chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: YF
Symptoms: Headache, Myalgia, Sinusitis
Clinical narrative: cluster headaches on left side of head since 1991, joints and muscle pain, balance problems. Dry mouth, ear and sinus infection, lower back pain etc.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Increasing redness, heat, swelling approx 8cm in circumfrence at injection site R deltoid from Tdap given 5/15/07.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left deltoid site became reddened, swollen and indurated, resolved completely
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Rash
Clinical narrative: Patient called to report that he developed pain in right buttocks on 05/20/2007, two days after receiving Zostavax.  He reports a rash developed on right buttocks three days after the pain.  The patient saw Dr. on 05/24/2007 and was diagnosed with Shingles and placed on Famvir 500mg three times a day and Lortab 5 mg every 4 to 6 hours as needed for pain.  The patient also reports pain radiates down entire right leg.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain
Clinical narrative: Patient called to report that he developed pain in right buttocks on 05/20/2007, two days after receiving Zostavax.  He reports a rash developed on right buttocks three days after the pain.  The patient saw Dr. on 05/24/2007 and was diagnosed with Shingles and placed on Famvir 500mg three times a day and Lortab 5 mg every 4 to 6 hours as needed for pain.  The patient also reports pain radiates down entire right leg.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMRV, TD
Symptoms: Cough, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose, cough, headache and fever of 100.7
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received IPV #4 and MMR-VZV#2 in right arm on 5/23/07.  Patient developed right arm swelling, redness, warmth, and pruritus 24 hours after vaccines. Patient also received DTaP #5 in left arm.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Injection site bruising, Injection site pain, Local reaction
Clinical narrative: I AM AN OPERATING ROOM NURSE.IT HAS BEEN 10 YEARS SINCE MY LAST TETANUS SHOT. I WENT TO EMPLOYEE HEALTH ON 5/15/07 TO BE RE-VACCINATED. BY 5/18 MY UPPER ARM WAS STILL SORE AND HAD A 4 INCH DIAMETER BRUISE. ON 5/23/07 I SHOWED IT TO SOME ANESTHESIOLOGISTS I WORK WITH AND THEY SAID I HAD A LOCALOZED REACTION TO THE SYRUM AND SHOULD REPORT IT TO FDA.VACCINE PRODUCED BY ADVENTIS PASTEUR INC.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Student fainted and lost consciousness for about 15 seconds at 11:00AM.  Vital signs were stable before and after the episode of syncope.  Student stated that she had not eaten anything that morning.  She told the nurse before receiving the vaccine that she had not had any reaction with the first dose of HPV vaccine.  After the syncope, she told the nurse that she had fainted with the first dose of HPV but she thought it was because she also had a large amount of blood drawn for tests at that same visit.  Student rested at the health center for a short time and then returned to her dorm room to get ready for the convocation for graduation.  She was informed about reaction symptoms and was instructed to return to the health center if she devloped any of these symptoms.  She was instructed to contact her doctor at home next week after graduation.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV, PNC
Symptoms: Body temperature increased, Peripheral coldness, Tremor
Clinical narrative: Patient was seen in the office for Vaccine administration on 5/21/07. He received 6 vaccines: Dtap, IPV, and Hep A were injected in the  left anterolateral and upper thigh. Prevnar, Hep A and Proquad were given in the right anterolateral and upper thigh. Father presented with the patient in the office today and states he was notified by patients babysitter today that the patient was having difficulty holding his bottle, that his hands would become very cold then 10-15 minutes later warm again and that the patients fingers had become "twisted" earlier and that the patient shook at one point today. Mom then came into the office and when asked if she had given Tylenol or Motrin prophylacticly on the day of the injections as she had been instructed by the nurse, she said no and today was the first treatment of Childrens Motrin since the vaccination date. She had given him 1.8ml at 7:30am today. There was no redness, swelling or erythema at any of the injection sites upon assessment today. Patients temperature in the office today was 102.8. Mother was advised to take patient to urgent care for proper evaluation.
