chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site induration, Oedema peripheral
Clinical narrative: Approximately 6" indurated, red, swollen from shoulder to mid left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Skin warm
Clinical narrative: Red, warm, swollen left deltoid muscle.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity
Clinical narrative: Rednes just below site of  DTaP injection.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Rash macular
Clinical narrative: Macular rash over abdomen within 5-10 minutes of injection. Claritin 2.5 Q D x3.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Fall
Clinical narrative: Shortly after receiving Hepatitis vaccine, Pt walked out of the office about 4-5 blocks and fell.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Syncope
Clinical narrative: Administered DTaP, IPOL, MMR witout incident immediately following, bumped head on wall, blacked out, unconscious for brief seconds. Regained consciousness. BP 82/64, O2 99%, P 110. Referred to ER to follow up. Agreed without arguments. Support and reassurance given.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity, Pain, Pruritus, Urticaria
Clinical narrative: Welts/hives near injection site, skin sensitivity from injection site and under arm with pain and itching. 05/23/05- states welts nearly resolved, hives, pain, and itching resolved. Cat bite almost healed on left hand.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Hypersensitivity, Pruritus, Vision blurred
Clinical narrative: Vaccine administered at 6:40 PM. At 7:00 PM- blurred vision, right upper arm itching and mild redness distal to vaccine administration site. Generalized warm felling. Zyrtec 10mg given at 7:45 PM. All SS resolved <2 hours of office visit except blurred vision which resolved the next day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site induration
Clinical narrative: 10x11 cm area of redness, induration, warmth around left deltoid. 1 day after immunizations. ? tender.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Rash
Clinical narrative: >100 lesions. Cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Swelling face
Clinical narrative: Hives 20-30 minutes after giving MMR, DTaP< and IPV- Mother gave Benadryl with relief. No respiratory distress. Lips swollen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Generalized erythematous raised macular rash. ? - Urticarial rash RX for Claritin 5mg QD.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Within 24 hours of receiving DTaP, patient developed fever up to 102.5 and a large erythematous/raised area at injection site 7 inches.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Red, warm, raised area at site of injection. Denies pain. Complained of mild nausea. No fever or other symptoms. Started 2 days after injection per patient.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Father called clinic later in the evening stating patient's left arm was warm to touch, firm, tender.
Sex: F
Vaccine: VARCEL
Symptoms: Face oedema
Clinical narrative: Information has been received from a healthcare professional concerning a female patient who was vaccinated with a first dose of varicella virus vaccine live. Thirteen days after vaccination the patient experienced swelling on her nose and right side of face as well as chicken pox on the trunk of her body. The patient was seen in the clinic, but treatment was unknown. No product quality complaint involved. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient may have developed a case of chicken pox. Unspecified medical attention was sought. THere was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a male adolescent who on 8/13/04 was vaccinated with a dose of varicella virus vaccine (lot # 647244/0897N). On 8/24/04, the patient presented with a red, swollen area at the injection site. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. The nurse also reported that the patient's adolescent sister developed a red, swollen area at the injection site after therapy with varicella virus vaccine live (WAES0409USA02187).
