chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Drug screen, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Transverse myelitis. Received Flu shot on 10/10/11 at local pharmacy. Seen in ED 10/17/11 got oral steroids. Saw Dr. 11 days later on 10/21/11. Referred to neurologist shortly after for tx w/ IV steroids.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Right arm anterior surface red, hot surface area 4 inches in diameter. Fever 103. Swelling of arm hard to move. Fever broke x 24 hours. No s/s since 10/22/11.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Developed a rash, itching of her throat, and nasal congestion immediately following the administration of the influenza vaccine on 14 Sep 11. She has no hx of egg allergies and has a history of asthma. She required BENADRYL and EPI.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Nasal congestion, Rash, Throat irritation
Clinical narrative: Developed a rash, itching of her throat, and nasal congestion immediately following the administration of the influenza vaccine on 14 Sep 11. She has no hx of egg allergies and has a history of asthma. She required BENADRYL and EPI.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dyspnoea, Pain, Pyrexia, Rash
Clinical narrative: Loss of taste and smell. Blistering on hands, feet, scalp. Drying of all mucus membranes (vaginal, eyes, mouth, nose).
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tongue disorder
Clinical narrative: Loss of taste and smell. Blistering on hands, feet, scalp. Drying of all mucus membranes (vaginal, eyes, mouth, nose).
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ageusia, Anosmia, Blister, Mucosal dryness
Clinical narrative: Loss of taste and smell. Blistering on hands, feet, scalp. Drying of all mucus membranes (vaginal, eyes, mouth, nose).
Age: 44.0
Sex: F
Vaccine: FLUX, PPV, FLU3
Symptoms: Movement disorder, Pain in extremity, Ultrasound abdomen, X-ray
Clinical narrative: Awoke at night with excruciating pain in right upper arm. Followed up by PA. Ortho - recommended MRI - Rx Prednisone and poss. physical therapy for neck muscles.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV, FLU3
Symptoms: Injection site pain, Middle insomnia, Muscle disorder, Ultrasound scan, X-ray limb
Clinical narrative: Awoke at night with excruciating pain in right upper arm. Followed up by PA. Ortho - recommended MRI - Rx Prednisone and poss. physical therapy for neck muscles.
Age: 68.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Nausea
Clinical narrative: Cough, chest tight - difficult to breathe, weak.
Age: 68.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Chest discomfort, Cough, Dyspnoea
Clinical narrative: Cough, chest tight - difficult to breathe, weak.
Age: 69.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Cough, Diarrhoea, Nausea, Vomiting
Clinical narrative: Bad cough, chest constriction, vomiting, diarrhea, dehydrated, muscle difficulty.
Age: 69.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Chest discomfort, Cough, Dehydration, Diarrhoea, Muscle disorder
Clinical narrative: Bad cough, chest constriction, vomiting, diarrhea, dehydrated, muscle difficulty.
Age: 69.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Vomiting
Clinical narrative: Bad cough, chest constriction, vomiting, diarrhea, dehydrated, muscle difficulty.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Arthralgia, Joint swelling, Juvenile arthritis, Laboratory test, Musculoskeletal stiffness
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no concomitant conditions and no pertinent medical history who on 31-MAR-2011 (also reported as in early to mid May 2011), was vaccinated with the first dose of GARDASIL (Lot #: 668229/1569Z). On 31-MAR-2011, the patient was also given VAQTA (Lot #: 669530/1510Z) and a tuberculin purified protein derivative (PPD). Concomitant medication concluded PPD. Around early to mid May 2011 (also reported as in March 2011, within a week from the first injection of GARDASIL by the mother), the patient experienced discomfort in her fingers which quickly spreading to all ten fingers. By mid April 2011 (reported by the mother), both hands were affected. When the patient went into the pediatrician office for the second dose they did not administer and doctor felt it was arthritis. The patient had now been appointed to a Rheumatoid Arthritis Doctor at Hospital. The patient was diagnosed with Juvenile idiopathic arthritis (JIA) in all ten joints in her fingers. Naproxen did not alleviate any symptoms so the patient now had to take methotrexate for the rest of her life. Physician performed a hand x-ray with results negative of joint damage. They believe the hand problems were possibly linked to the first injection of GARDASIL. Other lab studies have been performed including blood tests. The patient had been given naproxen for six weeks for the treatment of AE. Therapy with GARDASIL has been discontinued. The patient had not been recovered yet. X-ray of hand and blood work were "unremarkable". Juvenile Idiopathic Arthritis (JIA) diagnosis confirmed by the registered nurse, but despite what the patient's mother reported, the patient might not necessarily remain on methotrexate for life, the patient would be followed and evaluated. Juvenile Idiopathic Arthritis (JIA) was considered "could be disabling" but not life threatening by the nurse. At this time, relationship of Juvenile Idiopathic Arthritis (JIA) to GARDASIL was unknown per the nurse. On 21-JUN-2011, the patient presented to the office with swollen joints in hands and blood work drawn. The receptionist was unable to read the rest of the information in the chart. The patient had not been seen after 21-JUN-2011. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Blood test normal, Joint swelling, Juvenile arthritis, Limb discomfort, X-ray limb normal
