chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 4 year old male who on 04/16/2002 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot # 639139/0896L, exp. 06/19/2003).  Concomitant therapy included poliovirus vaccine (T Polio) and hepatitis A (HAVRIX) vaccine.  On 04/18/2002 the patient was seen in the physician's office because the patient would not walk.  The patient refused to bear weight and stated "it felt like needles".  The patient stated that it hurt to walk.  the patient described it as a pin prick feeling in his feet.  Upon examination, the patient was afebrile, and had no floor edema.  The patient's range of motion, and pedal pulses were within normal limits.  The patient's feel felt cool to touch.  There was no discomfort elicited with pressure to both feet on flexion.  The patient's physician stated that the patient had a sprain from a unknown injury.  The patient was "eating, drinking and talking fine" and subsequently recovered.  It was reported that the patient was going to be seen by a neurologist.  Additional information was not expected.
Age: 1.4
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 17 month old female with a history of pertussis who on 04/22/2002 was vaccinated on the left side with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #641618/0051M) (site not specified) and on the right side with varicella virus vaccine live (MSD) (lot #640157/1148L) (site not specified). On 05/07/2002 the pt developed rubella, which was diagnosed by a physician on 05/10/2002. The nurse reported that the pt had enlarged lymphnodes behind the ears, a high body temperature, and a rubella rash widespread across her body. In follow-up, it was reported that on 05/10/2002 the pt developed the "typical rubella type rash". The outcome of the pt's rubella was unknown. It was reported that the pt sought unspecified medical attention. In follow-up, it was reported that the pt recovered from the rubella, and that an ER/doctor visit was not required. No further info is expected.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Diarrhoea, Eye pain, Malaise, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old male student with a history of a genital rash who on 04/17/2002, at 12:00, was revaccinated SC with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot @ 641526/1522L).  Concomitant therapy included monetasone furoate (NASONEX) and hydrochlorothiazide (manufacturer unknown).  On 04/20/2002 the patient developed diarrhea.  On 04/21/2002 the patient developed chills and 102.2F oral temperature.  The patient took acetaminophen (Tylenol) and his temperature was 99.6 F at bedtime.  Follow up information received stated that on 04/29/2002 the patient was seen at the student health clinic.  His temperature was 101.6 F, blood pressure 146/92 mmHG, pulse 96 bpm and respirators 18/min.  He presented with a blanching macular rash (which began on 04/28/2002) on his face, chest, and extremities, nonspecifid malaise, and complained of a queasy stomach and that his eyes felt sore.  Laboratory resutls from 04/29/2002 revealed a normal urinalysis, serum protein 8.4 g/dL, serum albumin 5.2 g/dL, white blood cell count 3.2, red blood cell count 5.65 and a platelet count of 188.  The patient was told to increase his fluids and take ibuprofen (Advil) as needed and return 04/30/2002 to the clinic for a recheck.  On 04/30/2002 the patient returned to the clinic and per his medical record his temperature was 100.2 F, BP 142/96, pulse 92 bpm, and respirations 18/min.  The patient reported that the rash had spread to his lower back, that his eyes were still sore and that he had a sore throat.  His physical exam revealed a Koplik spot in his oral mucosa.  He also reported that he also had a rash on his supra pubic and genitalia area which he had several times previously.  The patient was diagnosed with a rubeola infection secondary to the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and Herpes Simplex.  The patient was treated with Valacyclovir hydrochloride (Valtrex) 50mg, three times a day at onset of genital rash.  At the time of this report the patient had recovered from his experience.  No further information is available.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Pharyngolaryngeal pain, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old male student with a history of a genital rash who on 04/17/2002, at 12:00, was revaccinated SC with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot @ 641526/1522L).  Concomitant therapy included monetasone furoate (NASONEX) and hydrochlorothiazide (manufacturer unknown).  On 04/20/2002 the patient developed diarrhea.  On 04/21/2002 the patient developed chills and 102.2F oral temperature.  The patient took acetaminophen (Tylenol) and his temperature was 99.6 F at bedtime.  Follow up information received stated that on 04/29/2002 the patient was seen at the student health clinic.  His temperature was 101.6 F, blood pressure 146/92 mmHG, pulse 96 bpm and respirators 18/min.  He presented with a blanching macular rash (which began on 04/28/2002) on his face, chest, and extremities, nonspecifid malaise, and complained of a queasy stomach and that his eyes felt sore.  Laboratory resutls from 04/29/2002 revealed a normal urinalysis, serum protein 8.4 g/dL, serum albumin 5.2 g/dL, white blood cell count 3.2, red blood cell count 5.65 and a platelet count of 188.  