chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Pruritus, Rash macular
Clinical narrative: Information has been received from a physician concerning a 19 year old female with depression, anxiety and hypercholesterolaemia and no history of drug reactions/allergies, who on 20 Nov 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (0.5 mL) (lot #653938/0954F). Concomitant therapy included Seasonale, Mevacor, Celexa, and Xlonopin. Concomitant vaccinations on 20 Nov 2006 included Menactra and influenza virus vaccine (unspecified). 0n 22 Nov 2006, the patient developed facial flushing and chin itching and burning. On 23 Nov 2006, the patient developed red spots on both hands and abdomen. On 23 Nov 2006, the patient sought medical attention at an emergency room while out of town. The patient was diagnosed with having an allergic reaction and administered Benadryl. The patient fully recovered on an unspecified date. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Asthenia, Injection site erythema, Injection site oedema, Pain, Pharyngeal oedema
Clinical narrative: Localized swelling and erythema, left deltoid. throat swelling and achy, weak legs.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Abnormal behaviour
Clinical narrative: Received Pediarix, Hib, Prevnar on 12/11/06 acting strangely after vaccine not interacting with parents normally per parents seems less engaged.
Age: 0.18
Sex: M
Vaccine: RVX
Symptoms: Choking, Cyanosis, Depressed level of consciousness, Respiratory rate decreased
Clinical narrative: 9 week old male given rotavirus IZ. 1st IZ (before any shots). Child immediately had decrease respiration and transient cyanosis and 5-10 mild decreased LOX. Looked stunned. No intervention NO O2, simple stimulation and holding, then fine other IZA given next day. Prof simple choking but did not have typical choking symptoms.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Laboratory test abnormal
Clinical narrative: Progressive weakness felt to be consistent with Guillain Barre Syndrome at this time he is still hospitalized so final outcome unknown.  MR received from ER admit for c/o progressive weakness in lower extremities.  Weakness began 1 ½-2 weeks prior to admission, which presented  as difficulty walking and progressed to inability to ambulate on the day of admission.  PE: WNL except diminished DTRs bilaterally in lower and upper extremities.  Decreased strength in lower extremities. The patient is noted to spontaneously move extremities, however is unable to upon request. Pt. was admitted and sent to acute rehab.  Was in hospital 22 days. DX: Guillain Barre Syndrome. Record also sent for re-admission for  altered mental status 2 days after discharge 2' to hypoglycemia and residual effects of narcotics.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Erythema, Wheezing
Clinical narrative: About 8 minutes after flu injection mother returned with client who was coughing, wheezing and face red. 10 minutes after injection evaluated by MD, Adrenalin 0.1 cc 1/1000 SQ. Evaluated by MD nebulizer treatment with xopenex 0.63 given. 20 minutes after injection (flu) Benadryl 25 mg PO. Admit to facility same day.   MR received from hospital for ER admit for anaphylactic reaction occuring within 30 minutes of flu vax.  Child initially began coughing and then had increased difficulty with breathing.  Child was brought back to pediatrician's office where he was given Benadryl and epinephrine and sent to the ER.  Upon arrival to the ED he was found to be wheezing. Txd with IV Benadryl, SoluMedrol, and H2 blocker and albuterol nebs PRN. Discharged in stable condition the next day. Discharge DX: Anaphylactic reaction to Influenza vaccine. 01/17/2007 PCP note received-no new MedDra codes.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Hypoxia, Livedo reticularis, Pyrexia
Clinical narrative: Child was given vaccines 1/8/07 and was febrile to 103, mottled and admitted to ICU. Baby has Hypoplastic left heart, on O2 N/O. 03/26/07-records received from facility for DOS 1/8-02/28/07 DC DX: Hypoaortic left heart syndrome. A-V fistula repair 1/18. Fever. Endocarditis. presented to ED with cyanosis and respiratory distress. Admitted for hypoxemia and febrile illness. Loose stools on date of admission. HX:Temp 103.5 in ED and pulse 180. Pulse Ox 73% with BB O2. Noted to be mottled with respitory distress. Seizures times three and results of A-V fistula.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Injection site pain, Pain, Paraesthesia
Clinical narrative: Tingling in fingers on L hand, aching and soreness from shot site (L del IM) down to finger tips. Started immediately. Also complaining for dry mouth. Unable to do BP, Pulse on 80, nailbeds reactive, due to breast cancer.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Viral infection
Clinical narrative: 10 Days after vaccination in the left arm the patient developed a shingles like reaction that was diagnosed and treated by above physician as if the lesion were shingles.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Few hours after flumist dev fever and itchy rash all over. SX resolved within one hour.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Tension
Clinical narrative: Swelling L arm 2 hours DTap 2D ago. L upper arm very swollen, erythematous, tense, non tender, swollen to elbow and 2" below onto forearm 6"x2 1/2"
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Dermatitis contact, Injection site reaction
Clinical narrative: 1 day post vaccine injection, contract dermatitis around the droppage site where serum dripped from the needle site, after needle popped out.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives occurred about 7 1/2 hours after injection. Extreme itching. I took 2 OTC Diphenhydramine Hydrochloride 25 mg tablets and used 1% hydrocortisone cream. Hives went away and itching stopped. However I continued to have out breaks for the next 8 days, which would subside by using the tablets and cream.
