss of appetite, was told to wait at least two weeks to see if more reactions occur.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient developed fever 103 during night, early morning after getting vaccine. C/O leg pain, weakness. Injection site red & swollen 4 to 5 in. Warm to touch per patient.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient developed fever 103 during night, early morning after getting vaccine. C/O leg pain, weakness. Injection site red & swollen 4 to 5 in. Warm to touch per patient.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Decreased appetite, Dysarthria, Fatigue, Headache
Clinical narrative: Symptoms verified with grandmother, fatigue, malaise, unable to walk, headache, decreased appetite, slurred speech, flimsy legs, slept for four hours after vaccine at one to two hours after vaccine administration.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Muscular weakness
Clinical narrative: Symptoms verified with grandmother, fatigue, malaise, unable to walk, headache, decreased appetite, slurred speech, flimsy legs, slept for four hours after vaccine at one to two hours after vaccine administration.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at site of injection (R) arm.
Age: 30.0
Sex: M
Vaccine: FLU3, HEPA, IPV, TYP, YF
Symptoms: Unevaluable event
Clinical narrative: Vaccines for impending travel: Hepatitis A #1 of 2, Influenza 2011-12, Polio IPV, Typhoid TYPHIM VI, Yellow Fever.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Headache, Mental status changes, Muscular weakness, Nausea
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 13-OCT-2010 was vaccinated SC with the first 0.5ml dose of GARDASIL (Lot# 0938AA/1354AA, exp date 26-JUN-2014) and on an unspecified date was vaccinated with the second dose of GARDASIL (Lot# and route not reported). On 15-NOV-2011 the patient experienced weakness in her body and lower extremities, nausea, headaches, vomiting and an altered mental status after receiving a second injection on GARDASIL. The patient was hospitalized in the ER at an unspecified location for an unspecified duration of time. MORPHINA (strength and manufacturer unspecified) was given for her headaches. The doses of GARDASIL were also given outside the recommended dosing schedule for this product. The patient did many unspecified tests. At the time of the report, the patient was not recovered from the events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 13-OCT-2010 was vaccinated SC with the first 0.5ml dose of GARDASIL (Lot# 0938AA/1354AA, exp date 26-JUN-2014) and on an unspecified date was vaccinated with the second dose of GARDASIL (Lot# and route not reported). On 15-NOV-2011 the patient experienced weakness in her body and lower extremities, nausea, headaches, vomiting and an altered mental status after receiving a second injection on GARDASIL. The patient was hospitalized in the ER at an unspecified location for an unspecified duration of time. MORPHINA (strength and manufacturer unspecified) was given for her headaches. The doses of GARDASIL were also given outside the recommended dosing schedule for this product. The patient did many unspecified tests. At the time of the report, the patient was not recovered from the events. Additional information has been requested.
Age: 1.59
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever to 104F 12 hrs after receiving vaccines.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Asthenia, Erythema, Expired drug administered, Injection site swelling
Clinical narrative: It started with swelling at the site of injection into the shoulder, and by night the first day, that entire arm was swollen and incredibly sensitive to touch and/or movement.  That night I woke up several times, and I'm usually a heavy sleeper, because subtle movements in my sleep would cause so much pain to my arm, it'd jolt me out of sleep.  The next morning and the entire next day I had a fever, and couldn't muster the energy to get out of bed.  I lay in bed all day moaning from the intense dull pain my ballooned arm was generating.  Even my fingers were swollen, and the whole limb a reddish purple.  I was fortunate that my partner was home to care for me and to keep my fluid intake up.  Despite severely disrupted sleep the night of 4/15/11 (Friday), I didn't manage a wink of sleep Saturday night.  I was in too much pain.  I was bedridden all day Sunday (the day after injection) as well.  By Monday the swelling had almost all subsided and the fever was gone.  I returned to work, but it would be another day before I felt back to normal again.  This happened over 7 months ago, yet I remember like it was yesterday because it was that horrific an experience.