The patient was told to increase his fluids and take ibuprofen (Advil) as needed and return 04/30/2002 to the clinic for a recheck.  On 04/30/2002 the patient returned to the clinic and per his medical record his temperature was 100.2 F, BP 142/96, pulse 92 bpm, and respirations 18/min.  The patient reported that the rash had spread to his lower back, that his eyes were still sore and that he had a sore throat.  His physical exam revealed a Koplik spot in his oral mucosa.  He also reported that he also had a rash on his supra pubic and genitalia area which he had several times previously.  The patient was diagnosed with a rubeola infection secondary to the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and Herpes Simplex.  The patient was treated with Valacyclovir hydrochloride (Valtrex) 50mg, three times a day at onset of genital rash.  At the time of this report the patient had recovered from his experience.  No further information is available.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Convulsion, Lethargy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 month old male, who on 6/29/02 was vaccinated with a dose of MMR (second generation) (lot #641458/0342M). On 6/29/02 within one our of vaccination, the patient became stiff and lethargic. His temp rose to 101.6 oral and some seizure activity was noted. Subsequently, the patient recovered from the events. Further information has been received from the reporting physician. The physician reported that the patient was in the office for his 15 month well visit. The patient was perfectly fine and had no fever or other concurrent conditions. In addition to receiving the MMR (second generation) on 6/29/02, the patient was also vaccinated with streptococcus pneumoniae vaccine and HIB conjugate vaccine. The physician reported that he did not witness the event, but he reported that the child's mother witnessed it in her car on the way home from the office visit. The physician reported that the child was taken to the emergency room by his mother, and was diagnosed with a febrile seizure by the emergency room physicians. The child had a complete blood count, magnesium and calcium level performed which resulted as normal. The child did not require any other intervention or treatment and recovered. The physician reported that he did go to the ER to see the patient and that he did look a little post-ictal. Upon internal review, febrile seizure was considered an other medical event (OMIC). No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male who on 6/21/02 was vaccinated with one dose of MMR II (641119/1377L). On 6/27/02 the pt developed a temp of 102. On 6/30/02 the pt developed a "measles-like" rash believed to be rubella. Unspecified medial attention was sought. Follow up info received from a registered nurse indicated that the pt had been diagnosed with rubella and recovered, without further problems, on an unknown date. Additional info is not expected.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Cough, Crying, Irritability, Pyrexia, Rash macular
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 16 month old white female with no known drug allergies who on 05/13/2002 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) subcutaneously (Lot # 637386/1511K).  On approximately 05/21/2002 the patient experienced generalized maculo-papular rash, fever (102-103.5F), cough, irritable and crying in sleep.  Subsequently, the patient recovered from the events.  It was reported that the child did not have any illness at the time of vaccination.  Unspecified medical attention was sought.  Additional information is not expected.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Rash papular
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 16 month old white female with no known drug allergies who on 05/13/2002 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) subcutaneously (Lot # 637386/1511K).  On approximately 05/21/2002 the patient experienced generalized maculo-papular rash, fever (102-103.5F), cough, irritable and crying in sleep.  Subsequently, the patient recovered from the events.  It was reported that the child did not have any illness at the time of vaccination.  Unspecified medical attention was sought.  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant cocnerning a 4 year old male who on 8/21/02 was vaccinated in the right arm with a dose of MMR II (641017/1097L). Concomitant therapy included poliovirus vaccine inactivated in the right arm and DTaP in the left arm. On 8/23/02 the pt was been in the physician's office for lab results and swelling and redness at the injection site of the MMR II were noticed. The reporter expressed a concern regarding the lot. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by GMP compliance and found to be satisfactory. The lot complies with the standards of the center for biologics evaluation and research and was released. It was also reported that another child (WAES0208USA03671) received a dose of MMR II (641017/1097L) and had a local cellulitis. In addition, three other children received a dose of MMR II (641017/1097L) and none had a reaction. Additional info has been requested.