chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Immunoglobulin therapy, Influenza virus test negative
Clinical narrative: This literature report (initial receipt: 10-Jul-2012) concerns a 9-year-old female patient, with a history of recurrent otitis media since 15 months of age, chronic sinusitis, and 2 episodes of pneumonia, who presented for the evaluation of a possible immune deficiency. According to the parents, the patient was always 'chronically' ill and has received multiple courses of antibiotics, including a trial of prophylactic antibiotics. The past history included symptoms consistent with asthma, for which she was being treated with a leukotriene modifier, and allergic rhinitis, for which she was being treated with topical nasal steroids and antihistamines. Family history was positive for allergic disease in both parents. Allergy skin test results are negative for inhalant allergens. There was no family history of an immune deficiency disorder. On an unknown date the patient received an influenza vaccine (brand name and manufacturer were not reported). Eight weeks after receiving vaccination, the patient had a blood work. Antibodies to influenza A and B were absent. The event was reported as poor response to influenza vaccine. The significant history of recurrent infections, ongoing chronic sinusitis, multiple antibiotic use, poor response to influenza and also PNEUMOVAX vaccines, and month of presentation (November) led to a consideration of starting replacement intravenous immunoglobulin (IVIG) therapy at 400 mg/kg on a monthly regimen. She did well on the replacement IVIG therapy, with markedly less episodes of otitis media and also improvement in the frequency of sinusitis. Shortly after her parents divorced, the patient moved out of town with her mother. She was lost to follow-up and apparently discontinued her replacement immunoglobulin therapy. At age 16 years, the patient decided to live with her father again and presented with recurrent infections, including draining ears, chronic cough, and recurrent sinusitis. High-resolution chest CT (computed tomography) showed no bronchiectasis, and spirometric results were normal. Repeat immune evaluation at age 16 years and after being off immunoglobulin replacement therapy for 3 years showed a serum IgG level of 376 mg/dL, IgA level of 7 mg/dL, and IgM level of 21 mg/dL. Specific antibody to influenza type A/B was absent. She also responded poorly to influenza vaccine with titers of only 1:4 for influenza A. The patient was restarted on replacement immunoglobulin therapy in hospital infusion center at 600 mg/kg per month, with a subsequent follow-up serum IgG level of 840 mg/dL.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: This literature report (initial receipt: 10-Jul-2012) concerns a 9-year-old female patient, with a history of recurrent otitis media since 15 months of age, chronic sinusitis, and 2 episodes of pneumonia, who presented for the evaluation of a possible immune deficiency. According to the parents, the patient was always 'chronically' ill and has received multiple courses of antibiotics, including a trial of prophylactic antibiotics. The past history included symptoms consistent with asthma, for which she was being treated with a leukotriene modifier, and allergic rhinitis, for which she was being treated with topical nasal steroids and antihistamines. Family history was positive for allergic disease in both parents. Allergy skin test results are negative for inhalant allergens. There was no family history of an immune deficiency disorder. On an unknown date the patient received an influenza vaccine (brand name and manufacturer were not reported). Eight weeks after receiving vaccination, the patient had a blood work. Antibodies to influenza A and B were absent. The event was reported as poor response to influenza vaccine. The significant history of recurrent infections, ongoing chronic sinusitis, multiple antibiotic use, poor response to influenza and also PNEUMOVAX vaccines, and month of presentation (November) led to a consideration of starting replacement intravenous immunoglobulin (IVIG) therapy at 400 mg/kg on a monthly regimen. She did well on the replacement IVIG therapy, with markedly less episodes of otitis media and also improvement in the frequency of sinusitis. Shortly after her parents divorced, the patient moved out of town with her mother. She was lost to follow-up and apparently discontinued her replacement immunoglobulin therapy. At age 16 years, the patient decided to live with her father again and presented with recurrent infections, including draining ears, chronic cough, and recurrent sinusitis. High-resolution chest CT (computed tomography) showed no bronchiectasis, and spirometric results were normal. Repeat immune evaluation at age 16 years and after being off immunoglobulin replacement therapy for 3 years showed a serum IgG level of 376 mg/dL, IgA level of 7 mg/dL, and IgM level of 21 mg/dL. Specific antibody to influenza type A/B was absent. She also responded poorly to influenza vaccine with titers of only 1:4 for influenza A. The patient was restarted on replacement immunoglobulin therapy in hospital infusion center at 600 mg/kg per month, with a subsequent follow-up serum IgG level of 840 mg/dL.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Oedema peripheral, Pain
Clinical narrative: 1/8/13 Received PNEUMOVAX / influenza shot (L) deltoid Tdap (R) deltoid. 1/9/13 C/O swollen (L) arm - ER visit / PCP office visit tx with PERCOCET, ibuprofen for pain. 1/10/13 Seen by Dr - tx with ROCEPHIN IM / KENALOG IM.
