chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.27
Sex: F
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis
Clinical narrative: Initial report received on 04 January 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; dose 1 received on 16 July 2009 (lot number C3299AA), dose 2 received on 17 September 2009 (lot number C3430AA), dose 3 received on 24 November 2009 (lot number C3470AA), and a dose of DAPTACEL; lot number C3380AA received on 26 August 2010 (route and site of administration not reported). The subject developed cold-like symptoms on 24 November 2011, approximately 15 months after the last dose. On 03 December 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced apnea and sleep disturbance. Laboratory testing included negative PCR on 22 December 2011. However, the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 22 December 2011. The subject was not hospitalized. At the time of final contact on 23 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.27
Sex: F
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 04 January 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; dose 1 received on 16 July 2009 (lot number C3299AA), dose 2 received on 17 September 2009 (lot number C3430AA), dose 3 received on 24 November 2009 (lot number C3470AA), and a dose of DAPTACEL; lot number C3380AA received on 26 August 2010 (route and site of administration not reported). The subject developed cold-like symptoms on 24 November 2011, approximately 15 months after the last dose. On 03 December 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced apnea and sleep disturbance. Laboratory testing included negative PCR on 22 December 2011. However, the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 22 December 2011. The subject was not hospitalized. At the time of final contact on 23 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray abnormal, Cough, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 04 January 2012 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; dose 1 lot number C3663AA received on 13 December 2010, dose 2 lot number C3759AA received on 10 February 2011 and dose 3 (lot not reported) received on 14 April 2011 (route and site of administration not reported). The subject developed cold-like symptoms on 03 November 2011, approximately 6 months after the last dose. On 10 November 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 21 November 2011. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 13 November 2011 for 7 days. The subject was hospitalized (dates of hospitalization not reported). At the time of final contact on 30 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 51 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pneumonia, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 04 January 2012 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; dose 1 lot number C3663AA received on 13 December 2010, dose 2 lot number C3759AA received on 10 February 2011 and dose 3 (lot not reported) received on 14 April 2011 (route and site of administration not reported). The subject developed cold-like symptoms on 03 November 2011, approximately 6 months after the last dose. On 10 November 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 21 November 2011. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 13 November 2011 for 7 days. The subject was hospitalized (dates of hospitalization not reported). At the time of final contact on 30 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 51 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching of affected right arm. Mother reports redness and swelling decreased significantly by report date of 1/9/12.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, C-reactive protein, Muscular weakness, Neuralgia, Neuralgic amyotrophy
Clinical narrative: Symptoms began approx. 2 weeks after vaccine. Parsonage-Turner Plexopathy syndrome including: heaviness, weakness, & neuropathic pain in left limb with tingling in fingers.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Red blood cell sedimentation rate, Sensation of heaviness
Clinical narrative: Symptoms began approx. 2 weeks after vaccine. Parsonage-Turner Plexopathy syndrome including: heaviness, weakness, & neuropathic pain in left limb with tingling in fingers.
