chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Osteomyelitis, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 27-SEP-2010, a 11 year old male patient with history of obesity, spinal cord tumor, left sided weakness and pre-existing illness of wound open in his hand was vaccinated IM with the first dose of GARDASIL (Lot # 666121/1778Y) into his right arm. Concomitant vaccinations included: the fifth dose of FLUZONE (lot # U3571AA) given IM into his left arm, the first dose of ADACEL (Lot # C3475AA) given IM into his right arm and the first dose of MENACTRA (Lot # U3463AA) given IM into his right arm. Concomitant medications included: DUODERM, nystatin, MSD, AQUAPHOR. It was reported that on 29-SEP-2010, 2 days after the vaccination, the patient developed fever. He was seen in the ER and he had a positive blood culture. The patient was admitted because he still had fever. Subsequently, he was diagnosed with left humerus osteomyelitis and with a subperiosteal abscess left humerus also. The patient was taken to surgery to drain the abscess. A PICC line was placed for antibiotics. The reported events extended the patient's hospital stay. Labs, MRI, CxR and an Echocardiogram were performed on an unspecified date (results not provided). The patient's outcome was not reported. The original reporting source was not provided. The VAERS ID # was 401591. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Abscess drainage, Blood culture positive, Bone abscess, Central venous catheterisation, Chest X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 27-SEP-2010, a 11 year old male patient with history of obesity, spinal cord tumor, left sided weakness and pre-existing illness of wound open in his hand was vaccinated IM with the first dose of GARDASIL (Lot # 666121/1778Y) into his right arm. Concomitant vaccinations included: the fifth dose of FLUZONE (lot # U3571AA) given IM into his left arm, the first dose of ADACEL (Lot # C3475AA) given IM into his right arm and the first dose of MENACTRA (Lot # U3463AA) given IM into his right arm. Concomitant medications included: DUODERM, nystatin, MSD, AQUAPHOR. It was reported that on 29-SEP-2010, 2 days after the vaccination, the patient developed fever. He was seen in the ER and he had a positive blood culture. The patient was admitted because he still had fever. Subsequently, he was diagnosed with left humerus osteomyelitis and with a subperiosteal abscess left humerus also. The patient was taken to surgery to drain the abscess. A PICC line was placed for antibiotics. The reported events extended the patient's hospital stay. Labs, MRI, CxR and an Echocardiogram were performed on an unspecified date (results not provided). The patient's outcome was not reported. The original reporting source was not provided. The VAERS ID # was 401591. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Echocardiogram, Nuclear magnetic resonance imaging, Osteomyelitis, Pyrexia, Surgery
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 27-SEP-2010, a 11 year old male patient with history of obesity, spinal cord tumor, left sided weakness and pre-existing illness of wound open in his hand was vaccinated IM with the first dose of GARDASIL (Lot # 666121/1778Y) into his right arm. Concomitant vaccinations included: the fifth dose of FLUZONE (lot # U3571AA) given IM into his left arm, the first dose of ADACEL (Lot # C3475AA) given IM into his right arm and the first dose of MENACTRA (Lot # U3463AA) given IM into his right arm. Concomitant medications included: DUODERM, nystatin, MSD, AQUAPHOR. It was reported that on 29-SEP-2010, 2 days after the vaccination, the patient developed fever. He was seen in the ER and he had a positive blood culture. The patient was admitted because he still had fever. Subsequently, he was diagnosed with left humerus osteomyelitis and with a subperiosteal abscess left humerus also. The patient was taken to surgery to drain the abscess. A PICC line was placed for antibiotics. The reported events extended the patient's hospital stay. Labs, MRI, CxR and an Echocardiogram were performed on an unspecified date (results not provided). The patient's outcome was not reported. The original reporting source was not provided. The VAERS ID # was 401591. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Asthenia, Erythema, Insomnia, Pain
Clinical narrative: Redness and Itching. Benadryl 3-4 days. Upper arm pain, throbbing, radiating to elbow and hand. Weakness, sore to touch, trouble sleeping due to pain. 11/08/2010- current (12/26/2010)
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Redness and Itching. Benadryl 3-4 days. Upper arm pain, throbbing, radiating to elbow and hand. Weakness, sore to touch, trouble sleeping due to pain. 11/08/2010- current (12/26/2010)
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: The area where the vaccine was given in my left arm was red, swollen, and there was a big knot. I would guess the inflammed area was approx 2-3in and it would hurt significantly when I would lay on that arm when in bed. I took 800mg Ibuprofen (one the night of the Dec 23, one the following morning and then night) and the swelling has reduced significantly. The knot still exists but it no longer hurts as it did in the beginning and it's nowhere near as big as before. I didn't have any of these symptoms until well after the vaccine was given but it was in the exact area where it was administered.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Feeling abnormal, Local swelling, Myalgia
Clinical narrative: Local redness and swelling within 24 hours, improving by 72 hours when patient was seen.  Local findings at time of evaluation were 5.5x8cm area of pinkish erythema and mild swelling.  General muscle/joint aches.  "Foggy" feeling.  Normal examination other than local erythema (pinkish) and mild swelling. No treatment given.  Symptoms did not mandate visit to aid station based upon severity, more so for patient concern and wondering if related to the vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Within 24 hours after vaccination developed reddened, warm area below armpits x 10 days. Doctors visit to MD inconclusive. Resolved without problems.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness & swelling & itching to left deltoid.