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no concomitant conditions and no pertinent medical history who on 31-MAR-2011 (also reported as in early to mid May 2011), was vaccinated with the first dose of GARDASIL (Lot #: 668229/1569Z). On 31-MAR-2011, the patient was also given VAQTA (Lot #: 669530/1510Z) and a tuberculin purified protein derivative (PPD). Concomitant medication concluded PPD. Around early to mid May 2011 (also reported as in March 2011, within a week from the first injection of GARDASIL by the mother), the patient experienced discomfort in her fingers which quickly spreading to all ten fingers. By mid April 2011 (reported by the mother), both hands were affected. When the patient went into the pediatrician office for the second dose they did not administer and doctor felt it was arthritis. The patient had now been appointed to a Rheumatoid Arthritis Doctor at Hospital. The patient was diagnosed with Juvenile idiopathic arthritis (JIA) in all ten joints in her fingers. Naproxen did not alleviate any symptoms so the patient now had to take methotrexate for the rest of her life. Physician performed a hand x-ray with results negative of joint damage. They believe the hand problems were possibly linked to the first injection of GARDASIL. Other lab studies have been performed including blood tests. The patient had been given naproxen for six weeks for the treatment of AE. Therapy with GARDASIL has been discontinued. The patient had not been recovered yet. X-ray of hand and blood work were "unremarkable". Juvenile Idiopathic Arthritis (JIA) diagnosis confirmed by the registered nurse, but despite what the patient's mother reported, the patient might not necessarily remain on methotrexate for life, the patient would be followed and evaluated. Juvenile Idiopathic Arthritis (JIA) was considered "could be disabling" but not life threatening by the nurse. At this time, relationship of Juvenile Idiopathic Arthritis (JIA) to GARDASIL was unknown per the nurse. On 21-JUN-2011, the patient presented to the office with swollen joints in hands and blood work drawn. The receptionist was unable to read the rest of the information in the chart. The patient had not been seen after 21-JUN-2011. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Obsessive-compulsive disorder
Clinical narrative: A serious spontaneous report of OCD like behavior and heart murmur and non-serious event of fever and tested positive for streptococcus has been received from a health professional concerning a five-year-old male, subsequent to FLUMIST. No relevant past medical history has been reported for this patient. The patient received FLUMIST on 27-Jan-2011. On the same day the patient was given vaccines for diphtheria & pertussis & tetanus & poliomyelitis, measles & mumps & rubella and varicella. About an hour and a half after receiving FLUMIST, the patient developed obsessive-compulsive disorder (OCD) like behavior and fever. The patient began using wet ones to wipe car seats and went through a whole pack of wet ones. On 28-Jan-2011, the patient excessively was washing his hands. He was also taking off his clothes and washing his toys. His behavior continued for weeks. He was seen by a neurologist, allergist and cardiologist since receiving the vaccines. The cardiologist detected a heart murmur in the patient. The patient was not hospitalized for the symptoms. The patient had IgG titers drawn and the laboratory values came back normal. The patient also tested positive for streptococcus on 03-Feb-2011. The outcome of the events of OCD like behavior, heart murmur, tested positive for streptococcus and fever was unknown.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Electroencephalogram normal, Immunology test normal, Laboratory test normal, Obsessive-compulsive disorder, Streptococcus test
Clinical narrative: A serious spontaneous report of OCD like behavior and heart murmur and non-serious event of fever and tested positive for streptococcus has been received from a health professional concerning a five-year-old male, subsequent to FLUMIST. No relevant past medical history has been reported for this patient. The patient received FLUMIST on 27-Jan-2011. On the same day the patient was given vaccines for diphtheria & pertussis & tetanus & poliomyelitis, measles & mumps & rubella and varicella. About an hour and a half after receiving FLUMIST, the patient developed obsessive-compulsive disorder (OCD) like behavior and fever. The patient began using wet ones to wipe car seats and went through a whole pack of wet ones. On 28-Jan-2011, the patient excessively was washing his hands. He was also taking off his clothes and washing his toys. His behavior continued for weeks. He was seen by a neurologist, allergist and cardiologist since receiving the vaccines. The cardiologist detected a heart murmur in the patient. The patient was not hospitalized for the symptoms. The patient had IgG titers drawn and the laboratory values came back normal. The patient also tested positive for streptococcus on 03-Feb-2011. The outcome of the events of OCD like behavior, heart murmur, tested positive for streptococcus and fever was unknown.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Streptococcus test positive
