chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt complains of soreness in the left arm on Friday, Saturday & Sunday. Pt's arm is red & swollen (5/7/12) in store. No itching just soreness and redness.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female patient with no drug reactions/ allergies and no pertinent medical history, who on an unknown date was vaccinated with PNEUMOVAX 23 0.5mL, IM (lot number 672781/1706AA, exp. 03-OCT-2013). The pharmacist reported that on 20-MAR-2012 the patient developed redness and swelling in left upper arm around injection site after receiving PNEUMOVAX 23. The treatment was given for an AE: BENADRYL and TYLENOL. At the time of the report the patient's outcome was unknown. No laboratory diagnostic studies were performed. Follow up information has been received from pharmacist via B-form. The reporter stated that the patient experienced itching, pain and swelling on left upper arm. Patient was given cold pack. Patient later developed cellulitis, given BENADRYL and cefuroxime. It has been reported that the event resulted with prolonged hospitalization. The patient recovered on 22-MAR-2012. Illness at the time of vaccination has been reported: chest pain, RA, heart disease and hypothyroidism. There were not known adverse events following prior vaccination. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female patient with no drug reactions/ allergies and no pertinent medical history, who on an unknown date was vaccinated with PNEUMOVAX 23 0.5mL, IM (lot number 672781/1706AA, exp. 03-OCT-2013). The pharmacist reported that on 20-MAR-2012 the patient developed redness and swelling in left upper arm around injection site after receiving PNEUMOVAX 23. The treatment was given for an AE: BENADRYL and TYLENOL. At the time of the report the patient's outcome was unknown. No laboratory diagnostic studies were performed. Follow up information has been received from pharmacist via B-form. The reporter stated that the patient experienced itching, pain and swelling on left upper arm. Patient was given cold pack. Patient later developed cellulitis, given BENADRYL and cefuroxime. It has been reported that the event resulted with prolonged hospitalization. The patient recovered on 22-MAR-2012. Illness at the time of vaccination has been reported: chest pain, RA, heart disease and hypothyroidism. There were not known adverse events following prior vaccination. Additional information has been requested.
Age: 0.27
Sex: M
Vaccine: DTP
Symptoms: Abnormal behaviour, Asperger's disorder, Autism, Childhood disintegrative disorder, Cyanosis
Clinical narrative: Became lethargic. Developed fine rash over entire body, went totally limp, became cyanotic, stopped breathing. Immed personality change refused to nurse or be held. No longer eye contact, development reversals.
Age: 0.27
Sex: M
Vaccine: DTP
Symptoms: Decreased eye contact, Diet refusal, Hypotonia, Immediate post-injection reaction, Learning disorder
Clinical narrative: Became lethargic. Developed fine rash over entire body, went totally limp, became cyanotic, stopped breathing. Immed personality change refused to nurse or be held. No longer eye contact, development reversals.
Age: 0.27
Sex: M
Vaccine: DTP
Symptoms: Lethargy, Personality change, Rash generalised, Respiratory arrest, Screaming
Clinical narrative: Became lethargic. Developed fine rash over entire body, went totally limp, became cyanotic, stopped breathing. Immed personality change refused to nurse or be held. No longer eye contact, development reversals.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Rash pruritic
Clinical narrative: Left arm swelling, pain, and rash that was itchy.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Left arm swelling, pain, and rash that was itchy.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash erythematous, Swelling
Clinical narrative: Left arm swelling, pain, and rash that was itchy.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: Swelling on RD, 10.2 cm width, 9 cm length. Warm to the touch underneath site vaccine was given. Dtap was administered.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Discomfort, Emotional distress, Injection site rash, Irritability
Clinical narrative: Child was fussy through the night. Difficult to console. When being held, child could not seem to get comfortable. Mother reports she did not see rash or anything different during child's bath 5/7/12. Woke up this AM 5/8/12 with a rash on Lt thigh. Rash sl raised. Unknown if hot to touch, child was at daycare when mother called. Denies any known fever. Child does not seem to bother rash as if to scratch so mother does not feel rash is itchy.  States rash covers area where shot was give. Total rash area about the size of moms hand.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain, Swelling, White blood cell count increased
Clinical narrative: Developed redness, swelling and pain four hours after vaccine administered. Went to ER and was treated for allergic reaction and released.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Abdominal pain, Gallbladder disorder, Painful respiration
Clinical narrative: About 6 months after receiving the 3rd shot I began to experience severe, reoccurring abdominal pain to the point where it hurt to breathe if I stood up. It happened nearly 10 times within a year after vaccination. Pain would cease sometimes for 6 months then happen sometimes weekly for the next couple months. I was diagnosed with gallbladder disease in March of 2012 which I believe was caused by the Gardasil shot and I am scheduled for surgery to have my gallbladder removed next week.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cervix carcinoma
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old patient, who in approximately 2009 (at the age of 15) was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). It was reported that the patient has now (date unspecified) been diagnosed with cervical cancer with severe dysplasia. It was stated the nurse was wondering if the product had been handled properly in the office where it was given. Unspecified treatment was given for the patient's symptoms. At the time of the report, the patient's outcome was unknown. Upon internal review, cervical cancer was determined to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident, Confusional state, Dizziness, Dyskinesia, Heart rate increased
