chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Enema administration, Intensive care, Intussusception, Lymphocyte count decreased, Mucous stools
Clinical narrative: Information has been received from the FDA (VAERS # 279026) through the CDC concerning a 14-week-old male who on 08-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656102/1165F). On 13-MAY-2007 the patient experienced intussusception. A gut resection was done. A standard lot check investigation was performed for Lot # 656102/1165F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Occult blood, Surgery, Vomiting, X-ray
Clinical narrative: Information has been received from the FDA (VAERS # 279026) through the CDC concerning a 14-week-old male who on 08-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656102/1165F). On 13-MAY-2007 the patient experienced intussusception. A gut resection was done. A standard lot check investigation was performed for Lot # 656102/1165F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intestinal resection, Intussusception, Surgery
Clinical narrative: Information has been received from the FDA (VAERS # 279026) through the CDC concerning a 14-week-old male who on 08-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656102/1165F). On 13-MAY-2007 the patient experienced intussusception. A gut resection was done. A standard lot check investigation was performed for Lot # 656102/1165F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium double contrast, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information has been received from the FDA (VAERS # 279032) through the CDC concerning a 17-week-old female who on 07-NOV-2006 was vaccinated with a second dose of Rotateq (Lot # 654664/0726F). On 13-NOV-2006 the patient experienced intussusception. A barium enema was done. A standard lot check investigation was performed for Lot # 654664/0726F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium enema, Intussusception, X-ray
Clinical narrative: Information has been received from the FDA (VAERS # 279032) through the CDC concerning a 17-week-old female who on 07-NOV-2006 was vaccinated with a second dose of Rotateq (Lot # 654664/0726F). On 13-NOV-2006 the patient experienced intussusception. A barium enema was done. A standard lot check investigation was performed for Lot # 654664/0726F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Contraception, Convulsion, Drug screen negative, Full blood count normal
Clinical narrative: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of bladder. ER physician said she had a seizure.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Laboratory test normal, Loss of consciousness, Mood swings, Pain, Pollakiuria
Clinical narrative: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of bladder. ER physician said she had a seizure.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Pregnancy test urine negative, Respiratory arrest, Urinary incontinence, Urine analysis normal
Clinical narrative: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of bladder. ER physician said she had a seizure.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Drug screen negative, Full blood count normal, Laboratory test normal
Clinical narrative: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of bladder. ER physician said she had a seizure.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Respiratory arrest, Urinary incontinence, Urine analysis normal
Clinical narrative: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of bladder. ER physician said she had a seizure.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Tremor
Clinical narrative: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of bladder. ER physician said she had a seizure.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Urinary incontinence, Urine analysis normal, Wheezing
Clinical narrative: first shot of series of 3 of Gardasil vaccine given on 05/28/2007. 4 days later, she collapsed, was trembling and shaking with eyes open, wheezing and loss of bladder. ER physician said she had a seizure.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Seizure-like behavior following vaccination, passed out, ongoing rapid heart beat, weakness, "just doesn't feel normal", lower abdominal/pelvic pain
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Asthenia, Blood test, Convulsion, Feeling abnormal
Clinical narrative: Seizure-like behavior following vaccination, passed out, ongoing rapid heart beat, weakness, "just doesn't feel normal", lower abdominal/pelvic pain
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Heart rate increased, Loss of consciousness, Pelvic pain
Clinical narrative: Seizure-like behavior following vaccination, passed out, ongoing rapid heart beat, weakness, "just doesn't feel normal", lower abdominal/pelvic pain
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site reaction, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Adacel/Tdap given on 6/19/07. Symptoms started 6/24/07. Extreme soreness in right arm shoulder arthralgia and crepitus extending to her right clavicle. Crepitus subsided in one day, pain subsided in two days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Amenorrhoea, Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from a physician for the Pregnancy Registry for Gardasil concerning a 16 year old female with no medical history or previous pregnancies who on 13-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil (lot # 655165/0137U). Concomitant therapy included pre-natal vitamins. On 01-MAY-2007 a pregnancy test was performed because of amenorrhea and found to be positive with an HCG results of 29576. The estimated conception date was 7 weeks and the estimated delivery date was 22-DEC-2007 (LMP was not known). On 16-MAY-2007, an additional HCG test was performed with a result of 74136. The patient sought unspecified medical attention. In May 2007, the patient experienced a spontaneous abortion. It was noted that the patient was currently under a physician's care and that she was permitted to return to normal activities without limitations. At the time of this report, the outcome was unknown. No further information is available.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Full blood count normal, Metabolic function test normal
