chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.15
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site papule
Clinical narrative: Initial report was received from a health care professional on 18 and 23 February 2011. A 13 month-old male patient who had no illness at the time of vaccination and pre-existing conditions were reported as none had received on 10 February 2011, a second dose intramuscular right thigh injection of DAPTACEL, lot number C3514AA. On 14 February 2011, the patient started to develop hives at the injection site and by 16 February 2011 the hives had spread to his arms, legs, body and back. The patient was evaluated by a physician. Treatments and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 28 March 2011 who reported that the event diagnosis was erythema multiforme. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. On 16 February 2011 the patient was evaluated by his physician for a rash that started five days after receiving a DAPTACEL vaccine. According to the physician the patient was doing well but developed the rash around the administration site of the vaccine. The rash worsened and spread to the whole body. Physical exam revealed the patient had hives over his entire body. He had "target lesions, pink mac-pap (illegible) lesions on legs and an increased concentration at vaccination site". The patient also had swollen eyes but "not shut". Treatment included BENADRYL 3 - 4 cc by mouth every six hours as needed. The patient was given a prescription for steroids however it was reported the Mother was hesitant to give them to the patient. The patient has a history of saggital synostosis and had an unspecified surgery. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Cyanosis, Depressed mood, Electrocardiogram normal, Gaze palsy, Hypotonia
Clinical narrative: Initial report received from a consumer, who is also the parent of the patient, on 24 March 2011. A 15 month old male child, with a milk allergy, received on 23 March 2011 a left leg injection (route not reported) of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, sanofi pasteur lot number not provided, an injection (route and site not provided) of PCV 13, Wyeth lot number not provided, and a left leg injection of HIB, GSK lot number not provided. He had no illness at the time of vaccination, no other medical history and took no concomitant medications. The patient received 3 previous doses of PEDIARIX. On 23 March 2011 and immediately after receiving the 3 vaccines, the patient turned blue, went limp, eyes deviated to the right and went to sleep. A few minutes later the patient woke up but was despondent and then became more reactive. The physician diagnosed the event as "pain response" and not a vaccine reaction. The patient had an electrocardiogram performed which was reported as normal. The outcome was reported as recovered. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Immediate post-injection reaction, Pain, Sudden onset of sleep
Clinical narrative: Initial report received from a consumer, who is also the parent of the patient, on 24 March 2011. A 15 month old male child, with a milk allergy, received on 23 March 2011 a left leg injection (route not reported) of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, sanofi pasteur lot number not provided, an injection (route and site not provided) of PCV 13, Wyeth lot number not provided, and a left leg injection of HIB, GSK lot number not provided. He had no illness at the time of vaccination, no other medical history and took no concomitant medications. The patient received 3 previous doses of PEDIARIX. On 23 March 2011 and immediately after receiving the 3 vaccines, the patient turned blue, went limp, eyes deviated to the right and went to sleep. A few minutes later the patient woke up but was despondent and then became more reactive. The physician diagnosed the event as "pain response" and not a vaccine reaction. The patient had an electrocardiogram performed which was reported as normal. The outcome was reported as recovered. Documents held by sender: None.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure inadequately controlled, General physical health deterioration
Clinical narrative: Initial report was received from a health care professional on 30 March 2011. A 79 year-old female patient had received an Influenza vaccine and a Pneumonia "shot" (manufacturers, lot numbers, routes and sites of administration not reported) on 24 March 2011 and an unspecified amount of time later, was reported to have "gone downhill" and to have a blood pressure that was "out of control". The patient had been transferred from another hospital to the reporter's hospital. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Chest pain, Chills, Dyspnoea
Clinical narrative: Pt. was administered GARDASIL vaccination on 9/30/10. Approximately around Thanksgiving pt.'s 1st symptoms were legs & arms tingling & hurting. Pt. received her 2nd GARDASIL vaccination on 12/10/10 and reported her whole body hurt. She reports having swollen glands, joint pain, tiredness, chills, leg pain, SOB, chest pain, aching muscles, muscle weakness, & stomach ache. Pt. had several doctor appointments in December who stated it may be caused by the vaccine. Pt. reports she is fine now.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Lymphadenopathy, Muscular weakness, Myalgia, Pain
