chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: IPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 6cmx7cm erythema, swelling, slight tender, warm right anterior thigh. Given on 5/10/05 IPV. Started on Cephalexin 250mg, 1 tsp. 1.5 tsp. TID for 10 days.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, redness, induration surrounding injection site.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Anxiety, Fatigue, Formication, Insomnia, Pain
Clinical narrative: Patient complained of tiredness the evening of the shot but couldn't sleep due to a feeling of anxiety and the feeling of bugs crawling under her skin. This anxiety and feeling of bugs continued Tuesday and Wednesday. Sent to other ER Wednesday afternoon when patient notified RN of a above reaction. Left arm achy. Not red or swollen. Had fever, low grade on Monday evening.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Patient complained of tiredness the evening of the shot but couldn't sleep due to a feeling of anxiety and the feeling of bugs crawling under her skin. This anxiety and feeling of bugs continued Tuesday and Wednesday. Sent to other ER Wednesday afternoon when patient notified RN of a above reaction. Left arm achy. Not red or swollen. Had fever, low grade on Monday evening.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a swollen, erythematous, slightly indurated and warm to the touch right thigh. (Almost complete anterior aspect of thigh was involved.)
Age: 34.0
Sex: M
Vaccine: JEV
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, severe myalgias requiring treatment at ER.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Patient noted to have left shoulder redness, + induration 6 days after vaccination. Patient was treated in ER; diagnosed with Cellulitis. Treated with antibiotics.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Marked swelling, redness, induration of left arm around injection site and enlarging for 24 hours.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives started from injection site, then to both legs. Claritin 10mg PO OD BID.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of vaccination about 15mm. Treatment with warm compresses at vaccine site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Depressed level of consciousness
Clinical narrative: When shots were administered, patient had an episode of decreased level of consciousness that lasted about 5 seconds. He was stimulated by his mother and normalized.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cough, Periorbital oedema, Rhinorrhoea, Wheezing
Clinical narrative: Patient received immunization at about 14:40 and at 15:80 came back to the clinic with cough, runny nose and right periorbital edema. He did not have wheezing on exam. He was given Benadryl 1.5 tsp PO for 1 dose and watched. At 15:20 he was feeling better; no cough. Still had periorbital edema and wheezing; no edema at injection site. At 16:00, much better; active CTA. No cough; slight periorbital edema.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site warmth, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a health professional concerning a 9 year old white female with PCN allergies, sulfa and cefprozil (Cefzil) allergies who on 04/06/2004, at approximately 9:35 was vaccinated SC in the left arm with a first dose of varicella virus vaccine, live. There was no concomitant medication. The pt had acute pharyngitis at the time of vaccination. On 04/08/2004, the pt was seen in the office for a local injection site rxn that was red, raised, itchy, and painful. The pt was treated with diphenhydramine hydrochlolride ( Benadryl) and cold compresses. The pt was seen on 04/16/04 for a non- related visit and sx had resolved. There was no product quality complaint involved. Follow up information from the MD indicated that the pt was seen 2 days post vacciantion with a 3" diameter red, raised, tender, pruritic, warm area at the site of injeciton in the LD which started on 04/06/04 at 9:35. On 04/10/04, the pt recovered. No laboratory or diagnostic tests were performed. It was reported the pt and her siblings did not have any adverse events following  prior vacciantions. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 11 year old Caucasian female with no relevant medical Hx who on 05/08/1999 was vaccinated SC in the arm with a 0.5ml first dose  of varicella virus vaccine, live. There was no concomitant medication. There was no illness at the time of vaccination. On 04/13/04, the pt presented to the office with chicken pox (about 100 lesions), also described at typical chickenpox presentation which lasted 1 week, with fever. There were no relevant laboratory or diagnostic tests performed. The pt sought medical attention but no medications or treatments were given. Subsequently, the pt recovered on 04/21/04. No product quality complaint was involved. No further information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Antinuclear antibody positive, Laboratory test abnormal, Medication error
Clinical narrative: Information has been received from a healthcare worker concerning a 31 year old white female pt with no pre-existing allergies, birth defects, or medical conditions who on 04/09/04 at 8:30 A.M. was vaccinated SQ in the LA with a dose of varicella virus vaccine, live. There was no illness at the time of vaccination. The pt was vaccinated because she had never had the chickenpox and was "planning a family soon". The HC worker reported that  the varicella virus vaccine, live, may have been recostituted with sailine instead of the dilutent provided. There were no sx reported. No Tx was required. There was no product quality complaint reported. Unspecified medical attention was sought. Follow up information received on 07/02/04 indicated that there was nothing furhter to report. Additional follow up information received 07/23/04 from a NP indicated that the pt was vaccinated with a dose of varicella virus vaccine,live that was stored in the refrigerator instead of the freezer for approximately 3 days.  Two months after the 2 vaccination, in July 2004, an IGG titer showed that antivaricella antibodies were "present but low" Additional information is expected.