Age: 63.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Five hours after immunizations, patient called & states arm red & swollen in arm where pneumonia shot (left arm) administered. Suggested to take some BENADRYL and seek medical help. Follow-up call on 12/26/10, patient states arm is better, swelling and redness relieved.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted about 2 minutes after receiving vaccine. Pt immediately regained consciousness (in about 1 min) - 911 was called. Pt was not taken to the hospital. Pt was able to walk out of clinic.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abasia, Activities of daily living impaired, Alanine aminotransferase normal, Anti-cyclic citrullinated peptide antibody positive, Arthralgia
Clinical narrative: Went, to clinic and received the Flu and pneumo vaccine the 27th of November 2007. The, same day of the vaccines in the afternoon started having reactions which were: very red as if being in a tanning bed all day - felt warm with a low grade fever. He was urinating frequently until late that night. Had muscle pain-aching felt very tired and weak. Did not feel like eating. The next day the redness was going away but continued to have flu like symptoms. Finally went to Dr. because of swelling of fingers and joint pain. Could not walk - feed his self or bathe. Dr. put him on methotrexate. Dr. sent him to a Rheumatologist. She continued methotrexate and added prednisone then changed to EMBREL shots. And is still having these problems as of today and all this started after the shots.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Aspartate aminotransferase normal, Asthenia, Blood albumin normal, Blood creatine phosphokinase normal, Blood creatinine increased
Clinical narrative: Went, to clinic and received the Flu and pneumo vaccine the 27th of November 2007. The, same day of the vaccines in the afternoon started having reactions which were: very red as if being in a tanning bed all day - felt warm with a low grade fever. He was urinating frequently until late that night. Had muscle pain-aching felt very tired and weak. Did not feel like eating. The next day the redness was going away but continued to have flu like symptoms. Finally went to Dr. because of swelling of fingers and joint pain. Could not walk - feed his self or bathe. Dr. put him on methotrexate. Dr. sent him to a Rheumatologist. She continued methotrexate and added prednisone then changed to EMBREL shots. And is still having these problems as of today and all this started after the shots.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Erythema, Fatigue, Haematocrit increased, Haemoglobin normal
Clinical narrative: Went, to clinic and received the Flu and pneumo vaccine the 27th of November 2007. The, same day of the vaccines in the afternoon started having reactions which were: very red as if being in a tanning bed all day - felt warm with a low grade fever. He was urinating frequently until late that night. Had muscle pain-aching felt very tired and weak. Did not feel like eating. The next day the redness was going away but continued to have flu like symptoms. Finally went to Dr. because of swelling of fingers and joint pain. Could not walk - feed his self or bathe. Dr. put him on methotrexate. Dr. sent him to a Rheumatologist. She continued methotrexate and added prednisone then changed to EMBREL shots. And is still having these problems as of today and all this started after the shots.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hepatitis B surface antigen negative, Hepatitis C antibody negative, Influenza like illness, Myalgia, Oedema peripheral
Clinical narrative: Went, to clinic and received the Flu and pneumo vaccine the 27th of November 2007. The, same day of the vaccines in the afternoon started having reactions which were: very red as if being in a tanning bed all day - felt warm with a low grade fever. He was urinating frequently until late that night. Had muscle pain-aching felt very tired and weak. Did not feel like eating. The next day the redness was going away but continued to have flu like symptoms. Finally went to Dr. because of swelling of fingers and joint pain. Could not walk - feed his self or bathe. Dr. put him on methotrexate. Dr. sent him to a Rheumatologist. She continued methotrexate and added prednisone then changed to EMBREL shots. And is still having these problems as of today and all this started after the shots.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Platelet count normal, Pollakiuria, Pyrexia, Red blood cell sedimentation rate increased, Skin warm
Clinical narrative: Went, to clinic and received the Flu and pneumo vaccine the 27th of November 2007. The, same day of the vaccines in the afternoon started having reactions which were: very red as if being in a tanning bed all day - felt warm with a low grade fever. He was urinating frequently until late that night. Had muscle pain-aching felt very tired and weak. Did not feel like eating. The next day the redness was going away but continued to have flu like symptoms. Finally went to Dr. because of swelling of fingers and joint pain. Could not walk - feed his self or bathe. Dr. put him on methotrexate. Dr. sent him to a Rheumatologist. She continued methotrexate and added prednisone then changed to EMBREL shots. And is still having these problems as of today and all this started after the shots.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: White blood cell count normal
Clinical narrative: Went, to clinic and received the Flu and pneumo vaccine the 27th of November 2007. The, same day of the vaccines in the afternoon started having reactions which were: very red as if being in a tanning bed all day - felt warm with a low grade fever. He was urinating frequently until late that night. Had muscle pain-aching felt very tired and weak. Did not feel like eating. The next day the redness was going away but continued to have flu like symptoms. Finally went to Dr. because of swelling of fingers and joint pain. Could not walk - feed his self or bathe. Dr. put him on methotrexate. Dr. sent him to a Rheumatologist. She continued methotrexate and added prednisone then changed to EMBREL shots. And is still having these problems as of today and all this started after the shots.