Age: 15.0
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Convulsion
Clinical narrative: This literature report (initial receipt 10-FEB-2011) concerns a 15 year old male patient with no medical history. On an unknown date, the patient received influenza vaccine. On the same day, the patient also received HepA vaccine. Seven (7) days post vaccination, the patient experienced new onset nonfebrile seizures. The event outcome was unknown. Reporter's comments: The reporter considered events to be serious. Case correction (16-Aug-2012): After internal review, it was noted that the company causality for the event was inadvertently captured. This has been corrected.
Age: 76.0
Sex: M
Vaccine: YF
Symptoms: Injection site pain
Clinical narrative: (L) arm pain at injection site, began after injection and became more severe over time. Saw his primary care physician - no treatment provided. Pain is still present at time of this report, worsening, especially with touch.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea, Hypersensitivity, Pyrexia, Rash
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 07-Jun-2012) concerns a patient. The patient developed a severe allergic reaction to an influenza vaccine (manufacturer and brand name unspecified) two years ago which consisted of a severe rash, difficulty breathing and a high temperature. The event outcome was not reported.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt called: on inside of arm vaccine was given red bumps above elbow pt took 50mg BENADRYL and cooled with ice.
Sex: M
Vaccine: FLUX
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 11-Jul-2012) concerns a male patient, who had penicillin and streptomycin allergies. The patient received an unspecified flu vaccine (brand name and manufacturer not reported) 'many years ago' and developed a rash. He stated that he had the same reaction of a rash two years in a row. The patient sought medical attention and was treated with epinephrine. The event outcome was recovered. Follow up (06-Aug-2012): patient had the same reaction of a rash two years in a row.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling, Injection site warmth
Clinical narrative: Day after receiving intradermal flu vaccine, injection site had swelling, redness and warmth to touch. Serosanguinous drainage from site in office today. Patient started on BACTROBAN ointment 2% and BACTRIM DS tablets x5 days.
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Local swelling, Rash generalised
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 10-Jul-2012) concerns a female patient. On an unknown date the patient received a flu vaccine (brand name and manufacturer not reported) for vaccination. After administration of the flu vaccine, the patient developed a 'head to toe rash' as well as nose and lip swelling. The patient was seen immediately by her physician and 'given a shot'. The patient fully recovered.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Chest pain, Dysphagia, Eye swelling, Oropharyngeal pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 24-Jul-2012) concerns an adult female patient, who had a medical history of an appendectomy at age 7, C-section in 1992, lasek in 2001 and stereotactic biopsy in May-2006. On an unspecified date in 2010 the patient received a flu shot (manufacturer and batch number not specified). The patient was previously exposed to the flu shot yearly. Within 4 hours of receiving the flu shot the patient experienced an anaphylactic reaction. The patient could not swallow, her tongue, periorbital and face were swollen and she experienced pain in her chest and throat. The events were considered life threatening and the patient sought medical attention. The event outcome was recovered. Reporters comment: The reporter considered the events as life threatening. Follow-up #1 (21-Aug-2012): The influenza vaccine administered was FLUZONE, not FLUVAX. FLUZONE is not a CSL product. Follow-up #2 (04-Sep-2012): Symptoms of anaphylactic reaction, outcome, medical history and serious criteria. Manufacturer of flu shot administered in 2010 was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Swollen tongue
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 24-Jul-2012) concerns an adult female patient, who had a medical history of an appendectomy at age 7, C-section in 1992, lasek in 2001 and stereotactic biopsy in May-2006. On an unspecified date in 2010 the patient received a flu shot (manufacturer and batch number not specified). The patient was previously exposed to the flu shot yearly. Within 4 hours of receiving the flu shot the patient experienced an anaphylactic reaction. The patient could not swallow, her tongue, periorbital and face were swollen and she experienced pain in her chest and throat. The events were considered life threatening and the patient sought medical attention. The event outcome was recovered. Reporters comment: The reporter considered the events as life threatening. Follow-up #1 (21-Aug-2012): The influenza vaccine administered was FLUZONE, not FLUVAX. FLUZONE is not a CSL product. Follow-up #2 (04-Sep-2012): Symptoms of anaphylactic reaction, outcome, medical history and serious criteria. Manufacturer of flu shot administered in 2010 was unknown.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Parent called on 12/28 to report rash on leg, top of arm, across chest to other arm. Began about 24 hrs after imm. seen by Dr on 12/28 & Dxd with urticaria.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient, who had not received any other vaccinations. On 26-Sep-2012 the patient received AFLURIA PFS (batch number: P58306) injection. Following vaccination, the patient developed injection site reactions. The reaction was reported to be 3 inches below the AFLURIA injection site, described as being 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Pain, Pain in extremity, Pruritus, Swelling
