chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Injection site reaction, Irritability, Oedema, 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.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Vasodilation procedure
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.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A physician reported that a 7 month old male received his 3rd dose of Prevnar and subsequently, developed an injection site reaction characterized by erythema and "a lot of" swelling. No further information was available at the date of this report. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar. See HQ1366125MAY2001.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: A pediatrician reported that a 12 month old female received her 4th dose of Prevnar vaccine, in the left arm, on 4/5/01. She also received Prevnar vaccine on 8/8/00 at 4 months of age, 10/13/00 at 6 months of age and 1/5/01 at 9 months of age. On 5/23/01, at 13 months of age, the child developed an injection site reaction characterized by tenderness, induration and warmth.
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A physician reported that a male pt received Prevnar and 72 hours later, developed a fever. No further information was available at the date of this report. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar. See HQ1284524MAY2001.
Age: 9.0
Sex: F
Vaccine: HEP, MMR, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 9 year old female developed an injection site reaction following vaccination with Prevnar (date unspecified). The child has a history of cerebral palsy and takes "many" unspecified medications. The child received other unspecified vaccinations on the day of vaccination with Prevnar. The child developed erythema (4" X 3") and swelling on the thigh at the Prevnar injection site. Benadryl (diphenhydramine hydrochloride was given and ice was placed on the injection site.
Age: 1.5
Sex: F
Vaccine: DTP, IPV, PNC
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: A mother reported that her 18 month old daughter received Prevnar, poliomyelitis and DTP vaccines on 2/27/01. On 3/4/01, she developed a fever of 103F and severe diarrhea. On 3/5/01, she developed vomiting. She was treated with ibuprofen. As of 3/6/01, her symptoms persisted.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Irritability, Oral intake reduced, Somnolence
Clinical narrative: A mother reported that her 9 month daughter received Prevnar and Hep-B vaccines on 3/1/01. A few hours, post vax, she developed crankiness, a decreased appetite and was sleeping more than usual. On 3/8/01, the crankiness was better, however; she was still sleeping more and eating less than she normally does.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Pyrexia, Vomiting
Clinical narrative: A physician reported that a 9 month old female received Prevnar and Hep-B vaccines on 12/20/00 and subsequently, developed a fever, vomiting and redness at an unspecified injection site. The fever and vomiting resolved the next day. The injection site reaction resolved within 48 hours.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: A physician reported that a 10 month old female received Prevnar and within 24 hours, post vax, developed a fever of 102F to 103F and an injection site reaction characterized by a 3cm to 4cm area of redness and induration. The infant was taken to the ER for further evaluation. No further information was available at the date of this report. The reporter indicated that 4 pts experienced this event following receipt of Prevnar lot 475383; however, 3 are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 0.75
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A nurse reported that an 8 month old infant received an injection of Prevnar on 3/5/01. On 3/6/01, the infant developed a fever of 102F. The infant was treated with acetaminophen and recovered.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A territory representative reported that a 7 month old male received his 1st dose of Prevnar in 3/01. Five days, post vax, he developed generalized urticaria. On 3/13/01, he was seen by the physician and treated "symptomatically". No further information was available at the date of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: After vaccinations on 03/04/2000 the pt developed hive on his face on 03/09/2001. He was treated with diphenhydramine.
Age: 0.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Agitation, Injection site erythema, Vomiting neonatal
Clinical narrative: The father reports after receiving vaccinations his son developed vomiting, injection site redness and experienced irritability. The father indicated that all sx resolved within 2 or 3 days.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site necrosis, Pyrexia, Wheezing
Clinical narrative: 2 days after being vaccinated, the pt developed a fever, wheezing, and injection site reaction that looked like necrosis at an unspecified site.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: One day after being vaccinated the pt developed a 1 cm-1.5 cm area of induration at the site of the Prevnar injection. She also developed a streak of erythema that extended from the area of induration.
Age: 1.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site hypersensitivity
Clinical narrative: One day after vaccinations, the pt's mother reported that her daughter developed hives at the injection site.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: Thirty six hours post immunization the pt developed urticaria in the form of welts and swollen area.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Irritability, Pyrexia, Urticaria
Clinical narrative: Thirty six hours post immunization the pt developed urticaria in the form of welts and swollen area.
Sex: U
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site induration
Clinical narrative: After receiving a an injection of Prevnar the pt developed an injection site reaction with redness and hardness. The reporter stated that the reaction sometimes lasted for 3 weeks
Age: 2.6
Sex: F
Vaccine: PNC
Symptoms: Irritability, Pyrexia, Vomiting
Clinical narrative: A physician's assistant reported that after receiving her first dose of Prevnar, that evening the child developed a fever of 101.8 F., irritability, and vomiting.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site swelling
Clinical narrative: A 2 yr old on the following day of receiving a second dose of Prevnar, developed an injection site rxn with redness and swelling and it appeared puffy.