Age: 38.0
Sex: F
Vaccine: DT
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt's arm started to get red less than 24-hours after given the vaccine - Tuesday late AM. Pt reports very sore to the touch, painful to lift arm.  Redness originally from top of shoulder to 10 inches down.  Pt used ice on arm and this was hardly noticed.  Pt in for visit today at clinic and the redness is reduced to 5.5 inches long by 6.5 inches wide.  The area is red, warm, no exudates, no wound.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash appeared on torso, arms, legs @18 hours after recieving vaccine.   Patient's mother denied possibility of insect bites.   Child was afebrile and in otherwise good health.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, PPV, TD
Symptoms: Abnormal behaviour, Crying, Diarrhoea, Diet refusal, Irritability
Clinical narrative: Pt had his 4 month vac (DTaP-HBV-POL and HIBPRP-OMP and PNUcn)) at approx.12pm. At approx. 3:20 pm he started a fever (102 degrees), diarrhea(from approx 3:30pm to 10pm he had 5-6 extremely runny, bright green bowel movements),there was an abundance of mucus in his nose, he was fussy and he had a on his chest, back, shoulders and upper arms. He was fussy, cranky and cried for extrememly long periords of time. Nothing conforted him, not even me nursing him because he did not want to eat and did not want me to touch his stomach.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, PPV, TD
Symptoms: Pyrexia, Rhinorrhoea, Wrong drug administered
Clinical narrative: Pt had his 4 month vac (DTaP-HBV-POL and HIBPRP-OMP and PNUcn)) at approx.12pm. At approx. 3:20 pm he started a fever (102 degrees), diarrhea(from approx 3:30pm to 10pm he had 5-6 extremely runny, bright green bowel movements),there was an abundance of mucus in his nose, he was fussy and he had a on his chest, back, shoulders and upper arms. He was fussy, cranky and cried for extrememly long periords of time. Nothing conforted him, not even me nursing him because he did not want to eat and did not want me to touch his stomach.
Age: 48.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: On 5/20/07, client stated urticaria on her left upper arm and neck area with itchiness two days after vaccinations were given.  No facial swelling, dyspnea, dysphasia noted.  Advised to report to E.R. if symptoms get worsened.  On 5/25/07, stated urticaria disappeared but rashes with pruritis noted on chest and left upper arm areas.  Advised client for M.D. visit.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dyspnoea, Flushing, Food allergy, Laboratory test, Seasonal allergy
Clinical narrative: About 1 hour and 15 minutes prior to receiving Menatra and Gardasil vaccinations in our office, the patient felt acute onset of throat tightness, throat burning, flushed face and trouble breathing. 05/30/07-records received-5/27/07-trouble breathing. shortness of breath. flushed face. lips slightly swollen. DC: anaphylactic reaction most likely to either Gardasil or Menactra This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician, his office manager and an allergist via medical records concerning an 18 year old (previously reported as 17 year old) female with no known drug allergies and a history of nasal congestion and sneezing after exposure to cut grass who on 25-MAY-2007 was vaccinated IM with the first 0.5mL dose of GARDASIL (lot #657737/0522U) and concomitant suspect therapy MENACTRA (lot #U2278AA). Additionally, information has been received through the Freedom of Information Act pertaining to this case. It was reported that the patient left the physician's office feeling fine after the vaccinations, and subsequently, returned home. The patient ate a turkey sandwich and a kiwi, and "I hour after receiving the vaccine", the patient experienced an acute onset of throat tightness, throat burning, flushed face and trouble breathing. The patient returned to the physician's office with throat tightness, throat burning, flushed face, shortness of breath and lips were slightly swollen. The patient was diagnosed with an anaphylactic reaction and was treated with one EPI-PEN injection, prednisone, 60 mg and BENADRYL, 50 mg. The patient's breathing returned to normal, and subsequently, the patient recovered from the anaphylactic reaction. On 18-JUN-2007, the patient was seen by an allergist who reported that percutaneous skin testing was performed on the patient and revealed positive reactions to kiwi and grass pollen. The patient was diagnosed with a kiwi allergy and grass pollen allergy with seasonal allergic rhinitis. ImmunoCap allergy testing to kiwi, other fruits, pollens and Latex was also performed on the patient (results pending). The patient was instructed on the proper technique and indications for EPI-PEN use and follow-up was pending laboratory results. The reporting physician considered the anaphylactic reaction to be a disabling immediately life-threatening and medically significant event and felt it was most likely related to either therapy with GARDASIL or MENACTRA, although, the allergist felt that the "vaccines were not likely the cause of her reaction" and recommended that an attempt to proceed with the GARDASIL series "can be done in a closely monitored and equipped setting." A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Skin test positive, Throat irritation, Throat tightness