Clinical narrative: Received Influenza vaccine 10/02/2012; developed swelling, itching, pain within 24 hrs. Signs and symptoms disappeared eventually but now has persistent (R) arm pain and discomfort. Has been seen and treated by physician and chiropractor. Symptoms persist.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: This medically confirmed report (initial receipt 06-Aug-2012) concerns a male patient, approximately 75 years old. The patient had previously received flu vaccine (unknown manufacturer) on an unknown date and developed Guillain Barre Syndrome. He was paralysed from the waist down (see case 2012033040). On an unknown date, the patient received influenza vaccine (manufacturer and batch number not specified). An unknown time later, the patient developed Guillain Barre Syndrome. He had a milder case (compared to the first episode). The patient recovered after each case of GBS (Guillain Barre Syndrome). Reporter's comment: On 20-Aug-2012 the pharmacist commented that the patient's GBS following vaccination with an unspecified flu vaccine occurred approximately 7 years ago. She had no idea which flu vaccine the patient received approximately 7 years ago. Follow up (20-Aug-2012): reporter's comment.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 13-Sep-2012) concerns a 46-year-old male patient. Concomitant medication included atorvastatin. On 11-Sep-2012 the patient received AFLURIA (batch number: P58507) injection at a dose of 0.5 (mL) once intramuscularly. On 11-Sep-2012, after receiving AFLURIA, the patient developed a high fever. He contacted the pharmacist. Treatment included acetaminophen. The event outcome was recovering.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: Employee received vaccine on 12/21/12; on 12/22/12 began to experience weakness and pain in the (L) arm. Noted swelling at injection site which has since disappeared, but pain in the (L) arm persists. No loss of mobility reported. Has not sought medical attention.
Sex: M
Vaccine: FLUX
Symptoms: Pain, Rash
Clinical narrative: This medically confirmed report (initial receipt 19-Sep-2012) concerns a male patient in his 80s with a medical history of chickenpox aged 10. Concomitant medication included prostaglandin. On 13-Sep-2012, the patient received an unspecified flu vaccine (manufacturer and batch no. nor specified). On 15-Sep-2012 the patient developed a rash on his mid stomach and back and pain. Treatment included unspecified antiviral medication, prednisone and topical medication. The outcome for the event was recovering.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Patient reported to the health unit on Jan 9, 2013 with h/o of discomfort to her left elbow region which began shortly after receiving the Influenza vaccine on 12/18/2012 currently she reports persistent aching to (L) arm especially when she lifts, pulls or pushes with the left hand. Pain is mainly located in the mid elbow area.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Sep-2012) concerns a female patient, who had an allergic reaction to pneumonia vaccine which she described as 'quite severe'. On an unknown date the patient received a flu vaccine (manufacturer, brand name and lot number were not provided) and experienced allergic reaction. The event outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This medically confirmed spontaneous report (initial receipt 11-May-2012) concerns a female adult patient. On an unknown date, the patient developed Guillain Barre after getting the flu shot (manufacturer unspecified). The reporter stated this adverse event was reported at the time of occurrence. The event outcome was unknown. Follow up (06-Jun-2012): patient's age group.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis, Vaccine positive rechallenge
Clinical narrative: This medically confirmed report (initial receipt 06-Aug-2012) concerns a male patient, approximately 75 years old. On an unknown date, the patient received influenza vaccine (manufacturer and batch number not specified). An unknown time later, the patient developed Guillain Barre Syndrome. He was paralysed from the waist down. After a second dose of flu vaccine, the patient developed a milder case (refer to case 2012033058). The patient recovered after each case of GBS (Guillain Barre Syndrome). Reporter's comment: On 20-Aug-2012 the pharmacist commented that the patient's GBS following vaccination with an unspecified flu vaccine occurred approximately 7 years ago. She had no idea which flu vaccine the patient received approximately 7 years ago. Follow up (20-Aug-2012): reporter's comment.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous consumer report (initial receipt: 21-Sep-2012) concerns a female patient. On 20-Sep-2012 the patient received AFLURIA (batch number was not provided) intramuscularly. The patient only received a partial dose of AFLURIA. She stated that an unspecified amount of vaccine dripped on her arm during administration. No adverse effect reported.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site rash, Injection site warmth
Clinical narrative: Pt came back to pharmacy on 1/8/13 c/o irritation at injection site. Pt presents w/warm, raised, red rash at inj. site approx 2-3" in diam. Pt was advised to seek MD consult/tx.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Chest discomfort, Dyspnoea, Flushing, Heart rate increased
