chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Muscle twitching, Necrosis, Nervous system disorder, Respiratory distress, Tachypnoea
Clinical narrative: In 4/90, 11 days post vax, the pt experienced recurrent focal seizures. At the time his HIV infection was diagnosed in 10/85, blood analysis consistently revealed leukopenia, mild thrombocytopenia and hemoglobin concentrations of 11.2 to 13.6, lymphocyte counts were around 200-300, CD4 to CD8 ratios of 0.2-0.47. In 10/89, therapy with zidovudine was initiated. The pt had no symptoms related to HIV infection or zidovudine therapy. Although he had received the measles vaccine in 1973 at the age of 3 and a dose of MMR in 1976 at the age of 7, the pt was admitted to the hospital for three days in 2/90 with uncomplicated measles. Tachypnea and respiratory distress responded promptly to therapy with oxygen and aerosolized ribavirin. The pt responded well until two months later, when he presented after two days of recurrent right arm twitches without fever. Physical exam revealed only continuous fine twitches of th right arm. CSF analysis and computed tomography of the head gave normal results, electroencephalography, however, showed right frontal slowing with spike discharges centrally, persisted despite therapeutic anticonvulsant concentrations in serum. the pt was admitted 11 days after the onset of seizures for further diagnostic evaluation. At the time of admission, he was conscious and afebrile. He had right-arm and right-leg twitching but was able to walk. His mental status and the results of motor and sensory examination were normal. Although the latter condition responded to the fluid restriction, the pt developed slurred speech and gradually became unresponsive requiring endotracheal intubation. A 10 day course of IV therapy was given. The pt remained comatose, experiencing continuous focal seizures that could not be controlled with anticonvulsant agents. Neurological and electroencepahlographic exam on day 24 of hospitalization indicated brain death. Mechanical ventilation was discontinued on day 30. The cause of death was subacute measles encephalitis.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Thrombocytopenia
Clinical narrative: In 4/90, 11 days post vax, the pt experienced recurrent focal seizures. At the time his HIV infection was diagnosed in 10/85, blood analysis consistently revealed leukopenia, mild thrombocytopenia and hemoglobin concentrations of 11.2 to 13.6, lymphocyte counts were around 200-300, CD4 to CD8 ratios of 0.2-0.47. In 10/89, therapy with zidovudine was initiated. The pt had no symptoms related to HIV infection or zidovudine therapy. Although he had received the measles vaccine in 1973 at the age of 3 and a dose of MMR in 1976 at the age of 7, the pt was admitted to the hospital for three days in 2/90 with uncomplicated measles. Tachypnea and respiratory distress responded promptly to therapy with oxygen and aerosolized ribavirin. The pt responded well until two months later, when he presented after two days of recurrent right arm twitches without fever. Physical exam revealed only continuous fine twitches of th right arm. CSF analysis and computed tomography of the head gave normal results, electroencephalography, however, showed right frontal slowing with spike discharges centrally, persisted despite therapeutic anticonvulsant concentrations in serum. the pt was admitted 11 days after the onset of seizures for further diagnostic evaluation. At the time of admission, he was conscious and afebrile. He had right-arm and right-leg twitching but was able to walk. His mental status and the results of motor and sensory examination were normal. Although the latter condition responded to the fluid restriction, the pt developed slurred speech and gradually became unresponsive requiring endotracheal intubation. A 10 day course of IV therapy was given. The pt remained comatose, experiencing continuous focal seizures that could not be controlled with anticonvulsant agents. Neurological and electroencepahlographic exam on day 24 of hospitalization indicated brain death. Mechanical ventilation was discontinued on day 30. The cause of death was subacute measles encephalitis.
Age: 1.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Anorexia, Diarrhoea
Clinical narrative: Child started with severe diarrhea and loss of appetite, 24 hours, post vax. Called pediatrician and child admitted to hospital on 1/13/01. Telephone call to mom (does not speak English). Information obtained through interpreter; on 1/12/01, had 1 stool. This AM, appetite remains poor.
Age: 1.75
Sex: F
Vaccine: DTAP, PNC
Symptoms: Arthritis bacterial, Gait disturbance
Clinical narrative: Limping and dragging left leg, started right after vaccine given on 12/29/2000. No swelling noted. Admitted to orthopedics. Informed that dx: fluid in hip ; dx was septic arthritis L hip. On 1/14/2001, arthrotomy and drainage done. Per F/U 3/27/01: treated with cephalexin and ASA.