Age: 55.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: I had vaccine given to me on 11/23/10. I had severe pain, swelling, a huge lump very red and warm at injection site until 12/10/10. There is still a small bump at site of injection, 12/15/10.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Constipation, Crying, Haematochezia, Intussusception
Clinical narrative: On Dec. 8th, child had inconsolable crying, paleness, constipation, bloody stools, vomiting. Diagnosed with intussusception on 12/10/10.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pallor, Urinary system X-ray, Vomiting
Clinical narrative: On Dec. 8th, child had inconsolable crying, paleness, constipation, bloody stools, vomiting. Diagnosed with intussusception on 12/10/10.
Age: 1.48
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Aldolase, Antinuclear antibody, Axillary pain, Biopsy muscle, Blood creatine phosphokinase
Clinical narrative: Child developed Dermatomyositis within 2 wks of receiving vaccines (MMR, DTaP, Hib.). Symptoms evolved over about 1 month. Initially crying with bending legs for diaper changes. This started about 1 week after the vaccines given. Then, not bending over to pick up objects; crying with being picked up under her arms; ongoing pain with diaper changes and with carrying on parents hip; laying around; not active.
Age: 1.48
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Blood lactate dehydrogenase, Crying, Decreased activity, Dermatomyositis, Full blood count
Clinical narrative: Child developed Dermatomyositis within 2 wks of receiving vaccines (MMR, DTaP, Hib.). Symptoms evolved over about 1 month. Initially crying with bending legs for diaper changes. This started about 1 week after the vaccines given. Then, not bending over to pick up objects; crying with being picked up under her arms; ongoing pain with diaper changes and with carrying on parents hip; laying around; not active.
Age: 1.48
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Liver function test, Nuclear magnetic resonance imaging, Pain in extremity, Red blood cell sedimentation rate, Renal function test
Clinical narrative: Child developed Dermatomyositis within 2 wks of receiving vaccines (MMR, DTaP, Hib.). Symptoms evolved over about 1 month. Initially crying with bending legs for diaper changes. This started about 1 week after the vaccines given. Then, not bending over to pick up objects; crying with being picked up under her arms; ongoing pain with diaper changes and with carrying on parents hip; laying around; not active.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm is swollen, red, and warm to touch. Patient was advised to put cool compresses on the swollen area and to take MOTRIN. Patient was also seen at the PCP's office she works for & was dx with cellulitis, was started on CIPRO & steroid dose pack. She was advised to avoid any additional pneumonia shots.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Extremely sore arm "muscle pain" at injection site. Tender to touch. No redness or swelling.