Clinical narrative: About 1 hour and 15 minutes prior to receiving Menatra and Gardasil vaccinations in our office, the patient felt acute onset of throat tightness, throat burning, flushed face and trouble breathing. 05/30/07-records received-5/27/07-trouble breathing. shortness of breath. flushed face. lips slightly swollen. DC: anaphylactic reaction most likely to either Gardasil or Menactra This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician, his office manager and an allergist via medical records concerning an 18 year old (previously reported as 17 year old) female with no known drug allergies and a history of nasal congestion and sneezing after exposure to cut grass who on 25-MAY-2007 was vaccinated IM with the first 0.5mL dose of GARDASIL (lot #657737/0522U) and concomitant suspect therapy MENACTRA (lot #U2278AA). Additionally, information has been received through the Freedom of Information Act pertaining to this case. It was reported that the patient left the physician's office feeling fine after the vaccinations, and subsequently, returned home. The patient ate a turkey sandwich and a kiwi, and "I hour after receiving the vaccine", the patient experienced an acute onset of throat tightness, throat burning, flushed face and trouble breathing. The patient returned to the physician's office with throat tightness, throat burning, flushed face, shortness of breath and lips were slightly swollen. The patient was diagnosed with an anaphylactic reaction and was treated with one EPI-PEN injection, prednisone, 60 mg and BENADRYL, 50 mg. The patient's breathing returned to normal, and subsequently, the patient recovered from the anaphylactic reaction. On 18-JUN-2007, the patient was seen by an allergist who reported that percutaneous skin testing was performed on the patient and revealed positive reactions to kiwi and grass pollen. The patient was diagnosed with a kiwi allergy and grass pollen allergy with seasonal allergic rhinitis. ImmunoCap allergy testing to kiwi, other fruits, pollens and Latex was also performed on the patient (results pending). The patient was instructed on the proper technique and indications for EPI-PEN use and follow-up was pending laboratory results. The reporting physician considered the anaphylactic reaction to be a disabling immediately life-threatening and medically significant event and felt it was most likely related to either therapy with GARDASIL or MENACTRA, although, the allergist felt that the "vaccines were not likely the cause of her reaction" and recommended that an attempt to proceed with the GARDASIL series "can be done in a closely monitored and equipped setting." A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: About 1 hour and 15 minutes prior to receiving Menatra and Gardasil vaccinations in our office, the patient felt acute onset of throat tightness, throat burning, flushed face and trouble breathing. 05/30/07-records received-5/27/07-trouble breathing. shortness of breath. flushed face. lips slightly swollen. DC: anaphylactic reaction most likely to either Gardasil or Menactra This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician, his office manager and an allergist via medical records concerning an 18 year old (previously reported as 17 year old) female with no known drug allergies and a history of nasal congestion and sneezing after exposure to cut grass who on 25-MAY-2007 was vaccinated IM with the first 0.5mL dose of GARDASIL (lot #657737/0522U) and concomitant suspect therapy MENACTRA (lot #U2278AA). Additionally, information has been received through the Freedom of Information Act pertaining to this case. It was reported that the patient left the physician's office feeling fine after the vaccinations, and subsequently, returned home. The patient ate a turkey sandwich and a kiwi, and "I hour after receiving the vaccine", the patient experienced an acute onset of throat tightness, throat burning, flushed face and trouble breathing. The patient returned to the physician's office with throat tightness, throat burning, flushed face, shortness of breath and lips were slightly swollen. The patient was diagnosed with an anaphylactic reaction and was treated with one EPI-PEN injection, prednisone, 60 mg and BENADRYL, 50 mg. The patient's breathing returned to normal, and subsequently, the patient recovered from the anaphylactic reaction. On 18-JUN-2007, the patient was seen by an allergist who reported that percutaneous skin testing was performed on the patient and revealed positive reactions to kiwi and grass pollen. The patient was diagnosed with a kiwi allergy and grass pollen allergy with seasonal allergic rhinitis. ImmunoCap allergy testing to kiwi, other