Clinical narrative: Pt. was administered GARDASIL vaccination on 9/30/10. Approximately around Thanksgiving pt.'s 1st symptoms were legs & arms tingling & hurting. Pt. received her 2nd GARDASIL vaccination on 12/10/10 and reported her whole body hurt. She reports having swollen glands, joint pain, tiredness, chills, leg pain, SOB, chest pain, aching muscles, muscle weakness, & stomach ache. Pt. had several doctor appointments in December who stated it may be caused by the vaccine. Pt. reports she is fine now.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt. was administered GARDASIL vaccination on 9/30/10. Approximately around Thanksgiving pt.'s 1st symptoms were legs & arms tingling & hurting. Pt. received her 2nd GARDASIL vaccination on 12/10/10 and reported her whole body hurt. She reports having swollen glands, joint pain, tiredness, chills, leg pain, SOB, chest pain, aching muscles, muscle weakness, & stomach ache. Pt. had several doctor appointments in December who stated it may be caused by the vaccine. Pt. reports she is fine now.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red swelling around injection site 24 hours after injection size of half dollar red itching, hurt to touch for 7 days - redness for 14 days.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: Swelling in axilla, left arm, left side of chest and face, left thigh.  Burning sensation / irriation of skin.  Tightness in chest.  Rash (diffuse macular), headache, dyspnea (mild), irritability and fatigue.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Irritability, Oedema peripheral, Rash macular, Skin irritation, Swelling face
Clinical narrative: Swelling in axilla, left arm, left side of chest and face, left thigh.  Burning sensation / irriation of skin.  Tightness in chest.  Rash (diffuse macular), headache, dyspnea (mild), irritability and fatigue.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: Red rash, started right arm & spread to left.  Increased pain at sites
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Broke out in itchy hives on 3-10 & seen in clinic.  Given Benadryl & calamine lotion. Increased spreading of rash and itching on 3-12 prompted visit to urgent care clinic.  Rash spread to extremities and trunk.  No difficulty breathing or wheezing.  Started prednisone with taper.  Follow up visit on 3-13 indicated rash/hives were resolving.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Called today 4-6-11 to report headache, chills, fever up to 100 degrees, & aches that started at 0100 on 4-5-11 after receiving Tdap. No MD txment. No signs or symptoms today. All symptoms resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness around injxn site 6 days later. Patient came to pharmacy & was examined. RPh felt site was hot to touch. Pt. was advised to go to MD.
Age: 3.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever & vomiting.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscular weakness, Myositis
Clinical narrative: Pain and weakness over the upper left extremity.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Immediate post-injection reaction, Mass, Nuclear magnetic resonance imaging, Pain
Clinical narrative: immediate pain..  immediate lump...  hot to touch
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: immediate pain..  immediate lump...  hot to touch
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient called 4/4/11 c/o red lump with larger circle around it. Brought pt in for review of reaction. Pt does have quarter-sized red, raised area on Lt. deltoid. No longer warm to touch & per pt. has decreased in size.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Asthenia, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Pt reports fever, headache and rash within 24 hrs. of receiving vaccine. Pt also reports extreme tiredness & weakness. Pt reports going to the emergency room 1 week later, and then saw her doctor. Reports sickness lasted 1 mth. No treatment was ever provided/needed.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Rash
Clinical narrative: Pt reports fever, headache and rash within 24 hrs. of receiving vaccine. Pt also reports extreme tiredness & weakness. Pt reports going to the emergency room 1 week later, and then saw her doctor. Reports sickness lasted 1 mth. No treatment was ever provided/needed.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Blood test normal, Hypoaesthesia, Immediate post-injection reaction, Influenza
Clinical narrative: Immediate arm pain, traveled to shoulder and neck. Ongoing since October 2010. MRI on neck spine. Three orthopedic visits to no avail. Neurologist visit on March 30, 2010. EMG scheduled.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Immediate arm pain, traveled to shoulder and neck. Ongoing since October 2010. MRI on neck spine. Three orthopedic visits to no avail. Neurologist visit on March 30, 2010. EMG scheduled.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: Immediate arm pain, traveled to shoulder and neck. Ongoing since October 2010. MRI on neck spine. Three orthopedic visits to no avail. Neurologist visit on March 30, 2010. EMG scheduled.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Swelling face, Urticaria
Clinical narrative: Facial swelling and hives covering body; no breathing or swallowing difficulty. Redness/swelling of right thigh at injection site. Seen in ER--Benadryl; steroids.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Dizziness, Nausea, Tachycardia
Clinical narrative: Dizziness, Tachycardia, Nausea.  Progressed within one hour of administration.  Patient returned to health center at 12:15 pm.  50 mg Benadryl administered.
Age: 1.41
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site dermatitis
Clinical narrative: Skin dermatitis noted above both injection sites - MD unsure if reaction to vaccines or alcohol pad used prior to giving vaccines to clean injection site.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: +/- large areas of erythematous rash around vaccine sites that has gradually cleared. No s/s cellulitis.