Sex: F
Vaccine: PNC, PPV
Symptoms: Drug ineffective
Clinical narrative: A pt who has a medical history of common variable immunodeficiency and has been treated with intravenous immunoglobulin received her first 2 injections of Prevnar and reportedly, has not had any antibody response. The mother indicated that her daughter's post-vaccination numbers were lower than her pre-vaccinations numbers. The mother also reported that her daughter received Pneumovax following immunization with Prevnar and still has no antibody response
Age: 8.0
Sex: M
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: A Dr reported that an 8 yr old  received an injection of Prevnar and developed a very nice local rxn
Age: 0.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Rash
Clinical narrative: A father reported that his son received his first dose of Prevnar and his second dose of DTaP on 03/22/2001. Within hours the infant developed a rash on his face which spread to his neck. The reporter indicated that the infant received 2 other vaccines, however they were not identified.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A pharmacist reported that a 2 to 4 month old infant received Prevnar and subsequently developed a fever of 102 degrees F. The infant was treated symptomatically. This is 1 of 5 pt from this facility who developed an adverse experience following receipt of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Otitis media, Pyrexia
Clinical narrative: Pharmacist reported that a 2-4 mo old infant developed a fever of 104 post vax. Pt taken to ER where a diagnosis of otitis media was made. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar.
Age: 1.25
Sex: U
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: A pharmacist reported that pt developed a "significant" local reaction post vax. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar.
Age: 1.25
Sex: U
Vaccine: PNC
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A pharmacist reported that pt developed a "significant" local reaction post vax. The reporter noted that the reaction looked as though it was possibly cellulitis. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar.
Age: 1.2
Sex: M
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: Pt had a recent history of ear infection when on 4/4/01, 2 days post vax, he experienced a seizure and developed a fever of 103. He was taken to the ER. He was not admitted to the hospital according to ER note because the pt was older than 1 year and they felt he experienced a febrile seizure. He was treated with acetaminophen and discharged.
Sex: U
Vaccine: PNC
Symptoms: Injection site mass
Clinical narrative: Nurse reported that pt developed a knot at injection site. No further info was available at the date of this report. The reporter submitted this report directly to VAERS. Manufacturer's comment: The reporter indicated that approximately 20 pts experienced this event; however, they are not presently identifiable. Addtl rpts will be generated when identifying info is provided.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Two days post vax, pt developed an injection site reaction measuring 7cm by 7cm and characterized by induration and erythema.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Pyrexia
Clinical narrative: Within 24 hrs post vax, pt developed a fever of 104. A copy of this report has been forwarded to Merck, manufacturer of MMRII.
Sex: F
Vaccine: PNC
Symptoms: Irritability, Restlessness
Clinical narrative: Pt became irritable and restless post vax. Pt's mother had a history of latex allergy. No further info was available at the time of this report. Pt experienced restlessness and irritability following second dose of Prevnar. See HQ1482831MAY2001.
Sex: U
Vaccine: DTAP, PNC
Symptoms: Crying, Dysphonia
Clinical narrative: A nurse reported that 4 pt's experienced hoarse voice or cry a few days post vax. No further information was available at the time of this report. Additional cases will be created upon receipt of individual pt specific information. A follow up report received 10/25/2001 adds: Follow-up info received on 08/03/2001 frmo the Center for Biologics Evaluation and Research (VAERS ID #172698) revealed the patients also received DTaP (manufacturer unknown) vaccine.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Restlessness, Vaccine positive rechallenge
Clinical narrative: Pt became irritable and restless following second dose of Prevnar. Pt's mother had a history of latex allergy. No further info was available at the time of this report. Follow-up stattes a nurse reported via a company representative that her daughter became irritable and restless following her second dose of Prevnar. The child's mother had a history of latex allergy. Info from the child's physician revealed the child also received DTaP, HIB, and IPV vaccines that same day. The child has since recovered.
Sex: U
Vaccine: PNC
Symptoms: Pruritus, Rash
Clinical narrative: Rash. a company representative reported that a pt received Prevnar and within 24 hrs developed an itchy rash. No further information was available at the date of this report.  This is on of two pt from the facility who experienced an event following receipt of Prevnar. See related case number HQ1288324MAY2001.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site nodule, Upper respiratory tract infection, Urticaria
Clinical narrative: Hives. A healthcare professional reported that a 4 month old male received Prevnar, IPV, Tripedia, and Pedvax HIB, on 2/27/01. The infant was also received Amoxicillin concomitantly for a respiratory infection. One day following vaccination the infant developed an erythematous nodule about the size of a dime at the site of injection, hives on his right and left thigh, and left wrist redness. It was noted that the wrist redness may have been caused by the child sucking on his wrist. Treatment with Atarax syrup was prescribed.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction. A physician reported that a 3 yr old male received 1st dose of Prevnar 2/26/01 he developed a rash 5cm by 6cm in area at the injection site. The rash was red in the middle surrounded by a raised red ring. The physician stated the rash resembled ring worm. the child was treated with diphenydramine. He recovered 3/5/01.
