chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Asthenia, Dysphonia, Dyspnoea, Pallor, Tachycardia
Clinical narrative: difficulty breathing, hoarseness, wheezing, paleness, weakness and fast heart beat. About 10 hours after immunization.  Treated in emergency room with ventilator, Benadryl & Prednisolone and kept for 4 hours for observation.  Treated with benadryl every 6 hours around the clock for 2 days and Prednisolone for 5 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Wheezing
Clinical narrative: difficulty breathing, hoarseness, wheezing, paleness, weakness and fast heart beat. About 10 hours after immunization.  Treated in emergency room with ventilator, Benadryl & Prednisolone and kept for 4 hours for observation.  Treated with benadryl every 6 hours around the clock for 2 days and Prednisolone for 5 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: difficulty breathing, hoarseness, wheezing, paleness, weakness and fast heart beat. About 10 hours after immunization.  Treated in emergency room with ventilator, Benadryl & Prednisolone and kept for 4 hours for observation.  Treated with benadryl every 6 hours around the clock for 2 days and Prednisolone for 5 days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 24 hours, patient noticed increased redness, swelling, and pain in the area of the injection.  She presented to the clinic for follow up approximately 36 hours after the injection.  Her upper arm has extensive erythema, edema, and pain to palpation.  She also complained of some genralized fatigue and malaise. She was scheduled for an upper extremity ultrasound. She was instructed on warm compresses.  She was given follow up appointment to monitor for resolution.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Oedema, Pain
Clinical narrative: Within 24 hours, patient noticed increased redness, swelling, and pain in the area of the injection.  She presented to the clinic for follow up approximately 36 hours after the injection.  Her upper arm has extensive erythema, edema, and pain to palpation.  She also complained of some genralized fatigue and malaise. She was scheduled for an upper extremity ultrasound. She was instructed on warm compresses.  She was given follow up appointment to monitor for resolution.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site reaction, Oedema peripheral, Pyrexia
Clinical narrative: Signifcant swelling of right thigh up to knees. Low grade fever (? local reaction) Referred to ER. Given Clindamycin. Called to check progression and mother said pt is doing fine.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Hypersensitivity, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Intense, local allergic reaction at administration site with swelling, redness, and itching. Symptoms lasted 8 days treated with antihistimine by mouth.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Pruritus
Clinical narrative: Intense, local allergic reaction at administration site with swelling, redness, and itching. Symptoms lasted 8 days treated with antihistimine by mouth.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema, Pyrexia, Vaccination complication
Clinical narrative: Child received Dtap #4 on 4/18/2005 Left Deltoid.  On 4/19/2005 mother reported that child's arm was red, swollen, and child was having low grade temperatures.  Mother took child to Emergency Room for treatment.  Child was diagnosed with Left arm Cellulitis, was treated with Motrin, Benadryl and Amoxicillin, and was released from ER.  On 4/20/2005 mother states child's arm was more swollen than previous day, and swelling was traveling down arm including elbow area.  Mother took child to ER. MD told mother that the child did not have cellulitis, but more than likely a reaction to the Dtap vaccine.  Child was given Decadron and released from ER, and told to follow up with pediatrician on the following day.  Mother took child to MD 4/21/2005 for follow up, and was told that the child did have a reaction to the Dtap vaccine, and to continue taking the antibiotic.  No other treatment or follow up was required by MD as per mother.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injury, Syncope
Clinical narrative: Child followed mother out of room where vaccine was given  While mother was paying she passed out and hit her head on the floor. Approximately 5 minutes after receiving vaccines.  Child was given some soda to drink.  Mother sat in waiting room with child for 20 minutes after she fainted before leaving facility. Child seemed fine when she left.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot
Clinical narrative: Pt came in with red 10cmx12cm round warm area to Rt theigh.  Was approx. 45 hrs after injection.  Was instructed to apply ice to area per M.D.
Age: 0.02
Sex: M
Vaccine: HEP
Symptoms: Constipation
Clinical narrative: CHRONIC  CONSTIPATION
Age: 0.27
Sex: M
Vaccine: HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Follow up information received from the patient's physician provided results of electroencephalogram, event onset time, Act-Hib lot number, and patient demographics. Information regarding Prevnar was received from a physician regarding a 3 month old male patient who experienced seizure like symptoms. At 3 months of age, the patient received the first dose on 12/15/03. The patient also received his first dose of Act-HIB on 12/15/03. The patient had no known drug allergies. Indication for Prevnar was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IM). Concomitant medications were not reported. On 12/15/03, about three hours post-vaccination, the patient experienced seizure like symptoms. Two days later, he had a similar event and was seen in an emergency room. The infant was admitted to the emergency room and monitored by electroencephalogram (results were normal). He was released on an unspecified date without medication. On 1/27/04, the infant was again evaluated for convulsions. On examination, he was awake, alert, and smiling appropriately. His pupils were reactive and equal. There was no evidence of focal weakness or tremor. The infant has had no further events as of 1/27/04. Information regarding this event has been forwarded to the manufacturer of the concomitantly administered vaccine.