Clinical narrative: A serious spontaneous report of OCD like behavior and heart murmur and non-serious event of fever and tested positive for streptococcus has been received from a health professional concerning a five-year-old male, subsequent to FLUMIST. No relevant past medical history has been reported for this patient. The patient received FLUMIST on 27-Jan-2011. On the same day the patient was given vaccines for diphtheria & pertussis & tetanus & poliomyelitis, measles & mumps & rubella and varicella. About an hour and a half after receiving FLUMIST, the patient developed obsessive-compulsive disorder (OCD) like behavior and fever. The patient began using wet ones to wipe car seats and went through a whole pack of wet ones. On 28-Jan-2011, the patient excessively was washing his hands. He was also taking off his clothes and washing his toys. His behavior continued for weeks. He was seen by a neurologist, allergist and cardiologist since receiving the vaccines. The cardiologist detected a heart murmur in the patient. The patient was not hospitalized for the symptoms. The patient had IgG titers drawn and the laboratory values came back normal. The patient also tested positive for streptococcus on 03-Feb-2011. The outcome of the events of OCD like behavior, heart murmur, tested positive for streptococcus and fever was unknown.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Abnormal behaviour, Blood immunoglobulin G normal, Cardiac murmur, Obsessive-compulsive disorder, Pyrexia
Clinical narrative: A serious spontaneous report of OCD like behavior and heart murmur and non-serious event of fever and tested positive for streptococcus has been received from a health professional concerning a five-year-old male, subsequent to FLUMIST. No relevant past medical history has been reported for this patient. The patient received FLUMIST on 27-Jan-2011. On the same day the patient was given vaccines for diphtheria & pertussis & tetanus & poliomyelitis, measles & mumps & rubella and varicella. About an hour and a half after receiving FLUMIST, the patient developed obsessive-compulsive disorder (OCD) like behavior and fever. The patient began using wet ones to wipe car seats and went through a whole pack of wet ones. On 28-Jan-2011, the patient excessively was washing his hands. He was also taking off his clothes and washing his toys. His behavior continued for weeks. He was seen by a neurologist, allergist and cardiologist since receiving the vaccines. The cardiologist detected a heart murmur in the patient. The patient was not hospitalized for the symptoms. The patient had IgG titers drawn and the laboratory values came back normal. The patient also tested positive for streptococcus on 03-Feb-2011. The outcome of the events of OCD like behavior, heart murmur, tested positive for streptococcus and fever was unknown.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: (R) arm hot to touch, redness, below deltoid to 2 inches below; no c/o itch, hive, SOB; requested to have PCP evaluation, counseled - 10-28-11 follow up medical eval. required steroid intervention.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Chest discomfort, Chest pain, Computerised tomogram, Fatigue
Clinical narrative: Patient representative notified pharmacist on 10/31/11 that pt had developed Guillain-Barre syndrome - with some paralysis.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lumbar puncture, Mobility decreased, Motor dysfunction, Muscle spasms, Muscle tightness
Clinical narrative: Patient representative notified pharmacist on 10/31/11 that pt had developed Guillain-Barre syndrome - with some paralysis.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Myalgia, Neck pain, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient representative notified pharmacist on 10/31/11 that pt had developed Guillain-Barre syndrome - with some paralysis.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient representative notified pharmacist on 10/31/11 that pt had developed Guillain-Barre syndrome - with some paralysis.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Patient representative notified pharmacist on 10/31/11 that pt had developed Guillain-Barre syndrome - with some paralysis.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Feeling hot, Pallor, Paraesthesia oral
Clinical narrative: Patient c/o feeling dizzy & warm. Denies SOB, CP, difficulty swallowing. BP 112/62, P 84 R, R 16, color pale. Patient laid down, feet elevated. MD at medical center notified. No further tx needed. Patient had not eaten given food, BP stable, color improved no further c/o dizziness. To f/u with primary care MD.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Feeling hot, Pallor
Clinical narrative: Patient c/o feeling dizzy & warm. Denies SOB, CP, difficulty swallowing. BP 112/62, P 84 R, R 16, color pale. Patient laid down, feet elevated. MD at medical center notified. No further tx needed. Patient had not eaten given food, BP stable, color improved no further c/o dizziness. To f/u with primary care MD.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: While INFLUENZA vaccine being administer area around injection site began to swell. Within the next 15-20 minutes area swelled to approx. size of 50 cent piece, and raised. Pt denied any itching or pain.