Age: 0.7
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Oedema, Urticaria
Clinical narrative: Urticaria. A physician reported that pt received Prevnar, Tripedia, and IPV vaccines and subsequently developed urticaria swelling. The onset of the adverse event was 1 hr post immunization. He recovered.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Oral intake reduced, Rhinorrhoea, Vomiting
Clinical narrative: Vomiting. A mother reported that her child received Prevnar and PPD on 3/8/01. That same day she developed vomiting and did not want to eat or drink anything. On 3/9/01 the vomiting resolved but the child developed a runny nose.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Decreased appetite, Pyrexia, Rash
Clinical narrative: Pyrexia. A nurse reported that a pt received 3rd injection of Prevnar on 3/8/01. Following vaccination the child developed a fever, generalized rash and decreased appetite. The generalized rash appeared on approximately the 4th day following vaccination. The fever lasted 3-4 days.
Age: 0.4
Sex: F
Vaccine: IPV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: Screaming. A nurse reported a pt received Prevnar and IPOL on 3/5/01. The reporter indicated that Prevnar was administered as a split dose. That same day, the infant developed crying and irritability. The crying and irritability resolved in 24 hrs. On 3/7/01 she was screaming for several hrs. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Rash erythematous
Clinical narrative: Rash erythematous. A nurse reported that a pt with a recent history of fever received her 1st dose of Prevnar on 3/20/01, within 24 hrs post immunization, she developed a generalized light red rash over her body. This is 1 of 2 patients from this facility who had an adverse event following receipt of Prevnar lot 474-946.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Agitation, Difficulty in walking, Pyrexia
Clinical narrative: Fever. A pharmacist reported that her son received injection of Prevnar on 3/21/01. Within 24 hrs of vaccine the child developed irritability and a fever of 101F to 102F. He also developed trouble walking and bending down. The mother treated the child with advil . This is 1 of 2 pt from this facility who had an adverse experience following receipt of Prevnar.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Candidiasis, Hypersensitivity, Respiratory disorder, Wheezing
Clinical narrative: Respiratory disorder. A nsg reported a pt with medical history of possible latex allergy, received his 1st doses of Prevnar, Hib-TITER, IPOL and DTaP vaccines on 1/21/01. On 3/19/01, when he was 5 months old the infant's mother reported to the pediatrician that the infant developed respiratory difficulty, wheezing and oral thrush. A copy of this report has been forwarded to Aventis Pasteur.
Age: 0.5
Sex: M
Vaccine: HEP, PNC
Symptoms: Agitation, Decreased appetite, Insomnia, Rash erythematous
Clinical narrative: Rash erythematous. A physician reports that a pt received 2nd dose of Prevnar and Engerix B vaccines on 3/23/01, within 12 hrs post IZ he developed a generalized erythematous rash, irritability, sleeplessness, and a decreased appetite. The reporter indicated that the pt did not sleep for 3 nights. A copy of this report has been forwarded to SKB.
Age: 0.8
Sex: U
Vaccine: PNC
Symptoms: Cough, Ear pain, Influenza like illness, Nasal congestion, Nausea
Clinical narrative: Influenza like illness. A mother reported that her child received the 1st Prevnar on 3/27/01 and within 1 hr developed flu-like symptoms described as fever between 102F and 103F, stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father, and 2 year old sibling(who did not receive Prevnar) also developed these symptoms within 1 hr following the 10 month old's IZ. This is 1 of 2 reports from this family following the 10 month old's receipt of Prevnar.
Age: 0.8
Sex: U
Vaccine: PNC
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Influenza like illness. A mother reported that her child received the 1st Prevnar on 3/27/01 and within 1 hr developed flu-like symptoms described as fever between 102F and 103F, stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father, and 2 year old sibling(who did not receive Prevnar) also developed these symptoms within 1 hr following the 10 month old's IZ. This is 1 of 2 reports from this family following the 10 month old's receipt of Prevnar.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Difficulty in walking, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction. A mother reported that her child received 1st dose of Prevnar on 3/28/01. Within 24 hrs the child developed an injection site reaction characterized by swelling and redness of the entire thigh and he experienced difficulty in walking. The child was treated with benadryl and the application of ice packs, he was recovering. Additional information received from the physician on 5/22/01, indicated that the child recovered.
