chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Received Menactra vaccine 5/16/07 PM. Arm became sore 6-8 hrs later. Woke 5/17/07 with temp 99.7, soreness in underarm. 5/18/07 soreness/swelling underarm worse. Developed body aches, back and hip pain. Slight headache. To HC provider 5/18/07 PM 5/21/07 recovered.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at site of shot 9cm x 7cm painful and itching
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Administered Tdap L arm 6/1/07 - mother called 6/4/07 - client had severe site reaction. Swelled to baseball size, red, hot, sore arm on 6/2/07 and 6/3/07.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Dysgeusia, Gingival pain, Gingivitis, Oral herpes
Clinical narrative: Two days after receiving Zostavax had a mild gingivitis/stomatitis which his dentist though and was viral and he has been steadily improving (just about resolved now), Since, accompanied by dysgeusia. Pt stated cold sore gum line, loss taste, small cold sore still.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis, Viral infection
Clinical narrative: Two days after receiving Zostavax had a mild gingivitis/stomatitis which his dentist though and was viral and he has been steadily improving (just about resolved now), Since, accompanied by dysgeusia. Pt stated cold sore gum line, loss taste, small cold sore still.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope about 5 minutes after vaccine
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient blacked out about 5 mins after the Gardasil was given
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Malaise, Nausea, Pallor
Clinical narrative: A few minutes after injection pt stated she didn't feel well. Pt put head down between legs, c/o nausea. Pt looked up and was completely pale, c/o blurred vision, ringing in ears, dizzy, clammy, lightheaded. Assisted pt to car and transported to ER. Was dx as pre-syncope and drink fluids was discharged at 15:00
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Tinnitus, Vision blurred
Clinical narrative: A few minutes after injection pt stated she didn't feel well. Pt put head down between legs, c/o nausea. Pt looked up and was completely pale, c/o blurred vision, ringing in ears, dizzy, clammy, lightheaded. Assisted pt to car and transported to ER. Was dx as pre-syncope and drink fluids was discharged at 15:00
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Basophil count increased, Crying, Full blood count, Monocyte count increased, Urine analysis normal
Clinical narrative: Cried continuously for 4 days
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: Severe pain at injection site so pt could not flex shoulder to > 45 hours the day after the injection.
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Vaccine 5/22/07 on 3/25/07 mom called to say fever 104 with hives and mon thought was a reaction to the HIB on 5/22/07 then was requested to come in for check to clinic (did not come in 2 hr to needs ride from friend). Then called MD on call with same sx, seen 9 days later no sx exam, no fever no hives.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pain
Clinical narrative: Localized reaction on day three 2 x 2cm localized redness and 10-11 cm area of pain.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema
Clinical narrative: Localized erythema Motrin, Tylenol as needed.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 6 hours post vaccine a red, raised, rash with itching started on neck and spread to chest and abdomen. Last x 10 days and resolved used Benadryl cream for itching - no doctor visit.
Age: 43.0
Sex: F
Vaccine: TYP
Symptoms: Chest discomfort, Cough, Reaction to preservatives
Clinical narrative: Had Typhoid injection on 5/24/07 at 0830. Called clinic with symptoms of chest pressure and cough at 1150. Denied SOB. Instructed to F/U in ER and did so.
Age: 8.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Chills, Headache, Injection site reaction, Pyrexia, Rash macular
Clinical narrative: Headache, fever, chills, blotchy red patch where vaccine administered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, PPV
Symptoms: Erythema, Injection site pain, Pyrexia, Rash macular
Clinical narrative: Pain where administered, fever, patchy red blotches where vaccine administered.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Left arm erythema x 4" induration x 3" warm to touch not fluctuant. Sx abscess d/w. Keflex 250 TID x 10 days.
Age: 18.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Dyspepsia, Pharyngolaryngeal pain, Rash pruritic, Throat tightness
Clinical narrative: Received phone call fro friend of pt about 4:45 pm. Stating pt began with rash/itching on stomach and neck; c/o heartburn and throat closing up and hurting. Symptoms began 2 hrs ago was given 2 Benadryl and taken to ER. Better and being released from ER.