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Furuncle, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 41 year old female with seasonal allergies who on 08/07/2002 at 11:40 AM was vaccinated subcutaneously in the right arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot 639527/1083L). Concomitant medication included loratadine (CLARITIN) taken daily for seasonal allergies. It was reported that at 39 years old, the pt was vaccinated with a first dose of influenza virus vaccine (manufacturer unknown) and had flu-like symptoms. On 08/09/2002 the pt developed 4 boils on her neck and chin, felt feverish, and had feelings of fatigue. The pt stated that she did not take her temperature. It was reported that after one week, on approx 08/14/2002 the pt developed severe joint pain in her right hip and leg. She states that she was able to function, did not seek medical advice, but has never had a pain so bad. The pt took acetaminophen (TYLENOL) which helped her feverish feeling, but did not relieve the joint pain. On 9/11/2002 the pt was reported as recovered. No further info is expected.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Malaise, Pyrexia, Rash macular
Clinical narrative: Information has been received from a registered nurse concerning a 37 year old white male student who on 09/04/2002 at 08:30 was vaccinated subcutaneously in the left upper extremity with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 642498/0345M).  Concomitant therapy included benztropine mesylate, fluoxetine HCl (Prozac) and carbamazepine (Tegretol).  Ten days after administration on 09/14/2002, the student developed a low grade fever, headache, malaise and a macular rash on his arms, legs and trunk.  The fever, headache and malaise resolved in a few days.  On 10/08/2002 the student was seen in the doctor's office, was afebrile and "only a few isolated erythemic spots remained".  No treatment was needed and no diagnostic tests were performed.  Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old white male with a history of febrile seizure following varicella illness in January 2002 who on 8/27/02 was vaccinated SC in the right deltoid with a first dose of MMR (second generation) (lot 639373/1206L). There was no concomitant medication and no illness at the time of vaccination. On 9/5/02, the patient presented to the physician's office with diarrhea. On 9/14/02 at 08:24AM the patient was admitted to the hospital via the emergency room for 1-2 days with a rectal temperature of 106F. Labs included a negative blood culture, a complete blood count and blood chemistry which were both OK. On 10/14/02, the patient was reported to be recovered. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Malabsorption, Musculoskeletal stiffness, Urticaria
Clinical narrative: Hives post-infection, diff. breathing, HA, malaise, stiff neck with ? decrease effectiveness of anti-epileptic drug- to do max; we are now increasing drug to see if can recapture control
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash papular
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old female pt with no allergies and no past medical history, who on 8/14/02 was vaccinated SC in the right thigh with a first dose of MMR II (640963/1379L). There was no illness at the time of vaccination. On 8/26/02 the pt developed a red area with a 1.5cm diameter on her left thigh and 3 papules, 2 of which were "scabbed." The reporter noted that there were no vesicles, no pustules and no infection. The reporter indicated that treatment included "kept clean, Neosporin and bandages until totally scabbed or gone." The reporter also indicated that the pt recovered. Adverse events following prior vaccination included papules around the injection site after vaccination with a first dose of varicella virus vaccine live at 12 months of age (WAES0211USA01945). Additional info is not expected.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dizziness, Influenza, Joint swelling, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old female, who had no illness at the time of vaccination and no medical history or allergies who was vaccinated intramuscular in the left deltoid on 11/12/2002 at 11:00 with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #641723/0426M). Concomitant medication included birth control pills (manufacturer unknown). It was noted that the pt had been previously vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live as a child (exact number of prior does not reported) and had no adverse events following prior vaccination. The reporter initially reported that the pt "developed rubeola and arthritic knee pain" about 2 weeks after receiving the vaccine. The reporter indicated in follow up info that on 11/22/2002 the pt developed flu symptoms, on 11/23/2002 the pt developed dizziness, on 11/24/2002 the pt developed a red rash and on 11/25/2002 the pt developed swollen left and right knees and swollen hands. Unspecified medical attention was sought. On 03/11/2003 it was reported that the pt recovered from these events. Additional info is not expected.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old female, who had no illness at the time of vaccination and no medical history or allergies who was vaccinated intramuscular in the left deltoid on 11/12/2002 at 11:00 with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #641723/0426M). Concomitant medication included birth control pills (manufacturer unknown). It was noted that the pt had been previously vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live as a child (exact number of prior does not reported) and had no adverse events following prior vaccination. The reporter initially reported that the pt "developed rubeola and arthritic knee pain" about 2 weeks after receiving the vaccine. The reporter indicated in follow up info that on 11/22/2002 the pt developed flu symptoms, on 11/23/2002 the pt developed dizziness, on 11/24/2002 the pt developed a red rash and on 11/25/2002 the pt developed swollen left and right knees and swollen hands. Unspecified medical attention was sought. On 03/11/2003 it was reported that the pt recovered from these events. Additional info is not expected.