chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTP, HEP, PNC
Symptoms: Dyspepsia, Insomnia
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 6 month old male patient who experienced difficulty sleeping and upset stomach. At 6 months of age, the patient received a dose on 26-SEP-2003. The patient also received a dose of haemophilus b vaccine (manufacturer unknown), a dose of DPT (manufacturer unknown) (diptheria and tetanus toxoids and pertussis) and a dose of Hepatitis B Vaccine (manufacturer unknown) on 26-SEP-20003.  The patient experienced sleeping difficulty (insomnia) and upset stomach (dyspepsia) on 26-SEP-2003. See related case: HQWYE975502OCT03 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 0.4
Sex: F
Vaccine: PNC
Symptoms: Otitis media
Clinical narrative: Information has been received from a mother regarding her 12 month old daughter. on 14-SEP-2001, at 5 months of age, she received her third dose of Prevnar. On 16-MAR-2002, she developed a unilateral ear infection. No further information was available at the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A pharmacist reported that an unidentified patient received a dose of Prevnar (penumococcal 7-valent conjugate vaccine) on (date not specified). "Within days" of vaccine administration, the patient developed localized cellulitis and possibly fever. MANUFACTURER'S COMMENT: The reporter indicated that over the past 2 months, 10 patients, aged 2-7 years of age experienced "localized cellulitis, some with fever, within days" of injection with a pneumococcal vaccine (manufacturer unknown). At the time of this report, all of the cases had resolved. No further information was available at the time of this report.
Age: 2.2
Sex: M
Vaccine: PNC
Symptoms: Lymphadenitis, Pyrexia
Clinical narrative: A mother reported that her 27 month old son received an injection of Prevnar on 21-APR-2003 at 26 months of age. He was not taking concomitant medications. Subsequently, he developed a fever that lasted approximately one week. On 03-MAY-2003, he developed lymph node inflammation described as a lump on the right side of his neck. He was seen by a physician and treated with Augmentin (amoxicillin/clavulanate). The reporter stated that the lymph node has not changed in size despite antibiotic treatment. The reporter declined to provide additional information and declined to grant permission for a follow up investigation.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site reaction, Swelling
Clinical narrative: Information has been received from a medical assistant regarding a 12 month old female who received her 4th dose of Prevnar (pneumococcal 7-valent conjugte vaccine) on 07-OCT-2003, and experienced a "cellulitis type event" , including redness, swelling and warmth at the injection site. Two days post immunization, the child experienced a "cellulitis type event" and an injection site reaction on her thigh characterized by redness, swelling and feeling "warm to the touch". Treatment included Benedryl (dephenhydramine) and ice. As of the date of this report, the caller had heard nothing back form the parent, and assumed the event was resolving. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: HEP, HIBV, IPV, PNC
Symptoms: Injection site reaction, Skin discolouration
Clinical narrative: Additional information received on 03-NOV-2003 provided patient demographics, product details, concomitant product details, and outcome (recovered). Information regarding Prevnar (penumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a two year old male who experienced a large scar at the site of Prevnar administration. The patient experienced vaccination site reaction (injection site reaction) and injection site scar (injection site scar) on 26-OCT-2002. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Hypersensitivity, Rectal haemorrhage
Clinical narrative: A pharmacist reported that his infant son received his first dose of Prevnar on an unspecified date at approximately 2 months of age. Around the same time, the infant developed mild rectal bleeding. He was diagnosed with a milk protein allergy and paced on special formula. Subsequently, the rectal bleeding resolved, and it was attributed to the milk protein allergy. No further information was available at the date of this report. The infant developed rectal bleeding following receipt of his second dose of Prevnar along with DTP (manufacturer unknown) and Motrin (ibuprofen) at approximately 4 months of age and his third dose of Prevnar along with DTP (manufacturer unknown) at approximatel 6 months of age (see MCN HQWYE492006JUN03 and MCN HQWYE492106JUN03)
Age: 0.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Hypersensitivity, Rectal haemorrhage
Clinical narrative: A pharmacist reported that his infant son received his second dose of Prevnar along with DTP (manufacturer unknown) on an unspecified date at approximately 4 months of age. The infant's medical history includes a milk protein allergy and rectal bleeding. The infant was treated with Motrin (ibuprofen) to prevent any pain associated with
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Rectal haemorrhage
Clinical narrative: A pharmacist reported that his infant son received his third dose of Prevnar along with DTP (manufacturer unknown) on an unspecified date at approximately 6 months of age. The infant's medical history includes a milk protein allergy and rectal bleeding. On day post vaccination, the infant developed mild rectal bleeding that lasted about 3 days. No further information was available at the date of this report. The infant developed rectal bleeding following receipt of his first dose of Prevnar at approximately 2 months of age and his second dose of Prevnar along with DTP (manufacturer unknown) and Motrin (ibuprofen) at approximately 4 months of age (see MCN HQWYE482905JUN03 and MCNHQWYE192006JUN03).