Age: 0.43
Sex: M
Vaccine: IPV, PNC
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: Follow up information pertaining to pt information and lab data has been received from the reporter. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 month old male pt who experienced high fever (103), irritability and was lethargic. At 5 months of age, the pt received the first dose on 22Jan04. The pt also received a dose of Polio vaccine (poliomyelitis vaccine inactivated) on 22Jan04. The pt had a past history of premature birth (born at 32 weeks 5 days). Pt is one child of triplets. Indication for Prevnar was immunization. Product was administered on 22Jan04. Dose regimen was 1 dose (IM). Concomitant therapy included Synagis. On 22Jan04 the pt experienced high fever (103), irritability and was lethargic. Unspecified blood work revealed normal results. The pt recovered.
Age: 4.0
Sex: M
Vaccine: IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site reaction, Medication error
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine injection) received from a nurse regarding a 4 year old male pt who developed warmth, redness, swelling and tenderness at the injection site, after he was inadvertently given a fifth dose on 12Feb04. The pt has a past history of premature baby. Indication for Prevnar was immunization. Product was administered on 12Feb04. Dose regimen was 0.5mL (IM). Concomitant therapy included IPOL on 12Feb04. On 12Feb04, the child inadvertently received a fifth dose of Prevnar instead of a fifth dose of Dtap. On 14Feb04, 2 days post immunization the pt presented to the ER with warmth, redness, swelling, and tenderness at the injection site on his anterior left thigh. Treatment included Keflex and the reaction resolved. Of note on 03Mar04, the child received his fifth dose of Dtap and on 05Mar04 went to the ER experiencing the same reaction, in the right deltoid. He was diagnosed with a local reaction to Dtap, and again treated with Keflex. The pt has recovered completely. A copy of this report has been forwarded to manf. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: IPV, PNC
Symptoms: Tenderness
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine injection) received from a nurse regarding a 4 year old male pt who developed warmth, redness, swelling and tenderness at the injection site, after he was inadvertently given a fifth dose on 12Feb04. The pt has a past history of premature baby. Indication for Prevnar was immunization. Product was administered on 12Feb04. Dose regimen was 0.5mL (IM). Concomitant therapy included IPOL on 12Feb04. On 12Feb04, the child inadvertently received a fifth dose of Prevnar instead of a fifth dose of Dtap. On 14Feb04, 2 days post immunization the pt presented to the ER with warmth, redness, swelling, and tenderness at the injection site on his anterior left thigh. Treatment included Keflex and the reaction resolved. Of note on 03Mar04, the child received his fifth dose of Dtap and on 05Mar04 went to the ER experiencing the same reaction, in the right deltoid. He was diagnosed with a local reaction to Dtap, and again treated with Keflex. The pt has recovered completely. A copy of this report has been forwarded to manf. No additional information was available at the time of this report.
Age: 19.0
Sex: F
Vaccine: PNC
Symptoms: Anaphylactic reaction, Bronchospasm, Hypoxia, Laboratory test abnormal, Similar reaction on previous exposure to drug
Clinical narrative: This case was considered medically important (OMIC). Follow up information from the reporter stated that the patient was given a test dose of vaccine and that the patient recovered. Information regarding Prevnar was received from an allergist regarding a 19 year old female patient who received a test dose on 5/21/04, and developed an anaphylactic reaction. The patient's concurrent illnesses include asthma and decreased immune responsiveness with a past history of anaphylactic reaction (having occurred approximately 2 years ago, following Pneumovax administration). Indication for Prevnar was immunization. Product was administered on 5/21/04. Dose regimen was 0.05cc 1 time per day. Concomitant therapy included Advair, Allegra-D, and Nasocort. On 5/21/04, at 08:45 AM, a 19 year old female patient received a test dose of Prevnar consisting of 0.05ml only, due to a previous anaphylactic reaction following a Pneumovax administration. At 11:45 AM, three hours after the test dose was administered, she developed an anaphylactic reaction, characterized by generalized hives, followed by bronchospasm, and throat constriction. The episode lasted approximately 10 minutes. Treatment included Benadryl 25mg, IM; epinephrine 1/1000, 0.3ml; 2 puffs of Albuterol and nasal oxygen. The reporter indicated that the patient recovered. Information regarding a previous anaphylactic reaction has been forwarded to the manufacturer of Pneumovax.
