chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Malaise, Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: 9/16 started "not feeling well" 9/17 ran a fever of 100 and dizzy with nausea. 9/18 Right arm and shoulder into the scapula was painfull and tender
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 9/16 started "not feeling well" 9/17 ran a fever of 100 and dizzy with nausea. 9/18 Right arm and shoulder into the scapula was painfull and tender
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site urticaria, Pain, Swelling
Clinical narrative: 10/10 8:45 am recieved Twinrix. Several hours after vaccine felt some pain. Hour later pain down arm, in armpit,and going down right side of back. Approximately 2:30 pm went to MC quick care recieved flexaril, prednisone ultram. 10/11/2007 States has quarter size red welt at shoulder site, continues to be swollen and painful States not any better not any worse.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram normal, Injection site pain
Clinical narrative: Patient reported that approx 30 min after recieving the Fluvirin that she experienced excutiating pain in her right arm and shoulder. She went to her Physician's office and there she began having breathing difficulties and was given a Benadryl injection. An EKG was performed and she reported that there were no abnormalities.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Dizziness, weakness, headache which lasted 5 hours.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Dizziness, Flushing
Clinical narrative: Approximately 5 minutes after administration, patient became very flush, dizzy and lightheaded. Also somewhat weepy. Pulse okay. Incident lasted 5 minutes. Patient stayed for observation for 20 minutes and felt fine at release. --Mother did disclose after reaction that child had egg allergy as infant but resolved at 3 years of age and has been eating eggs since.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Oedema, Skin warm, Tenderness
Clinical narrative: Tenderness, increased warmth, slightly edmatous. Area at site of injection began to sting almost immediately after injection per client
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Injection site pruritus, Injection site warmth, Limb discomfort, Oedema peripheral
Clinical narrative: 10/05/2007 P/C from Mom.  States patient started complaining of discomfort right arm the  morning of 10/03/2007, before school.  Stated it hurt to lift her arm.  After school that day she had swelling and redness right arm. Thursday, Oct. 4, complained of increased redness to elbow, hurt under right armpit.  Still had swelling.  Site was warm to touch.  On Friday, Oct 5th, less sore, decreased swelling, decreased redness - improving.  On Sunday, Oct 7th, site was "itchy".  On Mon, Oct 8th, no more complaints of discomfort.  Took Motrin while having discomfort, "don't know if it helped."  Never developed any fever.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Within 48 hrs of administration pt had redness and swelling and warmth of arm from shoulder to antecubital fossa
Age: 0.5
Sex: U
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received 0.5 ml dose of MMR. Dr notified immediately when realized MMR given in error. Dr. notified mother, and discussed incident with her, as well as answered questions for mother. Manufacturer (Merck) notified.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Nuclear magnetic resonance imaging normal, Rash, Red blood cell sedimentation rate normal, White blood cell count
Clinical narrative: developed  fairly diffuse rash with subsequent onset of headaches.  No fevers.  neg MRI head  Saw ID specialist who felt likely mild post vaccine menningitis 2/18/09-records received-8/1/07 rash resolved after reaction to vaccine. Pusble, erythematous rash.  8/27/07-C/O dizziness nausea times 10 days. Nausea with head rotation, eyelids seem droopy, mild eyeball pressure symptoms severe after work. Works in a lab with macaque monkeys including primate herpes B virus. Assessment vertigo suspected secondary to varicella vaccine.  9/18/07-neurology consult for C/O headaches. Two weeks after receiving vaccine developed rash and some pustules, vaccine-associated chicken pox. C/O head feels swollen. Enlarged lymph node left retroauricular aread, cerumen impaction. Impression vaccine associated varicella. 10/3/07-follow-up neurology visit, recurrent headaches. Potential exposure at work from spash in left eye when dealing with monkeys started on valacyclovir. Red bumps on knees and shoulders.