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 25 year old female with anaemia and a history of cardiac murmur as infant who on 05-MAY-2011 was vaccinated with the first dose of GARDASIL (lot # not report). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot # not report). On an unspecified date, the patient was vaccinated with the third dose of GARDASIL (lot # 668262/0841AA, expiration date 08-APR-2012). Concomitant therapy included birth control pills. The nurse practitioner reported that the patient stated "she experienced itchy legs after each GARDASIL vaccination. After the second dose, she had an increased heart rate and the itchy legs. Four and one half hours after the third dose of GARDASIL, she was dizzy, shaking, confused and her mouth was drawn to one side she thought she was having a stroke. She said that after each dose the severity of symptoms increased and the onset happened more quickly. She went to a hospital Emergency Room and she did not know if she was admitted." No treatment was given to the patient. No laboratory test was done. The nurse practitioner stated the patient was fine now but she did not ask her how long it took for her to recover from the symptoms. Upon internal review, stroke was determined to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 25 year old female with anaemia and a history of cardiac murmur as infant who on 05-MAY-2011 was vaccinated with the first dose of GARDASIL (lot # not report). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot # not report). On an unspecified date, the patient was vaccinated with the third dose of GARDASIL (lot # 668262/0841AA, expiration date 08-APR-2012). Concomitant therapy included birth control pills. The nurse practitioner reported that the patient stated "she experienced itchy legs after each GARDASIL vaccination. After the second dose, she had an increased heart rate and the itchy legs. Four and one half hours after the third dose of GARDASIL, she was dizzy, shaking, confused and her mouth was drawn to one side she thought she was having a stroke. She said that after each dose the severity of symptoms increased and the onset happened more quickly. She went to a hospital Emergency Room and she did not know if she was admitted." No treatment was given to the patient. No laboratory test was done. The nurse practitioner stated the patient was fine now but she did not ask her how long it took for her to recover from the symptoms. Upon internal review, stroke was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Headache, Loss of consciousness, Muscle twitching, Seizure like phenomena
Clinical narrative: Information has been received from a consumer concerning her approximately 18 year old daughter with penicillin allergy and no other pertinent medical history who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and route not reported). There was no concomitant medication. The mother reported that while on GARDASIL in 2010, her daughter experienced uncontrolled twitches and jerking of the body, excessive headaches, passing out and seizure like activity. The patient was admitted to the emergency room of an unspecified hospital on an unspecified date for an unspecified length of time (also reported as did not seek medical attention). At the time of the report the patient's uncontrolled twitches and jerking of the body, excessive headaches, passing out and seizure like activity persisted. Upon internal review seizure like activity was considered to be an other important medical event. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral disorder, Pain, Skin lesion
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 72 year old female patient with no drug reactions or allergies who on 11-OCT-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously (lot number not reported). On 01-NOV-2011, "3 weeks after receiving ZOSTAVAX (Merck)", the patient developed shingles. The patient initially developed lesions on her chest and back (unspecified if the lesions were on one side of the body or on both the right and left sides of the body). The patient was currently developing lesions in her mouth and nose. The patient described the lesions as being "painful". Unspecified medication was prescribed by patient's physician for the treatment of shingles. At the time of the report the patient's outcome was not recovered. No laboratory tests were performed. The patient sought medical attention, called pharmacist and visited physician. Follow-up information has been received from a doctor of pharmacy concerning a 75 year old female patient who on 11-OCT-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously (lot number not reported). It was unknown if a rash occur at the site of injection or elsewhere within 42 days of the vaccination. The patient developed shingles covering back about 1 month after receiving vaccine, in approximately November 2011, that spread to face and in mouth. The patient did not contact reporting pharmacist until March. At the time of the report the patient's outcome was unknown. No photo was taken. The patient sought medical attention. Shingles was considered by pharmacist to be disabling. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Enuresis, Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Red swollen, hard arm where vaccine was given and bedwetting at night and during the day for 3 days after receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Redness developed (R) arm 5/4 - blistered area 5/5.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Site became hot, hard, red, & gradually increased in size. Pharmacist said use BENADRYL which did not help. Went to Dr. on 4/30/2012 & ordered Clindamycin 300mg 4xday x10days.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Erythema and swelling of (L) delt area, streak (red) into axilla area. ? cellulitis or secondary hypersensitivity to PNEUMOVAX vaccine. Tx with ROCEPHIN 1 gm IM and KEFLEX PO. Immediate relief - no evidence of swelling by 5/7/12.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Arthralgia, C-reactive protein increased, Full blood count normal, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Polyarthralgias (shoulders, elbows, knees, hands) following administration of vaccines below. Elevated ESR and CRP, normal CBC & Rheumatoid factor. NSAID treatment resulted in symptom resolution.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site, temp of 102 degrees F, sweating, nausea and rigors day after vaccine administered.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Pain and swelling at injection site, temp of 102 degrees F, sweating, nausea and rigors day after vaccine administered.