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Patient received vaccines 4/4/2011. Left shoulder with swelling and redness, increase discomfort starting 4/6/2011 A.M.
Age: 11.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered MCV4 vaccine for patient, but the lot number that was entered into the patient record was for PCV13 vaccine.  It did not come to the attention of the RN Manager until several months later when the DOH asked for the lot number, and it was found that the lot number was for PCV13 and not MCV4.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT WAS ADMINISTERED HIBERIX (BOOSTER VACCINE) THIS VACCINE IS INTENDED FOR PATIENTS 15 MONTHS THRU 4 YEARS OF AGE ONLY.  PATIENT IS 4 MONTHS OLD.  THERE IS NO EVIDENCE OR REPORTS FROM PARENTS OF ADVERSE REACTION.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: "Wheal" redness and swelling near injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Fever, headache, neck pain, neck stiffness, decreased appetite.  Redness and swelling of both arms, with right arm having much more significant swelling and redness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Neck pain, Pyrexia
Clinical narrative: Fever, headache, neck pain, neck stiffness, decreased appetite.  Redness and swelling of both arms, with right arm having much more significant swelling and redness.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right thigh where varicella and MMR given was red. No swelling. Baby acting ok.  Waited another 15 minutes.  No change in redness.  No swelling. No itching.  Baby ok.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Laboratory test abnormal, Skin warm, Swelling
Clinical narrative: Started as a small bump and increased in size to a 2.5cm circular raised erythema area warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 3 x 3 cm area of redness and induration within 10 minutes of injection
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Infection, Laboratory test, Mechanical ventilation
Clinical narrative: Diagnosed with Guillain Barre Syndrome at Hospital on November 2, 2009.  Immunoglobulin IV started Nov. 3, 2009.  Developed paralysis throughout his body and placed on ventilator.  Transfered to Continuing Care Hospital and on February 2, 2010 unable to wean him from the ventilator, to Respiratory Care Center.  Transfered back to hospital and then to Nursing Home.  March 9, 2010 admitted to hospital for infection.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis, Weaning failure
Clinical narrative: Diagnosed with Guillain Barre Syndrome at Hospital on November 2, 2009.  Immunoglobulin IV started Nov. 3, 2009.  Developed paralysis throughout his body and placed on ventilator.  Transfered to Continuing Care Hospital and on February 2, 2010 unable to wean him from the ventilator, to Respiratory Care Center.  Transfered back to hospital and then to Nursing Home.  March 9, 2010 admitted to hospital for infection.
Age: 3.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Fever, moderate case of chickenpox appeared within 36hrs.
Age: 48.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None Misadministration.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives started on face 1 hr. after vaccine administration, hives spread to arms, abdom. and legs. Took BENADRYL 4/5/11. Hives come and go. Hives today on lower back, thighs, and arms. Continue BENADRYL.
Age: 1.65
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Upper respiratory tract infection, Urticaria
Clinical narrative: Urticaria s/p baths on 4/4 & 4/5, URI symptoms. No hx previous urticaria. No new foods or soaps recently. I doubt vaccines caused rash.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Chest X-ray, Pyrexia, Urine analysis normal
Clinical narrative: Fever to 105.8 on 4-1-11.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: Received injection in LA on 10/07/2010. 2-3 days later started to have pain in LA especially in the elbow and the muscles surrounding it. Has had flu shots before with no reaction. Now has pain in both elbows and muscle tenderness around the elbows. Pain is off and on but whenever he moves arm or tries to lift it is painful, wakes him at nite. Never had H1N1 before. No doctor has no insurance.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Pruritic rash, reported by mom 3 days after immunizations. Very itchy.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Location - Lt deltoid area large (circle) area, warm to touch, no complaint of itching. BENADRYL 25mg by mouth, and applied ice compress.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Administered vaccine - didn't check expiration date on vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling around injection site, since given 4-4-11. Measurements Rt leg 8 1/2cm x 7cm Lt leg - 13 1/2 cm x 10 1/2 cm. PEDIAPRED & TOPICORT cream given.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Bronchospasm, Electrocardiogram