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Facial palsy, Guillain-Barre syndrome
Clinical narrative: Approximately 6 weeks post vax, the pt developed Guillain [[name]] Syndrome. The pt was hospitalized on 1/3/00 for about 7 to 10 days. The pt now has Bell's Palsy. Further information has been requested. A 15-day follow up report received 02/14/2001 adds: It was reported that a male pt received a Tetanus Toxoid Adsorbed vaccination on 11/16/2000. Approx 6 weeks after vaccination the pt developed Gillain [[name]] Syndrome. Pt was hospitalized on 01/03/2000 for about 7 to 10 days. Pt now has Bell's Palsy. Further info requested. From follow-up correspondence received on 02/07/2001, it was reported the pt received plasma phoresis. Pt has developed Bell's Palsy, which began about 01/03/2001. Pt had some paralysis that has resolved. Reportedly the pt's recovery is in progress.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A territory representative reported that a 66 year old female received a 2nd dose of Pnu-Imune 23 on 111/28/00; she received a 1st dose on 4/10/98. That day, she developed a large area of cellulitis that extended from the injection site across her upper back. She was seen in the ER and admitted to the hospital. She was treated with IV antibiotics. She recovered.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Rash maculo-papular, Screaming
Clinical narrative: The same day as the vax, the pt developed a maculo papular non pruritic rash on the abdominal with unconsolable crying lasting for 12-24 hours then he developed high pitched unconsolable crying lasting more than 3 hours. No treatment was given except acetaminophen.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Postictal state
Clinical narrative: The pt experienced a convulsion (tonic) episode with post-ictal state.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: On 1/11/01 at 5:30 PM the pt experienced a fever of 101. On 1/12/01 in the AM, the pt continued to have a fever. This continued through 1/13/01.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Febrile convulsion
Clinical narrative: The pt experienced a febrile seizure the same day of vaccination.
Age: 0.75
Sex: M
Vaccine: IPV, PNC
Symptoms: Irritability, Pain, Pyrexia
Clinical narrative: The pt became febrile with a temp of 102 lasting over 24 hours after vax. The pt was also quite irritable and uncomfortable. No other symptoms were noted.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Myalgia
Clinical narrative: The pt experienced a headache within 15 minutes of vax. The pt also experienced weakness in arms, injection site sore (left more than right), muscle aches, dizziness, vomiting and nausea.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Nausea, Vomiting
Clinical narrative: The pt experienced a headache within 15 minutes of vax. The pt also experienced weakness in arms, injection site sore (left more than right), muscle aches, dizziness, vomiting and nausea.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Rash, Rash macular
Clinical narrative: The pt developed a hoarse voice lasting about 12 hours, rash all over whole body, blotchy spots, noticed the next morning. Duration of 24 hours.
Age: 4.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: The pt experienced severe pain in his right shoulder with swelling. 2 days later it had improved. No treatment needed.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Erythema, Hypokinesia, Malaise, Night sweats
Clinical narrative: The pt experienced a swollen arm from shoulder to wrist. It was painful and then a day later turned red all over. Could not bend or reach with arm. Felt sick, had a fever and chills along with night sweats and coughing and some itching.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema, Pain, Pruritus, Pyrexia
Clinical narrative: The pt experienced a swollen arm from shoulder to wrist. It was painful and then a day later turned red all over. Could not bend or reach with arm. Felt sick, had a fever and chills along with night sweats and coughing and some itching.
Age: 16.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: The pt presented to office 2 days post vax complaining of swelling and discomfort at injection site. Reaction to the right deltoid measured 3cm x 2 1/2 cm, was warm to the touch with erythema.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt was diagnosed with varicella 4 years post vax.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Hypertension, Pyrexia, Rash maculo-papular, Tachycardia, Viral infection
Clinical narrative: The pt complained of a macular rash (papular) to trunk, upper arms and upper thighs. Clear nasal drainage, throat and tympanic membranes are clear, chest is clear, abdomen is soft, heart rats in regular with no murmur. Temp of 99.5, BP 130/90, P - 88, R - 20. Symptoms appeared on 12/15/00 and resolved pm 12/20
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, TD, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The pt called 24 hours post vax, with intense reaction to the right arm red with fever. After 48 hours the pain spread to her back, recommended Motrin for pain. On 1/11/01 the pt came to the doctor's office and right arm had blotches, advised to avoid DT vaccine.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: The pt received the vaccine on 12/21/00. On 12/30/00, a red area with a white spot at the injection site was noticed. It was approximately 1 1/2" long.
Age: 24.0
Sex: F
Vaccine: MEN, TYP, YF
Symptoms: Injection site pain, Pain
Clinical narrative: Following the yellow fever vaccine, the pt experienced pain in the vaccinated arm from underarm to the wrist. No redness, fever, or swelling. Did not see MD for this. On 1/5/01 reports the arm feels about the same, maybe slightly better. Still has not followed up with MD.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Ear disorder, Feeling cold, Infection
Clinical narrative: On 1/2/01, one vesicle on the inner ankle was noted. The child complained of being cold and feeling tired. By the next morning the child had red, "pimply spots" on body. Had a fever for 2 days reaching 104.7. Child was covered with vesicles. Mother noted they didn't seem to itch as much as you might expect. All vesicles healed after 1 week. Treated for ear infection. Treated with Amoxicillin.
Age: 48.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Feeling cold, Feeling hot
Clinical narrative: The pt experienced severe cold spells alternating with hot spells. Temp was not taken.