Age: 1.33
Sex: M
Vaccine: PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none
Age: 1.92
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: maculopapular rash and hives on trunk, face, and extremities approx. 16 hours after infuenza virus-pediatric dose was given     Patient was also receiving augmentin for and ear infection at the time of vaccination.  So not sure if drug reaction or vaccine reaction.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash erythematous, Rhinorrhoea
Clinical narrative: Immunizations on Sept 28, 2007.  Rash started on Oct. 9. Erythematous rash spots on entire trunk including diaper area. Has had a runny nose for a couple of days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site pain, Injection site reaction, Pain
Clinical narrative: Site Reaction to Left Thigh- painful to touch - Prolonged crying - approx. 12 hours
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Pharyngeal oedema, Rash, Scleritis, Throat irritation
Clinical narrative: 2.5 hours after vaccine administered: scratchy throat, swelling throat, itchy eyes, red sclera, wheezing, rash on chest (that went away). Pt initally took 25 mg of Benadryl followed up later with 50 mg Benadryl with some relief to symptoms. Came to the ER next day due to wheezing (as past hx of cold related asthma, but not recently).Was given a nebulizer in ER.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: 2.5 hours after vaccine administered: scratchy throat, swelling throat, itchy eyes, red sclera, wheezing, rash on chest (that went away). Pt initally took 25 mg of Benadryl followed up later with 50 mg Benadryl with some relief to symptoms. Came to the ER next day due to wheezing (as past hx of cold related asthma, but not recently).Was given a nebulizer in ER.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient was vaccinated on 10-01-2007 and began to feel ill on 10-06-07.Patient missed work on 10-10-2007 and as of today is running a 103 fever. As of 10-10-2007 patient is drinking advil liquid gel, if fever persist patient will be taken to hospital tonight.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Patient had some swelling, slight blistering near local site of injection.  Was given 1 tab, po, 25mg of benadryl, and directed to go to the emergency room, and f/u with the employee health department on 10/12/2007.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Haemorrhoids, Pruritus, Skin discolouration
Clinical narrative: Itching burning hemmorhoids-6-12 hours after shot.bright pink skin tone all over after 3 days, with slight, all over itch which continues now on day 8.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Deafness, Dizziness, Headache, Injection site pain
Clinical narrative: Dizziness, loss of hearing, headache, fainting, mild convulsion (erratic arms), pallor, nausea, soreness and itchiness at injection site
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site pruritus, Nausea, Pallor, Syncope
Clinical narrative: Dizziness, loss of hearing, headache, fainting, mild convulsion (erratic arms), pallor, nausea, soreness and itchiness at injection site
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt developed 1 & 1/2 inch square red patch at the injection site 24 hours after Fluzone vaccine that was adminstered on 10/01/2007.  The patch was warm to the touch.  On 10/03/2007, pt. started applying Neosporin ointment and the patch resolved quickly.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received fluzone on Tuesday, Oct 9. Called pharmacy on Wednesday complaining of swelling and pain at injection site. Advised to take tylenol and possibly use some ice for swellling. Phoned again Thursday and complained swelling and pain had become worse. Asked patient to come down for an assessment. Swelling present on shoulder. Also had pain on top of arm and under arm. Skin appeared spotty with red patches. No other areas of body involved. Patient feels fine except for pain in shoulder. Phoned family physician for patient, and requested that she be seen. Physician did not believe it was a serious reaction and that swelling would subside soon.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Pain, Stress
Clinical narrative: THE INSURANCE COMPANY HAS NOT PAID FOR THE 2/3 HPV VACCINES DONE ON 6-13-07 AND 8-13-07. THE PROVIDER'S BILLING HAS BILLED THE INSURANCE FOR THE SAME VACCINE WITH THE BILLING CODE, BUT THE INSURANCE WILL NOT PAY. I HAVE BEEN TOLD THE INSURANCE HAS ANOTHER CODE, BUT THAT THE FDA HAS SAID THE GARDASIL VACCINE FOR HPV IS RECCOMENDED FOR FEMALES AGES 9 TO 26, SO INSURANCE COMPANIES DO NOT PAY FOR THE VACCINE IF WOMEN ARE 27 OR OLDER BECAUSE OF THE FDA STATING THE AGES 9 TO 26, EVEN IF THERE ARE WOMEN 27 AND OLDER WHO HAVE HPV AND GOT THE VACCINE, WHO NEED THEIR INSURANCE TO PAY THE BILL, LIKE MYSELF WHO IS 28. I HAVE ALSO SENT A COMPLAINT TO THE FDA AND I HAVE CALLED THE AMA. I HAVE SUFFERED CHRONIC PAIN, STRESS, ANXIETY, I HAVE BEEN ON THE PHONE WITH THE PROVIDER AND THE INSURANCE FOR HOURS ABOUT THIS. FINALLY, I FOUND OUT THE CPT CODE THE PROVIDER IS USING IS NOT FOR A SPECIFIC AGE GROUP OF 9-26, BUT JUST FOR THE HPV GARDASIL VACCINE. IT IS THE GARDASIL COMPANY AND FDA SAYING THAT IT IS FOR 9-26 THAT IS MAKING THE INSURANCE COMPANIES REFUSE TO PAY FOR WOMEN 27 AND OLDER GETTING THE VACCINE. THIS IS AN ADVERSE VACCINE EVENT AND IT IS NOT FAIR. i THINK IT IS FRAUD.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unevaluable event