Clinical narrative: Bronchospasms - administered oxygen, nebulizer txs.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Axillary mass, Axillary pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder pain, hip pain, upper legs pain (all bilateral), low grade fever (101 degrees on 4/4/11 at MD visit), rash on abdomen and both shoulders, pain with lumps in bilateral axillas. Patient has all sx resolved except axillary painful lumps. Patient saw MD on 4/4 with sx and fever.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Shoulder pain, hip pain, upper legs pain (all bilateral), low grade fever (101 degrees on 4/4/11 at MD visit), rash on abdomen and both shoulders, pain with lumps in bilateral axillas. Patient has all sx resolved except axillary painful lumps. Patient saw MD on 4/4 with sx and fever.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Rash, Rash papular, Red blood cell sedimentation rate normal
Clinical narrative: Shoulder pain, hip pain, upper legs pain (all bilateral), low grade fever (101 degrees on 4/4/11 at MD visit), rash on abdomen and both shoulders, pain with lumps in bilateral axillas. Patient has all sx resolved except axillary painful lumps. Patient saw MD on 4/4 with sx and fever.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Shoulder pain, hip pain, upper legs pain (all bilateral), low grade fever (101 degrees on 4/4/11 at MD visit), rash on abdomen and both shoulders, pain with lumps in bilateral axillas. Patient has all sx resolved except axillary painful lumps. Patient saw MD on 4/4 with sx and fever.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Shoulder pain, hip pain, upper legs pain (all bilateral), low grade fever (101 degrees on 4/4/11 at MD visit), rash on abdomen and both shoulders, pain with lumps in bilateral axillas. Patient has all sx resolved except axillary painful lumps. Patient saw MD on 4/4 with sx and fever.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Axillary mass, Axillary pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: 3/27/11 at 0630 woke up with severe bilateral shoulder pain - generalized joint pain x 2 days by 4/1/11 joint pain down to lower extremities to the knee. 4/3/11 rash was noted bilateral abdomen papular rash - scattered to bilat axilla - shoulder - legs. Temp 4/4/11 of 101.3.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: 3/27/11 at 0630 woke up with severe bilateral shoulder pain - generalized joint pain x 2 days by 4/1/11 joint pain down to lower extremities to the knee. 4/3/11 rash was noted bilateral abdomen papular rash - scattered to bilat axilla - shoulder - legs. Temp 4/4/11 of 101.3.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Rash, Rash papular, Red blood cell sedimentation rate normal
Clinical narrative: 3/27/11 at 0630 woke up with severe bilateral shoulder pain - generalized joint pain x 2 days by 4/1/11 joint pain down to lower extremities to the knee. 4/3/11 rash was noted bilateral abdomen papular rash - scattered to bilat axilla - shoulder - legs. Temp 4/4/11 of 101.3.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: 3/27/11 at 0630 woke up with severe bilateral shoulder pain - generalized joint pain x 2 days by 4/1/11 joint pain down to lower extremities to the knee. 4/3/11 rash was noted bilateral abdomen papular rash - scattered to bilat axilla - shoulder - legs. Temp 4/4/11 of 101.3.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: 3/27/11 at 0630 woke up with severe bilateral shoulder pain - generalized joint pain x 2 days by 4/1/11 joint pain down to lower extremities to the knee. 4/3/11 rash was noted bilateral abdomen papular rash - scattered to bilat axilla - shoulder - legs. Temp 4/4/11 of 101.3.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blood test, Dizziness, Fall, Fatigue, Gaze palsy
Clinical narrative: Waited 10-15 minutes after shot then returned to class. After being in class about 20 minutes, teacher states patient arched back, eyes rolled back & fell out of chair. Awoke oriented. Taken to E.R. M.D sts ? dizziness & tiredness per Mom.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Posturing
Clinical narrative: Waited 10-15 minutes after shot then returned to class. After being in class about 20 minutes, teacher states patient arched back, eyes rolled back & fell out of chair. Awoke oriented. Taken to E.R. M.D sts ? dizziness & tiredness per Mom.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Autonomic nervous system imbalance, Blindness, Cardiac disorder, Cerebrovascular accident
Clinical narrative: Case number PHHY2011US25117, is an initial spontaneous report from a consumer received on 25 Mar 2011. This report refers to a 67-year-old female patient. She was vaccinated with FLUVIRIN (seasonal influenza virus vaccine, batch number 89973) on an unspecified date in 2008. Approximately eight weeks after vaccination, she was diagnosed with the worst case of Gullain Barre Syndrome variant, a type of Miller Fisher, the university had ever seen. Every organ in her body shut down. Her autonomic nervous system was involved as well as she had serious cardiac complications. As corrective treatment, intravenous immunoglobulin (IVIG) was started. She suffered from two strokes at fifth day since starting of IVIG. Two years later, she had been completely paralyzed and wheel chair/bed bound. She was legally blind and could not stand, sit up, feed herself, toilet herself. The patient needed 24 hour care and had no life. Final event outcome was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Guillain-Barre syndrome, Immunoglobulin therapy, Miller Fisher syndrome, Multi-organ failure