Age: 60.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Diagnostic procedure, Dysphonia, Influenza like illness, Pyrexia, Retinal disorder
Clinical narrative: On 4-30-12 - patient in clinic to pick up rx. Noted past week had feeling of fever, c/o throat hoarseness, flu-like symptoms since taking vaccinations on 4-17-12. Noted at time s/s almost gone. However, planned see optometrist 5-3-12 d/t eye. See line to left eye. Noted abnormal sight of left eye.
Age: 60.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Visual impairment
Clinical narrative: On 4-30-12 - patient in clinic to pick up rx. Noted past week had feeling of fever, c/o throat hoarseness, flu-like symptoms since taking vaccinations on 4-17-12. Noted at time s/s almost gone. However, planned see optometrist 5-3-12 d/t eye. See line to left eye. Noted abnormal sight of left eye.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Asthenia, Chills, Drug eruption, Fatigue, Hyperhidrosis
Clinical narrative: FATIGUE, NAUSEA, VOMITING, RASH, WEAK, LOW GRADE FEVER, CHILLS, SWEATS. SEEN ON 05/07/12 BY DR. Skin: Diffuse maculo-papular erythematous almost purple in spots rash across arms trunk and legs. CLASSIC DRUG LIKE RASH. RX PREDNISONE AND BENADRYL.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Nausea, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: FATIGUE, NAUSEA, VOMITING, RASH, WEAK, LOW GRADE FEVER, CHILLS, SWEATS. SEEN ON 05/07/12 BY DR. Skin: Diffuse maculo-papular erythematous almost purple in spots rash across arms trunk and legs. CLASSIC DRUG LIKE RASH. RX PREDNISONE AND BENADRYL.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: FATIGUE, NAUSEA, VOMITING, RASH, WEAK, LOW GRADE FEVER, CHILLS, SWEATS. SEEN ON 05/07/12 BY DR. Skin: Diffuse maculo-papular erythematous almost purple in spots rash across arms trunk and legs. CLASSIC DRUG LIKE RASH. RX PREDNISONE AND BENADRYL.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Child was diagnosed with intussusception, hospitalized for 1 night in hospital.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast normal, Capillary nail refill test abnormal, Crying
Clinical narrative: Child was diagnosed with intussusception, hospitalized for 1 night in hospital.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Monocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: Child was diagnosed with intussusception, hospitalized for 1 night in hospital.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Occult blood positive, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray abnormal
Clinical narrative: Child was diagnosed with intussusception, hospitalized for 1 night in hospital.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling with erythema at vaccine site.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Within 2 days after immunization pt had confluent rash medial arms bilaterally and lateral trunk and upper thighs bilaterally also feverish.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash, Rash vesicular
Clinical narrative: Developed vesicular rash on legs. Rash has spread along legs & on arms and on face. Patient afebrile & does not appear ill.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Tenderness
Clinical narrative: Pt. c/o pain/itching/ swelling at injection site beginning 2 days after vaccines given. Exam today (5/4/2012) arm still tender and 2" area at injection site is swollen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: Full blown shingles requiring acyclovir, blood work.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Tenderness, Varicella virus test positive
Clinical narrative: Quarter sized fluid filled, tender blister 4 days after vaccine given.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness to (L) arm (7cm).