Age: 0.63
Sex: F
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Very intense seizures unlike those that she has normally. They lasted for about 2 minutes at a time and continued on and off all night.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood glucose normal, Nuclear magnetic resonance imaging, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm pain and swelling. Treatment of ice and heat along with Vicodin.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis normal
Clinical narrative: Left arm pain and swelling. Treatment of ice and heat along with Vicodin.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient stated she received INFLUENZA vaccine at that evening started feeling itchy. When she got up the next morning she had a rash on the inner and upper thigh and lower abdomen which she believes is a reaction to the vaccine. She has not had previous reactions in the past.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia
Clinical narrative: Leg, shoulders, arms joint pain; felt very weak. Received cortisone injections from Dr. Followed up w/ another Dr. who ordered blood & urine tests.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: WOKE UP FOLLOWING AM AFTER IMMUNIZATION AND C/O SORENESS TO TOUCH, REDNESS, ITCHING. SWOLLEN APPROX. 2 INCH DIAMETER. APPLIED ICE SAME DAY. 2 DAYS AFTER IMMUNIZATION NOT AS SWOLLEN, STILL SLIGHTLY TENDER TO TOUCH.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient experienced extensive inflammation and redness a the site of injection.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Patient stated discovered to have red, blotchy and itchy skin everywhere.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Shoulder and Arm Pain reported by pharmacy. On 12/8/2011 Saw Dr in office 2+ tender over and below injection site left deltoid. No additional work up.  12-14-2011 patient seen in office by Dr arm pain still present left shoulder/ arm diffusely swollen distal to deltoid. Prednisone pak ordered and MRI of the Humerus. Patient seen again by Dr on 01/03/2012 MRI abnormal diagnosis of Parsonage Turner Syndrome. Patient given pain meds and anti-inflammatory referred patient to Orthopedics.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Shoulder and Arm Pain reported by pharmacy. On 12/8/2011 Saw Dr in office 2+ tender over and below injection site left deltoid. No additional work up.  12-14-2011 patient seen in office by Dr arm pain still present left shoulder/ arm diffusely swollen distal to deltoid. Prednisone pak ordered and MRI of the Humerus. Patient seen again by Dr on 01/03/2012 MRI abnormal diagnosis of Parsonage Turner Syndrome. Patient given pain meds and anti-inflammatory referred patient to Orthopedics.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site mass, Injection site pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Shoulder and Arm Pain reported by pharmacy. On 12/8/2011 Saw Dr in office 2+ tender over and below injection site left deltoid. No additional work up.  12-14-2011 patient seen in office by Dr arm pain still present left shoulder/ arm diffusely swollen distal to deltoid. Prednisone pak ordered and MRI of the Humerus. Patient seen again by Dr on 01/03/2012 MRI abnormal diagnosis of Parsonage Turner Syndrome. Patient given pain meds and anti-inflammatory referred patient to Orthopedics.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Neuralgic amyotrophy, Neurological examination, Pain
Clinical narrative: Shoulder and Arm Pain reported by pharmacy. On 12/8/2011 Saw Dr in office 2+ tender over and below injection site left deltoid. No additional work up.  12-14-2011 patient seen in office by Dr arm pain still present left shoulder/ arm diffusely swollen distal to deltoid. Prednisone pak ordered and MRI of the Humerus. Patient seen again by Dr on 01/03/2012 MRI abnormal diagnosis of Parsonage Turner Syndrome. Patient given pain meds and anti-inflammatory referred patient to Orthopedics.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Ultrasound scan
Clinical narrative: Shoulder and Arm Pain reported by pharmacy. On 12/8/2011 Saw Dr in office 2+ tender over and below injection site left deltoid. No additional work up.  12-14-2011 patient seen in office by Dr arm pain still present left shoulder/ arm diffusely swollen distal to deltoid. Prednisone pak ordered and MRI of the Humerus. Patient seen again by Dr on 01/03/2012 MRI abnormal diagnosis of Parsonage Turner Syndrome. Patient given pain meds and anti-inflammatory referred patient to Orthopedics.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain in extremity, Radiculitis brachial
Clinical narrative: Approximately 24 hours following flu injection, patient experienced soreness in the left arm where shot was given; this persisted for more than a week and was somewhat relieved by Motrin for the pain. When the soreness at injection site persisted past 2 weeks, accompanied by stiffness and decreased range of motion in the arm, patient notified Employee Health and was advised by the personnel there to apply warm compresses to relax muscle and relieve local soreness. Symptoms worsened and patient notified person at Employee Health, and person advised her to seek medical evaluation. Patient was seen at Urgent Care on 1/5/2012 and the Nurse Practitioner there speculated that the symptoms appeared to be "brachial plexus neuritis" and prescribed Motrin and Flexaril for same. NP advised that patient see a Neurologist, which she will schedule in the very near future. As of January 11, 2012, patient reports some persistent decreased range of motion and soreness in the left arm.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Insomnia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Approx 12:30 PM same day..excrutiating pain in left shoulder..unable to move arm at all...used ice and Tylenol..didnt help almost went to ER but waited till next morning..called DR and they said use 600 mg ibuprofen. Pain was so bad first 48 hours could not stop tears...could not sleep..this is now Fri..1/13/12   have regianed about 65% range of motion..still hurts all the time.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Bone pain, Chills, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Fever, bone aches, stiff painful arm, chills- Motrin for two days I took Motrin and stayed in bed and slept. Facial red rash started 6 days after vaccine and I began to develop red bumps and thickening of the facial skin.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Rash, Rash erythematous, Skin hypertrophy