Clinical narrative: Case number PHHY2011US25117, is an initial spontaneous report from a consumer received on 25 Mar 2011. This report refers to a 67-year-old female patient. She was vaccinated with FLUVIRIN (seasonal influenza virus vaccine, batch number 89973) on an unspecified date in 2008. Approximately eight weeks after vaccination, she was diagnosed with the worst case of Gullain Barre Syndrome variant, a type of Miller Fisher, the university had ever seen. Every organ in her body shut down. Her autonomic nervous system was involved as well as she had serious cardiac complications. As corrective treatment, intravenous immunoglobulin (IVIG) was started. She suffered from two strokes at fifth day since starting of IVIG. Two years later, she had been completely paralyzed and wheel chair/bed bound. She was legally blind and could not stand, sit up, feed herself, toilet herself. The patient needed 24 hour care and had no life. Final event outcome was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Quality of life decreased, Wheelchair user
Clinical narrative: Case number PHHY2011US25117, is an initial spontaneous report from a consumer received on 25 Mar 2011. This report refers to a 67-year-old female patient. She was vaccinated with FLUVIRIN (seasonal influenza virus vaccine, batch number 89973) on an unspecified date in 2008. Approximately eight weeks after vaccination, she was diagnosed with the worst case of Gullain Barre Syndrome variant, a type of Miller Fisher, the university had ever seen. Every organ in her body shut down. Her autonomic nervous system was involved as well as she had serious cardiac complications. As corrective treatment, intravenous immunoglobulin (IVIG) was started. She suffered from two strokes at fifth day since starting of IVIG. Two years later, she had been completely paralyzed and wheel chair/bed bound. She was legally blind and could not stand, sit up, feed herself, toilet herself. The patient needed 24 hour care and had no life. Final event outcome was not reported.
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Anaphylactic reaction, Throat tightness, Urticaria
Clinical narrative: Anaphylactic response to MMR - hives and throat tightness. Rx EPIPEN/BENADRYL/SOLUMEDROL.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Asthenia, Blood test, Endodontic procedure, Fatigue, Gingival pain
Clinical narrative: Information has been received from a 27 year old male with tinea versicolor and no drug allergy who on 25-AUG-2001 was intramuscularly vaccinated with the first dose of 1ml VAQTA (lot# not reported). Late on 12-JUL-2003, the patient received the second dose (reported lot# "VHA745A6") and a dose of RECOMBIVAX HB which was administered intramuscularly 1ml (lot# 644388/1018M). Concomitant therapy included lisinopril (manufacturer unknown). On 16-JUL-2003 the patient experienced painful gums. The patient saw a dentist who performed dental x-rays (results not reported). The patient was diagnosed with gingivitis and the dentist performed "scaling and root planing". In May 2004, the patient experienced extraordinary fatigue and weakness. He was not able to complete a military fitness run. In March 2005, he saw a physician for the fatigue and symptoms of weakness. The patient received the third dose of VAQTA 1ml IM on 29-AUG-2005 (lot# not reported). In December 2008, he saw a neurologist and the neurologist diagnosed him with multiple sclerosis. In December 2010, the patient had hepatitis A and hepatitis B titers drawn and the result was that he had no immunity to hepatitis A or hepatitis B. The patient reported that he only received one dose of RECOMBIVAX HB (MSD) and did not complete the series. The labs included unspecified blood work, MRI, and spinal tap (on 15-DEC-2008) were performed, but the results were not provided. At the time of reporting, the patient had not recovered from gingivitis and multiple sclerosis. The outcome of no immunity to hepatitis A or hepatitis B was unknown. Upon internal review, multiple sclerosis was considered to be an other important event. No further information is available.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Gingivitis, Hepatitis A antibody negative, Hepatitis B antibody negative, Incorrect drug administration duration, Lumbar puncture