Clinical narrative: THE INSURANCE COMPANY HAS NOT PAID FOR THE 2/3 HPV VACCINES DONE ON 6-13-07 AND 8-13-07. THE PROVIDER'S BILLING HAS BILLED THE INSURANCE FOR THE SAME VACCINE WITH THE BILLING CODE, BUT THE INSURANCE WILL NOT PAY. I HAVE BEEN TOLD THE INSURANCE HAS ANOTHER CODE, BUT THAT THE FDA HAS SAID THE GARDASIL VACCINE FOR HPV IS RECCOMENDED FOR FEMALES AGES 9 TO 26, SO INSURANCE COMPANIES DO NOT PAY FOR THE VACCINE IF WOMEN ARE 27 OR OLDER BECAUSE OF THE FDA STATING THE AGES 9 TO 26, EVEN IF THERE ARE WOMEN 27 AND OLDER WHO HAVE HPV AND GOT THE VACCINE, WHO NEED THEIR INSURANCE TO PAY THE BILL, LIKE MYSELF WHO IS 28. I HAVE ALSO SENT A COMPLAINT TO THE FDA AND I HAVE CALLED THE AMA. I HAVE SUFFERED CHRONIC PAIN, STRESS, ANXIETY, I HAVE BEEN ON THE PHONE WITH THE PROVIDER AND THE INSURANCE FOR HOURS ABOUT THIS. FINALLY, I FOUND OUT THE CPT CODE THE PROVIDER IS USING IS NOT FOR A SPECIFIC AGE GROUP OF 9-26, BUT JUST FOR THE HPV GARDASIL VACCINE. IT IS THE GARDASIL COMPANY AND FDA SAYING THAT IT IS FOR 9-26 THAT IS MAKING THE INSURANCE COMPANIES REFUSE TO PAY FOR WOMEN 27 AND OLDER GETTING THE VACCINE. THIS IS AN ADVERSE VACCINE EVENT AND IT IS NOT FAIR. i THINK IT IS FRAUD.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Swollen sore red and hot to touch.  Baseball sized red swollen area around site of injection. Fever of 101 degrees for two days, sweats and chills
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Swollen sore red and hot to touch.  Baseball sized red swollen area around site of injection. Fever of 101 degrees for two days, sweats and chills
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Lumbar puncture, Nuclear magnetic resonance imaging brain, Pyrexia
Clinical narrative: vaccine given on 10/2/07 .  4a-5 days later developed severe headache while doing a few squats.  Several days later developed a 102.6 fever-ended up having lumbar puncture and MRI brain.  10/30/07 Received ER medical records which reveal patient experienced high fever x 1 day & bilateral frontal headache pain w/nausea & photosensitivity x 5 days.  Had been seen at outlying ER w/fever 102.6 & LP was unsuccessful.  Tx w/IV antibiotics x 1.  Transferred to higher level of care for MRI & LP. Exam revealed minimal redness of tonsils w/minimal swelling.  No neck pain.  No neuro deficits. Refused further attempts at LP.  Neurosurgery consulted.  Began to spike fever again & did allow LP at that point under fluoroscopy.  D/C to home w/neurosurgery & MRI f/u for cyst FINAL DX: headache, resolved; right ventricle cyst; fever.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: severe local reaction after 24 hours, patient's right arm was red, swollen and extremely sore,patient to take diphenhydramine and go to ER if have SOB, patient went to MD and got RX(unknown) and he is doing much better, swelling is almost gone
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Blood test, Computerised tomogram, Crying, Culture stool, Diet refusal
Clinical narrative: Patient vaccinated on a Wednesday morning.  By Friday afternoon he had screaming syndrome, and was inconsolable, refusing to breastfeed for over four hours.  Pediatrician suggested running labs and meeting at the office Saturday morning.  Upon examination patient was sent directly to the hospital for suspected encephalitis.  Patient received IV fluids for 3 days, and numerous testing.  On third night, the pediatrician determined it was a long-standing EBV infection, prescribed acyclovir, and discharged patient. 10/22/07-records received for DOS 12/6-12/8/03-DC DX: Failure to thrive and irritability. Doing well until the past three month block when he was noted to have weight loss and increased irritability. On going viral process.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Screaming, Urine analysis
Clinical narrative: Patient vaccinated on a Wednesday morning.  By Friday afternoon he had screaming syndrome, and was inconsolable, refusing to breastfeed for over four hours.  Pediatrician suggested running labs and meeting at the office Saturday morning.  Upon examination patient was sent directly to the hospital for suspected encephalitis.  Patient received IV fluids for 3 days, and numerous testing.  On third night, the pediatrician determined it was a long-standing EBV infection, prescribed acyclovir, and discharged patient. 10/22/07-records received for DOS 12/6-12/8/03-DC DX: Failure to thrive and irritability. Doing well until the past three month block when he was noted to have weight loss and increased irritability. On going viral process.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient has developed multiple raised bumps on the right arm from elbow to shoulder, as rash.  Have recommend to take benadryl or claritin for the allergic reaction.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: chills, sweats, shakes, fever (101), hives, headache.  Shot received 5:00 PM Thursday, October 4, 2007. Symptoms appeared the following day, Friday, October 5, 2007 and progressed into the Friday evening when symptoms reach maximum and Saturday by 10 am, disappeared, except for the mild hives on my right shoulder which have remained
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: chills, sweats, shakes, fever (101), hives, headache.  Shot received 5:00 PM Thursday, October 4, 2007. Symptoms appeared the following day, Friday, October 5, 2007 and progressed into the Friday evening when symptoms reach maximum and Saturday by 10 am, disappeared, except for the mild hives on my right shoulder which have remained
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea
Clinical narrative: I was given the vaccine & within 30min.I began having trouble breathing.I used my Xopenex inhaler & took 25mg Benadryl PO.I was also given Epi 0.3mg SQ via Epi-Pen.The reaction continued to progress & I was taken to the ED.There I was given another dose of Epi,2 more Xopenex resp.treatments,120 mg Sol-U-Medrol IV & placed on Bi-Papp.I was also give 60mg of Prednisone PO & another 60mg PO to be taken today.I was released from the Ed 5.5hr.later.Today I remain unable to speak above a whisper.ED doctor notifed my primary MD & I notifed my Pulmonary MD today.
