chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Pyrexia
Clinical narrative: A nurse reported that a 4 month old female received her 2nd dose of Prevnar, her 1st dose of Hib-Titer, as well as, Tripedia and IPV on 4/3/01. The pt had a recent medical history of bilateral otitis media, dx'd on 3/19/01 and treated with amoxicillin until 3/28/01 or 3/31/01. On the evening of 4/3/01, her parents noticed a jerking motion that did not stop. She was seen by the physician and her temperature at that time was 101.8F. The pt was taken to the ER and admitted to the pediatric ICU due to seizure activity. According to the reporter, her seizure resolved in approx. 45 minutes. As of 4/4/01, the pt was still in the pediatric ICU. No further seizure activity was noted. Follow-up information received 4/17/01, from the physician, included EEG and CT scan of head. Both tests were normal.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anaemia, Bacterial infection, Meningitis
Clinical narrative: A territory representative reported that a 5 month old female received her 2nd dose of Prevnar along with Hib-Titer, DTAP and IPV vaccines on 2/7/01. On 3/16/01, the infant developed "acute" meningitis. The following day, she was hospitalized. An unspecified culture was positive for Streptococcus pneumonia, serotype unknown. The infant was treated with ampicillin and Rocephin (ceftriaxone).
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Meningitis
Clinical narrative: A territory representative reported that a 5 month old female received her 2nd dose of Prevnar along with Hib-Titer, DTAP and IPV vaccines on 2/7/01. On 3/16/01, the infant developed "acute" meningitis. The following day, she was hospitalized. An unspecified culture was positive for Streptococcus pneumonia, serotype unknown. The infant was treated with ampicillin and Rocephin (ceftriaxone).
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction. A nsg reported that a child received an injection of Prevnar on 4/25/01 and subsequently developed an injection site reaction characterized by redness and swelling. The reporter submitted this report directly to VAERS. Addition information received form the reporter on 5/24/01 indicated that the child was seen by the physician on 5/27/01 and was prescribed Augmentin 350mg BID for 10 days and Amoxil 350mg BID.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction. A nsg reported that a child received an injection of Prevnar on 4/25/01 and subsequently developed an injection site reaction characterized by redness and swelling. The reporter submitted this report directly to VAERS. Addition information received form the reporter on 5/24/01 indicated that the child was seen by the physician on 5/27/01 and was prescribed Augmentin 350mg BID for 10 days and Amoxil 350mg BID.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction. A nsg reported that a 2 month old received injections of Prevnar, Act-HIB, IPV and DTaP on 4/11/01. 2 1/2 hr post vaccination the infant began to cry inconsolably. The infant's mother brought her daughter back to the physician later that same day. An injection site reaction was noted in the right thigh characterized by an area of swelling, warmth, tenderness measuring 3" in diameter. Bruising developed between the Prevnar and Act-HIB injection site. Cold compresses were applied. The child continued to cry until 9pm that evening. On 04/12/2001, the reporter spoke to infant's mother who stated that the infant "looked 100% bettter" and was acting fine. A hard lump was noted at the Act-HIB injection site. Follow up info received from the reporter on 06/18/2001 provided clarification of manufacturers, lot numbers and number of previous doses received by the infant. The infant remained recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Contusion, Crying, Injection site induration, Injection site reaction
Clinical narrative: Injection site reaction. A nsg reported that a 2 month old received injections of Prevnar, Act-HIB, IPV and DTaP on 4/11/01. 2 1/2 hr post vaccination the infant began to cry inconsolably. The infant's mother brought her daughter back to the physician later that same day. An injection site reaction was noted in the right thigh characterized by an area of swelling, warmth, tenderness measuring 3" in diameter. Bruising developed between the Prevnar and Act-HIB injection site. Cold compresses were applied. The child continued to cry until 9pm that evening. On 04/12/2001, the reporter spoke to infant's mother who stated that the infant "looked 100% bettter" and was acting fine. A hard lump was noted at the Act-HIB injection site. Follow up info received from the reporter on 06/18/2001 provided clarification of manufacturers, lot numbers and number of previous doses received by the infant. The infant remained recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Injection site reaction. A nsg reported that a 2 month old received injections of Prevnar, Act-HIB, IPV and DTaP on 4/11/01. 2 1/2 hr post vaccination the infant began to cry inconsolably. The infant's mother brought her daughter back to the physician later that same day. An injection site reaction was noted in the right thigh characterized by an area of swelling, warmth, tenderness measuring 3" in diameter. Bruising developed between the Prevnar and Act-HIB injection site. Cold compresses were applied. The child continued to cry until 9pm that evening. On 04/12/2001, the reporter spoke to infant's mother who stated that the infant "looked 100% bettter" and was acting fine. A hard lump was noted at the Act-HIB injection site. Follow up info received from the reporter on 06/18/2001 provided clarification of manufacturers, lot numbers and number of previous doses received by the infant. The infant remained recovered.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Bacterial infection, Bronchiolitis, CSF test abnormal, Convulsion, Laboratory test abnormal