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of facial flushing in a 34-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to eggs and multiple allergies. On 8 January 2013 at 10:45 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 8 January 2013, 15 minutes after vaccination with FLULAVAL, the subject experienced facial flushing, increased heart rate, chest tightness and shortness of breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL at 11:15 on 8 January 2013. On 8 January 2013, at 12:00, the events were resolved. The nurse reported that the immunisation series was not delayed and was discontinued. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject had received flu shot in the past with a history of an allergic reaction with one previous influenza injection. Details in case A1007735B.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Dyspnoea, Flushing, Heart rate increased
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of facial flushing in a 34-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to eggs and multiple allergies. On 8 January 2013 at 10:45 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 8 January 2013, 15 minutes after vaccination with FLULAVAL, the subject experienced facial flushing, increased heart rate, chest tightness and shortness of breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL at 11:15 on 8 January 2013. On 8 January 2013, at 12:00, the events were resolved. The nurse reported that the immunisation series was not delayed and was discontinued. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject had received flu shot in the past with a history of an allergic reaction with one previous influenza injection. Details in case A1007735B.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Abasia, Asthenia, Dysarthria, Dyspnoea, Electromyogram
Clinical narrative: Received a Tetanus vaccine and Influenza immunization on 1/16/2012. On 1/23/2012 I begin to develop numbness and pain in hands and feet by 1/29/12 I had extreme weakness in my legs and body and was unable to walk. I was admitted to the hospital and underwent a series of test that include complete blood work, MRI, Lumbar Punctures, X-rays and it was concluded and I was diagnosed with Guillain-Barre Syndrome due to vaccines as I was in normal active working individual prior to the vaccines. At the hospital I received two 5-day courses of IVIG. I was then transferred to a rehabilitation center where within a week my symptoms worsened and I developed puffiness in lips and tongue with a slurred speech and weakness in breath. I was sent back to the hospital and readmitted on 2/23/12 I had an EMG study and underwent additional lumbar puncture tests and blood work. I was intubated by 2/25/12 and by 3/12/12 I required a tracheostomy and feeding tube. I underwent plasmapheresis several times in the hospital. I was discharged back to the rehabilitation center where I continue to receive plasmapheresis twice a week and steroids and medication for pain management. Today 1/5/13 I am still in the rehabilitation center still receiving plasmapheresis 2x weekly and undergoing daily physical therapy I no longer require a vent or feeding tube and have improved movement but still unable to walk.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Endotracheal intubation, Full blood count, Gastrointestinal tube insertion, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Received a Tetanus vaccine and Influenza immunization on 1/16/2012. On 1/23/2012 I begin to develop numbness and pain in hands and feet by 1/29/12 I had extreme weakness in my legs and body and was unable to walk. I was admitted to the hospital and underwent a series of test that include complete blood work, MRI, Lumbar Punctures, X-rays and it was concluded and I was diagnosed with Guillain-Barre Syndrome due to vaccines as I was in normal active working individual prior to the vaccines. At the hospital I received two 5-day courses of IVIG. I was then transferred to a rehabilitation center where within a week my symptoms worsened and I developed puffiness in lips and tongue with a slurred speech and weakness in breath. I was sent back to the hospital and readmitted on 2/23/12 I had an EMG study and underwent additional lumbar puncture tests and blood work. I was intubated by 2/25/12 and by 3/12/12 I required a tracheostomy and feeding tube. I underwent plasmapheresis several times in the hospital. I was discharged back to the rehabilitation center where I continue to receive plasmapheresis twice a week and steroids and medication for pain management. Today 1/5/13 I am still in the rehabilitation center still receiving plasmapheresis 2x weekly and undergoing daily physical therapy I no longer require a vent or feeding tube and have improved movement but still unable to walk.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Immunoglobulin therapy, Lip swelling, Lumbar puncture, Muscular weakness, Nerve conduction studies