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site reaction, Swelling
Clinical narrative: Information was received from a medical assistant regarding an 8 month old female who received her 3rd dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 25-JUN-2003, and experienced a "cellulitis-type event", including redness, swelling and warmth at the injection site.  On 27-JUN-2003, 2 days post immunization, the child experienced a "cellulitis type even" and an injection site reaction on her thigh characterized by redness, swelling ad feeling "warm to the touch". Symptoms resolved without treatment. No additional information was available at the time of this report.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Difficulty in walking
Clinical narrative: Information regarding Prevnar (penumococcal 7-valent conjugate vaccine information) was received from a nurse regarding a 15 month old male patient whose mother reported that he did not want to walk after receiving his fourth dose on 22-JAN-2004. The patient also received his fourth dose of Tripedia (diphtheria and tetanus toxoid and accellular pertussis vaccine) (Aventis), and his third dose of Covax (Haemophilus b conjugate and hepatitis B vaccine) (Merck) on 22-Jan-2004. On the afternoon of 22-JAN-2004, the child was "not wanting to walk." Early the next day, on 23-Jan-2004, the nurse spoke with the mother who stated her child still did not want to walk. Later in the day, on 23-Jan-2004, it was reported the symptoms has resolved. Information regarding this event has been forwarded to Aventis and Merck, manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Pain, Paralysis, Pyrexia
Clinical narrative: A nurse reported that an 18 month old male patient received his fourth dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 07-APR-2003. On the morning of 08-APR-2003, the child developed a fever and "sore" leg. During the evening of 08-APR-2003, the child developed a "trigger" finger of the thumb. The reporter indicated that child's "thumb was flexed back and remained rigid in this flexed position." ON 09-APR-2003, the child was examined by a pediatrician and referred to an orthopedic surgeon. As of the date this was reported, the thumb remained "rigid and flexed." No further information was available at the date of this report.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blister, Rash, Rash pustular
Clinical narrative: Follow up information received 06-MAY-2003 from the nurse practitioner provided concomitant therapy and patient outcome (recovered). A nurse practitioner reported that a 6 month old male received his 1st dose of Prevnar (penumococcal 7-valent conjugate vaccine) vaccine and his third dose of Comvax (Haemophilus b cnjugate vaccine and hepatitis B vaccine), diphtheria and tetanus toxoid an accellular pertussis vaccine adsorbed (manufacturer unknown), and Polio vaccine "Pasteur" (poliomyelitis vaccine inactivated) (Aventis) on 07-APR-2003. Concurrent history include a diaper rash. On the evening of 08-APR-2003 the child developed a rash and his parents brought him to the clinic the next day. The rash appeared more so on his distal extremities, including his legs and arms; it involved a small part of the child's trunk, and there was a "butterfly distribution" of the rash on the child's face. The rash was described as being "very pointed", with very small pustules, and "one of the pustules looked like it could blister". The parents stated that they thought the child was "lethargic", but the nurse practitioner stated that "the patient seemed to have normal energy". There was no report of treatment for the rash. The child recovered.
Age: 1.2
Sex: M
Vaccine: PNC
Symptoms: Gait disturbance, Injection site reaction, Pain
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) injection) was received from a healthcare professional regarding a 14 month old male patient who experienced an injection reaction characterized by pain, which caused him to limp. the patient received the fifth dose on 30-Aug-2003. The patient experienced an injection site reaction characterized by pain (injection site pain) in the left leg, which caused him to limp (gait abnormal). This lasted about ten days. The physician indicated that the child had completely recovered. See related cases: HQWYE362326AUG03 (The patient's fourth dose of Prevnar was inadvertently administered subcutaneously, no adverse event had occurred). No additional information was available at the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Screaming
Clinical narrative: A nurse reported that several unidentified pt's received Prevnar (pneumococcal 7-valent conjugate vaccine) on (dates not specified).  It was reported that while administering Prevnar, the pt's "always scream".  Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose (IM).  Concomitant medications often included various other childhood immunizations.  A nurse has observed that whenever a dose of Prevnar is given in the office, "the pt's let out a scream".  Despite the sequence in which the Prevnar is given with other childhood immunizations, or the age of the child, the pt's always scream while Prevnar is being administered.  The pt's are often comforted by the end of the visit.  The nurse stated that the names and pt information was "too numerous to list".