Clinical narrative: Received vaccines on 6-29-07. Onset of fever with cough & respiratory symptoms & SOB (inspiratory stidor) after 12-24 hours. 7/26/07-records received from PCP-seen in office 7/5/07-for follow-up after hospitalization for croup. Coughing but is more of a congestive cough. No more fevers. PE unremarkable. Tubes are in place. Assessment:croup improved. Note for 7/9/07- seen for upper respiratory infection fever up to 101 but at office 98.2. Nebulizer treatment. Harsh grade 3/6 systolic murmur heard.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC
Symptoms: Pyrexia, Stridor, Virus serology test
Clinical narrative: Received vaccines on 6-29-07. Onset of fever with cough & respiratory symptoms & SOB (inspiratory stidor) after 12-24 hours. 7/26/07-records received from PCP-seen in office 7/5/07-for follow-up after hospitalization for croup. Coughing but is more of a congestive cough. No more fevers. PE unremarkable. Tubes are in place. Assessment:croup improved. Note for 7/9/07- seen for upper respiratory infection fever up to 101 but at office 98.2. Nebulizer treatment. Harsh grade 3/6 systolic murmur heard.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site swelling, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: Patient received vacc on 6/8/07. Returned to clinic on 6/11/07 to report that the evening at vacc the began having fever, chills, nausea, arm pain. SX resolved by 6/11/07 but right arm still swollen and warm at injection site.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient received vacc on 6/8/07. Returned to clinic on 6/11/07 to report that the evening at vacc the began having fever, chills, nausea, arm pain. SX resolved by 6/11/07 but right arm still swollen and warm at injection site.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site rash, Rash, Rash vesicular
Clinical narrative: Varicella after Varivax rash on stomach, chest - arms -legs and injection site. Varicella like lesions onset 7-1-07. Resolved by 7-10-07
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood pressure decreased, Nausea, Syncope
Clinical narrative: Fainted/nausea/decreased BP - Trendelenberg used. Unable to get a B/P but pt was alert. B/P after 10 min was 100/58 (normal per pt)
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electroencephalogram, Hyperhidrosis, Neurological examination, Presyncope
Clinical narrative: First Gardasil given 2-14-07 pt returned 4-11-07. Informed nurse of episode of dizziness severe with diaphoresis - near syncope - within 3 days of 1st injection - ER visit - DX possible seizure - referred to neurology. Neuro cleared pt feels not related to Gardasil event occurred actually 3wks after injection.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: C/O deep pain at site of injection, and arm weakness
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Eczema, Psoriasis, Rash
Clinical narrative: 3-4 weeks after her Gardasil shot (#1) She began exhibiting a rash which escalated over the next 5-6 weeks until she was covered with psoriasis and eczema on her arms (upper and lower), her legs (upper and lower), tops of her feet and hands, her neck, and slightly on her torso, body and face.
Age: 1.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Blister, Inappropriate schedule of drug administration, Rash papular, Varicella
Clinical narrative: Varicella vaccine breakthrough. Diagnosed with Varicella 7-5-07. Had about 20 vesicles and papules. Afebrile.
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hepatitis B surface antigen, Injection site swelling, Rash macular, Urticaria
Clinical narrative: Gave baby Hep B shot in R thigh IM. Immediately sit of injection swelled and rest of body got red and hives. Shot was given at 0633. Called Dr ordered Benadryl. Gave Benadryl at 0659. Then redness, and blotches started to go away. No respiratory difficulty at time of reaction.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hypoaesthesia, Pain
Clinical narrative: Pain in the bones and all the body. Headache all the time. Numbness in the arms.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness
Clinical narrative: At 9:45 AM pt received ordered vaccines Menactra and Hepatitis A. Prior to shots, pt screened with history of passing out or problems with shots. None noted by pt or parent. Pt stated she ate breakfast prior to app shots given. After last shot pt stated she felt fine. Pt sat for a few seconds got up easily with steady gait. Pt passed out while checking out mom caught her no head or body injury occurred. Doctor and physicians assistant notified of this. Pt BP rechecked 105/65 at 9:45 am, 108/71 at 10 am, 110/74 at 10:10 am. CPA assessed pt and ok'd her to leave office.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Child received Dtap 7-9-07 seen in office 7-11-07 with rash noted where Dtap given on thigh - large rash right thigh. No cellulitis. Fever was present at visit. No itching at site.