Clinical narrative: Fever, bone aches, stiff painful arm, chills- Motrin for two days I took Motrin and stayed in bed and slept. Facial red rash started 6 days after vaccine and I began to develop red bumps and thickening of the facial skin.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pt. received flu shot, within 24 hrs. her left arm felt very sore. Within 5 days of the shot, patient cannot move her arm due to extreme pain. Pt. took some Ibuprofen 600 mg with no relief, went to see Dr. but nothing was resolved. Pt. had been having difficulty sleeping due to pain. Pt. had seen also orthopedic surgeon, physical therapist. Pt. just received MRI 1/12/12, still awaiting result. Pt. also takes some VICODIN w/ little relief. Pt. to start FLEXERIL to see if she will get relief.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Patient received flu shots on 12/1/2011. Client states that she experienced redness pain & swelling at site. Redness & pain subsided but despite felt some discomfort at site. Did not go to see doctor. She stated that she became busy with the holidays. After the holiday were over, this past week she had some mobility problem with her arm. She called the public health nurse in the afternoon of 1/12/2012. I advised her to go to doctor and get checked. Reported incident 1/12/12 in afternoon.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Fatigue, Vertigo
Clinical narrative: 49 y.o. healthy female received Typhim-Vi 12/16/11 c/o fatigue 12/19/11, vertigo 12/20/11 and diarrhea 12/20/11. Reported symptoms 12/22/11 - vertigo persists, improved with meclizine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site rash
Clinical narrative: Pt received shot on 11/28/11. Pt came back on 1/13/12 and has a visible bruise and a small rash around injection site up to top of arm. Pt wanted me to look at it so that's why I am filling out form since it wasn't normal.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis reactive, Asthenia, Malaise
Clinical narrative: Generalized malaise weakness the day after vaccination. Reactive arthritis, roaming from ankles, knees, wrists, individual fingers, foot arches with no previous injury to any of affected joints. Affected joint generally painful for several days even with MOTRIN 800mg TID, then another set of joints affected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Dyskinesia
Clinical narrative: Mother states child was jerking the day after shots were administered.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Secondary transmission
Clinical narrative: Patient was given the ZOSTAVAX on 9/19/11. On 10/10/11 his wife was diagnosed with shingles (10/8/11 onset). She is on immune-suppressing medicine for RA. She is worried that her husbands vaccine gave her the shingles. I advised her that there no evidence of this in the literature.
Age: 22.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Nickel sized circular red mark over the injection site along with itching.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Crying, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Routine fevers started, odd skin rashes, and with each episode the lumps at the injection sites would become red and warm to the touch.  To this day, he still has periodic fever and terrible itching and swelling in those spots.  Spoke with the doc's on several ocassions...finally got someone to tell me that there was an issue with the shots and to do heat therapy on the legs to dissolve the lumps.  This worked for a while but recently they flamed up with a vengeance and we're back at square one. He received DTaP on 2/10/11...and hib and MMR together on 3/9/2011. All lumps are still there and flaring to this day. Recently he has started awaking at night with leg spasms and having episodes of inconsolable crying...with each event he is reaching at his thighs where the shots were.  The itching is almost non-stop for him.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site warmth, Muscle spasms, Pyrexia, Rash
Clinical narrative: Routine fevers started, odd skin rashes, and with each episode the lumps at the injection sites would become red and warm to the touch.  To this day, he still has periodic fever and terrible itching and swelling in those spots.  Spoke with the doc's on several ocassions...finally got someone to tell me that there was an issue with the shots and to do heat therapy on the legs to dissolve the lumps.  This worked for a while but recently they flamed up with a vengeance and we're back at square one. He received DTaP on 2/10/11...and hib and MMR together on 3/9/2011. All lumps are still there and flaring to this day. Recently he has started awaking at night with leg spasms and having episodes of inconsolable crying...with each event he is reaching at his thighs where the shots were.  The itching is almost non-stop for him.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Headache, Joint stiffness
Clinical narrative: Severe pain, hard to breathe, vomiting, fever over 100. Headaches, diarrhea, arm swelling, body paralysis, hands completely locked up, dizzy.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Oedema peripheral, Pain, Paralysis, Pyrexia, Vomiting
Clinical narrative: Severe pain, hard to breathe, vomiting, fever over 100. Headaches, diarrhea, arm swelling, body paralysis, hands completely locked up, dizzy.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Blood creatinine increased, Blood electrolytes normal, Blood urea normal, Chest X-ray normal, Diplegia
Clinical narrative: Severe pain, hard to breathe, vomiting, fever over 100. Headaches, diarrhea, arm swelling, body paralysis, hands completely locked up, dizzy.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Dyspnoea, Electrocardiogram normal, Liver function test normal, Nausea, Paraesthesia
Clinical narrative: Severe pain, hard to breathe, vomiting, fever over 100. Headaches, diarrhea, arm swelling, body paralysis, hands completely locked up, dizzy.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Severe pain, hard to breathe, vomiting, fever over 100. Headaches, diarrhea, arm swelling, body paralysis, hands completely locked up, dizzy.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Gastrooesophageal reflux disease, Irritability
Clinical narrative: Fussy, crying, decreased appetite, symptoms of GERD.  Seen 1/9/12 and started on medical therapy for GERD.
Age: 1.11
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Swelling
Clinical narrative: Swelling, warmth. Area is 4cm redness, 2 cm induration.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever (104.0).
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Fatigue
Clinical narrative: Severe fatigue and pain in back near right should blade.  Pain is intermittent and occurs in throbbing pulses lasting from 5 minutes to 2 hrs.
Age: 0.72
Sex: M
Vaccine: DTAP
Symptoms: Crying, Injection site swelling, Mass, Pyrexia, Screaming
Clinical narrative: Infant began uncontrollably screaming and crying for 5 hours without stopping. Fever and swelling on thigh at shot site. A knot appeared. Took 2 months for knot to disappear.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: 4 inch wide redness circle around injection site rash on back of neck.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass
Clinical narrative: Patient noticed a lump at vaccine site 2 weeks after the vaccine was administered.
Age: 1.35
Sex: M
Vaccine: DTAPH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Hives on arms, legs, and torso. Red, warm, swelling around area where shot was given. Fever
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Convulsion, Pyrexia, Staring, Tremor
Clinical narrative: Mother states fever 100.5 for 1 1/2 days (since injection) Rt side shaking and staring for 30 seconds thinking it was a seizure.
Age: 40.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Incoherent, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient developed chills, body aches, mild fever (didn't take actual temp) and local redness & swelling at site of injection, left deltoid. Pt said he felt incoherent for awhile. He also received Tdap same day.
Age: 40.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient developed chills, body aches, mild fever (didn't take actual temp) and local redness & swelling at site of injection, left deltoid. Pt said he felt incoherent for awhile. He also received Tdap same day.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Adverse event, Chills, Injection site cellulitis, Injection site erythema
Clinical narrative: See attached. Patient was vaccinated on January 3, 2012 with both FLUZONE and PNEUMOVAX. The following day on Wednesday the 4th, she experienced fever, chills, and nausea. She had also developed cellulitis at the PNEUMOVAX injection site. Photos showed red inflamed skin on right deltoid to elbow. Patient called her doctor on Thursday, the 5th, and received antibiotics at office visit on Friday, the 6th. On Saturday, the 7th, patient went to hospital to receive more antibiotics. Cellulitis was noted for size and she was instructed that if cellulitis had not receded by Sunday, to return to hospital. On Sunday, the 8th, patient returned to hospital for IV antibiotics and hydration. On Monday, the 9th, patient returned to hospital for second course of IV antibiotics. On Saturday, the 14th, patient reported adverse event with time line, to pharmacist. Although patient's cellulitis is receding, she is not fully recovered. She was out of work on January 5, 6, and 10th. She is seeking compensation for medical expenses incurred and time out of work.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Nausea, Pyrexia
Clinical narrative: See attached. Patient was vaccinated on January 3, 2012 with both FLUZONE and PNEUMOVAX. The following day on Wednesday the 4th, she experienced fever, chills, and nausea. She had also developed cellulitis at the PNEUMOVAX injection site. Photos showed red inflamed skin on right deltoid to elbow. Patient called her doctor on Thursday, the 5th, and received antibiotics at office visit on Friday, the 6th. On Saturday, the 7th, patient went to hospital to receive more antibiotics. Cellulitis was noted for size and she was instructed that if cellulitis had not receded by Sunday, to return to hospital. On Sunday, the 8th, patient returned to hospital for IV antibiotics and hydration. On Monday, the 9th, patient returned to hospital for second course of IV antibiotics. On Saturday, the 14th, patient reported adverse event with time line, to pharmacist. Although patient's cellulitis is receding, she is not fully recovered. She was out of work on January 5, 6, and 10th. She is seeking compensation for medical expenses incurred and time out of work.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Lethargy, Unresponsive to stimuli
Clinical narrative: Child had 4hr period of lethargy/non responsiveness. No witnessed sz or apnea. Seen in ER - normal exam at that time - seen the next day - normal exam.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abscess, Cellulitis, Erythema, Mass
Clinical narrative: Started as red lump. 1-14-12 Dx with cellulitis & abscess. Treated with AUGMENTIN.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Local maculopapular rash at upper arm 48 hours after HepA injection given, pruritus.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal distension, Decreased appetite, Faeces discoloured, Intussusception, Lethargy