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old white female patient with a history of hives and a drug allergy to amoxicillin causing hives who on 12/04/2002 was vaccinated subcutaneously in the left arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 643502/0837M).  concomitant suspect vaccination given intramuscularly in the left thigh included a fourth dose of Haemophilus B conjugate vaccine (HIBTITER)(Lot # 479271).  There was no illness at the time of vaccination.  On 12/05/2002, the patient was taken to the emergency room with a fever and redness and swelling in the left thigh.  She was treated with ceftriaxone sodium (ROCEPHIN), given a prescription for cephalexin and then discharged.  On 12/06/2002, the patient was seen at the physician's office with some swelling and diagnosis of cellulitis at the site of the Haemophilus B conjugate vaccine administration was made.  The fever resolved and the patient was doing better the next day.  It was reported that the patient recovered on 12/05/2002.  On 01/07/2003, it was reported that the doctors at the practice determined that the cause of the adverse event was Haemophilus B conjugate vaccine and not the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  No further information is expected.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old white female patient with a history of hives and a drug allergy to amoxicillin causing hives who on 12/04/2002 was vaccinated subcutaneously in the left arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 643502/0837M).  concomitant suspect vaccination given intramuscularly in the left thigh included a fourth dose of Haemophilus B conjugate vaccine (HIBTITER)(Lot # 479271).  There was no illness at the time of vaccination.  On 12/05/2002, the patient was taken to the emergency room with a fever and redness and swelling in the left thigh.  She was treated with ceftriaxone sodium (ROCEPHIN), given a prescription for cephalexin and then discharged.  On 12/06/2002, the patient was seen at the physician's office with some swelling and diagnosis of cellulitis at the site of the Haemophilus B conjugate vaccine administration was made.  The fever resolved and the patient was doing better the next day.  It was reported that the patient recovered on 12/05/2002.  On 01/07/2003, it was reported that the doctors at the practice determined that the cause of the adverse event was Haemophilus B conjugate vaccine and not the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  No further information is expected.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old white female patient with a history of hives and a drug allergy to amoxicillin causing hives who on 12/04/2002 was vaccinated subcutaneously in the left arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 643502/0837M).  concomitant suspect vaccination given intramuscularly in the left thigh included a fourth dose of Haemophilus B conjugate vaccine (HIBTITER)(Lot # 479271).  There was no illness at the time of vaccination.  On 12/05/2002, the patient was taken to the emergency room with a fever and redness and swelling in the left thigh.  She was treated with ceftriaxone sodium (ROCEPHIN), given a prescription for cephalexin and then discharged.  On 12/06/2002, the patient was seen at the physician's office with some swelling and diagnosis of cellulitis at the site of the Haemophilus B conjugate vaccine administration was made.  The fever resolved and the patient was doing better the next day.  It was reported that the patient recovered on 12/05/2002.  On 01/07/2003, it was reported that the doctors at the practice determined that the cause of the adverse event was Haemophilus B conjugate vaccine and not the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  No further information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eye oedema, Urticaria
Clinical narrative: Information has been received from a consumer concerning a 4 year old male with allergies to peanuts and eggs and eczema who on 11/8/02 at 10:15am was vaccinated in the leg with a second dose of MMR II (641334/1384L). It was reported that the pt experienced redness around the eyes after the first dose of the vaccine. Concomitant medications at 10:15am included a fifth dose in the leg of Infanrix (52809) and a fourth dose in the leg of IPOL (V0614). There was no illness at the time of vaccination. On 11/8/02, within one hour of administration, the pt broke out in hives on the right side of his neck and his eyes appeared swollen. On 11/9/02 the pt broke out in a rash on both arms. Unspecified medical attention was sought in the ER on 11/8/02. Follow up info indicated that the tp has eczema and the mother believes that the pt's "reaction to the egg in the vaccine" is making it worse. Follow up info from a nurse manager indicated that the mother of the child reported that the child had hives