Age: 1.0
Sex: F
Vaccine: MMRV, HIBV, MMRV, PPV
Symptoms: Rash maculo-papular
Clinical narrative: Pt developed maculopapular rash
Age: 1.0
Sex: F
Vaccine: MMRV, HIBV, MMRV, PPV
Symptoms: Diet refusal, Inappropriate schedule of drug administration, Insomnia, Pruritus, Rash
Clinical narrative: Pt developed maculopapular rash
Age: 1.0
Sex: F
Vaccine: MMRV, HIBV, MMRV, PPV
Symptoms: Rash maculo-papular
Clinical narrative: CHILD DEVELOPED RASH, ITCH, DECREASED SLEEPING AND NOT EATING ABOUT NOON ON 6/22/07.  MOTHER TOOK HER TO HOSPITAL ER 6/23 am. MOTHER SAYS NO LABWORK WAS DONE. TEMP WAS 36.8 CELSIUS. DIPHENHYDRAMINE WAS DISPENSED FOR ITCH.
Age: 1.0
Sex: F
Vaccine: MMRV, HIBV, MMRV, PPV
Symptoms: Diet refusal, Inappropriate schedule of drug administration, Insomnia, Pruritus, Rash
Clinical narrative: CHILD DEVELOPED RASH, ITCH, DECREASED SLEEPING AND NOT EATING ABOUT NOON ON 6/22/07.  MOTHER TOOK HER TO HOSPITAL ER 6/23 am. MOTHER SAYS NO LABWORK WAS DONE. TEMP WAS 36.8 CELSIUS. DIPHENHYDRAMINE WAS DISPENSED FOR ITCH.
Age: 18.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Error - gave Pediarix instead of Hep B no immediate symptoms.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Hypersensitivity, Lethargy, Rash
Clinical narrative: Pt presented to the medical clinic on 6/26/07 for follow up after ER visit on 6/25/07 in which patient was treated for an allergic reaction to include visible rash with Epi Pen and Benadryl. On presentation on 6/26/07 he continued to c/o lethargy and was given IV NS at that time with improvement in sx. noted. Pt had received Anthrax and Hep B vaccination the previous day.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Temperature 103(AURAL)within 5 hours of receiving vaccinations on 09 July 07; 24 hours later fever had resolved and approx. 3 in circumference red, warm, swollen area ("hard as a rock") appeared on (R) lateral thigh. Seen on 11 Jul 07, diagnosed cellulitis, prescribed ice, motrin and Cephalexin. Telephonic contact with Mother on 12 July 07: patient did not start Cephalexin but all symptoms have fully resolved.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia, Tongue disorder
Clinical narrative: 7-4-07 Numbness started on lt side of face and progressed to entire face.  Tongue felt thick. Numbness worsened with time.  7-9-07 In the middle of night, client felt prickling and numbness in both arms.  Saw PCP next am.  The sensation had resolved by the time of the drs visit.  7-12-07 Spoke with client this am, symptoms some better.  At this time the only area affect is her chin and jaw.
Age: 53.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Rash with itching noted to left armpit and left back 5 days after vaccination.  Employee presents to Employee Health on 7/5/07 and placed on Administrative Leave.  Employee rec'd follow-up care from PCP beginning 7/9/07.  PCP diagnosis of Herpes Zoster.  Treatment includes Acyclovir, Tylenol and Benedryl.  Employee with continued rash/itching at time of this writing.  Employee advised by PCP against having 2nd Varicella vaccination in 30 days.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Cold compress therapy, Cold sweat, Heart rate, Pallor
Clinical narrative: Pt. given vaccine, was in the process of checking out and became fainty, clammy, poor skin color, would not acknowldege questions asked or instructions. BP at that time was 70/40, with a pulse of 50. Cold compresses applied to forehead, fan was turned to pt.,coke and saltines to pt. BP 10 minutes later was 86/58 , pulse 74. Pt. continued to rest and vitals again taken after 10 minutes-BP 90/60 and pulse 74. Pt. was no longer clammy, was speaking when spoken to, color good.Stated that she had not eaten anything this am. Felt better and was told to call the office prn.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt. given vaccine, was in the process of checking out and became fainty, clammy, poor skin color, would not acknowldege questions asked or instructions. BP at that time was 70/40, with a pulse of 50. Cold compresses applied to forehead, fan was turned to pt.,coke and saltines to pt. BP 10 minutes later was 86/58 , pulse 74. Pt. continued to rest and vitals again taken after 10 minutes-BP 90/60 and pulse 74. Pt. was no longer clammy, was speaking when spoken to, color good.Stated that she had not eaten anything this am. Felt better and was told to call the office prn.