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: It started with swelling at the site of injection into the shoulder, and by night the first day, that entire arm was swollen and incredibly sensitive to touch and/or movement.  That night I woke up several times, and I'm usually a heavy sleeper, because subtle movements in my sleep would cause so much pain to my arm, it'd jolt me out of sleep.  The next morning and the entire next day I had a fever, and couldn't muster the energy to get out of bed.  I lay in bed all day moaning from the intense dull pain my ballooned arm was generating.  Even my fingers were swollen, and the whole limb a reddish purple.  I was fortunate that my partner was home to care for me and to keep my fluid intake up.  Despite severely disrupted sleep the night of 4/15/11 (Friday), I didn't manage a wink of sleep Saturday night.  I was in too much pain.  I was bedridden all day Sunday (the day after injection) as well.  By Monday the swelling had almost all subsided and the fever was gone.  I returned to work, but it would be another day before I felt back to normal again.  This happened over 7 months ago, yet I remember like it was yesterday because it was that horrific an experience.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: It started with swelling at the site of injection into the shoulder, and by night the first day, that entire arm was swollen and incredibly sensitive to touch and/or movement.  That night I woke up several times, and I'm usually a heavy sleeper, because subtle movements in my sleep would cause so much pain to my arm, it'd jolt me out of sleep.  The next morning and the entire next day I had a fever, and couldn't muster the energy to get out of bed.  I lay in bed all day moaning from the intense dull pain my ballooned arm was generating.  Even my fingers were swollen, and the whole limb a reddish purple.  I was fortunate that my partner was home to care for me and to keep my fluid intake up.  Despite severely disrupted sleep the night of 4/15/11 (Friday), I didn't manage a wink of sleep Saturday night.  I was in too much pain.  I was bedridden all day Sunday (the day after injection) as well.  By Monday the swelling had almost all subsided and the fever was gone.  I returned to work, but it would be another day before I felt back to normal again.  This happened over 7 months ago, yet I remember like it was yesterday because it was that horrific an experience.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Injection site reaction, Lymph node pain, Lymphadenopathy
Clinical narrative: Temperature of 100.2. Extremely swollen, red, painful axillary lymph nodes. Generalized muscle aches. Red splotches upper arm seperate from injection site.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Rash macular
Clinical narrative: Temperature of 100.2. Extremely swollen, red, painful axillary lymph nodes. Generalized muscle aches. Red splotches upper arm seperate from injection site.
Age: 15.0
Sex: M
Vaccine: HPVX, FLU3, HPV4
Symptoms: Decreased appetite, Disturbance in attention, Dizziness, Injection site pain, Lethargy
Clinical narrative: Pain in shot area, down arm. Dizzy, Fever, Nausea, Lethargic, Vomit, No appetite, Hard to focus, Very sleepy.
Age: 15.0
Sex: M
Vaccine: HPVX, FLU3, HPV4
Symptoms: Nausea, Pain in extremity, Pyrexia, Somnolence, Vaccination complication
Clinical narrative: Pain in shot area, down arm. Dizzy, Fever, Nausea, Lethargic, Vomit, No appetite, Hard to focus, Very sleepy.
Age: 15.0
Sex: M
Vaccine: HPVX, FLU3, HPV4
Symptoms: Vomiting
Clinical narrative: Pain in shot area, down arm. Dizzy, Fever, Nausea, Lethargic, Vomit, No appetite, Hard to focus, Very sleepy.
Age: 15.0
Sex: M
Vaccine: HPVX, FLU3, HPV4
Symptoms: Chills, Dizziness, Pain in extremity
Clinical narrative: Pain in shot area, down arm. Dizzy, Fever, Nausea, Lethargic, Vomit, No appetite, Hard to focus, Very sleepy.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Oropharyngeal pain, Rash, Swelling face
Clinical narrative: Patient c/o "throat hurts". Developed swelling of face, visible rash.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blister, Oropharyngeal blistering, Pyrexia, Vomiting
Clinical narrative: Side effects began with vomiting and fever on day after vaccination.  Vomiting continued for 4 days.  In addition to symptoms above patient developed blisters inside her nose and around her mouth.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT DELTOID WAS SWOLLEN, RED, HOT FOR 2 WKS AFTER VACCINE WAS GIVEN 10-27-2011. NO TREATMENT WAS GIVEN.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eyelid oedema, Feeling hot, Lip swelling, Pruritus
Clinical narrative: On 9/19/2011 noticed itching of hands. On 9/20/2011 eye swollen shut, hands red, hot itching. Went to Urgent Care. 9/21/2011 noticed swelling of lips. Advised to go to ER.