Age: 8.0
Sex: F
Vaccine: DT, HEP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash macular
Clinical narrative: Macular rash started on face within 18 seconds of administration of vaccines, spread over entire body; pruritus. Epinephrine 0.2cc administered, SC, with complete symptoms stop approx. 10-15 minutes after administration.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Convulsion, Dyskinesia, Eye disorder, Insomnia, Irritability
Clinical narrative: A pediatrician reported that a 6 month old female received Prevnar on 09/21/2000. The physician reported that the mother stated the infant developed a fever of 99.9 to 100.5 F, fussiness, irritability, and difficulty sleeping on the day of immunization. On 09/23/00, the infant was seen in an emergency room after a 2-3 minute episode of "squeezing eyes shut, thrusting her head backwards, jerking, and rhythmic movements of her head". The reporter indicated that this infant experienced a seizure, however, she was "not post ictal" after the episode. Unspecified lab work and a CT scan were normal. On 09/26/00, the irritability resolved. This event is considered medically important.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Movement disorder, Pyrexia
Clinical narrative: A pediatrician reported that a 6 month old female received Prevnar on 09/21/2000. The physician reported that the mother stated the infant developed a fever of 99.9 to 100.5 F, fussiness, irritability, and difficulty sleeping on the day of immunization. On 09/23/00, the infant was seen in an emergency room after a 2-3 minute episode of "squeezing eyes shut, thrusting her head backwards, jerking, and rhythmic movements of her head". The reporter indicated that this infant experienced a seizure, however, she was "not post ictal" after the episode. Unspecified lab work and a CT scan were normal. On 09/26/00, the irritability resolved. This event is considered medically important.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Convulsion, Laboratory test abnormal
Clinical narrative: A parent reported that her 2 year old son received his first dose of Prevnar on 08/22/00. On 08/30/00, he experienced a seizure. Twenty-two days later, he experienced a second seizure. The seizure is considered a medically important event. The reporter stated that she submitted this report directly to VAERS. Follow up information was received from the child's neurologist on 11/14/00, who stated that an EEG was performed and that the results were "abnormal."
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Bacterial infection, Pneumonia, Sepsis
Clinical narrative: On 10/7/00 a blood culture was positive for Streptococcus pneumonia. Septicemia is considered "medically important".
Age: 0.6
Sex: F
Vaccine: PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: The same day of vaccination, the infant developed a fever and experienced a seizure. She was hospitalized where the reporter noted that the child was "sedated".
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma
Clinical narrative: Approximately 24-36 hours post vax, the parents observed that the infant no longer responded to noise. No further information was available at the date of this report. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL.
Age: 0.5
Sex: U
Vaccine: DTAP, IPV, PNC
Symptoms: Cyanosis, Diarrhoea, Rash, Urticaria, Vomiting
Clinical narrative: Within 24 hours post vax, the pt became blue at the mouth and toes. The pt also developed a rash, vomiting, diarrhea and hives. The pt was seen in an urgent care center. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: One week post vax, the pt developed a red, itchy rash on her lower body. Additional information indicates that the pt has sickle cell thalassemia disease.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: One week post vax, the pt developed a red, itchy rash on her lower body.
Sex: U
Vaccine: DTAP, PNC
Symptoms: Agitation, Crying
Clinical narrative: Subsequent to receiving Prevnar, DTaP, ActHIB and IPV, the pt screamed for 40 minutes. The reported indicated that the pt received the third dose of DTaP, ActHIB and IPV and did not have a reaction. The physician indicated that Prevnar was withheld. This is one of two pts from this facility who experienced screaming following vax administration. A copy of this report has been forwarded to Aventis Pasteur.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema
Clinical narrative: One day post vax, the pt developed redness on her chin, cheeks, and forehead.  the reporter indicated the child was afebrile. A copy of this report has been forwarded to Aventis Pasteur.
Age: 0.8
Sex: U
Vaccine: PNC
Symptoms: Cough, Diarrhoea, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Subsequent to receiving vax, the pt developed a fever. One day post vax, the pts fever rose to 103 degrees F. the pt also developed diarrhea, facial rash, and runny nose with a mild cough.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Rash maculo-papular
Clinical narrative: Two weeks post vax, the pt developed a maculopapular rash that covered her entire body, including the soles of her feet and the palms of her hands. The rash improved after treatment with diphenhydramine. The reporter indicated that the pt has a family history of allergic reactions.