Age: 19.0
Sex: F
Vaccine: PNC
Symptoms: Throat tightness, Urticaria
Clinical narrative: This case was considered medically important (OMIC). Follow up information from the reporter stated that the patient was given a test dose of vaccine and that the patient recovered. Information regarding Prevnar was received from an allergist regarding a 19 year old female patient who received a test dose on 5/21/04, and developed an anaphylactic reaction. The patient's concurrent illnesses include asthma and decreased immune responsiveness with a past history of anaphylactic reaction (having occurred approximately 2 years ago, following Pneumovax administration). Indication for Prevnar was immunization. Product was administered on 5/21/04. Dose regimen was 0.05cc 1 time per day. Concomitant therapy included Advair, Allegra-D, and Nasocort. On 5/21/04, at 08:45 AM, a 19 year old female patient received a test dose of Prevnar consisting of 0.05ml only, due to a previous anaphylactic reaction following a Pneumovax administration. At 11:45 AM, three hours after the test dose was administered, she developed an anaphylactic reaction, characterized by generalized hives, followed by bronchospasm, and throat constriction. The episode lasted approximately 10 minutes. Treatment included Benadryl 25mg, IM; epinephrine 1/1000, 0.3ml; 2 puffs of Albuterol and nasal oxygen. The reporter indicated that the patient recovered. Information regarding a previous anaphylactic reaction has been forwarded to the manufacturer of Pneumovax.
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Hirsutism, Injection site reaction
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine( diphteria crml97 protein) injection) was received from a nurse practicioner regarding a 2 month old female pt who developed a "hairy patch surrounding the injection site". The pt received the first dose on 25-MAY-2004. Approximately two weeks after immunization, the pt's mother called to report that a "hairy patch" had grown in the injection site area of the chils'd thigh. On 14-Sep-2004, the child received a second dose of Prevenar. The reporter stated that she she "has not received a complaint of further hair growth" after the second dose. A copy of this report has been forwarded to the manufacturer of Pediarix. No additional information was available at the time of this report.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: This case was considered medically important (OMIC). Follow up information received from a physician provided additional adverse event information, length of hospitalization stay, treatment medication and noted that the patient had no relevant history of reactions to prior vaccinations. Information regarding Prevnar was received from a pediatrician regarding a 4 month old female patient who experienced three seizures without fever. At 4 months of age, the patient received the second dose on 10/7/04. The patient also received the second dose of Daptacel vaccine, the second dose of Act-HIB vaccine and the second dose of IPOL vaccine on 10/7/04. The reporter indicated that the patient does not have any relevant medical history. Indication for Prevnar was immunization. Product was administered on 10/7/04. Dose regimen was 1 dose. The patient was not taking any concomitant medications. On 10/8/04, one day post immunization, a 4 month old female patient experienced three seizures without fever. She was hospitalized for four days. Treatment included phenobarbital. On 10/23/04, the patient experienced another seizure. The reporter stated that no changes were made at that time. No additional information was available at the time of this report.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Epilepsy, Musculoskeletal stiffness, Nystagmus
Clinical narrative: This case was considered medically important (OMIC). Follow up information received from a physician provided additional adverse event information, length of hospitalization stay, treatment medication and noted that the patient had no relevant history of reactions to prior vaccinations. Information regarding Prevnar was received from a pediatrician regarding a 4 month old female patient who experienced three seizures without fever. At 4 months of age, the patient received the second dose on 10/7/04. The patient also received the second dose of Daptacel vaccine, the second dose of Act-HIB vaccine and the second dose of IPOL vaccine on 10/7/04. The reporter indicated that the patient does not have any relevant medical history. Indication for Prevnar was immunization. Product was administered on 10/7/04. Dose regimen was 1 dose. The patient was not taking any concomitant medications. On 10/8/04, one day post immunization, a 4 month old female patient experienced three seizures without fever. She was hospitalized for four days. Treatment included phenobarbital. On 10/23/04, the patient experienced another seizure. The reporter stated that no changes were made at that time. No additional information was available at the time of this report.