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old white female student who on 10/30/00 was vaccinated with a second dose of varicella virus vaccine live. On 6/29/04 the patient developed spots and had a case of breakthrough chicken pox. The reporter noted that the patient had not been hospitalized and she recovered on approximately 7/12/04. No additional information is expected.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning an 12 month old male, with seasonal allergies and no pertinent medical history, who on 8/26/04 at 18:45 was vaccinated SC in his right thigh with a first dose of varicella virus vaccine live (lot # 648049/1348N). Concomitant vaccination the same day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine and HIB conjugate vaccine given in the other leg. There was no illness at the time of vaccination. Other concomitant medication included cetirizine hydrochloride. Within 5 minutes of vaccination the injection site on his leg was slightly red and warm. Unspecified medical attention was sought and the patient was treated with diphenhydramine hydrochloride. There was no product quality complaint involved. Follow up information from the nurse practitioner indicated that on 8/26/04 at 19:45 the patient developed approximately 3cm of redness and edema at the injection site of the varicella virus vaccine live. No relevant diagnostic test were done. The patient recovered on 8/27/04.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old male who was vaccinated SQ with a 0.5ml dose of varicella virus vaccine live when he was younger. There was no concomitant medication. On 8/16/04, the patient presented to the office with herpes zoster. The patient was given Acyclovir as treatment and sent home. No product quality complaint was involved. The nurse practitioner also reported another patient (WAES0409USA01767) who experienced herpes zoster after vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old white male with asthma, seasonal allergies, an amoxicillin allergy, hyperglycemia and a history of chicken pox exposure who on 8/12/98, at 6:00 PM, was vaccinated SC in the lateral thigh with a first dose of varicella virus vaccine live (lot # 624724/01327E). On 12/31/02, at 9:00 PM, the child broke out with a chicken pox rash. The rash began on the torso area and spread over the entire body including the face, genitalia and scalp. He was afebrile. The rash dried and cleared up by 1/6/03. It was noted that his chicken pox exposure was 7-10 days prior to breaking out. Medical attention was not sought. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning an approximately 4 year old white male with no known drug allergies who on 8/12/04 at 3:00 PM was vaccinated SC with a first dose of varicella virus vaccine live (lot # 648086/0098P). Suspect therapy that day at 3:00 PM included a first dose of MMR (lot # 646590/1051N) administered SC. Subsequently, the patient experienced a reaction. The reporter did not know the nature of the reaction. Unspecified medical attention was sought. There was no product quality complaint. No other information was available. Follow up information indicated that the adverse event was unknown. No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning an adult female patient who was vaccinated with a dose of varicella virus vaccine live (lot number not available). The physician reported that the patient had experienced a varicella rash. She was treated with valacyclovir hydrochloride. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 43 month old white female who on 2/5/02 was vaccinated SC in the left arm with a dose of varicella virus vaccine live (lot # 640090/1147L). On 8/31/04 the patient presented with about 30 vesicular lesions. No other symptoms were noted. It was reported that the patient was recovering. A product quality complaint was not involved. Follow up information was received from the registered nurse who reported that on 8/31/04, the patient presented with about 30 vesicular lesions on the stomach and back and one to two on each arm. The patient was afebrile and only complained of itching. Symptomatic treatment was advised. The patient subsequently recovered. No further information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 7/28/01 was vaccinated with a dose of varicella virus vaccine live. On 8/10/04, the patient presented with breakthrough chicken pox, less than fifty lesions were noted. There was no product quality complaint involved. Follow up information indicated that the patient was seen on 8/10/04 with skin lesions and was diagnosed with chicken pox. The reporter indicated that the patient's brother (WAES0409USA02580) had a similar experience following exposure to varicella virus vaccine live. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old male who on 6/27/03 was vaccinated with a dose of varicella virus vaccine live (lot # 643587/0803M). On 8/21/03 the patient developed a varicella outbreak. There was no fever and there were less than 50 lesions. The patient was recovering without any complications. Unspecified medical attention was sought. There was no product quality complaint. The reporter also mentioned other patients who developed adverse events (WAES0411USA02898 and WAES0412USA00269). Additional information has been requested.
Age: 1.68
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 20 month old male who on 8/19/04 was vaccinated with a dose of varicella virus vaccine live (lot # 648045/0197P). On 8/29/04, the patient developed lesions on his body. It was reported that the child had not been seen by a physician, but the mother was pretty sure it is chicken pox. Unspecified medical attention was sought and it was noted that the patient is recovering. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning her 12 month old son who on 8/23/04 was vaccinated with a dose of varicella virus vaccine live. Th RN reported that on 8/24/04, her son broke out in a rash. The RN indicated that her son continued to break out for three more days totaling less than 10 spots that were red, but not itchy and did not crust over. A large one on his chest was noted to be painful. The RN indicated that the spots looked like bug bites and when they disappeared left only a pin sized discoloration. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the patient's events were almost completely resolved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 13 year old son who had asthma and a grass allergy who on 8/20/04 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included montelukast sodium and fluticasone propionate. The patient's mother reported that on 8/31/04, 11 days after being vaccinated, her son developed a mild case of chicken pox. The mother indicated that her son had pox marks on his face, neck, back, stomach, and legs but they were not closely spaced together and were few in number (approximately three on his face, three on his neck and six on his back). Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No further information is available.
Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 32 month old white male with no known medical history who on 4/1/03 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot # 643821/0865M). There was no concomitant medication. There was no illness at the time of vaccination. On 8/31/04, the patient experienced 10-12 lesions on his trunk and a few behind the knee crease. He was afebrile. Unspecified medical attention was sought and he was treated with diphenhydramine hydrochloride. There was no product quality complaint involved. Follow up information indicated that on 8/31/04, the patient developed a rash which lasted two to three days and the patient recovered. No further information is available.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash papular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 24 month old male who on 7/3/03, was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot # 644571/1160M). There was on illness at the time of vaccination. Concomitant therapy that day included a first dose of MMR administered in the right thigh, and a third dose of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 643164/0285M) administered in the right thigh. Subsequently, on 8/27/04, the patient developed a breakthrough case of varicella. The patient had 10 lesions, with 1 being vesicular and the 9 other were papular. No additional information was given. Unspecified medical attention was sought. There was no product quality complaint. There were no relevant diagnostic test or laboratory data. No additional information is expected.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Fatigue, Herpes zoster, Irritability, Lethargy, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 23 month old white male with juvenile xanthogranuloma who on 9/29/03 was vaccinated IM in the left arm with a first dose of varicella virus vaccine live (lot # 645298/0332N). Concomitant vaccination the same day included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 493274) given IM in the right arm. On 9/3/04, the patient presented with shingles. The vesicular lesions developed on the left scapula and followed down his left arm and hand. The patient was also cranky and tired. It was reported that the patient was recovering. A specimen was obtained for PCR analysis. Follow up information indicated that in 8/27/04 the patient developed a rash on his left shoulder which on 9/3/04 progressed to a herpes zoster rash on his left upper back. No fever was noted. The patient's other systemic symptoms included cranky and lethargic. It was reported that the patient had no history of chicken pox or no recent exposure to chicken pox or herpes zoster. Subsequently, the patient recovered. It was reported that the lesions which was sent for PCR analysis was an adequate specimen and was VZV positive vaccine type. No further information is expected.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 23 month old white male with juvenile xanthogranuloma who on 9/29/03 was vaccinated IM in the left arm with a first dose of varicella virus vaccine live (lot # 645298/0332N). Concomitant vaccination the same day included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 493274) given IM in the right arm. On 9/3/04, the patient presented with shingles. The vesicular lesions developed on the left scapula and followed down his left arm and hand. The patient was also cranky and tired. It was reported that the patient was recovering. A specimen was obtained for PCR analysis. Follow up information indicated that in 8/27/04 the patient developed a rash on his left shoulder which on 9/3/04 progressed to a herpes zoster rash on his left upper back. No fever was noted. The patient's other systemic symptoms included cranky and lethargic. It was reported that the patient had no history of chicken pox or no recent exposure to chicken pox or herpes zoster. Subsequently, the patient recovered. It was reported that the lesions which was sent for PCR analysis was an adequate specimen and was VZV positive vaccine type. No further information is expected.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from  a health professional concerning a female e who in 1998 was vaccinated with a dose of varicella virus vaccine live. Subsequently a titer did not show evidence  of seroconversion. Unspecified medical attention was sought. There was no product quality control complaint. Follow up infomation indicated that the vaccine was not given at this office and they do not have any additonal information. No additonal information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter with n allergy to PCN who on 03/03/2004 was vaccinated with a dose  of varicella virus vaccine live. There was no illness at the time of vaccination. On 08/30/04 the pt developed lesions on her abdomen which was reported to be chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that the pt had no adverse events following prior vaccination. Follow up information from a physician indicated that the morning of 08/30/2004 the pt had mild breakthrough case. Subsequently the pt had recovered. It was also reported that on 03/29/2000 the pt was vaccinated with a SQ first dose of MMR live vaccine on her right side, an IM 3rd dose of poliovirus vaccine inactivated on her lower left side and an IM first dose of diphtheria toxoid + Hib conj vaccine (tetanus toxoid) + pertussis whole cell vaccine + tetanus toxoid (ACTHibDTP), on her left side. It was reported that the pt had no adverse events following prior vaccination. No further informtaion is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a pharmacist concerning a child who in approximately September 2004, was vaccinated with a dose of varicella virus vaccine live.  