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: The reporter indicated that the pt experienced quite impressive screaming for an unknown duration post vax. This is one of two pts from this facility who experienced screaming following vax administration. A copy of this report has been forwarded to Aventis Pasteur manufacturer of to concomitantly administered vaccines.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Agitation, Crying, Pyrexia, Rash, Urticaria
Clinical narrative: Approximately 3 weeks post vax the pt was seen by a pediatrician who indicated that the infant had developed an urticarial type rash and increased temperature. A diagnosis of Henoch-Schonlein purpura was made. At the date of the office visit the infant experienced a 30 minute period of uncontrollable crying. Blood culture and CT performed on 09/07/2000 were negative. The infant recovered. A copy of this report has been forwarded to Aventis Pasteur, maker of the concomitantly administered vaccines.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Cough, Nasopharyngitis, Pyrexia
Clinical narrative: One day post vax the pt developed a fever. Approximately nine days post vax the pt developed a cold with cough. The pt was treated with Robitussin and recovered. A copy of this report has been forwarded to Merck, manufacturer of Varivax.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Cough, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: One day post vax the pt developed a fever. Approximately nine days post vax the pt developed a cold with cough. The pt was treated with Robitussin and recovered. A copy of this report has been forwarded to Merck, manufacturer of Varivax.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Hypotonia, Lethargy, Oral intake reduced, Stupor
Clinical narrative: Subsequent to receiving vax, the pt developed lethargy, hypotonia and poor oral intake. He also became expressionless.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Hypotonia, Lethargy
Clinical narrative: Subsequent to receiving vax, the pt developed hypotonia, lethargy and poor oral intake. The pt also became expressionless.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Injection site erythema, Rash maculo-papular, Skin ulcer
Clinical narrative: A physician reported that an 11 month old male received his 2nd dose of Prevnar on 9/22/00 and 24 hours, post vax, he developed diffuse redness on his left thigh, excoriated lesions on his hands and a generalized maculopapular rash. He was seen in the ER and prescribed hydroxyzine.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Blister, Dry skin, Erythema, Injury, Oedema peripheral
Clinical narrative: A physician reported that an 11 month old male received his 2nd dose of Prevnar on 9/22/00 and 24 hours, post vax, he developed diffuse redness on his left thigh, excoriated lesions on his hands and a generalized maculopapular rash. He was seen in the ER and prescribed hydroxyzine.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Otitis media, Rash erythematous, Rash vesicular, Skin ulcer
Clinical narrative: A physician reported that an 11 month old male received his 2nd dose of Prevnar on 9/22/00 and 24 hours, post vax, he developed diffuse redness on his left thigh, excoriated lesions on his hands and a generalized maculopapular rash. He was seen in the ER and prescribed hydroxyzine.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Injection site reaction, Pyrexia, Urticaria
Clinical narrative: A nurse reported that a 9 month old female received an injection of Prevnar on 3/29/00. On 3/30/00, she developed a fever and a "quarter-sized" welt at the injection site. The infant recovered.
Age: 0.25
Sex: M
Vaccine: PNC
Symptoms: Irritability, Lethargy, Pyrexia, Rash
Clinical narrative: A nurse reported that a 3 month old male received an injection of Prevnar on 9/11/00. Within 24 hours, post vax, he developed a generalized body rash, experienced lethargy and irritability. He recovered within the next 24 hours. Additional information received from the reporter on 10/30/00, stated that, post vax, the infant developed a fever greater than 101F. The reporter provided additional pt identifiers. The infant remained recovered.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, PNC, DTAP, MMR, PNC
Symptoms: Eczema, Pruritus, Rash erythematous, Sleep disorder
Clinical narrative: A parent reported that her 17 month old daughter received her 1st dose of Prevnar, along with doses of DTAP and MMR II vaccines on 9/8/00. On 9/10/00, the child's mom reported that her daughter awoke screaming. She had developed a "bumpy rash" and experienced itchiness of her feet. A red rash developed on her back and hip. The child's mother indicated that since 9/10/00, her daughter has experienced restless sleep and continues to pound her feet. The mother stated that the rash resolved in 5 days; but reappeared all over her daughter's body. As of 9/28/00, the child's mother stated that her daughter's feet remain itchy. Additional information received from the child's physician on 10/27/00, stated that the child had been seen on 9/11/00 and again on 9/26/00. The child had been examined on both of these occasions by another physician who felt that the rash was eczema; "not a reaction to any vaccine." The physician stated that the child had been adopted from Russia on 8/27/00.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, PNC, DTAP, MMR, PNC
Symptoms: Anxiety, Eczema, Erythema, Irritability, Nightmare
Clinical narrative: A parent reported that her 17 month old daughter received her 1st dose of Prevnar, along with doses of DTAP and MMR II vaccines on 9/8/00. On 9/10/00, the child's mom reported that her daughter awoke screaming. She had developed a "bumpy rash" and experienced itchiness of her feet. A red rash developed on her back and hip. The child's mother indicated that since 9/10/00, her daughter has experienced restless sleep and continues to pound her feet. The mother stated that the rash resolved in 5 days; but reappeared all over her daughter's body. As of 9/28/00, the child's mother stated that her daughter's feet remain itchy. Additional information received from the child's physician on 10/27/00, stated that the child had been seen on 9/11/00 and again on 9/26/00. The child had been examined on both of these occasions by another physician who felt that the rash was eczema; "not a reaction to any vaccine." The physician stated that the child had been adopted from Russia on 8/27/00.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, PNC, DTAP, MMR, PNC
Symptoms: Pruritus, Rash, Sleep disorder
Clinical narrative: A parent reported that her 17 month old daughter received her 1st dose of Prevnar, along with doses of DTAP and MMR II vaccines on 9/8/00. On 9/10/00, the child's mom reported that her daughter awoke screaming. She had developed a "bumpy rash" and experienced itchiness of her feet. A red rash developed on her back and hip. The child's mother indicated that since 9/10/00, her daughter has experienced restless sleep and continues to pound her feet. The mother stated that the rash resolved in 5 days; but reappeared all over her daughter's body. As of 9/28/00, the child's mother stated that her daughter's feet remain itchy. Additional information received from the child's physician on 10/27/00, stated that the child had been seen on 9/11/00 and again on 9/26/00. The child had been examined on both of these occasions by another physician who felt that the rash was eczema; "not a reaction to any vaccine." The physician stated that the child had been adopted from Russia on 8/27/00.
