chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram, Electroencephalogram, Lumbar puncture abnormal
Clinical narrative: LockJaw accompanied by recurring severe Spasms and seizures causing me to bite through my tongue and cheeks repeatedly...all the while with complete locked down tightness in jaw.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle spasms, Muscle tightness, Nuclear magnetic resonance imaging, Post lumbar puncture syndrome, Scan with contrast
Clinical narrative: LockJaw accompanied by recurring severe Spasms and seizures causing me to bite through my tongue and cheeks repeatedly...all the while with complete locked down tightness in jaw.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Tongue biting, Trismus
Clinical narrative: LockJaw accompanied by recurring severe Spasms and seizures causing me to bite through my tongue and cheeks repeatedly...all the while with complete locked down tightness in jaw.
Age: 1.63
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3/22/12 Mother called re: red area "quarter-sized" on (lt) leg inj. site of vaccines given on 3/21/12. Presented today 3/23/12 with 17x15cm, red, sl. swollen & tender area on (Lt) thigh inj. site that mother states "worsened overnight." SOLUMED 20 mg I.M. given in (Rt) thigh, BENADRYL 3/4 tsp, TID & instructions to alternate warm/cold compresses TID per dr's orders & follow-up if symptoms do not improve.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: (L) arm where DTAP/IPV administration has a 2 cm oval redness tender. Placed on AUGMENTIN/warm compress.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 3 days developed shingles. Confirmed by PA on 2/17/2012.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Developed redness & hives on torso, face, & extremities.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Full blood count, Lip blister, Malaise, Myalgia
Clinical narrative: Fever (over 103 degrees) facial swelling, blisters in mouth and on lips, muscle & joint aches (severe), malaise.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Pyrexia, Swelling face, Urine analysis
Clinical narrative: Fever (over 103 degrees) facial swelling, blisters in mouth and on lips, muscle & joint aches (severe), malaise.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a 18 year old female patient with a history of liver injury who on 21-NOV-2011, was vaccinated with the first dose of GARDASIL. On 27-NOV-2011 (reported as "6 days following her initial dose"), the patient developed loss of hair. It was also reported that the patient was referred to an unspecified dermatologist for the hair loss, and was told that the cause of the hair loss might have been due to liver injury suffered by the patient 3 months before the administration of GARDASIL. The patient called office for medical attention. At the time of the report the patient's outcome was not recovered. Follow up information has been received from a nurse practitioner concerning an 18 year old female patient with no illness at time of vaccination and with no known drug allergies and significant health problems who on 21-NOV-2011 at 15.53 pm, was vaccinated intramuscularly with the first dose of GARDASIL, in left deltoid, (dose not reported) (lot number: 668554/0306AA). It was reported that patient's hair was falling out by the handfuls and she was beginning to have bald spots. Worsened over a few weeks, but finally it stopped and now had new hair growth. It was also reported that the patient was seen by dermatologist. At the time of the report the patient's outcome was recovered. It was reported that the patient's hair loss required medical/surgical intervention by the reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Eye swelling, Irritability, Rash generalised
Clinical narrative: Developed non raised red rash 3/12/12, entire body, concentrated on trunk, MMR/VARIVAX 3/5/12. Fussy, afebrile. Right eye swollen/puffy, no discharge from eye. Diarrhea one time.