Age: 12.0
Sex: F
Vaccine: HPV4, TD
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mother reportrd patient's arm swollen to the size of a lemon at the injection site and is sore. The swelling started after the shot but was larger today. The area is not warm to touch. No fever. The patient does not feel bad. Dr advise to use 500mgs of Tylenol 2-3 times a day for 2-3days and warm compresses to the site several times a day till the swelling resolves.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: STARTED EVENING OF 6/13/07 WITH A "PIMPLY RASH" ACROSS SHOULDERS AND A 2 INCH IN DIAMETER CIRCLE ON CHEEK. NEXT MORNING SPREAD TO OTHER CHEEK AND DOWN NECK, BACK AND TORSO, "MACULAR AND PAPULAR IN APPEARANCE." THIRD DAY SPREAD TO LEGS. WOKE UP ON DAY FOUR AND RASH WAS GONE.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Chromaturia, Contusion, Haematoma, Jaundice
Clinical narrative: TEMP. 103 ON 6/30/07, ITERIC, ORANGE URINE, BRUISES WITH HEMATOMAS 8/27/07-records received for DOS 07/02-07/06/07-DC DX: Hemolytic anemia and thrombocytopenia, likely secondary to adverse reaction from Hepatitis B vaccine. Jaundice secondary to hemolytic anemia. Hyperglycemia secondary to oral steroids and dextros containing intravenous fluids. Admitted after complaining of jaundice and bruising. Markedly thrombocytopenic along with anemia and elevated bilibrubin consistent with hemolytic anemia.  C/O weakness fatigue, subjective fever. Positive for scleral icterus, headache, chills, bruising and occasional gum bleeding, urine has become dark.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Dtap given instead of Tdap for childs age.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Heart rate normal
Clinical narrative: A seizure that lasted about 5 seconds occured 5 to 10 minutes after the meningococcal vaccine was given.  Patient was taken back to doctor and heart rate was monitored for a half hour and everything was normal.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood glucose normal, Nausea, Pallor, Syncope, Vomiting
Clinical narrative: Became pale and nauseated after vaccines were given. Vomited a small amount clear mucus. Appeared to faint, then would not respond. Vitals normal. Paramedics called. After 20 minutes he was responding (stood up and talking).Mother decided not to seek treatment at hospital and signed release.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray normal, Full blood count normal, Lumbar puncture, Meningitis aseptic, Metabolic function test
Clinical narrative: Fever 104F, nasal congestion. Hospitaliced SCIU @ Hospital. CBC (normal),BMP,CXR(normal),UA(normal), Spinal tad done. Treated Ceftrioxone, IV ampicillin, IV cefotaxime and IV fluids. Afebrile while admitted, normal feeding, no vomiting. diagnosed aseptic meningitis 8/2/07-records received for DOS 5/2-5/8/07- DC DX: Aseptic meningitis. Chief complaint: fever 104, nasal congestion. Lethargic, weak. No vomiting.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Nasal congestion, Pyrexia, Urine analysis normal
Clinical narrative: Fever 104F, nasal congestion. Hospitaliced SCIU @ Hospital. CBC (normal),BMP,CXR(normal),UA(normal), Spinal tad done. Treated Ceftrioxone, IV ampicillin, IV cefotaxime and IV fluids. Afebrile while admitted, normal feeding, no vomiting. diagnosed aseptic meningitis 8/2/07-records received for DOS 5/2-5/8/07- DC DX: Aseptic meningitis. Chief complaint: fever 104, nasal congestion. Lethargic, weak. No vomiting.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Deafness, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Lightheadedness, dizziness, blackout, temporary loss of hearing, chills and sweats.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Blood test, Cardiac stress test normal, Chest pain, Dyspepsia
Clinical narrative: Felt sick and weak for 3 days right after shot. Frequent heartburn (acid reflux), chest pains, heart palpitations, insomnia, pains in head, and pains in left arm and left shoulder where shot was administered that lasted for approximately 3 months. 1 20 mg tablet of Prilosec (1-2 times a day) for 2 months Ketoconazole 2% shampoo applied to scalp 2-3 times per week Clobetasol topical solution applied to scalp once a day
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Electrocardiogram ambulatory normal, Electrocardiogram normal, Endoscopy normal, Gastrooesophageal reflux disease, Headache
Clinical narrative: Felt sick and weak for 3 days right after shot. Frequent heartburn (acid reflux), chest pains, heart palpitations, insomnia, pains in head, and pains in left arm and left shoulder where shot was administered that lasted for approximately 3 months. 1 20 mg tablet of Prilosec (1-2 times a day) for 2 months Ketoconazole 2% shampoo applied to scalp 2-3 times per week Clobetasol topical solution applied to scalp once a day