Age: 0.3
Sex: F
Vaccine: DTP, HIBV, IPV, PNC
Symptoms: Cough, Dysphonia, Wheezing
Clinical narrative: A nurse reported that the mother of a 4 month old female called to report that her daughter who received Prevnar, HIB, DPT and IPV vaccines on 8/7/00, sounded hoarse, "like trying to clear her throat", 1 1/2 hours, post vax. She also developed a cough and "funny" wheeze. The pt was prescribed diphenhydramine. She recovered. On the date this report was received, the pt was seen by the physician and was described as "doing fine". The reporter questioned whether this event was an allergic reaction.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Irritability, Rash papular
Clinical narrative: A 6 month old female received her 1st dose of Prevnar on 10/2/00, as well as, her 3rd doses of Acel-Imune and IPV and 1 day later, developed a flat, papular rash on her face, trunk and diaper area. She was also "a little" fussy. She was seen in the physician's office and prescribed diphenhydramine.
Age: 1.0
Sex: U
Vaccine: HEP, PNC, VARCEL
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A sales representative reported that a 12 month old received Prevnar, Varivax and Hep-B on 10/4/00 and the next day, developed "swollen eyes which were almost shut for a couple of hours". The reporter indicated that the child's mother has a history of allergies. Additional information received on 10/16/00, from the sales representative, included the Prevnar lot #. Additional information received on 10/23/00, indicated that the pt developed an injection site reaction, the evening of immunization characterized by a raised area of redness and warmth at the Prevnar injection site. The pt recovered.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Difficulty in walking, Injection site swelling, Injection site warmth, Pyrexia, Sleep disorder
Clinical narrative: A nurse reported that an 18 month old male received vaccinations on 9/26/00 and the next day, developed a fever of 100F and "cried when walking". He also developed an injection site reaction characterized by warmth and swelling at the site of Acel-Imune administration. The mother treated the child with Tylenol. On 9/28/00, the mother reported that the child slept restlessly and that the swelling now extended from the upper thigh to the knee. That same day, he was seen by the physician who noted that his "right knee appeared larger that his left knee" and that the fever, swelling and difficulty walking had resolved. He recovered.
Age: 0.4
Sex: M
Vaccine: PNC
Symptoms: Erythema, Eye disorder, Eye swelling
Clinical narrative: A father reported that his 5 month old son received an injection of Prevnar on 10/5/00 and on 10/7/00, the infant's eye "became extremely swollen and red". The reporter stated that the physician treated him with Benadryl and an unspecified antibiotic.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Henoch-Schonlein purpura, Nasopharyngitis
Clinical narrative: A territory representative reported that a 24 month old male received an injection of Prevnar on 10/4/00 and on 10/9/00, the child developed a cold. Subsequently, he developed a syndrome described as "Henoch-Schonlein Purpura". Follow up states the patient recovered.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: A NP reported that a 25 month old female received her 1st dose of Prevnar on 10/9/00 and 2 day later, developed erythema with a warm and tender area at the injection site along with "secondary cellulitis". The pt was seen in the office that day and was prescribed cephalexin hydrochloride and warm compresses. The pt recovered.
Sex: U
Vaccine: PNC
Symptoms: Dysphonia
Clinical narrative: A sales representative reported that a pt received the 1st dose of Prevnar on 10/5/00 and the next morning, developed hoarseness. As of 10/12/00, no further information was available.
Sex: U
Vaccine: PNC
Symptoms: Crying
Clinical narrative: A pharmacist reported that pediatric nurses have reported that babies are screaming more than with any other injections. As of 10/13/00, no further information was available. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Muscle spasms
Clinical narrative: A physician reported that a 9 month old male received his 1st dose of Prevnar (approx. 1 month ago) and subsequently, experienced muscle spasms in both of his lower extremities. The physician indicated that the pt's mother called and reported that her son hand "no fever, no irritability, just pulling up of his legs".
Age: 1.0
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported that a 12 month old male received vaccines on 10/4/00 and on 10/13/00, the infant developed an injection site reaction characterized by redness, warmth, tenderness, swelling and blisters at the site of Prevnar administration. He was treated with Keflex and hot soaks.
Age: 1.25
Sex: U
Vaccine: HIBV, PNC
Symptoms: Injection site erythema
Clinical narrative: A physician reported that a 15 month old child received an injection of HIB vaccine on 10/14/00, and the vial was inadvertently reconstituted with Prevnar. On 10/16/00, the child had redness at the injection site. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Age: 1.7
Sex: F
Vaccine: PNC
Symptoms: Bronchitis, Cough, Lethargy, Pneumonia, Pyrexia
Clinical narrative: A physician reported that a 20 month old female received an injection of Prevnar on 10/6/00. That evening, the child developed a fever of 102F, coughing and was lethargic. On 10/14/00, she was dx'd with bronchitis. The reporter stated that the bronchitis "turned into pneumonia". She was treated with Zithromax, albuterol nebulizer and Ryna (pseudoephedrine/chlorpheniramine). The child recovered.