Clinical narrative: A physician reported that a 2 month old male received his 1st dose of Prevnar on 1/18/01. On 3/11/01, at 4 month of age, he was hospitalized. The pt contracted pneumococcal meningitis; serotype 9V. He was treated with vancomycin for 3 days (until sensitivities were known, then discontinued) and ceftriaxone for 2 weeks. On 3/15/01, he experienced a seizure. As of the date of this report, no further information was available. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life- threatening. Additional follow-up information from a duplicate report received o3/22/2001 and incorporated into this report on 08/30/2001 indicated that the patient was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The patient received 2 weeks of antibiotic therapy.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Meningitis, Respiratory syncytial virus infection
Clinical narrative: A physician reported that a 2 month old male received his 1st dose of Prevnar on 1/18/01. On 3/11/01, at 4 month of age, he was hospitalized. The pt contracted pneumococcal meningitis; serotype 9V. He was treated with vancomycin for 3 days (until sensitivities were known, then discontinued) and ceftriaxone for 2 weeks. On 3/15/01, he experienced a seizure. As of the date of this report, no further information was available. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life- threatening. Additional follow-up information from a duplicate report received o3/22/2001 and incorporated into this report on 08/30/2001 indicated that the patient was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The patient received 2 weeks of antibiotic therapy.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Bacterial infection, Convulsion, Meningitis
Clinical narrative: A physician reported that a 2 month old male received his 1st dose of Prevnar on 1/18/01. On 3/11/01, at 4 month of age, he was hospitalized. The pt contracted pneumococcal meningitis; serotype 9V. He was treated with vancomycin for 3 days (until sensitivities were known, then discontinued) and ceftriaxone for 2 weeks. On 3/15/01, he experienced a seizure. As of the date of this report, no further information was available. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life- threatening. Additional follow-up information from a duplicate report received o3/22/2001 and incorporated into this report on 08/30/2001 indicated that the patient was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The patient received 2 weeks of antibiotic therapy.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Bacterial infection, Convulsion, Laboratory test abnormal, Meningitis
Clinical narrative: A physician reported that a 2 month old male received his 1st dose of Prevnar on 1/18/01. On 3/11/01, at 4 month of age, he was hospitalized. The pt contracted pneumococcal meningitis; serotype 9V. He was treated with vancomycin for 3 days (until sensitivities were known, then discontinued) and ceftriaxone for 2 weeks. On 3/15/01, he experienced a seizure. As of the date of this report, no further information was available. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life- threatening. Additional follow-up information from a duplicate report received o3/22/2001 and incorporated into this report on 08/30/2001 indicated that the patient was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The patient received 2 weeks of antibiotic therapy.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Bacterial infection, Bronchiolitis, CSF test abnormal, Convulsion, Laboratory test abnormal
Clinical narrative: A physician (through a sales representative) reported that an infant received the 1st dose of Prevnar and in February, 2001, developed pneumococcal meningitis and was hospitalized. According to the reported, the physician performed a serotyping and the results were positive for 1 of the strains contained in Prevnar. As of 5/2/01, no further information was available. Follow-up info received on 06/26/2001 indicated that a 2 month old male received his first doses of Prevnar, Infanrix and IPV, as well as, his second dose of Engerix-B on 01/18/2001. The pt had a medical history of recent hospitalization in February, 2001 for RSV bronchiolitis. On 03/11/2001 at 3 months of age, he was hospitalized. Blood and spinal fluid cultures were performed and were positive for streptococcus pneumoniae; a diagnosis of pneumococcal meningitis was made. Blood and cerebrospinal fluid isolates revealed serotype, 9V. The pt experienced a seizure on 03/15/2001. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life-threatening. The reporter submitted this report directly to VAERS. Additional follow-up info from the duplicate report received on 05/22/2001 and incorporated into this report on 08/30/2001 indicated that the pt was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The pt received two weeks of antibiotic therapy.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Meningitis, Respiratory syncytial virus infection