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine injection) was received from a pediatrician regarding a 2 month old female pt who experienced excessive crying, thrashing of the legs, decreased appetite and watery bowel movement. The pt received her first dose on 05/27/2004. Concomitant therapy: additional suspect vaccines included ActHib (Aventis) and Pediarix (GSK) administered on 05/27/04. Event Details: On 05/27/04, the pt experienced excessive crying and thrashing of the legs. The child's mother called the MD in the middle of the night, and brought the child to the office the next day. The child also had a decreased appetite, and a bowel movement that was " watery" with " no blood". On exam, it was noted that the child had no fever, no redness, no tenderness at the injection site, and her joint movement was normal. The child was treated with Benadryl. Information regarding these events has been forwarded to Aventis and GSK, manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Decreased appetite, Diarrhoea, Screaming
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine injection) was received from a pediatrician regarding a 2 month old female pt who experienced excessive crying, thrashing of the legs, decreased appetite and watery bowel movement. The pt received her first dose on 05/27/2004. Concomitant therapy: additional suspect vaccines included ActHib (Aventis) and Pediarix (GSK) administered on 05/27/04. Event Details: On 05/27/04, the pt experienced excessive crying and thrashing of the legs. The child's mother called the MD in the middle of the night, and brought the child to the office the next day. The child also had a decreased appetite, and a bowel movement that was " watery" with " no blood". On exam, it was noted that the child had no fever, no redness, no tenderness at the injection site, and her joint movement was normal. The child was treated with Benadryl. Information regarding these events has been forwarded to Aventis and GSK, manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Follow up information received from the physician provided additional patient details, laboratory test results, concomitant medications, vaccination time, and event onset time. Information regarding Prevnar was received from a pediatrician via a company representative regarding a 4 month old male patient who experienced a non-febrile seizure. At 4 months of age, the patient received a dose on 12/14/04. The patient also received a dose of Pediarix and a dose of PedvaxHIB on 12/14/04. The patient has a past history of gastroenteritis rotavirus. Past therapies included Hepatitis B vaccine, given at birth. The patient reportedly has no other health complications. Indication for Prevnar was immunization. Product was administered on 12/14/04. Dose regimen was 0.5ml 1 time per day. Concomitant therapy included Singulair. On 12/14/04, the patient experienced a non-febrile seizure. He was given two rescue breaths at home and was taken to an emergency room. The patient was then admitted to a hospital. An electroencephalogram and electrolytes were normal. Further treatment details were not reported. The patient recovered on an unspecified date. The reporting physician considered the event to be life threatening. The reporter indicated that no such reaction occurred at 2 month immunization. Information regarding this event has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Convulsion, Cyanosis, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Follow up information received from the physician provided additional patient details, laboratory test results, concomitant medications, vaccination time, and event onset time. Information regarding Prevnar was received from a pediatrician via a company representative regarding a 4 month old male patient who experienced a non-febrile seizure. At 4 months of age, the patient received a dose on 12/14/04. The patient also received a dose of Pediarix and a dose of PedvaxHIB on 12/14/04. The patient has a past history of gastroenteritis rotavirus. Past therapies included Hepatitis B vaccine, given at birth. The patient reportedly has no other health complications. Indication for Prevnar was immunization. Product was administered on 12/14/04. Dose regimen was 0.5ml 1 time per day. Concomitant therapy included Singulair. On 12/14/04, the patient experienced a non-febrile seizure. He was given two rescue breaths at home and was taken to an emergency room. The patient was then admitted to a hospital. An electroencephalogram and electrolytes were normal. Further treatment details were not reported. The patient recovered on an unspecified date. The reporting physician considered the event to be life threatening. The reporter indicated that no such reaction occurred at 2 month immunization. Information regarding this event has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count increased
Clinical narrative: Follow up information received from the physician provided additional patient details, laboratory test results, concomitant medications, vaccination time, and event onset time. Information regarding Prevnar was received from a pediatrician via a company representative regarding a 4 month old male patient who experienced a non-febrile seizure. At 4 months of age, the patient received a dose on 12/14/04. The patient also received a dose of Pediarix and a dose of PedvaxHIB on 12/14/04. The patient has a past history of gastroenteritis rotavirus. Past therapies included Hepatitis B vaccine, given at birth. The patient reportedly has no other health complications. Indication for Prevnar was immunization. Product was administered on 12/14/04. Dose regimen was 0.5ml 1 time per day. Concomitant therapy included Singulair. On 12/14/04, the patient experienced a non-febrile seizure. He was given two rescue breaths at home and was taken to an emergency room. The patient was then admitted to a hospital. An electroencephalogram and electrolytes were normal. Further treatment details were not reported. The patient recovered on an unspecified date. The reporting physician considered the event to be life threatening. The reporter indicated that no such reaction occurred at 2 month immunization. Information regarding this event has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.37