Age: 0.6
Sex: F
Vaccine: HEP, PNC
Symptoms: Rash maculo-papular
Clinical narrative: A physician reported a 7 month old female received Prevnar and Recombivax-HB vaccines on 10/10/00 and on 10/12/00, she developed a maculopapular rash on her arms and lower extremities. She was treated with oral diphenhydramine.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia, Rash papular
Clinical narrative: A NP reported that a pt received an injection of Prevnar and subsequently, developed a fever of 102F. The fever resolved in 2 days. The pt then developed a generalized papular rash that was described as "not quite roseola in appearance". No further information was available at the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Sex: U
Vaccine: PNC
Symptoms: Otitis media
Clinical narrative: A territory representative reported that a pt inadvertently received 0.4 ml of Prevnar instead of the recommended dose of 0.5 ml. A few days, post vax, the pt developed an ear infection. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Fatigue, Hypotonia, Injection site reaction, Irritability, Oral intake reduced
Clinical narrative: A physician reported that her 1 year old son received an injection of Prevnar on 10/29/00. That same day, he developed irritability, restlessness, decreased appetite, drowsiness, fatigue, hyperactivity and an unspecified injection site reaction. The reporter also believes that her child may have experienced hypotonic-hyporesponsive episodes as "he looked a little floppy last night". As of 10/24/00, the symptoms had not resolved.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Psychomotor hyperactivity, Restlessness, Somnolence, Stupor
Clinical narrative: A physician reported that her 1 year old son received an injection of Prevnar on 10/29/00. That same day, he developed irritability, restlessness, decreased appetite, drowsiness, fatigue, hyperactivity and an unspecified injection site reaction. The reporter also believes that her child may have experienced hypotonic-hyporesponsive episodes as "he looked a little floppy last night". As of 10/24/00, the symptoms had not resolved.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Erythema, Injection site erythema, Injection site induration, Rash papular
Clinical narrative: A physician reported that a 9 month old female received Prevnar and Hep-B vaccines on 10/24/00 and subsequently, developed a "strange" rash. The rash was described as red and papular rash over her body and a confluent, bright red rash over her entire face. She also developed an injection site reaction characterized by a "1/2 dollar-sized" area of induration and erythema at the injection site of the Prevnar injection. She was treated with diphenhydramine. As of 10/26/00, the rash persisted.
Age: 1.0
Sex: F
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Cough, Febrile convulsion, Otitis media, Pneumonia, Roseola
Clinical narrative: A mother reported that her 12 month old daughter received Prevnar, varicella and poliomyelitis vaccines on 10/2/00 and subsequently, developed a fever. On 10/11/00, her fever was 105.2F and the mother reports that she "may have had a febrile seizure because she was not responding appropriately and would just stare ahead at times". The mother treated her with Tylenol and the fever resolved. On 10/13/00, the child developed a rash on her trunk and face. On 10/16/00, she was seen by the physician who dx'd roseola. The roseola resolved on 10/18/00. On 10/23/00, the child developed a cough and fever of 103F. On 10/27/00, the fever resolved and she was seen by the physician who dx'd "a touch of pneumonia" and a left ear infection. She was treated with amoxicillin. As of 10/30/00, the child is improving but has developed "occasional vomiting due to coughing and gagging".
Age: 1.0
Sex: F
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Somnolence, Staring, Vomiting
Clinical narrative: A mother reported that her 12 month old daughter received Prevnar, varicella and poliomyelitis vaccines on 10/2/00 and subsequently, developed a fever. On 10/11/00, her fever was 105.2F and the mother reports that she "may have had a febrile seizure because she was not responding appropriately and would just stare ahead at times". The mother treated her with Tylenol and the fever resolved. On 10/13/00, the child developed a rash on her trunk and face. On 10/16/00, she was seen by the physician who dx'd roseola. The roseola resolved on 10/18/00. On 10/23/00, the child developed a cough and fever of 103F. On 10/27/00, the fever resolved and she was seen by the physician who dx'd "a touch of pneumonia" and a left ear infection. She was treated with amoxicillin. As of 10/30/00, the child is improving but has developed "occasional vomiting due to coughing and gagging".
Age: 1.0
Sex: F
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Cough, Decreased appetite, Febrile convulsion, Irritability, Nasal congestion
Clinical narrative: A mother reported that her 12 month old daughter received Prevnar, varicella and poliomyelitis vaccines on 10/2/00 and subsequently, developed a fever. On 10/11/00, her fever was 105.2F and the mother reports that she "may have had a febrile seizure because she was not responding appropriately and would just stare ahead at times". The mother treated her with Tylenol and the fever resolved. On 10/13/00, the child developed a rash on her trunk and face. On 10/16/00, she was seen by the physician who dx'd roseola. The roseola resolved on 10/18/00. On 10/23/00, the child developed a cough and fever of 103F. On 10/27/00, the fever resolved and she was seen by the physician who dx'd "a touch of pneumonia" and a left ear infection. She was treated with amoxicillin. As of 10/30/00, the child is improving but has developed "occasional vomiting due to coughing and gagging".