fruits, pollens and Latex was also performed on the patient (results pending). The patient was instructed on the proper technique and indications for EPI-PEN use and follow-up was pending laboratory results. The reporting physician considered the anaphylactic reaction to be a disabling immediately life-threatening and medically significant event and felt it was most likely related to either therapy with GARDASIL or MENACTRA, although, the allergist felt that the "vaccines were not likely the cause of her reaction" and recommended that an attempt to proceed with the GARDASIL series "can be done in a closely monitored and equipped setting." A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: right deltoid red, swollen and warm to touch, ice pack to area 15 minutes q 2hours
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site swelling, Myalgia, Nausea, Pharyngolaryngeal pain
Clinical narrative: Swelling at injection site, chills, fever, nausea, sore throat, muscle aches in arms and legs.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Swelling at injection site, chills, fever, nausea, sore throat, muscle aches in arms and legs.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypokinesia, Injection site swelling, Oedema peripheral
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of swelling injection site in a female subject aged between 10 and 49 years old who was vaccinated with Twinrix for prophylaxis. Medical history included no allergies to yeast or neomycin. The subject's concurrent conditions and concurrent medications were not reported. On an unspecified date in 2007, approximately 2 weeks prior to 23 May 2007, the subject received 1st dose of Twinrix (unknown, right arm). In 2007, less than one day after vaccination with Twinrix, the subject experienced swelling injection site, swelling arm, swelling of fingers and unable to close hand due to swelling. The physician described the events to the sales representative as swelling at the injection site that proceeded to travel down the arm to the fingers. The swelling of the fingers prohibited the subject from forming a fist with that particular hand. The subject was seen at a physician's office. The physician considered the events were disabling. At the time of initial reporting, it was noted that the events resolved "48 hours later." The physician considered the events were probably related to vaccination with Twinrix.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: CSF culture positive, Enterovirus infection, Musculoskeletal stiffness
Clinical narrative: Stiffening for 1 minute the evening after vaccination.  06/13/07-vac rec received information entered in VAERS record faxed to CDC.  6/22/07 Received hospital medical records which reveal patient admitted 5/23-5/25/07 for observation after febrile seizure & r/o sepsis w/u.  Cultures neg.  IV antibiotics d/c after 48 hrs.  Had been seen 5/9 in endocrinology clinic for low TSH which normalized spontaneously. FINAL DX: Enterovirus meningitis.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Culture urine negative, Developmental delay
Clinical narrative: Child received MMR and Influenza vaccine on 1/25/07. Developed seizures on 2/4/07 for which he was  hospitalized from 2/4/07 to 2/13/07. Regression of developmental occurred which are gradually returning with therapy.  07/17/2007 MR received for admission 2/23/2007.  Child presented with 10 day hx of fever with regression of developmental milestones. Pt had been hospitalized for new onset seizures 2/3/2007.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Child received MMR and Influenza vaccine on 1/25/07. Developed seizures on 2/4/07 for which he was  hospitalized from 2/4/07 to 2/13/07. Regression of developmental occurred which are gradually returning with therapy.  07/17/2007 MR received for admission 2/23/2007.  Child presented with 10 day hx of fever with regression of developmental milestones. Pt had been hospitalized for new onset seizures 2/3/2007.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Rotavirus given at 13 weeks of age.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Palpitations, Similar reaction on previous exposure to drug
Clinical narrative: Patient started (o) typhoid-Vivotif at approx 24 hr after 1st capsules, Felt "heart racing (+) increased dizziness" Attempted to reach Pt to tell her to hold further but she took 2nd dose with similar response. Then d/c'd-symptoms stopped-no other c/o. Didn't follow up P.C.P
Age: 22.0
Sex: F
Vaccine: HEP, TDAP, UNK
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized induration and erythema at site of Tdap.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, PNC
Symptoms: Staring
Clinical narrative: Father states evening of immunization that baby experienced staring episodes x 3 - called sister FNP and CCPHC - was told to monitor and if condition worsened to go to ER. Did not have to take to hospital.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Patient given Dtap after age 6 age 8  Lot # U1813BA.