Sex: M
Vaccine: HIBV, PNC
Symptoms: Crying, Irritability, Muscle rigidity, Screaming
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician regarding a 4 month old male pt who experienced screaming, rigidity and irritability. At 4 months of age, the pt received the second dose on 13Dec04. The pt also received the second dose of ActHib on 13Dec04. The pt's concurrent illness includes wheezing. Indication for Prevnar was immunization. Product was administered on 13Dec04. Dose regimen was 1 dose (IM). Concomitant therapy included Albuterol and Qvar (beclomethasone dipropionate). Ipol  (poliomyelitis vaccine inactivated) and Daptacel (diphtheria and tetanus toxoids/acellular pertussis vaccine adsorbed) vaccines were administered on 06Dec04. On 15Dec04, the pt's mother reported that for the past two days her son was screaming, rigid, and irritable. The pt's mother stated that the symptoms were intermittent and seemed to resolve on their own. Treatment included infant Tylenol. As of 16Dec04, the physician indicated that the symptoms persisted intermittently. The physician reported that she decided to separate the vaccinations for the second administration due to the child crying uncontrollably post administration of the first vaccinations. See related case: HQWYE123121DEC04. NO additional information was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Contusion, Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: Follow up information from a nurse provided additional injection site descriptors and event outcome. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a health care professional regarding a 29 month old female pt who experienced a large swollen area at the injection site, a red, hard knot in center of the injection site, injection site "coloration is purplish and blanches to white" a dime sized bruised area at injection site and " red, hot to touch" at injection site. The patient received the fourth dose on 12/14/2004. Event Details: On 12/15/05, the pt developed an injection site reaction described as a large swollen area at the injection site measuring 7 cm long and 5 cm wide on the left anterior thigh. There was a "red, hard knot in center" and "coloration is purplish and blanches to white". On 12/16/05 the child was seen in the office where the injection site was "red, hot to touch" with a dime sized bruised area. The child was prescribed Clarinex and sent home with parents for observation. The pt has recovered.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Skin discolouration
Clinical narrative: Follow up information from a nurse provided additional injection site descriptors and event outcome. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a health care professional regarding a 29 month old female pt who experienced a large swollen area at the injection site, a red, hard knot in center of the injection site, injection site "coloration is purplish and blanches to white" a dime sized bruised area at injection site and " red, hot to touch" at injection site. The patient received the fourth dose on 12/14/2004. Event Details: On 12/15/05, the pt developed an injection site reaction described as a large swollen area at the injection site measuring 7 cm long and 5 cm wide on the left anterior thigh. There was a "red, hard knot in center" and "coloration is purplish and blanches to white". On 12/16/05 the child was seen in the office where the injection site was "red, hot to touch" with a dime sized bruised area. The child was prescribed Clarinex and sent home with parents for observation. The pt has recovered.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site oedema, Skin discolouration
Clinical narrative: Follow up information from the healthcare professional provided additional description of the event, treatment, event outcome and a copy of the report completed and sent in by the reporter. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 26 month old female pt who developed an injection site reaction characterized as a large swollen area with a red, hard knot in center, and injection site discoloration described as purplish red and blanches to white. The pt received the fourth dose on 14Dec04. The child was reported to be a healthy child. Indication for Prevnar was immunization. Product was administered on 14Dec04. Dose regimen was 0.5 mL 1 time per day (IM). Concomitant medications were not reported. On 15Dec04, the child's mother reported her child had a red swollen area that had a small knot.  On 16Dec04, when the knot became bigger, the child was seen in the office. There was a large swollen area at the injection site extending approx 10cm down the leg and approx 7 cm wide. There was a red, hard knot in center of the injection site; it was described as purplish red and blanches to white and hot to touch. The nurse instructed the mother to use witch hazel and Tylenol. The pt recovered.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Laboratory test abnormal, Leukocytosis, Pulmonary embolism, Pyrexia
Clinical narrative: Patient received immunizations on 9/28/04. He developed a pseudomonal sepsis and multiple pulmonary emboli 6 days later and expired that same day.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Sepsis
Clinical narrative: Patient received immunizations on 9/28/04. He developed a pseudomonal sepsis and multiple pulmonary emboli 6 days later and expired that same day.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Pulmonary embolism, Sepsis