Sex: U
Vaccine: MU
Symptoms: Serology negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with mumps virus vaccine live (Jeryl Lynn). Three years after receiving virus vaccine (Jeryl Lynn), the patient has "low titers.' The outcome was not reported. The patient's twin sibling had a similar experience (WAES#0609USA08026). Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MU
Symptoms: Blepharospasm, Hypoaesthesia oral
Clinical narrative: Information has been received from a physician's assistant concerning a 34 year old female who on 19-SEP-2006 was vaccinated SC with a dose mumps virus live (Jeryl Lynn) (lot # 650394/1113R). There was no concomitant medication. On 26-SEP-2006 the patient developed numbness of her tongue and eye twitching. Unspecified medical attention was sought, there were no lab diagnostics. At the time of the report, the patient had not recovered. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MU
Symptoms: Serology negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with mumps virus vaccine live (Jeryl Lynn). Three years after receiving mumps virus vaccine live (Jeryl Lynn), the patient had "low titers." The outcome was not reported. The patient's twin sibling had a similar experience (WAES#0609USA00430). Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MU
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a male with a history of vaccination adverse reaction who "about three weeks ago" on approximately 28-SEP-2006 was vaccinated with a SC dose of MUMPSVAX. There was no concomitant medication. Three weeks after the vaccination, on approximately 19-OCT-2006, the patient developed a wheal and flare at the injection site. He was treated with antihistamines and the symptoms resolved. There was no product quality complaint involved. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: MU
Symptoms: Influenza like illness, Mumps antibody test negative, Pyrexia
Clinical narrative: Information has been received from a 51 year old female nurse with a penicillin allergy and no other pertinent medical history who, "4 years ago", in approximately August 2002, was vaccinated with a dose of MUMPSVAX. There was no concomitant medication. Subsequently when she received the vaccine she experienced a low grade fever and had mild flu-like symptoms. The patient had a titer in the "past few weeks", in November 2006 which was negative. Unspecified medical attention was sought. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MU
Symptoms: Headache, Pain, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse concerning a 27-year-old female who on 13-JUL-2007 was vaccinated with a 0.5 ml dose of MUMPSVAX. On 20-JUL-2007 the patient developed a rash on her abdomen and back. On 23-JUL-2007 the patient developed fever, aches and a headache. It was reported that the patient was seen in the clinic on 25-JUL-2007. It was reported that, at the time of the clinic visit, the rash was heat sensitive and fever was no longer present. There was no outcome reported. Additional information has been requested.
Sex: F
Vaccine: MU
Symptoms: Fatigue, Feeling hot, Rash
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female who on 13-JUL-32-2007 was vaccinated with a 0.5ml SC dose of MUMPSVAX (Lot# 652337/1187F) into the left the left upper arm. On 13-JUL-2007 the patient developed symptoms of rash, fatigue and a feverish feeling, which were noted to have diminishing on 20-JUL-2007. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Insomnia, Irritability, Rash, Rash papular
Clinical narrative: Information has been received from a licensed practical nurse (L.G.P.N.) concerning a 16-month old white female who on 20-APR-2007 was vaccinated with a first dose of PROQUAD (lot# reported as "06184"). On 27-APR-2007 the patient became irritable, and had decreased sleep. The irritability and decreased sleep intensified over the next few days. On 01-May-2007, a rash erupted with small red papules on the trunk, back and a few on the face, and she had a fever. No medical treatment was sought. On an unspecified date, the patient recovered. This is one of several reports from the same reporter. Additional has been requested.
Age: 1.3
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Insomnia, Irritability, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Information has been received from a licensed practical nurse (L.G.P.N.) concerning a 16-month old white female who on 20-APR-2007 was vaccinated with a first dose of PROQUAD (lot# reported as "06184"). On 27-APR-2007 the patient became irritable, and had decreased sleep. The irritability and decreased sleep intensified over the next few days. On 01-May-2007, a rash erupted with small red papules on the trunk, back and a few on the face, and she had a fever. No medical treatment was sought. On an unspecified date, the patient recovered. This is one of several reports from the same reporter. Additional has been requested.
Age: 1.3
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Diarrhoea, Immunisation reaction, Irritability, Pyrexia, Rash
Clinical narrative: Information has been received from a licensed graduate practical nurse (L.P.G.N.) concerning a 15-month-old male who on 23-APR-2007 was vaccinated with a first dose of PROQUAD (Lot# 656720/0168U). On 02-May-2007 the patient vomited once. The patient was seen in the office on 02-May-2007 with a maculopapular rash on his neck and back, he was cranky but consolable, and had a fever and diarrhea that lasted for 3 days. The reporter felt that diarrhea, fever, cranky, maculopapular rash on neck and vomited were related to therapy with PROQUAD. On an unspecified date the patient recovered. This is one of several reports from the same reporter. Additional information is expected.