Age: 2.25
Sex: M
Vaccine: PNC
Symptoms: Gait disturbance, Injection site oedema
Clinical narrative: Gait disturbance. a mother reported that her child received 1st dose of Prevnar on 3/29/01. Within 3 hrs the child developed a limp in the leg in which Prevnar was administered. Follow-up info was received from the physician on 06/25/2001. The reporter indicated that the child developed slight swelling at the injection site. He recovered approximately 3 days later.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Fever. A grandmother reported that her grandson received his 2nd Prevnar on 3/29/01, approximately 6 hrs post immunization, he developed a fever of 101F. He later developed hives and swelling in his calves and legs, The reporter thinks the swelling is a result of scratching.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Agitation, Gait disturbance, Pyrexia
Clinical narrative: Fever. A mother reported that her son received injection of Prevnar on 1/24/01. Subsequently, the child developed a fever of 101F, irritability and limb restrictions. He recovered. Follow-up info received from the phsyician on 07/17/2001 indicated tha the child received an injection of Prevnar on 01/22/2001.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, OPV, PNC
Symptoms: Agitation, Bronchiolitis, Ear disorder, Eye discharge, Infection
Clinical narrative: Bronchiolitis. A mother reported that her child received 2nd Prevnar, Haemophilus B conjugate, DTaP and poliomyelitis virus vaccine administration the infant developed wheezing, irritability, weepy eyes and a runny nose. The mother reported that the infant was diagnosed with bronchiolitis and an ear infection. He was treated with Albuterol and Amoxicillin. The wheezing resolved by 1/21/01. The infant recovered fully from bronchiolitis. Follow-up info received from the physician on 06/08/2001, indicated tha the infant was seen by the physician on 01/20/2001 with bronchiolitis, wheezing, and otitis media. The physician stated that at the time the child was immunized, "bronchiolitis was epidemic in the community," and that she "did not believe his illness was an adverse reaction to Prevnar."
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, OPV, PNC
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Bronchiolitis. A mother reported that her child received 2nd Prevnar, Haemophilus B conjugate, DTaP and poliomyelitis virus vaccine administration the infant developed wheezing, irritability, weepy eyes and a runny nose. The mother reported that the infant was diagnosed with bronchiolitis and an ear infection. He was treated with Albuterol and Amoxicillin. The wheezing resolved by 1/21/01. The infant recovered fully from bronchiolitis. Follow-up info received from the physician on 06/08/2001, indicated tha the infant was seen by the physician on 01/20/2001 with bronchiolitis, wheezing, and otitis media. The physician stated that at the time the child was immunized, "bronchiolitis was epidemic in the community," and that she "did not believe his illness was an adverse reaction to Prevnar."
Age: 2.9
Sex: M
Vaccine: PNC
Symptoms: Blindness transient, Eye disorder, Headache
Clinical narrative: Transient Blindness. A territory representative reported that a pt received an injection on Prevnar on 4/5/01. Approximately 3 hrs post vaccine the child developed a headache, sensitivity to light and couldn't see. He recovered about 1.5 hrs later that same day. Follow-up info received from the physician on 06/08/2001 indicated that the child was seen by the physician.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia, Serum sickness
Clinical narrative: Serum sickness. An infant received an injection of Prevnar. The infant developed a fever of 102F and was treated or serum sickness with Amoxicillin/potassium clavulanate. This is 1 of 5 pt from this facility who developed an adverse experience following receipt of Prevnar.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash. A nsg reported that a pt received Prevnar, DTaP, and Hib vaccines on 3/29/01, within 24 hrs post vaccines he developed a maculopapular rash that extended from his R deltoid to his R elbow all the way around the arm. Prevnar was injected into the R deltoid. As of 4/10/01 the rash persisted.
Age: 1.7
Sex: F
Vaccine: DTAP, PNC
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain. A nsg reported that a 20 month old received Prevnar and Acel-Imune vaccines on 3/21/01. That evening she developed intermittent abdominal pains. As of 3/23/01, the abdominal pains persisted. This is 1  of 2 pt from this facility who had an adverse experience following receipt of Prevnar lot 474-946.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PNC
Symptoms: Urticaria
Clinical narrative: Hives. A physician reported via a Co representative that a infant received Prevnar, Hib-Titer, DTaP, and IPV, and hepatitis B vaccines on the same date in 4/01 and subsequently developed generalized hives over his body. Follow-up information received from the physician on 09-JUL-2001 indicated that unspecified skin testing was performed on 13-JUN-2001, and the patient was determinedd to be allergic to the pertussis component of the DTaP vaccine.
Age: 1.5
Sex: U
Vaccine: DTAP, DTAPH, PNC
Symptoms: Urticaria
Clinical narrative: Urticaria NOS. A physician reported that an infant received the 1st dose of Prevnar along with DTaP/Hib combination and immediately developed hives.