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot skin area around shot area - immunization given 5/11/07 - saw patient 5/14/07.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Red, swollen, painful arm
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Red, swollen, painful
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Cold compress therapy, Skin warm, Swelling, Tenderness
Clinical narrative: 24 hours after Varivax vaccine was administered the child began c/o tenderness, swelling and warmth. Mom gave Tylenol and applied cold compress.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Convulsion, Electroencephalogram
Clinical narrative: seizures, first seizure was five days after immunizations. She was asleep than woke up and it started, her eyes were rolled to the side and her whole body was shaking it lasted at least two minutes. Eight days later she had another seizure once again she was asleep than woke up and it started. It did'nt last as long but like the first her eyes rolled to the side and her body was shaking, it lasted 45 seconds to one minute. Six days later she started having staring seizures. She had several a day, I was not sure they were seizures for a few days, but then they started get more frequent. She would be staring for about 30-45 seconds and then fall right to sleep,this continued for 2 days then I took her to the emergency room where she had another full seizure eyes rolled to the side and her whole body shaking. They did more test and found ct scan normal, blood work normal, chest x-ray normal. I had taken her to urgent care after the first seizure. Then I made an appointment with her doctor, it just so happened that the next seizure came the day before. He ordered a eeg and blood work which all came back normal. Now pt is taking Phenabarbotol to control the seizures. She has seen a neurologist he says he sees no developmental delays she is actually above average. The medicine is working well so far. His diagnosis is epilepsy.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Epilepsy, Eye rolling, Sleep disorder, Staring, Tremor
Clinical narrative: seizures, first seizure was five days after immunizations. She was asleep than woke up and it started, her eyes were rolled to the side and her whole body was shaking it lasted at least two minutes. Eight days later she had another seizure once again she was asleep than woke up and it started. It did'nt last as long but like the first her eyes rolled to the side and her body was shaking, it lasted 45 seconds to one minute. Six days later she started having staring seizures. She had several a day, I was not sure they were seizures for a few days, but then they started get more frequent. She would be staring for about 30-45 seconds and then fall right to sleep,this continued for 2 days then I took her to the emergency room where she had another full seizure eyes rolled to the side and her whole body shaking. They did more test and found ct scan normal, blood work normal, chest x-ray normal. I had taken her to urgent care after the first seizure. Then I made an appointment with her doctor, it just so happened that the next seizure came the day before. He ordered a eeg and blood work which all came back normal. Now pt is taking Phenabarbotol to control the seizures. She has seen a neurologist he says he sees no developmental delays she is actually above average. The medicine is working well so far. His diagnosis is epilepsy.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Dermatitis, Rash maculo-papular
Clinical narrative: 2 days post #1 Anthrax vaccine developed severe dermatitits, macularpapular rash on the chest,:back,arms, and thights.  Quarters x 1Day, RX:  Dehenydramine PO 50 mg cap Q 8 hrs PRN. Triamcinolone 1% QD.  Start date 05/25/07.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Lymphadenopathy
Clinical narrative: Bilat cervical lymphadenopathy for >3 days, starting day after injection.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Shot administer on the 5/14/07. Fever of 104 on 5/22/07 - fever remained through 5/24/07 (dropping to 101). Onset of generalized rash on 5/24/07 through present. Rash is all over body & itchy. Rash & fever have inhibited sleeping pretty drastically.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Pain, Swelling, Tenderness