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Induration, Rash erythematous, Skin warm
Clinical narrative: Pt w/ hard, red bump warm to the touch. BENADRYL, MOTRIN, cool compresses.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Skin burning sensation, Skin lesion
Clinical narrative: Patient came back to pharmacy 1 week and 1 day after receiving ZOSTAVAX. She showed me one small lesion on her forehead that was red and burning. She stated that the area around injection and all around upper arm was itching and burning one to two days after injection. She also had a lesion on each shoulder blade but they are going away.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. presented 3 days after vaccine given with a 3 x 3" raised red area on (R) upper arm.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Body temperature increased, Febrile convulsion, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: On 5/4/12, patient received PCV 13 & Hep A on 5/5/12 patient developed 104 degree F temp and had a febrile seizure, seen in ER then. On 5/7/12 patient seen back in office with persistent fever Dx with Strep pharyngitis.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 12 x 14 red rash (Lt) deltoid - treatment ATARAX 10/5ml 10 ml PO Q6hrs. Warm compresses.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Evening of immunization, child went to mother & stated "arm hurts." Mother noted redness, swelling, & warm to touch (R) upper arm. No fever, no change in behavior all day long. Good appetite. Mother did nothing. Reported to Public Health today (2 dys. later) Minimal swelling, pink in color, still with warmth. No fever. Behavior normal. Enc. to place cool cloth (R) upper arm 2-3 times a day until better. Return if symptoms don't subside.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Large local reaction - red, slightly raised approx 4x6 inches, pain.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Eye swelling, Fatigue, Lip swelling, Oedema peripheral
Clinical narrative: Fever, chills, fatigue swelling in hands and feet at 24 hours. Followed by facial swelling (eyes/lip, blisters in mouth   took Advil only.  Lasted about 2 days.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Oral mucosal blistering, Pyrexia, Swelling face
Clinical narrative: Fever, chills, fatigue swelling in hands and feet at 24 hours. Followed by facial swelling (eyes/lip, blisters in mouth   took Advil only.  Lasted about 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 2 vaccines in (L) leg on 5/4/12. Mom calls & comes in on 5/7/12; child c/o it hurts. Red & warm to touch with some swelling & itching. Temp - 98.0.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Morphoea
Clinical narrative: White Spot Syndrome MENDS
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chorioretinitis, Eye pain, Headache, Maculopathy, Metamorphopsia
Clinical narrative: White Spot Syndrome MENDS
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Ophthalmological examination abnormal, Vision blurred, Visual acuity reduced, Visual field defect, Visual impairment
Clinical narrative: White Spot Syndrome MENDS
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: After recieving all three doses of Gardasil vaccine, had first ever Abnormal Pap.  All prior Pap's were normal.  Patient had no sexual contact over course of vaccines.
Age: 1.36
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Patient developed a 2.5 cm wheal immediately adjacent to subcutaneous injection site of MMR on right anterolateral thigh.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Pt had rash come up on both lower arms and pain that "felt like it went to bones" lasted for a few days.
Age: 15.0
Sex: F
Vaccine: FLU3, HPVX, MNQ, TDAP
Symptoms: Abdominal pain lower, Abdominal pain upper, Back pain, Convulsion, Cystitis
Clinical narrative: She started have long menstral cycles after the 1st shot like 3 weeks at a time. After the 2nd shot 7/14/2011. She begin have migranes about 2 weeks after the shot. Then in Sept. she begin having seizures. After the 3rd shot she now have fainting spells, lower abdominal pain, stomach pain, back pain, she now have UTI/bladder infection/yeast infection all the time. And also diarrhea.
Age: 15.0
Sex: F
Vaccine: FLU3, HPVX, MNQ, TDAP
Symptoms: Diarrhoea, Echocardiogram normal, Electrocardiogram normal, Fungal infection, Migraine
Clinical narrative: She started have long menstral cycles after the 1st shot like 3 weeks at a time. After the 2nd shot 7/14/2011. She begin have migranes about 2 weeks after the shot. Then in Sept. she begin having seizures. After the 3rd shot she now have fainting spells, lower abdominal pain, stomach pain, back pain, she now have UTI/bladder infection/yeast infection all the time. And also diarrhea.
Age: 15.0
Sex: F
Vaccine: FLU3, HPVX, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Oligomenorrhoea, Smear cervix abnormal, Syncope, Ultrasound scan normal
Clinical narrative: She started have long menstral cycles after the 1st shot like 3 weeks at a time. After the 2nd shot 7/14/2011. She begin have migranes about 2 weeks after the shot. Then in Sept. she begin having seizures. After the 3rd shot she now have fainting spells, lower abdominal pain, stomach pain, back pain, she now have UTI/bladder infection/yeast infection all the time. And also diarrhea.
