chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Coma, Confusional state, Constipation, Convulsion, Delirium
Clinical narrative: Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Demyelination, Discomfort, Disorientation, Eczema vaccinatum, Exercise tolerance decreased
Clinical narrative: Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Flushing, Hypokinesia, Injection site erythema, Injection site necrosis
Clinical narrative: Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Joint swelling, Lymphocytic infiltration
Clinical narrative: Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Meningism, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Palpitations, Rash, Restlessness, Skin reaction, Skin warm
Clinical narrative: Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Somnolence, Urinary incontinence, Urinary retention
Clinical narrative: Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster
Clinical narrative: Flank pain began 1 week after shingles vaccine and shingles rash began in area of pain 9 days after vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site discomfort, Joint crepitation, Middle insomnia, X-ray normal
Clinical narrative: Unable to lift my arm. Unable to dress. Popping and cracking in my shoulder.  Went to chiropractor 1 week later and advised me to contact my dr. Reported it to my drs office. 1 week later made a appt. Sent me to PT. 1st pt appt last week. Return next week. Cannot sleep on my right side. Wakes me up during tge night. Can still feel where the injection went in. Have to use my left hand to pick up my right arm. At drs visit he ordered a xray of right shoulder came back normal.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: I began to experience aches that evening. Fell asleep around 8:30 PM. Woke up throughout the night with aches all over my body. On the morning of 10/19/13 woke up to get ready for work but was very dizzy and hot. Fever was 101.9. Slept literally the entire day but for about 90 min total. Fever didn't break until morning of 10/20. Still very tired and headachy.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: I began to experience aches that evening. Fell asleep around 8:30 PM. Woke up throughout the night with aches all over my body. On the morning of 10/19/13 woke up to get ready for work but was very dizzy and hot. Fever was 101.9. Slept literally the entire day but for about 90 min total. Fever didn't break until morning of 10/20. Still very tired and headachy.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Large, hard lump under skin at injection site (size of a lemon), very red skin over lump with rashy area; pain and stiffness; itching. Headache; abdominal cramps; extreme fatigue.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site rash, Musculoskeletal stiffness, Pain, Pruritus
Clinical narrative: Large, hard lump under skin at injection site (size of a lemon), very red skin over lump with rashy area; pain and stiffness; itching. Headache; abdominal cramps; extreme fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Inflammation, X-ray
Clinical narrative: Inflammation of entire body; 48 hours following vaccine; extreme pain at arthritis sites.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Muscle ache and limited range of motion in the shoulder persisting for 2 weeks. Pain relieved by NSAIDs per patient.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Had anaphylactic attack where couldn't breathe.  Administered Epi-pen.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Very severe swelling at injection site. The whole top of my arm swelled out about 4 inches from my skin. A very distinct circular redness in the area. I have a little swelling from the injection every year, but this was very out of the ordinary. The are is still very swollen and painful today, but I have begun applying ice packs and taking Benadryl and the swelling is beginning to come down slowly. I just thought you might want to know.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fatigue, nausea, fever.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: Stuffy nose, runny nose, headache.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Developed fever of 102.4. Tylenol taken for fever. Fever remained at 102 until approx 10:00 am 10/18/2013. Fever then reduced to 100-101 for the next 10 hours. The above was reported to the employee health nurse at hospital (who administered the injection) and she advised writer to take Tylenol for the fever.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Pruritus, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Fever, reddened eyes, itching, rash on bilateral legs, trunk, bilateral arms and chest.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Ligament disorder, Neuropathy peripheral
Clinical narrative: Severe joint pain involving all joint. Ligament and nerve dysfunction. x 4 weeks. Now on prednisone oral.
Age: 38.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Raised, hive like rash with significant itching over whole body below nipple line on Friday. Started Benadryl 25mg at 6pm. recurs exactly 12 hours after Benadryl. Today is Sunday 10/20/13 and it continues.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Muscle spasms, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Right shoulder in which I received PPSV vaccine began to ache, stiffen.  Went to bed around 11 pm, with shoulder pain, couldn't get comfortable in any position, severe muscle spasms began about 11:30 pm and continued until around 2:30 am.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Malaise, Neuralgia
Clinical narrative: Severe nerve and joint pain. Pain still persisting. Pt reports got sick shortly after and sickness lasted weeks.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Influenza, Malaise, Neuralgia, Pain
Clinical narrative: Joint and nerve pain throughout body. Reports got flu and was sick for weeks. Symptoms of pain persist.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness and nausea. No treatment just rest.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema, Swollen tongue
Clinical narrative: Swelling of lips eyes tongue and throat.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient had mild fever and chills and aching in the arm of injection.  Called pharmacy to report and it was recommended to take Tylenol as directed on package and let us know if worsening occurred.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Pruritus, Wheezing
Clinical narrative: Heart palpitations, itching, wheezing.
Age: 1.23
Sex: F
Vaccine: FLUX, HEPA, MMR, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling in the area where 2 vaccines where applied. Mild fever between 100.3 F and 101.5 F were recorded on a 12 hour period.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Diarrhoea, Dyspnoea, Fatigue, Vomiting
Clinical narrative: I went home after the shot.  Not long after I felt 'clammy' and eventually vomited, had some diarrhea, was very tired, and had mild shortness of breath.  I laid down and eventually fell asleep for several hours.  I took it easy around the house for the rest of the evening but felt better with some mild diarrhea. I slept okay that night and have been fine since.  Am not sure if this was a reaction or not to the flu shot.  I have had many flu shots over the years but have never had a reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Balance disorder, Dizziness, Fatigue
Clinical narrative: Weakness, exhaustion, loss of balance, dizziness, aches, pains from back down through legs.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Weakness, exhaustion, loss of balance, dizziness, aches, pains from back down through legs.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Site with streaking redness from mid upper arm spreading to neck and armpit with swelling, tenderness and very hot to touch.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site warmth, Skin warm, Swelling, Tenderness
Clinical narrative: Site with streaking redness from mid upper arm spreading to neck and armpit with swelling, tenderness and very hot to touch.
Age: 0.51
Sex: M
Vaccine: HIBV, PPV, RVX
Symptoms: Crying, Dyspnoea, Injection site pain, Irritability, Nasal congestion
Clinical narrative: Found my son face down in bed with labored breathing. He usually moves his head. This has happened again on 10/17 and 10/18 and with the most recent event he gasped for air when I picked him up off his face at 3 am and had to rouse him.  He also has had restless sleep, very fussy since Monday, and he had exquisite pain at the injection site, which he has never had previously. 5 hours after he was given the vaccine, he cried inconsolably for 40 minutes straight. Also, He now has a runny/congested nose (as of 10/20/13).
Age: 0.51
Sex: M
Vaccine: HIBV, PPV, RVX
Symptoms: Poor quality sleep, Rhinorrhoea
Clinical narrative: Found my son face down in bed with labored breathing. He usually moves his head. This has happened again on 10/17 and 10/18 and with the most recent event he gasped for air when I picked him up off his face at 3 am and had to rouse him.  He also has had restless sleep, very fussy since Monday, and he had exquisite pain at the injection site, which he has never had previously. 5 hours after he was given the vaccine, he cried inconsolably for 40 minutes straight. Also, He now has a runny/congested nose (as of 10/20/13).
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Severe pain in left shoulder.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: At the site of injection sub cut, 5 cm x 4 cm induration, erythema, edema, tender to palpation.
Age: 31.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Nausea, Vision blurred, Vomiting
Clinical narrative: 10/20/13 - Reported having onset of sx after receiving the Tetanus injection. Started with w/onset of sx at approximately 18:35 w/nausea, then blurred vision, & lightheaded lasting approximately 2 minutes, per donor and all sx resolved per donor after vomiting. MSA arrived while donor was vomiting in the trash can with moderate amount of thick brownish colored food that had the appearance of beans. Donor's skin was dry, pink, alert/oriented and was brought to the medical office for vitals. Immunization site w/o any any noted reaction.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Wrong drug administered
Clinical narrative: Patient allergic to thimerosal. Instead of getting FLUVIRIN prefilled syringe which only contains < 1mcg of thimerosal patient received FLUVIRIN vial which contains 25mcg of thimerosal. Spoke with patient on 10/20/13 approximately 2pm she stated she is fine. On 10/19/13 she stated some soreness and redness at injection site but is fine today. Has had vial before previous year. Her reaction was soreness and redness.
Age: 69.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Rash on face with pain diagnosed as shingles by MD and treated -is now resolved.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local swelling, Pruritus, Skin disorder
Clinical narrative: Pt received vaccine on same day as Flu shot in same arm and within 24 hours developed itching progressing to large red area 4-5" in diameter with swelling causing skin sagging and firmness and heat.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Pt received vaccine on same day as Flu shot in same arm and within 24 hours developed itching progressing to large red area 4-5" in diameter with swelling causing skin sagging and firmness and heat.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Local swelling, Pain, Pain in extremity
Clinical narrative: 10/18/13 - sore at injection site. 10/19/13 - sore and red on back side of arm. Pt called 10/20/13 - sore and swollen on front side of arm from bend to shoulder.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Pt presented with redness, bruising, and tenderness on inside of elbow of arm where vaccine was administered.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Right arm - 2 spots - red next to each other swelling, parts of area raised, warm to touch, painful.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Shot administered 10/9/13. Patient came back on 10/12/13 with redness, slight swelling at site of injection.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Pt got light headed, dizziness, nausea, weakness.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Dysuria, Pain
Clinical narrative: Fluid like blister-like on arm. Lower back, and body ache. Burning urination.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient called to ask about "protruding" swelling of injection site. Pharmacist advised her to take ibuprofen and apply cool compresses. Patient called back later complaining of larger swelling and stiff neck. She was told to take BENADRYL, checked on her after 1 hour and she was better.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Sinus congestion
Clinical narrative: Sinus congestion, cough, sore throat aches on day of injection. Reported to pharmacy 10/18/13.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyskinesia, Fatigue, Grip strength decreased
Clinical narrative: Pt awoke with light headedness and fatigue. Experienced "jerking" in trunk area, had to rest on floor several time on way to kitchen. Was very weak and dropped two glasses while trying to get a drink. Had to rest on floor several times while returning to bed. Pt went back to sleep and felt better in afternoon. Felt fully recovered by following morning.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at site of vaccination. Requiring anitbiotics.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis at site of vaccination. Requiring anitbiotics.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with none drug reactions/allergies. On 02-OCT-2013 (also reported as 02-OCT-2014) the patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # H014653, exp. 19-APR-2014) intramuscularly in the right arm and influenza virus vaccine (manufacturer unknown) (strength, dose, frequency and lot # were not provided) in the left arm in the same vaccination session. Concomitant therapies included ranitidine, TOPROL XL Tablets, atorvastatin and LIALDA. On 02-OCT-2013, the patient experienced swelling, redness and pain at injection site. The patient had call to pharmacy for seeking medical attention. None treatment was given for AE. None lab diagnostics studies performed. The patient had been putting ice packs on the site, and was planning on taking BENADRYL at the time of the conversation with the pharmacist. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Urticaria, Vision blurred
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old male patient. The patient had drug reactions/allergies with penicillin. The patient had no pertinent medical history. On 10-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J003360, expiry date: 21-JUN-2014), dose, route and location unspecified. The patient became feverish and developed an itchy rash all over his body as well as hives on his chest and groin area and blurry vision after receiving ZOSTAVAX. The patient developed these symptoms on an unspecified date approximately 2 weeks after (on 24-SEP-2013) receiving ZOSTAVAX. The patient had sought medical attention via contacted pharmacist. BENADRYL was given for treatment for the events. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Human papilloma virus test positive, Smear cervix normal
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 25-year-old female patient of unknown age with no pertinent medical history and drug reactions/allergies. On an unknown date in 2008 the patient who completed GARDASIL (20 micrograms(mcg) - 40 mcg-20mcg/0.5 ml 1 standard package vial of 0.5) (lot#, expiration date not reported) series, 0.5 milliliter (ml), intramuscularly. Concomitant medications included unspecified birth control pills. On an unknown date in 2013 (reported as recently) patient had Pap smear and HPV DNA test done. The Pap smear result came back normal but she tested positive for HPV 16 on an unknown date in September 2013. No additional information provided. Treatment was not rendered for the event. Additional laboratory investigations included Colposcopy (results pending). Patient sought medical attention by office visit. The event was not resolved at the time of this report. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (lot#, expiration date and route not reported). The patient completed the series of RECOMBIVAX HB on an unspecified date. The patient had negative titer tests. The outcome for the event was unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative refers to a handful of patients of unknown ages and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date the patients experienced developed shingles. The physician assistant was not able to confirm the exact number or identities of the patients involved. It was unspecified whether laboratory diagnostic studies were performed for the event. The patients sought unspecified medical attention. The outcome of the event was unknown. Causality was not reported. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient. Concurrent conditions included unspecified reaction to Talwin generic, morphine, cephalosporins, quinolines, iodides and phenothiazines and shingles. On 12-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J006156, expiration date 30-AUG-2014 and route not reported). Concomitant therapies included KCl. Patient reported on an unknown date after 12-OCT-2013 she was experiencing a "shingles outbreak" on her hand described as red bumps on her hand. Pharmacist could not clarify if the red bumps on the patient's hand began before ZOSTAVAX was administered on 12-OCT-2013. The patient was being treated for shingles and prescribed valacyclovir and hydrocodone on 01-OCT-2013. The event was reported to be resolving. No laboratory diagnostic studies were performed. Patient did not seek medical attention for the event. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on an unspecified date was vaccinated with ZOSTAVAX (lot # and expiration date as reported by claims administrator # HC17443, expiration date 20DEC2013). ON 20DEC2012 the patient experienced an adverse reaction (not further specified) to the ZOSTAVAX vaccine. Treatment and outcome of the adverse event was unknown. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Culture, Staphylococcal infection, Vaccination complication
Clinical narrative: I woke up that morning (approximately 14-15 hours after administration) with extreme pain and minor swelling and erythema in my left deltoid and left biceps muscles. This is the arm the vaccine was administered in. I also had noticable chills. I took my temperature with typmanic membrane thermometer and it read 102.9 degre F. An hour later after a dose of 800mg Ibuprofen it was 103.6 degrees F.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood culture negative, Body temperature increased, Chills, Full blood count abnormal, Injection site erythema
Clinical narrative: I woke up that morning (approximately 14-15 hours after administration) with extreme pain and minor swelling and erythema in my left deltoid and left biceps muscles. This is the arm the vaccine was administered in. I also had noticable chills. I took my temperature with typmanic membrane thermometer and it read 102.9 degre F. An hour later after a dose of 800mg Ibuprofen it was 103.6 degrees F.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Necrotising fasciitis, White blood cell count increased
Clinical narrative: I woke up that morning (approximately 14-15 hours after administration) with extreme pain and minor swelling and erythema in my left deltoid and left biceps muscles. This is the arm the vaccine was administered in. I also had noticable chills. I took my temperature with typmanic membrane thermometer and it read 102.9 degre F. An hour later after a dose of 800mg Ibuprofen it was 103.6 degrees F.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Blood test abnormal, Gait disturbance, Inflammation
Clinical narrative: Severe joint and muscle pain - duration ongoing - Doctor diagnosed "polymyalgia rheumatica" after 2 visits. Extensive blood work - saw specialist (rheumatologist) who agreed with diagnosis.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Myalgia, Polymyalgia rheumatica
Clinical narrative: Severe joint and muscle pain - duration ongoing - Doctor diagnosed "polymyalgia rheumatica" after 2 visits. Extensive blood work - saw specialist (rheumatologist) who agreed with diagnosis.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test abnormal, C-reactive protein increased, Myalgia, Polymyalgia rheumatica
Clinical narrative: Severe joint and muscle pain - duration ongoing - Doctor diagnosed "polymyalgia rheumatica" after 2 visits. Extensive blood work - saw specialist (rheumatologist) who agreed with diagnosis.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Ear pain, Lymphadenopathy, Palpitations, Speech disorder, Swollen tongue
Clinical narrative: Per pt: Numbness in left arm (same as vaccinated arm), anxious, shaky, "floaters" in vision lasting 30"; headache and slight stutter to speech; tightness low back. 7:30pm at home shaking worse, tearful, difficulty with speech. Emergency Dept at 10:28pm same day. Temp - 37.7, HR 120. Normal labs. Meds - ATIVAN, Acetaminophen, 1 L NS IV. Dx: Adverse Reaction to Flu Vaccine.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Tremor, Vaccination complication, Vitreous floaters
Clinical narrative: Per pt: Numbness in left arm (same as vaccinated arm), anxious, shaky, "floaters" in vision lasting 30"; headache and slight stutter to speech; tightness low back. 7:30pm at home shaking worse, tearful, difficulty with speech. Emergency Dept at 10:28pm same day. Temp - 37.7, HR 120. Normal labs. Meds - ATIVAN, Acetaminophen, 1 L NS IV. Dx: Adverse Reaction to Flu Vaccine.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Anxiety, Dysphemia, Full blood count, Headache, Hypoaesthesia
Clinical narrative: Per pt: Numbness in left arm (same as vaccinated arm), anxious, shaky, "floaters" in vision lasting 30"; headache and slight stutter to speech; tightness low back. 7:30pm at home shaking worse, tearful, difficulty with speech. Emergency Dept at 10:28pm same day. Temp - 37.7, HR 120. Normal labs. Meds - ATIVAN, Acetaminophen, 1 L NS IV. Dx: Adverse Reaction to Flu Vaccine.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Metabolic function test, Muscle tightness, Speech disorder, Tearfulness, Tremor
Clinical narrative: Per pt: Numbness in left arm (same as vaccinated arm), anxious, shaky, "floaters" in vision lasting 30"; headache and slight stutter to speech; tightness low back. 7:30pm at home shaking worse, tearful, difficulty with speech. Emergency Dept at 10:28pm same day. Temp - 37.7, HR 120. Normal labs. Meds - ATIVAN, Acetaminophen, 1 L NS IV. Dx: Adverse Reaction to Flu Vaccine.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Vaccination complication, Vitreous floaters
Clinical narrative: Per pt: Numbness in left arm (same as vaccinated arm), anxious, shaky, "floaters" in vision lasting 30"; headache and slight stutter to speech; tightness low back. 7:30pm at home shaking worse, tearful, difficulty with speech. Emergency Dept at 10:28pm same day. Temp - 37.7, HR 120. Normal labs. Meds - ATIVAN, Acetaminophen, 1 L NS IV. Dx: Adverse Reaction to Flu Vaccine.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, HPV4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 11 year old male patient with no pertinent medical history and no drug reactions and allergies. On 14-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date were reported as H021861 and 09-OCT-2015 respectively, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in October 2013, the patient developed pain and significant swelling at the injection site. The swelling was increasing and extending beyond his upper arm and into his lower arm. The patient sought medical attention (seen in office). The patient was treated with ice and unspecified pain relievers. The patient was not recovered from the events. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, HPV4
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 11 year old male patient with no pertinent medical history and no drug reactions and allergies. On 14-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date were reported as H021861 and 09-OCT-2015 respectively, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in October 2013, the patient developed pain and significant swelling at the injection site. The swelling was increasing and extending beyond his upper arm and into his lower arm. The patient sought medical attention (seen in office). The patient was treated with ice and unspecified pain relievers. The patient was not recovered from the events. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, HPV4
Symptoms: Injection site pain, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 11 year old male patient with no pertinent medical history and no drug reactions and allergies. On 14-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date were reported as H021861 and 09-OCT-2015 respectively, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in October 2013, the patient developed pain and significant swelling at the injection site. The swelling was increasing and extending beyond his upper arm and into his lower arm. The patient sought medical attention (seen in office). The patient was treated with ice and unspecified pain relievers. The patient was not recovered from the events. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: 5" diameter hard, red, raised sore spot that was hot to the touch. Symptoms persisted after icing and Tylenol were applied.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Lethargy, Myalgia, Rhinorrhoea
Clinical narrative: Extreme lethargy, muscle pain, headache, cough, running nose, sputum production, lasting over 10 days.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Sputum increased
Clinical narrative: Extreme lethargy, muscle pain, headache, cough, running nose, sputum production, lasting over 10 days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Incorrect route of drug administration, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Could not lift right arm for two days as very painful to try. Gradually over the next five weeks could move the arm up slowly but could not do normal activity with right arm even putting on clothes. As an active female who does yoga & works out at the gym I've had to change my exercise routine. The vaccination needle was inserted very high and toward back of my shoulder/arm which was different than in the past flu shots. Finally saw my internist who prescribed physical therapy.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Induration, Mass, Skin warm
Clinical narrative: Large, hard, swollen lump.  3.5 inches diameter.  Hot to the touch.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Urticaria
Clinical narrative: Developed hives over body and severe chest tightness and severe burning in chest area.
Age: 24.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Neck pain, Odynophagia, Pain
Clinical narrative: At around 11:00PM, the patient began feeling severe muscle pain in his right upper arm, near the site of injection.  Patient was able to go to bed without incident or needing OTC pain meds, however when he woke up the pain had spread all throughout the right upper arm, from the elbow up to near the clavicle.  Pain was aching on rest/non-touch, but when touched or the arm was moved the pain turned into a sharp and shooting pain.  Pain was also noticeable when the patient swallowed (sending pain down the neck into the arm).
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a female consumer (of unknown age) for GARDASIL a Pregnancy Registry product, refers to her self. In May 2012 the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL, lot# not reported. Shortly after her injection she discovered that she was 2 months pregnant at the time of the injection. The patient stated that at the time of the report she was 5 months pregnant. Follow up information was received from a nurse who stated that the patient was dismissed from their clinic and possibly delivered by another physician, and the baby was fine after being delivered by cesarean section (c-section). Upon internal review, the event "Caesarean section" was considered to be medically significant. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Infarix given to adult in place of TDap.
Age: 1.89
Sex: M
Vaccine: FLUX, HEPA, HPV4
Symptoms: Abnormal behaviour, Aggression, Poor quality sleep, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 22 month old male patient. On 30-SEP-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (lot#, expiration date and route not reported) and VAQTA (lot#, expiration date and route not reported). The patient's father informed the physician that since that date the patient's behavior had changed and became very aggressive. Example of this is that the patient "climbed up on a chair and pulled the television down" on 01-OCT-2013. The patient had also "taken his stool out of his diaper and smeared it on the rug" and "taken eggs out of the refrigerator, cracked them and smeared them all over the floor". The physician also reported that the patient's sleeping patterns had changed and patient woke up at 1 am and tried to feed his younger infant sibling. Outcome of the reported events were unknown. Causality was not reported. Additional information is not expected.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Disorientation, Dizziness, Pyrexia
Clinical narrative: Self reported incident, RN saw employee 10/16/13. "10/12/13" reported by patient - employee, "Saturday, felt weak, dizzy, disoriented, wrists hurt." Monday 10/14/2013, "had a fever 101.6" - did not report to RN on job. Tues 10/15, "had a fever 100.5" 10/16/13 "asked RN to take Temp" 99.2 "was wheezing", not noted nor cough, 10/17/13 "Afebrile - No wheezing noted.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Fall, Skin warm, Tonic clonic movements, Tremor
Clinical narrative: Morning after 5 year shots including KINRIX, PROQUAD, and FLUZONE, had used the bathroom and was washing hands went fell to floor and dad found "shaking". Eyes went "wide" per dad and then sat up and tried to get up. Dad is EMT and thought it was not trembling but more tonic/clonic. Lasted about 30 sec. After was not confused or disoriented and did not lose condense (but had just used bathroom before). Noted to feel warm but no fever when dad took temp minutes after episode. Observed by dad and felt to be stable. Had not had breakfast yet but had dinner night before. Past history and head injury few month before but had had no symptoms from head injury since is occurred but did have LOC at the time. Decided to monitor at home for now. Called later and did give Motrin just in case had fever. Ate pancakes and seems fine now.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Burning sensation, Erythema, Injection site erythema, Pain, Pruritus
Clinical narrative: Shortly after the vaccine was administered I began to have discomfort at the vaccination site. It would cycle through five to ten minutes each of severe itching, then burning, then soreness. This went on for a couple of hours. Later it was just sore. I've never previously had any reaction to a flu vaccine.  I had the pneumonia vaccine at the same time. That vaccination site became raised and red in the diameter of about a half dollar. There was also a bright red streak bout three inches long and about a half inch wide extending from the vaccination site over my shoulder towards the breast. The site and line were very sore.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination site discomfort, Vaccination site swelling
Clinical narrative: Shortly after the vaccine was administered I began to have discomfort at the vaccination site. It would cycle through five to ten minutes each of severe itching, then burning, then soreness. This went on for a couple of hours. Later it was just sore. I've never previously had any reaction to a flu vaccine.  I had the pneumonia vaccine at the same time. That vaccination site became raised and red in the diameter of about a half dollar. There was also a bright red streak bout three inches long and about a half inch wide extending from the vaccination site over my shoulder towards the breast. The site and line were very sore.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Lymphadenopathy, Tenderness
Clinical narrative: Injection arm: pain/tenderness in armpit. Slight swelling of lymph.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Malaise, Nausea
Clinical narrative: GI upset, Nausea, Malaise.