Clinical narrative: large area of erythema, swelling, tenderness.  cellulitis and pain. occured approximately 24 hours after vaccine administration.  treated with warm compress and Keflex.  to return for follow up in 24 hours.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Ecchymosis, Gait disturbance, Injection site pain, Oedema, Pyrexia
Clinical narrative: fever to 103,edema, ecchymosis, tenderness at vaccination site and limping on shot-administered leg 48 hours after vaccination with DTaP.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Chest pain, Fatigue, Headache, Pruritus, Pyrexia
Clinical narrative: Felt fatigue mins. after vaccine. Mild headaches/fever for 6 days beginning the next morning after vaccine; rash and itch all over body and face (esp. on right side of body and face where vaccine was) beginning the day after vaccine for over 10 days; chest pain twice 2 or 3 days after vaccine. Have been using cortisone cream for allergy/rash. Slept in late to get over headaches.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Rash generalised
Clinical narrative: Felt fatigue mins. after vaccine. Mild headaches/fever for 6 days beginning the next morning after vaccine; rash and itch all over body and face (esp. on right side of body and face where vaccine was) beginning the day after vaccine for over 10 days; chest pain twice 2 or 3 days after vaccine. Have been using cortisone cream for allergy/rash. Slept in late to get over headaches.
Age: 52.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Musculoskeletal pain, Sleep disorder
Clinical narrative: I was given two shots,one in each arm.That night I could not lie on either side becouse of the pain in my sholders.I thought it was becouse they were sore from the shots but the pain has remained every day and night since.Most of the time I cant raise my arms higher than my sholders and cannot sleep on my sides.I am writing becouse I saw something on TV about joint pain after having the flu shot.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: Patient took her first Vivotif live oral vaccine capsule on 5/21/07  She took her second capsule on 5/23/07, her third on 5/25/07 and was taken to the emergency room on 5/27/07 with fever(102 plus) muscle pain and bad headache.  She was given tylenol and one bag of IV solution.  Blood tests were taken and white blood count was somewhat elevated which they believed meant that her body was fighting off the infection.  She was not able to take her fourth capsule on 5/27/07.
Age: 1.2
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Abnormal faeces, Bowel movement irregularity, Rash generalised, Rhinorrhoea, Vaccination complication
Clinical narrative: Increased nasal drainage and stooling throughout the course of the day of 5/27/07 - received vaccine the morning of 5/24/07. Sudden onset of full-body rash (with the only exceptions being the hands and feet) at 1830 hrs following diaper change, bath, and dressing since 1800 hrs. Red spot appeared at the spine in the low back at 1900 hrs; we are watching for more. I believe this is a rare reaction to the Varicella - this is reported over Memorial Day weekend; not all information is available at the time of submission.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain upper, Chills, Gait disturbance, Lethargy, Pyrexia
Clinical narrative: Monday afternoon pt received the Menactra vaccine.  When he awoke the next morning, Tuesday, around 9:30AM he had a stomach ache.  When he got up he immediately vomited.  He felt better and laid back down.  He had the chills and within the hour was vomiting again.  I called his Doctor and informed her of this and asked for Ondansetron tablets and mentioned hydration.  By this time it was 3:00PM and pt had not urinated since the previous day.  He had his graduation ceremony that night at 7PM and he tried and tried to get up and get ready for that.  By now, around 6:30PM he had a fever, was continuing to vomit, and still had not urinated.  He was becoming increasingly lethargic and it was clear there was no way he would make it to his graduation.  I am a Pediatric Anesthesiologist and was growing inceasingly concerned about hydration and that this was a reaction to the vaccine.  By 7:30PM pt was having difficulty ambulating and his speech was very slow and he would barely open his eyes.  At this point I took him to a nearby Station House where an EMT placed an IV.  After 3 liters of NS, pt finally perked up a little bit.  We hep locked the IV and I took supplies home with me.  At 10PM he finally urinated.  