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: A nurse reported that a 12 month old male received a dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 12/06/02.  Concomitant vaccine therapy included MMRII (measles, mumps and rubella vaccine) administered on an unspecified date.  Four hours post-immunizaton, the child developed an injection site reaction characterized by an "itchy rash."  He was treated with Benadryl (diphenhydramine) and the symptoms resolved.  No further information was available at the date of this report.
Age: 1.1
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site warmth, Skin irritation
Clinical narrative: A nurse reported that a 13 month old male received a dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 09/15/03.  Concomitant therapy included a 3rd dose of Act-Hib (Haemophilus b conjugate vaccine).  Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on 09/15/03.  Dose regimen was 0.5mL (IM).  Concomitant therapy included Act-Hib (Haemophilus b conjugate vaccine).  On 09/17/03, 2 days post-immunization, the pt developed redness and warmth at the injection site (right thigh), as well as irritation.  No additional information was available at the time of this report.
Age: 2.2
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Medication error
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a health professional regarding a 26 month old male pt who experienced wrong route of vaccination, injection site reaction, injection site warmth, injection site redness and injection site inflammation.  At 26 months of age, the pt received a dose on 09/18/03.  Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on 09/18/03.  Dose regimen was 0.5mL (SC).  Pt was not taking concomitant therapy.  The pt was inadvertently administered a SC injection (medication error) and experienced injection site reaction (injection site reaction NOS), injection site warmth (injection site warmth), injection site redness (injection site erythema) and injection site inflammation (injection site inflammation) on 09/18/03.  No treatment was prescribed.  No additional information was available at the time of this report.
Age: 0.8
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, UNK
Symptoms: Alopecia, Contusion, Irritability, Ocular hyperaemia, Photophobia
Clinical narrative: A mother reported that her 8 month old son received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine) on 07/09/02.  Concomitant vaccine therapy included Engerix B, Infanrix, Act-Hib, and EIPZ.  Medical history included sepsis and apnea at one week of age.  On 07/11/02, the child developed a fever, and "broke out in a rash all over his body, including the "bottom of his feet."  The rash got "progressively worse for two days" before spontaneously resolving.  During that same time period, the child developed "spontaneous bruising over his entire body, bloody eyes, sun sensitivity, irritability , and all hair on his hair on his head fell out".  The reporter indicated that her son "had a dark complexion and dark eyes, and now has a pasty, white complexion" and light eyes which appear "glossed over".  In August 2002, the child experienced hair regrowth and spontaneous resolution of the bruising and "bloody eyes".  She stated his hair color "changed from brown to light blonde".  From 07/02 through 10/02, the child did not gain weight; he currently weighs 22lbs.  In October 2002, the child was tested for "platelet pool storage disorder"; the results were negative.  At that date of this report, the child continues to experience irritability.  Information regarding these events has been forwarded to manufacturers of the concomitantly administered vaccines.
Age: 0.8
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, UNK
Symptoms: Platelet disorder, Pyrexia, Rash, Skin depigmentation
Clinical narrative: A mother reported that her 8 month old son received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine) on 07/09/02.  Concomitant vaccine therapy included Engerix B, Infanrix, Act-Hib, and EIPZ.  Medical history included sepsis and apnea at one week of age.  On 07/11/02, the child developed a fever, and "broke out in a rash all over his body, including the "bottom of his feet."  The rash got "progressively worse for two days" before spontaneously resolving.  During that same time period, the child developed "spontaneous bruising over his entire body, bloody eyes, sun sensitivity, irritability , and all hair on his hair on his head fell out".  The reporter indicated that her son "had a dark complexion and dark eyes, and now has a pasty, white complexion" and light eyes which appear "glossed over".  In August 2002, the child experienced hair regrowth and spontaneous resolution of the bruising and "bloody eyes".  She stated his hair color "changed from brown to light blonde".  From 07/02 through 10/02, the child did not gain weight; he currently weighs 22lbs.  In October 2002, the child was tested for "platelet pool storage disorder"; the results were negative.  At that date of this report, the child continues to experience irritability.  Information regarding these events has been forwarded to manufacturers of the concomitantly administered vaccines.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Child developed nausea and diarrhea with temp 100 degrees on 4/27/04 at 3PM. Parents returned to HD on 4/28/04 at 8AM. Instructed to provide pedialyte for hydration, seek medical care if no wt diapers, diarrhea or sx's worsen.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, OPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling right quadramuscle with warmth, Motrin and Ice to area.