and swollen eyes within 2 hrs of receiving the vaccination. The child was already home at this point since the children only stay in the clinic for approximately 15 to 20 minutes after receiving the vaccination. The reporter stated that she had followed up with the ER and they reported that the child only had a rash. There was no info available on the child's past medical history because the nurse manager did not have access to the chart and the child has not been back to the clinic since the visit of 11/8/02. Additional follow up info from a consumer about her son indicated that the pt broke out in hives on his neck and head, and he became very itchy and uncomfortable. The report indicated that "they took vital sings and administered Benadryl." The report also indicated that the pt's "hives went away but his eczema continues to flare from this MMR II vaccine." It was noted that the pt recovered the same day. Additional info has been requested.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Influenza like illness, Laboratory test abnormal, Rash pruritic
Clinical narrative: Information has been received from a Registered Nurse concerning a 45 year old while male student with a Rubeola titer positive and Rubella titer negative on 12/05/2002, no known drug allergies and no relevant medical history who on 12/06/2002 was vaccinated subcutaneously in the left upper arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 643497/0770M).  There was no illness at the time of vaccination.  On 12/25/2002 the patient developed flu-like symptoms.  The student notified campus health services on 12/18/2002 that he developed a rash "all over upper body and arms", with itching.  Unspecified medical attention was sought.  It was noted that the student had recovered.  No further information is requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Strabismus
Clinical narrative: Information has been received from a physician concerning a 12 month old male pt who on 1/15/03 was vaccinated with a first dose of MMR II into the right arm. Concomitant therapies that day included a first dose of varicella virus vaccine live into the left arm and a fourth dose of Prevnar into the left arm. The pt was not ill at the time of vaccination. Follow up info received from the physician the pt's mother indicates that on 1/17/03 at 1700 the pt developed a fever of 99.5 degrees F, "red rash bumps" on his arms and legs and was crying and restless. The pt was given Tylenol with an antihistamine and finally slept. The mother reported that the rash was reduced with the Tylenol. On 1/20/03 the pt developed strabismus, which was described as an inturning eye and "right eye not tracking." The pt was seen by the physician on 1/28/03. The mother reports that as of 1/30/03 the pt was "currently doing much better, small tracking difficulty with right eye still observed but lessening." Additional info has been received from the physician and indicates that the pt has recovered completely as of 2/21/03. Additional info is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Agitation, Pyrexia, Rash, Restlessness, Strabismus
Clinical narrative: Information has been received from a physician concerning a 12 month old male pt who on 1/15/03 was vaccinated with a first dose of MMR II into the right arm. Concomitant therapies that day included a first dose of varicella virus vaccine live into the left arm and a fourth dose of Prevnar into the left arm. The pt was not ill at the time of vaccination. Follow up info received from the physician the pt's mother indicates that on 1/17/03 at 1700 the pt developed a fever of 99.5 degrees F, "red rash bumps" on his arms and legs and was crying and restless. The pt was given Tylenol with an antihistamine and finally slept. The mother reported that the rash was reduced with the Tylenol. On 1/20/03 the pt developed strabismus, which was described as an inturning eye and "right eye not tracking." The pt was seen by the physician on 1/28/03. The mother reports that as of 1/30/03 the pt was "currently doing much better, small tracking difficulty with right eye still observed but lessening." Additional info has been received from the physician and indicates that the pt has recovered completely as of 2/21/03. Additional info is not expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Urticaria
Clinical narrative: Information has been received from a physician via a company representative concerning a 12 month old male pt, with no relevant medical history, who on 02/18/2003 was vaccinated subcutaneously at 16:15 into the left deltoid with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #641882/0531M). It was reported that the pt had cold symptoms 1 week prior to vaccination with a temperature over the weekend. Concomitant vaccinations on the same day included a third dose of Haemophilus B conjugate vaccine (MSD) (lot #644170/0861M) intramuscularly into the right upper arm and a first dose of varicella virus vaccine live (MSD) (lot #643530/0599M) subcutaneously into the right lower arm. It was reported that the pt had an immediate reaction at the site of the injection where the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) was given on 02/18/2003 at 16:15. There was swelling and redness in the arm. Initial measurement was reported to be 6 cm by 5 cm and was warm to the touch. There was no itching. The pt received a teaspoonful of diphenhydramine (BENADRYL) at 16:20. Ten to 15 minutes later after receiving the diphenhydramine (BENADRYL) the measurement was reported to be a 3 cm by 5 cm (also reported as a 3.5 cm by 3 cm) erythematous wheal and then developed into a raised wheal. The pt was moving the arm well. The reporter indicates that on the following day on 02/19/2003 the pt's arm was better, the swelling and redness was gone and there was some hardness at the injection site. Follow up info has been received and indicates that "spoke with me the following day and no further reaction that night or the next day." The pt's arm was reported as being better, with no redness by the time the pt returned home on 02/18/2003. It was reported that the pt recovered. Additional info is not expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Erythema, Injection site induration, Oedema, Urticaria
Clinical narrative: Information has been received from a physician via a company representative concerning a 12 month old male pt, with no relevant medical history, who on 02/18/2003 was vaccinated subcutaneously at 16:15 into the left deltoid with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #641882/0531M). It was reported that the pt had cold symptoms 1 week prior to vaccination with a temperature over the weekend. Concomitant vaccinations on the same day included a third dose of Haemophilus B conjugate vaccine (MSD) (lot #644170/0861M) intramuscularly into the right upper arm and a first dose of varicella virus vaccine live (MSD) (lot #643530/0599M) subcutaneously into the right lower arm. It was reported that the pt had an immediate reaction at the site of the injection where the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) was given on 02/18/2003 at 16:15. There was swelling and redness in the arm. Initial measurement was reported to be 6 cm by 5 cm and was warm to the touch. There was no itching. The pt received a teaspoonful of diphenhydramine (BENADRYL) at 16:20. Ten to 15 minutes later after receiving the diphenhydramine (BENADRYL) the measurement was reported to be a 3 cm by 5 cm (also reported as a 3.5 cm by 3 cm) erythematous wheal and then developed into a raised wheal. The pt was moving the arm well. The reporter indicates that on the following day on 02/19/2003 the pt's arm was better, the swelling and redness was gone and there was some hardness at the injection site. Follow up info has been received and indicates that "spoke with me the following day and no further reaction that night or the next day." The pt's arm was reported as being better, with no redness by the time the pt returned home on 02/18/2003. It was reported that the pt recovered. Additional info is not expected.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Injection site erythema, Type III immune complex mediated reaction
Clinical narrative: Information has been received from a radiology technician concerning a 5 year old female with no past medical history or allergies, who on March 11, 2003 was vaccinated in the upper arm with a second dose of MMR II (lot # 644576/1013M). Concomitant therapy, that same day, included a dose of poliovirus vaccine (lot # not reported) and a dose of diptheria toxoid/pertussis vaccine teta (lot # not reported). On March 12, 2003 the patient developed erythema of the upper arm and the arm was "rock hard" from shoulder down. Unspecified medical attention was sought and the patient was treated with hydroxide hydrochloride (Atarax). The reporter stated that the patient had "probably recovered because they had not heard back from the parents." The office wants an investigation into the lot number. The reporter noted that they have a new person at the office giving vaccinations and she wasn't sure if this person's techniques was improper or if it was the vaccine. The reporter further noted that she herself gave out a some doses of this lot and none of her patients called with reactions. It was also noted that another female patient (WAES0303USA01370)vaccinated from the same lot on March10, 2003 developed erythema and induration on her left thigh, suspected cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Information has been received from a radiology technician concerning a 5 year old female with no past medical history or allergies, who on March 11, 2003 was vaccinated in the upper arm with a second dose of MMR II (lot # 644576/1013M). Concomitant therapy, that same day, included a dose of poliovirus vaccine (lot # not reported) and a dose of diptheria toxoid/pertussis vaccine teta (lot # not reported). On March 12, 2003 the patient developed erythema of the upper arm and the arm was "rock hard" from shoulder down. Unspecified medical attention was sought and the patient was treated with hydroxide hydrochloride (Atarax). The reporter stated that the patient had "probably recovered because they had not heard back from the parents." The office wants an investigation into the lot number. The reporter noted that they have a new person at the office giving vaccinations and she wasn't sure if this person's techniques was improper or if it was the vaccine. The reporter further noted that she herself gave out a some doses of this lot and none of her patients called with reactions. It was also noted that another female patient (WAES0303USA01370)vaccinated from the same lot on March10, 2003 developed erythema and induration on her left thigh, suspected cellulitis.