Throughout the night I gave him 2 more liters of fluid and he again urinated at 6AM Wednesday moring.  By then, he said he felt much better.  He ate a piece of toast and a few bites of egg.  He then went back to sleep for the next 6 hours.  After the IV was started the Tuesday night, he had no further emesis.  There was no one else sick in the home nor has there been since nor was he around anyone with gastroenteris prior to this.  Had I taken him to an emergency room, and I would have by ambulance had he not responded to the IV fluid, he would have been hospitalized overnight and probably discharged the following afternoon and there would have been laboratory data. I think it was his Right arm, but that, the lot number, and the nurse's name administering and be gotten from the Doctor's office.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Speech disorder, Urinary retention, Vomiting
Clinical narrative: Monday afternoon pt received the Menactra vaccine.  When he awoke the next morning, Tuesday, around 9:30AM he had a stomach ache.  When he got up he immediately vomited.  He felt better and laid back down.  He had the chills and within the hour was vomiting again.  I called his Doctor and informed her of this and asked for Ondansetron tablets and mentioned hydration.  By this time it was 3:00PM and pt had not urinated since the previous day.  He had his graduation ceremony that night at 7PM and he tried and tried to get up and get ready for that.  By now, around 6:30PM he had a fever, was continuing to vomit, and still had not urinated.  He was becoming increasingly lethargic and it was clear there was no way he would make it to his graduation.  I am a Pediatric Anesthesiologist and was growing inceasingly concerned about hydration and that this was a reaction to the vaccine.  By 7:30PM pt was having difficulty ambulating and his speech was very slow and he would barely open his eyes.  At this point I took him to a nearby Station House where an EMT placed an IV.  After 3 liters of NS, pt finally perked up a little bit.  We hep locked the IV and I took supplies home with me.  At 10PM he finally urinated.  Throughout the night I gave him 2 more liters of fluid and he again urinated at 6AM Wednesday moring.  By then, he said he felt much better.  He ate a piece of toast and a few bites of egg.  He then went back to sleep for the next 6 hours.  After the IV was started the Tuesday night, he had no further emesis.  There was no one else sick in the home nor has there been since nor was he around anyone with gastroenteris prior to this.  Had I taken him to an emergency room, and I would have by ambulance had he not responded to the IV fluid, he would have been hospitalized overnight and probably discharged the following afternoon and there would have been laboratory data. I think it was his Right arm, but that, the lot number, and the nurse's name administering and be gotten from the Doctor's office.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Cheilitis, Injection site erythema
Clinical narrative: ERYTHEMA AND REDNESS AT THE SITE AND ALSO ON HIS RIGHT WRIST AND AROUND HIS LIPS
Age: 27.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Headache, Influenza like illness, Mobility decreased, Myalgia
Clinical narrative: Severe arm pain where shot was administered. Difficulty moving my arm due to pain. Entire upper arm in pain. Sick with flu-like systems for two days. Fever as high as 100.8, muscle aches, headache, fatigue, difficulty sleeping, etc. I feel like I have the flu. I've been down for two days because of this vaccine. It ruined all of my plans for the Memorial Day weekend.
Age: 27.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Severe arm pain where shot was administered. Difficulty moving my arm due to pain. Entire upper arm in pain. Sick with flu-like systems for two days. Fever as high as 100.8, muscle aches, headache, fatigue, difficulty sleeping, etc. I feel like I have the flu. I've been down for two days because of this vaccine. It ruined all of my plans for the Memorial Day weekend.
Age: 27.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: Severe arm pain where shot was administered. Difficulty moving my arm due to pain. Entire upper arm in pain. Sick with flu-like systems for two days. Fever as high as 100.8, muscle aches, headache, fatigue, difficulty sleeping, etc. I feel like I have the flu. I've been down for two days because of this vaccine. It ruined all of my plans for the Memorial Day weekend.