Age: 1.0
Sex: F
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Otitis media, Pneumonia, Pyrexia, Roseola, Staring
Clinical narrative: A mother reported that her 12 month old daughter received Prevnar, varicella and poliomyelitis vaccines on 10/2/00 and subsequently, developed a fever. On 10/11/00, her fever was 105.2F and the mother reports that she "may have had a febrile seizure because she was not responding appropriately and would just stare ahead at times". The mother treated her with Tylenol and the fever resolved. On 10/13/00, the child developed a rash on her trunk and face. On 10/16/00, she was seen by the physician who dx'd roseola. The roseola resolved on 10/18/00. On 10/23/00, the child developed a cough and fever of 103F. On 10/27/00, the fever resolved and she was seen by the physician who dx'd "a touch of pneumonia" and a left ear infection. She was treated with amoxicillin. As of 10/30/00, the child is improving but has developed "occasional vomiting due to coughing and gagging".
Age: 1.0
Sex: F
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Vomiting
Clinical narrative: A mother reported that her 12 month old daughter received Prevnar, varicella and poliomyelitis vaccines on 10/2/00 and subsequently, developed a fever. On 10/11/00, her fever was 105.2F and the mother reports that she "may have had a febrile seizure because she was not responding appropriately and would just stare ahead at times". The mother treated her with Tylenol and the fever resolved. On 10/13/00, the child developed a rash on her trunk and face. On 10/16/00, she was seen by the physician who dx'd roseola. The roseola resolved on 10/18/00. On 10/23/00, the child developed a cough and fever of 103F. On 10/27/00, the fever resolved and she was seen by the physician who dx'd "a touch of pneumonia" and a left ear infection. She was treated with amoxicillin. As of 10/30/00, the child is improving but has developed "occasional vomiting due to coughing and gagging".
Age: 1.6
Sex: U
Vaccine: PNC
Symptoms: Bacterial infection, Corneal disorder, Keratitis
Clinical narrative: A physician reported that a 19 month old child received an injection of Prevnar and a few days later, developed a "cloudy right cornea". The child was seen by the physician and dx'd with keratitis. A culture was positive for Streptococcus viridans which the reporter believed was a "skin contaminant". The pt is being treated with an unspecified topical antibiotic".
Age: 1.2
Sex: F
Vaccine: HEP, HIBV, PNC
Symptoms: Pyrexia, Rash maculo-papular, Rhinorrhoea, Sinusitis, Viral infection
Clinical narrative: A father, who is a physician, reported that his 14 month old daughter received Prevnar, Hep-B and HIB vaccines on 10/18/00. Thirty-six hours, post vax, she developed a persistent low-grade fever and a runny nose that started as a clear discharge and has changed to yellow-green in color. She also developed a maculopapular rash on her legs, trunk and scalp. The rash was "very, very fine" on her face and spared the diaper area. On 10/27/00, her white blood cell count was reportedly normal and a "strept test" was negative. The treating pediatrician is presuming a viral infection, possibly a sinus infection. She was treated initially with a course azithromycin and then IM ceftriaxone. Of note; this pt's grandmother became ill, following receipt of pneumococcal vaccine. See report HQ4704411DEC2000. Additional information received 12/28/2000 indicated that the rash resolved after 2 weeks.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Abasia, Anorexia, Coma, Pyrexia, Staring
Clinical narrative: A 15 month old female received Prevnar, Acel-Imune, Hib-Titer and MMR II vaccines on 7/6/00. That same day, the child developed a fever of 105.7F, "unresponsiveness, periods of blank staring, would not eat, fall over in sitting position and fall down when standing, could not walk for days".
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: White blood cell count increased
Clinical narrative: A 15 month old female received Prevnar, Acel-Imune, Hib-Titer and MMR II vaccines on 7/6/00. That same day, the child developed a fever of 105.7F, "unresponsiveness, periods of blank staring, would not eat, fall over in sitting position and fall down when standing, could not walk for days".
Age: 1.08
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Febrile convulsion, Pain, Rash erythematous
Clinical narrative: This report is concerning a 13 month old female who received Prevnar and Varivax vaccines on 7/30/00 and on 8/10/00, developed a fever, pain, "red papules, and vesicles". She was seen by the physician. The next day, the child's fever was 102F and she experienced a febrile seizure which lasted for 2 to 3 minutes.
Age: 1.25
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Cough, Febrile convulsion, Nasal congestion, Otitis media
Clinical narrative: This report concerns a 15 month old male who received Prevnar, Comvax, Varivax and MMRII vaccines on 7/19/00. On 7/26/00, the child developed a cough and congestion. On 7/28/00, he experienced a febrile seizure which lasted for 4 to 5 minutes. ER services was called and the child was treated with albuterol. He was seen in an ER and dx'd with an ear infection. The child was treated with amoxicillin.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: A nurse reported that a 3 year old male received an injection of Prevnar on 11/9/00 and within 2 to 3 hours, he developed an injection site reaction characterized by an area a "quarter in size" of redness, swelling and tenderness. He also had the chills. On 11/10/00, the child was not feeling well. Follow up information received 12/29/2000 indicated the patient recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Oedema peripheral, Rash
Clinical narrative: A physician reported that her 2 month old daughter received Prevnar, Comvax, IPV and DTAP vaccines on 11/06/00. On 11/11/00, she developed a rash. On 11/12/00, the child developed swelling of her hands and feet.