Clinical narrative: Received a Tetanus vaccine and Influenza immunization on 1/16/2012. On 1/23/2012 I begin to develop numbness and pain in hands and feet by 1/29/12 I had extreme weakness in my legs and body and was unable to walk. I was admitted to the hospital and underwent a series of test that include complete blood work, MRI, Lumbar Punctures, X-rays and it was concluded and I was diagnosed with Guillain-Barre Syndrome due to vaccines as I was in normal active working individual prior to the vaccines. At the hospital I received two 5-day courses of IVIG. I was then transferred to a rehabilitation center where within a week my symptoms worsened and I developed puffiness in lips and tongue with a slurred speech and weakness in breath. I was sent back to the hospital and readmitted on 2/23/12 I had an EMG study and underwent additional lumbar puncture tests and blood work. I was intubated by 2/25/12 and by 3/12/12 I required a tracheostomy and feeding tube. I underwent plasmapheresis several times in the hospital. I was discharged back to the rehabilitation center where I continue to receive plasmapheresis twice a week and steroids and medication for pain management. Today 1/5/13 I am still in the rehabilitation center still receiving plasmapheresis 2x weekly and undergoing daily physical therapy I no longer require a vent or feeding tube and have improved movement but still unable to walk.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Plasmapheresis, Swollen tongue, Tracheostomy
Clinical narrative: Received a Tetanus vaccine and Influenza immunization on 1/16/2012. On 1/23/2012 I begin to develop numbness and pain in hands and feet by 1/29/12 I had extreme weakness in my legs and body and was unable to walk. I was admitted to the hospital and underwent a series of test that include complete blood work, MRI, Lumbar Punctures, X-rays and it was concluded and I was diagnosed with Guillain-Barre Syndrome due to vaccines as I was in normal active working individual prior to the vaccines. At the hospital I received two 5-day courses of IVIG. I was then transferred to a rehabilitation center where within a week my symptoms worsened and I developed puffiness in lips and tongue with a slurred speech and weakness in breath. I was sent back to the hospital and readmitted on 2/23/12 I had an EMG study and underwent additional lumbar puncture tests and blood work. I was intubated by 2/25/12 and by 3/12/12 I required a tracheostomy and feeding tube. I underwent plasmapheresis several times in the hospital. I was discharged back to the rehabilitation center where I continue to receive plasmapheresis twice a week and steroids and medication for pain management. Today 1/5/13 I am still in the rehabilitation center still receiving plasmapheresis 2x weekly and undergoing daily physical therapy I no longer require a vent or feeding tube and have improved movement but still unable to walk.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: X-ray
Clinical narrative: Received a Tetanus vaccine and Influenza immunization on 1/16/2012. On 1/23/2012 I begin to develop numbness and pain in hands and feet by 1/29/12 I had extreme weakness in my legs and body and was unable to walk. I was admitted to the hospital and underwent a series of test that include complete blood work, MRI, Lumbar Punctures, X-rays and it was concluded and I was diagnosed with Guillain-Barre Syndrome due to vaccines as I was in normal active working individual prior to the vaccines. At the hospital I received two 5-day courses of IVIG. I was then transferred to a rehabilitation center where within a week my symptoms worsened and I developed puffiness in lips and tongue with a slurred speech and weakness in breath. I was sent back to the hospital and readmitted on 2/23/12 I had an EMG study and underwent additional lumbar puncture tests and blood work. I was intubated by 2/25/12 and by 3/12/12 I required a tracheostomy and feeding tube. I underwent plasmapheresis several times in the hospital. I was discharged back to the rehabilitation center where I continue to receive plasmapheresis twice a week and steroids and medication for pain management. Today 1/5/13 I am still in the rehabilitation center still receiving plasmapheresis 2x weekly and undergoing daily physical therapy I no longer require a vent or feeding tube and have improved movement but still unable to walk.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity, Tenderness
Clinical narrative: 2 inch circular redness around injection area.  Pain in arm when touched and a dull ache.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Nausea, Pain of skin, Paraesthesia, Urticaria
Clinical narrative: 12/24 - Nausea/general discomfort. 12/28 - Skin pain (sharp pricking and general skin ache) on left torso from belly button around to back. 12/31 - eruption of painful welts in the same area. 1/8/2013 - pain is abating and welts are shrinking.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Rash
Clinical narrative: 12/24 - Nausea/general discomfort. 12/28 - Skin pain (sharp pricking and general skin ache) on left torso from belly button around to back. 12/31 - eruption of painful welts in the same area. 1/8/2013 - pain is abating and welts are shrinking.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy, Injection site swelling
Clinical narrative: About one month after receiving the flu vaccine, I noticed a dimpling in the area of the injection.  Over a period of about 1 month, the dimpling had worsened and there is an area directly below the dimpling that looks swollen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dysgeusia
Clinical narrative: Patient complained of a metal after taste in her moth that she never experienced before.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: Pain at the sight of injection which adversly affects day to day activities such as dressing and other regular uses of the arm.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Patient states her right arm started out being slightly sore (as usual) but progressively worsened till it was continuous pain (7/10).  She went to the Immediate Care Center on 12/23/12.  On 12/28/12 she came in to Employee Health b/c it was no better. Patient was unable to lift her arm above her waist.  She also needed assistance taking her coat off and putting it on.  There is no swelling nor redness.  There is pain upon palpation and she rates the pain 7-8/10 depending on the movement. Questioned where the injection was given and she did point to the correct area of the deltoid.  She is unable to lift a coffee cup unless she assists with her left hand.  She saw an ortho MD on 12/31/12 and has a f/u appt. on 2/5/13.  Spoke with her again today (1/10/13) and she states her right arm remains the same.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site reaction, Muscular weakness, X-ray limb normal