Age: 0.17
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: Fine, Maculo papular rash 1 day after receiving flu shot.
Age: 1.24
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Injection site erythema, Injection site oedema, Rash papular, Skin discolouration, Tenderness
Clinical narrative: Erythema, swelling left lateral thigh at injection site, developed about 3 days after injection increased in size, tenderness over next week. Developed pink papular rash over trunk and proximal extremities over past 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: L thigh cellulitis at administration site, treated with Keflex.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Fatigue, Headache, Injection site induration, Oedema
Clinical narrative: Redness, swelling, induration, pain, headache, fatigue, fever.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Redness, swelling, induration, pain, headache, fatigue, fever.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient called to report onset of sl fever, chills, achy beginning about midnight following vaccination for influenza earlier in day (patient did not know exact temp but states felt slightly feverish).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Temp 100-101 Sun and Mon in bed, asleep, for Sun and Mon, Body aches.
Age: 30.0
Sex: F
Vaccine: MER, TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Rash, Rash erythematous, Skin burning sensation
Clinical narrative: Patient called in describing a rash all over chest, neck, armpits and back. Later rash moved to arms but not to legs or torso. Says rash started the night she got the vaccines but was not significant enough to mention when she returned 2 days later for TB read. Rash is red slightly raised bumps 1/2 inch around. Some bumps are dry and at night it burns. Taking Benadryl. No other symptoms. Patient is from out of the country dose not know immunization status. Had chickenpox as a child. Patient had been taking Benadryl allergy and Benadryl allergy and sinus at night, 2 capsules every other day. Since 12/28/06 she had taken 2 capsules in the morning and at night every day. At night the rash burns, it seems the warmer she gets the more it burns. The Benadryl made the bumps/rash feel tingly and numb. She has not been hiking recently, she has not changed lotions or detergents, she has not worn new clothes, she changed shampoos, but returned to her usual shampoo after the rash started. Advised to see doctor 12/29/06. Called patient on 1/3/07. Patient reported feeling better. Said that the rash was disappearing.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient received vaccines, then felt nauseous, dizzy, was pale and diaphoretic, BP decreased to 80/50, pt placed supine with feet elevated, given Benadryl 20 mg PO, sips water, felt better after about 1 hour.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Top of Lt thigh swollen, hot to touch and red. Site of Dtap received 12/29/06. Parent took pt to ER 12/31/06 and was treated for cellulitis with Keflex. Today 1/2/07 area improved no redness or swelling.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Feeling hot
Clinical narrative: Quarter sized area red and hot to touch at injection site of Tdap. Advised to apply cold compress by on call doctor.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Somnolence
Clinical narrative: Fever/chills/body aches for 48 hours. Ibuprofen 600 mg twice a day. Slept alot.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site haemorrhage, Nausea, Pruritus, Stomatitis
Clinical narrative: Redness and swelling at injection site. Hematone at injection site 1.5 inch. Nausea and upper GI distress for 3 days (12/30, 12/31, 1/1). Skin "hot spots isolated...severe itching, redness, no swelling (groin) lasted one day. Inflamed oral cavity-redness, burning, raw, swelling for 3 days. Unable to wear dentures.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Redness and swelling at injection site. Hematone at injection site 1.5 inch. Nausea and upper GI distress for 3 days (12/30, 12/31, 1/1). Skin "hot spots isolated...severe itching, redness, no swelling (groin) lasted one day. Inflamed oral cavity-redness, burning, raw, swelling for 3 days. Unable to wear dentures.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Rash