Clinical narrative: A physician (through a sales representative) reported that an infant received the 1st dose of Prevnar and in February, 2001, developed pneumococcal meningitis and was hospitalized. According to the reported, the physician performed a serotyping and the results were positive for 1 of the strains contained in Prevnar. As of 5/2/01, no further information was available. Follow-up info received on 06/26/2001 indicated that a 2 month old male received his first doses of Prevnar, Infanrix and IPV, as well as, his second dose of Engerix-B on 01/18/2001. The pt had a medical history of recent hospitalization in February, 2001 for RSV bronchiolitis. On 03/11/2001 at 3 months of age, he was hospitalized. Blood and spinal fluid cultures were performed and were positive for streptococcus pneumoniae; a diagnosis of pneumococcal meningitis was made. Blood and cerebrospinal fluid isolates revealed serotype, 9V. The pt experienced a seizure on 03/15/2001. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life-threatening. The reporter submitted this report directly to VAERS. Additional follow-up info from the duplicate report received on 05/22/2001 and incorporated into this report on 08/30/2001 indicated that the pt was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The pt received two weeks of antibiotic therapy.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Bacterial infection, Convulsion, Meningitis
Clinical narrative: A physician (through a sales representative) reported that an infant received the 1st dose of Prevnar and in February, 2001, developed pneumococcal meningitis and was hospitalized. According to the reported, the physician performed a serotyping and the results were positive for 1 of the strains contained in Prevnar. As of 5/2/01, no further information was available. Follow-up info received on 06/26/2001 indicated that a 2 month old male received his first doses of Prevnar, Infanrix and IPV, as well as, his second dose of Engerix-B on 01/18/2001. The pt had a medical history of recent hospitalization in February, 2001 for RSV bronchiolitis. On 03/11/2001 at 3 months of age, he was hospitalized. Blood and spinal fluid cultures were performed and were positive for streptococcus pneumoniae; a diagnosis of pneumococcal meningitis was made. Blood and cerebrospinal fluid isolates revealed serotype, 9V. The pt experienced a seizure on 03/15/2001. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life-threatening. The reporter submitted this report directly to VAERS. Additional follow-up info from the duplicate report received on 05/22/2001 and incorporated into this report on 08/30/2001 indicated that the pt was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The pt received two weeks of antibiotic therapy.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, PNC, DTAP, HEP, IPV, PNC
Symptoms: Bacterial infection, Convulsion, Laboratory test abnormal, Meningitis
Clinical narrative: A physician (through a sales representative) reported that an infant received the 1st dose of Prevnar and in February, 2001, developed pneumococcal meningitis and was hospitalized. According to the reported, the physician performed a serotyping and the results were positive for 1 of the strains contained in Prevnar. As of 5/2/01, no further information was available. Follow-up info received on 06/26/2001 indicated that a 2 month old male received his first doses of Prevnar, Infanrix and IPV, as well as, his second dose of Engerix-B on 01/18/2001. The pt had a medical history of recent hospitalization in February, 2001 for RSV bronchiolitis. On 03/11/2001 at 3 months of age, he was hospitalized. Blood and spinal fluid cultures were performed and were positive for streptococcus pneumoniae; a diagnosis of pneumococcal meningitis was made. Blood and cerebrospinal fluid isolates revealed serotype, 9V. The pt experienced a seizure on 03/15/2001. He was hospitalized for 9 days and recovered. The reporter indicated that these events were life-threatening. The reporter submitted this report directly to VAERS. Additional follow-up info from the duplicate report received on 05/22/2001 and incorporated into this report on 08/30/2001 indicated that the pt was treated with vancomycin and ceftriaxone for 3 days until the sensitivities were known. Vancomycin was then discontinued. The pt received two weeks of antibiotic therapy.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Irritability, Lethargy, Muscle twitching, Pyrexia
Clinical narrative: Nine hours post immunization the patient developed a fever which rose to 102.2 and spiked 3-4 times in a 24 hour period. The patient also experienced 2-3 episodes of emesis, alternating irritability and lethargy and the affected limb twitched. As of 5/3/01, the pt was fine. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Prevnar lot #475385. No further information was available at the date of this report. See related HQ0866415MAY2001.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Vomiting
Clinical narrative: Nine hours post immunization the patient developed a fever which rose to 102.2 and spiked 3-4 times in a 24 hour period. The patient also experienced 2-3 episodes of emesis, alternating irritability and lethargy and the affected limb twitched. As of 5/3/01, the pt was fine. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Prevnar lot #475385. No further information was available at the date of this report. See related HQ0866415MAY2001.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Lethargy, Muscle twitching, Pyrexia, Vomiting
Clinical narrative: Nine hours post immunization the patient developed a fever which rose to 102.2 and spiked 3-4 times in a 24 hour period. The patient also experienced 2-3 episodes of emesis, alternating irritability and lethargy and the affected limb twitched. As of 5/3/01, the pt was fine. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Prevnar lot #475385. No further information was available at the date of this report. See related HQ0866415MAY2001.