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a radiology technician concerning a 15 month old female with no past medical history or allergies, who on 03/10/2003 was vaccinated in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #644576/1013M). Concomitant therapy that same day included a dose of HIB conjugate vaccine (MSD) (lot # not reported), a dose of varicella virus vaccine live (MSD) (lot # not reported) and a dose of Streptococcus pneumoniae vaccine (PREVNAR) (lot # not reported). It was initially reported that the pt developed cellulitis in the injected arm, but during a follow-up phone call the reporter stated that on 03/12/2003 the pt developed erythema on her left thigh which covered the diameter of her thigh with an indurated area. The pt was started on amoxicillin (+) clavulanate potassium (AUGMENTIN) for suspected cellulitis, and this cleared within 48 hours. The office wants an investigation into the lot number. The reporter noted that they have a new person at the office giving vaccinations and she wasn't sure if this person's technique was improper or if it was the vaccine. The reporter further noted that she herself gave out some doses of this lot and none of her patients called with reactions. It was also noted that another female pt (WAES #0303USA01698) vaccinated from the same lot on 03/11/2003 developed erythema and hardness in her arm. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a radiology technician concerning a 15 month old female with no past medical history or allergies, who on 03/10/2003 was vaccinated in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #644576/1013M). Concomitant therapy that same day included a dose of HIB conjugate vaccine (MSD) (lot # not reported), a dose of varicella virus vaccine live (MSD) (lot # not reported) and a dose of Streptococcus pneumoniae vaccine (PREVNAR) (lot # not reported). It was initially reported that the pt developed cellulitis in the injected arm, but during a follow-up phone call the reporter stated that on 03/12/2003 the pt developed erythema on her left thigh which covered the diameter of her thigh with an indurated area. The pt was started on amoxicillin (+) clavulanate potassium (AUGMENTIN) for suspected cellulitis, and this cleared within 48 hours. The office wants an investigation into the lot number. The reporter noted that they have a new person at the office giving vaccinations and she wasn't sure if this person's technique was improper or if it was the vaccine. The reporter further noted that she herself gave out some doses of this lot and none of her patients called with reactions. It was also noted that another female pt (WAES #0303USA01698) vaccinated from the same lot on 03/11/2003 developed erythema and hardness in her arm. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a radiology technician concerning a 15 month old female with no past medical history or allergies, who on 03/10/2003 was vaccinated in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #644576/1013M). Concomitant therapy that same day included a dose of HIB conjugate vaccine (MSD) (lot # not reported), a dose of varicella virus vaccine live (MSD) (lot # not reported) and a dose of Streptococcus pneumoniae vaccine (PREVNAR) (lot # not reported). It was initially reported that the pt developed cellulitis in the injected arm, but during a follow-up phone call the reporter stated that on 03/12/2003 the pt developed erythema on her left thigh which covered the diameter of her thigh with an indurated area. The pt was started on amoxicillin (+) clavulanate potassium (AUGMENTIN) for suspected cellulitis, and this cleared within 48 hours. The office wants an investigation into the lot number. The reporter noted that they have a new person at the office giving vaccinations and she wasn't sure if this person's technique was improper or if it was the vaccine. The reporter further noted that she herself gave out some doses of this lot and none of her patients called with reactions. It was also noted that another female pt (WAES #0303USA01698) vaccinated from the same lot on 03/11/2003 developed erythema and hardness in her arm. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 47.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Insomnia, Lymphadenopathy, Night sweats, Pyrexia, Skin striae
Clinical narrative: Original smallpox site on arm developed drainage and a scab again starting one week ago.  Yesterday, he developed on his left lower abdomen what appears to be a smallpox lesion.  Area is reddened but does not appear to have fluid at present.  Patient denies any other symptoms except he states he has really not felt well since he got the vaccine.  He does have an appointment with Dr. next Tuesday June 10, 2003.  Patient advised to keep both lesions covered at all times until he sees the doctor.
Age: 47.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Vaccination complication
Clinical narrative: Original smallpox site on arm developed drainage and a scab again starting one week ago.  Yesterday, he developed on his left lower abdomen what appears to be a smallpox lesion.  Area is reddened but does not appear to have fluid at present.  Patient denies any other symptoms except he states he has really not felt well since he got the vaccine.  He does have an appointment with Dr. next Tuesday June 10, 2003.  Patient advised to keep both lesions covered at all times until he sees the doctor.