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: High density lipoprotein decreased, Insomnia, Malaise, Pain in extremity, Palpitations
Clinical narrative: Felt sick and weak for 3 days right after shot. Frequent heartburn (acid reflux), chest pains, heart palpitations, insomnia, pains in head, and pains in left arm and left shoulder where shot was administered that lasted for approximately 3 months. 1 20 mg tablet of Prilosec (1-2 times a day) for 2 months Ketoconazole 2% shampoo applied to scalp 2-3 times per week Clobetasol topical solution applied to scalp once a day
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Back pain, C-reactive protein increased
Clinical narrative: Patient experienced pain about vaccination site (Adacel) followed by radiating pain to shoulder and neck over several days. Vaccine given on 5/11/07. Over the next several weeks she experienced worsening pain that radiated to her back, hips and lateral aspect of her knees. Pain was severe enough to decrease activity and cause an antalgic gait. She had no objective weakness, ataxia or other neurologic finding but did have weakness in her hip extensor/flexors on exam 7 weeks after vaccine reciept. Labs drawn on 6/20 - at time of evaluation for pain revealed a CRP that was elevated at 71 and a ESR of 30 that was drawn at the same time. Repeat CRP today is pending. Labs suggestive of a more global inflammatory response.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Inflammation, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Patient experienced pain about vaccination site (Adacel) followed by radiating pain to shoulder and neck over several days. Vaccine given on 5/11/07. Over the next several weeks she experienced worsening pain that radiated to her back, hips and lateral aspect of her knees. Pain was severe enough to decrease activity and cause an antalgic gait. She had no objective weakness, ataxia or other neurologic finding but did have weakness in her hip extensor/flexors on exam 7 weeks after vaccine reciept. Labs drawn on 6/20 - at time of evaluation for pain revealed a CRP that was elevated at 71 and a ESR of 30 that was drawn at the same time. Repeat CRP today is pending. Labs suggestive of a more global inflammatory response.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Patient experienced pain about vaccination site (Adacel) followed by radiating pain to shoulder and neck over several days. Vaccine given on 5/11/07. Over the next several weeks she experienced worsening pain that radiated to her back, hips and lateral aspect of her knees. Pain was severe enough to decrease activity and cause an antalgic gait. She had no objective weakness, ataxia or other neurologic finding but did have weakness in her hip extensor/flexors on exam 7 weeks after vaccine reciept. Labs drawn on 6/20 - at time of evaluation for pain revealed a CRP that was elevated at 71 and a ESR of 30 that was drawn at the same time. Repeat CRP today is pending. Labs suggestive of a more global inflammatory response.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Hypokinesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: vaccine given at 10:30am in treatment room. soreness of right arm at injection site within 4 hours, painful to lift overhead. within 8 hours suffering headache, neck stiffness & several (3) periods of tingling sensations in the left leg (lasting 10 minutes each or so)and a spell of itchiness. 12 hours after injection, went to bed with headache (still), fever & chills. restless night. fever of 102F at 7AM (22 hours after shot).  went back to sleep and was difficult to wake. i called doctor -- mentioned my concerns over a reaction of some sort & was told this vaccine did not cause these symptoms. i scheduled an appointment because this was not normal for patient and i was not quite sure what to do. by noon, most symptoms were gone except for the headache. we saw the doctor who pronounced her fine & told us to watch for other symptoms of illness. he told us that it was not the vaccine, but would note my concerns on her file as a precaution. this was the 3rd and final injection of this vaccine, she had only soreness at the injection sight with the first two shots. she took an aleve around 8pm the night of the shot & 2 motrins - 6 hours apart - the next day because of the headache. no relief was provided by the pills.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Paraesthesia, Pruritus, Pyrexia, Restlessness