Age: 1.29
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Ageusia, Altered visual depth perception, Anxiety, Balance disorder, Blepharospasm
Clinical narrative: Headache, head felt heavy 11/26 headache worsened on 11/28 has improved since, but feeling of heaviness has continued. Feeling mentally fuzzy slow mental processing 11/27 began to notice on 11/27 has worsened over time. Feeling dizzy, off balance, depth perception is off 11/27 continued to present. Eye problems, at the start seemed like depth perception was off. Intermittent twitch in left eye 11/29 continues to present. Pain in jaw, hurts to smile, hard to keep lower jaw closed 11/30 pain has lessened in jaw, still hurts to smile. Reported symptoms to clinic 12/02 they advised symptoms should go away with time. Unable to taste food difficulty performing work on computer noticing difficulty remembering names 12/4 continues to present. Reported to Urgent Care who recommended a blood test and to make an appointment with Dr. 12/5. Body feels numb, can't feel hot water in shower or hands don't feel heat on the stove 12/6 continues to present. Trouble sleeping, sleep four hours and wake up don't get deep sleep 12/7 noticed this around 11/26, but thought it would go away. Slower reaction time when driving 12/7 continues to present.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test normal, Condition aggravated, Depression, Dizziness, Eye disorder
Clinical narrative: Headache, head felt heavy 11/26 headache worsened on 11/28 has improved since, but feeling of heaviness has continued. Feeling mentally fuzzy slow mental processing 11/27 began to notice on 11/27 has worsened over time. Feeling dizzy, off balance, depth perception is off 11/27 continued to present. Eye problems, at the start seemed like depth perception was off. Intermittent twitch in left eye 11/29 continues to present. Pain in jaw, hurts to smile, hard to keep lower jaw closed 11/30 pain has lessened in jaw, still hurts to smile. Reported symptoms to clinic 12/02 they advised symptoms should go away with time. Unable to taste food difficulty performing work on computer noticing difficulty remembering names 12/4 continues to present. Reported to Urgent Care who recommended a blood test and to make an appointment with Dr. 12/5. Body feels numb, can't feel hot water in shower or hands don't feel heat on the stove 12/6 continues to present. Trouble sleeping, sleep four hours and wake up don't get deep sleep 12/7 noticed this around 11/26, but thought it would go away. Slower reaction time when driving 12/7 continues to present.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Head discomfort, Headache, Hypoaesthesia, Impaired driving ability
Clinical narrative: Headache, head felt heavy 11/26 headache worsened on 11/28 has improved since, but feeling of heaviness has continued. Feeling mentally fuzzy slow mental processing 11/27 began to notice on 11/27 has worsened over time. Feeling dizzy, off balance, depth perception is off 11/27 continued to present. Eye problems, at the start seemed like depth perception was off. Intermittent twitch in left eye 11/29 continues to present. Pain in jaw, hurts to smile, hard to keep lower jaw closed 11/30 pain has lessened in jaw, still hurts to smile. Reported symptoms to clinic 12/02 they advised symptoms should go away with time. Unable to taste food difficulty performing work on computer noticing difficulty remembering names 12/4 continues to present. Reported to Urgent Care who recommended a blood test and to make an appointment with Dr. 12/5. Body feels numb, can't feel hot water in shower or hands don't feel heat on the stove 12/6 continues to present. Trouble sleeping, sleep four hours and wake up don't get deep sleep 12/7 noticed this around 11/26, but thought it would go away. Slower reaction time when driving 12/7 continues to present.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired work ability, Insomnia, Memory impairment, Mental impairment, Pain in jaw
Clinical narrative: Headache, head felt heavy 11/26 headache worsened on 11/28 has improved since, but feeling of heaviness has continued. Feeling mentally fuzzy slow mental processing 11/27 began to notice on 11/27 has worsened over time. Feeling dizzy, off balance, depth perception is off 11/27 continued to present. Eye problems, at the start seemed like depth perception was off. Intermittent twitch in left eye 11/29 continues to present. Pain in jaw, hurts to smile, hard to keep lower jaw closed 11/30 pain has lessened in jaw, still hurts to smile. Reported symptoms to clinic 12/02 they advised symptoms should go away with time. Unable to taste food difficulty performing work on computer noticing difficulty remembering names 12/4 continues to present. Reported to Urgent Care who recommended a blood test and to make an appointment with Dr. 12/5. Body feels numb, can't feel hot water in shower or hands don't feel heat on the stove 12/6 continues to present. Trouble sleeping, sleep four hours and wake up don't get deep sleep 12/7 noticed this around 11/26, but thought it would go away. Slower reaction time when driving 12/7 continues to present.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: 2 days after administration pt had 2 seizures. Unsure if vaccine was related or not.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Sleep disorder, Tendonitis
Clinical narrative: Pain in shoulder during the night, when sleeping on my left shoulder.  Pain would wake me up.  Pain has persisted for 3 months and have indentified it as inflamed tendons in the shoulder (armpit), back of the arm above the elbow and upper wrist. Areas are sensitive to touch, especially above the elbow.  Doctor visit scheduled for 1/3/2011.
Age: 0.69
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: No adverse reactions
Age: 0.79
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Lethargy, Listless, Pyrexia, Vomiting
Clinical narrative: Loss of Appetite, Lethargy, Listlessness, Repeated Vomiting, High Fever (104)
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: Employee states onset of bilateral ear ringing began about 2 days after receiving influenza vaccine.  Tinnitis has persisted since onset.  Seen by ENT specialist and exams included AVR and ECOG testing.  Given diagnosis of high frequency hearing loss, possible Meniere's disease.
Age: 0.58
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Dyskinesia, Dysphagia, Fatigue, Muscle twitching, Staring
Clinical narrative: Around 11:00 AM I checked on my child. He was lying down. I looked at him closely in the face his eyes were open staring w/no response. The next day he started to jerk his head to the right side and his face started to twitch. He seemed to be very exhausted, tired, and lazy. He was having difficulty swallowing baby foods juices & TYLENOL. The symptoms occurred everyday after his vaccinations.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blister, Injection site vesicles, Papule
Clinical narrative: Vesicles 0.3cm on trunK & extremities multi 20-30 pink papules.