Age: 1.3
Sex: M
Vaccine: HIBV, PNC, VARCEL, HIBV, PNC, VARCEL
Symptoms: Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: Three hours post immunization pt developed a fever which rose to 104 and chills. He subsequently developed 3 episodes of fever respiking and 3 episodes of vomiting. Pt experienced alternating irritability and lethargy. As of 5/3/01 the pt was fine. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Prevnar lot #475385. No further info was available at date of this report. See related HQ0854614MAY2001.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, PNC, HEP, IPV, MMR, PNC
Symptoms: Dyskinesia, Lymphadenopathy, Pyrexia, Restlessness, Somnolence
Clinical narrative: Within 48 hrs post vax, pt experienced violent shaking of his head from side to side and jerking forward uncontrollably. These episodes resolved in less than a minute and gradually subsided approximately 2.5 wks later. At the same time, pt also experienced a mild fever and restless sleep. Pt developed swollen lymph nodes, especially at his groin, which was "quite" noticeable 2 wks following immunizations. The pt's mother notified his MD on 5/3/01 at his 15-month-checkup. Copies of this report have been forwarded to Merck and Aventis-Pasteur, manufacturers of the concomitantly administered vaccines.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, PNC, HEP, IPV, MMR, PNC
Symptoms: Tremor
Clinical narrative: Within 48 hrs post vax, pt experienced violent shaking of his head from side to side and jerking forward uncontrollably. These episodes resolved in less than a minute and gradually subsided approximately 2.5 wks later. At the same time, pt also experienced a mild fever and restless sleep. Pt developed swollen lymph nodes, especially at his groin, which was "quite" noticeable 2 wks following immunizations. The pt's mother notified his MD on 5/3/01 at his 15-month-checkup. Copies of this report have been forwarded to Merck and Aventis-Pasteur, manufacturers of the concomitantly administered vaccines.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, PNC, HEP, IPV, MMR, PNC
Symptoms: Dyskinesia, Insomnia, Lymphadenopathy, Pyrexia, Tremor
Clinical narrative: Within 48 hrs post vax, pt experienced violent shaking of his head from side to side and jerking forward uncontrollably. These episodes resolved in less than a minute and gradually subsided approximately 2.5 wks later. At the same time, pt also experienced a mild fever and restless sleep. Pt developed swollen lymph nodes, especially at his groin, which was "quite" noticeable 2 wks following immunizations. The pt's mother notified his MD on 5/3/01 at his 15-month-checkup. Copies of this report have been forwarded to Merck and Aventis-Pasteur, manufacturers of the concomitantly administered vaccines.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Erythema, Urticaria
Clinical narrative: A physician reported that a 2 month old female received her 1st dose of Prevnar on 5/18/01. One post vax, the infant developed generalized redness all over her body which turned to hives and totally abated within 30 minutes. A few minutes after the reaction, the child then received doses of DTAP, Hep-B, IPV and Hib vaccines. No further information was available at the date of this report. The follow up received from the vaccine provider on 07/13/2001 provided product names, lot numbers, routes and sites of administration and time of vaccinatio administration and adverse event onset. The pt remained recovered.
Age: 2.2
Sex: M
Vaccine: PNC, PNC
Symptoms: Hypersensitivity, Rash
Clinical narrative: Three hours post vax, pt developed redness on his trunk and arms resembling sunburn. He was seen by MD and advised to watch for further reaction.
Age: 2.2
Sex: M
Vaccine: PNC, PNC
Symptoms: Erythema
Clinical narrative: Three hours post vax, pt developed redness on his trunk and arms resembling sunburn. He was seen by MD and advised to watch for further reaction.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Ear disorder, Eyelid oedema, Rash, Rash macular, Respiratory rate increased
Clinical narrative: Approximately 10-15 minutes post vax, the pt's mom noted blotchy skin, and alerted staff. The Child had grunting respirations at 44 per minutes, BBS, CTA, ears reddened bilaterally, rash to extremities, upper eyelids swollen. The pt was given epinephrine and Benadryl and was admitted for observation. The pt was discharged on 6/23/01.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Eyelid oedema, Grunting, Rash
Clinical narrative: Approximately 10-15 minutes post vax, the pt's mom noted blotchy skin, and alerted staff. The Child had grunting respirations at 44 per minutes, BBS, CTA, ears reddened bilaterally, rash to extremities, upper eyelids swollen. The pt was given epinephrine and Benadryl and was admitted for observation. The pt was discharged on 6/23/01.