Age: 1.7
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fever. A physician reported via a territory representative that a child received Prevnar and subsequently developed a fever of 104.9F. No further information was available at the date of this report. This is 1 of 2 patients from this facility who developed a fever following receipt of Prevnar.
Age: 2.8
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Injection site reaction. A nsg reported that a child received Prevnar on 4/10/01, she developed an injection site reaction characterized by a large hard, reddened area. She was treated with cold compresses. She recovered. Additional information received from the physician on 5/22/01 indicated that no other vaccines were given within 4 weeks of Prevnar administration.
Sex: U
Vaccine: PNC, PPV
Symptoms: Injection site swelling
Clinical narrative: Injection site edema. A physician reported that an unidentified child received Prevnar vaccine and subsequently developed swelling at the injection site. No further information was available as of the date of this report. This report was received via Merck & Co, Inc.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fever. A nsg reported that a child received an injection of Prevnar and subsequently developed a fever of 103F. No further information was available at the date of this report.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction. A physician reported that an infant received her 2nd dose of Prevnar along with her 1st dose of Varicella on 4/16/01. Nine days later the child developed an injection site reaction at the Prevnar site, characterized by redness, warmth and hardness.
Sex: U
Vaccine: PNC
Symptoms: Injection site mass
Clinical narrative: Injection site mass. A medical assistant reported that a patient received an injection of Prevnar and subsequently developed a lump at the injection site. No further information was available at the date of this report. Manufacturer's comment: The reporter indicated that 6-7 pt experienced this event' however they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Injection site reaction. A nsg reported that a child received Prevnar, TriHibit, hepatitis B and IPV vaccines on 4/30/01. The following day the child developed an injection site reaction characterized by redness, warmth, and swelling. The specific sites on vaccine administration were not reported. She was also fussy. The child was seen in an ER where they marked the area of reaction. On 5/2/01 she was seen by the physician because the redness had spread outside the markings. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of TriHibit and IPV.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fever. A physician reported via a territory representative that a child received Prevnar and subsequently developed a fever of 104.3F. No further information was available at the date of this report. This is 1 of 2 pt's from this facility who developed a fever following receipt of Prevnar.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Diarrhea. A nsg practitioner reported that an infant received her 2nd Prevnar on 10/18/00. Medical history includes sickness. On 10/23/00, the infant developed diarrhea for 4 days. She recovered.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Erythema, Irritability, Pyrexia, Rash erythematous
Clinical narrative: Fever. A pharmacist reported that her 18month old child received an injection of Prevnar on 3/21/01. Approximately 2-3 hrs post vaccine. The child developed a fever of 101 - 102F and irritability. He also developed 2 raised red spots on his face that are the size of a dime. The mother is treating him with Benadryl, Advil and an unspecified corticosteroid. This is 1 of 2 pt from this facility who had an adverse experience following receipt of Prevnar. Follow-up info received on 07/30/2001 from the physician indicated that the child recovered.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Rash erythematous
Clinical narrative: Rash erythematous. A nsg reported that an infant received her 2nd injection of Prevnar on 4/30/01. On 5/4/01 she developed an overall body rash described as little red bumps all over her body.
Sex: M
Vaccine: PNC
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Injection site urticaria. a physician reported that a child received an injection of Prevnar and subsequently developed a red welt at the injection site. Additional information received from the physician on 5/22/01 indicated that the child was a 2 yr old male. He recovered.
Age: 4.0
Sex: U
Vaccine: HIBV, IPV, MER, PNC
Symptoms: Cough, Ear pain, Influenza like illness, Nasal congestion, Nausea
Clinical narrative: Influenza like illness. A mother reported that her child received the 1st Prevnar, as well as Haemophilus influenza type B, MMRII, and IPV on 3/27/01 and within 1 hr, developed flu like symptoms described as fever between 102 - 103F, stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father and 2 yr old sibling who did not receive Prevnar also developed these symptoms within an hour of the 4 yr old's receipt of Prevnar. This is 1 of 2 reports form this family following the 4 yr old's receipt of Prevnar. A copy of this report has been forwarded to Merck & Aventis Pasteur, manufactures of the concomitantly administered vaccines.
Age: 4.0
Sex: U
Vaccine: HIBV, IPV, MER, PNC
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Influenza like illness. A mother reported that her child received the 1st Prevnar, as well as Haemophilus influenza type B, MMRII, and IPV on 3/27/01 and within 1 hr, developed flu like symptoms described as fever between 102 - 103F, stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father and 2 yr old sibling who did not receive Prevnar also developed these symptoms within an hour of the 4 yr old's receipt of Prevnar. This is 1 of 2 reports form this family following the 4 yr old's receipt of Prevnar. A copy of this report has been forwarded to Merck & Aventis Pasteur, manufactures of the concomitantly administered vaccines.