Clinical narrative: Patient received immunizations on 9/28/04. He developed a pseudomonal sepsis and multiple pulmonary emboli 6 days later and expired that same day.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Pulmonary embolism, Sepsis
Clinical narrative: Patient received immunizations on 9/28/04. He developed a pseudomonal sepsis and multiple pulmonary emboli 6 days later and expired that same day.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor, Tremor neonatal
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother regarding her 4 year old some who developed shaking and tremors. The pt received a dose on 13Sep04. The pt's mother stated she felt, what appeared to be the baby experiencing tremors twice during the pregnancy. Indication for Prevnar was immunization. Product was administered on 13Sep04. Dose regimen was 1 dose 1 time per day. Suspect vaccines included Pediarix and Pedvax Hib. Additional suspect medication included Tylenol. Concomitant medication were not reported. On 24Sep04, 11 days post immunization, the pt developed shaking and tremors while nursing. The event lasted about 10 seconds. On 27Sep04, the child developed a tremor described as head shaking, which lasted a shorter period of time than the tremors on 24Sep04. On 02Oct04, the child again developed a tremor in both his legs. The pt was seen at the physicians' office. As of 11Nov04 the event was ongoing. This report was received from manf of Pediarix. (manf Ref: A0528466A). No additional information was available at the time of this report.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother regarding her 4 year old some who developed shaking and tremors. The pt received a dose on 13Sep04. The pt's mother stated she felt, what appeared to be the baby experiencing tremors twice during the pregnancy. Indication for Prevnar was immunization. Product was administered on 13Sep04. Dose regimen was 1 dose 1 time per day. Suspect vaccines included Pediarix and Pedvax Hib. Additional suspect medication included Tylenol. Concomitant medication were not reported. On 24Sep04, 11 days post immunization, the pt developed shaking and tremors while nursing. The event lasted about 10 seconds. On 27Sep04, the child developed a tremor described as head shaking, which lasted a shorter period of time than the tremors on 24Sep04. On 02Oct04, the child again developed a tremor in both his legs. The pt was seen at the physicians' office. As of 11Nov04 the event was ongoing. This report was received from manf of Pediarix. (manf Ref: A0528466A). No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: HIBV, PNC, HEP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine injection) was received from a pediatrician, via a company representative, regarding a 2 month old female pt who developed a few hives on her face. The pt received the first dose on 09Jun04. The pt was reported to have no medical history. Indication for Prevnar was immunization. Product was administered on 09Jun04. Dose regimen was 0.5mL 1 time per day (IM). Concomitant vaccines on 09Jun04 included Acthib and Engerix B. On 09Jun04, one hour after administration, the pt developed a few hives on her face. The hives resolved without treatment. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine injection) was received from a physician regarding a 4 month old female pt who developed hives over her upper body. The pt received the second dose on 22Jun04. The pt was reported to have a negative medical history. Indication for Prevnar was immunization. Product was administered on 22Jun04. Dose regimen was 0.5mL 1 time per day (IM). The pt also received a dose each of Tripedia, IPOL, and Acthib on 22Jun04. On 22Jun04, post immunization, the child immediately developed hives over her upper body. It was reported that the child was in no distress and required no emergency medication. The physician observed the child for 15 minutes, at which time the hives were fading, and the child went home with her family. The pt recovered. Information regarding this event has been forwarded to manf of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine injection) was received from a physician regarding a 4 month old female pt who developed hives over her upper body. The pt received the second dose on 22Jun04. The pt was reported to have a negative medical history. Indication for Prevnar was immunization. Product was administered on 22Jun04. Dose regimen was 0.5mL 1 time per day (IM). The pt also received a dose each of Tripedia, IPOL, and Acthib on 22Jun04. On 22Jun04, post immunization, the child immediately developed hives over her upper body. It was reported that the child was in no distress and required no emergency medication. The physician observed the child for 15 minutes, at which time the hives were fading, and the child went home with her family. The pt recovered. Information regarding this event has been forwarded to manf of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.38
Sex: M
Vaccine: HIBV, IPV, DTAP, HIBV, IPV, PNC, DTAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from an allergist's office, regarding a 4 month old male pt who developed a low grade fever and hives. The pt received a dose on 20Dec01.  Relevant medical history was unk. Indication for Prevnar was immunization. Product was administered on 20Dec01. Dose regimen was 1 dose 1 time per day (IM). Additional suspect vaccines included Infanrix, Ipol and Acthib. Concomitant medications were not reported. On 21Dec01, twenty four hours post immunization, the pt developed a low grade fever and hives. He recovered. Information regarding these events has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: Pt develop papular rash in bilat armpits and inguinal crease 15 days post smallpox vaccination.  Good take.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Erythema, diffuse left upper arm.