Age: 0.7
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Arrested labour, Caesarean section, Laboratory test normal, Maternal exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with no drug allergies or pertinent medical history who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 663454/0672Y) (route not reported). On 16-SEP-2011, the patient received the second dose of GARDASIL (lot # 666931/0337Z) (route not reported) while pregnant. At the time of the report the patient was 33 weeks and 4 days pregnant. An ultrasound was performed. The last menstrual period (LMP) was on approximately 17-MAR-2011. The estimated delivery date would be on 22-DEC-2011. No adverse effect was reported. Concomitant therapy included prenatal vitamins (unspecified). Follow up information has been received from the infant's pediatrician via initial pregnancy questionnaire concerning the female patient with no known medical history or concurrent conditions and an obstetrical history of 0 pregnancies. Concomitant  therapy also included ferrous gluconate, prenatal vitamins and docusate. It was reported that on 07-NOV-2011 at 33 weeks pregnant, the patient had an ultrasound done due to late care that resulted normal. The patient denied being sexually active before given her GARDASIL vaccine. The nurse also reported that the patient had normal routine tests. On 31-DEC-2011, the patient delivered a female baby via C-section due to failure to progress. The baby's weight was 6 pounds 11 ounces, her length was 20 inches, head circumference 13 inches and Apgar score 9-9. The registered nurse reported that the baby's right hand was absent. No other complications or abnormalities were reported and no infections or illnesses during pregnancy. Upon internal review C-section due to failure to progress was determined to be an other important medical event. The baby's experiences were captured in WAES # 1111USA00983B1. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with no drug allergies or pertinent medical history who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 663454/0672Y) (route not reported). On 16-SEP-2011, the patient received the second dose of GARDASIL (lot # 666931/0337Z) (route not reported) while pregnant. At the time of the report the patient was 33 weeks and 4 days pregnant. An ultrasound was performed. The last menstrual period (LMP) was on approximately 17-MAR-2011. The estimated delivery date would be on 22-DEC-2011. No adverse effect was reported. Concomitant therapy included prenatal vitamins (unspecified). Follow up information has been received from the infant's pediatrician via initial pregnancy questionnaire concerning the female patient with no known medical history or concurrent conditions and an obstetrical history of 0 pregnancies. Concomitant  therapy also included ferrous gluconate, prenatal vitamins and docusate. It was reported that on 07-NOV-2011 at 33 weeks pregnant, the patient had an ultrasound done due to late care that resulted normal. The patient denied being sexually active before given her GARDASIL vaccine. The nurse also reported that the patient had normal routine tests. On 31-DEC-2011, the patient delivered a female baby via C-section due to failure to progress. The baby's weight was 6 pounds 11 ounces, her length was 20 inches, head circumference 13 inches and Apgar score 9-9. The registered nurse reported that the baby's right hand was absent. No other complications or abnormalities were reported and no infections or illnesses during pregnancy. Upon internal review C-section due to failure to progress was determined to be an other important medical event. The baby's experiences were captured in WAES # 1111USA00983B1. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Foetal disorder, Maternal exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with no drug allergies or pertinent medical history who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 663454/0672Y) (route not reported). On 16-SEP-2011, the patient received the second dose of GARDASIL (lot # 666931/0337Z) (route not reported) while pregnant. At the time of the report the patient was 33 weeks and 4 days pregnant. An ultrasound was performed. The last menstrual period (LMP) was on approximately 17-MAR-2011. The estimated delivery date would be on 22-DEC-2011. No adverse effect was reported. Concomitant therapy included prenatal vitamins (unspecified). Follow up information has been received from the infant's pediatrician via initial pregnancy questionnaire concerning the female patient with no known medical history or concurrent conditions and an obstetrical history of 0 pregnancies. Concomitant  therapy also included ferrous gluconate, prenatal vitamins and docusate. It was reported that on 07-NOV-2011 at 33 weeks pregnant, the patient had an ultrasound done due to late care that resulted normal. The patient denied being sexually active before given her GARDASIL vaccine. The nurse also reported that the patient had normal routine tests. On 31-DEC-2011, the patient delivered a female baby via C-section due to failure to progress. The baby's weight was 6 pounds 11 ounces, her length was 20 inches, head circumference 13 inches and Apgar score 9-9. The registered nurse reported that the baby's right hand was absent. No other complications or abnormalities were reported and no infections or illnesses during pregnancy. Upon internal review C-section due to failure to progress was determined to be an other important medical event. The baby's experiences were captured in WAES # 1111USA00983B1. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Foetal exposure during pregnancy, Limb reduction defect
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with no drug allergies or pertinent medical history who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 663454/0672Y) (route not reported). On 16-SEP-2011, the patient received the second dose of GARDASIL (lot # 666931/0337Z) (route not reported) while pregnant. At the time of the report the patient was 33 weeks and 4 days pregnant. An ultrasound was performed. The last menstrual period (LMP) was on approximately 17-MAR-2011. The estimated delivery date would be on 22-DEC-2011. No adverse effect was reported. Concomitant therapy included prenatal vitamins (unspecified). Follow up information has been received from the infant's pediatrician via initial pregnancy questionnaire concerning the female patient with no known medical history or concurrent conditions and an obstetrical history of 0 pregnancies. Concomitant  therapy also included ferrous gluconate, prenatal vitamins and docusate. It was reported that on 07-NOV-2011 at 33 weeks pregnant, the patient had an ultrasound done due to late care that resulted normal. The patient denied being sexually active before given her GARDASIL vaccine. The nurse also reported that the patient had normal routine tests. On 31-DEC-2011, the patient delivered a female baby via C-section due to failure to progress. The baby's weight was 6 pounds 11 ounces, her length was 20 inches, head circumference 13 inches and Apgar score 9-9. The registered nurse reported that the baby's right hand was absent. No other complications or abnormalities were reported and no infections or illnesses during pregnancy. Upon internal review C-section due to failure to progress was determined to be an other important medical event. The baby's experiences were captured in WAES # 1111USA00983B1. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Neck pain, Pain in extremity
Clinical narrative: Arm was very painful, woke up to neck sore on left side where shot given, later felt prickly sensation & rash started to appear near where shot was given. Continued to get worse went back to doctor 3/2/12 said was strange reaction. Continued to get worse. 3/4/12 went to Urgent Care & they said it was shingles. That night felt like I was on fire at the sight. 3 weeks later still recovering from rash. I do believe this was triggered by the vaccine. I had no precursor symptoms, came on suddenly. Also I didn't have chicken pox as a kid, so was vaccinated 6 yrs ago.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Paraesthesia
Clinical narrative: Arm was very painful, woke up to neck sore on left side where shot given, later felt prickly sensation & rash started to appear near where shot was given. Continued to get worse went back to doctor 3/2/12 said was strange reaction. Continued to get worse. 3/4/12 went to Urgent Care & they said it was shingles. That night felt like I was on fire at the sight. 3 weeks later still recovering from rash. I do believe this was triggered by the vaccine. I had no precursor symptoms, came on suddenly. Also I didn't have chicken pox as a kid, so was vaccinated 6 yrs ago.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, YF, ANTH, SMALL, YF
Symptoms: Activities of daily living impaired, Chest X-ray, Chest discomfort, Dyspnoea, Laboratory test
Clinical narrative: Vaccine was administered on 29 Feb 2012. Patient states felt tightness in chest started 9 Mar 12.  Shortness of breath occasionally through 23 Mar 12. Patient came in to Clinic on 23 Mar 2012 and was seen by Dr. Patient is a pilot so he was restricted from flying duties and from running/speed walking for 30 days.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Papule, Pyrexia, Rash
Clinical narrative: Rash - 5 days after vaccine - fever papules - then - 5 days later 3 family members got same rash.