Age: 0.6
Sex: F
Vaccine: PNC
Symptoms: Rash erythematous
Clinical narrative: Rash erythematous. A nsg reported that an infant received her 1st injection of Prevnar in 3/01.  Approximately 4 days post vaccination the infant developed an overall body rash described as little red bumps all over the body.
Age: 0.3
Sex: F
Vaccine: PNC
Symptoms: Malaise
Clinical narrative: Sickness. A nsg practitioner reported that an infant received her 1st Prevnar on 8/16/00. On 9/5/00 the mother called the Hlth care provider office and stated that her infant was sick.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Diarrhoea, Malaise, Sinusitis, Upper respiratory tract infection
Clinical narrative: Sinusitis. A nsg practitioner reported that a 9month old infant received her 3rd Prevnar vaccine as well as hepatitis B on 1/18/01. Medical history includes diarrhea and sickness. On 2/13/01 the infant developed sinusitis and an upper respiratory infection. she was treated with Amoxicillin.
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Respiratory disorder
Clinical narrative: Respiratory disorder. A territory representative reported that a male patient, with a history of asthma, received an injection of Prevnar. Subsequently he developed a fever and the need for extensive breathing treatments. No further information was available at the date of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Musculoskeletal stiffness, Torticollis
Clinical narrative: Neck stiffness. A nsg reported that an infant received his 1st Prevnar along with doses of Tripedia, Act-HIB, and IPOL vaccines on 5/2/01. 4 hrs post immunization the infant developed neck stiffness, described as the infant's head leaning to one side. The next day, he was seen in the ER. A lumbar puncture was performed, the result was clear. The reporter indicated that the infant refuses breast milk but will take a bottle. The physician suspects possible torticollis. Follow-up info received from the vaccine provider on 07/17/2001 indicated that the infant was evaluated by an MRI; no results werre found. The infant's symptoms improved over the next 4 to 6 weeks. On 07/09/2001, the physician stated that the infant received Prevnar, OPOL HIB and DTaP vaccines with no symptoms or adverse effects. The reporter also provided lot numbers for the concomitantly administered vaccines.
Age: 0.6
Sex: F
Vaccine: DTAP, PNC
Symptoms: Rash vesicular
Clinical narrative: Vasculitis rash. A physician reported an infant received her 2nd injection of Prevnar in the R thigh and 3rd injection of Tripedia in the L thigh on 4/18/01. Three days later on 4/21/01 the child developed a vasculitis like rash on the right lower leg and ankle.
Age: 1.09
Sex: M
Vaccine: HBHEPB, PNC, VARCEL, HBHEPB, PNC, VARCEL
Symptoms: Injection site nodule, Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with PREVNAR, VARIVAX, and COMVAX on4/25/01. On 4/30/01 5 days later, the infant developed a nodule (less than 2.4cm) at the PREVNAR injection site on the R thigh. On 5/2/01, he was vaccinated with IPV in the R thigh, and MMR and DTaP in the L thigh. One week later (2 weeks post PREVNAR vaccination) the infant developed lymphadenopathy at the inguinal region, tenderness and swelling.
Age: 1.09
Sex: M
Vaccine: HBHEPB, PNC, VARCEL, HBHEPB, PNC, VARCEL
Symptoms: Injection site nodule, Lymphadenopathy, Oedema, Tenderness
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with PREVNAR, VARIVAX, and COMVAX on4/25/01. On 4/30/01 5 days later, the infant developed a nodule (less than 2.4cm) at the PREVNAR injection site on the R thigh. On 5/2/01, he was vaccinated with IPV in the R thigh, and MMR and DTaP in the L thigh. One week later (2 weeks post PREVNAR vaccination) the infant developed lymphadenopathy at the inguinal region, tenderness and swelling.
Sex: F
Vaccine: PNC
Symptoms: Gastroenteritis, Gastrointestinal disorder
Clinical narrative: Gastroenteritis Rotavirus. A mother reported her child received her 1st dose of Prevnar on 2/22/01. Subsequently, she developed diarrhea. a stool sample was positive for rotavirus. No further information was available at the date of this report. This pt developed a fever and diarrhea following receipt of her second dose of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Flushing
Clinical narrative: Flushing. A company representative reported that a child received Prevnar and within 1 hr of vaccine administration, developed flushing of the neck and back. No further information was available at the date of this report. This is on of two pt's from this facility who experienced an event following receipt of Prevnar.
Age: 8.0
Sex: M
Vaccine: PNC
Symptoms: Obsessive-compulsive disorder, Tic
Clinical narrative: Obsessive-compulsive disorder. A mother reported that her child who has a history of OCD trends and tics received his 1st dose of Prevnar on 4/18/01. Soon after vaccination he experienced an exacerbation of his OCD trends and tics.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, VARCEL
Symptoms: Diarrhoea, Pyrexia, Sinusitis, Upper respiratory tract infection
Clinical narrative: Pyrexia. a nsg practitioner reported that an infant received her  4th dose of Prevnar, as well as DTaP, IPV, Haemophilus B Conjugate, MMR, and Varivax vaccines on 4/16/01. Medical history includes diarrhea, sinusitis, and upper respiratory infection. On 4/17/01 the child developed  fever and thick green drainage.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: The day of receiving vax pt developed a "significant" local reaction characterized by swelling, redness, itching, and hives at the Prevnar injection site. Pt was treated with Benadryl and Keflex 250 mg tid for 10 days for possible cellulitis. The pt recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, PNC
Symptoms: Urticaria
Clinical narrative: The day of receiving vax pt developed a "significant" local reaction characterized by swelling, redness, itching, and hives at the Prevnar injection site. Pt was treated with Benadryl and Keflex 250 mg tid for 10 days for possible cellulitis. The pt recovered.
Age: 3.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Ear pain, Pharyngitis
Clinical narrative: Pt awoke from nap on day of receiving vax screaming that his left ear was hurting. The health care provider treated him with "drops" and oral antibiotics (not specified). Later that evening child again complained of ear pain and was seen in the ER. He was given a diagnosis of "mild" pharyngitis. The following day he was seen by his health care provider with no signs of ear pain and was found to be "fine." He recovered.
Age: 6.0
Sex: M
Vaccine: PNC
Symptoms: Arthralgia, Gastrointestinal disorder, Urticaria, Viral infection
Clinical narrative: At the time of vax, pt had tiny raised clear blisters on his wrist. A few days post vax, he experienced aching knee joints and then a stomach "virus." On 4/19/01, he developed "huge" hives. He was treated with Pedipred but the hives persisted. Concomitant therapy included Singulair, Claritin and "Homocort."
Sex: U
Vaccine: PNC
Symptoms: Crying
Clinical narrative: Pt experienced crying immediately post vax described as "worse...compared to (other) vaccines." Manufacturer's comment: The reporter was unable to specify the number of patients involved. Addtl rpts will be generated when identifying info is provided.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: One day post vax, pt developed a "welt-like rash all over body and was itchy." He was treated with Benadryl. The pt recovered by 2/20/01. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of the concomitantly administered vaccines.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Irritability, Otitis media
Clinical narrative: Otitis Media - A medical assistant reported that a 2 mo rec'd Prevnar, Tripedia (Aventis Pasteur), Comvax (MSD) and IPOL (Aventis Pasteur SA) vaccines on 11/15/00. On 11/17/00, the infant developed crying and irritability. She was seen in an ER and diagnosed with otitis media. A copy of this report has been forwarded to Merck Sharp Dome and Aventis Pasteur., manufacturers of the concomitantly administered vaccine. Follow-up info received on 06/12/2001 indicated that the infant recovered.
Age: 53.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site reaction, Laboratory test abnormal, Pruritus
Clinical narrative: Injection site reaction. A nsg reported that a pt rec'd his 1st Prevnar in 4/01 and immediately developed an injection site reaction characterized by erythema, tenderness and itchiness. Erythema and tenderness resolved within 4-5 days. and itchiness resolved within 10-14 days. The pt rec'd Prevnar because he is immunodeficient and is not to 21 valent pneumococcal vaccine (manufacturer unknown). Additional info rec'd on 5/23/01 indicated that the pt is IgG deficient and had a decreased antibody response following receipt of Prevnar.
Age: 53.0
Sex: M
Vaccine: PNC
Symptoms: Tenderness
Clinical narrative: Injection site reaction. A nsg reported that a pt rec'd his 1st Prevnar in 4/01 and immediately developed an injection site reaction characterized by erythema, tenderness and itchiness. Erythema and tenderness resolved within 4-5 days. and itchiness resolved within 10-14 days. The pt rec'd Prevnar because he is immunodeficient and is not to 21 valent pneumococcal vaccine (manufacturer unknown). Additional info rec'd on 5/23/01 indicated that the pt is IgG deficient and had a decreased antibody response following receipt of Prevnar.