Age: 15.0
Sex: F
Vaccine: FLU3, HPVX, MNQ, TDAP
Symptoms: Urinary tract infection
Clinical narrative: She started have long menstral cycles after the 1st shot like 3 weeks at a time. After the 2nd shot 7/14/2011. She begin have migranes about 2 weeks after the shot. Then in Sept. she begin having seizures. After the 3rd shot she now have fainting spells, lower abdominal pain, stomach pain, back pain, she now have UTI/bladder infection/yeast infection all the time. And also diarrhea.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Abnormal dreams, Differential white blood cell count normal, Electrocardiogram normal, Fatigue, Flushing
Clinical narrative: Patient's eyes rolled back and he appeared pale. Once he was positioned supine on the exam table, his arms stiffened and had tonic-clonic movements of both lower extremities and his face became flush. The episode lasted less than 1 minute. When he returned to consciousness, he said he was really tired and he "a really crazy dream." He was able to orient himself to person, place, time, and reason why he was there.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Full blood count normal, Gaze palsy, Loss of consciousness, Metabolic function test normal, Musculoskeletal stiffness
Clinical narrative: Patient's eyes rolled back and he appeared pale. Once he was positioned supine on the exam table, his arms stiffened and had tonic-clonic movements of both lower extremities and his face became flush. The episode lasted less than 1 minute. When he returned to consciousness, he said he was really tired and he "a really crazy dream." He was able to orient himself to person, place, time, and reason why he was there.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Pallor, Tonic clonic movements
Clinical narrative: Patient's eyes rolled back and he appeared pale. Once he was positioned supine on the exam table, his arms stiffened and had tonic-clonic movements of both lower extremities and his face became flush. The episode lasted less than 1 minute. When he returned to consciousness, he said he was really tired and he "a really crazy dream." He was able to orient himself to person, place, time, and reason why he was there.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Headache, Influenza virus test negative
Clinical narrative: Fever 102, chills, headaches, dizziness, body aches, weakness generalized.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 102, chills, headaches, dizziness, body aches, weakness generalized.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Injection site pain, Oedema peripheral, Ultrasound scan
Clinical narrative: Pt presented to clinic 5-7-12 painful swelling under (L) arm. She was given Tdap on Wed, had painful arm at site of injection by Sat. Then swollen mass (L) axillary region.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Arthropathy, Headache, Injected limb mobility decreased, Injection site nodule, Muscular weakness
Clinical narrative: Knot at injection site lasting over a month. Both upper arms sore for over a week. Knees weak and joints loose. Fever & headache (lasting approx a week). Could not lift injection site arm comfortably for a week.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Knot at injection site lasting over a month. Both upper arms sore for over a week. Knees weak and joints loose. Fever & headache (lasting approx a week). Could not lift injection site arm comfortably for a week.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Arthropathy, Asthenia, Headache, Injected limb mobility decreased, Injection site nodule
Clinical narrative: Knot at injection site lasting over a month. Both upper arms sore for over a week. Knees weak and joints loose. Fever & headache (lasting approx a week). Could not lift injection site arm comfortably for a week.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Knot at injection site lasting over a month. Both upper arms sore for over a week. Knees weak and joints loose. Fever & headache (lasting approx a week). Could not lift injection site arm comfortably for a week.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Musculoskeletal discomfort, Pallor, Skin tightness, Somnolence
Clinical narrative: Initial report received from a consumer on 27 June 2011. A 64-year-old female patient, with a history of arthritis, received dose 3 intramuscular injection of IMOVAX, sanofi pasteur lot number not reported, on 13 June 2011 for post exposure series. She took no concomitant medications. The patient had no illness at the time of vaccination and no other adverse event following prior vaccination. On 14 June 2011, the patient complained of fatigue, becoming drowsy during the day, moving more slowly, skin under eyes becoming drawn, and skin was pale. The symptoms have become more exaggerated with each dose. The patient was also having joint discomfort. The outcome was reported as not recovered. Follow-up information was received n 08 August 2011 from a health care professional. According to the reporter, dose three of IMOVAX was not administered by her and therefore they had no records of the lot number or the injection site. The patient did receive subsequent doses of IMOVAX including: dose four lot number E0236 given intramuscularly in the left buttock on 16 June 2011, dose five lot number E1031 in the right buttock on 20 June 2011 and dose six lot number E1031 given in the left buttock on 20 June 2011. It was not reported if the patient had recovered after dose three and prior to subsequent doses. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 06 September 2011. The patient did not recover prior to the administration of subsequent doses of IMOVAX. The patient still received the vaccine on 28 June 2-11. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 23 September 2011. The patient received dose 3 intramuscular right buttocks injection of IMOVAX, lot number E1031. The patient received dose five lot number E1031 in the left buttock (previously reported as right). No additional information at this time. The outcome was reported as recovered in August 2011. Documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Disturbance in attention, Nausea, Pain, Skin warm, Swelling
Clinical narrative: Significant swelling, extreme heat on skin, pain, mild nausea, inability to stay focused or pay attention.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient swooned to the floor, mom screamed, pt alert and oriented. Vitals stable BP 108/64 Pulse 58 oxygen 99%.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Fall, Lethargy, Swelling, Syncope, Unresponsive to stimuli
Clinical narrative: Almost immediately after receiving the HPV vaccine, my daughter fainted as she was walking.  She was unresponsive and lethargic.  She has a bump on her head from falling into the door.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat at injection site. No course of treatment.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Personality change
Clinical narrative: He totally turned into a diff child went from normal to autistic in a matter of 2 days after this shot was administered.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging, Strabismus
Clinical narrative: Pt given immunization 2/20/12. Called office 3/9/12 stating she noticed the day before (3/8/12) pt's eye was cross-eyed & getting worse. Referred to ER. Sent pt to another ER.