Age: 1.19
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Malaise, Rash vesicular, Scab, Skin lesion
Clinical narrative: Malaise, vesicular rash x 2-3 days, lesions to extremities, trunk, scalp at hairline. Some lesions scabies, some vesicular. All lesions <0.5 cm.
Age: 1.44
Sex: M
Vaccine: DTAP
Symptoms: Full blood count normal, Metabolic function test normal, Pyrexia, Tonic clonic movements
Clinical narrative: 36 hrs later fever to 104 degrees tonic clonic movements - no focal cause.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Dysphonia, Oedema peripheral, Swelling face, Throat tightness, Urticaria
Clinical narrative: Diffuse urticaria & swelling on face, trunk, bilateral upper & lower extremities and hoarseness/throat tightening.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: PT DEVELOPED PETECHIAE FROM THROMBOCYTOPENIA DIAGNOSED WITH IDIOPATHIC THROMBOCYTOPENIA AFTER ADMISSION TO HOSPITAL
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: After shingles vaccine, redness, soreness, swelling, itching, rash.  Rash started 12/23/2011 still persisting on 12/27/2011.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Pain at injection site worsening later in the day.  Overnight, more pain in arm, forearm & neck.  Redness & swelling the following day, 12/22. All symptoms worsened by 12/23.  Physician diagnosed cellulitis in ER, prescribed antibiotics.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pain at injection site worsening later in the day.  Overnight, more pain in arm, forearm & neck.  Redness & swelling the following day, 12/22. All symptoms worsened by 12/23.  Physician diagnosed cellulitis in ER, prescribed antibiotics.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Back pain, Chest pain, Dyspnoea, Myocarditis
Clinical narrative: Chest pain radiating to back Shortness of breath
Age: 15.0
Sex: F
Vaccine: FLU3, HEP, HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a Registered Nurse concerning a 0 day male baby patient. On 13-OCT-2010 the patient's mother was vaccinated IM with the third dose of GARDASIL (Lot# 666596/0766Z) (Expiration date: 15-OCT-2012). The patient's mother also received on the same day a third dose of RECOMBIVAX HB (Lot# unknown) (manufacturer unknown) and a first dose of AFLURIA (Lot# unknown) (manufacturer unknown). The nurse reported that the patient was born at gestation age of 36 weeks and 5 days. The baby boy was admitted to neonatal intensive care unit (NICU) for oxygen desaturation and was diagnosed with severe laryngomalacia. Epiglottis prolapsed was present as well. At the time of the report, the patient's outcome was unknown. The mother's experience has been captured in WAES# 1012USA02470. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no drug allergies or medical history who on 09-NOV-2010 was vaccinated with the second dose of GARDASIL (lot # not reported), 0.5 ml, IM. It was not certain of date of first dose. There was no concomitant medication. On 09-NOV-2010 after vaccination, the patient experienced "all of the side effects listed in the prescribing information", nausea, headache, vomiting, stomach cramps, weak, dizzy and heart racing. Mother had placed call to physician. Mother also stated she was sick they ate at the same place and was not sure if they had food poisoning. The patient's events persisted. No lab diagnostics studies performed. Information has been received from a physician concerning an 18 year old female non smoker who on 07OCT2010 received a dose of GARDASIL (lot # 662529/1317Y) in her L deltoid. On 09NOV2010 the pt received a second dose of GARDASIL (lot #666163/0664Z) in L deltoid. 23NOV2010 pt reported to physician she experienced cephalgia, stomach pains dizziness, nausea, emesis, insomnia, fever, achy, poor concentration, ringing in ears and diarrhea which pt reported she had been ill since HPV vaccine on 09NOV2010. Labs were drawn (CBC, Comp. Metabolic panel w/ EGFR and monospot). Results were reported as normal. Physician stated he doubted nausea was HPV vaccine related. 02DEC2010 pt mom called physician office as pt was still experiencing symptoms of severe headache, nausea, vomiting. An MRI was performed on 03DEC2010 which was normal. On approx 10DEC2010 pt experience pharyngitis with sore throat and pain in ears and had strep screen in physician office on 13DEC2010 ( results not reported). Pt reported on 14DEC2010 that throat was still very sore. Physician considered the stomach cramps/pain, diarrhea, poor concentration, headache/cephalgia, insomnia, achy, fever ringing in ears and vomiting/emesis as disabling and pt has not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Full blood count normal, Glomerular filtration rate normal, Headache, Insomnia