Clinical narrative: Information has been received from a 27 year old male with tinea versicolor and no drug allergy who on 25-AUG-2001 was intramuscularly vaccinated with the first dose of 1ml VAQTA (lot# not reported). Late on 12-JUL-2003, the patient received the second dose (reported lot# "VHA745A6") and a dose of RECOMBIVAX HB which was administered intramuscularly 1ml (lot# 644388/1018M). Concomitant therapy included lisinopril (manufacturer unknown). On 16-JUL-2003 the patient experienced painful gums. The patient saw a dentist who performed dental x-rays (results not reported). The patient was diagnosed with gingivitis and the dentist performed "scaling and root planing". In May 2004, the patient experienced extraordinary fatigue and weakness. He was not able to complete a military fitness run. In March 2005, he saw a physician for the fatigue and symptoms of weakness. The patient received the third dose of VAQTA 1ml IM on 29-AUG-2005 (lot# not reported). In December 2008, he saw a neurologist and the neurologist diagnosed him with multiple sclerosis. In December 2010, the patient had hepatitis A and hepatitis B titers drawn and the result was that he had no immunity to hepatitis A or hepatitis B. The patient reported that he only received one dose of RECOMBIVAX HB (MSD) and did not complete the series. The labs included unspecified blood work, MRI, and spinal tap (on 15-DEC-2008) were performed, but the results were not provided. At the time of reporting, the patient had not recovered from gingivitis and multiple sclerosis. The outcome of no immunity to hepatitis A or hepatitis B was unknown. Upon internal review, multiple sclerosis was considered to be an other important event. No further information is available.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging, X-ray dental
Clinical narrative: Information has been received from a 27 year old male with tinea versicolor and no drug allergy who on 25-AUG-2001 was intramuscularly vaccinated with the first dose of 1ml VAQTA (lot# not reported). Late on 12-JUL-2003, the patient received the second dose (reported lot# "VHA745A6") and a dose of RECOMBIVAX HB which was administered intramuscularly 1ml (lot# 644388/1018M). Concomitant therapy included lisinopril (manufacturer unknown). On 16-JUL-2003 the patient experienced painful gums. The patient saw a dentist who performed dental x-rays (results not reported). The patient was diagnosed with gingivitis and the dentist performed "scaling and root planing". In May 2004, the patient experienced extraordinary fatigue and weakness. He was not able to complete a military fitness run. In March 2005, he saw a physician for the fatigue and symptoms of weakness. The patient received the third dose of VAQTA 1ml IM on 29-AUG-2005 (lot# not reported). In December 2008, he saw a neurologist and the neurologist diagnosed him with multiple sclerosis. In December 2010, the patient had hepatitis A and hepatitis B titers drawn and the result was that he had no immunity to hepatitis A or hepatitis B. The patient reported that he only received one dose of RECOMBIVAX HB (MSD) and did not complete the series. The labs included unspecified blood work, MRI, and spinal tap (on 15-DEC-2008) were performed, but the results were not provided. At the time of reporting, the patient had not recovered from gingivitis and multiple sclerosis. The outcome of no immunity to hepatitis A or hepatitis B was unknown. Upon internal review, multiple sclerosis was considered to be an other important event. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity, Unresponsive to stimuli, Wheezing
Clinical narrative: Initial report was received on 29 March 2011 from a health care professional. A four year-old male patient with a history of asthma, had received on 22 March 2011 a fourth dose intramuscular left deltoid injection of DAPTACEL, lot number C3515AA; a fourth dose right deltoid injection of IPOL, lot number D1086; a second dose right deltoid injection of MMR, lot number 1250Z (route of administration not reported) and a second dose left deltoid injection of VARIVAX, lot number 1311Z (route of administration not reported) and within minutes, experienced vomiting, respiratory distress and loss consciousness. He was treated with an EPI PEN, oxygen and Albuterol. The patient was transported to the emergency room (ER), was kept for five hours and discharged (D/C) in stable condition. Needle length was reported as 5/8 of an inch. Concomitant medications included Albuterol. The patient had no illness at the time of vaccination and has no known allergies. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Loss of consciousness, Respiratory distress, Vomiting
Clinical narrative: Initial report was received on 29 March 2011 from a health care professional. A four year-old male patient with a history of asthma, had received on 22 March 2011 a fourth dose intramuscular left deltoid injection of DAPTACEL, lot number C3515AA; a fourth dose right deltoid injection of IPOL, lot number D1086; a second dose right deltoid injection of MMR, lot number 1250Z (route of administration not reported) and a second dose left deltoid injection of VARIVAX, lot number 1311Z (route of administration not reported) and within minutes, experienced vomiting, respiratory distress and loss consciousness. He was treated with an EPI PEN, oxygen and Albuterol. The patient was transported to the emergency room (ER), was kept for five hours and discharged (D/C) in stable condition. Needle length was reported as 5/8 of an inch. Concomitant medications included Albuterol. The patient had no illness at the time of vaccination and has no known allergies. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Loss of consciousness, Respiratory distress, Vomiting