Age: 1.63
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: 3 cm erythema surround injection site.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema
Clinical narrative: Area of redness around injection site approximately 2cm in diameter.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Erythema
Clinical narrative: Gave the flu shot on the right arm and in an instant it turned red and then it turned blue.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Feeling hot, Local swelling, Pain, Swelling
Clinical narrative: Remained with baseline redness/swelling from time of injection (3/16/12) until 2 days ago when he began c/o increased pain, swelling, redness & warmth. No fevers. Today has area of redness/swelling 4cm x 3.3cm. Prescribed AUGMENTIN ES & BACTROBAN.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Lip swelling, Pharyngeal oedema, Pruritus
Clinical narrative: Patient's mother states patient's lips swelled, throat swelled, and experienced itching.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, HOT, PRURITUS ON AREA OF VACCINE INJECTION.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Angiogram, Hypoaesthesia, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Left arm was sore at shot site. Then entire arm went numb. Woke up next morning entire left side and face including head were numb. Two days later entire right and left legs arms and head numb.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Rash
Clinical narrative: Where the injection site was (left thigh) it was red/raised and was sore to the touch. On 3-21-12 I noticed some red spots on face and chest. She had a fever in the evening that lasted on and off through 3-22-12. Called the doctors office on 3-22-12 who instructed to continue to give Motrin (every 8 hours) and Tylenol (every 4 hours) for the fever and use an cold wash cloth for the swelling. Today 3-23-12 I have noticed the rash starting to disappear, the fever to be gone and the redness on her leg starting to go away.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Where the injection site was (left thigh) it was red/raised and was sore to the touch. On 3-21-12 I noticed some red spots on face and chest. She had a fever in the evening that lasted on and off through 3-22-12. Called the doctors office on 3-22-12 who instructed to continue to give Motrin (every 8 hours) and Tylenol (every 4 hours) for the fever and use an cold wash cloth for the swelling. Today 3-23-12 I have noticed the rash starting to disappear, the fever to be gone and the redness on her leg starting to go away.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Hives on torso followed the next day by rash.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: S/S Itching, rash and warmth on neck chest and back. Time course: 2 hours 30 mins approx. Rx: OC Oral Benadryl and Epinephrine pen. Both Rx not used. Tx: n/a
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Blood urine present, Cough, Headache, Joint stiffness, Lymphadenopathy
Clinical narrative: Symptoms started wtih headache, neck lymphadenopathy.  By 03/21/2012 progressed to diffuse myalgia, stiff joints, sore throat, and diffuse pruritic rash on face and trunk.  Rash spread to extremities on 03/22/2012 and cough started on 03/23/2012.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Myalgia, Oropharyngeal pain, Rash pruritic, Red blood cells urine, Streptococcus test negative
Clinical narrative: Symptoms started wtih headache, neck lymphadenopathy.  By 03/21/2012 progressed to diffuse myalgia, stiff joints, sore throat, and diffuse pruritic rash on face and trunk.  Rash spread to extremities on 03/22/2012 and cough started on 03/23/2012.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Urine ketone body present
Clinical narrative: Symptoms started wtih headache, neck lymphadenopathy.  By 03/21/2012 progressed to diffuse myalgia, stiff joints, sore throat, and diffuse pruritic rash on face and trunk.  Rash spread to extremities on 03/22/2012 and cough started on 03/23/2012.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever, tired, not eating. Ongoing now over 24 hrs.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Aphthous stomatitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, Severe Sore Throat, Canker Sores developing in mouth.
Age: 0.33
Sex: M
Vaccine: DTAP, IPV, RVX
Symptoms: Crying, Haematochezia, Irritability, Somnolence
Clinical narrative: BLOOD IN STOOL, IRRITABLE, CRYING, DROWSY.
Age: 37.0
Sex: M
Vaccine: MEN, PPV
Symptoms: Balance disorder, Chills, Dizziness, Feeling hot, Pain
Clinical narrative: Chills, light-headed, became extremely warm in the shower and almost blacked out, loss of balance, aches throughout the body.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gastrooesophageal reflux disease, Gaze palsy, Loss of consciousness, Pain, Sandifer's syndrome
Clinical narrative: Sandifer's Syndrome caused by sudden onset of severe acid reflux. Patient had no history of reflux or symptoms of reflux prior to vaccination. Attacks occurred several times per day with patient twisting body and tensing in pain, momentarily losing consciousness, and eyes rolling back into head.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Hyperemic swelling at Lt leg (thigh) shot site within 24 hrs of vaccine.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever to 102, myalgias.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: After receiving tdap states developed fever in evening with fatigue. Did not take actual temperature. Developed redness/tenderness swelling left deltoid. Had body aches. Began to feel better today - states no fever or body aches at present. 3/23/12 afebrile erythema deltoid no induration.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: After receiving tdap states developed fever in evening with fatigue. Did not take actual temperature. Developed redness/tenderness swelling left deltoid. Had body aches. Began to feel better today - states no fever or body aches at present. 3/23/12 afebrile erythema deltoid no induration.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Lt arm red & swollen 12cm x 10cm. Firm swelling. BENADRYL 25mg 1-6hrs #40. Hydrocortisone cream 2.5mg 4x a day PRN.