Sex: F
Vaccine: PNC
Symptoms: Accidental overdose, Laboratory test abnormal
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a female pt who experienced extra dose of Prevnar and antibody result abnormal.  The pt received a dose on an unspecified date. Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day.  Concomitant medications were not reported.  The pt experienced extra dose of Prevnar (accidental overdose) and antibody result abnormal (antibody NOS abnormal).
Sex: U
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a pt who experienced urticaria.  The pt received the second dose of Prevnar on an unspecified date.  Relevant medical history was not provided.  The indication for Prevnar was immunization. The product was administered on an unspecified date.  The dose regimen was one dose of 0.5mL (IM).  Concomitant medications were not reported.  The pt experienced urticaria.  The physician reported that the pt also experienced urticaria following receipt of the first dose of Prevnar; however, the reaction following receipt of the second dose was "more severe."  No additional information was available at the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) injection) was received form a healthcare professional regarding a patient who experienced urticaria. The patient received the first dose of Prevnar on an unspecified date. See related case HQWYE067318JUL03 (adverse event, non-expedited: urticaria following receipt of the second dose of Prevnar). No additional information was available at the date of this report.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a male pt who experienced generalized rash.  The pt received the first dose on 04/03/01.  The pt also received a dose of Varivax, a dose of Comvax, a dose of MMRII, a dose of IPV and a dose of Tripedia on 04/03/01.  Relevant medical history was not provided.  Indication for Prevnar was immunization. Product was administered on 04/03/01.  Dose regimen was 1 dose (IM).  Concomitant medications were not reported.  The pt experienced generalized rash (rash generalized).  Information regarding this report has been forwarded to manufacturers of the concomitantly administered vaccines.  No additional information was available at the time of this report.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Anorexia, Injection site erythema, Injection site induration, Irritability, Pyrexia
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine injection) was received from a nurse regarding a 7 month old female pt who experienced a fever of 101 deg. F., increased fussiness and irritability, poor appetite and an injection site reaction, characterized by redness and a large hard area in the muscle around the injection site.  The pt received the first dose on 01/05/04.  The pt had a "negative" medical history.  Indication for Prevnar was immunization.  Product was administered on 01/05/04.  Dose regimen was 0.5mL (IM).  Pt was not taking concomitant therapy.  On 01/06/04, within 24 hours of receiving Prevnar, the pt developed a fever of approximately 101 deg. F., and a local redness around the injection site.  On 01/07/04, the child was seen in the MD's office and "a large hard area approximately the size of a golf ball" was noted in muscle around the injection site.  As of 01/07/04, the infant continued to have a low grade fever, poor appetite, and increased fussiness and irritability.  No additional information was available at the time of this report.
Age: 1.3
Sex: F
Vaccine: HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Follow up information received provided additional pt and event details and recovery status.  Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 16 month old female pt who experienced a fever.  At 15 months of age, the pt received the fourth dose on 09/30/03.  The pt also received a dose of Hib-Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm197 protein conjugate) injection) on 09/30/03.  Relevant medical history was not provided.  Indication for Prevnar was immunizaton.  Product was administered on 09/30/03.  Dose regimen was 1 dose 1 time per day (IM).  Pt was not taking concomitant therapy.  The pt developed a fever (pyrexia) of 99 deg. F on 10/12/03.  On 10/13/03, her temperature was 101.5 deg. F. That same day, she was seen by a physician.  On 10/14/03, her temperature was 101.6 deg. F.  On 10/15/03, the fever subsided.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema multiforme, Rash
Clinical narrative: Follow up information received 06/09/03 from the physician provided concomitant vaccines, the date vaccines were administered, date of event onset and event outcome (recovered).  A pediatrician reported that a 4 month old female received her 2nd dose of Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) on 04/22/03.  Concomitant vaccines included IPV vaccines (poliomyelitis vaccine inactivated), Infanrix vaccine (diphtheria and tetanus toxoid and acellular pertussis vaccine) and PedvaxHIB vaccine (haemophilus b conjugate).  On 05/03/03, the child developed an "ulcerated rash up and down the trunk of her body (on the sides) as well as a small amount on her legs and arms".  One week later she presented to the physician's office.  She was diagnosed with erythema multiforme and received unspecified treatment.  She recovered.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: A mother reported that her 4 month old son received a dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 09/22/03, and later experienced "slight" fever and fussiness.  Concomitant vaccines included Haemophilus b conjugate vaccine (manufacturer unknown), diptheria and tetanus toxoids and acellular pertussis vaccine (manufacturer unknown), hepatitis B vaccine (manufacturer unknown) and Ipol (poliomyelitis vaccine inactivated).  Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on 09/22/03.  Dose regimen was 1 dose.  Concomitant therapy included Haemophilus b conjugate vaccine (manufacturer unknown), diphtheria and tetanus toxoids and acellular pertussis vaccine (manufacturer unknown), hepatitis B vaccine (manufacturer unknown) and Ipol (poliomyelitis vaccine inactivated).  On 09/22/03, post immunization, the child experienced a "slight" fever and fussiness.  This report was received from the child's mother and has not been verified by a physician or other health care professional.  No additional information was available at the time of this report.  This report was received by manufacturer.
Age: 0.8
Sex: M
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine injection) was received from a nurse regarding an 8 month old male pt who experienced a fever of 104 deg. F., and an injection site reaction characterized by a lump and redness at the injection site.  The pt received the third dose on 05/19/03.  The pt also received his second dose of Recombivax-HB (hepatitis B vaccine) on 05/19/03.  The pt had no medical history.  Indication for Prevnar was immunization.  Product was administered on 05/19/03.  Dose regimen was 1 dose (IM).  The pt was not taking concomitant therapy.  On 05/19/03, the evening of vaccination, the infant developed a fever of 104 deg. F.  The reporting nurse indicated that the pt's mother reported the infant developed a lump and redness at the injection site.  However, the specific site where the injection site reaction occurred was not reported.  The pt was not seen in the physician's office. The fever "gradually resolved" by 05/2/03.  Information regarding this event has been forwarded to manufacturer of Recombivax-HB.  No additional information was available at the time of this report.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Follow up information received 06/23/03 from the physician provided specific dating of event, other vaccines administered that day, and event outcome (recovered).  A physician reported that a 6 month received his 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine on 05/13/2003.  He also received his 3rd doses of Infanrix (diphtheria and tetanus toxoid and acellular pertussis vaccine) vaccine, polio vaccine (poliomyelitis vaccine inactivated), and Act-Hib (haemophilus b conjugate vaccine) vaccine.  Four days post-immunization, on 05/17/03, the child developed a fever of 103.2 deg. F.  On 05/19/03, he was seen by the physician and prescribed Tylenol (acetaminophen) and Motrin (ibuprofen).  On 05/20/03, he developed a rash on the trunk of his body.  He has recovered.
Age: 0.4
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a medical assistant regarding a 4 month old female who received her 2nd dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 02/04/03, and developed some redness at the injection site.  This pt experienced redness at the injection site after receiving her 1st dose of Prevnar on 12/03/02.  She also experienced a "cellulitis-type event", 2 days after receiving her 3rd and 4th doses of Prevnar on 06/25/03 and 10/07/03 respectively.  Indication for Prevnar was immunization.  Product was administered on 02/04/03.  Dose regimen was 1 dose (IM).  Concomitant medications were not reported.  On 02/06/03, two days post-immunization, the child developed redness at the injection site.  The redness resolved without treatment.  No additional information was available at the time of this report.