Age: 16.0
Sex: F
Vaccine: HPVX, TDAP, HPV4, TDAP
Symptoms: Convulsion, Dizziness, Dyskinesia, Injection site pain, Loss of consciousness
Clinical narrative: Immediately after giving HPV shot child fainted.
Age: 16.0
Sex: F
Vaccine: HPVX, TDAP, HPV4, TDAP
Symptoms: Musculoskeletal stiffness, Pain, Pallor
Clinical narrative: Immediately after giving HPV shot child fainted.
Age: 16.0
Sex: F
Vaccine: HPVX, TDAP, HPV4, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after giving HPV shot child fainted.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Agitation, Barium enema, Haematochezia, Intussusception, Lethargy
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report # WAES0704USA04521. The initial reporter to this manufacturer had been the regulatory agency. "Information has been received from the regulatory agency concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot# 6537355/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, intussusception which required surgery was considered an other important medical event. Further information has been received from the regulatory agency through the government concerning the 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot# 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, Hib second dose, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating barium enema which failed to reduce it. The patient was hospitalized and went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening." "The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." "This is an amended report. The statement the patient was hospitalized was added to the narrative to match the previously report serious criteria of hospitalization in the field."
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Surgery
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report # WAES0704USA04521. The initial reporter to this manufacturer had been the regulatory agency. "Information has been received from the regulatory agency concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot# 6537355/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, intussusception which required surgery was considered an other important medical event. Further information has been received from the regulatory agency through the government concerning the 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot# 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, Hib second dose, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating barium enema which failed to reduce it. The patient was hospitalized and went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening." "The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." "This is an amended report. The statement the patient was hospitalized was added to the narrative to match the previously report serious criteria of hospitalization in the field."
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Agitation neonatal, Appendix disorder, Barium enema, Cardiac murmur, Haematochezia
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report # WAES0704USA04521. The initial reporter to this manufacturer had been the regulatory agency. "Information has been received from the regulatory agency concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot# 6537355/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, intussusception which required surgery was considered an other important medical event. Further information has been received from the regulatory agency through the government concerning the 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot# 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, Hib second dose, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating barium enema which failed to reduce it. The patient was hospitalized and went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening." "The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." "This is an amended report. The statement the patient was hospitalized was added to the narrative to match the previously report serious criteria of hospitalization in the field."
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Irritability, Lethargy, Surgery, X-ray
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report # WAES0704USA04521. The initial reporter to this manufacturer had been the regulatory agency. "Information has been received from the regulatory agency concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot# 6537355/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, intussusception which required surgery was considered an other important medical event. Further information has been received from the regulatory agency through the government concerning the 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot# 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, Hib second dose, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating barium enema which failed to reduce it. The patient was hospitalized and went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening." "The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." "This is an amended report. The statement the patient was hospitalized was added to the narrative to match the previously report serious criteria of hospitalization in the field."
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Agitation, Barium enema, Cardiac murmur, Haematochezia, Intussusception
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report # WAES0704USA04521. The initial reporter to this manufacturer had been the regulatory agency. "Information has been received from the regulatory agency concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot# 6537355/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, intussusception which required surgery was considered an other important medical event. Further information has been received from the regulatory agency through the government concerning the 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot# 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, Hib second dose, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating barium enema which failed to reduce it. The patient was hospitalized and went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening." "The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." "This is an amended report. The statement the patient was hospitalized was added to the narrative to match the previously report serious criteria of hospitalization in the field."
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Lethargy, Surgery, X-ray
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report # WAES0704USA04521. The initial reporter to this manufacturer had been the regulatory agency. "Information has been received from the regulatory agency concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot# 6537355/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, intussusception which required surgery was considered an other important medical event. Further information has been received from the regulatory agency through the government concerning the 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot# 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, Hib second dose, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating barium enema which failed to reduce it. The patient was hospitalized and went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening." "The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the government and was released." "This is an amended report. The statement the patient was hospitalized was added to the narrative to match the previously report serious criteria of hospitalization in the field."
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Eye haemorrhage, Fatigue, Nausea
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.