Age: 1.07
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Rash erythematous
Clinical narrative: Rash of small red bumps on rear end, legs, feet, hands, arms, stomach, back, face, ears. Loss of appetite.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Blood thyroid stimulating hormone decreased, Dysstasia, Fatigue, Gait disturbance, Muscular weakness
Clinical narrative: Weak knees, could no longer walk up or down stairs, extreme fatigue, milk dried up, could not stand from sitting postion without assistance.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Thyroxine free normal, Tissue polypeptide antigen increased, Tri-iodothyronine free
Clinical narrative: Weak knees, could no longer walk up or down stairs, extreme fatigue, milk dried up, could not stand from sitting postion without assistance.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: CSF test abnormal, Cluster headache, Migraine
Clinical narrative: Severe migraine headache limited to one side diagnosed as Cluster Migraine.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness erythema & itching to site of varicella or TD vaccine. Received 4 vaccines 2 to left arm.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: (L) back of arm - redness, warm to touch firm upon palpation. Pain.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Blood test, Crying, Decreased appetite, Lumbar puncture, Pyrexia
Clinical narrative: Extremely high fever, no appetite, crying uncontrollably. Tylenol & Motrin were given for 2 days to control.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: DEATH.
Age: 0.4
Sex: M
Vaccine: DTP
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High Fever that led to diagnosis of Febrile Seziures.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Contraindication to vaccination, Fatigue, Grip strength decreased, Hypoaesthesia
Clinical narrative: Pain, numbness, aching from right shoulder to right hand.  Loss of grip strength, continuous aching and numbness in arm muscles, extreme fatigue and weakness.  Symptoms have continued to date and have not improved.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site anaesthesia, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Pain, numbness, aching from right shoulder to right hand.  Loss of grip strength, continuous aching and numbness in arm muscles, extreme fatigue and weakness.  Symptoms have continued to date and have not improved.
Age: 1.78
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV
Symptoms: Abnormal behaviour, Aggression, Crying, Emotional distress, Screaming
Clinical narrative: For over an hour he was screaming, yelling, crying and very upset. He can talk and I can understand him, and I have never seen him so upset. He tried to push me and every toy I tried to distract him with he threw it away. I'm extremely alarmed because I know him well and this is absolutely not normal behavior for him as his normal tantrums are short and infrequent.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Labyrinthitis, Lymphadenopathy, Otitis externa
Clinical narrative: Severe swelling of lymph node and inner/outer ear infection on left side. Doctor prescribed ciprofloxacin-hydrocortisone, but insurance only covered ofloxacin otic solution 0.3%.
Age: 2.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Abnormal behaviour, Anger, Decreased eye contact, Depressed mood, Poor quality sleep
Clinical narrative: On the day he got his vaccinations, he woke up and said, "There's the kitty cat! There's my car! I so happy!" He was so sweet at the doctor's office. I was so proud of him - my sweet and polite little boy. I haven't see that boy again. Since his vaccination he yells, screams, throws, kicks, screams, he doesn't sleep well. He doesn't look his mommy and daddy in the eye anymore. He can no longer sit still and count or do his ABCs. He's angry all day every day. He is not so happy anymore...and he is not the same.
Age: 2.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Screaming
Clinical narrative: On the day he got his vaccinations, he woke up and said, "There's the kitty cat! There's my car! I so happy!" He was so sweet at the doctor's office. I was so proud of him - my sweet and polite little boy. I haven't see that boy again. Since his vaccination he yells, screams, throws, kicks, screams, he doesn't sleep well. He doesn't look his mommy and daddy in the eye anymore. He can no longer sit still and count or do his ABCs. He's angry all day every day. He is not so happy anymore...and he is not the same.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Pt was diagnosed with shingles on his eye (a mild/moderate case) pt was treated & treated with ZOVIRAX 400 (2 tabs five x day for 7 days).