Clinical narrative: vaccine given at 10:30am in treatment room. soreness of right arm at injection site within 4 hours, painful to lift overhead. within 8 hours suffering headache, neck stiffness & several (3) periods of tingling sensations in the left leg (lasting 10 minutes each or so)and a spell of itchiness. 12 hours after injection, went to bed with headache (still), fever & chills. restless night. fever of 102F at 7AM (22 hours after shot).  went back to sleep and was difficult to wake. i called doctor -- mentioned my concerns over a reaction of some sort & was told this vaccine did not cause these symptoms. i scheduled an appointment because this was not normal for patient and i was not quite sure what to do. by noon, most symptoms were gone except for the headache. we saw the doctor who pronounced her fine & told us to watch for other symptoms of illness. he told us that it was not the vaccine, but would note my concerns on her file as a precaution. this was the 3rd and final injection of this vaccine, she had only soreness at the injection sight with the first two shots. she took an aleve around 8pm the night of the shot & 2 motrins - 6 hours apart - the next day because of the headache. no relief was provided by the pills.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: vaccine given at 10:30am in treatment room. soreness of right arm at injection site within 4 hours, painful to lift overhead. within 8 hours suffering headache, neck stiffness & several (3) periods of tingling sensations in the left leg (lasting 10 minutes each or so)and a spell of itchiness. 12 hours after injection, went to bed with headache (still), fever & chills. restless night. fever of 102F at 7AM (22 hours after shot).  went back to sleep and was difficult to wake. i called doctor -- mentioned my concerns over a reaction of some sort & was told this vaccine did not cause these symptoms. i scheduled an appointment because this was not normal for patient and i was not quite sure what to do. by noon, most symptoms were gone except for the headache. we saw the doctor who pronounced her fine & told us to watch for other symptoms of illness. he told us that it was not the vaccine, but would note my concerns on her file as a precaution. this was the 3rd and final injection of this vaccine, she had only soreness at the injection sight with the first two shots. she took an aleve around 8pm the night of the shot & 2 motrins - 6 hours apart - the next day because of the headache. no relief was provided by the pills.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Seen 2 days later at clinic with severe swelling in Left arm, where IPV (aventis) and DTap (sanofi) were given.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Back pain, Hyperhidrosis, Nausea, Neck pain
Clinical narrative: c/o sore neck and back, nausea and sweating 7/10. 7/11 - some better, still no fever, cont. to have nausea and sweating. 7/12 feels better.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt got hives and a low grade fever mom gave pt Benadryl and the hives went away.
Age: 0.5
Sex: F
Vaccine: HEP, PNC, RV5
Symptoms: Erythema, Injection site erythema, Injection site reaction, Pyrexia, Rash
Clinical narrative: Vaccines Pediarix given in R thigh on 7/5/07 2d later onset fever Tm 99 ax, red "bump" at injection site appeared 3d after inj. Pt seen on 7/11/07 Dx injx vs focal rxn. Started on Keflex x 10d.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Back of R upper arm - redness area 8cm x 4cm with slight edema, pain at site - SQ injection of Varicella
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy, Nausea
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pt 1hr complains of generalized itching particularly in upper torso, no redness, no rash, occurred about 1 wk after vaccine still persists 1 month later.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension
Clinical narrative: Acute onset dizziness and documented hypotension
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Contusion, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Started swelling and redness shortly after Varicella immunization. Continued to swell, itch and increased skin temp. Area 12cm x 10.5cm with bruising in area.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Injection site induration
Clinical narrative: Inconsolable crying x 6 hours - 2 hours after receiving vaccines. (+) 2cm induration right ant thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Healthy 4 year old well child visit. One hour after receiving vaccines developed fever 102.8 (Tympanic) and bilateral leg pain. Symptoms lasted 48 hours.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting projectile
Clinical narrative: Patient did not like the oral vaccine before administering all of the vaccine - she projectile vomited quite a lot of formula vomiting continued next morning.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Monoplegia, Postictal state
Clinical narrative: 1 Week after MMR patient had a 20 minute seizure. No fever. Was treated with Diastate and in emergency room was postictal and had brief left arm paralysis. Recovered over 2 days then back to normal.