Clinical narrative: rash all over body for 3 days prior to visit on 12-29-06, been using hydrocortisone.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a patient who may have been vaccinated with a dose of with HPV vaccine (yeast) (lot#653650/0697F) in which while preparing the syringe for administration, the safety syringe activated prematurely. It was reported that she may have touched the side of the syringe near the fingers and the activated the safety device. It was also reported that the second syringe scared the patient when it pooped down. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient (age and demographics not reported) who on 01-Dec-2006 was vaccinated with the first dose of HPV  vaccine (yeast) (Lot# not reported). On 01-Dec-2006 immediately after being vaccinated the patient developed widespread hives. No respiratory difficulty was noted. The patient was transported to the emergency room for evaluation and was not admitted to the hospital. At the time of this report the patient had not recovered from the hives. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Urticaria
Clinical narrative: Information has been received from a health professional concerning a female patient who on 01-Dec-2006 was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). It was noted that medroxyprogesterone acetate (DEPO-PROVERA) may have been given concomitantly. On 01-Dec-2006 the patient developed hives and turned pale white. She was admitted to the emergency room and there was no further information if she will be admitted. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently the patient developed a rash 10 minutes after vaccination. The patient was treated with antihistamine. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HPV4
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional who was told by her sister in law that in October 2006, a 24 month old patient was vaccinated by mistake with HPV vaccine. It was reported that the patient became very ill and began vomiting and developed a high fever. It was reported that the patient recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Injection site discomfort, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning her 19 year old daughter with no medical history or drug allergies who on 27 Nov 2006 was vaccinated intramuscularly in the mid top gluteal region with a first dose of HPV Vaccine. There was no concomitant medication. On 27 Nov 2006 the patient mentioned that the site of injection hurt and caused discomfort. The patient was uncomfortable for 24 hours. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Rash
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a urinary tract infection who on 28 Nov 2006 at 10:15 was vaccainted IM in the left deltoid with the first dose Gardasil (lot#653938/0954F). Concomitant therapy included CIPRO. On 29 Nov 2006 the patient developed a rash on her face and weakness in her legs and arms. Laboratory results completed the same day included complete blood cell count, blood eosinophilic leukocyte count and white blood cell count which were all normal. Subsequently, the patient "slowly" recovered from the rash and weakness in her arms and legs.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from an nurse concerning a 21 year old female with allergic reaction to antibiotics (Septra) who on 01 Dec 2006 was vaccinated intramuscularly in the left deltoid with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 01 Dec 2006 about three hours post vaccination the patient developed blurry vision in her left eye. No other symptoms were reported. Unspecified medical attention was sought. At the time of this report the patient had not recovered from the blurry vision. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysgeusia, Headache
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 29 Nov 2006 was vaccinated with the second dose (first dose date not reported) Gardasil (Lot 653938/0954F). Concomitant therapy included Adderall tablets and Zoloft. On 30 Nov 2006 the patient experienced dizziness, a bad taste in her mouth and a headache. It was reported that the patient was able to attend school that day. The patient's dizziness and bad taste and headache persisted. It was noted that the patient did not have adverse events after her first dose of Gardasil. The patient sought unspecified medical attention. Additional information has been requested. Follow up information received from a nurse practitioner stated that the vaccination that the patient received on 29-NOV-2006 intramuscularly in her right deltoid was the first dose of GRDASIL (Lot# 653938/0954F), not the second as previously reported. It was also reported that the patient had recovered from the dizziness and bad taste in her mouth. Additional information not requested.
Age: 24.0
Sex: U
Vaccine: HPV4
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Information has been received from a physician concerning a 24 year old patient who on 27 Nov 2006 was vaccinated in the arm with the first dose of HPV Vaccine. There was no concomitant medications. On 28 Nov 2006, it was reported that the patient developed generalized itching throughout her body. The patient called the physician on the following day and reported she was itchy. The physician stated that she believed the patient experienced an allergic reaction and dose not want to give the second and third shot. It was reported that the patient sought unspecified medical attention. It was reported that a couple of days later, the patient had recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female in her early 20's who sometime in mid November was vaccinated with her first dose of HPV Vaccine. It was reported that within 24 hours the patient experienced numbness in one of her legs and in her arm. The physician stated the patient still had numbness and that it had been over a week now and it had not subsided. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pharyngeal oedema
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of HPV Vaccine. Subsequently, the patient experienced throat swelling. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Fluid retention, Injection site erythema, Injection site oedema, Urinary bladder rupture
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or allergies, who on 25 Sept 2006 was vaccinated IM into the left deltoid with a first 0.5ml dose of HPV vaccine (lot 653735/0688F). There was no concomitant medication. Twenty four hours after vaccination, the patient experienced redness and swelling at the injection site and one vesicle was fluid filled and ruptured. Unspecified medical attention was sought. No diagnostic studies were performed. Subsequently, the patient recovered. The nurse stated that the physician will discontinue the therapy and will not be administering any further doses of this vaccine to this patient. No product quality complaint was involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a female (age not reported) who (approximately one month ago) in approximately November 2006, was vaccinated with Gardasil (yeast). On 04 Dec 2006, the patient just now experienced redness and swelling at what the patient believes is the injection site. The patient had not yet been seen at the office at the time of the reporting. The outcome of the event was unknown. Additional information has been requested. Additional information was received from the medical assistant. On 04-DEC-2006, the patient reported redness and puffiness at the site. On 11-DEC-2006, the patient was examined by the physician. The area inflamed was similar than one half inch diameter. The patient was given antibiotics for one week. No diagnostic tests were performed. On an unspecified date, the patient recovered. No additional information is expected.
Age: 38.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a female (age not reported) who (approximately one month ago) in approximately November 2006, was vaccinated with Gardasil (yeast). On 04 Dec 2006, the patient just now experienced redness and swelling at what the patient believes is the injection site. The patient had not yet been seen at the office at the time of the reporting. The outcome of the event was unknown. Additional information has been requested. Additional information was received from the medical assistant. On 04-DEC-2006, the patient reported redness and puffiness at the site. On 11-DEC-2006, the patient was examined by the physician. The area inflamed was similar than one half inch diameter. The patient was given antibiotics for one week. No diagnostic tests were performed. On an unspecified date, the patient recovered. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies, who on 03 Nov 2006 was vaccinated with Gardasil (yeast) (0.5 ml). There was no concomitant medication. On 03 Nove 2006 the patient experienced shortness of breath, chest pain, chest tightness and numbness in the arm that lasted approximately 30 minutes. Unspecified medical attention was sought. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Initial and follow up information has been received from an RN concerning an 18 year old white female student who on 16 Aug 2006 was vaccinated with her first dose of Gardasil (yeast). It was reported that she experienced pain at injection site several days post injection. On 13 Oct 2006 the patient received her second dose of Gardasil (yeast), IM, lot #653736/0689F. After the injection the patient complained of pain at injection site with radiating pain even at shoulder blade area several days post injection. Medical attention was sought. On 16 Oct 2006 the patient recovered from injection site pain and radiating pain. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Syncope