Age: 18.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Chest discomfort, Dyspepsia, Rash, Throat tightness
Clinical narrative: Received phone call fro friend of pt about 4:45 pm. Stating pt began with rash/itching on stomach and neck; c/o heartburn and throat closing up and hurting. Symptoms began 2 hrs ago was given 2 Benadryl and taken to ER. Better and being released from ER.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9cm x 7.5cm cellulitis at site of injections. Augmentin x 10 days, warm compresses. Redness, swelling, warmth to site.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Following his first anthrax vaccine, which was given subcutaneously in the left triceps area, he describes a reaction consistent with a large local. He received two other vaccines that day in right arm and denies any significant problems at their vaccination sites. Per patient history, he had swelling, pain erythema, increased warmth, pruritus and a marble-sized subcutaneous nodule on left upper arm which was first noted about 6 hours after vaccine receipt. Symptoms increased to the point where swelling, redness, warmth and tenderness (rated as 4-5/10 on pain scale) extended from posterior left shoulder area to just blow his left elbow. He sought evaluation on post vaccine day 4, but was told that it was a normal reaction and was given Tylenol or Ibuprofen, he does not recall which. He self limited his activities due to pain and swelling, but was not placed on quarters. Range of motion of his left upper arm was limited. No VAERS was filed. All the symptoms except the subcutaneous nodule resolved by the time of his second anthrax vaccine on 1/21/03. He denies paresthesias, fever, chills, joint or muscle pains, fatigue or headaches. He denies left axillary lymphadenopathy. Service member reports small local reactions (minimal redness, swelling, tenderness and nodule lasting a couple days) following anthrax vaccines 2-4. He believes at least one of these vaccines was given over the triceps area.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Following his first anthrax vaccine, which was given subcutaneously in the left triceps area, he describes a reaction consistent with a large local. He received two other vaccines that day in right arm and denies any significant problems at their vaccination sites. Per patient history, he had swelling, pain erythema, increased warmth, pruritus and a marble-sized subcutaneous nodule on left upper arm which was first noted about 6 hours after vaccine receipt. Symptoms increased to the point where swelling, redness, warmth and tenderness (rated as 4-5/10 on pain scale) extended from posterior left shoulder area to just blow his left elbow. He sought evaluation on post vaccine day 4, but was told that it was a normal reaction and was given Tylenol or Ibuprofen, he does not recall which. He self limited his activities due to pain and swelling, but was not placed on quarters. Range of motion of his left upper arm was limited. No VAERS was filed. All the symptoms except the subcutaneous nodule resolved by the time of his second anthrax vaccine on 1/21/03. He denies paresthesias, fever, chills, joint or muscle pains, fatigue or headaches. He denies left axillary lymphadenopathy. Service member reports small local reactions (minimal redness, swelling, tenderness and nodule lasting a couple days) following anthrax vaccines 2-4. He believes at least one of these vaccines was given over the triceps area.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Varicella vaccine breakthrough diagnosed with Varicella (10 lesions) on 5/24/07. No fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site reaction, Skin warm, Swelling
Clinical narrative: Left upper arm redness, swelling, warmth 4cm x 4cm - area at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Erythema, Induration, Injection site swelling, Tenderness
Clinical narrative: Injection site swollen, indurated, red, tender, edge not well defined size approximately 5 x 10cm a few blister, no treatment given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Left arm swelling from shoulder to forearm and vesicles.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site erythema, Injection site induration
Clinical narrative: Patient developed fever (Temperature = 100.3) and redness/swelling around vaccination site within 12 hours of administration. In past 24 hours area increased to 10cm x 7cm area of erythema/ induration with a 1.5cm cluster of vesicles. Itchy. Also developed HA and temperature = 100.3. Tx with ALRP. This is a followup report previously submitted on 5/16/2007. Information has been received from a registered nurse concerning a 5 year old male with no medical history, drug reaction or allergies who on 22 MAY 2007 was vaccinated intramuscularly into the left arm with a first of varicella virus vaccine live (oka/Merck) (Lot 01250). The patient also developed a headache, and temperature of 100.4 and was treated with acetaminophen (TYLENOL). Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles, Pyrexia
Clinical narrative: Patient developed fever (Temperature = 100.3) and redness/swelling around vaccination site within 12 hours of administration. In past 24 hours area increased to 10cm x 7cm area of erythema/ induration with a 1.5cm cluster of vesicles. Itchy. Also developed HA and temperature = 100.3. Tx with ALRP. This is a followup report previously submitted on 5/16/2007. Information has been received from a registered nurse concerning a 5 year old male with no medical history, drug reaction or allergies who on 22 MAY 2007 was vaccinated intramuscularly into the left arm with a first of varicella virus vaccine live (oka/Merck) (Lot 01250). The patient also developed a headache, and temperature of 100.4 and was treated with acetaminophen (TYLENOL). Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received DTaP (3rd dose) on 5/21/07 24 hours later, entire upper half of left arm was hot red and swollen to twice the size of normal. Treated by applying cool compresses - symptoms still exist unchanged the next day - subsiding on 5/24/07 - not entirely resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Right arm swelling, erythema of entire upper arm elbow to shoulder (3 1/2cm difference in diameter from non affected arm) no fever, no tenderness, no itching