Age: 31.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Activities of daily living impaired, Antinuclear antibody positive, Arthralgia, Condition aggravated, Joint swelling
Clinical narrative: Noticed the first rashes on body while bathing. The swelling increased in the left knee which had been injured previously. It got so bad that patient had to be sent home on convalescent leave. While home on leave, was doing physical therapy in the water and after four hours in the sun, the next day patient could not get out of bed, had a rash all over body and severe joint pain. Patient has documentation from the ER where seen. Went through many flare ups of lupus. Patient was never diagnosed. Went through literally hell trying to get better and post medical discharge, almost a year to the date of discharge patient had another severe reaction to the sun and was finally was diagnosed and treated for lupus. Is now dealing with the agency not recognizing the lupus as a service connected condition where the obvious cause is the vaccination reaction but also am dealing with the agency not making a decision either. Patient left to deal with this on own.
Age: 31.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Mobility decreased, Photosensitivity reaction, Pyrexia, Rash generalised, Systemic lupus erythematosus
Clinical narrative: Noticed the first rashes on body while bathing. The swelling increased in the left knee which had been injured previously. It got so bad that patient had to be sent home on convalescent leave. While home on leave, was doing physical therapy in the water and after four hours in the sun, the next day patient could not get out of bed, had a rash all over body and severe joint pain. Patient has documentation from the ER where seen. Went through many flare ups of lupus. Patient was never diagnosed. Went through literally hell trying to get better and post medical discharge, almost a year to the date of discharge patient had another severe reaction to the sun and was finally was diagnosed and treated for lupus. Is now dealing with the agency not recognizing the lupus as a service connected condition where the obvious cause is the vaccination reaction but also am dealing with the agency not making a decision either. Patient left to deal with this on own.
Age: 1.54
Sex: F
Vaccine: FLUX, HIBV, PNC13
Symptoms: Confusional state, Disorientation, Pyrexia, Restlessness
Clinical narrative: High fever (104.8 degrees F), restlessness, disorientation, confusion.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hyperhidrosis, Hypotension, Presyncope, Vomiting
Clinical narrative: Complained of being hot, diaphoretic. Vomited x 2, low blood pressure. Seen in ED - told it was a vagal reaction. No hives, itching.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Headache, Nausea, Wheezing
Clinical narrative: 1421 Received flu vaccine. 1427 Sudden onset of severe headache, feeling hot all over, shortness of breath, wheezing, nausea. 1430 Taken to emergency room to receive treatment.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Mass
Clinical narrative: Patient experienced a lump which was the size of 1/2 of a softball. It was also red in color, but not itchy. He put ice on it one evening according to his wife.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Quarter sized swelling-around site. Tender to touch at center. Warm/heat with redness.
Sex: F
Vaccine: HPVX
Symptoms: Fatigue, Full blood count normal, Metabolic function test, Thyroid function test normal
Clinical narrative: Patient developed fatigue the day after receiving her 2nd HPV vaccine (no problems after the 1st/dose). I saw her on 11/2/11 - normal exam/normal neuro exam. I explained HPV not likely a problem but mom wanted it reported. We discussed other possible causes of fatigue.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Patient given injection intramuscular in deltoid muscle. Patient having pain in the arm. Patient claims gave inside of arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: 10 AM - Vaccines given. 11 AM - Mother reports itching and rash on stomach. Goes to hospital ER. MD reports red itchy rash on body. Child given BENADRYL, DECADRON and DUO NEB. Child back in school and doing "OK" on 10/25/11 according to mother.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red, painful.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Flu shot at 2:30 PM 11/7/11. At 5:30 PM felt her throat closing up. Took an antihistamine at 9 PM and relief 1 hr. later.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: Redness and mild swelling with few indurated wheals on bilateral lower extremities and redness at injection sites 5 minutes after vaccinations. Diphenhydramine given and redness, swelling and wheals resolved 15 minutes later. 2 petechial spots on left lower leg appeared.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Feeling abnormal
Clinical narrative: Pt. received vaccine on 10/18/11 - started to feel funny on 10/19/11. By 10/21/11 patient lost all hearing in left ear. Went to MD on 10/21/11. Received steroid shot on 10/21/11 and 11/4/11. Patient stated on 11/7/11 hearing was coming back. Scheduled for another injection on 11/18/11 then hearing test to follow last injection.