Age: 0.17
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a medical assistant regarding a 2-month-old female who received her 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 03-DEC-2002, and experienced redness at the injection site. Medical History: This patient developed redness at the injection site after receiving her 2nd dose of Prevnar on 04-FEB-2003 (see related case #HQWYE511924OCT03). She also experienced a "cellulitis-type event", 2 days after receiving her 3rd and 4th doses of Prevnar on 25-JUN-2003 and 07-OCT-2003 (see related cases #HQWYE511824OCT03 and #HQWYE330220OCT03), respectively.  Product Details: Indication for Prevnar was immunization. Product was administered on 03-DEC-2002. Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant Therapy: Concomitant medications were not reported.  Event Details: On 05-DEC-2002, 2 days post-immunization, the child experienced "some redness" at the injection site. The redness resolved without treatment. No additional information was available at the time of this report.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an unidentified 2-month-old child who received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on (date unknown). Medical History: Relevant medical history was not provided.  Product Details: Indication for Prevnar was immmunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant Therapy: Additional suspect therapy included Haemophilus b conjugate vaccine (manufacturer unknown) and Pediarix (diptheria and tetanus toxoid and acellular pertussis and hepatitis B vaccine, polio virus inactivated) (GSK).  Event Details: At a unspecified time post immunization, the child developed a fever of 101 deg. F. The fever resolved after an unspecified period of time. This report was received from GlaxoSmithKline, manufacturer of Pediarix (reference #A0412688A).  Related Case (s): See related case(s): HQWYE958911JUL03 (adverse event, non-expedited).
Age: 0.17
Sex: M
Vaccine: DPP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: A physician reported that his 2-month-old son received his 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine on 05-JUN-2003. Concomitant vaccines included Haemophilus b conjugate vaccine (manufacturer unknown) and DPT (diptheria and tetanus toxoids and pertussis vaccine) vaccine (manufacturer unknown). One day post-immunization, the child developed a fever.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a healthcare professional regarding a 2-month-old male patient who experienced fever, an injection site reaction characterized by injection site swelling and injection site redness. The patient received his first dose on 02-Jul-2003. The patient also received his first dose of Hib-Titer vaccine (Haemophilus b conjugate vaccine (diptheria crm197 protein conjugate), the first dose of Infanrix (diptheria/tetanus toxoid/acellular pertussis vaccine) (GlaxoSmithKline) and the first dose of Polio vaccine (poliomyelitis vaccine inactiviated) "Pasteur" (Pasteur Vaccine) on 02-Jul-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 02-Jul-2003. Dose regimen was one dose. Concomitant therapy: Concomitant medications were not reported. Event Details: The patient experienced fever (pyrexia), injection site swelling (injection site swelling), injection site redness (injection site erythema) and injection site reaction (injection site reaction NOS) on 03-Jul-2003. No additional information was available at the time of this report. Manufacterer's comment: This report was received from GlaxoSmithKline manufacturer of Infanrix (Ref. No. A0415375A).
Age: 0.83
Sex: F
Vaccine: PNC
Symptoms: Erythema multiforme, Pyrexia, Rash
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a consumer regarding a 10-month-old female patient who experienced erythema multiforme. At 10 months of age, the patient received the third dose on 23-OCT-2003. Medical History: The patient previously experienced diarrhea while taking Prevnar. Product Details: Indication for Prevnar was immunization. Product was administered on 23-OCT-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The patient developed a fever of 103 deg. F on the evening of 23-Oct-2003. On 24-Oct-2003, she developed a rash that spread over the next several days. On 27-Oct-2003, she was seen by a physician because the fever of 103 deg. F persisted and the rash has spread over the whole body except from the knees down. The patient's mother stated that the rash was diagnosed as erythema multiforme (erythema multiforme); however, the mother indicated that the physician did not consider it to be related to multiforme); however, the mother indicated that the physician did not consider it to be related to Prevnar. As of 28-Oct-2003, fever persisted and the rash had spread over the whole body including eyes, ears, and mouth. Related case(s): The patient experienced diarrhea following receipt of her first two doses of Prevnar (see MCN HQWYE671131OCT03 and HQWYE671231OCT03). No additional information was available at the date of this report.
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a female patient who experienced diarrhea. The patient received the second dose on an unspecified date. Medical History: The patient previously experienced diarrhea while taking Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection).  Product Details: Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experience diarrhea (diarrhea NOS). Related Case(s): The patient experienced diarrhea following receipt of her first dose of Prevnar on an unspecified date and erythema multiforme following receipt of her third dose of Prevnar on 23-Oct-2003, at 10 months of age (see MCN HQWYE671231OCT03 and HQWYE613229OCT03). No additional information was available at the date of this report.