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Rash on legs, urticaria, fever 100.0 rectal
Age: 1.1
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: C/O 25 maculopapular lesions appeared on trunk (abd) and arms on May 19, 2007. No treatment provided as of May 24, 2007. No fever.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Asthenia, Balance disorder, Deafness
Clinical narrative: Significant hearing loss, itchy skin, joint and muscle pain including arthritis, loss of energy and constant tiredness, difficulty sleeping, vertigo, balance problems and lightheadness, short term memory loss, reduced concentration, rashes not near injection site.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Disturbance in attention, Dizziness, Fatigue, Insomnia, Myalgia
Clinical narrative: Significant hearing loss, itchy skin, joint and muscle pain including arthritis, loss of energy and constant tiredness, difficulty sleeping, vertigo, balance problems and lightheadness, short term memory loss, reduced concentration, rashes not near injection site.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash, Vertigo
Clinical narrative: Significant hearing loss, itchy skin, joint and muscle pain including arthritis, loss of energy and constant tiredness, difficulty sleeping, vertigo, balance problems and lightheadness, short term memory loss, reduced concentration, rashes not near injection site.
Age: 1.2
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Rash generalised
Clinical narrative: Patient developed a rash in trunk, legs and arms, after his vaccines.  MMR reaction?
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Vaccination failure, Varicella
Clinical narrative: Patient with breakthrough VZV approximately 30 lesions 3 1/2 years after vaccine
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm redness and swelling and warmth at site of vaccine administration.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Nausea, Skin tightness, Swelling
Clinical narrative: Localized swelling, mild face tightness, HA, nausea, Naprosyn didn't relief HA. Hydroxyzine
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid swollen, very red, measures 120 x 100cm, mildly tender using arm well.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Injection site erythema, Injection site pain, Injection site swelling, Pneumonia
Clinical narrative: Left deltoid area of arm painful firm on day of shot, next day redness and swelling increased to the left deltoid. Had previous vaccine in 1996.
Sex: M
Vaccine: MMR
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a male child with an egg allergy who was vaccinated with a dose of MMR II. The physician reported that the patient subsequently developed a swollen leg. Unspecified medical attention was sought, Subsequently, the patient's swollen leg resolved on its own. No further information is available.
Age: 6.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Allergy test, Flushing, Hypersensitivity, Pruritus, Swelling
Clinical narrative: Information has been received from a consumer and a health professional concerning a 6 year old male with a penicillin allergy an allergy to gelatin and a history of an allergic reaction to a Kosher gelatin candy who on 23-AUG-2005, was vaccinated with a second subcutaneous dose in the right arm of MMR II (lot 647107/0464R(. Concomitant vaccines included a first dose of Varivax (lot 649643/0421R), a dose of PedvaxHib, a fifth intramuscular dose in the left arm of Infanrix (Lot # AC4B005AA) and a fourth intramuscular dose in the left arm of IPOL (Lot# y0343). There was no illness at the time of vaccination and no adverse events following prior vaccination. The patient's mother reported that in June 2005 the child had an allergic reaction with swelling from head to tow. The health care professional indicated that the child developed hives and itching all over the body. There was no shortness of breath. The Varivax was the only vaccine that the patient had not received in the past. Treatment included Benadryl, ice packs and oral prednisone. The patient recovered in June 2005. No product quality complaint was involved. Follow-up information from a physician indicated that on 23-AUG-2005, the patient left the office but referred in 10 minutes with an allergic reaction, described as flushed with itching especially on the feet and hands. There was no difficulty breathing. The patient was given Benadryl, 2 teaspoons and a cool compress. It was noted that the patient developed a few hives. The patient was sent out on Benadryl and oral prednisone. The patient was reported as recovered on 23-AUG-2005. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer and a health professional concerning a 6 year old male with a penicillin allergy an allergy to gelatin and a history of an allergic reaction to a Kosher gelatin candy who on 23-AUG-2005, was vaccinated with a second subcutaneous dose in the right arm of MMR II (lot 647107/0464R(. Concomitant vaccines included a first dose of Varivax (lot 649643/0421R), a dose of PedvaxHib, a fifth intramuscular dose in the left arm of Infanrix (Lot # AC4B005AA) and a fourth intramuscular dose in the left arm of IPOL (Lot# y0343). There was no illness at the time of vaccination and no adverse events following prior vaccination. The patient's mother reported that in June 2005 the child had an allergic reaction with swelling from head to tow. The health care professional indicated that the child developed hives and itching all over the body. There was no shortness of breath. The Varivax was the only vaccine that the patient had not received in the past. Treatment included Benadryl, ice packs and oral prednisone. The patient recovered in June 2005. No product quality complaint was involved. Follow-up information from a physician indicated that on 23-AUG-2005, the patient left the office but referred in 10 minutes with an allergic reaction, described as flushed with itching especially on the feet and hands. There was no difficulty breathing. The patient was given Benadryl, 2 teaspoons and a cool compress. It was noted that the patient developed a few hives. The patient was sent out on Benadryl and oral prednisone. The patient was reported as recovered on 23-AUG-2005. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3). On approximately 07-APR-2006, the patient had a negative titer to mumps. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a liscensed practical nurse concerning a patient who was vaccinated with a dose measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (WISTER RA 27/3). Subsequently the patient developed mumps. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: DTAPH, MMR
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning a 17 month old female who on 19-FEB-2006 was vaccinated with one dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3). Concomitant vaccine administered on the same day included a dose of diphtheria toxoid (+) Hib conj vaccine (tet toxoid) (+) pertussis acellular Biken vaccine (+) tetanus toxoid (TRIHIBIT). Concomitant therapy included sulfamethazole/trimethoprim (BACTRIM) for the treatment of bladder reflux. "Within 24 hours of administration", on approximately 20-FEB-2006, the patient developed a maculopapular rash. The patient was treated with oral prednisone and diphenhydramine hydrochloride (BENADRYL). It was reported that the rash resolved after one week. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Mumps, Parotid gland enlargement, Salivary gland pain
Clinical narrative: Information has been received from a a physician concerning a 4 year old male with no known drug allergies and no pertinent medical history who on 15-AUG-2005 was vaccinated SQ with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (WISTER RA 27/3) (lot# 649238/0029R). There was no concomitant medication. On 13-APR-2006 the patient developed mumps. On 13-Apr-2006, the patient was seen in the office with pain and swelling in his parotid gland. The patient's outcome was reported as recovering. Unspecified medial attention was sought. There was no product quality complaint involved. Additional information has been requested. This is an amended report. The reporter did not indicate other important medical event.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Immunoglobulins, Platelet count decreased, Red cell distribution width increased
Clinical narrative: Information has been received from a physician concerning a 12-month-old female with no pre-existing allergies, birth defects, or medical conditions who on 25-MAR-2006 (also reported as 10-APR-2006) was vaccinated SC in the right leg with a first dose of MMR II (Lot # 649515/0937P). Concomitant therapy that day included a first dose of Varivax (Lot # 652518/1021R) administered SC in the left leg. On 11-APR-2006, the day after vaccination, the patient presented to the physician's office with bruising. A CBC showed low platelets. She was noted to have developed idiopathic thrombocytopenic purpura (ITP) and was hospitalized. The patient was given IGG intravenously. After administration of IGG, her platelets went from 5000 to 68000 to 130000. The patient was discharged on 14-APR-2006, and was noted to be followed by a hematologist weekly. The outcome was recovered on 14-APR-2006. There was no product quality complaint. Follow up information received from a physician indicated that on 10-APR-2006, the patient was noted to have multiple bruises on her extremities and back. Blood work was done and the platelet count was extremely low (5000). The patient was admitted to the hospital and received IV IGG under a hematologist's care. The platelet count improved. The patient was discharged to home after 2 days. Weekly platelet counts will be obtained. The reporter indicated that the event was considered to be an other important medical event. Additional information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Blood immunoglobulin G, Cough, Mumps, Mumps antibody test negative, Parotid gland enlargement
Clinical narrative: Information has been received from a a physician concerning a 47 month old white male with allergy to cefdinir (OMNICEP) (hives) who on 25-APR-2003 was vaccinated SC in the right thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (WISTER RA 27/3) (lot# 640790/1378L). Concomitant vaccination included a first dose of varicella virus vaccine live (oka/Merck) (MSD) (lot # 644564/1148M) given SC in the right thigh and a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot # 493-187) given IM in the left anterior thigh. In April 2006, the patient experienced "what looked like" a classic case of mumps. The child had the typical mumps symptoms with swelling. He did not have a fever and was still active. The parent's did not know of any exposure the child could have had to mumps. He is also not in daycare and all his contacts seem fine. At the time of this report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information from the physician indicated that on 09-APR-2006 (also reported as 10-APR-2006) the patient developed left parotid gland edema and he presented with URI symptoms 1 week prior. His symptoms included swollen cheek, runny nose, cough, and mild fever. On 10-APR-2006 serum IgG was positive and IgM was negative. It was reported that an "outbreak" was associated. The patient was kept out of school for 9 days after the onset of the edema. He was treated with amoxicillin (+) clavulanate potassium(AUGMENTIN) for a possible bacterial etiology without complications. Subsequently on an unspecified date, the patient recovered, it was reported that the patient "didn't return". No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Information has been received from a a physician concerning a 47 month old white male with allergy to cefdinir (OMNICEP) (hives) who on 25-APR-2003 was vaccinated SC in the right thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (WISTER RA 27/3) (lot# 640790/1378L). Concomitant vaccination included a first dose of varicella virus vaccine live (oka/Merck) (MSD) (lot # 644564/1148M) given SC in the right thigh and a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot # 493-187) given IM in the left anterior thigh. In April 2006, the patient experienced "what looked like" a classic case of mumps. The child had the typical mumps symptoms with swelling. He did not have a fever and was still active. The parent's did not know of any exposure the child could have had to mumps. He is also not in daycare and all his contacts seem fine. At the time of this report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information from the physician indicated that on 09-APR-2006 (also reported as 10-APR-2006) the patient developed left parotid gland edema and he presented with URI symptoms 1 week prior. His symptoms included swollen cheek, runny nose, cough, and mild fever. On 10-APR-2006 serum IgG was positive and IgM was negative. It was reported that an "outbreak" was associated. The patient was kept out of school for 9 days after the onset of the edema. He was treated with amoxicillin (+) clavulanate potassium(AUGMENTIN) for a possible bacterial etiology without complications. Subsequently on an unspecified date, the patient recovered, it was reported that the patient "didn't return". No further information is available.
Sex: F
Vaccine: MMR
Symptoms: Erythema multiforme, Rash, Stevens-Johnson syndrome, Urticaria
Clinical narrative: Information has been received from a health professional concerning a female child who, "years ago", was vaccinated with a dose of MMR II. Subsequently, "years ago", the patient developed Stevens Johnson Syndrome, erythema multiforme, urticaria and rash. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Stevens Johnson Syndrome was considered to be an other important medical event. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (WISTER RA 27/3). The pharmacist reported that the patient subsequently failed to seroconvert. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a consumer, who is a nurse, concerning her 4 year old daughter who in March 2006, was vaccinated IM with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (lot # 649812/0492R). In March 2006, the patient experienced redness and swelling at the injection site. It was noted that the child's arm was twice it's size and the reporter was concerned it may be cellulitis. This happened over a weekend and the physician on call suggested diphenhydramine hcl (BENADRYL). ibuprofen (MOTRIN) and warm packs. The child responded to this  treatment and the swelling subsided in 3 days. It was reported that she recovered in March 2006.  No product quality complaint was involved. 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 and Evaluation Research and was released by the regulatory agency. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 5 year old female who, "at one year of age", in approximately 2002, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3). "At that time", in approximately 2002, the patient developed a fever, rash and malaise. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that the patient was not under the reporter's care at that time, the patient was fine, and that there was no additional information available. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Parotid gland enlargement, Pyrexia, Tonsillar hypertrophy
Clinical narrative: Infromtion has been received from a nurse practitioner concerning a 36 month old white male who on 15-MAR-2004 at 11:15 am was vaccinated in the left leg with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 643955/1083M). Concomitant vaccination that day at 11:15 am included a first dose in the right leg of varicella virus vaccine live (VARIVAX) (lot # 644796/0336N). There was no illness at the time of vaccination. On 06-APR-2006 the patient presented to the physicians office with severely enlarged parotid glands bilaterally, 3- tonsiller, hypertrophy, fever. He initially responded to rocephin IM then symptoms recurred 5 days later. The fever resolved with cefdinir (OMNICEF) x5d. The tonsil and gland enlargement persisted. The nurse practitioner believed that the patient had mumps but no diagnostic tests were performed. No laboratory tests were performed. In May 2006 the patient  recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M increased, Mumps, Serology test, Testicular swelling
Clinical narrative: Information has been received from a a physician concerning a 6 year old male who was previously vaccinated with two doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). In April 2006, the patient experienced a severe case of mumps. It was reported that the child has swelling on both sides and it is considered a clinically significant case. A serology and IGG were done. A IGM was high and follow up was scheduled for 24-APR-2006. At the time of this report the patient had not recovered. It was noted that the child's 3 year old sibling only received one shot of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and does not have the mumps. Unspecified medical attention was sought. No product quality involved. Additional information has been requested.