Clinical narrative: Decrease appetite / Black stools / Lethargy / Distended abdomen. Sent to ER. Dx: Intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Decrease appetite / Black stools / Lethargy / Distended abdomen. Sent to ER. Dx: Intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Decreased appetite, Diarrhoea
Clinical narrative: Decrease appetite / Black stools / Lethargy / Distended abdomen. Sent to ER. Dx: Intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Enema administration, Faeces discoloured, Haematochezia, Haematocrit decreased, Intussusception
Clinical narrative: Decrease appetite / Black stools / Lethargy / Distended abdomen. Sent to ER. Dx: Intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Irritability, Lethargy, Lymphocyte percentage increased, Melaena, Neutrophil percentage decreased
Clinical narrative: Decrease appetite / Black stools / Lethargy / Distended abdomen. Sent to ER. Dx: Intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray normal, X-ray with contrast upper gastrointestinal tract normal
Clinical narrative: Decrease appetite / Black stools / Lethargy / Distended abdomen. Sent to ER. Dx: Intussusception.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Visual brightness
Clinical narrative: Immediately following vaccination, pt had pallor, c/o dizziness, and "lights seeming too bright".
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Convulsion, Culture, Electroencephalogram abnormal, Encephalitis
Clinical narrative: Limbic Seizures later diagnosed as Inflammatory/autoimmune Limbic Encephalitis.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Immunology test, Lumbar puncture, Nuclear magnetic resonance imaging brain, Serology test, Viral test
Clinical narrative: Limbic Seizures later diagnosed as Inflammatory/autoimmune Limbic Encephalitis.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Localized allergic reaction: redness, swelling, pain around area of injection that lastest for 7 days. Saw doctor and no medical attention required.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm induration at injection site.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Patient received vaccination on 9/14/2011. Started having symptoms about "4-6 weeks" after vaccination. Signs and symptoms: general weakness of hands and feet; hands started to tingle and became numb, patient stated that it "felt like a glove pushing all the blood out of his hands"; left forearm, shoulder and left thigh started having sudden sharp pain. Went to ER, kept him there for 5 ½ days and was diagnosed with GBS. When patient's wife called to report event he was still having general weakness of entire body, cold hands and a feeling of being constantly run down, needs a cane to get around.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Paraesthesia, Peripheral coldness, Walking aid user
Clinical narrative: Patient received vaccination on 9/14/2011. Started having symptoms about "4-6 weeks" after vaccination. Signs and symptoms: general weakness of hands and feet; hands started to tingle and became numb, patient stated that it "felt like a glove pushing all the blood out of his hands"; left forearm, shoulder and left thigh started having sudden sharp pain. Went to ER, kept him there for 5 ½ days and was diagnosed with GBS. When patient's wife called to report event he was still having general weakness of entire body, cold hands and a feeling of being constantly run down, needs a cane to get around.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Immediate pain in left arm, which was unusual. Within an hour, stiffness and pain increased. When removing band-aid that evening, noticed that the actual injection site was above band-aid placement. The injection site was higher on left arm/closer to shoulder area than usual. Pain and stiffness was at highest within the weeks following vaccine. 2 months after vaccine, still experiencing pain, stiffness, reduced movement in left arm. Pain is experienced in upper arm and sometimes elbow area. Still very uncomfortable 2 months post vaccine. Will be seeking medical treatment.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Narcolepsy, Sleep study
Clinical narrative: Nacrolepsy.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Narcolepsy, Sleep study abnormal, Somnolence
Clinical narrative: Nacrolepsy.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm pain.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Abscess to left thigh.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, numbness at site of HPV and MCV4.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Abscess on left thigh.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: R arm swollen and hot elbow to shoulder; couldn't lift arm more than 1" without pain; fever/chills; 1/14/2012 - R arm still hot and swollen, but better.
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Heat rash, Induration, Rash erythematous, Tenderness
Clinical narrative: Red rashy heat present tender to touch and hardened area approx 4 inches.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Nervousness, Palpitations, Tunnel vision
Clinical narrative: Pt reported feeling light-headed/dizziness, vision changes (tunnel vision) and shaky, also reported palpitations (she attributed all symptoms to insufficient caloric intake), felt feverish but no fever, temp was 97.3F. Hands were stable, no rash or difficulty breathing.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Weight loss diet
Clinical narrative: Pt reported feeling light-headed/dizziness, vision changes (tunnel vision) and shaky, also reported palpitations (she attributed all symptoms to insufficient caloric intake), felt feverish but no fever, temp was 97.3F. Hands were stable, no rash or difficulty breathing.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy lymph gland abnormal, Lymphadenitis, Lymphadenopathy, Lymphoma
Clinical narrative: This case was reported by a physician (also the subject's husband) and described the occurrence of lymphoma in a 75-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included HCTZ, Naproxen and Vitamin D. On 13 October 2011 the subject received a dose of FLULAVAL (unknown route, left deltoid). In November 2011, 1 month after vaccination with FLULAVAL, the subject experienced lymphadenopathy and was diagnosed as having reactive lymphadenitis. Less than a year after vaccination with FLULAVAL, the subject experienced lymphoma. At the time the lymphadenopathy (enlarged lymph node) was discovered it was diagnosed as reactive lymphadenitis; however, once it was biopsied, it was lymphoma. This case was assessed as medically serious by GSK. Relevant test results included lymph node biopsy indicating lymphoma. At the time of reporting the outcome of the events was unspecified. According to the physician (also the subject's husband), the subject had received the flu vaccine for the past 10 years and may have had local pain as a side effect only in the past. See case A0960863B for details.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood pressure decreased, Catatonia, Cold sweat, Convulsion
Clinical narrative: Patient showed signs of going into a catatonic shock acompanied by seizures, skin clammy and moist to touch. Blood Pressure dropped to 60/20, patient was in and out of this state for about 10 minutes. 911 was called and patient was taken to Emergency room.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Nausea, Tachycardia
Clinical narrative: Tachycardic, difficulty breathing, nauseated. Went to medical aid unit - shot of epi, BENADRYL.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dysgeusia, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Received vaccine at 1:50pm. Began to have site soreness and swelling that radiated to right shoulder and down to rt. elbow. Experienced redness associated with area of swelling. She began to experience fatigue, shivers and had night sweats Friday night (1-13-12). She states began to have a "metallic" taste in mouth beginning at approx 5:00pm on 1-12-12. Still has faint metallic taste today 1/16/12.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Night sweats
Clinical narrative: Received vaccine at 1:50pm. Began to have site soreness and swelling that radiated to right shoulder and down to rt. elbow. Experienced redness associated with area of swelling. She began to experience fatigue, shivers and had night sweats Friday night (1-13-12). She states began to have a "metallic" taste in mouth beginning at approx 5:00pm on 1-12-12. Still has faint metallic taste today 1/16/12.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented to office 3 days after vaccine. Large swollen area, warm to touch. Has "improved" since initial reaction. (R) deltoid -> site of PNEUMOVAX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness, mild induration (R) thigh. No tenderness.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, FLU3, HEPA
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of passing out in a 11-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), INFLUENZA (non-gsk). Concurrent medical conditions included syncope. There were no concurrent medications. On the afternoon of 29 December 2011 the subject received 2nd dose of HAVRIX at 0.5 ml in the right arm and 1st dose of INFLUENZA (Sanofi) in the left arm. On 29 December 2011, 2 minutes after vaccination with HAVRIX and INFLUENZA (sanofi), the subject went into the bathroom to find her brother and passed out. This case was assessed as medically serious by GSK. On 29 December 2011, the event was resolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX and INFLUENZA (Sanofi).
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion spontaneous, Chorioamnionitis, Maternal exposure during pregnancy, Pregnancy test positive, Premature rupture of membranes
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck) and MMR II, a Pregnancy Registry products, concerning a 35 year old female patient with not pertinent medical history and no allergies, who on 07-OCT-2010 was vaccinated in the left side with a 0.5 ml dose of VARIVAX (Merck) (Lot # 665912/1772Y, Exp date 08-APR-2012). On the same day, the patient received a 0.5 ml dose into the right arm of MMR II (Lot # 667188/0444Z, Exp date 26-MAR-2012). There was no concomitant medication. The nurse reported that after receiving the vaccines, on an unknown date, the patient did a home pregnancy test and it was positive. On 01-NOV-2010 the patient went to the clinic and it was confirmed via a pregnancy test that she was approximately 8 weeks pregnant. The last menstrual period was approximately on 06-SEP-2010. The estimated delivery date is on 13-JUN-2011. Follow up information has been received via telephone call from a healthcare worker regarding the patient's pregnancy outcome. The health care worker reported that the patient's pregnancy ended with a spontaneous abortion on 20-DEC-2010 at 16 weeks of gestation. It was also reported that the baby was not viable and fetal demise was due to spontaneous membrane rupture. The pathology report of the maternal/fetal contents of conception revealed there was acute chorioamnionitis with retro-placental hematoma of 90% of placenta. The reporter stated there was no mention of trauma in the record and there was no mention of defects or sex of fetus in the pathology report. At the time of the report the patient's outcome was unknown. It was reported that the patient only received one VARIVAX (Merck) immunization. Upon internal review pregnancy ended with a spontaneous abortion was determined to be an other important medical event. No further information is available.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Retroplacental haematoma
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck) and MMR II, a Pregnancy Registry products, concerning a 35 year old female patient with not pertinent medical history and no allergies, who on 07-OCT-2010 was vaccinated in the left side with a 0.5 ml dose of VARIVAX (Merck) (Lot # 665912/1772Y, Exp date 08-APR-2012). On the same day, the patient received a 0.5 ml dose into the right arm of MMR II (Lot # 667188/0444Z, Exp date 26-MAR-2012). There was no concomitant medication. The nurse reported that after receiving the vaccines, on an unknown date, the patient did a home pregnancy test and it was positive. On 01-NOV-2010 the patient went to the clinic and it was confirmed via a pregnancy test that she was approximately 8 weeks pregnant. The last menstrual period was approximately on 06-SEP-2010. The estimated delivery date is on 13-JUN-2011. Follow up information has been received via telephone call from a healthcare worker regarding the patient's pregnancy outcome. The health care worker reported that the patient's pregnancy ended with a spontaneous abortion on 20-DEC-2010 at 16 weeks of gestation. It was also reported that the baby was not viable and fetal demise was due to spontaneous membrane rupture. The pathology report of the maternal/fetal contents of conception revealed there was acute chorioamnionitis with retro-placental hematoma of 90% of placenta. The reporter stated there was no mention of trauma in the record and there was no mention of defects or sex of fetus in the pathology report. At the time of the report the patient's outcome was unknown. It was reported that the patient only received one VARIVAX (Merck) immunization. Upon internal review pregnancy ended with a spontaneous abortion was determined to be an other important medical event. No further information is available.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: Information has been received from a physician concerning a 15 year old male who was vaccinated with his third dose of GARDASIL (Lot number not reported) on approximately on 02-JAN-2012. Subsequently, the patient experienced what appeared to be seizure-like activity. The physician stated that the patient lost consciousness and his body tensed; he might have "stopped breathing momentarily." The physician reported that he managed the patient accordingly, (intervention and monitored) and that the patient regained consciousness. Upon internal review seizure like activity was determined to be an other important medical event. This is one of the several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Acne, Erythema, Groin pain, Heat rash, Hemiparesis