Age: 1.1
Sex: F
Vaccine: PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Awoke at 5:40 am seizure. Seizure lasted about 20 minutes. Was afebrile at the time but had a fever by the afternoon. Was evaluated in emergency room - postictal but otherwise fine.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Convulsion, Viral pharyngitis
Clinical narrative: 2 Days after getting Varivax. Patient had first a brief seizure (20 seconds) and then a longer seizure (20 minutes). Was evaluated in ER - had temp 101 and viral pharyngitis.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Infanrix given to adult patient. She is without complaints.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Swelling
Clinical narrative: Secondary swelling (? cellulitis) - left thigh, started antibiotics
Age: 1.0
Sex: F
Vaccine: IPV, MMRV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old white female, who on 23-JAN-2007 was vaccinated with an IM dose of Proquad (lot number "0215F" not valid for this vaccine). There was no concomitant medications. it was reported that on 24-JAN-2007 the patient developed redness at the injection site. The next day a measle rash started on her face, then spread to the entire body. Subsequently, the patient recovered from the measles rash with no medical treatment. Unspecified medical attention was sought. No laboratory tests were performed. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: IPV, MMRV, MMRV
Symptoms: Injection site erythema, Rash generalised, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old white female, who on 23-JAN-2007 was vaccinated with an IM dose of Proquad (lot number "0215F" not valid for this vaccine). There was no concomitant medications. it was reported that on 24-JAN-2007 the patient developed redness at the injection site. The next day a measle rash started on her face, then spread to the entire body. Subsequently, the patient recovered from the measles rash with no medical treatment. Unspecified medical attention was sought. No laboratory tests were performed. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: HIBV, MMRV, MMRV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) concerning a 14-month-old female with no medical history or allergies, who on 22-FEB-2007 was vaccinated subcutaneously in the left thigh with a 0.5 ml dose of MMRV (lot# 656641/1555F). Concomitant therapy included azithromycin (ZITHROMAX) given for a resolving ear infection. On 06-MAR-2007 the patient became "completely red and blotchy from head to toe". Medical attention was sought and the nurse practitioner diagnosed her with measles. At the time of the report the patient was recovering. The nurse requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency.  Additional information has been received from a physician concerning a 13 month old female with AMOXICILLIN allergy and a history of rash who on 23-FEB-2007 was vaccinated with the first dose of MMRV (Oka/Merck upgrade process) (lot # 658641/1855P), SQ in the left thigh and the third dose of pedvax HIB (Lot #654677/1124F), IM in the right thigh. On 05-MAR-2007 the patient experienced dark pink macular papular rash diffusely scattered throughout body, on head, somewhat spared in diaper area and feet, none in mouth. It was reported that hips and right arm had confluent rash and seems dry. The patient recovered from the event. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HIBV, MMRV, MMRV
Symptoms: Measles, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) concerning a 14-month-old female with no medical history or allergies, who on 22-FEB-2007 was vaccinated subcutaneously in the left thigh with a 0.5 ml dose of MMRV (lot# 656641/1555F). Concomitant therapy included azithromycin (ZITHROMAX) given for a resolving ear infection. On 06-MAR-2007 the patient became "completely red and blotchy from head to toe". Medical attention was sought and the nurse practitioner diagnosed her with measles. At the time of the report the patient was recovering. The nurse requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency.  Additional information has been received from a physician concerning a 13 month old female with AMOXICILLIN allergy and a history of rash who on 23-FEB-2007 was vaccinated with the first dose of MMRV (Oka/Merck upgrade process) (lot # 658641/1855P), SQ in the left thigh and the third dose of pedvax HIB (Lot #654677/1124F), IM in the right thigh. On 05-MAR-2007 the patient experienced dark pink macular papular rash diffusely scattered throughout body, on head, somewhat spared in diaper area and feet, none in mouth. It was reported that hips and right arm had confluent rash and seems dry. The patient recovered from the event. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMRV, HPV4
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 14 month old female, on 16-FEB-2007 (AM), was vaccinated in the left thigh with MMRV (Lot # 655267/0971E) There was no concomitant medication. On 28-FEB-2007 the patient developed papular lesions, one day prior to being seen by the doctor, and they continued to appear over her body. Unspecified medical attention was sought. At the time of the report the final outcome was unknown. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMRV, HPV4
Symptoms: Inappropriate schedule of drug administration, Rash papular
Clinical narrative: Information has been received from a physician concerning a 14 month old female, on 16-FEB-2007 (AM), was vaccinated in the left thigh with MMRV (Lot # 655267/0971E) There was no concomitant medication. On 28-FEB-2007 the patient developed papular lesions, one day prior to being seen by the doctor, and they continued to appear over her body. Unspecified medical attention was sought. At the time of the report the final outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Blood pressure decreased, Fall, Syncope