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Skin warm
Clinical narrative: Left arm became red, swollen & hot after vaccination. No fever. Patient saw her physician & was told it was an allergic reaction to the vaccine. Treated with cortisone cream.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Fall, Musculoskeletal stiffness, Skin discolouration, Syncope, Vomiting
Clinical narrative: Patient fainted & fell to the ground. Was slightly stiff in upper extremities, dusky in color. Episode lasted <2 minutes. 911 called patient sent to local E.R. Vomiting x1.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area 8 x 8 cm erythema around site of inoculation 1 cm induration at the site of inoculation non fluctuant.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intestinal anastomosis, Intussusception, Septic shock, Small intestinal resection
Clinical narrative: Child presented with intussusception & septic shock on 3/19/12.
Sex: F
Vaccine: VARCEL
Symptoms: Blindness unilateral, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning a female patient who in 1997, was vaccinated with a first dose of VARIVAX (Merck) (dose, route, lot number not reported) and in 1998, was vaccinated with a second dose of VARIVAX (Merck) (dose, route, lot number not reported). In October 2011, the patient developed herpes zoster in her eye and became blind in that eye. Unspecified antibiotics were given for herpes zoster in her eye and became blind in that eye. At the time of the report the patient's outcome was recovering. The patient sought unspecified medical attention. Herpes zoster in her eye and became blind in that eye were considered to be disabling. No further information is available.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blood pressure decreased, Chest X-ray, Chest discomfort, Cough, Dyspnoea
Clinical narrative: A pharmacist (also reported as physician) reported she heard from an unknown source that in October 2011, there were a patient who developed unspecified reactions post vaccination with ZOSTAVAX (Merck) (Lot # and route not reported) and the "flu" vaccine (manufacturer and name unspecified). The patient's reactions were so severe that led to the emergency room. At the time of the report, patient's outcome was unknown. Follow up information was received from the registered pharmacist concerning the 72 year old male patient who at 12:30 PM on 26-SEP-2011 was vaccinated with his first dose of ZOSTAVAX (Merck) (Lot# 670754/0621AA, "Exp Date: 24-JUL-2012") by SC route and his second dose of FLUZONE (Lot# UH2152AA, "Exp Date: 03-APR-2012") (was vaccinate the 1 dose prior years) in a pharmacy. The pharmacist stated that the patient was given vaccine at 12:30 PM on 26-SEP-2011 and adverse reaction started at 17:00 PM on 26-SEP-2011. The patient experienced cough, wheezing, chest tightness, dropping in blood pressure, losing of color in face and shortness of breath. The patient required emergency room and 1 day hospitalization. Electrocardiogram (EKG), chest x-ray, heart attack work-up and blood pressure monitoring were performed with unknown results. Attempts are being made to verify the existence of an identifiable patient. This is one of several reported received from the same source. No further information is available.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Electrocardiogram, Laboratory test, Pallor, Wheezing
Clinical narrative: A pharmacist (also reported as physician) reported she heard from an unknown source that in October 2011, there were a patient who developed unspecified reactions post vaccination with ZOSTAVAX (Merck) (Lot # and route not reported) and the "flu" vaccine (manufacturer and name unspecified). The patient's reactions were so severe that led to the emergency room. At the time of the report, patient's outcome was unknown. Follow up information was received from the registered pharmacist concerning the 72 year old male patient who at 12:30 PM on 26-SEP-2011 was vaccinated with his first dose of ZOSTAVAX (Merck) (Lot# 670754/0621AA, "Exp Date: 24-JUL-2012") by SC route and his second dose of FLUZONE (Lot# UH2152AA, "Exp Date: 03-APR-2012") (was vaccinate the 1 dose prior years) in a pharmacy. The pharmacist stated that the patient was given vaccine at 12:30 PM on 26-SEP-2011 and adverse reaction started at 17:00 PM on 26-SEP-2011. The patient experienced cough, wheezing, chest tightness, dropping in blood pressure, losing of color in face and shortness of breath. The patient required emergency room and 1 day hospitalization. Electrocardiogram (EKG), chest x-ray, heart attack work-up and blood pressure monitoring were performed with unknown results. Attempts are being made to verify the existence of an identifiable patient. This is one of several reported received from the same source. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash on face, neck, torso. Tx: Anti-histamine.