Age: 1.3
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Rash maculo-papular, Vomiting
Clinical narrative: Information has been received from a licensed graduate practical nurse (L.P.G.N.) concerning a 15-month-old male who on 23-APR-2007 was vaccinated with a first dose of PROQUAD (Lot# 656720/0168U). On 02-May-2007 the patient vomited once. The patient was seen in the office on 02-May-2007 with a maculopapular rash on his neck and back, he was cranky but consolable, and had a fever and diarrhea that lasted for 3 days. The reporter felt that diarrhea, fever, cranky, maculopapular rash on neck and vomited were related to therapy with PROQUAD. On an unspecified date the patient recovered. This is one of several reports from the same reporter. Additional information is expected.
Age: 1.3
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Diarrhoea, Irritability, Pyrexia, Rash maculo-papular, Vomiting
Clinical narrative: Information has been received from a licensed graduate practical nurse (L.P.G.N.) concerning a 15-month-old male who on 23-APR-2007 was vaccinated with a first dose of PROQUAD (Lot# 656720/0168U). On 02-May-2007 the patient vomited once. The patient was seen in the office on 02-May-2007 with a maculopapular rash on his neck and back, he was cranky but consolable, and had a fever and diarrhea that lasted for 3 days. The reporter felt that diarrhea, fever, cranky, maculopapular rash on neck and vomited were related to therapy with PROQUAD. On an unspecified date the patient recovered. This is one of several reports from the same reporter. Additional information is expected.
Age: 1.5
Sex: M
Vaccine: HEP, MMRV, PNC, HEP, MMRV, PNC
Symptoms: Arthropod bite, Computerised tomogram, Local swelling
Clinical narrative: Information has been received from a registered nurse reporting on her grandson, an 18 month old male with no allergies and a history of a solid mass tumor called rhabdoid that has been successfully treated with 8 rounds of aggressive chemotherapy, last round done in JUL-2006, who on 25-MAY-2007 was vaccinated with PROQUAD in the right leg. The patient was possibly vaccinated with hepatitis B virus vaccine (manufacturer unspecified) on the same day. One lump was found in the groin on 06-JUN-2007 and there have been a total of 3 lumps as of 11-JUN-2007. The patient also had a bug bite on the right leg, a few inches from the groin area. The patient was seen at a facility on 06-JUN-2007 after the lump was discovered. Unspecified medical attention was sought. No laboratory or diagnostic tests were done however, it was reported that, "the grandson is scheduled for a scan on 14-JUN-2007". At the time of this report, the patient was not recovered. No product quality complaint was involved. Follow-up information received from a registered nurse stated that the patient has had no recurrence in the rhabdoid since the completion of chemotherapy last July. The patient was vaccinated with PROQUAD and 12 days later developed 3 enlarged lymph nodes in the right groin. The patient's ?bug/spider bite was on the right leg, lateral to the injection site which was red with five areas of hives around the site. Concomitant vaccines administered include PREVNAR and hepatitis B vaccine in the left leg as well as TYLENOL. The patient's complete blood count (CBC) done in January of 2007 was normal. The patient will have radiologic imaging studies of the chest wall, pelvis and abdomen on 14-JUN-2007. Follow-up information stated that the patient has "tumors" and will be seeing a surgeon. Follow-up information stated that the computed tomography (CT) scan results of 14-JUN-2007 revealed "unidentifiable tissue" located between the aorta and the diaphragm. A biopsy was taken from the two areas. A needle biopsy showed "no obvious cancer". Lung fields were "clean" and an abdominal CT was normal. A prior CT of the chest performed in October of 2006 was negative. The reporter stated that the lymph node enlargement has not changed since the previous report and was told by the patient's healthcare professional that they may not go away. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEP, MMRV, PNC, HEP, MMRV, PNC
Symptoms: Arthropod bite, Biopsy, Computerised tomogram abnormal, Erythema, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse reporting on her grandson, an 18 month old male with no allergies and a history of a solid mass tumor called rhabdoid that has been successfully treated with 8 rounds of aggressive chemotherapy, last round done in JUL-2006, who on 25-MAY-2007 was vaccinated with PROQUAD in the right leg. The patient was possibly vaccinated with hepatitis B virus vaccine (manufacturer unspecified) on the same day. One lump was found in the groin on 06-JUN-2007 and there have been a total of 3 lumps as of 11-JUN-2007. The patient also had a bug bite on the right leg, a few inches from the groin area. The patient was seen at a facility on 06-JUN-2007 after the lump was discovered. Unspecified medical attention was sought. No laboratory or diagnostic tests were done however, it was reported that, "the grandson is scheduled for a scan on 14-JUN-2007". At the time of this report, the patient was not recovered. No product quality complaint was involved. Follow-up information received from a registered nurse stated that the patient has had no recurrence in the rhabdoid since the completion of chemotherapy last July. The patient was vaccinated with PROQUAD and 12 days later developed 3 enlarged lymph nodes in the right groin. The patient's ?bug/spider bite was on the right leg, lateral to the injection site which was red with five areas of hives around the site. Concomitant vaccines administered include PREVNAR and hepatitis B vaccine in the left leg as well as TYLENOL. The patient's complete blood count (CBC) done in January of 2007 was normal. The patient will have radiologic imaging studies of the chest wall, pelvis and abdomen on 14-JUN-2007. Follow-up information stated that the patient has "tumors" and will be seeing a surgeon. Follow-up information stated that the computed tomography (CT) scan results of 14-JUN-2007 revealed "unidentifiable tissue" located between the aorta and the diaphragm. A biopsy was taken from the two areas. A needle biopsy showed "no obvious cancer". Lung fields were "clean" and an abdominal CT was normal. A prior CT of the chest performed in October of 2006 was negative. The reporter stated that the lymph node enlargement has not changed since the previous report and was told by the patient's healthcare professional that they may not go away. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEP, MMRV, PNC, HEP, MMRV, PNC