Before vaccination, the child was exposed to another child that received the vaccine in approximately August 2004.  In approximately September 2004, the patient experienced spots.  Unspecified medical attention was sought.  A product quality complaint was not involved.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from an RN concerning a 6 year old female with juvenile rheumatoid arthritis who on 12/14/1998 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy for her arthritis included rofecoxib, methotrexate, Embrel and Prelone syrup. On 06/14/2004 the pt was seen in the office for varicella with 20 lesions. On 06/15/04 her lesions were worse and she retruned to the office. She was admitted to the hospital and treated with IV acyclovir and she had an immunology consult. On 06/21/2004 she was discharged from the hospital and on 06/25/04 she was seen in the office for followup and her varicella was resolved. The reporter indicated that the pt's sister (WAES0407USA00733) experienced chickenpox following exposure to varicella virus vaccine live. No further inoformation is available.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Lethargy, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from an office manager concerning a 10 year old white female pt who on 11/02/1998 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the pt experienced full blown chicken pox with well over 50 lesions. The pt sought unspecified medical Tx in an ER and is now recovered. No product quality complaint was involved. Follow up information indicated that on 06/17/04 the pt had a fever, was lethargic and had a rash all over the body including the mouth and the vagina. The child was given meds to limit the duration "due to her twin sisters earlier illness" It was reported that the event lasted for 4 days and the pt recovered on 06/30/2004. The pt's twin sister (WAES 0408USA002071)also experienced a full blown case of chickenpox after vacciantion with varicella virus vaccine live. Additional information is not expected.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 6 year old white female with no pre existing allergies, birth defects or medical conditions who on 10/09/1998 was vaccinated SQ with a 0.5ml first dose of varicella virus vaccine live. There were no illness at  the time of vaccination. Concomitant medications included a first dose of MMR virus vaccine live administered SQ on 09/07/2004, the pt developed 20 lesions. The MD told the pt to take Benadryl for itching. Unspecified medical attention was sought. Ther ewas no product quality compalint. Follow up infomration receivedd from a RN indicated that on 09/04/04 the pt developed a varicella rash with 20-50 lesions that lasted for 1.5 weels/ The outcome was reported as recovered on approximatiely 09/15/2004. There were no relevant diagnostic tests or lab data.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 9 year old white male with no pre existing allergies, birth defects or medical conditions who on 09/16/1997 was vaccinated with  a dose of varicella virus vaccine live. On 08/18/2004 developed chickenpox. Subsequently the pt recovered from the chickenpox. Additional infomation has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 01/25/1996 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on 03/07/1997 the pt developed chicken pox. It was noted that the mother had chicken pox also. The pt was seen  in the office. The reporter also indicated that 30 other pt's were vaccianted. with varicella virus vaccine live and developed chickenpox. (WAES 0409USA01045, 0409USA01046, 0409USA01047, 0409USA01048, 0409USA01049, 0409USA01050, 0409USA01051, 0409USA01052, 0409USA01053, 0409USA01054, 0409USA01055, 0409USA01056, 0409USA01057, 0409USA01058, 0409USA01059, 0409USA01060, 0409USA01061, 0409USA01062, 0409USA01063, 0409USA01064, 0409USA01065, 0409USA01066, 0409USA01067, 0409USA01068, 0409USA01069, 0409USA01070, 0409USA01071, 0409USA01072, 0409USA01073, AND 0409USA01074. No further infomration is expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 9 year old female with no medical Hx or allergies who on 04/03/96 was vaccinated with a first dose of varicella virus vaccine live. On 09/02/2004 the pt was seen in the office with chicken pox. The nurse reported that the case was not serious and there was no Tx or testing done at the office visit. Recovery status was unknown. the nurse also reported on 06/25/1996 and 04/17/2000 th pt was vaccinated with a first and second dose respecitvely of MMR. Additonal information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Asthma
Clinical narrative: Information has been received from a health professional concerning a female pt who on 30Aug04 was vaccinated with a dose of varicella virus vaccine live (lot 642633/1315N). Subsequently the pt experienced an episode of asthma. It was reported that the child was treated with prednisolone sodium phosphate (Orapred). Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a 29 yr old female with no allergies or medical history who on 23Aug04 was vaccinated with two 0.5ml doses of varicella virus vaccine live at the same time. There was no concomitant therapy. The pt reported that on 06Sep04, two weeks after being vaccinated, she developed chickenpox. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Otitis media, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a RN concerning a 6 yr old white female who on 02Dec99 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccinations included Hib conj vaccine (manf unk), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, hep B virus vaccine rHBsAg (yeast) (manf unk), measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  and poliovirus vaccine inactivated (unspecified). Illness at the time of vaccination included right otitis media. The RN reported that on 08Sep04 the pt developed a rash characterized by 30+ vesicular lesions that started on her leg and spread to the trunk. The pt was also noted to have a mild fever. On 09Sep04, the pt presented to a physician's office and no other symptoms were noted. On 16Sep04, the pt recovered from the rash and fever. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Contusion, Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an approx 4 yr old female who on 23Aug04 was vaccinated SC with a dose of varicella virus vaccine live (lot 647092/0885N). Within 2 weeks of the vaccination, the pt experienced redness, swelling, tenderness and warmth at the injection site. On 04Sep04 the pt was examined by the physician and the physician found 6 varicella lesions on her face, neck, scalp and right forearm. On 07Sep04 the pt was seen again and a blackening scar was observed at the injection site. It was reported that it looked to be developing cellulitis. The pt was treated with (Duricep) and will be seen for follow up on 17Sep04. It was reported that the pt was recovering. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Tenderness
Clinical narrative: Information has been received from a physician concerning an approx 4 yr old female who on 23Aug04 was vaccinated SC with a dose of varicella virus vaccine live (lot 647092/0885N). Within 2 weeks of the vaccination, the pt experienced redness, swelling, tenderness and warmth at the injection site. On 04Sep04 the pt was examined by the physician and the physician found 6 varicella lesions on her face, neck, scalp and right forearm. On 07Sep04 the pt was seen again and a blackening scar was observed at the injection site. It was reported that it looked to be developing cellulitis. The pt was treated with (Duricep) and will be seen for follow up on 17Sep04. It was reported that the pt was recovering. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Patient called reported that 5-7 days after received Menactra Vaccine that has a course of 1-2 days of headache , nausea, fatigue, and fever.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Headache, Influenza like illness, Neck pain, Pain
Clinical narrative: 16-24 hours after vaccine adminstered complaint of flu-like symptoms, fever, chills, arm soreness, body aches, neck pain, headache.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: 16-24 hours after vaccine adminstered complaint of flu-like symptoms, fever, chills, arm soreness, body aches, neck pain, headache.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Facial palsy, Headache
Clinical narrative: Bell's Palsy, headache that began 4 days after vaccine administration.
Age: 0.0
Sex: F
Vaccine: VARCEL
Symptoms: Injury, Medication error
Clinical narrative: Call came to Immunization Program on-call staff.  Situation: On 5/18/05, Nurse at a family practice clinic was administering varicella vaccine. The boy receiving the vaccine squirmed, the needle came out, and some varicella vaccine got into the administering nurse's eye. She rinsed the eye thoroughly two times, then called the State Immunization Program for guidance. Spoke to nurse on the morning of 5/20, she reported no adverse events to the eye.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pyrexia, Shoulder pain
Clinical narrative: Fatigue, beginning 12 hours after injection and lasting 3 days. Fever of 101.4 beginning 2 1/2 days after inj and lasting about 10 hours. Stiff and sore shoulders and neck, beginning about 24 hours after inj and lasting 3 days.  Treated with ibuprofin for fever and headache.
Sex: F
Vaccine: TTOX
Symptoms: Cough, Joint range of motion decreased, Lacrimation increased, Myalgia
Clinical narrative: 2nd day: extreme soreness in entire left arm. difficulty using arm.  4th day: allergy conditions, i.e. watery eyes, sinus drainage, coughing. Continued muscle pain.  9th day: deep muscle pain from left shoulder to elbow; difficulty raising left arm.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Patient started with red, itchy rash on chest and arms starting approximately one hour after immunizations. Rash spread and grew more itchy through today. IV Solumedrol give in the office. Patient sent home on Prednisone, Loratadine, and Ranitidine.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient started with red, itchy rash on chest and arms starting approximately one hour after immunizations. Rash spread and grew more itchy through today. IV Solumedrol give in the office. Patient sent home on Prednisone, Loratadine, and Ranitidine.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Hypersensitivity, Rash pruritic, Urticaria
Clinical narrative: Patient started with red, itchy rash on chest and arms starting approximately one hour after immunizations. Rash spread and grew more itchy through today. IV Solumedrol give in the office. Patient sent home on Prednisone, Loratadine, and Ranitidine.
Age: 37.0
Sex: M
Vaccine: HEP, HEPA, IPV, TD
Symptoms: Abdominal pain, Cough, Diarrhoea, Headache, Muscle spasms
Clinical narrative: Abdominal pain, cramps, diarrhea, headache, cough, nausea with 1 episode of vomiting.
Age: 37.0
Sex: M
Vaccine: HEP, HEPA, IPV, TD
Symptoms: Nausea, Vomiting
Clinical narrative: Abdominal pain, cramps, diarrhea, headache, cough, nausea with 1 episode of vomiting.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Fatigue, Headache, Laboratory test abnormal, Medication error
Clinical narrative: Vaccine was a multidose vial that was reconstituted. Expired 1 month after reconstituted, but vial expiration date was noted, not 30 days reconstitution date. Vial expired 3 months prior to dose given. Company notified. Concern for bacteremia/subtherapeutic dosing noted from company. Called to notify patient and the following symptoms reported a few days after vaccine given (1 week): paresthesias upper extremities, dizziness, LE pain, headache, fatigue.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Pain, Paraesthesia
Clinical narrative: Vaccine was a multidose vial that was reconstituted. Expired 1 month after reconstituted, but vial expiration date was noted, not 30 days reconstitution date. Vial expired 3 months prior to dose given. Company notified. Concern for bacteremia/subtherapeutic dosing noted from company. Called to notify patient and the following symptoms reported a few days after vaccine given (1 week): paresthesias upper extremities, dizziness, LE pain, headache, fatigue.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Clenching of fists and rolling of the eyes; lasted about 20 minutes after 26 hours of immunization.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Erythema, Injection site erythema, Injection site induration, Pain, Swelling
Clinical narrative: Erythema, indurated grape fruit sized cellulitis at left upper arm. Pain, red, swollen.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area red, warm, and swollen at site approximately 6cmx8cm.
Age: 5.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left bicep area with erythema and induration about 5cmx5cm.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Feeling hot, Pyrexia, Tremor
Clinical narrative: Patient became cyanotic, felt warm in the head area. Then began shaking which lasted 15-20 minutes and patient became real warm. This happened on Thursday night. Repeated twice on Friday and once on Sunday. Mother also reported that temperature on Thursday night was 104 F. Did not take infant to ER.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site induration, Pain, Swelling
Clinical narrative: 6-8 hours after immunizations, increased pain right arm. Most arm red and swollen; presented to MD at 24 hours with large indurated area.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Pruritus
Clinical narrative: Erythema, warm, non-tender, itchy area approximately 8cmx11cm to right upper arm. No treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: 7cmx9cm red area to left upper arm. Treated with Benadryl.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Bumps on back, stomach, and legs with low grade temperature.
Age: 1.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Hypersensitivity, Pruritus, Pyrexia, Rash papular
Clinical narrative: 5 days after MMR (right thigh) and Varivax, Pediarix, HIB (left thigh) were given, patient developed papular rash around injection site on the right thigh. Over next 3 days, spread to left thigh, arms, perioral, full body. Fever also started about 5 days after shots given and lasted about 4 days. No URI symptoms. Seen in ED on day 4 of rash and told possible allergic reaction to shot and given Benadryl without resolution of symptoms.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Medication error
Clinical narrative: Hepatitis A vaccine given mistakenly instead of HIB. Patient received the correct HIB vaccine today 6/1/05. No swelling, no pain, no redness per mom. Patient is doing well.
Age: 1.26
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Medication error
Clinical narrative: Hepatitis A vaccine was given mistakenly for HIB. Patient will come in for correct dose of HIB. No fever, no swelling, no redness, and no pain per mom. Patient is perfectly fine after shots mom said.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Medication error, Rash, Rhinorrhoea
Clinical narrative: Hepatitis A vaccine given mistakenly for HIB. Patient will get HIB at 15 months. Patient had a runny nose and was fussy. Rash with itty bitty bumps for 2-3 days; none now. No pain, no fever, no swelling per mom.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Irritability, Medication error, Musculoskeletal stiffness
Clinical narrative: Hepatitis A vaccine mistakenly given for HIB. Patient will come in for second dose of HIB. Patient was crabby for 1 day after; legs were stiff. Mom massaged. No redness, no pain, no fever, no swelling per mom. Patient is fine now.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Medication error, Pyrexia
Clinical narrative: Hepatitis A vaccine given mistakenly. Patient will come back for HIB vaccine. Low grade fever resolved with Tylenol. No swelling, no pain, no redness. Patient is ok per mom.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Erythema, Medication error, Pain, Swelling
Clinical narrative: Patient's left leg swollen and painful. Patient's mom states there is a little bump where injection was given. It was red for 3-4 days. No fever, no pain and no fussiness. Hepatitis A vaccine mistakenly given for HIB. Patient will come in for HIB.
Age: 1.36
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Medication error
Clinical narrative: No swelling, redness, pain or fever. No abnormal signs or symptoms per mother. Hepatitis A given instead of HIB.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Medication error
Clinical narrative: No swelling, fever, or redness. No abnormal signs or symptoms. Hepatitis A vaccine given mistakenly for HIB. Patient will come back for HIB.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Medication error
Clinical narrative: Hepatitis A vaccine given instead of a HIB. Patient will come back for HIB. No fever, redness, swelling per mom.
Age: 0.26
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, High-pitched crying, Pain, Swelling
Clinical narrative: Crying and screaming for a half hour. Swollen, painful left leg.
Age: 0.51
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, IPV, PNC
Symptoms: Pyrexia, Skin reaction
Clinical narrative: Fever (low grade 101.1) and local papular rash both thighs. URI at same time; present prior to shots.
Age: 0.51
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, IPV, PNC
Symptoms: Pyrexia, Rash papular, Upper respiratory tract infection
Clinical narrative: Fever (low grade 101.1) and local papular rash both thighs. URI at same time; present prior to shots.
Age: 0.54
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Condition aggravated, Neutropenia, White blood cell count decreased, White blood cell count increased
Clinical narrative: Information regarding Prevnar was received from an investigator regarding a 22 month old female participant in a study who experienced neutropenia. The participant received the third dose on 5/29/01. The participant also received the third dose of Hib-Titer vaccine, the first dose of hepatitis B vaccine, and the third dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis vaccine on 5/29/01. The patient's concurrent illnesses include asthma, thalassemia beta and neutropenia since 11/15/01. Indication for Prevnar was immunization. Product was administered on 5/29/01. Dose regimen was 1 dose. Additional suspect medication included Poliomyelitis vaccine inactivated, Hepatitis B vaccine, Hib-Titer vaccine, Diphtheria/Tetanus toxoids/Acellular Pertussis Vaccine, MMR, and Varicella Virus vaccine live. The patient was admitted to the hospital on 9/21/02 with neutropenia. Neutropenia initially diagnosed on 11/15/01. The event resolved. No additional information was available at the time of this report. The investigator considered neutropenia possibly related to the study product. The medical monitor considered neutropenia not related to the study product.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Dehydration, Neutropenia, Platelet count decreased, Thrombocytopenia, White blood cell count decreased
Clinical narrative: Information regarding Prevnar was received from an investigator regarding a 14 month old male participant in a study who experienced neutropenia and dehydration. At 5 months of age, the participant received the third dose on 1/5/01. The participant also received the third dose of Hib-Titer Vaccine, the third dose of poliomyelitis vaccine inactivated, the third dose of Hepatitis B vaccine and the third dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis vaccine on 1/5/01. The patient's concurrent illnesses include asthma, wheezing, upper respiratory tract infection (since 9/18/01 with symptoms of runny nose, fever, and slight cough), viral infection (since 9/21/01), pyrexia (seen in the emergency room on 9/22/01) and oral intake reduced (seen in the emergency room on 9/22/01). Indication for Prevnar was immunization. Product was administered on 1/5/01. Dose regimen was 1 dose. Concomitant therapy included Prevnar, Poliomyelitis vaccine inactivated, Hib-Titer vaccine, Hepatitis B vaccine and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. The patient was admitted to the hospital on 9/23/01 for neutropenia and dehydration. Lab test results revealed a decreased white blood cell count of 1.5 K/uL (6.0-17.0), decreased platelet count of 107 K/uL (140-400) and a normal neutrophil percentage of 38% (16-60). Bone marrow aspiration was normal. No recurrence of the neutropenia or thrombocytopenia was noted. The patient recovered (date unspecified). The assessments of the investigator and medical monitor for dehydration were unknown. The investigator considered neutropenia possibly related to the study product as well as study protocol. The medical monitor considered neutropenia not related to the study product but related to concurrent viral illness.