Age: 45.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pyrexia, Swelling
Clinical narrative: Pain noted at injection site within 2 hrs after receiving vaccine. Swelling increased throughout night. Fever noted next AM. Pt reports missing 2 days of work due to being unable to lift (R) arm. Pt given antibiotic by family friend who is Nurse Practitioner. By 3/23/12 symptoms had resolved.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Says he had ADR (tremors) after he had HD flu shot. Had to go to hospital.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Systemic rash; started 1 day post injection.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray abnormal, Cough, Laboratory test normal, Pertussis
Clinical narrative: Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 8-month-old male subject  was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 20 June 2011, 23 August 2011 and 24 October 2011 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 13 January 2012, approximately 2 months after the last dose and paroxysmal cough on 20 January 2012 with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included negative PCR on 18 January 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 18 January 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 39 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pneumonia, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 8-month-old male subject  was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 20 June 2011, 23 August 2011 and 24 October 2011 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 13 January 2012, approximately 2 months after the last dose and paroxysmal cough on 20 January 2012 with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included negative PCR on 18 January 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 18 January 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 39 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood test normal, Pyrexia, Urine analysis normal
Clinical narrative: Patient had vaccines on 03/02/12. He has had fever of 102 degrees - 103 degrees since then, today is 03/08/12.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Myalgia, Pain in extremity, Pharyngeal oedema, Throat tightness
Clinical narrative: Initial report was received 19 September 2011 from a health care professional which involved a cluster of two patients. The other patient has been captured in case number 2011-08894. A 14-year-old female patient had received an injection of FLUZONE, lot number UH467AB (date of administration not reported; route and site unknown) and on 17 September 2011 the patient developed muscle aches and arm soreness. The patient presented to the emergency room on 19 September for throat tightness. Outcome was not recovered. No additional information was provided at the time of the report. Follow-up information was received from a health care professional on 19 March 2012. Based upon the new information provided, this case has been upgraded to serious. The patient experienced throat swelling and numbness on 18 September 2011. The patient's outcome was not reported. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Muscle tightness
Clinical narrative: Muscle is tight, area where vaccine was administered is red and hot. The red area is a large circle about 2 1/2 inches in diameter and a solid red color.
Age: 1.28
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Post-tussive vomiting
Clinical narrative: Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3362AA received on 14 August 2009, lot number C3471AA received on 12 October 2009, lot number C3545AB received on 13 January 2010 and 1 dose of DAPTACEL; lot number C3473AA received on 20 September 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 February 2012, approximately 16 months after the last dose. On 13 February 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 15 February 2012 for 8 days. The subject was not hospitalized. According to the reporter, the case is epidemiologically linked directly to a laboratory-confirmed case. At the time of the final contact on 24 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3362AA received on 14 August 2009, lot number C3471AA received on 12 October 2009, lot number C3545AB received on 13 January 2010 and 1 dose of DAPTACEL; lot number C3473AA received on 20 September 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 February 2012, approximately 16 months after the last dose. On 13 February 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 15 February 2012 for 8 days. The subject was not hospitalized. According to the reporter, the case is epidemiologically linked directly to a laboratory-confirmed case. At the time of the final contact on 24 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 7-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3723AA received on 21 June 2011, lot number C3723AA received on 06 September 2011 and lot number C3872AB received on 21 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 03 December 2011, approximately 1 month after the last dose. The subject developed a cough on 05 December 2011 and paroxysmal cough on 23 December 2011 without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 29 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 19 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 7-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3723AA received on 21 June 2011, lot number C3723AA received on 06 September 2011 and lot number C3872AB received on 21 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 03 December 2011, approximately 1 month after the last dose. The subject developed a cough on 05 December 2011 and paroxysmal cough on 23 December 2011 without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 29 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 19 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Swelling face