Age: 13.0
Sex: F
Vaccine: DT, HEP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: The pt developed numbness in the toes, fingers, tongue and vaginal area occurring 5 days post vax which progressively got worse. The pt was sent to the ER. The pt was admitted to the hospital with a diagnosis of Guillain Barre and was treated with IV IgG.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Difficulty in walking, Fatigue, Headache, Influenza like illness
Clinical narrative: From 8/00 to 5/01 the pt experienced fatigue, followed by extreme joint and muscle pain, flu symptoms, headaches, problems walking, and working because of pain and fatigue. 5/01 the pt started antibiotic treatment and felt a slight improvement, may be related to treatment and weather change.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: From 8/00 to 5/01 the pt experienced fatigue, followed by extreme joint and muscle pain, flu symptoms, headaches, problems walking, and working because of pain and fatigue. 5/01 the pt started antibiotic treatment and felt a slight improvement, may be related to treatment and weather change.
Age: 1.2
Sex: F
Vaccine: DTAP, HEP, MMR, PNC
Symptoms: Apnoea, Coma, Convulsion, Pyrexia, Speech disorder
Clinical narrative: The pt experienced severe seizures with apnea requiring resuscitation with long periods of unresponsiveness. Intermittent speech ability after seizures. Follow upinformation received 09/23/02 states "Severe seizures with apnea requiring hospitalization, Subsequent apraxia and speech delay". The annual follow-up states "severe seizures with apnea requiring hospitalization. Subsequent apraxia and speech delay."
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Red dot rash resembling prickly heat appeared Friday 6/15/01, with temperature of 99.F-100F. Received above immunizations 6/6/01. Fever resolved by 6/16/01. Rash fading, but still present all over body. Is recovering.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Post vax of Prevnar #2, pt's arm was sore and had a fever within 24 hours.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Febrile convulsion, Hyponatraemia
Clinical narrative: On 6/1/01, the pt received the MMR, Prevnar #3 and a PPD and on 6/13/01, the pt was seen in the ER for a febrile seizure.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Laboratory test abnormal, Pyrexia, Staring
Clinical narrative: Generalized seizure which started with staring then generalized tonic-clonic X about 13 minutes. Pt was given valium in ambulance; temperature 102F.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Irritability
Clinical narrative: Severe crying/irritability
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Mom came to clinic and said child began with a rash "about 2 hours before (papular rash). No SOB, wheezing or swelling of face/airway. Was given Benadryl 2cc po every 6 hours and it resolved in less than 24 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Pt developed cellulitis in left thigh.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Screaming
Clinical narrative: Pt awoke at 10:30 the day after receiving vaccines and cried nonstop until 13:30. He was totally inconsolable.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Hyperhidrosis, Injection site warmth, Muscle twitching, Oedema
Clinical narrative: Pt sweaty; local heat and cold. Per a telephone call to clinic on 6/22/01, pt developed the following symptoms. "Even slight movement of the right forearm or hand causes intense pain in the elbow and wrist. No red streaks, no fever and no history of arthritis. Dx reflex sympathetic dystrophy RUE. Treatment with Prednisone 30mg po bid X 5 days, then 1 tablet in AM and 1/2 tablet in PM X 5 days. Use Tylenol. Occupation therapy evaluation 1 X weekly. Cold packs prn.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Osteoporosis
Clinical narrative: Pt sweaty; local heat and cold. Per a telephone call to clinic on 6/22/01, pt developed the following symptoms. "Even slight movement of the right forearm or hand causes intense pain in the elbow and wrist. No red streaks, no fever and no history of arthritis. Dx reflex sympathetic dystrophy RUE. Treatment with Prednisone 30mg po bid X 5 days, then 1 tablet in AM and 1/2 tablet in PM X 5 days. Use Tylenol. Occupation therapy evaluation 1 X weekly. Cold packs prn.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom called, complaining of 1 1/2" redness at injection site and swelling from shoulder to elbow on 6/22/01 to right arm after TriHibit shot. Giving Tylenol and compresses.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mother noted 3 1/2cm X 5cm localized reaction to left deltoid area on 6/19/01 when preparing pt for babysitter. Area reddened and warm to touch. Pt alert and oriented X 3 with no illness. Mother using cool wash cloth to area and Tylenol prn.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Cheilosis, Dry mouth, Eye swelling, Hypersensitivity, Mouth haemorrhage
Clinical narrative: On 6/14/01, pt started with dry lips (breakdown and bloody) on 6/15/01 with periorbital swelling and redness which progressed to entire face, ears/periauricular, eye canthus/cheilosis, sparred nose and forehead, denuded area on chest. Treated with prednisolone 2mg/kg tapered over 8 days. Improved to fine peel of large areas on arms, neck and face. Dx: hypersensitivity Steven's Johnson-like reaction.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Skin necrosis, Stevens-Johnson syndrome
Clinical narrative: On 6/14/01, pt started with dry lips (breakdown and bloody) on 6/15/01 with periorbital swelling and redness which progressed to entire face, ears/periauricular, eye canthus/cheilosis, sparred nose and forehead, denuded area on chest. Treated with prednisolone 2mg/kg tapered over 8 days. Improved to fine peel of large areas on arms, neck and face. Dx: hypersensitivity Steven's Johnson-like reaction.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site pain, Neck pain, Pain, Urticaria
Clinical narrative: On 6/12/01, pain up neck, shoulder and down left arm. On 6/19/01, red welts, swollen and painful on left arm and shoulder. No drainage, not pus filled and no itching. Pain resolved but welts still present.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Localized erythema and induration, initially at right thigh which progressed to > 4.5cm diameter with associated warmth. Gradually resolved with warm compresses and Tylenol for comfort.