Age: 1.61
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Drug ineffective, Pain, Pharyngolaryngeal pain, Photophobia
Clinical narrative: Information has been received from a LPN concerning an 8 year old white female who on 01/30/1997 was vaccinated with a dose of varicella virus vaccine, live. Additional immunization on 08/14/2000 included a 2nd dose of MMR administered SQ in the LL, a 5th dose of DTaP (INFANRIX) administered IM in the RL and a 4th dose of poliovirus vaccine inactivated administered SQ in her LL. On 04/22/2004, the pt was diagnosed with a severe case of chickenpox. The pt had pox in her throat, ears, and nose. She also had a fever, body aches, and photophobia. The pt's tx was rest and antipyretics. It was noted that the pt had greater than 50 lesions. No additional information was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint . There were no adverse event following prior vaccinations of the pt or siblings. Follow up information from a physician indicated that on 04/22/04, the pt presented with a rash "over entire body". It was noted to be possible chickenpox. The child had a very sore throat and an increased temperature. The mother was also concerned about the pox in the pt's throat and ears. There were numerous red maculopapules everywhere. There was also some clear fluid filled vesicles. There was also a red vesicular lesion on the post palate. No nodes were noted. Her lungs were clear to auscultation. The pt's heart had a regular rhythm and no murmur. The rapid strep test was -. The strep culture was (-). The pt was Dx with chickenpox and a sore throat. Additional information has been requested.
Age: 1.61
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a LPN concerning an 8 year old white female who on 01/30/1997 was vaccinated with a dose of varicella virus vaccine, live. Additional immunization on 08/14/2000 included a 2nd dose of MMR administered SQ in the LL, a 5th dose of DTaP (INFANRIX) administered IM in the RL and a 4th dose of poliovirus vaccine inactivated administered SQ in her LL. On 04/22/2004, the pt was diagnosed with a severe case of chickenpox. The pt had pox in her throat, ears, and nose. She also had a fever, body aches, and photophobia. The pt's tx was rest and antipyretics. It was noted that the pt had greater than 50 lesions. No additional information was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint . There were no adverse event following prior vaccinations of the pt or siblings. Follow up information from a physician indicated that on 04/22/04, the pt presented with a rash "over entire body". It was noted to be possible chickenpox. The child had a very sore throat and an increased temperature. The mother was also concerned about the pox in the pt's throat and ears. There were numerous red maculopapules everywhere. There was also some clear fluid filled vesicles. There was also a red vesicular lesion on the post palate. No nodes were noted. Her lungs were clear to auscultation. The pt's heart had a regular rhythm and no murmur. The rapid strep test was -. The strep culture was (-). The pt was Dx with chickenpox and a sore throat. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old female with a history of ulcerative colitis who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the patient was vaccinated and a year or so later, had a severe case of chicken pox. She had been on steroid treatment when exposed to wild type chicken pox. Subsequently, the patient was hospitalized for three days. A product quality complaint was not involved. Additional information has been requested.
Age: 1.57
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 04/13/2000 was vaccinated with varicella virus vaccine, live. On 04/19/04, the pt came with a mild case of chicken pox. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that another pt has a similar experience. (WAES#0404USA02069). Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 year old white male pt who on 10/06/1997 was vaccinated with a first dose of varicella virus vaccine, live. On 04/12/04, the pt developed 5-6 papules on his back, which changed and scabbed and then a few more followed. The ppt had a doctor visit and was given symptomatic tx by the MD. Laboratory tests were not performed. Subsequently, the pt recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 13 year old white female student with a history of a renal transplant (1997) who several years ago was vaccinated with a dose of varicella virus vaccine live. Illness at the time of vaccination included end stage renal disease secondary to hemolytic uremic syndrome. Concomitant therapy included several anti-rejection drugs. On 4/22/04, the patient presented for a doctor's visit with clinical chicken pox. An onset date of 4/22/04 at 09:00 was noted. The patient had more than 100 lesions, but there was no evidence of complications. The patient had been exposed 3 weeks prior to AE onset. The patient was referred to the hospital for acyclovir and was hospitalized for 5 days. Subsequently the patient recovered. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a healthy 9 year old male who on05/20/1997 was vaccinated with a dose of varicella virus vaccine, live. On 03/15/04, the pt experienced breakthrough described as a vesicular rash and itching. Medical attention was sought and 1% cortisone was prescribed. No product quality complaint was involved. The nurse also reported another pt (WAES#0403USA01632) who experienced breakthrough after vaccination with varicella virus vaccine, live. Additional information has been requested.