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no drug allergies or medical history who on 09-NOV-2010 was vaccinated with the second dose of GARDASIL (lot # not reported), 0.5 ml, IM. It was not certain of date of first dose. There was no concomitant medication. On 09-NOV-2010 after vaccination, the patient experienced "all of the side effects listed in the prescribing information", nausea, headache, vomiting, stomach cramps, weak, dizzy and heart racing. Mother had placed call to physician. Mother also stated she was sick they ate at the same place and was not sure if they had food poisoning. The patient's events persisted. No lab diagnostics studies performed. Information has been received from a physician concerning an 18 year old female non smoker who on 07OCT2010 received a dose of GARDASIL (lot # 662529/1317Y) in her L deltoid. On 09NOV2010 the pt received a second dose of GARDASIL (lot #666163/0664Z) in L deltoid. 23NOV2010 pt reported to physician she experienced cephalgia, stomach pains dizziness, nausea, emesis, insomnia, fever, achy, poor concentration, ringing in ears and diarrhea which pt reported she had been ill since HPV vaccine on 09NOV2010. Labs were drawn (CBC, Comp. Metabolic panel w/ EGFR and monospot). Results were reported as normal. Physician stated he doubted nausea was HPV vaccine related. 02DEC2010 pt mom called physician office as pt was still experiencing symptoms of severe headache, nausea, vomiting. An MRI was performed on 03DEC2010 which was normal. On approx 10DEC2010 pt experience pharyngitis with sore throat and pain in ears and had strep screen in physician office on 13DEC2010 ( results not reported). Pt reported on 14DEC2010 that throat was still very sore. Physician considered the stomach cramps/pain, diarrhea, poor concentration, headache/cephalgia, insomnia, achy, fever ringing in ears and vomiting/emesis as disabling and pt has not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Metabolic function test, Mononucleosis heterophile test negative, Nausea, Non-smoker
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no drug allergies or medical history who on 09-NOV-2010 was vaccinated with the second dose of GARDASIL (lot # not reported), 0.5 ml, IM. It was not certain of date of first dose. There was no concomitant medication. On 09-NOV-2010 after vaccination, the patient experienced "all of the side effects listed in the prescribing information", nausea, headache, vomiting, stomach cramps, weak, dizzy and heart racing. Mother had placed call to physician. Mother also stated she was sick they ate at the same place and was not sure if they had food poisoning. The patient's events persisted. No lab diagnostics studies performed. Information has been received from a physician concerning an 18 year old female non smoker who on 07OCT2010 received a dose of GARDASIL (lot # 662529/1317Y) in her L deltoid. On 09NOV2010 the pt received a second dose of GARDASIL (lot #666163/0664Z) in L deltoid. 23NOV2010 pt reported to physician she experienced cephalgia, stomach pains dizziness, nausea, emesis, insomnia, fever, achy, poor concentration, ringing in ears and diarrhea which pt reported she had been ill since HPV vaccine on 09NOV2010. Labs were drawn (CBC, Comp. Metabolic panel w/ EGFR and monospot). Results were reported as normal. Physician stated he doubted nausea was HPV vaccine related. 02DEC2010 pt mom called physician office as pt was still experiencing symptoms of severe headache, nausea, vomiting. An MRI was performed on 03DEC2010 which was normal. On approx 10DEC2010 pt experience pharyngitis with sore throat and pain in ears and had strep screen in physician office on 13DEC2010 ( results not reported). Pt reported on 14DEC2010 that throat was still very sore. Physician considered the stomach cramps/pain, diarrhea, poor concentration, headache/cephalgia, insomnia, achy, fever ringing in ears and vomiting/emesis as disabling and pt has not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain, Palpitations, Pharyngitis
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no drug allergies or medical history who on 09-NOV-2010 was vaccinated with the second dose of GARDASIL (lot # not reported), 0.5 ml, IM. It was not certain of date of first dose. There was no concomitant medication. On 09-NOV-2010 after vaccination, the patient experienced "all of the side effects listed in the prescribing information", nausea, headache, vomiting, stomach cramps, weak, dizzy and heart racing. Mother had placed call to physician. Mother also stated she was sick they ate at the same place and was not sure if they had food poisoning. The patient's events persisted. No lab diagnostics studies performed. Information has been received from a physician concerning an 18 year old female non smoker who on 07OCT2010 received a dose of GARDASIL (lot # 662529/1317Y) in her L deltoid. On 09NOV2010 the pt received a second dose of GARDASIL (lot #666163/0664Z) in L deltoid. 23NOV2010 pt reported to physician she experienced cephalgia, stomach pains dizziness, nausea, emesis, insomnia, fever, achy, poor concentration, ringing in ears and diarrhea which pt reported she had been ill since HPV vaccine on 09NOV2010. Labs were drawn (CBC, Comp. Metabolic panel w/ EGFR and monospot). Results were reported as normal. Physician stated he doubted nausea was HPV vaccine related. 02DEC2010 pt mom called physician office as pt was still experiencing symptoms of severe headache, nausea, vomiting. An MRI was performed on 03DEC2010 which was normal. On approx 10DEC2010 pt experience pharyngitis with sore throat and pain in ears and had strep screen in physician office on 13DEC2010 ( results not reported). Pt reported on 14DEC2010 that throat was still very sore. Physician considered the stomach cramps/pain, diarrhea, poor concentration, headache/cephalgia, insomnia, achy, fever ringing in ears and vomiting/emesis as disabling and pt has not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Streptococcus test, Tinnitus, Vomiting