Age: 36.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash
Clinical narrative: Pt developed a rash on anterior thighs and left hip area.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Mother called to report that child got 3-4 hives on back at injection site approx. 1 hour after getting shot. She gave the child 1 Claritin and hives were gone in 4-5 hours. Mother also reports child was very "hyper" and talkative, post vax.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Blister, Feeling hot, Pain
Clinical narrative: Babysitter called on 6/19/01 and explained patch of little tiny pinhead size blisters grouped together and area was reddened and warm to touch. Child was brought in on Monday 6/21/01, to have TB test read and it still looked the same but not as much and still warm. The patch was > 3" X 1" and still sore. On 6/25/01, still the same.
Age: 1.6
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Erythema, Feeling hot, Rash macular
Clinical narrative: Right gluteal area with macular erythema and warm to touch but not tender.
Age: 2.3
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abnormal behaviour, Crying, Speech disorder
Clinical narrative: Impaired speech, stuttering, insecure and constantly wanting to be held. He was very independent prior to shot. Cries a lot now. A follow up report received 10/25/2002 adds: From follow-up mailed correspondence received on 08/27/2001, the pt's birth weight, number of siblings and the pt's history was provided. From follow-up correspondence received on 12/03/2001 it was reported that the pt recovered from this experience. The correct Facility Name where the vaccine was administered was also provided. This case is closed.
Age: 0.3
Sex: U
Vaccine: PNC
Symptoms: Bacterial infection, Meningitis, Pyrexia
Clinical narrative: A physician reported that a 4 month old infant received a dose of Prevnar and presented with a fever. A lumbar puncture was done which war purulent. The culture grew out pneumococcus. Dx: Pneumococcal Meningitis. This event was considered "Medical Important". No further information was available as of the date of this report.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Cough, Ear disorder, Infection, Irritability
Clinical narrative: A medical assistant reported that a 9 month old female received her 2nd dose of Prevnar on 3/13/01. On 3/14/01, she developed fever of 100.9F, was fussy and vomited once. On 3/30/01, she developed a cold and cough; she was irritable. On 4/6/01, she was seen by the physician and a dx of bilateral ear infections was made. The pt was treated with azithromycin. At her check-up in 4/01, her ear infections had resolved. 72 hours, prior to 4/27/01, the pt developed fever of 103.3F (ax). She was seen by the physician that day and blood cultures were drawn. The pt was prescribed ceftriaxone sodium. Her blood cultures were positive for "strep pneumonia bacteremia". As of 5/2/01, she was afebrile, still a "little" fuzzy and improving. Septicemia streptococcal is considered "Medically Important". Follow-up information received on 5/3/01, indicated that the pt experienced symptoms on 4/24/01. Blood work was performed on 4/27/01 and a culture was positive for Streptococcus pneumoniae. A dx of bacteremia was made. The pt was not hospitalized. Follow-up information received on 5/30/01, indicated that the pt was administered an injection of ceftriaxone sodium. A CBC and blood cultures were drawn. Her blood cultures were positive at 48 hours for "strep pneumonia". On 4/29/01, the pt was afebrile and acting better. She was prescribed a 10-day course of amoxicillin.  Follow up 09/12/2002: "The patient subsequently recovered."