Clinical narrative: Information has been received from a 72 year old female patient with allergy to sulfa medications and sulfides and penicillin who on 30-DEC-2011, was vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot # 671554/1297AA). In 2002, the patient received the a first dose of PNEUMOVAX 23 without incidence (dose, route and lot# were not reported). Concomitant therapy included gabapentin and baclofen and "provacol". On 30-DEC-2011, right after receiving the vaccine, the patient experienced "soreness at the sight" and on 30-DEC-2011, that night, the patient noticed redness in her arm. On 31-DEC-2011, in the morning the patient developed " a prickly heat like pimply rash". On an unknown date the patient started to have pain in her left groin, which turned into weakness in her left side. The pain was to the point that the patient did had to lift her legs manually to tie her shoes this pain began within the last few days. It was reported that routine tests were done before adverse event took place. The patient's treatment included BENADRYL. The patient did not seek medical attention. At the time of the report patient's outcome was not recovered. Upon internal review, Weakness in left side was determined to be an other important medical event. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Laboratory test
Clinical narrative: Information has been received from a 72 year old female patient with allergy to sulfa medications and sulfides and penicillin who on 30-DEC-2011, was vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot # 671554/1297AA). In 2002, the patient received the a first dose of PNEUMOVAX 23 without incidence (dose, route and lot# were not reported). Concomitant therapy included gabapentin and baclofen and "provacol". On 30-DEC-2011, right after receiving the vaccine, the patient experienced "soreness at the sight" and on 30-DEC-2011, that night, the patient noticed redness in her arm. On 31-DEC-2011, in the morning the patient developed " a prickly heat like pimply rash". On an unknown date the patient started to have pain in her left groin, which turned into weakness in her left side. The pain was to the point that the patient did had to lift her legs manually to tie her shoes this pain began within the last few days. It was reported that routine tests were done before adverse event took place. The patient's treatment included BENADRYL. The patient did not seek medical attention. At the time of the report patient's outcome was not recovered. Upon internal review, Weakness in left side was determined to be an other important medical event. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Injection site haematoma
Clinical narrative: Bruise at injection site and lump under armpit noticed.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: 11/23/2011 - Pt presented for flu vaccine. Pt tolerated well. Pt represented to office following week with c/o soreness, stiffness, and swelling. Pt was seen by Dr who referred he to Dr for possible shoulder effusion.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm was sore and continued to stay sore for over 8-10 weeks. Had limited mobility in arm.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: #1 9-20-07. #2 5-27-11. Has had 2 varicella vac - diagnosed varicella.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal pain, Constipation, Crying, Irritability, Muscle spasms
Clinical narrative: Fever 100.1 F for 24 hr then 99.6, very fussy for 4-5 days, sudden episode of crying, abd. pain, cramps and constipated. Possible reaction to ROTATEQ.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 100.1 F for 24 hr then 99.6, very fussy for 4-5 days, sudden episode of crying, abd. pain, cramps and constipated. Possible reaction to ROTATEQ.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: Has dime sized, slightly raised area at injection site. Area affected has diminished slightly over months since dosage administered. No pain; no discoloration. No temperature diff.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site discolouration
Clinical narrative: Has dime sized, slightly raised area at injection site. Area affected has diminished slightly over months since dosage administered. No pain; no discoloration. No temperature diff.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: Redness of (L) arm x 1 day & today. Arm is sore x 7 days. No fevers. No treatment.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Arm pain, fever, erythema of (R) arm 5cm x 3cm very tender to palpation, tx with prednisone & AUGEMTIN.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cough, Fatigue, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Client states she felt "funny" immediately after vaccination. Returned to clinic to have PPD read, and now client is complaining of fatigue, elevated temp (100-101 degrees F), cough & sore throat. Started by supper time on 1/4/12. Client states she feels this is due to the pertussis part of the vaccine. She has not seen a physician. Encouraged rest, pain/fever reducer & follow up with physician if no improvement in symptoms.