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no drug allergies or medical history who on 09-NOV-2010 was vaccinated with the second dose of GARDASIL (lot # not reported), 0.5 ml, IM. It was not certain of date of first dose. There was no concomitant medication. On 09-NOV-2010 after vaccination, the patient experienced "all of the side effects listed in the prescribing information", nausea, headache, vomiting, stomach cramps, weak, dizzy and heart racing. Mother had placed call to physician. Mother also stated she was sick they ate at the same place and was not sure if they had food poisoning. The patient's events persisted. No lab diagnostics studies performed. Information has been received from a physician concerning an 18 year old female non smoker who on 07OCT2010 received a dose of GARDASIL (lot # 662529/1317Y) in her L deltoid. On 09NOV2010 the pt received a second dose of GARDASIL (lot #666163/0664Z) in L deltoid. 23NOV2010 pt reported to physician she experienced cephalgia, stomach pains dizziness, nausea, emesis, insomnia, fever, achy, poor concentration, ringing in ears and diarrhea which pt reported she had been ill since HPV vaccine on 09NOV2010. Labs were drawn (CBC, Comp. Metabolic panel w/ EGFR and monospot). Results were reported as normal. Physician stated he doubted nausea was HPV vaccine related. 02DEC2010 pt mom called physician office as pt was still experiencing symptoms of severe headache, nausea, vomiting. An MRI was performed on 03DEC2010 which was normal. On approx 10DEC2010 pt experience pharyngitis with sore throat and pain in ears and had strep screen in physician office on 13DEC2010 ( results not reported). Pt reported on 14DEC2010 that throat was still very sore. Physician considered the stomach cramps/pain, diarrhea, poor concentration, headache/cephalgia, insomnia, achy, fever ringing in ears and vomiting/emesis as disabling and pt has not recovered. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Convulsion
Clinical narrative: Information has been received from a consumer concerning her 6 year old grandson's cousin who on an unspecified date was vaccinated with a dose of MMR II (Lot# not reported).  The consumer stated that in the evening of the day the vaccine was given, her grandson's cousin "went in to convulsions" and was taken to the emergency department for evaluation.  Her grandson's cousin was diagnosed with a mild case of autism and on unspecified date, was receiving treatment for the autism.  At the time of the report the patient had not recovered.  Upon internal review, autism and autism were determined to be an other important medical event.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Computerised tomogram normal, Convulsion, Culture negative, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Fever of 101.8.  1 tsp of Ibuprofen administered.  10 minutes later child started having a seizure that lasted over 30 minutes.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Pyrexia
Clinical narrative: Fever of 101.8.  1 tsp of Ibuprofen administered.  10 minutes later child started having a seizure that lasted over 30 minutes.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Endotracheal intubation, Febrile convulsion, Status epilepticus
Clinical narrative: Fever of 101.8.  1 tsp of Ibuprofen administered.  10 minutes later child started having a seizure that lasted over 30 minutes.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Headache, Nausea, Vertigo, Vision blurred
Clinical narrative: VERTIGO, HEADACHE, NAUSEA, WEAKNESS, VISUAL DISTURBANCE (BLURRY DISTANCE.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Visual impairment
Clinical narrative: VERTIGO, HEADACHE, NAUSEA, WEAKNESS, VISUAL DISTURBANCE (BLURRY DISTANCE.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Pain
Clinical narrative: On 11/12/10 pt started having pain in her back, in the muscle between her shoulder blades.  The pain worsened and is described as "excruciating, almost incapacitating pain" which lasted for 2 weeks.  Pt. treated the pain with Advil, ice, and rest; no medical care sought.  Occasionally now notices a dull ache in the same region - very mild, almost imperceptible.  On 12/8/10 and 12/9/10, pt had soreness at the injection site.  (This is the first time she had soreness at the site since receiving the injection on 11/9/10.)