Age: 47.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Malaise, Vaccination complication
Clinical narrative: Original smallpox site on arm developed drainage and a scab again starting one week ago.  Yesterday, he developed on his left lower abdomen what appears to be a smallpox lesion.  Area is reddened but does not appear to have fluid at present.  Patient denies any other symptoms except he states he has really not felt well since he got the vaccine.  He does have an appointment with Dr. next Tuesday June 10, 2003.  Patient advised to keep both lesions covered at all times until he sees the doctor.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Laboratory test abnormal
Clinical narrative: Chest pain (squeezing), pain traveling down left arm. First symptoms lasted 15-20 minutes (symptoms began 11 days after vaccination). 2nd incident lasted 20 minutes. Patient stated he had frequent chest pains during hospital stay. (Non-ST elevation MI)
Age: 1.3
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Bacterial infection, Drug ineffective
Clinical narrative: A physician reported that a 16 month old male received his fourth dose of Prevnar vaccine on 12/27/02. He subsequently developed streptococci pneumoniae and was hospitalized. The child previously received three doses of Prevnar. No further information was available at the date of this report.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Lethargy, Musculoskeletal stiffness
Clinical narrative: Seizure like activity with eye movement, stiffening of body with lethargy afterwards lasting 30 seconds, 4 episodes. Admitted to hospital. Placed on Phenobarbital.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site reaction, Pain, Pyrexia
Clinical narrative: Approximately 3 hrs post vaccine administration pt began c/o leg pain. When seen in clinic next day L thigh (vaccine site) measured 40cm. R thigh 34.5cm. Temp of 100 degrees on Motrin. L thigh red with increased heat. L inguinal node enlarged and tender. Benadryl, IV Clindamycin pain mgmt-Tylenol #3 elevation, Nafcillin, compresses d/c'd on PO Clindamycin.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Dyskinesia
Clinical narrative: On Tuesday night she had a seizure while sleeping. On Wed. afternoon she had another one. Wed. evening at about 8:15pm, she was sleeping next to me. She had a seizure loosing control of arms. 2nd one at 10-15 min later loosing control of head and arms.
Age: 15.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Asthma, Fatigue, Fibromyalgia
Clinical narrative: Diagnosed fibromyalgia 12/17/02. Diagnosed with asthma 4/3/01. A 60-day follow up report received 8/18/2003 adds: Continues to have myalgias and chronic fatigue syndrome. I do not know if it is from the immunizations. Mother believes it may be.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Agitation, Pyrexia
Clinical narrative: 5/23/03 9pm temp 103.4 crying, temp cont. to elevate to 104 degrees. Was seen in ER-observed for 2-3 hrs then admitted because temp cont. to remain elevated even with analgesics. Temp broke 5/25/03 evening. Dismissed 5/26/03 at 7am.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Hypersensitivity, Irritability, Oedema
Clinical narrative: Severe swelling and redness all over his body and fussy. No resp. problems. The hospital discharge summary received on 1/8/04 states an allergic reaction.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash papular
Clinical narrative: Papular, targetoid eruption over limbs. Pruritic. 1 week after Anthrax #3 and 2 weeks after smallpox.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Urticaria
Clinical narrative: Broke out with hives. Itching started 2 days after shot and (1st shot) hives at 9 days and (2nd shot) at 4 days.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Erythema, Oedema, Pain
Clinical narrative: Right arm swelling, redness, pain consistent with cellulitis vs allergic reaction after anthrax shot. Started 2 days after shot. Placed on antibiotics, antihistamine, NSAIDs.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Bronchospasm, Chest discomfort, Cough, Dysphonia, Dyspnoea
Clinical narrative: Onset of rhinnorhea, PND and bronchospasm within 72 hours of anthrax #2. Constellation of symptoms suggestive of a hypersensitivity reaction. On evening of 5/16-5/17, became feverish, experienced malaise, and sore throat began. Symptoms continued through the weekend. On 5/18 developed significant PND-increased swallowing and extremely raw throat. On 5/19 clinic evaluation for sore throat, PND and low-grade fever. Treated with Afrin, Deconsal and Allegra. Throat culture negative. Around 5/22 sore throat improved somewhat, but developed itchy, SOB, chest tightness and wheezing with nonproductive cough. Also, lost voice and experienced hoarseness. Fevers resolved. Clinic evaluation on 5/22 - medications changed to Deconamine, Flonase and Tessalon. Clinic evaluation on 5/28 for continued sore throat, chest tightness and cough with pleural rub. New onset of sinus tenderness with greenish drainage and blister on tongue. Diagnosed with sinusitis and prescribed Levaquin. Instructed to take Allegra, Flonase, Deconsal and Benadryl. On 5/29, significant improvement reported after taking Benadryl.