Age: 1.31
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Pyrexia, Rash erythematous, Urticaria, Vomiting
Clinical narrative: Information has been received from a MD and a consumer concerning her15 month old son with allergies and a Hx of atopic dermatitis who on 04/12/04 was vaccinated in the left leg with a first dose of varicella virus vaccine live. Concomitant vaccination at the same time included a dose of MMR. In the evening on 04/20/04 the pt developed hives on his inner thighs and was TX with Benadryl., which helped the hives. During the night he woke up and vomited. On 04/21/04 he had a low grade fever of 99.1 and hives on arms, legs and feet. Some were raised and bumpy and some were not. It was reported that the hives were more severe than they were on 04/20/04. The pt's mother stated that she didn't think that it was an allergic rxn to something the pt ate, because no new food was introduced. She reported that at the time of vaccination the MD told her that her son could have a rxn for up to 3 weeks, so she wondered if his hives were from the vaccine that was given 9 days earlier. The pt mother scheduled a DR appt for 04/21/04. The mD felt the pt had hives vs. chicken pox appearance. He felt that the hives were caused by a food allergy to either peaches  or strawberries. The MD statied it was unknwon if the hives were  secondary to varicella virus vaccine live, MMR, or environmental exposure. the pt mother reported the hives improved by the evening of 4/21  and resolved  by 4/22. as of 05/11/04 the pt mother reported she eliminated peaches and strawberries from her son's diet and the hives ahve not reappeared. His fever and vomiting also resolved. She stated that she agreed with teh MD and felt iswas from the food. Additoonal info is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning an 8 year old female who on 31Jul98 was vaccinated with a first dose of varicella virus vaccine live (lot 625047/1574E) (SC). Subsequently, during week of 18Apr04, the pt developed a full blown case of chicken pox. Unspecified medical attention was sought. The pt recovered. No product quality complaint involved. The RN also reported on two other pt's who had a similar experience after being vaccinated with varicella virus vaccine live (WAES0404USA02308 and 0404USA02309). Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a nurse practitioner concerning an 43 year old female research assistant with no medical history and no allergies. On 24Feb04 the pt was vaccinated IM with a dose of diphtheria toxoid/tetanus toxoid (Td) (lot U1018BA). On 30Mar04 the pt was vaccinated SC on the left with a first dose of varicella virus vaccine live (lot 647268/1100N). There was no illness at the time of vaccination. On the morning of 13Apr04 the pt developed generalized itching, especially on the scalp, neck and ankles leaving flat, elongated reddened areas from the itching. There were some macular papular areas noted on the ankles and neck. The pt was seen and was treated with diphenhydramine (Benadryl) 25mg stat and 1-2 q 6 hrs and cortisone cream. On 14Apr04, 16Apr04 and 20Apr04 the pt was seen and at each visit there was less itching and rash. On 20Apr04 the pt was back to normal and reported as recovered. It was noted that teh pt will not receive the second dose of varicella virus vaccine live. No further information is expected.
Age: 71.0
Sex: M
Vaccine: HEPA, IPV, TD, YF
Symptoms: Arthralgia, Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: Shaking, chills, muscle aches, fever, weak, joints ache. Talk in sleep.