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Gait disturbance, Induration, Injection site pain
Clinical narrative: Pain in right shoulder began 10 days after vaccination (11/9/10) with small nodule up toward neck; pt's sister massaged knot and it resolved; R shoulder pain lasted x 3 weeks; then L shoulder pain x 1 week.  Then pain went to back and L hip - pt reports the back & hip pain as severe, "can hardly walk or sit down."  Reports fever in the 3rd week after vacciantion - intermittent fever, unknown measurement.  Beginning approx 12/8/10, pt states vision is cloudy, "like fog in the room."  Now with "hard knots, hard line on middle of L hand" on top toward middle finger; no pain.  Pt continues with severe back and left hip pain.   Has seen primary care physician regarding the pain; was advised to see chiropractor but she has not yet made that appointment.  Pt has been treating the pain with massage, heating pad, occasional Percocet (prescribed previously for other condition).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nodule, Pyrexia, Vision blurred
Clinical narrative: Pain in right shoulder began 10 days after vaccination (11/9/10) with small nodule up toward neck; pt's sister massaged knot and it resolved; R shoulder pain lasted x 3 weeks; then L shoulder pain x 1 week.  Then pain went to back and L hip - pt reports the back & hip pain as severe, "can hardly walk or sit down."  Reports fever in the 3rd week after vacciantion - intermittent fever, unknown measurement.  Beginning approx 12/8/10, pt states vision is cloudy, "like fog in the room."  Now with "hard knots, hard line on middle of L hand" on top toward middle finger; no pain.  Pt continues with severe back and left hip pain.   Has seen primary care physician regarding the pain; was advised to see chiropractor but she has not yet made that appointment.  Pt has been treating the pain with massage, heating pad, occasional Percocet (prescribed previously for other condition).
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Rash
Clinical narrative: I noticed rash at base of spine followed shortly by bouts of diarrhea that lasted 12 days. The rash spread all over my trunk, then down my thighs. I still have it although it is fading. Bouts of diarrhea got worse the second week but are intermittent now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema
Clinical narrative: Angioedema of nose and upper lip
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Onset of rash typical of primary varicella
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: C/O NAUSEA. VOMITED ONCE. REMAINED NAUSEATED THROUGH 12/25/2010 AND DID NOT FEEL BETTER UNTIL 12/26/2010 UPON WAKING IN THE A.M.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Confusional state, Feeling abnormal, Flushing, Malaise, Sensation of heaviness
Clinical narrative: Pt states around 2 pm her arms & legs felt very heavy had trouble walking to car. Then she felt mentally foggy. Facial flushing & confusion. Pt arrived at HD at 3:45 pm & referred to Emergency Dept for further eval.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Flank pain, Swollen tongue
Clinical narrative: Tongue swelling -> once ER eval x 3 flank pain.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Tinnitus, Visual impairment
Clinical narrative: Pt states on 12-24-10 at 7am she had intense ringing in her ears, and her hands & fingers were tingling, her vision was spotty. Episode did not last long.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting projectile
Clinical narrative: 12-20-10 Pt reports projectile vomiting, 1/2 hr after feeding - 3-4 x day.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Fear, Hallucination, visual, Nightmare
Clinical narrative: Nightmare that caused hallucinations when wakened up. Saw things that were not there and lasted 2 hours. Is now currently showing signs of fear that were not there before.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Sepsis
Clinical narrative: Cellulitis/sepsis required hospitalization.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, FLUX, RV1
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: MA inadvertently gave pt injection of adult flu dose with immunizations listed below. No tx necessary d/t no adverse event noted. Pt's mother notified of error & instructed to monitor & bring back into office.
Age: 1.61
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Seen 12/22, received PCV13 in left thigh. 12/23 redness, swelling near injection site.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: After receiving second HPV, later PT had a seizure.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Nausea, Pruritus, Swelling
Clinical narrative: Received shot on 12/10/10. The reaction occurred first day of vaccination. By evening, site was swollen, red, itchy and she had to use an ice pack. She saw physician Monday, 12/13/10 and he recommended IBU and diphenhydramine. As of now, area is still swollen and very hard 2 inch by 2 inch, and redness spread down 2 inch past elbow and up to under arm. Red area near elbow is also swollen and hard. There is also pain at red, swollen areas.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Lymphocyte count increased, Oedema peripheral, Pain in extremity
Clinical narrative: Received shot on 12/10/10. The reaction occurred first day of vaccination. By evening, site was swollen, red, itchy and she had to use an ice pack. She saw physician Monday, 12/13/10 and he recommended IBU and diphenhydramine. As of now, area is still swollen and very hard 2 inch by 2 inch, and redness spread down 2 inch past elbow and up to under arm. Red area near elbow is also swollen and hard. There is also pain at red, swollen areas.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Received shot on 12/10/10. The reaction occurred first day of vaccination. By evening, site was swollen, red, itchy and she had to use an ice pack. She saw physician Monday, 12/13/10 and he recommended IBU and diphenhydramine. As of now, area is still swollen and very hard 2 inch by 2 inch, and redness spread down 2 inch past elbow and up to under arm. Red area near elbow is also swollen and hard. There is also pain at red, swollen areas.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Computerised tomogram normal, Convulsion, Culture negative, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Febrile seizure requiring intubation for status epilepticus.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Pyrexia
Clinical narrative: Febrile seizure requiring intubation for status epilepticus.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Endotracheal intubation, Febrile convulsion, Status epilepticus
Clinical narrative: Febrile seizure requiring intubation for status epilepticus.