Clinical narrative: Intial and follow-up information has been received from a physician concerning a 16 year old healthy female who was vaccinated on an unspecified date with Gardasil (lot number unknown). Concomitant therapy included Menactra (lot # U200AC(. On an unspecified date the patient slumped over and fell to the floor after the physician administered Menactra vaccine first then Gardasil. They called 911 and the patient was taken to the hospital and released. She was not hospitalized. The patient outcome was not reported The patient recovered on 15-Mar-2007. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Intial and follow-up information has been received from a physician concerning a 16 year old healthy female who was vaccinated on an unspecified date with Gardasil (lot number unknown). Concomitant therapy included Menactra (lot # U200AC(. On an unspecified date the patient slumped over and fell to the floor after the physician administered Menactra vaccine first then Gardasil. They called 911 and the patient was taken to the hospital and released. She was not hospitalized. The patient outcome was not reported The patient recovered on 15-Mar-2007. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. No further information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no illness at time of vaccination and no medical history who on 03-APR-2007 was vaccinated in the left arm with a second dose of MMRV (lot ## 656887/0150U). Concomitant vaccination included Pediarix (lot# C2569AA) and Infanrix-IPV (lot# Z0923). On 04-APR-2007 the patient developed cellulitis on left arm. The patient sought unspecified medical attention. The patient was treated with sulfamethoxazole (+) trimethoprim (Bactrim). The patient recovered. No further information is available.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with no allergies or medical history who on 12-APR-2007 at 09:00 AM was vaccinated SC in the lower left leg with a first dose of MMRV. Concomitant vaccination at the same time included a third dose in the right leg of Prevnar (lot # B08689K) and an IM fourth dose in the upper left leg of ACTHIB (UF06AB). There was no other concomitant medication. There was no illness at the time of vaccination. On 21-APR-2007, at 09:00 AM, the patient woke with a rash consisting of about 10 large red spots that developed pustules and multiple smaller does with no pustules. The patient's temperature was 102.8 at highest. The patient was treated with acetaminophen (TYLENOL) and observed. He was improved by 23-APR-2007. No diagnostic laboratory tests were performed. It was also noted that the patient, at 8 weeks of age, had an adverse event following prior vaccination with a first dose of Prevnar consisting of local redness. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Body temperature increased, Rash erythematous, Rash pustular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with no allergies or medical history who on 12-APR-2007 at 09:00 AM was vaccinated SC in the lower left leg with a first dose of MMRV. Concomitant vaccination at the same time included a third dose in the right leg of Prevnar (lot # B08689K) and an IM fourth dose in the upper left leg of ACTHIB (UF06AB). There was no other concomitant medication. There was no illness at the time of vaccination. On 21-APR-2007, at 09:00 AM, the patient woke with a rash consisting of about 10 large red spots that developed pustules and multiple smaller does with no pustules. The patient's temperature was 102.8 at highest. The patient was treated with acetaminophen (TYLENOL) and observed. He was improved by 23-APR-2007. No diagnostic laboratory tests were performed. It was also noted that the patient, at 8 weeks of age, had an adverse event following prior vaccination with a first dose of Prevnar consisting of local redness. Additional information is not expected.
Age: 1.25
Sex: F
Vaccine: MMR, MMRV
Symptoms: Injection site erythema, Injection site rash, Rash generalised, Rash maculo-papular
Clinical narrative: Information has been received from the father of a 15 month old female who was vaccinated with ProQuad (Oka/Merck upgrade process) (Lot # "01434"). Subsequently the patient developed a "bad injection site reaction" and fever of 103 at day 9 post vaccination. The fever had to be controlled with acetaminophen (TYLENOL) or ibuprofen (MOTRIN) every 5 hours for almost 48 hours. It was reported that the child's fever had resolved. The injection site was still "looking bad" on day 12 postvaccination. Further information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Follow up information received from a licensed practical nurse indicated that on 08-APR-2007 the patient developed a maculopapular rash all over that was light red. There was also a bump around the injection site with increased redness. The patient had a fever of 102 to 103. The patient recovered on 10-APR-2007. No additional information is expected.
Age: 1.25
Sex: F
Vaccine: MMR, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from the father of a 15 month old female who was vaccinated with ProQuad (Oka/Merck upgrade process) (Lot # "01434"). Subsequently the patient developed a "bad injection site reaction" and fever of 103 at day 9 post vaccination. The fever had to be controlled with acetaminophen (TYLENOL) or ibuprofen (MOTRIN) every 5 hours for almost 48 hours. It was reported that the child's fever had resolved. The injection site was still "looking bad" on day 12 postvaccination. Further information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Follow up information received from a licensed practical nurse indicated that on 08-APR-2007 the patient developed a maculopapular rash all over that was light red. There was also a bump around the injection site with increased redness. The patient had a fever of 102 to 103. The patient recovered on 10-APR-2007. No additional information is expected.