Age: 1.4
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: Patches of bumps - on right bottom side - cheeks on face - also on arms and shoulder.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 67 year old mother who on an unknown date was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL, IM in her rotator cuff (lot number not reported). It was reported that patient could not move her arm. There was no treatment given. The patient sought medical attention by an office visit. The patient's condition did not improve and the patient's status was not recovered. Cannot move her arm was considered to be disabling. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching around area of injection. Area is about 2.5 inch long and 1 inch wide. Reaction started 1 week after injection.
Age: 0.5
Sex: F
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Blood test, Enema administration, Haematemesis, Haematochezia, Intussusception
Clinical narrative: Information has been received from an investigator concerning a 6 month old female with gastrooesophageal reflux (November 2011) who entered a study. On 28-DEC-2011, consent was obtained and was randomized to be vaccinated with DTaP+IPV+HepB+Hib at 2 months, 4 months and 6 months of age. On 28-DEC-2011, 28-FEB-2012 and 24-APR-2012, the subject was vaccinated IM with the first, second and third 0.5 ml doses, respectively, of DTaP+IPV+HepB+Hib (injection site not reported). Other study vaccines included on 28-DEC-2011, 28-FEB-2012 and 24-APR-2012 the first, second and third doses of the following ROTATEQ 2ml po and PREVNAR 13 0.5ml IM (injection site not reported) to complete childhood vaccination series. Previous therapy history included HepB 0.5 ml IM on 26-OCT-2011. On 29-APR-2012, the subject experienced intussusception (intensity severe) and was hospitalized on 30-APR-2012. On 27-APR-2012 (Friday), day 3 post vaccination (as reported), the subject's parents called with symptoms of light blood in stool. Parents were informed to watch if more blood shows up then to go to the clinic. On 29-APR-2012 (Sunday), day 6 (as reported), more was noticed. The subject was brought to the clinic. The subject was sent to the ER for blood work (no further information provided) and was then sent home. On 30-APR-2012, day 7, subject presented to the clinic for vomiting blood. Subject was sent to the hospital. An ultrasound was done and showed intussusception. An air enema was done to correct the intussusception and was successful. The subject was "held" overnight for observation until 01-MAY-2012. On 01-MAY-2012, the subject was doing well and was released. At the time of reporting the subject was recovering from the intussusception. There was no action taken with study vaccine therapy. The investigator considered the third dose (24-APR-2012) of ROTATEQ was related to intussusception. The investigator reported that "given past known association of intussusception with an earlier generation rotavirus vaccine, the possibility that the ROTATEQ is the cause must be considered even though large scale studies showed a decreased risk over general population of developing such a bowel obstruction." The investigator considered DTaP+IPV+HepB+Hib and PREVNAR 13 as not related to intussusception. Intussusception was considered to be an other important medical event by the investigator. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Information has been received from an investigator concerning a 6 month old female with gastrooesophageal reflux (November 2011) who entered a study. On 28-DEC-2011, consent was obtained and was randomized to be vaccinated with DTaP+IPV+HepB+Hib at 2 months, 4 months and 6 months of age. On 28-DEC-2011, 28-FEB-2012 and 24-APR-2012, the subject was vaccinated IM with the first, second and third 0.5 ml doses, respectively, of DTaP+IPV+HepB+Hib (injection site not reported). Other study vaccines included on 28-DEC-2011, 28-FEB-2012 and 24-APR-2012 the first, second and third doses of the following ROTATEQ 2ml po and PREVNAR 13 0.5ml IM (injection site not reported) to complete childhood vaccination series. Previous therapy history included HepB 0.5 ml IM on 26-OCT-2011. On 29-APR-2012, the subject experienced intussusception (intensity severe) and was hospitalized on 30-APR-2012. On 27-APR-2012 (Friday), day 