Age: 7.0
Sex: F
Vaccine: PNC
Symptoms: Dyskinesia, Eye movement disorder, Injection site pain, Loss of consciousness
Clinical narrative: A mother reported that her 7 year old daughter received an injection of Prevnar on 11/14/00. Approx. 15 minutes, post vax, the child "fell to the floor, her eyes rolled back into her head and she was jerking". She was treated with an "ammonia inhaler". The child also developed soreness at the injection site. Follow up states the patient recovered.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: A mother who is a nurse, reported that her 10 month old daughter received an injection of Prevnar on 11/13/00 which may have inadvertently been given SC. The child subsequently developed an injection site reaction characterized by redness and a bump.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Hypokinesia, Injection site pain, Pyrexia
Clinical narrative: A physician reported that a 9 month old male received an injection of Prevnar in 8/00. Seven to 10 days, post vax, he developed a fever, led discomfort and a decrease in the use of the leg in which the Prevnar was administered. The reporter indicated that the child may have experienced a minor trauma from "a fall" around the time of the event. The child recovered.
Age: 1.25
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Eye swelling, Nasal congestion, Rash, Urticaria
Clinical narrative: A nurse reported that a 13 month old male received Prevnar, TriHibit and IPV vaccines on 11/16/00. Within 24 hours, he developed "migratory hives" over his body and swelling around the eyes. The reporter indicated that the child had mild congestion and a rash at the time of immunization. Follow up information received 12/29/2000 indicated the patient recovered.
Age: 0.3
Sex: M
Vaccine: DTP, HIBV, IPV, PNC
Symptoms: Asthma, Otitis media, Upper respiratory tract infection, Vomiting
Clinical narrative: A mother reported that her 4 month old son received Prevnar, IPV, HIB and DPT vaccines on 8/8/00. On 8/10/00, he experienced an upper respiratory tract infection and "severe reflux". The pt was seen by an ENT physician, who surgically removed the child's adenoids and dx'd him with asthma. The child was also seen in the ER for both upper respiratory tract and an ear infection. He was treated with numerous antibiotics; however, "none of them have helped".
Sex: U
Vaccine: PNC
Symptoms: Upper respiratory tract infection
Clinical narrative: A territory representative reported that a pt inadvertently received a 0.4 ml dose of Prevnar instead of the recommended dose of 0.5 ml. A few days, post vax, the child developed an upper respiratory infection. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar.
Age: 0.9
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 10 month old female received a SC injection of Prevnar on 11/28/00. The next day, she developed an injection site reaction characterized by swelling and redness. Follow up states the day after the Prevnar injection the patient was seen by a physician and diagnosed with cellulitis. The patient was treated with Augmentin and recovered by 12/01/2000.
Age: 0.71
Sex: F
Vaccine: PNC
Symptoms: Erythema multiforme, Pyrexia, Vomiting
Clinical narrative: A physician reported that an 8 month old female received an injection of Prevnar on 10/17/00 and within 12 hours, post vax, the child experienced vomiting. Twenty-four hours, post vax, she developed a fever of 102F and erythema multiforme. The fever and vomiting resolved. This is 1 of 3 pts from this facility who had an adverse event following receipt of Prevnar. Follow up information received on 12/29/2000 the erythema multiforme resolved.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Eye movement disorder, Otitis media, Pyrexia, Somnolence, Vaccine positive rechallenge
Clinical narrative: A mother reported that her 8 month old daughter received her 2nd dose of Prevnar on 11/14/00. That afternoon, her eyes began rolling around and she was sleepy. Between 21:00 on 11/14/00 and 04:30 on 11/15/00, she vomited 8 times. She was taken to the hospital; she had a fever of 102.5F and an ear infection. She was treated with azithromycin, acetaminophen and IV fluids. She was released from the hospital at 09:30 on 11/15/00. The fever resolved by 11/17/00. This child developed a fever, vomiting and an ear infection following a previous dose of Prevnar. See MCN HQ4086327NOV2000.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Vomiting
Clinical narrative: A mother reported that her 8 month old daughter received her 2nd dose of Prevnar on 11/14/00. That afternoon, her eyes began rolling around and she was sleepy. Between 21:00 on 11/14/00 and 04:30 on 11/15/00, she vomited 8 times. She was taken to the hospital; she had a fever of 102.5F and an ear infection. She was treated with azithromycin, acetaminophen and IV fluids. She was released from the hospital at 09:30 on 11/15/00. The fever resolved by 11/17/00. This child developed a fever, vomiting and an ear infection following a previous dose of Prevnar. See MCN HQ4086327NOV2000.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A physician reported that a 2 year old female received an injection of Prevnar on 9/20/00. That same day, the child developed a fever of greater than 102F. She recovered. This is 1 of 5 pts from this facility who experienced this event following receipt of 3 different lots of Prevnar.