Clinical narrative: Information has been received from an RN concerning an 18 year old female patient with allergies to penicillin and morphine who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Concomitant therapy included Midrin. The patient was " a little lightheaded" during the first injection. On 05 Dec 2006 the patient was vaccinated with her second dose of Gardasil vaccine (yeast), lot # 653937/0637F. She developed syncope less than 10 minutes after the second injection was given. Her blood pressure dropped and she did not awake for 15 minutes. The patient was sent to the emergency room, and the nurse reported she was not sure if she recovered. Additional information has been requested.In follow up it was reported that the patient "felt faint" and that the patient "did faint" after her first injection with GRDASIL. The following significant reaction to GRDASIL was reported after her second injection: the patient began hyperventiling, complaining of headache, nausea, and feeling hot. She covered her eyes and was not answering questions, only nodding. There was no history of panic attacks, however she had been seen by another physician earlier that week and prescribed acetaminophen (+) dichloralphenazone(+) isometheptene mucate for migraine headache. She was lying down on the exam room table and was provided with a cool pack, cold juice, blanket and dark room. The nurse tool vital signs (see blood pressure measurements in laboratory data section). Her symptoms appeared to resolve and she "feel asleep?", but then apparently awoke in another panic and had a repeat of the same symptoms, worse then before. After attempts to calm the patient/stabilizing in the office failed, the decision was made to her go tot the ER for further evaluation. There was no evidence of anaphylaxis. The patient was reported as recovered from feeling hot, headache, hyperventilation, and nausea on 05-DEC-2006. Assessment of patient on 05-DEC-2006 included adverse effects of drug and panic disorder. Additional information not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Smear cervix abnormal
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 22 year old female patient with genital warts and history of abnormal Pap smears who on 21 Nov 2006 was vaccinated IM in the left deltoid with her first dose of Gardasil (yeast), lot #653736/0868F. Concomitant therapy included Ortho Tri-Cyclen Lo. The patient called to report that prior to the vaccination she had 2 undiagnosed "bumps" in the vulva area. Two weeks after the vaccination, on 05 Dec 2006, the patient had an increase in amount of genital warts (3 more "bumps" appeared in the surrounding area). Medical attention was sought. The patient had undergone a Pap smear and cervical biopsy on 21 Nov 2006 (results were not reported). At the time of the report the patient had not recovered. Additional information has been requested. Follow-up information has been received concerning the female student with genital warts who on 21-NOV-2006 at 2:00 p.m. had received her first dose of GRDASIL, lot # 653736/0868F. The patient stated she had a history of bumps in vaginal area, and was never diagnosed with any disease. On 05-DEC-2006 the bumps increased in size and number. The patient was positive for HPV 6. On 15-JAN-2007 at 3:00 p.m. she was vaccinated IM in left deltoid with her second dose of GRDASIL, lot # 655617/1447F. Her outcome was unknown. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil (yeast). Subsequently, the patient developed a few hives in the upper abdominal area. It was noted that the patient plans to continue with the vaccine series by getting the second and third dose as recommended. Unspecified medical attention was sought. On 04 Dec 2006, the patient recovered. No product quality complaint was involved. Additional informatio has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007.  Information has been received from a physician concerning a 26 year old female patient who on 15-NOV-2006 was vaccinated IM into the left deltoid with a first dose of GARDASIL (lot # 653938/0954F).  On 17-NOV-2006, the patient developed a few hives in the upper abdominal area.  It was noted that the patient plans to continue with the vaccine series by getting the second and third dose as recommended.  The patient was treated with BENADRYL.  On 04-DEC-2006, the patient recovered.  No product quality complaint was involved.  The physician stated that it was highly unlikely that hives were from the vaccine because hives developed 48 hours later.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 22 year old female patient who in 2006 was vaccinated with a first dose of Gardasil (yeast). In 2006, the patient experienced a raised, red, itchy lump at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/5/2007. Information has been received from a physician concerning a 23 year old female who on 01-NOV-2006 was vaccinated, in the left arm, with a first dose of GARDASIL (lot #653938/0954F). On approximately 23-NOV-2006, the patient developed swelling in her lymph node in her axilla (previously reported as swelling in her lymph node area). Unspecified medical attention was sought. On approximately 03-JAN-2007, the patient recovered. Additional information is not available.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Alopecia, Attention deficit/hyperactivity disorder, Blood albumin normal, Blood thyroid stimulating hormone, C-reactive protein normal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with an eating disorder and attention deficit/hyperactivity disorder who on 10 Oct 2006, was vaccinated with a dose of Gardasil. The patient was concomitantly vaccinated with a dose of Menactra. Concomitant therapy included unspecified therapy for ADHD. Subsequently, the patient experienced thinning of hair/alopecia. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007. Information has been received from a licensed practical nurse concerning a 17 year old female student with bulima and attention deficit/hyperacticity disorder who on 15-SEP-2006 (previously reported as 10-OCT-2006), was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot 653735/0688F). The patient was concomitantly vaccinated with a dose of MENACTRA. Concomitant therapy included ADDERALL XR. Subsequently, the patient experienced thinning of hair/alopecia. The patient was seen in the office and thinning hair was noted. Laboratory evaluations revealed that CMP, complete blood count, thyroid stimulating hormone, c-reactive protein, WESR, and pre-albumin were all within normal limits. It was reported that the physician was having the patient monitor the condition. At the time of this report, the patient had not recovered. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Eating disorder, Full blood count normal, Metabolic function test, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with an eating disorder and attention deficit/hyperactivity disorder who on 10 Oct 2006, was vaccinated with a dose of Gardasil. The patient was concomitantly vaccinated with a dose of Menactra. Concomitant therapy included unspecified therapy for ADHD. Subsequently, the patient experienced thinning of hair/alopecia. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007. Information has been received from a licensed practical nurse concerning a 17 year old female student with bulima and attention deficit/hyperacticity disorder who on 15-SEP-2006 (previously reported as 10-OCT-2006), was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot 653735/0688F). The patient was concomitantly vaccinated with a dose of MENACTRA. Concomitant therapy included ADDERALL XR. Subsequently, the patient experienced thinning of hair/alopecia. The patient was seen in the office and thinning hair was noted. Laboratory evaluations revealed that CMP, complete blood count, thyroid stimulating hormone, c-reactive protein, WESR, and pre-albumin were all within normal limits. It was reported that the physician was having the patient monitor the condition. At the time of this report, the patient had not recovered. No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pruritus
Clinical narrative: Information has been received from a physician and a nurse concerning a 25 year old female who on 06 Nov 2006 was vaccinated intramuscularly with the first single dose vial of Gardasil. On 06 Nov 2006, that evening, the patient developed itching all over her body, but no rash was associated with it. The physician and nurse reported that the patient also developed nausea. Unspecified medical attention was sought. The nurse told the patient to try some over the counter Benadryl to treat the itching as was recommended by the physician. There was no lot number provided. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Alopecia, Hypotrichosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old female with no pertinent medical history or drug reactions/allergies, who on 05 Sept 2006 and 03 Nov 2006 was vaccinated with the first and second doses of Gardasil (lot 653735/0688F). There was no concomitant medication. Subsequently the patient experienced thinning of hair or alopecia. Unspecified medical attention was sought. At the time of this report the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007.  Initial and follow-up information has been received from a licensed practical nurse concerning a 9 year old female with no pertinent medical history or drug reaction/allergies, who on 10-OCT-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (lot # 653735/0688F).  There was no concomitant medication.  Subsequently, approximately ten days after vaccination on approximately 20-OCT-2006, the patient's mother noticed a balding spot behind the patient's ear.  The patient used a steroid cream on the area and had an appointment with a dermatologist.  It was reported that the patient has some hair re-growth but not in the whole area.  The patient's mother was unsure about the completion of the recommended vaccine schedule.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of HPV Vaccine (Lot not provided) Subsequently, the day after she was vaccainted the patient developed a sort of rash all over her body. The physician recommended that the patient treat the rash with Benadryl, which the patient did. subsequently, the rash resolved and no additional treatment was needed. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a 25 year old female consumer who on 05 Dec 2006 was vaccainted with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). The consumer stated that her period is normally 7 days long, and it started on 04 Dec 2006. On 08 Dec 2006, her period ended. two days earlier than normal. The consumer did not seek medical attention and stated the adverse experience did not improve. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fear, Pallor, Presyncope
Clinical narrative: information has been received from a physician concerning a 16 year old female who on 08 Dec 2006 was vaccinated in the arm with a pre filled syringe of HPV Vaccine. There was no concomitant medication. On 08 Dec 2006, immediately following the vaccination, the patient turned white and nearly passed out. The patient was not hospitalized and was not pregnant. Subsequently, the patient fully recovered. The physician felt that the events were not a result of the vaccine, however a result of the patient being afraid of injections. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning an 18 or 19 year old female patient who in approximately Nov 2006, was vaccinated with a dose of HPV vaccine. Concomitant suspect therapy included YAZ, an oral contraceptive, which was started at the same time (dose and duration not reported). Subsequently, the patient developed papillary rash and pruritis on lower extremities after Gardasil injection. Medical attention was sought. It was reported that the rash went away after therapy with YAZ was discontinued. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Information has been received from an RN concerning a female patient who on 05 Dec 2006 was vaccainted with her first dose of HPV vaccine. While she was receiving the injection she developed syncope and a drop in blood pressure. The nurse reported that the patient recovered and was sent home after 30 minutes. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of HPV Vaccine and developed rash and pruritus. The patient's outcome was unknown. Additional information had been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Patient returned 24 hours after receiving varicella vaccine. Site of administration red, swollen and harden center. Bactrin prescribed given with instructions for care of site. Follow up on 1/5/07 area resolved.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Abscess, Erythema, Feeling hot, Infection, Injection site reaction
Clinical narrative: Erythema, edema, warmth at shot site that expanded to more than 4 cm and started to track. Extend medially along the thigh. Much larger than typical localized reaction. Minimized on abscess/infection.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Oedema
Clinical narrative: Erythema, edema, warmth at shot site that expanded to more than 4 cm and started to track. Extend medially along the thigh. Much larger than typical localized reaction. Minimized on abscess/infection.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, IPV, PNC
Symptoms: Erythema, Feeling hot
Clinical narrative: 24 hours after shots knees and elbows were red and hot to touch. No temp. Went to Emergency Room and told was reaction from shots. Next day developed red areas in body and face-went back to ER and advised same. No treatment given.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, IPV, PNC
Symptoms: Erythema, Joint swelling, Oedema peripheral, Rash, Skin warm
Clinical narrative: 24 hours after shots knees and elbows were red and hot to touch. No temp. Went to Emergency Room and told was reaction from shots. Next day developed red areas in body and face-went back to ER and advised same. No treatment given.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: 24 hours after shots knees and elbows were red and hot to touch. No temp. Went to Emergency Room and told was reaction from shots. Next day developed red areas in body and face-went back to ER and advised same. No treatment given.
Age: 1.28
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Swelling
Clinical narrative: Swelling, redness around injection site on left thigh began within 24 hours of vaccine administration.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia, Screaming, Swelling
Clinical narrative: Screaming consistently for 4 hours evening of injection. Temp 99.6 (Sy) mild swelling right leg.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Eye disorder, Eyelid oedema, Hypersensitivity, Pyrexia, Swelling
Clinical narrative: Mother called clinic 1 day following vaccines. Mom stated 1 hour after vaccines child vomited  1 days. Second started with fever greater than equal to 101 (fever reduction with the use of Motrin and Tylenol.) and also nose running. Morning following vaccines child awoke with eyelid, under eye and nasal edema. Erythema at site of Dtap injection. Mom states "swollen to her elbow." After discussion of side effects from vaccines and review of VIS Forms child taken to primary hospital and mom told she "was" in fact having an allergic reaction to vaccine. VAERS form sent.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Vomiting
Clinical narrative: Mother called clinic 1 day following vaccines. Mom stated 1 hour after vaccines child vomited  1 days. Second started with fever greater than equal to 101 (fever reduction with the use of Motrin and Tylenol.) and also nose running. Morning following vaccines child awoke with eyelid, under eye and nasal edema. Erythema at site of Dtap injection. Mom states "swollen to her elbow." After discussion of side effects from vaccines and review of VIS Forms child taken to primary hospital and mom told she "was" in fact having an allergic reaction to vaccine. VAERS form sent.
Age: 1.06
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient broke out with varicella after being vaccinated.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Rash on upper torso on the eve of 1-1-07. Rash is itchy.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cellulitis, Injection site induration, Tenderness
Clinical narrative: Induration on right thigh, mild cellulitis 2 days post vaccination. Treated with Benadryl, warm packs, and Keflex. 1/3/07 Mom reported redness gone, still slight tender.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Phone call from patients mother 1-2-07 reports child had hives on face and chest/abdomen 1 hour after Hep B #2. Tolerated Hep B #1 without problem. Was seen at urgent care and given Benadryl with good results and no further hives. Had mild upper respiratory symptoms then.
Age: 0.14
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Feeding disorder, Injection site swelling, Irritability
Clinical narrative: About 6:00 pm parents noticed he was more fussy then usual and he wasn't feeding normally. A few hours later (about 3) noticed his legs were almost double in size so took him to ER. They didn't do any treatment and it slowly went away the next day. Also other note, the nurse that dose his vaccines. Started using a longer needles and he has not had problems since.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: 7 red papules-pustule. Right chest wall.