3 post vaccination (as reported), the subject's parents called with symptoms of light blood in stool. Parents were informed to watch if more blood shows up then to go to the clinic. On 29-APR-2012 (Sunday), day 6 (as reported), more was noticed. The subject was brought to the clinic. The subject was sent to the ER for blood work (no further information provided) and was then sent home. On 30-APR-2012, day 7, subject presented to the clinic for vomiting blood. Subject was sent to the hospital. An ultrasound was done and showed intussusception. An air enema was done to correct the intussusception and was successful. The subject was "held" overnight for observation until 01-MAY-2012. On 01-MAY-2012, the subject was doing well and was released. At the time of reporting the subject was recovering from the intussusception. There was no action taken with study vaccine therapy. The investigator considered the third dose (24-APR-2012) of ROTATEQ was related to intussusception. The investigator reported that "given past known association of intussusception with an earlier generation rotavirus vaccine, the possibility that the ROTATEQ is the cause must be considered even though large scale studies showed a decreased risk over general population of developing such a bowel obstruction." The investigator considered DTaP+IPV+HepB+Hib and PREVNAR 13 as not related to intussusception. Intussusception was considered to be an other important medical event by the investigator. Additional information has been requested.
Age: 1.63
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Injection site erythema, Injection site induration
Clinical narrative: 4/26 (L) thigh red and swollen, Temp 102 (Ax). 4/27 OV (L) thigh redness/swelling, temp 103.5. 4/30 OV no temp, energy & appetite returned, modest amt induration to (L) thigh, no erythema or warmth.
Age: 1.63
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC
Symptoms: Injection site swelling
Clinical narrative: 4/26 (L) thigh red and swollen, Temp 102 (Ax). 4/27 OV (L) thigh redness/swelling, temp 103.5. 4/30 OV no temp, energy & appetite returned, modest amt induration to (L) thigh, no erythema or warmth.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site swelling, Pyrexia, Swelling
Clinical narrative: Swollen injection site, low grade fever, redness, increased swelling and blisters.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Allergic respiratory symptom, Allergy test negative, Asthenia, Asthma, Blood immunoglobulin G
Clinical narrative: May 2010-Allergy-type symptoms in patient with no allergies, weak, sneezing.  No history of same; have been in the area for 20+ years.  Followed by severe coughing and wheezing. July 2010- Treated for upper respiratory but unsuccessful using 3 different antibiotics/breathing treatments.  Hospitalized with pulse/ox of 89. Diagnosed with asthma in November 2010. May 2012 - dependent on daily asthma meds, condition is permanent.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Laboratory test, Pulmonary function test, Sneezing, Upper respiratory tract infection
Clinical narrative: May 2010-Allergy-type symptoms in patient with no allergies, weak, sneezing.  No history of same; have been in the area for 20+ years.  Followed by severe coughing and wheezing. July 2010- Treated for upper respiratory but unsuccessful using 3 different antibiotics/breathing treatments.  Hospitalized with pulse/ox of 89. Diagnosed with asthma in November 2010. May 2012 - dependent on daily asthma meds, condition is permanent.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Wheezing
Clinical narrative: May 2010-Allergy-type symptoms in patient with no allergies, weak, sneezing.  No history of same; have been in the area for 20+ years.  Followed by severe coughing and wheezing. July 2010- Treated for upper respiratory but unsuccessful using 3 different antibiotics/breathing treatments.  Hospitalized with pulse/ox of 89. Diagnosed with asthma in November 2010. May 2012 - dependent on daily asthma meds, condition is permanent.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Swelling
Clinical narrative: Swelling/cellulitis.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Feeling hot, Local reaction
Clinical narrative: Heat, redness - local reaction; symptoms are resolving spontaneously.
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site urticaria, Irritability, Respiration abnormal, Urticaria
Clinical narrative: Vaccines given 05-1-12 at 4:30pm, by 10:00pm she had large & small whelps all over legs starting at injection site & on her butt. BENADRYL given whelps gone 30 mins. On 5-2-12 with worsen whelps BENADRYL give and taken to Dr. At 12pm whelps spread to face & arms baby very fussy and heavy raspy breathing child taken to ER. BENADRYL at 7pm prednisone started.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Pt. reports redness & swelling approximately 4 cm in diameter. Red area was warm to touch. Pt. also reports itching.
Age: 11.0
Sex: U
Vaccine: MMR, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever after received 3 vaccinations from 5/3/12. Fever 101-102 F.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg and right leg at site of injection on upper thigh was red, swollen and warm to touch about the size of a fifty cent piece.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Chest X-ray, Lethargy, Listless, Metabolic function test
Clinical narrative: Vomiting copious mucousy green fluid. Extreme lethargy. Pale and listless.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pallor, Vomiting
Clinical narrative: Vomiting copious mucousy green fluid. Extreme lethargy. Pale and listless.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Culture throat, Laboratory test normal, Rash, Rash pruritic, Streptococcus test
Clinical narrative: Pruritic rash on arms. Rash not on trunk. Rash developed within 2 hours of receiving vaccines. Pt given 7.5 ml of of diphenhydramine in office.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Culture throat negative, Rash, Rash pruritic, Streptococcus test
Clinical narrative: Pruritic rash on arms. Rash not on trunk. Rash developed within 2 hours of receiving vaccines. Pt given 7.5 ml of of diphenhydramine in office.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm- reddened 5" x 5" redness and swollen at (R) upper thigh IM. Cephalexin 250/5cc 7 ml tid x 10days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Local reaction to DTaP warm redness. Treatment cool compresses, Ibuprofen and BENADRYL.
Age: 59.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Erythema, Pallor, Serum sickness
Clinical narrative: Initial case received from healthcare professional on 04 February 2012. A 59-year-old male patient, who weighed 92 kilograms, received an infiltration of 2 puncture wounds on his hand and the remainder of the 1858 units in an intramuscular injection (site not reported) of Imogam Rabies-H7, sanofi pasteur SA, (lot number not reported, on 30 January 2012 (also reported as 20 January 2012). The patient also received an intramuscular injection (site not reported) of IMOVAX Rabies, sanofi pasteur SA, (lot number not reported, on 30 January 2012 (also reported as January 2012). On 30 January 2012, the patient was reaching under his truck to pick up garbage and a raccoon came out and bit him on the hand. The patient was given vaccines as post exposure immunizations. The patient's medical history was not reported. The patient took no concomitant medications and had no illnesses at the time of vaccination. The patient had no known allergies. The patient returned to the Emergency Room (ER) reported as on 04 August 2012 (1 day late for dose 2); and reported that on the night of vaccines, he had red blanching in both hands and also had diffuse joint pain. The physician reported it looked like serum sickness. The outcome was reported as not recovered. Documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Initial report received from a consumer on 27 September 2011. A 61-year-old male patient with no reported medical history had received a dose of IMOVAX (lot number unknown) on 23 September 2011, and 3 days later, on 26 September 2011, she received a dose of RABAVERT (manufacturer Novartis, lot number unknown). Following the RABAVERT vaccination the patient experienced chest pressure and throat tightness that was continued at the time of this report. The patient did not receive medical evaluation. No indication for the vaccinations were provided. The patient has not recovered. The reporter declined to give further information; and no other contact information was provided. No further information is expected. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chest discomfort, Oropharyngeal pain, Throat tightness, Wrong drug administered
Clinical narrative: Initial report received from a consumer on 27 September 2011. A 61-year-old male patient with no reported medical history had received a dose of IMOVAX (lot number unknown) on 23 September 2011, and 3 days later, on 26 September 2011, she received a dose of RABAVERT (manufacturer Novartis, lot number unknown). Following the RABAVERT vaccination the patient experienced chest pressure and throat tightness that was continued at the time of this report. The patient did not receive medical evaluation. No indication for the vaccinations were provided. The patient has not recovered. The reporter declined to give further information; and no other contact information was provided. No further information is expected. Documents held by sender: None.
Sex: U
Vaccine: RAB
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: Initial case received from a health care professional on 24 March 2011. It involves a cluster of 3 patients who "did not convert" after receiving three doses of IMOVAX. Three patients received 3 pre-exposure doses of IMOVAX (lot number not reported), intramuscularly into the deltoid. After 45 days they had titers drawn, and "they did not convert"; per the reporter, REFIT results were less than 0.1IU/mL. No adverse events were reported. The patients were scheduled to receive a fourth dose of IMOVAX, and a titer was to be re-drawn. No additional information was reported.