Age: 1.16
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Irritability, Laboratory test abnormal, Pyrexia, Sepsis
Clinical narrative: A physician reported (by a sales representative) that a 9 month old child received the 2nd dose of Prevnar and subsequently, developed invasive pneumococcal bacteremia. As of 5/2/01, no further information was available. Septicemia streptococcal is considered "Medically Important". Follow-up info received on 06/25/2001 indicated that a 9 month old female received her second dose of Prevnar on 03/13/2001. On 04/27/2001 at 10 months of age, she presented to the physician with irritability and fever. Her physical examination was normal; complete blood cell count, urine and blood cultures were obtained. White blood cell count was 25,100 with segmented neutrophils at 25, bands at 16 and lymphocytes at 23. Her hemoglobin was 12.0 with a hematocrit of 35.3. Urine culture was negative; her blood culture was positive for stretococcus pneumoniae. A diagnosis of pneumococcal bacteremia was made. The pt was treated with ceftriaxone socium and subsequenty with amoxicillin; she recovered. From follow up: Cancelled- This case has been found to be a duplicate of HQ0472203May2001 which will remain the case of record.
Sex: U
Vaccine: DTAP, IPV, PNC
Symptoms: Convulsion, Infection
Clinical narrative: CONVULSIONS.  A sales representative reported that a physician informed her that a child who received Prevnar.  Infanrix (SKB)  and IPV (Aventis Pasteur SA) subsequently, experienced a seizure.  As of 07 Mar 2001. no further information was available.  Copies of this report have been forwarded to SKB and Aventis Pasteur, Manufacturers of the concomitantly administered vaccines.  This event is considered medically important.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Dyskinesia
Clinical narrative: 12/11/00 Received telephone call from mom inquiring about any known connection between her A vaccine & survey reports patient's "body jerks" when tired. Began with in 1 week of getting hepatitis A (#1) vaccine (10-20-00) Initially occurred only when falling asleep (night time and nap time). Describes as when you're falling asleep and someone startles you." Family went on vacation Nov. 3rd - November 4th, began having same during daytime (A few every day) Now occurs up to 30 every hour - seems to occur when most fatigued seen by Dr. Witnessed x1. Exam, including neurological exam wnl. Scheduled to have ? MRI on thursday, December 21st. mom trying to think of anything new and different in past 2 months.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Dyskinesia, Sleep disorder
Clinical narrative: 12/11/00 Received telephone call from mom inquiring about any known connection between her A vaccine & survey reports patient's "body jerks" when tired. Began with in 1 week of getting hepatitis A (#1) vaccine (10-20-00) Initially occurred only when falling asleep (night time and nap time). Describes as when you're falling asleep and someone startles you." Family went on vacation Nov. 3rd - November 4th, began having same during daytime (A few every day) Now occurs up to 30 every hour - seems to occur when most fatigued seen by Dr. Witnessed x1. Exam, including neurological exam wnl. Scheduled to have ? MRI on thursday, December 21st. mom trying to think of anything new and different in past 2 months.
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Brain oedema, Cerebrovascular accident, Child maltreatment syndrome, Convulsion, Haemorrhage intracranial
Clinical narrative: A male pt received Hib-Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate), Polio vaccine "Pasteur" (poliomyelitis vaccine conjugate), Tripedia (diphtheria and tetanus toxoids and pertussis) and Hep-B vaccines and subsequently, experienced seizures and strokes. He was hospitalized with intracranial bleeding and retinal bleeding. No additional information was available as of the date of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Retinal haemorrhage, Subdural haematoma, Vomiting
Clinical narrative: A male pt received Hib-Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate), Polio vaccine "Pasteur" (poliomyelitis vaccine conjugate), Tripedia (diphtheria and tetanus toxoids and pertussis) and Hep-B vaccines and subsequently, experienced seizures and strokes. He was hospitalized with intracranial bleeding and retinal bleeding. No additional information was available as of the date of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Cerebrovascular accident, Convulsion, Haemorrhage intracranial, Retinal haemorrhage
Clinical narrative: A male pt received Hib-Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate), Polio vaccine "Pasteur" (poliomyelitis vaccine conjugate), Tripedia (diphtheria and tetanus toxoids and pertussis) and Hep-B vaccines and subsequently, experienced seizures and strokes. He was hospitalized with intracranial bleeding and retinal bleeding. No additional information was available as of the date of this report.
Age: 13.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Pruritus, Rash, Sleep disorder, Urticaria
Clinical narrative: Received hepatitis b #3 on Feb. 8th (morning) at Gustavus School.  Mom called PHN thurs.  Feb. 15th.- On Webs, Feb 14th, Mckenzie come home from school, showered, ate dinner  then soon after developed generlized itching, then hives which began gradually worse covering trunk, neck, shoulders, arms, behind knees.  Didn't sleep well due to itching, but no other symptoms.  At time of initial conversation, mom wasn't sure whether daughter had eaten anything new at school valentine's celebration, or had used a new body wash, shampoo or cream rinse.  In a hurry to get off phone to purchase benadryl at only local store before closing.  Inquiring about any known connection with hepatitis b vaccine.