Age: 0.28
Sex: M
Vaccine: PNC
Symptoms: Neutropenia
Clinical narrative: Information regarding Prevnar was received from an investigator concerning a 4 month old male participant in a study who experienced transient neutropenia. The participant received a dose on 4/30/01 at 3 months of age. The patient's concurrent illness includes a febrile illness. The indication for Prevnar was immunization. The product was administered on 4/30/01 and the patient received 1 dose. Concomitant medications were not reported. On 6/17/01, the patient was hospitalized with transient neutropenia. Relevant lab tests were not provided. No additional information was available at the time of this report. The investigator considered neutropenia possibly related to the study product. The medical monitor considered neutropenia related to the patient's febrile illness and not related to the study product.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Condition aggravated, Neutropenia, White blood cell count decreased
Clinical narrative: Information regarding Prevnar was received from an investigator concerning a 12 month old white male participant in a study who experienced benign chronic neutropenia. At 5 months of age, the participant received the third dose on 1/24/02. The participant also received the third dose of Hib-Titer Vaccine, the third dose of Poliomyelitis Vaccine Inactivated, the third dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine, and the third dose of Hepatitis B vaccine on 1/24/02. The patient has a past history of pyelonephritis, chronic otitis media, recurrent febrile episodes, and neutropenia. Indication for Prevnar was immunization. The product was administered on 1/24/02. The infant received 1 dose. Additional suspect medication included Hib-Titer Vaccine, Poliomyelitis Vaccine Inactivated, Hepatitis B Vaccine, Diphtheria/Tetanus Toxoid/Acellular Pertussis Vaccine, MMR, Varicella Virus Vaccine Live and Haemophilus Influenzae B. Concomitant medications were not reported. On 8/10/02, the infant was hospitalized to rule out sepsis. On that day, his absolute neutrophil count was 62 and neutrophil percentage was 1% of the total white blood cell volume (normal: 16-60). A diagnosis of neutropenia was made. Chronic neutropenia continued until 4/23/03 when the child was considered recovered with a normal white blood cell count. The investigator considered neutropenia possibly related to the study product. The medical monitor considered neutropenia related to the child's history of neutropenia diagnosed on 5/13/02 and not related to the study products administered.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Condition aggravated, Neutropenia, White blood cell count decreased, White blood cell count increased
Clinical narrative: Follow up information provided clarification of the event reported, additional suspect vaccines, test results, patient medical history, and a change in the relatedness assessment by the investigator. Information regarding Prevnar was received from an investigator concerning a 4 month old white male participant in a study who experienced neutropenia. At 4 months of age, the participant received the second dose on 7/11/00. The participant also received the second dose of Hib-Titer Vaccine, the second dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine, and the second dose of Poliomyelitis vaccine Inactivated on 7/11/00. The patient's concurrent illness includes hyper IgE syndrome with a history of recurrent staphylococcal skin infections and neutropenia originally documented on 1/5/00. The indication for Prevnar was immunization. The product was administered on 7/11/00. The dose regimen was 1 dose 1 time per day. Additional suspect medication included Hib-Titer Vaccine, Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine, and Poliomyelitis Vaccine Inactivated. Concomitant medications were not reported. On 7/17/00, the child was hospitalized for neutropenia with a neutrophil percentage of 22% (normal: 16-60 and a WBC count of 22.5 K/uL (normal: 6.0-17.0). No additional information was available at the time of this report. The investigator considered neutropenia possibly related to Prevnar administration. The medical monitor considered neutropenia not related to any of the study products but related to the patient's history of neutropenia.