Clinical narrative: Initial report was received on 29 March 2011 from a health care professional. A four year-old male patient with a history of asthma, had received on 22 March 2011 a fourth dose intramuscular left deltoid injection of DAPTACEL, lot number C3515AA; a fourth dose right deltoid injection of IPOL, lot number D1086; a second dose right deltoid injection of MMR, lot number 1250Z (route of administration not reported) and a second dose left deltoid injection of VARIVAX, lot number 1311Z (route of administration not reported) and within minutes, experienced vomiting, respiratory distress and loss consciousness. He was treated with an EPI PEN, oxygen and Albuterol. The patient was transported to the emergency room (ER), was kept for five hours and discharged (D/C) in stable condition. Needle length was reported as 5/8 of an inch. Concomitant medications included Albuterol. The patient had no illness at the time of vaccination and has no known allergies. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUN3
Symptoms: Arthritis, Chest pain, Diabetes mellitus, Diagnostic procedure, Dyspnoea
Clinical narrative: Rash started out on left leg, spread to right leg, than all over body.  Treated twice over the course of month with allergy medication, topical solution and prednisone. Pneumonia lasted for month, then had difficulty breathing, shortness of breath, chest pains, arthritis diagnosed, and diabetes diagnosed.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUN3
Symptoms: Laboratory test, Pneumonia, Rash generalised
Clinical narrative: Rash started out on left leg, spread to right leg, than all over body.  Treated twice over the course of month with allergy medication, topical solution and prednisone. Pneumonia lasted for month, then had difficulty breathing, shortness of breath, chest pains, arthritis diagnosed, and diabetes diagnosed.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: Less than 30 seconds after receiving vaccines she reported tingling sensation from upper arm to tip of fingertips. She also reported "twitching" at base of thumb. Twitching lasted few seconds.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Headache, Hypoaesthesia oral, Nausea, Rash
Clinical narrative: Patient had headache, nausea, diarrhea, rash on upper torso, numbness of tongue. Mother took child to ER was advised by physician not to get anymore HPV vaccine.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Brain death, Faecal incontinence, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 1 year old female who on an unspecified date was vaccinated with MMR II. Subsequently, it was reported the patient spiked a fever and was stated to be "brain dead." The patient cannot walk or control her bowels and attends a special school. The patient was now 5 years old. The patient sought medical attention (NOS). Upon internal review, "brain dead" was determined to be an other important medical event. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal distension, Computerised tomogram abdomen abnormal, Enema administration, Faeces discoloured, Intussusception
Clinical narrative: Information has been received from a nurse concerning a 23 weeks male child with no pertinent medical history and drug allergies, who on 24-NOV-2010 was vaccinated with the first dose of ROTATEQ (lot # unknown), and on 31-JAN-2011 was vaccinated with the second dose of ROTATEQ (6690691/1645Z). There was no concomitant medication. On 08-MAR-2011, the patient experienced abdominal distention, maroon stool, and one episode of non-bilious vomiting followed by one episode of bilious vomiting. On the same day, the patient was examined in the Emergency Room. Abdominal scan showed intussusception. The patient was admitted and treated nonsurgically with air enema. The NP added that there were no pre-disposing factors; the patient was born at 39 weeks, 1 day; and weighed 4025 grams (8.87 pounds). On 09-MAR-2011, the patient was recovered and went back home. On 21-MAR-2011, the patient visited the office and the baby was 17pounds 12oz. No further information is available.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a 23 weeks male child with no pertinent medical history and drug allergies, who on 24-NOV-2010 was vaccinated with the first dose of ROTATEQ (lot # unknown), and on 31-JAN-2011 was vaccinated with the second dose of ROTATEQ (6690691/1645Z). There was no concomitant medication. On 08-MAR-2011, the patient experienced abdominal distention, maroon stool, and one episode of non-bilious vomiting followed by one episode of bilious vomiting. On the same day, the patient was examined in the Emergency Room. Abdominal scan showed intussusception. The patient was admitted and treated nonsurgically with air enema. The NP added that there were no pre-disposing factors; the patient was born at 39 weeks, 1 day; and weighed 4025 grams (8.87 pounds). On 09-MAR-2011, the patient was recovered and went back home. On 21-MAR-2011, the patient visited the office and the baby was 17pounds 12oz. No further information is available.