Age: 71.0
Sex: M
Vaccine: HEPA, IPV, TD, YF
Symptoms: Tremor
Clinical narrative: Shaking, chills, muscle aches, fever, weak, joints ache. Talk in sleep.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a RN concerning an 11 year old male who on 23Aug96 at 10:25 was vaccinated with a first dose of Varicella virus vaccine live (lot 617265/0566D) (SC) in the left leg. On 17Apr04 the pt developed an itchy, raised rash, and headache. The pt recovered. Unspecified medical attention was sought. No product quality complaint involved. It was also noted that the pt's sibling had also developed symptoms following vaccination with varicella virus vaccine live (WAES0405USA00092). No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Dry skin, Irritability, Pruritus
Clinical narrative: Information has been received from a physician concerning a 12 month old biracial female who on 17Mar04 was vaccinated SC in the left thigh with a dose of varicella virus vaccine live (lot 647521/1108N). There was no illness at the time of vaccination. The physician reported that on 28Mar04, the pt developed scattered blisters on her extremities (base to legs), cheeks and chest. A few of the blisters had scabbing. The pt was also noted to be itchy and cranky, but was afebrile. The pt was seen in the physician's office and was treated with 0.1% triamcinolone (Aristocort) cream and diphenhydramine HC1 (Benadryl). Subsequently, the pt recovered from her events. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 28Dec99 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 13Apr04 the pt experienced 8-10 lesions on the trunk and was seen in the office. No treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 08Jun1999 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot 626409/0666H). There was no concomitant medication. On 14Apr04 the pt presented to the office with scattered lesions on the trunk area. Medical attention was sought, but no treatment was required for the event. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning an 8 year old male who on 24Mar1998 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot 62447/1419E). There was no concomitant medication. On 27Apr04 the pt broke out with chickenpox with an unk number of non itchy lesions that started on his chest and then moved to his back. Unspecified medical attention was sought and no treatment or prescription drug was required. No product quality complaint was involved. Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 42 month old male who on 01Nov01 was vaccinated SC with a first dose of varicella virus vaccine live (lot 637957/1882K). Concomitant therapy that day included a third dose of hep B virus vaccine rHBsAg (yeast) (Engerix B) (lot ENG5173A2) (IM) and a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 639916/0903L) given SC. Subsequently, during week of 18Apr2004, the pt developed a few lesions on scalp and chest. Follow-up reported that the pt had developed chicken pox. The pt recovered. No product quality complaint involved. The RN also reported on two other pt's who had similar experience after being vaccinated with varicella virus vaccine live (WAES0404USA02232 and 0404USA02309). No further information is expected.
Age: 1.81
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 year old while male who on 21May1998 was vaccinated with a first dose of varicella virus vaccine live (lot 622850/0537E) (SC). Subsequently, the pt developed a mild to moderate case of chickenpox on an unspecified day in Apr 2004. The pt recovered. No product quality complaint involved. The registered nurse also reported on two other pt's who had a similar experience after being vaccinated with varicella virus vaccine live (WAES0404USa02232 and 0404USa02308). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old male pt who was vaccinated on 21Aug00 with a dose of varicella virus vaccine live. Subsequently, on approx 23Mar04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 10 year old female pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 26Mar04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 8 year old male pt who was vaccinated on 01Nov1996 with a dose of varicella virus vaccine live. Subsequently, on approx 29Mar04, the pt developed breakthrough chickenpox with greater than 500 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old female pt who was vaccinated on 22Aug1999 with a dose of varicella virus vaccine live. Subsequently, on approx 31Mar04, the pt developed breakthrough chickenpox with50v to 500 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old male pt who may have been vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 06Apr04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 37 year old female pt who on 07Nov1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 07Apr04, the pt developed breakthrough chickenpox 50 to 500 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579,  WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old male pt who on 07Dec1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 08Apr04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 11 year old male pt who on 01Nov1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 08Apr04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Anorexia, Dehydration, Injection site pain, Lethargy, Pyrexia
Clinical narrative: High fever of 103 and very lethargic, loss of appetite lots of pain at injection site for 4 days following vaccine, apparent dehydration no wet diapers for 18hrs. following vaccine.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Condition aggravated, Migraine
Clinical narrative: She had mild migraines lasting a couple of days for the last year and a half. The next day after She received the vaccine she started a severe migaine headache that has not stopped for more than a couple of times for two days, one time after being hospitalized and receiving solumedral and DHE. Went to the ER three times to try to relieve the headache. On preventative medication for her daily headache but it has not helped yet. Has been out of school since 4/18.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Diagnosed with varicella on 5-24-2005.
Age: 1.21
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Musculoskeletal stiffness, Pyrexia, Vomiting
Clinical narrative: Client given 3rd dose of Pediarix and a Dtap at the same time.  The Dtap was given in error.  Client vomited once the following day, and he had a fever of 102.0 which lasted about 2 hours before it was controlled with motrin.  Both injections were given in the same leg.  The mother reported redness and stiffness for 2 days following the injection.  At 15 days after the event the mother reports no other adverse reactions.
Sex: F
Vaccine: HEPAB
Symptoms: Medication error
Clinical narrative: A nurse prospectively reported that a 24 year old female patient received a dose of hepatitis A inactivated and hepatitis B recombinant vaccine during the second trimester of pregnancy. On 2/23/01 and 3/29/04, the patient received the first two doses of Twinrix. On an unspecified date in May 2004, the patient became pregnant. On 9/7/04, during the second trimester of pregnancy, the patient received the third dose of Twinrix. This case was reported by a nurse and described the occurrence of growth under the lip in a female newborn infant. The mother of the subject received the third dose of hepatitis A inactivated and hepatitis B recombinant vaccine on 9/7/04, during the second trimester of pregnancy. Case A0528858B refers to the infant. Please see case A0528858A for details of the mother of the infant. The subject was born. At the time of birth, the subject had a red, raised growth on the under the lip. As of 5/19/05, the nurse reported that, "the area has gotten smaller since birth." Comment: Growth on lip was assessed as medically serious (OMIC).
Sex: M
Vaccine: HIBV
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a nurse regarding a now 3 year old male patient who received a third dose on 11/19/02. Additionally, the child received a fourth dose to complete his primary series of Act-HIB on an unspecified date. In December 2004, he was diagnosed with autism. Relevant medical history was not provided. Indication for HIb-Titer Vaccine was immunization. Product was administered on 11/19/02. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included Act-HIB administered as a fourth dose in the primary series on an unspecified date. Concomitant medications were not reported. On an unspecified date, the child completed his primary series of haemophilus B conjugate vaccine when he received a dose of Act-HIB. On 11/19/02, the child received a third dose of Hib-Titer. On an unspecified date, he was evaluated at a child development clinic and received a behavioral assessment (results unknown). In December 2004, he was diagnosed with autism. As of 5/12/05, the patient's outcome is unknown. Information regarding this event has been forwarded to the manufacturer of Act-HIB. No additional information was available at the time of this report.
Age: 22.0
Sex: M
Vaccine: TD
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Periodic leg weakness and numbness lasting 24 hours.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Cold sweat, Dysphagia, Pallor, Vomiting
Clinical narrative: 3:35 PM Patient received Adult Td. 3:50 Patient experienced difficulty swallowing, cool clammy skin, pale, color around mouth and eyes. 3:55 Patient vomiting, chest clear, no wheeze. 4:03 PM Feeling better; color improved, vomiting eases, RR stable, continued no respiratory symptoms. 4:03 - 5:30 PM Monitored; patient stable, reading novel. Tolerated fluids well. Discharged to home in stable condition. Follow up with TC 5/5/05 9:30 AM No concerns; no symptoms, no sequelae
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen with redness, complaint of tenderness. Recommended to apply ice.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Asthenia, Headache, Myalgia, Nasal congestion, Nausea
Clinical narrative: Immediately following administration of second vaccine, patient became nauseated, weak, color paled, assisted to exam table; laid down, given sips of soda and was feeling better within 5-10 minutes after sitting up and feeling better approximately 10 minutes. Home with mom. Returned next day with complaints of fever, headache, and weakness. Advised fluids, rest and monitor.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Pallor, Pyrexia
Clinical narrative: Immediately following administration of second vaccine, patient became nauseated, weak, color paled, assisted to exam table; laid down, given sips of soda and was feeling better within 5-10 minutes after sitting up and feeling better approximately 10 minutes. Home with mom. Returned next day with complaints of fever, headache, and weakness. Advised fluids, rest and monitor.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Pain
Clinical narrative: Patient phoned in 2-3 weeks after Td in December 2004 to state left arm still sore. Told her this was not unusual. Phoned back May 2005 that arm still a little sore and also has discomfort left breast (near sternum). Wants to know if related to tetanus injection. Told her to inform her doctor and I would submit a report to state.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Feeling hot, Pruritus
Clinical narrative: Complained of itching and warmth of upper body. No wheezing, shortness of breath, or skin eruptions noted. Benadryl 50mg given PO stat.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Face oedema, Pruritus
Clinical narrative: Complaining of facial itching and feeling swollen. Denies shortness of breath. No wheezing observed. No obvious facial edema or any skin eruptions noted. Given Benadryl 25mg PO stat. Left ambulatory without any signs of distress.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Alopecia, Dysphonia, Pruritus, Rash, Restlessness
Clinical narrative: On 5/12/05, she got three shots. On 5/13/05, she broke out with little bumps all over her body; head to torso were swelling and itching. Restless and hoarseness now on 5/24/05. Skin is peeling all over; hair falling out and has odor. 2 Benadryl bottles, Prednisolone and Keflex.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Skin odour abnormal, Swelling
Clinical narrative: On 5/12/05, she got three shots. On 5/13/05, she broke out with little bumps all over her body; head to torso were swelling and itching. Restless and hoarseness now on 5/24/05. Skin is peeling all over; hair falling out and has odor. 2 Benadryl bottles, Prednisolone and Keflex.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: 5/19/05 DTaP, IPV administered in right arm. Arm began to redden and swell that day. 5/20 developed fever > 100 degrees F. Now arm swollen, red, and tender. Good ROM and pulses right arm and hand. Treated with cool compresses and Benadryl ever 4-6 hours, RIC increase syrup.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm with redness, induration, warm to touch. No treatment; observe.