Age: 5.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Joint range of motion decreased, Swelling
Clinical narrative: Right arm erythema, pain, swelling from injection site. 26 cm long by 11 cm wide cross right elbow. Decreased range of motion. Temp 98.2F.
Age: 5.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Hypersensitivity, Injection site swelling, Oedema peripheral
Clinical narrative: Right arm erythema, pain, swelling from injection site. 26 cm long by 11 cm wide cross right elbow. Decreased range of motion. Temp 98.2F.
Age: 57.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, swelling, erythema Left arm at site of Pneumoccal. Area extreme swelling 12 cm long by 7 cm wide from injection site Left arm to elbow.
Age: 57.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Hypersensitivity, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Pain, swelling, erythema Left arm at site of Pneumoccal. Area extreme swelling 12 cm long by 7 cm wide from injection site Left arm to elbow.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site swelling, Rash macular
Clinical narrative: Red macular rash to forehead, raised red rash to chest. Vital signs= 1515 HR 168, RA sat 94%, LCTA, no wheeze, no increase work of breathing noted; 1525 HR 154, RR 48, RA Sat 98%, LCTA bilat, no wheeze, no increase work of breathing; 1550 HR 144, RR 44, RA sat 96%, assessment unchanged.
Age: 1.01
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Urticaria
Clinical narrative: Break through chickenpox disease 20 lesions
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Arthritis, Injection site swelling
Clinical narrative: 12/26/06 immunizations. 12/28/06 pm right arm swollen at Dtap injection site - seen at clinic - called agency. Diagnosis: arthritis reaction - Motrin and hot compresses prescribed. 01/02/07 pm swelling resolved and no further symptoms per facility (aunt and legal guardian).
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Disseminated intravascular coagulation, Dysuria
Clinical narrative: First visit PCP office 8/9/06 vomiting, headache and stomach x 1 day. Diagnosis viral syndrome, headache, abdominal pain, medications: none. Seen at medical center ER 8/10/06 earache started on 8/10/06 am. Diagnosis Otitis media. Treatment Auralgan and Zithromax. Seen at medical center ER 8/14/06 abdominal and flank pain, painful urination and vomiting. Morphine given in ER. Seen at medical center ER 8/15/06 lethargic, weak, low grade fever, and unable to get out of bed and walk. Developed these symptoms on 8/15/06. Diagnosis encephalitis. He was transferred to another Hospital. Patient died on 8/21/06. Autopsy revealed acute hemorrhagic leukoencephalitis (Hurst disease), a rare, fulminant form of acute disseminated encephalomyelitis. The cause of death was likely acute disseminated encephalomyelitis secondary to prominent cytokine release prompted from a prior infection, which ultimately let to development of early DIC and multi organ system failure. 01/16/07-records received and reviewed from Med Ctr.  ER visits 8/14/06 and 8/16/06.  DX on 8/16/06- meningoencephalitis, cerebral edema. 02/09/07-records received and reviewed from another Hospital for DOS 8/15-8/21/06 DC DX: Cerebral edema basal ganglia edema with right sided thalamic edema in a vascular distribution antiphospholipid antibody positive Presented to ER with persistent vomiting times 10 days leading to ataxia and altered mental status. On transfer to another Hospital he was intubated for a Glasgow Coma Score of 8 Hospital course included antimicrobial therapy and steroids.  Developed hydrocephalus and an EVD was placed and subsequently lost all cranial nerve function and was noted on hospital day 6 to be breathing only slightly on the ventilator, also had renal insufficiency of unknown etiology with a rising creatinine. Hypertensive episode with bradycardia and expired.  Neuro exam: pupils 2mm and nonreactive to light on left side and 3-2mm and nonreactive to light on right side. Doll eye sign negative. No response to deep pain stimulation. Deep tendon reflexes 0-1 plus. Babinski sign negative. Clonus negative. Gag reflex negative. Funduscopic exam shows obvious papillary edema on right side, left eye was unable to be examined due to small size. Intermittent spontaneous movement of right arm. no movement of left arm.