Age: 1.98
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Bumps entire body started on 04/16/2005. Fever x 4 days 101-103 degrees Fahrenheit.
Age: 1.6
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash papular, Rash vesicular
Clinical narrative: Multiple erythematous papules with central vesicle consistent with varicella.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Pt received varicella vaccine and came down with very mild disease- #90 Pox, no complications.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema/ induration at DTaP site on leg. RX ancef, Keflex x 5 days warm compresses. 04/18/05- completely resolved, no further problems.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site oedema, Oedema, Oedema peripheral, Pyrexia
Clinical narrative: 04/01/2005- temp 100.9 approximately 11:30 AM, child awoke at 9:30 pm with right arm swollen from mid upper arm to and involving entire shoulder. Instructed mom to apply cold compress and give childrens Advil. Contact MD if worsens over weekend.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abnormal behaviour, Feeling cold, Pyrexia
Clinical narrative: Pt dad noticed onset of fever on 04/15 to be around 102-103 degrees that evening. Started treating with Childrens Tylenol and ibuprofen, cool baths, increased fluids. Fever spiked 04/17 at 104.4 degrees, slight rash on chest, waist, legs, noted per father. Continued above treatment. 04/18/05-5:00 fever 103.8 by 10:00 98.8 while on phone at 2:00 dad mentioned pt to be "chilled" again. Recommeded  to continue treatments and notify MD if not better by 04/19. Father denies any breathing difficulties or seizure activity, only "sillyness" when fever spiked.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Chills, Dizziness, Pyrexia, Rash
Clinical narrative: Pt dad noticed onset of fever on 04/15 to be around 102-103 degrees that evening. Started treating with Childrens Tylenol and ibuprofen, cool baths, increased fluids. Fever spiked 04/17 at 104.4 degrees, slight rash on chest, waist, legs, noted per father. Continued above treatment. 04/18/05-5:00 fever 103.8 by 10:00 98.8 while on phone at 2:00 dad mentioned pt to be "chilled" again. Recommeded  to continue treatments and notify MD if not better by 04/19. Father denies any breathing difficulties or seizure activity, only "sillyness" when fever spiked.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site erythema, Oedema
Clinical narrative: Within one minute of injecting baby, Noticed redness, swelling to right brow. Redness to both thighs at injection sites, irregular, baby free of distress. Examined by MD and observed x 30 minutes. 04/05/2005 10:11 AM called mom: reports baby was ok after discharge.
Age: 21.0
Sex: F
Vaccine: HEP, TD
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: 50x35mm induration occurred after having shot on Thurs. 04/14/05. Pt states each day area got bigger and red. Soreness in area occurred also. Warm compress and massage did not help. Nothing eles follows. Lump is still.
Age: 25.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Dizziness, Nausea
Clinical narrative: Light headed, near passing out, nausea.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash maculo-papular, Urticaria
Clinical narrative: 04/06/05- c/o temp 101 degrees, relieved with Tylenol: itchiness and rash. 04/18/2005- c/o rash noted to axilla bilaterally, red blotches and temp, with increased itchyness. RX Betamethasone dipronate x 1 week
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Nausea and vomiting approximately 8 hours after injection lasting less than 12 hours. General malaise lasting approximately 24 hours.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema, Injection site warmth, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Right upper arm swollen, redened, warm to touch, tender, muscle tight- referred to family MD for evaluation.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Immediately upon receiving varivax SQ in right arm, greater than usual redness, noted at injection site. Kept for observation x 10 minutes. 5mmx10mm induration and 20mm surrounding redness. Benadryl 1/2 tsp given per MD verbal order. Checked by MD (+) wheal and flare reaction. Advised to go straight to ER if respiratory difficult develops.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Red area where DTaP was given in left thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Tenderness
Clinical narrative: Right deltoid area with large area of redness and mild tenderness- (within 24 hours of receiving DaPT and IPV)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Injection site warmth
Clinical narrative: 4 1/2 x 5in induration, warmth, and erythema right thigh. Pain medication and warm compresses.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Eye oedema, Face oedema, Urticaria
Clinical narrative: Swelling to lips, eyes, face, redness all over body. Hives all over body.