Clinical narrative: Patient states her right arm started out being slightly sore (as usual) but progressively worsened till it was continuous pain (7/10).  She went to the Immediate Care Center on 12/23/12.  On 12/28/12 she came in to Employee Health b/c it was no better. Patient was unable to lift her arm above her waist.  She also needed assistance taking her coat off and putting it on.  There is no swelling nor redness.  There is pain upon palpation and she rates the pain 7-8/10 depending on the movement. Questioned where the injection was given and she did point to the correct area of the deltoid.  She is unable to lift a coffee cup unless she assists with her left hand.  She saw an ortho MD on 12/31/12 and has a f/u appt. on 2/5/13.  Spoke with her again today (1/10/13) and she states her right arm remains the same.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Barium enema abnormal, Enema administration, Intussusception
Clinical narrative: Intussuception.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Diagnostic procedure, Gait disturbance, Mobility decreased, Nerve conduction studies
Clinical narrative: At about 6 pm I began to have pain in my legs. Felt like a million pins and a vice grip on them. Pain grew stronger & in following days (week) moved up my body. Could not get into or out of bed by myself. When husband got me upright I could scoot my feet on floor and could walk a little with help. This lasted about a week. Was so filled with pain could not do anything for myself. Went to see Orthopedic Surgeon who had done a knee scope about a month earlier. Saw Dr. 10/23/2012. Dr. thought I had spinal stenosis. He referred me to Spine Specialist. Saw Dr. on 11/10/2012. He could not determine exact cause of pain. Thought it could be pinched nerve in neck and lower back.  He referred me to Neurologist for a "needle" test. Shoulders, back, arms, wrists, hands became so painful to move. For the past month I have had no decrease in pain. I have been going to physical therapy twice each week. I take 300mg gabapentin three time daily for the pain.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia
Clinical narrative: At about 6 pm I began to have pain in my legs. Felt like a million pins and a vice grip on them. Pain grew stronger & in following days (week) moved up my body. Could not get into or out of bed by myself. When husband got me upright I could scoot my feet on floor and could walk a little with help. This lasted about a week. Was so filled with pain could not do anything for myself. Went to see Orthopedic Surgeon who had done a knee scope about a month earlier. Saw Dr. 10/23/2012. Dr. thought I had spinal stenosis. He referred me to Spine Specialist. Saw Dr. on 11/10/2012. He could not determine exact cause of pain. Thought it could be pinched nerve in neck and lower back.  He referred me to Neurologist for a "needle" test. Shoulders, back, arms, wrists, hands became so painful to move. For the past month I have had no decrease in pain. I have been going to physical therapy twice each week. I take 300mg gabapentin three time daily for the pain.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: Intra-articular shot- currently no other sx.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Viral infection, Vomiting
Clinical narrative: Neighbor reported that the patient died 1-7-13. Inital cause has been diagnosed as vomiting and diarrhea probably caused by a virus. Due to its close approximation to vaccination I am reporting this incident.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Gastroenteritis viral, Vomiting
Clinical narrative: Neighbor reported that the patient died 1-7-13. Inital cause has been diagnosed as vomiting and diarrhea probably caused by a virus. Due to its close approximation to vaccination I am reporting this incident.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Vomiting
Clinical narrative: Neighbor reported that the patient died 1-7-13. Inital cause has been diagnosed as vomiting and diarrhea probably caused by a virus. Due to its close approximation to vaccination I am reporting this incident.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Viral infection, Vomiting
Clinical narrative: Neighbor called and reported patient's death the day after vaccination. Initial cause is thought to be vomiting and diarrhea related to a stomach virus. I am reporting due to close proximity to vaccination.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Gastroenteritis viral, Vomiting
Clinical narrative: Neighbor called and reported patient's death the day after vaccination. Initial cause is thought to be vomiting and diarrhea related to a stomach virus. I am reporting due to close proximity to vaccination.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Vomiting
Clinical narrative: Neighbor called and reported patient's death the day after vaccination. Initial cause is thought to be vomiting and diarrhea related to a stomach virus. I am reporting due to close proximity to vaccination.