Age: 12.0
Sex: M
Vaccine: DTAP, HPV4, VARCEL
Symptoms: Disorientation, Dyskinesia, Gaze palsy, Injection site pain, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning her 12 year old son who on 19-JUL-2011 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) in his right arm. The patient was given 2 other vaccines at the same time. She had tetanus toxoid (manufacturer unknown) in his left arm, VARIVAX (Merck) in his left arm. The reporter stated that after getting GARDASIL, her son "fainted, and his left arm shot up as a tonic clonic movement while he was unconscious. After a couple minutes he recovered and was fine. The patient did not remember fainting. No treatment was given for adverse events. The patient sought unspecified medical attention. Follow up information has been received from the nurse (licensed practical nurse) concerning a 12 year old male with no illness at the time of vaccination (camp physical) who on 19-JUL-2011 was vaccinated with the first dose of GARDASIL (lot # not reported) into right arm. Secondary suspect therapy included VARIVAX (Merck) (lot # not reported, the second dose in his left arm). Concomitant therapy included DTaP (manufacturer unknown, in his left arm). The reporter stated that the patient had 3 immunizations that day-after GARDASIL and VARIVAX (Merck) were given (at same time by 2 nurses). On 19-JUL-2011 at 3:00 PM, the patient's left arm jerked upwards, the eyes rolled back and he fainted. He was sitting on exam table during injections. No injury was noted. There were some jerking movements (looked like a seizure). The patient came "back" in about 5-10 seconds. He was unaware of what happened, did not remember getting shots, wondered where he was and said it all went black. He was re-oriented. Cool wash cloth on head. He was given DTaP by staff. He was watched for 30 minutes and then went home. No further treatment was needed. The patient only complained of site pain at injection site for 2 days. He had not had the second injection yet. The patient did not seek medical attention. Additional information is not expected. This is an amended report. Another adverse event "some jerking movement (looked like a seizure)" was added into AE information screen and made it as an other important medical event.
Age: 12.0
Sex: M
Vaccine: DTAP, HPV4, VARCEL
Symptoms: Memory impairment, Seizure like phenomena, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a nurse concerning her 12 year old son who on 19-JUL-2011 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) in his right arm. The patient was given 2 other vaccines at the same time. She had tetanus toxoid (manufacturer unknown) in his left arm, VARIVAX (Merck) in his left arm. The reporter stated that after getting GARDASIL, her son "fainted, and his left arm shot up as a tonic clonic movement while he was unconscious. After a couple minutes he recovered and was fine. The patient did not remember fainting. No treatment was given for adverse events. The patient sought unspecified medical attention. Follow up information has been received from the nurse (licensed practical nurse) concerning a 12 year old male with no illness at the time of vaccination (camp physical) who on 19-JUL-2011 was vaccinated with the first dose of GARDASIL (lot # not reported) into right arm. Secondary suspect therapy included VARIVAX (Merck) (lot # not reported, the second dose in his left arm). Concomitant therapy included DTaP (manufacturer unknown, in his left arm). The reporter stated that the patient had 3 immunizations that day-after GARDASIL and VARIVAX (Merck) were given (at same time by 2 nurses). On 19-JUL-2011 at 3:00 PM, the patient's left arm jerked upwards, the eyes rolled back and he fainted. He was sitting on exam table during injections. No injury was noted. There were some jerking movements (looked like a seizure). The patient came "back" in about 5-10 seconds. He was unaware of what happened, did not remember getting shots, wondered where he was and said it all went black. He was re-oriented. Cool wash cloth on head. He was given DTaP by staff. He was watched for 30 minutes and then went home. No further treatment was needed. The patient only complained of site pain at injection site for 2 days. He had not had the second injection yet. The patient did not seek medical attention. Additional information is not expected. This is an amended report. Another adverse event "some jerking movement (looked like a seizure)" was added into AE information screen and made it as an other important medical event.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fall, Gait disturbance, Injection site pain, Muscular weakness
Clinical narrative: Excruciating pain shoulder to finger tips in static as well as any movement (left) nausea, shock symptoms, shaking, dizziness can't sit up, barely walk for 24 hr up to 3 days, then continued arm in sling & pain for still weakness with aching distal ROM left shoulderabduct-extend & overhead flex.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Nausea, Pain, Pain in extremity, Shock
Clinical narrative: Excruciating pain shoulder to finger tips in static as well as any movement (left) nausea, shock symptoms, shaking, dizziness can't sit up, barely walk for 24 hr up to 3 days, then continued arm in sling & pain for still weakness with aching distal ROM left shoulderabduct-extend & overhead flex.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Excruciating pain shoulder to finger tips in static as well as any movement (left) nausea, shock symptoms, shaking, dizziness can't sit up, barely walk for 24 hr up to 3 days, then continued arm in sling & pain for still weakness with aching distal ROM left shoulderabduct-extend & overhead flex.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Malaise, Skin warm
Clinical narrative: Pt. states "didn't feel well" night given. Localized reaction noticed next day. Tx cold pack. Seen by MD 11-1-11 - 2x3 warm erythema area - no skin break down. No oral edema. No pulmonary changes. Tx Prednisone, doxy & pain med.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: 10/26 O.V. for generalized, erythematous, and itchy rash. Pt. had received flu shot 10/25. No local reaction at site.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Local reaction
Clinical narrative: - Localized injection site reaction (redness, swelling, bruising in arm administered in left arm) at injection site - 5 min after vaccine. - Took a BENADRYL 1st used ice pack, swelling went down.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: INFLUENZA vaccine administered on 10-28-11 IM left deltoid, on Saturday, October 29, 2011 child arm began to swell, became hot to touch and red. Gave BENADRYL (mom). Treated at hospital.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Redness, pain & swelling at injection site with red streaks & warmth traveling up her arm to underneath her armpit.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: Seemingly local reaction with induration erythema, warmth within 24 hrs of vaccination which improved on its own (8-11cm) (L) arm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Myalgia, Oedema peripheral
Clinical narrative: Client received High Dose Flu vaccine 10/11/11. States later that night started with muscle pain in all extremities. Could not drive for 4 days still has muscle pain & swelling on hands & feet at night - saw private MD 10/12 & 10/17 preformed blood test & gave pain medication.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: - Significant pain in arm vaccine was injected (L arm) around 15 min after gave vaccine. - Administered ice pack with ibuprofen & ORAPRED patient. - No swelling or redness. - Called patient 4 hrs later & pain was reduced, no other symptoms.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt. called - pain, redness, & swelling used ice & rested it. Better when called to followup - 10/30/11.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Chills, pain, soreness, swelling, shivering, shooting pain in left arm, --> PNEMOVAX.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted about 5-10 minutes after getting flu shot. We elevated legs, gave water, applied ice to head. Patient sat near pharmacy with father for 20 minutes. Denied offer to call ambulance.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Nausea, Syncope
Clinical narrative: About 5-7 mins after injection patient standing walked out to where parent was waiting. Felt queasy & dizzy - fainted. Landed on tailbone. Had patient lie down with cool compress on head. Stated felt nauseated & hot. Feeling better 25 min after incident.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Patient developed itching and hives initially only at injection site which resolved but several days later, itching and hives appeared over various parts of body.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site scar, Injection site vesicles, Pyrexia
Clinical narrative: Pt. did not report the reaction right away or sooner. Stated "started" as blister on the top of the injection site. He pinched it to drain the fluid. No signs of injection but left a black scar. Felt little feverish. 10-11-11 pt informed of reaction to the nurse.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Dyskinesia, Excessive eye blinking, Muscle twitching, Pyrexia, Tourette's disorder
Clinical narrative: Started having Tourette like syndromes eye blinking (extreme). Jerking head, some body twitches, right after he had his 4 year old shots and his 5/year old shots, also had fevers on every vaccination time.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Small intestinal resection
Clinical narrative: Patient developed intussusception diagnosed on 10/19. Required surgical resection with loss of some small bowel. Seven day admission.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Induration
Clinical narrative: Severe erythema/induration/warmth of large section of upper arm. Hospitalized after ER visit. Resolved overnite after IV SOLUMEDROL & IV ROCEPHIN.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Decreased appetite, Hemiparesis, Irritability, Ischaemic stroke, Lethargy
Clinical narrative: Seen for 6 month physical 10/8/11. Developed fever, vomiting, fussiness and decreased appetite 10/11/11. On 10/13/11 episodes of (L) sided weakness, lethargy. Weakness resolved by the time seen in office. Also noted to have viral exanthem. Sent to ER but will be observed for developmental sequelae. Currently some residual weakness.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Patent ductus arteriosus, Protein C deficiency, Pyrexia, Viral rash
Clinical narrative: Seen for 6 month physical 10/8/11. Developed fever, vomiting, fussiness and decreased appetite 10/11/11. On 10/13/11 episodes of (L) sided weakness, lethargy. Weakness resolved by the time seen in office. Also noted to have viral exanthem. Sent to ER but will be observed for developmental sequelae. Currently some residual weakness.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Seen for 6 month physical 10/8/11. Developed fever, vomiting, fussiness and decreased appetite 10/11/11. On 10/13/11 episodes of (L) sided weakness, lethargy. Weakness resolved by the time seen in office. Also noted to have viral exanthem. Sent to ER but will be observed for developmental sequelae. Currently some residual weakness.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Small red wheal 24 hrs after progressing to large 8x10 area of red induration at site. Tender & warm to touch.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Pt had immediate allergic reaction to flu vaccine - hive at site & itching redness = 2 inches - 3 inches in diameter.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Eyelid oedema, Headache, Neck pain, Pain in extremity
Clinical narrative: After she had flu shot, she had pain on arm, neck, head and her eyelids were swollen (Friday afternoon) she had headache and all joints were aching. She took ALEVE for pain and it took whole 2 days to recover (Sunday afternoon).