Age: 1.03
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Red, swollen, itchy, hot area noted on left thigh.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: 11cmx9cm left deltoid. Hard, warm to touch. Treated with Keflex 250/5, 2tsp PO BID for 10 days.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: Cellulitis left thigh at vaccine site, fever 104.5. Seen in ER 5/14/05. 00:00 CBC with differential, blood culture 18:26; Cath/Urine culture. Seen in office 5/16/05. Rx BID to Cafril 250/5mg BID.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Feeling hot, Hypokinesia, Injection site erythema, Injection site reaction
Clinical narrative: Cellulitis left thigh at vaccine site, fever 104.5. Seen in ER 5/14/05. 00:00 CBC with differential, blood culture 18:26; Cath/Urine culture. Seen in office 5/16/05. Rx BID to Cafril 250/5mg BID.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: Cellulitis left thigh at vaccine site, fever 104.5. Seen in ER 5/14/05. 00:00 CBC with differential, blood culture 18:26; Cath/Urine culture. Seen in office 5/16/05. Rx BID to Cafril 250/5mg BID.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Irritability, Pyrexia
Clinical narrative: Cellulitis left thigh at vaccine site, fever 104.5. Seen in ER 5/14/05. 00:00 CBC with differential, blood culture 18:26; Cath/Urine culture. Seen in office 5/16/05. Rx BID to Cafril 250/5mg BID.
Age: 1.05
Sex: M
Vaccine: IPV, PNC, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at right thigh vaccine site. Started on Augmentin ES 600mg 15ml BID for 10 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: 5/12 Cellulitis left thigh; Duricef 250/5ml BID for 7 days. 5/14 ER with increase in size of cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Severe local reaction (cellulitis); 11x5 inches of erythema and induration. Treatment given: Benadryl syrup 2tsp down to 1tsp and Hydrocortisone cream 25%.
Age: 1.59
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Swelling, Urticaria
Clinical narrative: 10 minutes after immunizations, mom in patient room states "he's having problems." Visible hives and swelling, good air exchange on auscultation. Unable to get O2 saturation because of patient movement. 0930 given 15mg diphenhydramine (Benadryl) PO; 911 called. To ED about 1048 and discharged at 1245.
Age: 1.04
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: 4/26/05 Presented in office with rash for 2 days. Diagnosed with chicken pox (vaccine failure).
Age: 1.08
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient had induration and erythema around injection site. Patient given Benadryl and waited for 30 minutes. Patient had no airway complications. Patient sent home with mom.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: 5/19/05 DTaP, IPV administered in right arm. Arm began to redden and swell that day. 5/20 Developed fever >100 F. Now arm swollen, red, and tender. Good ROM and pulses right arm and hand. Treated with cool compresses and Benadryl ever 4-6 hours. RIC increase syrup.
Age: 56.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria
Clinical narrative: Developed a red spot and itching for several days on the right arm that was injected with polio and yellow fever vaccines.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, myalgia, fatigue, HA, L axillary pain. Treated with ice and NSAID's, Tylenol. Missed 2 days of work.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Severe left arm pain, myalgias, weakness, fever, fatigue. Treated with Tylenol, Motrin and rest. Missed 1 day of work.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Abscess, Agitation, Bacterial infection, Cellulitis, Injection site swelling
Clinical narrative: Received DTaP and HIB in right thigh on 4/21/05. Swelling noted on 5/14/05; increased irritability. Began with fever to 100.6; not consolable. Information frommedical records states abcess, cellulitis. msv
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Irritability, Laboratory test abnormal, Pyrexia
Clinical narrative: Received DTaP and HIB in right thigh on 4/21/05. Swelling noted on 5/14/05; increased irritability. Began with fever to 100.6; not consolable. Information frommedical records states abcess, cellulitis. msv