Age: 1.09
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No symptoms at this time.  Mom instructed to call if any symptoms appear.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, cough, slight fever; followed the next morning (01/06/2013) by fever, body aches, headache, fatigue which persisted 72 hours.  By 01/10/2013 no fever, but congestion, cough, fatigue.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Sore throat, cough, slight fever; followed the next morning (01/06/2013) by fever, body aches, headache, fatigue which persisted 72 hours.  By 01/10/2013 no fever, but congestion, cough, fatigue.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Discomfort, Muscle spasms, Pain
Clinical narrative: Discomfort / pain / cramping in ankles and knees. Progressed throughout out the day to intense pain / burning sensation in both legs to lower back.  Subsided by 09/30/12.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness
Clinical narrative: PATIENT FELT FAINT AND GOT CLAMMY. PATIENT LAID DOWN AND MD CHECKED BLOOD PRESSURE AND PULSE. GAVE PT SOME JUICE AND HAD THEM REST FOR 10-15 MINS. PATIENT DIDNT HAVE LUNCH AND GOT THE VACCINE AROUND DINNER TIME.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Dehydration, Diarrhoea
Clinical narrative: Complete explosive liquid diarrhea for day and half. Chills, joint aches, light headed as became dehydrated. That night started IV .9% NS on self to rehydrate. Took Kaopectate and out of work 1 day.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness
Clinical narrative: Complete explosive liquid diarrhea for day and half. Chills, joint aches, light headed as became dehydrated. That night started IV .9% NS on self to rehydrate. Took Kaopectate and out of work 1 day.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: HE BROKE OUT IN HIVES FROM HEAD TO TOE. MOM BROUGHT HIM IN TO THE OFFICE ON 1/10/2013 TO BE SEEN. PLAN OF TREATMENT IS ORAL STEROIDS AND A ANTIHISTAMINE.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Plunger on Fluvirin prefilled syringe did not depress...regave shot in same arm.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warmth to touch.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Extreme nausea, lasted well into bedtime (approx 10:00pm).
Age: 1.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Aphasia, Complex partial seizures, Diarrhoea, Electroencephalogram abnormal, Encephalopathy
Clinical narrative: 5 Weeks Post Vaccination Vomit 4 days, Diarrhea 6 days, Encephalopathy >24hrs, Seizure, Lost speech, Regressed over a 6 week period. Receives IVIG monthly.
Age: 1.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Immunoglobulin therapy, Lumbar puncture, Nuclear magnetic resonance imaging, Regressive behaviour, Vomiting
Clinical narrative: 5 Weeks Post Vaccination Vomit 4 days, Diarrhea 6 days, Encephalopathy >24hrs, Seizure, Lost speech, Regressed over a 6 week period. Receives IVIG monthly.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Dizziness, Immediate post-injection reaction, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient was found passed out on ground after leaving the Pediatric Mobile Unit.  Also had a seizure during this time when found unresponsive.  Patient complained of feeling dizzy immediately after receiving Tdap immunization.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: Patient was found passed out on ground after leaving the Pediatric Mobile Unit.  Also had a seizure during this time when found unresponsive.  Patient complained of feeling dizzy immediately after receiving Tdap immunization.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Feeling abnormal, Foreign body sensation in eyes, Oropharyngeal pain
Clinical narrative: Throat swelling & sore, eyes swelling & gritty feeling, coughing, generalized bad feeling.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Throat swelling & sore, eyes swelling & gritty feeling, coughing, generalized bad feeling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Extra dose of Varicella given.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Extreme dizziness, vertigo, nausea.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Immunoglobulin therapy, Laboratory test, Muscular weakness
Clinical narrative: Weakness in hands and upper extremities. Started a few d after a cold but 34d after Tdap. Onset was sudden and progressed quickly over 4-8hr.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Patient presented to outside ER c/o arm being swollen, red, painful after Pneumovax injection on 01/07/13. Area of swelling is 6cm. Patient also febrile to 102.9F evening of 01/08/13 and with slight fever on 01/09/13. Blood cultures drawn in ER, followed by administration of 2 IV antibiotics. Pt discharged to home on oral antibiotics.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Hives/rash on face, very red and itchy. Some itchiness on rest of body but not as bed. No throat/tongue swelling.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red/pink raised rash to (L) thigh, warm to touch, non painful. No fever present (same area as vaccination site per FOC).
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Maternal exposure before pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 years old female patient with none drug reactions or allergies and none pertinent medical history. The patient's history of previous pregnancies and live births was not known. On 24-JAN-2012, the patient was vaccinated with the first dose of GARDASIL, intramuscularly (lot number reported as H011350, expiration date 21-FEB-2015) (dose not reported). No other co-suspects were reported. There was no concomitant medications. The patient was then administered her second dose of GARDASIL, intramuscularly (lot number reported as H011350, expiration date 21-FEB-2015) (dose not reported0 that day on 03-jAN-2013 and subsequently found out later in the day that she was pregnant. the second dose of GARDASIL and urine pregnancy test were conducted at the health department. At the time of the report the patient was in a six weeks pregnancy. Her estimated LMP was on 22-NOV-2012 and an EDD will be on 29-AUG-2013. Initial exposure to GARDASIL was at 6 week. The patient was exposed to GARDASIL during trimester 1. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 69 years old female patient with environmental allergies and drug hypersensitivity. The patient's medical history included hypothyroidism, hypercholesterolemia and neuropathy. The patient was vaccinated with ZOSTAVAX in the 1990's. No other co-suspects were reported. Concomitant medications included NASONEX and other unspecified medications. In DEC-2012 the patient experienced ocular herpes zoster and shingles lesions on the right side of her face. Patient was treated with unspecified antiviral medication. The outcome of ocular herpes zoster and shingles lesions on the right side of her face was reported as recovered on an unknown date. The relatedness for ocular herpes zoster and shingles lesions on the right side of her face was not reported for ZOSTAVAX.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer refers to his 4 years old daughter. On an unknown date, the patient was vaccinated (route unknown) with dose 1 (Merck) VARIVAX (lot # and expiry date not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that his daughter had the chicken pox vaccine follow up shot on an unknown date and now a had a mild case of chicken pox. However she was still turning up new spots on her back and waist even though her blisters showed up roughly 2.5 weeks ago (on approximately 08-DEC-2012). The patient's symptoms otherwise have been mild. Roughly 20-30 spots in all. No treatment information was reported. The patient's doctor saw no trouble with the spots when initially diagnosed over two weeks ago. The outcome of mild case of chicken pox was reported as not recovered/not resolved. The relatedness for mild case of chicken pox is unknown for (Merck) VARIVAX. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Unilateral tingling/pain "nerve pain" on left side starting from sternum to finger tops.
Age: 1.0
Sex: F
Vaccine: FLUX, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 12 to 15-month-old female patient. On 15-Oct-2012 the patient received an unspecified flu vaccine (manufacturer, brand name and batch number were not provided). On the same day she also received VARIVAX injection and PREVNAR. At some point on Tuesday evening (16-Oct-2012) the patient developed a fever of 104 degrees Fahrenheit. The mother treated her with paracetamol and ibuprofen. By Wednesday morning (17-Oct-2012) the patient's temperature was 99 degrees Fahrenheit. The mother took the patient to day care on Wednesday morning. At some point during the morning the patient developed a rash. The mother took her to the physician for treatment (treatment unspecified by the reporter). The event outcome was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Maternal exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 16-Sep-2011) concerns a 25 year old female pregnant patient, who was allergic to oxycodone and bee stings. Concomitant medications included cetirizine hydrochloride, rizatriptan and omeprazole. On an unknown date the patient received unspecified flu vaccine (manufacturer unknown). On 16-Sep-2011 the patient also requested to receive her first dose of 0.5 mL of GARDASIL (batch number: 0841AA) intramuscular injection. After receiving her first dose of GARDASIL, the patient requested to be on birth control pills. The standard policy of the office was to do a urine pregnancy test prior to receiving birth control pills. The patient was found to be positive for pregnancy. The event outcome was not reported. In the absence of a reported date of last menstrual period (LMP) or estimated date of delivery (EDD), CSL has approximated the EDD to be 11-May-2012, using the CSL receipt date of this initial report to be the date of six week gestation. Follow up (29-Sep-2011): concomitant medication (dose, frequency, indication for use).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: This medically confirmed spontaneous report (initial receipt 18-Nov-2011) concerns a 52-year-old female patient, who had no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination. In the morning of 28-Sep-2011 the patient received AFLURIA (batch number 04649221A) intramuscularly in deltoid on back side of arm. On 30-Sep-2011 the patient developed 'red, raised' and was hot to touch. The event outcome was recovered. The reporter considered events to be non serious. No further information was available. Case correction (02-Mar-2012): After internal review, Preferred Term and listedness assessment for the event 'Raised' were updated. Follow-up 1 (11-Jun-2012) : event outcome, no further information available.