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Haematoma
Clinical narrative: Hematoma (round).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Fatigue, Headache, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: 3 hours after flu shot symptoms started with low grade fever, eyes burning and red, scratchy sore throat, shaking body aches, headache & fatigue. No rash, no difficulty breathing no swelling at injection site. Plan: BENADRYL, fluids, ibuprofen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: 3 hours after flu shot symptoms started with low grade fever, eyes burning and red, scratchy sore throat, shaking body aches, headache & fatigue. No rash, no difficulty breathing no swelling at injection site. Plan: BENADRYL, fluids, ibuprofen.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient was given FLUVIRIN vaccination on 10/12/2011 to right IM arm. Called pharmacy on 10/25/11 and complained that her arm was still hurting so bad that she could no raise it. (see back). Talked with the patient on 10/25/11 in the evening. She said she did research in the web and said it was common to have pain. Also said she had a doctor's appointment on 10/26/11. Asked the patient to call the pharmacy and let us know what the physician said. Patient called again on 11/4 and wanted to file an official complaint. Her arm is still hurting but she has not as of then seen a physician.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Pruritus generalised
Clinical narrative: After being injected with vaccine, area around injection site started to itch, the spread to arm, shoulder, neck, chest, & back. Within 1 hour of injection.
Age: 1.8
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 24 hours after vaccine administration, red/hot area developed on lateral (L) at site of vaccine; grew to 18 x 18 cm, no fever, not tender.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Site on left arm had redness, was tender and had hard knot underneath with heat associated with it.
Age: 14.0
Sex: F
Vaccine: HEPA, MEN, TDAP
Symptoms: Convulsion, Dyskinesia, Juvenile myoclonic epilepsy
Clinical narrative: On June 4th she felt first jerk. Had a seizure on June 29th. After waking up from nap. Jerks are worse during menstrual cycle. Never any health problems before. Now has Juvenile myoclonic epilepsy.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Pyrexia
Clinical narrative: All joints ached a ran a fever for 7 days high of 102 degrees on Sunday & went to the hospital.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Exercise tolerance decreased, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Left arm went numb at work 3 days after vaccination. 2 days later I was diagnosed with GBS and all 4 extremities, tongue, lips and esophagus were numb I was unable to use arms or legs. Now beginning to learn to walk with a walker. Experience very low endurance. Use 4-leg cane to go up and down stairs.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Mobility decreased, Pharyngeal hypoaesthesia, Walking aid user
Clinical narrative: Left arm went numb at work 3 days after vaccination. 2 days later I was diagnosed with GBS and all 4 extremities, tongue, lips and esophagus were numb I was unable to use arms or legs. Now beginning to learn to walk with a walker. Experience very low endurance. Use 4-leg cane to go up and down stairs.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident
Clinical narrative: Patient had a stroke and was hospitalized.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dysphagia, Headache, Wheezing
Clinical narrative: On 10/26/11 patient received HIGH DOSE flu vaccine through her local pharmacy with 2hrs developed coughing/wheezing headache, swallowing difficulty & chills on way to event dinner stopped at pharmacy to ask for advice. They recommended BENADRYL. Her 101.1 F temp went down & symptoms dissipated within the hour. When she returned home called an EMT friend who recommended TYLENOL. Pt went to bed & symptoms absent on AM.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation mucosal, Erythema, Mucosal haemorrhage, Mucosal inflammation, Oropharyngeal pain
Clinical narrative: Pain back of throat, burning, red & inflamed urethra, same inner lips, white sores & bleeding a little. Prednisone prescribed. (Mucositis) Also vaginal symptoms same as above.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Breast mass, Injection site swelling, Injection site warmth, Mass
Clinical narrative: Swelling heat at sight of injection & lump developed in breast & under arm on same side of injection. They are currently getting smaller.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis treated with cephalexin on 10/31/11. Improving with treatment.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Induration, Pyrexia
Clinical narrative: Fever, local induration.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash on arm 4" x 3 " left arm itching. Reported starting after shot & still present after 3 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: 1 week after administration patient has pain in arm at site of injection. She describes as muscle pain and sometimes a "shooting" pain that does not affect her all the time but with certain movements.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Developed itchy rash on hands - called at home approximately 30 minutes later and had progressed to arms, head and other parts of body. Advised to take BENADRYL and go to ER if increased in severity.
Age: 1.05
Sex: F
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Body temperature increased, Crying, Febrile convulsion, Screaming, Tremor
Clinical narrative: 10/26 0235: Shaking, crying, screaming, vomiting, emergency room, gave suppository T 100.2, dx with tempermatic seizure per mom. 1130-1202 - Shaking, T 100.9, ibuprofen given.