Age: 2.3
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 27 month old male who on 06-MAY-2005 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 648478/0634P). On 13-APR-2006 the patient developed mumps. The patient was diagnosed with mumps on 18-APR-2006. The diagnosis was made clinically and with lab values. The child progressed from unilateral to bilateral involvement. It was later reported that the laboratory results received for the patient, IgM level less than 10, showed that the patient did not have mumps. It was noted that the patients IGG was 1.6. The patient had not yet recovered at the time of reporting. There was no product quality complaint involved. Follow-up information indicated that the patient did not have mumps. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 649812/0492R) - The patient experienced redness and swelling at the injection site. It was unknown if medical attention was sought. 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 of Biologics and Evaluation Research and was released by the regulatory agency. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Laboratory test, Rash
Clinical narrative: Information has been received from a consumer on 24-APR-2006 concerning his 12-month-old son with no pertinent medical history and no allergies, who was vaccinated in the leg with a dose of MMR II. Concomitant therapy included an "IPI vaccine". "Last Tuesday", on approximately 18-APR-2006, the patient experienced two seizures in one day, each lasted 4 minutes. One was at 01:00 am and the other was at 02:00 am. His son was taken to the emergency room but was not admitted to the hospital. A "bacterium cast" was performed, no results were reported. It was reported that after both seizures the child broke out with a rash on his body. At the time of this report the patient had recovered, it was reported that "he's doing okay now". No further information was reported. Upon internal review the patient's two seizures were determined to be other important medical events. Additional information is not expected.
Age: 1.6
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 month old male who 21-APR-2006 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There were 4 additional vaccinations, unspecified, given on the same day. On 26-APR-2006, more than 48 hours later, the patient experienced hives on his back, which were examined by a physician. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a registered nurse concerning a patient who may have been vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The nurse reported that it was not known if the patient received measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or mumps virus vaccine live (Jeryl Lynn) (MAD) or no vaccine. In April 2006, the patient developed a suspected case of mumps. Unspecified attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Culture throat, Haematology test, Mumps
Clinical narrative: Information has been received from a nurse concerning a 16 year old male with a history of 1st immunisation in 1991 who in 2000 was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# not reported). In April 2006, the patient developed a possible case of mumps. The patient had a culture swabs and blood samples (results not reported). As of 27-Apr-2006, the patient had not recovered. Unspecified medical attention sought. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Laboratory test, Mumps
Clinical narrative: Information has been received from a health professional concerning a male who may have been vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 27-APR-2006 it was reported that the patient developed symptoms of mumps. It was unknown whether the patient has been previously vaccinated. "Currently" tests are being run to confirm whether the patient has mumps. Unspecified medical attention was sought. No further information is available. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Developmental delay, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her 3-year-old son with no pertinent medical history and no drug reactions/allergies who in approximately 2004 was vaccinated SC with a 0.5mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included a probiotic. In approximately 2005 the patient was noted to have developmental problem. "Several tests" were obtained. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin M, Blood test, Fatigue, Mumps, Parotid gland enlargement
Clinical narrative: Information has been received from a registered nurse concerning a 15-year-old white male who on 20-AUG-1992 and 24-AUG-2004 was vaccinated with the first and second doses of MMR II. Subsequently, the patient experienced mumps. It was noted that the patient visited the emergency room 2 to 3 times. Blood work done in the ER was not conclusive, and new blood work was pending at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a registered nurse indicated that on 15-APR-2006, the patient developed fatigue and fever with parotid swelling. A mumps IgM Ab was borderline at 1.0. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning a 15-year-old white male who on 20-AUG-1992 and 24-AUG-2004 was vaccinated with the first and second doses of MMR II. Subsequently, the patient experienced mumps. It was noted that the patient visited the emergency room 2 to 3 times. Blood work done in the ER was not conclusive, and new blood work was pending at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a registered nurse indicated that on 15-APR-2006, the patient developed fatigue and fever with parotid swelling. A mumps IgM Ab was borderline at 1.0. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash morbilliform, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who 14-APR-2006 was vaccinated with a 0.5 mL SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 650104/0828R). There was no concomitant medication. On 28-APR-2006 he presented with fever and a morbilliform, itchy, red rash over his entire body including his mouth. At the time of the report, the patient was recovering. Unspecified medical attention was sought. There was no product complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a mother concerning her 5-year-old daughter who had no pertinent medical history or allergies who on 31-JAN-2003 was vaccinated SC with a 0.5 mL dose of MMR II (Lot #643499/0538M). There was no concomitant therapy. The mother reported that on approximately 07-FEB-2003, her daughter experienced vomiting and fever. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient's vomiting and fever persisted. No further information is available.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Local swelling
Clinical narrative: Information has been received from a physician's assistant concerning a 12 month old patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, 5 days after receiving the vaccine, the patient experienced swelling to the neck. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a public health nurse concerning an 11 year old female patient who was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The nurse reported that the patient may have mumps. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a consumer concerning a patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The consumer reported that she heard the patient had subsequently developed mumps. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown.
Sex: F
Vaccine: MMR
Symptoms: Rash, Sleep disorder
Clinical narrative: Information has been received from a consumer concerning her daughter who, on unspecified date, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the patient experienced a rash and sleep disturbance. It was not reported if medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, TTOX
Symptoms: Body temperature increased, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician and a 29-year-old female with no drug reactions / allergies and with a history of rubella, measles and chickenpox and a history of pneumonia at 1-year of age, who on 17-APR-2006 was vaccinated with a dose of MMR II. Concomitant therapy included tetanus toxoid and tuberculin purified protein derivatives (MANTOUX SKIN TEST). It was noted that the patient may have previously been vaccinated with rubella vaccine. There were no other concomitant medications. It was noted that the patient became pregnant on approximately 01-APR-2006. Since the time of vaccination, on 17-APR-2006, the patient had a temperature of between 99 and 101 degrees on and off. ON 26-APR-2006, the patient presented to the physician's office. It was noted that she did not know she was pregnant at the time of vaccination. The outcome was reported as not recovered. No lab diagnostic studies were performed. There was no product quality complaint. No other information was available. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: Blood amylase, Blood immunoglobulin G, Eating disorder, Full blood count, Pain in jaw
Clinical narrative: Information has been received from a physician concerning a 13-year-old patient who was vaccinated with the first and second dose of measles virus live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn)(+) rubella virus vaccine live (Wistar RA 27/3). Subsequently the patient experienced difficulty eating and right jaw pain. At the time of the report, the  following studies were being done to confirm or rule out mumps: IgG titer; amylase; complete blood count; and sed rate. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Information has been received from a physician concerning a 13-year-old patient who was vaccinated with the first and second dose of measles virus live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn)(+) rubella virus vaccine live (Wistar RA 27/3). Subsequently the patient experienced difficulty eating and right jaw pain. At the time of the report, the  following studies were being done to confirm or rule out mumps: IgG titer; amylase; complete blood count; and sed rate. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Allergy test, Skin test, Vomiting
Clinical narrative: Information has been received from a consumer concerning a 6 year old male with an allergy to  the protein in chicken and fish and no other medical history who at 13 months of age was vaccinated with a SC dose of measles virus live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn)(+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. Subsequently the patient developed non stop vomiting.  Unspecified medical attention was sought. "Back pricking with the panel" was performed. The patient recovered after 2 days. There was no product quality complaint. Additional information has been requested.