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a consumer regarding a female patient who experienced diarrhea. The patient received the first dose on an unspecified date. Medical History:Relevant medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant Therapy: Concomitant medicatios were not reported. Event Details: The patient experienced diarrhea ( diarrhea NOS). Related Case(s): The patient experienced diarrhea following receipt of her second dose of Prevnar on an unspecified date and erythema multiforme following receipt of her third dose of Prevnar on 23-Oct-2003, at 10 months of age (see MCN HQWYE671131OCT03 and HQWYE613229OCT03). No additional information was available at the date of this report.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Pyrexia
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a healthcare professional regarding an infant who experienced pyrexia and irritability post vaccination. The patient received the first dose in Jan-2003. The patient also received the first dose of Haemophilus Influenzae B (manufacturer unknown) and a dose of Pediarix (Glaxosmithkline) (diptheria/tetanus/acellular pertussis/hepatits b vaccine/polio virus inactivated) on an unspecified date in Jan-2003. Medical History: Relevant medical history was not provided.  Product Details: Indication for Prevnar was immunization. Product was administered an unspecified date in Jan-2003. Dose regimen was one dose. Concomitant Therapy: Concomitant medications were not reported.  Event Details: Six to eight hours post-immunization, the infant experienced pyrexia ranging from 102 to 103 degrees F. (pyrexia) and irritability post vaccination (irritability) in Jan-2003. The infant experienced an injection site reaction at the Pediarix administration site. This report was received from GSK (A0423044A). No additional informatin was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria orm197 protein) injection) was received from a mother regarding her daughter who developed an injection site reaction characterized by a slight lump and a little redness at the thigh injection site. The patient received the first dose in Sept-2003.  Medical History: Relevant medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered in Sep-2003. Dose regimen was 1 dose (intramuscular).  Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient developed an injection site reaction characterized by a slight lump and redness at the thigh injection site (injection site mass) (injection site erythema) in Sep-2003. Related Case(s): HQWYE780802FEB04 and HQWYE824405FEB04. No additional information was available at the date of this report.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Additional information received 31-MAR-2003 provided vaccines received within 4 weeks and patient outcome (recovered). A physician reported that a 4-month-old male received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine and a 2nd dose of ActHIB (Haemophilus b conjugate vaccine) vaccine (Aventis) on 26-FEB-2003. Concomitant therapy included pimecrolimus cream (Elidel). On 28- JAN-03 the patient received 2nd doses of Infanrix (diphtheria and tetanus toxiod and acellular pertussis vaccine) vaccine (SKB) and Polio Vaccine "Pasteur" (poliomyelitis vaccine inactivated) (Aventis). Medical history included allergy to milk and eczema. On 26-FEB-2003, a couple hours post-immunization, the child developed urticaria on his thighs and whole body. Symptoms resolved in "about 6 hours". The child recovered.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an unidentified 4 month old child who received a second dose of Prevnar (pneumococcal 7 valent conjugate vaccine) on 16-JUN-2003. On 17-JUN-2003, one day post immunization, the child developed a fever of 104 deg F, as reported by the child's mother. This report was received on 11-JUL-2003, from GlaxoSmithKline, manufacturer of Pediarix (Information reference number A0412688A). Related cases : See related case HQWYE52091JUL03 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site rash
Clinical narrative: vaccines were given on 4/23/04. patient presented to office on 4/26/04 with rash on left thigh around the sites where the vaccines were administered.  after evaluated by a doctor and was diagnosed with cellulitis.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Apnoea, Breath holding, Irritability
Clinical narrative: Irritablity, 2 episodes of apnea/breath holding.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Patient received her second dose of varicella vaccine on 04/28/04 at a school immunization clinic without any reaction at that time.  I was called to her school to evaluate her left upper arm.  There is a round, raised area of redness measuring 5 cms x 6 cms.  The area is a bit 'itchy' and is around the injection site.