Symptoms: Mass, Urticaria
Clinical narrative: Information has been received from a registered nurse reporting on her grandson, an 18 month old male with no allergies and a history of a solid mass tumor called rhabdoid that has been successfully treated with 8 rounds of aggressive chemotherapy, last round done in JUL-2006, who on 25-MAY-2007 was vaccinated with PROQUAD in the right leg. The patient was possibly vaccinated with hepatitis B virus vaccine (manufacturer unspecified) on the same day. One lump was found in the groin on 06-JUN-2007 and there have been a total of 3 lumps as of 11-JUN-2007. The patient also had a bug bite on the right leg, a few inches from the groin area. The patient was seen at a facility on 06-JUN-2007 after the lump was discovered. Unspecified medical attention was sought. No laboratory or diagnostic tests were done however, it was reported that, "the grandson is scheduled for a scan on 14-JUN-2007". At the time of this report, the patient was not recovered. No product quality complaint was involved. Follow-up information received from a registered nurse stated that the patient has had no recurrence in the rhabdoid since the completion of chemotherapy last July. The patient was vaccinated with PROQUAD and 12 days later developed 3 enlarged lymph nodes in the right groin. The patient's ?bug/spider bite was on the right leg, lateral to the injection site which was red with five areas of hives around the site. Concomitant vaccines administered include PREVNAR and hepatitis B vaccine in the left leg as well as TYLENOL. The patient's complete blood count (CBC) done in January of 2007 was normal. The patient will have radiologic imaging studies of the chest wall, pelvis and abdomen on 14-JUN-2007. Follow-up information stated that the patient has "tumors" and will be seeing a surgeon. Follow-up information stated that the computed tomography (CT) scan results of 14-JUN-2007 revealed "unidentifiable tissue" located between the aorta and the diaphragm. A biopsy was taken from the two areas. A needle biopsy showed "no obvious cancer". Lung fields were "clean" and an abdominal CT was normal. A prior CT of the chest performed in October of 2006 was negative. The reporter stated that the lymph node enlargement has not changed since the previous report and was told by the patient's healthcare professional that they may not go away. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC, DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia, Rash pruritic
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-month-old male in which the mother denied any allergies, birth defects and medical conditions, who had a history of "red swollen spots about the size of a penny on his body", and no adverse events following prior vaccinations.  On 06-JUN-2007 at 2 pm, he was vaccinated subcutaneously in the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657301/0473U).  Concomitant vaccinations on 06-Jun-2007 at 2 pm included an intramuscular first dose in the right anterior thigh of Vaqta (MSD) (Lot # 656320/1281F), an intramuscular second dose in the right anterior thigh of PEDIARIX (lot# AC21B074BA), an intramuscular second dose in the left anterior thigh of ACTHIB (SANOFI PASTEUR) (lot# UFO10AA), and an intramuscular second dose in the left anterior thigh of PREVNAR (lot# UFO1OAA).  There were no illnesses at the time of vaccination.  In the afternoon of 06-Jun-2007, the child had a fever that was controlled with ibuprofen x 2 doses.  On 07-JUN-2007 at 10 pm, about 36 hours after vaccination, the patient broke out in raised, red, pruritic lesions the size of pennies.  His hands and feet became red and swollen.  The areas were still present the following morning on 08-Jun-2007.  The mother notified the doctor's office about the events on 08-Jun-2007 and was instructed to take the child to the emergency room.  It is reported that the child did not have any respiratory effects, shortness of breath or wheezing.  It was reported that the nurse asked the parents to follow up with her after visiting the ER, but she never heard back.  The patient outcome was unknown.  Additional information is expected.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC, DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-month-old male in which the mother denied any allergies, birth defects and medical conditions, who had a history of "red swollen spots about the size of a penny on his body", and no adverse events following prior vaccinations.  On 06-JUN-2007 at 2 pm, he was vaccinated subcutaneously in the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657301/0473U).  Concomitant vaccinations on 06-Jun-2007 at 2 pm included an intramuscular first dose in the right anterior thigh of Vaqta (MSD) (Lot # 656320/1281F), an intramuscular second dose in the right anterior thigh of PEDIARIX (lot# AC21B074BA), an intramuscular second dose in the left anterior thigh of ACTHIB (SANOFI PASTEUR) (lot# UFO10AA), and an intramuscular second dose in the left anterior thigh of PREVNAR (lot# UFO1OAA).  