Age: 75.0
Sex: M
Vaccine: VARCEL
Symptoms: Death, Herpes simplex, Herpes zoster, Simplex virus test positive
Clinical narrative: Information has been received from a physician concerning a 75 year old male with "chronic leukopenia" who in April 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included hydrocortisone (manufacturer unknown). In May 2010, the patient developed shingles spread to his face. In October 2010, the patient was admitted to hospital with dissemination. Acyclovir IV was given for two weeks then Acyclovir oral for 2 weeks for the treatment of the adverse event. In December 2010, the patient was admitted again to the hospital and died three weeks later. On unspecified date, lab study was performed on the ZOSTAVAX (Merck) which confirmed it was the oka strain. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a office manager concerning a 65 year old female patient with allergies to LIPITOR, CRESTOR, "MS04", ciprofloxacin and no pertinent medical history who on 22-MAR-2011 was vaccinated intramuscularly in the left arm with 0.5mL of PNEUMOVAX 23 (Lot# reported as 1158211261 and unspecified expiration date). Concomitant therapy included BENADRYL. On 23-MAR-2011 the patient experienced swelling, pain and itching at the injection site, and the patient went to the hospital emergency room. It was reported that the emergency room records stated the patient's left arm had a red ring around the injection site, and the patient's left arm and biceps were swollen, painful and the patient complained of itching at the injection site. It was reported that an ice pack was applied to the affected area at the emergency room. Also while in the emergency room the patient received dexamethasone (manufactured unspecified) 10mg IV, ranitidine (manufactured unspecified) 50mg IV, ketorolac tromethamine (manufactured unspecified) 30mg IV. The patient was discharged from the emergency room with an improved condition, and the patient was given a prescription for a MEDROL and ZANTAC 150mg. The office manager reported that the patient went to the physician office today on 30-MAR-2011 and her left arm was still swollen and had some redness. The physician recommended that the patient took BENADRYL and performed range of motion exercises. No laboratories were performed. Upon internal review, swelling, pain redness and itching at the injection site treated with dexamethasone IV (manufactured unspecified) were determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chest X-ray, Injection site urticaria, Pneumonia, Skin warm
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with no allergies or drug reaction and no pertinent medical history who on 22-MAR-2011, was vaccinated with the first dose of PNEUMOVAX 23 (route and expiration date not reported) (lot number 667914/1067Z). There was no concomitant medication. On 22-MAR-2011, the patient was complaining of quarter-sized welt on injection site arm and fever to the touch. The physician was notified on 25-MAR-2011, that the patient was admitted to the hospital "with documented pneumonia and severe cellulitis from the shoulders to the elbow". While at the hospital, the patient received an IV antibiotic and a chest x-ray was performed (no results were provided). At the time of the report the patient was recovering. Pneumonia was considered to be immediately life-threatening by the physician. A lot check has been initiated. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with no allergies or drug reaction and no pertinent medical history who on 22-MAR-2011, was vaccinated with the first dose of PNEUMOVAX 23 (route and expiration date not reported) (lot number 667914/1067Z). There was no concomitant medication. On 22-MAR-2011, the patient was complaining of quarter-sized welt on injection site arm and fever to the touch. The physician was notified on 25-MAR-2011, that the patient was admitted to the hospital "with documented pneumonia and severe cellulitis from the shoulders to the elbow". While at the hospital, the patient received an IV antibiotic and a chest x-ray was performed (no results were provided). At the time of the report the patient was recovering. Pneumonia was considered to be immediately life-threatening by the physician. A lot check has been initiated. Additional information has been requested.
Sex: M
Vaccine: PNC
Symptoms: Death, Pneumonia staphylococcal
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative.  A male patient received the fourth dose of PREVNAR on an unknown date.  Relevant medical history, drug history and concomitant medications or vaccines were unknown.  Vaccines taken within the last four weeks were unknown.  On an unspecified date, the patient developed staphylococcal pneumonia disease.  It was unknown if the patient was hospitalized.  In Nov2010, the patient died.  The cause of death was staphylococcal pneumonia disease.  At the time of the report, it was unknown if an autopsy was performed.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction to face, urticaria and hives.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, REDNESS TO UPPER RIGHT ARM NEAR DELTOID MUSCLE, WARM TO TOUCH AND PAINFUL
Age: 32.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, soreness at injection site, hard lump at injection site
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram, Cardiac electrophysiologic study, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: palpitations and SOB
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Nuclear magnetic resonance imaging, Palpitations, White blood cell scan
Clinical narrative: palpitations and SOB
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram, Cardiac electrophysiologic study, Diagnostic procedure, Dyspnoea, Echocardiogram
Clinical narrative: palpitations and SOB
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram, Nuclear magnetic resonance imaging, Palpitations
Clinical narrative: palpitations and SOB
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Adenovirus test, Gastroenteritis salmonella, Human herpes virus 6 serology negative, Influenza virus test negative, Rash morbilliform
Clinical narrative: Patient given MMR, VARIVAX, Hep A vaccines on 3/18/2011. Patient subsequently developed salmonella gastroenteritis followed by a morbilliform rash. Was on Amoxil 3/18/11 for OM as well. Hospitalized due to rash and concerns for Stevens Johnson syndrome-never developed.