Age: 1.45
Sex: M
Vaccine: IPV, PNC, VARCEL
Symptoms: Bacterial infection, Convulsion, Drug ineffective, Ear pain, Influenza
Clinical narrative: Follow up information provided updated patient and reporter demographics, dates of administration and additional vaccines administered and updated details regarding patient diagnosis, including additional diagnosis and recovery status and lot numbers. Information regarding Prevnar was received from a nurse regarding a now, 5 year old male patient who, at 17 months of age, received a second dose of Prevnar, a first dose of Varivax, and a third dose of IPOL on 5/17/01. In January 2005, the child was diagnosed with bilateral otitis media, an upper respiratory tract infection, influenza, and developed pneumococcal meningitis. Relevant medical history reported as none. Indication for Prevnar was immunization. Product was administered on 5/17/01. Dose regimen was 0.5ml  1 time per day. Concomitant therapy included Varivax and IPOL. On 5/17/01, a 17 month old male received a second dose of Prevnar. On 1/20/05, at 5 years of age, the child was evaluated and diagnosed with bilateral otitis media and an upper respiratory tract infection. Treatment included Omnicef and Motrin. On 1/22/05, he was evaluated at a local urgent care and diagnosed with influenza after a rapid test was positive. On 1/24/05, he was evaluated in the physician's office after developing increased ear pain and nuchal rigidity. The child was sent to the emergency room where he was admitted to the pediatric intensive care unit. On 1/24/05, Streptococcus pneumoniae was confirmed. On 1/28/05, the patient developed intractable seizures and was placed  in a coma. On 2/1/05, the pentobarbital was weaned. On 2/8/05, an external shut was placed. The reporter considered the events of meningitis pneumococcal, drug ineffective, and convulsions to be life threatening, resulting in persistent or significant disability. As of 2/23/05, the patient had not recovered and remained hospitalized.
Age: 1.45
Sex: M
Vaccine: IPV, PNC, VARCEL
Symptoms: Meningitis, Otitis media, Upper respiratory tract infection, Viral infection
Clinical narrative: Follow up information provided updated patient and reporter demographics, dates of administration and additional vaccines administered and updated details regarding patient diagnosis, including additional diagnosis and recovery status and lot numbers. Information regarding Prevnar was received from a nurse regarding a now, 5 year old male patient who, at 17 months of age, received a second dose of Prevnar, a first dose of Varivax, and a third dose of IPOL on 5/17/01. In January 2005, the child was diagnosed with bilateral otitis media, an upper respiratory tract infection, influenza, and developed pneumococcal meningitis. Relevant medical history reported as none. Indication for Prevnar was immunization. Product was administered on 5/17/01. Dose regimen was 0.5ml  1 time per day. Concomitant therapy included Varivax and IPOL. On 5/17/01, a 17 month old male received a second dose of Prevnar. On 1/20/05, at 5 years of age, the child was evaluated and diagnosed with bilateral otitis media and an upper respiratory tract infection. Treatment included Omnicef and Motrin. On 1/22/05, he was evaluated at a local urgent care and diagnosed with influenza after a rapid test was positive. On 1/24/05, he was evaluated in the physician's office after developing increased ear pain and nuchal rigidity. The child was sent to the emergency room where he was admitted to the pediatric intensive care unit. On 1/24/05, Streptococcus pneumoniae was confirmed. On 1/28/05, the patient developed intractable seizures and was placed  in a coma. On 2/1/05, the pentobarbital was weaned. On 2/8/05, an external shut was placed. The reporter considered the events of meningitis pneumococcal, drug ineffective, and convulsions to be life threatening, resulting in persistent or significant disability. As of 2/23/05, the patient had not recovered and remained hospitalized.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Drug ineffective, Meningitis
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 4 month old male patient who experienced pneumococcal meningitis and drug ineffective. At 4 months of age, the patient received the second dose on 1/25/05. The patient also received second doses of Daptacel, IPOL, and Act-HIB on 1/25/05. The patient has a past history of premature baby (infant is part of a multiple birth (triplet)). Indication for Prevnar was immunization. Product was administered on 1/25/05. Dose regimen was 1 dose (IM). Concomitant therapy included Daptacel, Polio Vaccine, and Act-HIB. The patient experienced pneumococcal meningitis on 2/7/05. He was hospitalized and given unspecified IV antibiotics. As of 2/14/105, the infant was still hospitalized but doing better. The reporter considered the event to be life-threatening. The serotype still pending. No additional information was available at the time of this report.