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Pharyngitis, Pyrexia, Rhinitis, Vomiting
Clinical narrative: A medical assistant reported that a 9 month old female received her 2nd dose of Prevnar on 3/13/01. On 3/14/01, she developed fever of 100.9F, was fussy and vomited once. On 3/30/01, she developed a cold and cough; she was irritable. On 4/6/01, she was seen by the physician and a dx of bilateral ear infections was made. The pt was treated with azithromycin. At her check-up in 4/01, her ear infections had resolved. 72 hours, prior to 4/27/01, the pt developed fever of 103.3F (ax). She was seen by the physician that day and blood cultures were drawn. The pt was prescribed ceftriaxone sodium. Her blood cultures were positive for "strep pneumonia bacteremia". As of 5/2/01, she was afebrile, still a "little" fuzzy and improving. Septicemia streptococcal is considered "Medically Important". Follow-up information received on 5/3/01, indicated that the pt experienced symptoms on 4/24/01. Blood work was performed on 4/27/01 and a culture was positive for Streptococcus pneumoniae. A dx of bacteremia was made. The pt was not hospitalized. Follow-up information received on 5/30/01, indicated that the pt was administered an injection of ceftriaxone sodium. A CBC and blood cultures were drawn. Her blood cultures were positive at 48 hours for "strep pneumonia". On 4/29/01, the pt was afebrile and acting better. She was prescribed a 10-day course of amoxicillin.  Follow up 09/12/2002: "The patient subsequently recovered."
Age: 0.6
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Decreased appetite, Irritability, Pyrexia, Somnolence
Clinical narrative: This report was received on 3/6/01, from a healthcare professional concerning a 7 month old female pt who received her 3rd dose of Prevnar, along with IPV and Infanrix on 3/1/01. The reporter is not aware of any concomitant medication and medical history was not provided. On 3/1/01, 3 hours, post vax, the pt experienced fever as high as 103.2F (rectally), irritability, decreased appetite and increased sleep. At the time of this report, events continue. Additional information was received on 4/27/01, from the reporting healthcare professional, indicating that the pt was admitted to a hospital for 3 days for sepsis work-up. The pt developed a rash on day 5 of the fever. The fever abated, 1 day following the appearance of the rash. Blood, urine and spinal fluid cultures were obtained with negative results. The child was discharged from the hospital after 2 days of IV antibiotics. A follow-up appointment with the child's physician on 3/13/01, revealed a healthy child without sequela.
Sex: M
Vaccine: DTP, PNC
Symptoms: Convulsion
Clinical narrative: An aunt reported that her nephew received Prevnar and DTP on 2/3/01. On 2/24/01, he reportedly experienced a seizure. He experienced another seizure on 3/2/01 and from that date, he experienced seizures every 2 to 3 hours. The pt was hospitalized the next day. He was treated with phenobarbital and transferred to a tertiary care facility. As of 3/5/01, the pt was still hospitalized. The reporter declined to provide additional information.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Lobar pneumonia, Meningitis
Clinical narrative: A nurse reported that a 12 month old female received her 4th dose of Prevnar, as well as, MMRII, Comvax and Varivax on 11/22/00. The pt has a medical history of premature birth at 34 weeks gestation. On 4/22/01, at the age of 17 months, she was hospitalized for pneumococcal meningitis, serotype 19F. The pt recovered. The follow-up info received on 06/11/2001 indicated that the pt also received her first dose of MMR, her second dose of Comvax and her first dose of Varivax on 11/22/2000. She was hospitalized and blood cultures, chest x-ray and complete blood count were performed. The pt's blood cultures were positive for "Strep pneumoniae, serotype 19F" and her chest x-ray revealed a right lower lobe pneumonia. Her white blood cell count was 21.5 with lymphocytes at 25, monocytes at 14 and segmented neutrophils at 59. The pt was hospitalized for 2 days.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Pneumonia
Clinical narrative: A nurse reported that a 12 month old female received her 4th dose of Prevnar, as well as, MMRII, Comvax and Varivax on 11/22/00. The pt has a medical history of premature birth at 34 weeks gestation. On 4/22/01, at the age of 17 months, she was hospitalized for pneumococcal meningitis, serotype 19F. The pt recovered. The follow-up info received on 06/11/2001 indicated that the pt also received her first dose of MMR, her second dose of Comvax and her first dose of Varivax on 11/22/2000. She was hospitalized and blood cultures, chest x-ray and complete blood count were performed. The pt's blood cultures were positive for "Strep pneumoniae, serotype 19F" and her chest x-ray revealed a right lower lobe pneumonia. Her white blood cell count was 21.5 with lymphocytes at 25, monocytes at 14 and segmented neutrophils at 59. The pt was hospitalized for 2 days.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Pneumonia, White blood cell count increased
Clinical narrative: A physician reported that a 9 month old female received her second dose of Prevnar on 11/21/00. On 4/15/01, at 14 months of age, she was hospitalized due to pneumonia. An unspecified culture was performed for strain determination and was positive for "Group 19". Follow-up information received on 5/18/01, indicated that the pt was febrile for 1 week. She was hospitalized for 1 week and a blood culture was performed and it was positive for streptococcus pneumonia. The pt was administered a 10 day course of unspecified antibiotics. The pt recovered. Additional blood work included pneumococcal antibody titers performed prior to 5/16/01 (on this date her 3rd dose of Prevnar was administered) and were reported as "normal". A titer on serotype 19F was also included in this group. Follow-up information received on 5/23/01, indicated that the pt's white blood cell count was "high" for 10 days. The titer result indicated that the pneumococcus was serotype 19. Further follow-up info received on 06/05/2001 indicated tha tthe specimen was serogrouped; however, the reporter was unable to obtain the serotype of the blood culture isolate.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A physician reported that a child, over the age of one, received Prevnar and developed a fever. The reporter indicated that other children experienced a fever following receipt of Prevnar; however, he did not provide the number of pts. Additional reports will be generated when identifying information is provided.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 17 month old male received his 1st dose of Prevnar along with doses of Hib-Titer, MMR, Varivax and Tripedia on 3/1/01. The child's mother indicated that the Prevnar injection site was red and "more pronounced" compared to the other injections that the child had received. Additional information received from the reporter on 5/30/01, indicated that the child also received Hep-B vaccine on 3/1/01. The child recovered.