There were no illnesses at the time of vaccination.  In the afternoon of 06-Jun-2007, the child had a fever that was controlled with ibuprofen x 2 doses.  On 07-JUN-2007 at 10 pm, about 36 hours after vaccination, the patient broke out in raised, red, pruritic lesions the size of pennies.  His hands and feet became red and swollen.  The areas were still present the following morning on 08-Jun-2007.  The mother notified the doctor's office about the events on 08-Jun-2007 and was instructed to take the child to the emergency room.  It is reported that the child did not have any respiratory effects, shortness of breath or wheezing.  It was reported that the nurse asked the parents to follow up with her after visiting the ER, but she never heard back.  The patient outcome was unknown.  Additional information is expected.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC, DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Erythema, No reaction on previous exposure to drug, Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-month-old male in which the mother denied any allergies, birth defects and medical conditions, who had a history of "red swollen spots about the size of a penny on his body", and no adverse events following prior vaccinations.  On 06-JUN-2007 at 2 pm, he was vaccinated subcutaneously in the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657301/0473U).  Concomitant vaccinations on 06-Jun-2007 at 2 pm included an intramuscular first dose in the right anterior thigh of Vaqta (MSD) (Lot # 656320/1281F), an intramuscular second dose in the right anterior thigh of PEDIARIX (lot# AC21B074BA), an intramuscular second dose in the left anterior thigh of ACTHIB (SANOFI PASTEUR) (lot# UFO10AA), and an intramuscular second dose in the left anterior thigh of PREVNAR (lot# UFO1OAA).  There were no illnesses at the time of vaccination.  In the afternoon of 06-Jun-2007, the child had a fever that was controlled with ibuprofen x 2 doses.  On 07-JUN-2007 at 10 pm, about 36 hours after vaccination, the patient broke out in raised, red, pruritic lesions the size of pennies.  His hands and feet became red and swollen.  The areas were still present the following morning on 08-Jun-2007.  The mother notified the doctor's office about the events on 08-Jun-2007 and was instructed to take the child to the emergency room.  It is reported that the child did not have any respiratory effects, shortness of breath or wheezing.  It was reported that the nurse asked the parents to follow up with her after visiting the ER, but she never heard back.  The patient outcome was unknown.  Additional information is expected.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC, DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-month-old male in which the mother denied any allergies, birth defects and medical conditions, who had a history of "red swollen spots about the size of a penny on his body", and no adverse events following prior vaccinations.  On 06-JUN-2007 at 2 pm, he was vaccinated subcutaneously in the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657301/0473U).  Concomitant vaccinations on 06-Jun-2007 at 2 pm included an intramuscular first dose in the right anterior thigh of Vaqta (MSD) (Lot # 656320/1281F), an intramuscular second dose in the right anterior thigh of PEDIARIX (lot# AC21B074BA), an intramuscular second dose in the left anterior thigh of ACTHIB (SANOFI PASTEUR) (lot# UFO10AA), and an intramuscular second dose in the left anterior thigh of PREVNAR (lot# UFO1OAA).  There were no illnesses at the time of vaccination.  In the afternoon of 06-Jun-2007, the child had a fever that was controlled with ibuprofen x 2 doses.  On 07-JUN-2007 at 10 pm, about 36 hours after vaccination, the patient broke out in raised, red, pruritic lesions the size of pennies.  His hands and feet became red and swollen.  The areas were still present the following morning on 08-Jun-2007.  The mother notified the doctor's office about the events on 08-Jun-2007 and was instructed to take the child to the emergency room.  It is reported that the child did not have any respiratory effects, shortness of breath or wheezing.  It was reported that the nurse asked the parents to follow up with her after visiting the ER, but she never heard back.  The patient outcome was unknown.  Additional information is expected.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEPA, PNC, HBHEPB, HEPA, MMRV, PNC
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old female with no medical history or allergies who on 29-MAY-2007 at 9:00 AM was vaccinated IM on right thigh with a first dose ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657537/0476U).  Concomitant therapy on the same day and time included a IM first dose on left thigh of Vaqta (MSD) (Lot # 656497/1213F), a third IM dose on right thigh of Comvax (OMPC) (MSD) (Lot # 654908/0999F) and a fourth IM dose on left leg of PREVNAR (Lot # B08684K).  There was no illness at the time of vaccination.  On 03-JUN-2007 5 days after vaccination patient developed fever.  On approximately 05-JUN-2007, 2 days after patient developed chickenpox.  No medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from the nurse practitioner who stated that 5 days after vaccination the patient developed fever and after 7 days had varicella.  The patient recovered on 10-JUL-2007.  There was no adverse event following prior vaccination for the patient and her sibling.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEPA, PNC, HBHEPB, HEPA, MMRV, PNC
Symptoms: Incorrect route of drug administration, No reaction on previous exposure to drug, Pyrexia, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old female with no medical history or allergies who on 29-MAY-2007 at 9:00 AM was vaccinated IM on right thigh with a first dose ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657537/0476U).  Concomitant therapy on the same day and time included a IM first dose on left thigh of Vaqta (MSD) (Lot # 656497/1213F), a third IM dose on right thigh of Comvax (OMPC) (MSD) (Lot # 654908/0999F) and a fourth IM dose on left leg of PREVNAR (Lot # B08684K).  There was no illness at the time of vaccination.  On 03-JUN-2007 5 days after vaccination patient developed fever.  On approximately 05-JUN-2007, 2 days after patient developed chickenpox.  No medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from the nurse practitioner who stated that 5 days after vaccination the patient developed fever and after 7 days had varicella.  The patient recovered on 10-JUL-2007.  There was no adverse event following prior vaccination for the patient and her sibling.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, IPV, MMRV, PNC, DTAP, HIBV, IPV, MMRV
Symptoms: Erythema, Measles antibody negative, Pyrexia, Rash morbilliform, Rash papular
Clinical narrative: Information has been received from a physician concerning a 16 month old female who on 27-JUL-2007 was vaccinated with a 0.5 ml dose of PROQUAD (Lot # ). On 05-AUG-2007 the patient developed a rash on forehead that spread to rest of her body. It was reported that the patient's fever went up to 103 degrees. The physician diagnosed with measles. Unspecified medical attention was sought. At the time of report had recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/6/2007.  Information has been received from a physician concerning a 16 month old female with no medical history or allergies who on 27-JUL-2007 evening was vaccinated with a first 0.5 ml dose of PROQUAD (Merck) (Lot # 656311/0296U).  Concomitant therapy included a third dose of INFANRIX (Lot # AC148044AA), a third dose of poliovirus vaccine (Wyeth) (Lot # AVB205272) and a third dose of Hib conj vaccine (OMPC) (MSD) (Lot # 655397/0073U).  There was no illness at the time of vaccination.  On 05-AUG-2007 the patient developed a rash on forehead that spread to the rest of her body.  It was reported that the patient's fever went up to 103 degrees.  The physician diagnosed the patient with measles.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been received from the physician who stated that the patient developed measles like rash and fever to 103 that required an office visit and numerous phone calls.  The rash was reported as multiformed with red papules that began on face and progressed.  The fever began on 05-AUG-2007 and the rash on 07-AUG-2007.  At the time of report the patient had recovered.  There was no adverse event following prior vaccination for patient.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, IPV, MMRV, PNC, DTAP, HIBV, IPV, MMRV
Symptoms: Measles, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 month old female who on 27-JUL-2007 was vaccinated with a 0.5 ml dose of PROQUAD (Lot # ). On 05-AUG-2007 the patient developed a rash on forehead that spread to rest of her body. It was reported that the patient's fever went up to 103 degrees. The physician diagnosed with measles. Unspecified medical attention was sought. At the time of report had recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/6/2007.  Information has been received from a physician concerning a 16 month old female with no medical history or allergies who on 27-JUL-2007 evening was vaccinated with a first 0.5 ml dose of PROQUAD (Merck) (Lot # 656311/0296U).  Concomitant therapy included a third dose of INFANRIX (Lot # AC148044AA), a third dose of poliovirus vaccine (Wyeth) (Lot # AVB205272) and a third dose of Hib conj vaccine (OMPC) (MSD) (Lot # 655397/0073U).  There was no illness at the time of vaccination.  On 05-AUG-2007 the patient developed a rash on forehead that spread to the rest of her body.  It was reported that the patient's fever went up to 103 degrees.  The physician diagnosed the patient with measles.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been received from the physician who stated that the patient developed measles like rash and fever to 103 that required an office visit and numerous phone calls.  The rash was reported as multiformed with red papules that began on face and progressed.  The fever began on 05-AUG-2007 and the rash on 07-AUG-2007.  At the time of report the patient had recovered.  There was no adverse event following prior vaccination for patient.
Age: 5.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who, on 05-SEP-2007 was vaccinated with GARDASIL (Lot # not reported). It was reported that the patient fainted about ten minutes after (also reported as "immediately after injection") receiving her first dose of GARDASIL. She continued to feel light headed 40 minutes later but went home. As of 06-SEP-2007, the outcome of the patient's fainting and light-headedness was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/8/2007. Initial and follow-up information has been redeived from two physicians concerning a female with gastrooesophageal reflux disease who, on 05-SEP-2007, at 16:00 was vaccinated IM, into left arm, with a first 0.5 ml dose of GARDASIL (Lot # 658558/1061U). Concomitant therapy included PREVACID. On 05-SEP-2007, at 16:12, (previously reported as "immediately after injection") the patient complained to her mother about feeling "very dizzy." The patient fainted and went unconscious. The patient was laid on the floor with legs elevated. In less than a minute the patient began to rouse. It was reported that she was "in and out" for a few minute. She was given sips of coke. After 40 minutes she was still too dizzy to stand. She was sent to the emergency room. The outcome of dizziness was unknown. Additional information is not expected.