Clinical narrative: Patient recently had shingles & presented w/similar, but less severe symptoms; including headache & swollen left side of face.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Abortion missed, Human chorionic gonadotropin negative, Maternal exposure during pregnancy, Pregnancy test urine negative
Clinical narrative: Initial report was received 10 August 2011 from a health care professional. A 16-year-old pregnant female patient with no known pregnancy history, had received a first dose intramuscular left deltoid injection of MENACTRA, lot number U3542AA on 30 July 2011. The patient's date of last menstrual period was 10 February 2011 which calculates to 24 weeks gestation at the time of vaccination. According to the reporter, the patient had not experienced any adverse events since receiving MENACTRA. No additional information was provided. Follow-up information was received on 12 March 2012 from a health care professional. Based upon the new information, this case has been upgraded to serious. The patient had a human chorionic gonadotropin (hCG) blood test on 12 August 2011 and the result was 0.0 which was non-pregnant. The patient had a urine pregnancy test on 09 September 2011 and the result was negative. The patient was diagnosed with missed abortion. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Laboratory records.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Computerised tomogram head, Fall, Skull fracture
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an approximately 11 year old female patient who on an unknown date, was vaccinated with GARDASIL, IM (dose, site and lot number not reported). Concomitant therapy included Tdap and meningococcal vaccine (unspecified) (manufacturer unknown). The Licensed Practical Nurse reported that the patient was given GARDASIL and about 15 minutes later she fell and cracked her head. Unspecified treatment was given. It was stated that the patient went to the Emergency Room and CT scan was performed. At the time of the report the patient's outcome was unknown. Indication for CT scan was considered to be an other important medical event by the Licensed Practical Nurse. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient called to the pharmacy complaining that is experiencing a very painful in her arm and shoulder. She also said that the injection site is redness and heat and is red in a diameter of above 2 - 3 inches. Patient is taking APAP and is working at moment.
Age: 5.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: RASH ON BODY NOT FACE/ 100.4 TEMP ON 03/25/2012 PM.
Age: 0.25
Sex: M
Vaccine: PNC13, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Runny diarrhea and fever of over 100.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Red Blotches on arms and legs. Warm to the touch and swollen. No fever.
Age: 1.32
Sex: M
Vaccine: MMR
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Red rash on left rear calf of leg, spread to outer buttocks, chest, right cheek and left arm over the next several days. Benadryl given at 3:00 pm on 3/23/12 and rash on leg began to clear up.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Cellulitis, Injection site erythema, Pyrexia, Vaccination site warmth
Clinical narrative: After his vaccination, child started to run a fever.  Vaccination site was red and warm to the touch.  Injection site redness spread past 5 x 4.5 mm circle.  Required ER visit; MD diagnosed cellulitis and prescribed Omnicef.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, edema, erythema, warm to site. Treated with Septra DS 10mg take po BID x 10 days.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site warmth
Clinical narrative: Pain, swelling, edema, erythema, warm to site. Treated with Septra DS 10mg take po BID x 10 days.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Received annual flu shot in right arm; 3 days later noticed slight arm pain which has progressed so that now when I put my arm at a certain angle, I get a sharp pain in my upper arm. (Can't use left arm for injections due to prior breast surgery).
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: System was down; unable access record. According to Yellow shot card patient provided. #1 HPV given 12-21-2011. No other doses shown. Administered #2 03-09-2012. Later in day when clerk entered information which was now up it showed that she had #1 on 07-09-2009, so the 12-20-2011 dose was actually #2, which would make #3 due 03-21-2012. This made on 03-12-2012 twelve days early. We need to repeat #3.
Age: 1.03
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Irritability, Joint swelling, Rash
Clinical narrative: Rash, swollen joints, irritability occurred 2 days after receiving vaccines. Patient was also on day 6 of amoxicillin. Patient received prednisolone, ZYRTEC, BENADRYL & MOTRIN.