Age: 0.0
Sex: F
Vaccine: TD
Symptoms: Diabetes mellitus
Clinical narrative: Development of type 2 diabetes after starting Seroquel
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm, hard near injection site (2.5" diam.)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Skin ulcer
Clinical narrative: The day after vaccine patient conplained of pain at site and developed small area of redness, which grew overnight to 7 cm diameter urticarial lesion around the site of injection.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: alopecia
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: FEBRILE SEIZURE 8 DAYS AFTER VACCINATION
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PPV
Symptoms: Diarrhoea, Infection, Oral intake reduced, Pyrexia, Screaming
Clinical narrative: Shuddering spells-started evening after vaccine admin. Persistent crying after vaccination. Resolved.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PPV
Symptoms: Vomiting
Clinical narrative: Shuddering spells-started evening after vaccine admin. Persistent crying after vaccination. Resolved.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PPV
Symptoms: Agitation, Chills, Crying
Clinical narrative: Shuddering spells-started evening after vaccine admin. Persistent crying after vaccination. Resolved.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Anaphylactic reaction, Heart rate increased, Insomnia, Pharyngeal oedema, Pyrexia
Clinical narrative: Pt seen 4/23 for Travel Counseling for trip overseas. Received yellow fever vaccine only. Reported reaction- hives, itching, swelling of mouth and throat. Seen by MD, given injection cortizone steroid.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Urticaria
Clinical narrative: Pt seen 4/23 for Travel Counseling for trip overseas. Received yellow fever vaccine only. Reported reaction- hives, itching, swelling of mouth and throat. Seen by MD, given injection cortizone steroid.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Pharyngeal oedema, Pruritus, Swelling face, Urticaria
Clinical narrative: Pt seen 4/23 for Travel Counseling for trip overseas. Received yellow fever vaccine only. Reported reaction- hives, itching, swelling of mouth and throat. Seen by MD, given injection cortizone steroid.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Pt seen 4/23 for Travel Counseling for trip overseas. Received yellow fever vaccine only. Reported reaction- hives, itching, swelling of mouth and throat. Seen by MD, given injection cortizone steroid.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Disturbance in attention
Clinical narrative: Information has been received from the mother of an approximately 12 year old male with allergies to unspecified foods, food coloring and milk and no other reported medical history who on 10/22/98, 11/23/98, and 5/3/99 was vaccinated with a first, second, and third dose of hepatitis B virus vaccine (lot # 624808/1532E, 625394/1554E and 628407/1590H), respectively. There was no concomitant medication. After administration of the vaccines in sixth grade, her son developed learning problems. The patient functioned normally during sixth grade, but barely finished seventh grade and was pulled from school by his parents in eighth grade. The mother stated that her son cannot function in public school and has not found success with placement in private schools. The patient's learning disability has been significantly detrimental to his development and his condition has not improved. No medical attention was sought but when the patient was younger, his family tried several unidentified medications for ADD which did not prove successful and were discontinued. The mother noted that she recently verified that the reported lot numbers contained mercury and expressed her concerns related to a correlation between thimerosal and autism. No product quality complaint was involved. The mother considered learning problems/learning disability to be disabling. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Atrial fibrillation, Cough, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: Tuesday 11/4/03 Received flu shot about 2:00 Pm. Thursday 11/6/03 7:00 PM started getting extreme rapid heart beat. After a couple hours, heart rate went lower but was still rapid. Friday 11/7/03 Heart rate was still rapid but felt like it dropped considerably. Felt a little warm so started taking Tylenol. That made me feel better so I felt like was beating it so I did not call doctor Friday. I was wrong; my throat started hurting Friday night. Saturday 11/8/03 throat was worse and could not stop coughing. Saturday morning, had temp of 100. Saturday night had temp of 101. Called clinic consulting nurse at 9:20 PM. She said if temp got over 101 to go to the emergency room at hospital. Did not go to emergency room and seen doctor first thing Monday morning 11/10/03. Monday 11/10/03 AM When I arrived at doctor's office, I had extreme rapid heart beat. At one point, they said my rate was 165. They sent me immediately by ambulance to Emergency room at hospital to get my heart rate down. They wouldn't even let my wife ride in ambulance with me. Took 3 hours to get heart rate down. They released me to go home. After a couple days my heart was back on track. Had slight temperatures on and off and it took four weeks for coughing to stop. I was coughing so hard and it felt like a lot of the time it was coming from center of my stomach so stomach hurt for several days. If you need further information from my medical records, I will approve for release to you. I was in good health on 11/4/03 when I received flu shot. Of course, we don't know if it was the flu shot that created the extreme rapid heart beat, sore throat, high temperature and so much coughing. I have never had this type of flu before with extreme rapid heart beat. Right now I have mixed feelings about ever taking another flu shot. I will be meeting with my doctor in August and discuss the upcoming flu season and flu shot. I would not want anyone to get this particular flu that I had. And as I said above, any medical information you want from my records I will approve for release. Nurse follow up on 05/25/04: "atrial fib, viral syndrome."