Age: 1.05
Sex: F
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: 10/26 0235: Shaking, crying, screaming, vomiting, emergency room, gave suppository T 100.2, dx with tempermatic seizure per mom. 1130-1202 - Shaking, T 100.9, ibuprofen given.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Dysstasia, Nausea, Presyncope
Clinical narrative: Nausea 7:30 pm -> until treated at ER; Diarrhea  7:45 pm -> until treated at ER; Inability to get standing 8:15 pm; near fainting  8:15 pm; breathing difficulty 8:15 pm.
Age: 0.71
Sex: F
Vaccine: FLU3
Symptoms: Alopecia
Clinical narrative: Two days after flu vaccine 6 mos to 36 mos hair started falling out.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient developed a red, swollen upper arm (entire upper arm) within 36 hrs of vaccination. Lasted about 2 days.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Flu shot given then approximately 5 minutes later patient complained of seeing black, then fainted. I (intern) then quickly checked for signs of breathing and pulse. Patient's pulse & breathing seemed normal. During checking pulse & breathing the patient opened her eyes & seemed alert. Approximately 3-5 minutes later the patient fainted again. After second episode, the patient was moved to be lying on the floor & feet elevated emergency resource was called after second episode. EMT took patient BP & was normal. Pt was told she could go home by EMT.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Malaise, Pyrexia
Clinical narrative: Chills, fever 101.5 degrees, exhaustion, sense of extreme sickness, anorexia but no nausea. The acute phase lasted about 14 hours & symptoms disappeared in about 18 hours. Treatment: I went to bed with electric blanket on high.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chest discomfort, Chills, Dysphonia, Fatigue
Clinical narrative: Day 1, 10/26/11, Patient symptoms: warm, red, swollen area (approximately 6" oval) around injection site on left arm. Left arm felt stiff, painful. Patient had sensation of tendonitis in deltoid musculature (popping, catching, sensation) when actively using left arm. Patient felt fatigued around 1600. Symptoms waxed and waned. Treatment: Patient took 400 mg of ADVIL at 11:30 and at 18:30. Day 2, 10/27, Patient symptoms: generalized fatigue; mild runny nose, chills. Left upper arm pain radiated into the left side of neck, chest wall, axilla, scapula region and extended through the full length of the left arm. Patient's tendonitis sensations increased, involving shoulder flexor and extensor muscles, elbow flexor, extensor and supinator muscles and wrist flexors. Left arm joint pain increased, especially in the elbow. Deltoid region felt warm to the touch. Symptoms waxed and waned. Day 3-4, 10/28-29, Patient symptoms: generalized fatigue, mild runny nose, heaviness in chest, rash on chest, left arm and face, chills. Left arm tendonitis sensations as described in day 2 increased, and on day 4, included mild numbness on the left side of face, left axilla and throughout length of left arm. The numb sensations lasted for a few hours. Symptoms waxed and waned. Day 5, 10/30, Patient symptoms: generalized fatigue, mild runny, stuffy nose and sinuses; left arm tendonitis decreased; warmth in deltoid region, chills. Symptoms waxed and waned. Day 6, 10/31, patient symptoms: sneezing, mild runny nose, sinus pain, hoarse voice, chills. Symptoms waxed and waned. Symptoms stopped by day 7, Nov 1.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Day 1, 10/26/11, Patient symptoms: warm, red, swollen area (approximately 6" oval) around injection site on left arm. Left arm felt stiff, painful. Patient had sensation of tendonitis in deltoid musculature (popping, catching, sensation) when actively using left arm. Patient felt fatigued around 1600. Symptoms waxed and waned. Treatment: Patient took 400 mg of ADVIL at 11:30 and at 18:30. Day 2, 10/27, Patient symptoms: generalized fatigue; mild runny nose, chills. Left upper arm pain radiated into the left side of neck, chest wall, axilla, scapula region and extended through the full length of the left arm. Patient's tendonitis sensations increased, involving shoulder flexor and extensor muscles, elbow flexor, extensor and supinator muscles and wrist flexors. Left arm joint pain increased, especially in the elbow. Deltoid region felt warm to the touch. Symptoms waxed and waned. Day 3-4, 10/28-29, Patient symptoms: generalized fatigue, mild runny nose, heaviness in chest, rash on chest, left arm and face, chills. Left arm tendonitis sensations as described in day 2 increased, and on day 4, included mild numbness on the left side of face, left axilla and throughout length of left arm. The numb sensations lasted for a few hours. Symptoms waxed and waned. Day 5, 10/30, Patient symptoms: generalized fatigue, mild runny, stuffy nose and sinuses; left arm tendonitis decreased; warmth in deltoid region, chills. Symptoms waxed and waned. Day 6, 10/31, patient symptoms: sneezing, mild runny nose, sinus pain, hoarse voice, chills. Symptoms waxed and waned. Symptoms stopped by day 7, Nov 1.