Age: 1.6
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: A mother reported that her 19 month old daughter received her 2nd injection of Prevnar on 5/1/01. Approx. 6 hours, post vax, the child developed a fever of 102F and 20 to 25 episodes of diarrhea. She was treated with Advil, Tylenol and Anusol (hydrocortisone). This child developed rotavirus gastroenteritis following receipt of her 1st dose of Prevnar. See HQ1046118MAY2001.
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A father reported that his son received his 1st dose of Prevnar and subsequently, developed a "high" fever. No further information was available at the date of this report.
Age: 1.75
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: A physician reported that a 21 month old male received a dose of Prevnar and within 12 to 18 hours, post vax, he developed fever, vomiting and diarrhea. The pt recovered after 3 to 4 days. As of this date, no further information was available. The pt remained recovered.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Hypersensitivity, Skin ulcer, Urticaria
Clinical narrative: A physician reported that a 4 month old male received (his routine vaccinations at 4 months of age) Prevnar, diphtheria, tetanus and acellular pertussis, haemophilus influenza type B, Hep-B and IPV vaccines on 4/16/01 and later that day, developed urticaria with a few target lesions. He was seen by the physician on 4/17/01 and was treated with diphenhydramine. The pt has been referred to an allergist to "sort out allergy". As of this date, no further information was available.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Oral intake reduced, Pyrexia
Clinical narrative: A nurse reported a 6 month old pt (gender not specified) received a 3rd injection of Prevnar, and Tripedia on 5/15/01. Within 12 hours, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar (lot 474724). For information on the other 2 pts, see HQ1206422MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided.
Age: 1.8
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: A physician reported that a 22 month old male received a dose of Prevnar and within 12 to 18 hours following immunization, developed fever, vomiting and diarrhea. The pt recovered after 3 to 4 days. As of the date of this report, no further information was available. This is 1 of 2 reports from this facility of adverse events following receipt of Prevnar. See HQ0814314MAY2001.
Age: 5.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 5 year old female with mild bronchitis, received her 1st dose of Prevnar on 5/15/01. On 5/16/01, she developed an injection site reaction characterized by redness and swelling that extended from her shoulder to her elbow.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Oral intake reduced, Pyrexia
Clinical narrative: A nurse reported a 2 month old pt (gender not specified) received a 1st injection of Prevnar and Tripedia, IPV and Comvax on 5/16/01. Within 12 hors, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar lot 474724. For information on the other 2 pts see HQ1115021MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Injection site reaction, Irritability, Oedema, Pyrexia
Clinical narrative: A nurse reported a 2 month old pt (gender not specified) received a 1st injection of Prevnar and Tripedia, IPV and Comvax on 5/16/01. Within 12 hors, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar lot 474724. For information on the other 2 pts see HQ1115021MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Vasodilation procedure
Clinical narrative: A nurse reported a 2 month old pt (gender not specified) received a 1st injection of Prevnar and Tripedia, IPV and Comvax on 5/16/01. Within 12 hors, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar lot 474724. For information on the other 2 pts see HQ1115021MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Oral intake reduced, Pyrexia
Clinical narrative: A nurse reported a 3 month old pt (gender not specified) received a 1st injection of Prevnar and Tripedia, IPV and Comvax on 5/16/01. Within 12 hours, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is 1 of 3 identifiable pts from this reporter who experienced events following receipts of Prevnar lot 474724. For information on the other 2 pts see HQ1206422MAY2001 and HQ1115021MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided.