chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.38
Sex: M
Vaccine: HIBV, MMR
Symptoms: Metal poisoning, Mood altered, Nervous system disorder, Neurotransmitter level altered, Rhinitis
Clinical narrative: 5 days after vaccine, his belly became distended and he couldn't bend over. He began to have chronic diarrhea, rhinitis, sleep problems, chewing problems, moodiness, and wanted to be carried non-stop. 10 days after the vaccine, he slept for 40 out of 48 hours. After that, he started to lose speech, the desire to eat, the ability to sleep. He stopped reacting to his name and couldn't play with toys.  He began to toe walk, hand flap, and head bang. 6 weeks after the vaccine he received antibiotics which left him in a severely autistic state. We put him on a gluten free, casein free diet which helped. We treated his candida overgrowth and began supplementing with nutrients. We are currently chelating him to remove heavy metals. 5/4/06 Received medical records from provider which reveal patient experienced normal development as of day of vax.  However, he was referred on that visit for OT & echocardiogram for 2/6 murmur (WNL).  Patient with frequent otitis media, runny nose & diarrhea.  Labs pointed to diet high in protein. Parents refused further vaccination. 6/19/06 Received medical records from diagnosing/treating physician which revealed patient experienced excessive thirst & hunger, speech delay, eczema, allergic shiners.  Rx'd with chelation therapy & progressed well with improved speech, less diarrhea & improved sleep.  Multiple lab reports with records revealed multiple malabsorption & metabolic disturbances./ss. He continues to have neurological immune, and Gastromtestinc problems. He has delayed speech and has done ABA therapy to work on developmental issues. He continues to be on a very constrained diet due to food intolerances and reduced enzyme activity. His body has had an inappropriate response to many of his vaccines. He also displays symptoms of metal toxicity and hes been helped by chelation. His urine toxic meltals test showed elevated mercury (Tyi level =5:7, ref. range is >5). His mother received a Rhogam shot while pregnant with him (it contained 25mg thimerosal) and we believe that was the start of his heavy metal toxicity. Older brother also received an autism diagnosis and he has similar ongoing health issues and lab values. He too was exposed to mercury inutero and has elevated viral titers. Interestingly, he has no immunity to Hep B despite getting three shots, including me on the day he was born. In our doctor's office, of all their children on the autism spectrum who got thier first Hep B vaccine on the day they were born, over 75% of those kids do not have HepB immunity. Why are the vaccines not working for these kids, how are their immune systems different from the non-autistic kids, and should they be getting vaccines at all ? I want to see someone screen these kids before they get  injections. My two children have been permanently damaged by vaccines and I do not want this to happen to other children.
Age: 1.38
Sex: M
Vaccine: HIBV, MMR
Symptoms: Sleep disorder, Speech disorder, Speech disorder developmental, Therapeutic response unexpected, Thirst
Clinical narrative: 5 days after vaccine, his belly became distended and he couldn't bend over. He began to have chronic diarrhea, rhinitis, sleep problems, chewing problems, moodiness, and wanted to be carried non-stop. 10 days after the vaccine, he slept for 40 out of 48 hours. After that, he started to lose speech, the desire to eat, the ability to sleep. He stopped reacting to his name and couldn't play with toys.  He began to toe walk, hand flap, and head bang. 6 weeks after the vaccine he received antibiotics which left him in a severely autistic state. We put him on a gluten free, casein free diet which helped. We treated his candida overgrowth and began supplementing with nutrients. We are currently chelating him to remove heavy metals. 5/4/06 Received medical records from provider which reveal patient experienced normal development as of day of vax.  However, he was referred on that visit for OT & echocardiogram for 2/6 murmur (WNL).  Patient with frequent otitis media, runny nose & diarrhea.  Labs pointed to diet high in protein. Parents refused further vaccination. 6/19/06 Received medical records from diagnosing/treating physician which revealed patient experienced excessive thirst & hunger, speech delay, eczema, allergic shiners.  Rx'd with chelation therapy & progressed well with improved speech, less diarrhea & improved sleep.  Multiple lab reports with records revealed multiple malabsorption & metabolic disturbances./ss. He continues to have neurological immune, and Gastromtestinc problems. He has delayed speech and has done ABA therapy to work on developmental issues. He continues to be on a very constrained diet due to food intolerances and reduced enzyme activity. His body has had an inappropriate response to many of his vaccines. He also displays symptoms of metal toxicity and hes been helped by chelation. His urine toxic meltals test showed elevated mercury (Tyi level =5:7, ref. range is >5). His mother received a Rhogam shot while pregnant with him (it contained 25mg thimerosal) and we believe that was the start of his heavy metal toxicity. Older brother also received an autism diagnosis and he has similar ongoing health issues and lab values. He too was exposed to mercury inutero and has elevated viral titers. Interestingly, he has no immunity to Hep B despite getting three shots, including me on the day he was born. In our doctor's office, of all their children on the autism spectrum who got thier first Hep B vaccine on the day they were born, over 75% of those kids do not have HepB immunity. Why are the vaccines not working for these kids, how are their immune systems different from the non-autistic kids, and should they be getting vaccines at all ? I want to see someone screen these kids before they get  injections. My two children have been permanently damaged by vaccines and I do not want this to happen to other children.
Age: 1.38
Sex: M
Vaccine: HIBV, MMR
Symptoms: Toe walking, Urine mercury abnormal, Vitamin B12 deficiency, Zinc deficiency
Clinical narrative: 5 days after vaccine, his belly became distended and he couldn't bend over. He began to have chronic diarrhea, rhinitis, sleep problems, chewing problems, moodiness, and wanted to be carried non-stop. 10 days after the vaccine, he slept for 40 out of 48 hours. After that, he started to lose speech, the desire to eat, the ability to sleep. He stopped reacting to his name and couldn't play with toys.  He began to toe walk, hand flap, and head bang. 6 weeks after the vaccine he received antibiotics which left him in a severely autistic state. We put him on a gluten free, casein free diet which helped. We treated his candida overgrowth and began supplementing with nutrients. We are currently chelating him to remove heavy metals. 5/4/06 Received medical records from provider which reveal patient experienced normal development as of day of vax.  However, he was referred on that visit for OT & echocardiogram for 2/6 murmur (WNL).  Patient with frequent otitis media, runny nose & diarrhea.  Labs pointed to diet high in protein. Parents refused further vaccination. 6/19/06 Received medical records from diagnosing/treating physician which revealed patient experienced excessive thirst & hunger, speech delay, eczema, allergic shiners.  Rx'd with chelation therapy & progressed well with improved speech, less diarrhea & improved sleep.  Multiple lab reports with records revealed multiple malabsorption & metabolic disturbances./ss. He continues to have neurological immune, and Gastromtestinc problems. He has delayed speech and has done ABA therapy to work on developmental issues. He continues to be on a very constrained diet due to food intolerances and reduced enzyme activity. His body has had an inappropriate response to many of his vaccines. He also displays symptoms of metal toxicity and hes been helped by chelation. His urine toxic meltals test showed elevated mercury (Tyi level =5:7, ref. range is >5). His mother received a Rhogam shot while pregnant with him (it contained 25mg thimerosal) and we believe that was the start of his heavy metal toxicity. Older brother also received an autism diagnosis and he has similar ongoing health issues and lab values. He too was exposed to mercury inutero and has elevated viral titers. Interestingly, he has no immunity to Hep B despite getting three shots, including me on the day he was born. In our doctor's office, of all their children on the autism spectrum who got thier first Hep B vaccine on the day they were born, over 75% of those kids do not have HepB immunity. Why are the vaccines not working for these kids, how are their immune systems different from the non-autistic kids, and should they be getting vaccines at all ? I want to see someone screen these kids before they get  injections. My two children have been permanently damaged by vaccines and I do not want this to happen to other children.
Age: 1.03
Sex: F
Vaccine: MMRV
Symptoms: Angioneurotic oedema, Oedema peripheral, Urticaria
Clinical narrative: Patient Received pro-quad vaccine. 4/24/2006. Developed diffuse urticaria next day (4/25/06). Developed angioedema/extremity edema (4/26/06). No concurrent illness. No daily medications. No other exposures identified. Started on 3 day course of prednisone and prn benadryl for itching.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Numbness ran up rt knee then few weeks later went in lt leg to knee.  Treated by two doctors.  Doctor in middle of diagnosis of (mild case) Guillian Barre syndrome when insurance ran out.  I am ok now but have chosen not to get 2nd mmr shot.
Age: 3.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: RASH ON RIGHT CHEEK PER PHONE CALL FROM MOTHER AT 3:30 PM, VACCINE ADMINISTERED AT APPROXIMATELY 2:20 PM. NO PREVIOUS PROBLEMS WITH VACCINATIONS REPORTED FROM HISTORY GIVEN BY FATHER.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and mild swelling to area surrounding injection sites. 7x7 cm. area surrounding TdaP site, 10x8 cm area surrounding Menactra site.
Age: 3.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Abasia, Anorexia, Feeling hot, Gait disturbance, Red blood cell sedimentation rate increased
Clinical narrative: Mom states child fine & playing on 3/29 until 3 p.m. when great grandmother told mom child couldn't walk; mom states she gave him tylenol becuse he felt hot but temp not taken; sympoms continued until Friday when child c/o anorexia and child still unable to walk; PHN observed child attempting to walk and dragging right thigh; no redness, edema, noted by inspection; Temp 97.7 F.  Referred to doctor 3/30 for further evaluation; mom stated she has noticed child limp before now. Returned to Doctor 4/7/06
Age: 3.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Speech disorder
Clinical narrative: Mom states child fine & playing on 3/29 until 3 p.m. when great grandmother told mom child couldn't walk; mom states she gave him tylenol becuse he felt hot but temp not taken; sympoms continued until Friday when child c/o anorexia and child still unable to walk; PHN observed child attempting to walk and dragging right thigh; no redness, edema, noted by inspection; Temp 97.7 F.  Referred to doctor 3/30 for further evaluation; mom stated she has noticed child limp before now. Returned to Doctor 4/7/06
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left deltoid swollen, red, warm to touch. Mother called when she noticed the reaction after his bath on 4-25-06. Seen in office today (4-26-06). L. deltoid still the same. No pain; no treatment.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: DTAP GIVEN ON RIGHT DELTOID. HER ARM WAS RED, HOT TO TOUCH, SWOLLEN FROM HER SHOULDER TO THE ELBOW.  SHE WAS GIVEN ICE PACKS, TOLD TO TAKE HER TO THE MD FOR CHECK UP IF IT WORSENS.
Age: 48.0
Sex: M
Vaccine: HEP, TD
Symptoms: Alopecia, Atrial fibrillation
Clinical narrative: Hair loss diagnosed as scarring alopecia; began 30days after first dose. Atrial fibrillation: diagnosed first symptoms 30 days after first dose.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: Had DPT and Pneumovax on 4/20/06 within 24 hours developed pain, swelling, redness at site of Pneumovax and temp 103.7, fever lasted until 4/24.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Swelling of right arm, extending below elbow 2 inches, right arm warm and red to touch, difficulty moving arm also.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: 24 hours after child received immunizations, mother noted redness increased warmth, swelling and some hardness in area of left deltoid. This morning 48 hrs after admin. No hardness noted at site, but some rubor and calor still remain. Seen at clinic here. Mother states child never c/o discomfort, no fever noted. Mother gave Tylenol x 2.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Agitation, Oedema, Pain in extremity, Urticaria
Clinical narrative: Hives, Swelling in arms, pt complained that feet hurt really bad, extremely agitated problems resolved in 1 hour.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity
Clinical narrative: Large, red area to left upper arm, treated with Benadryl PRN, Augmentin 400/5 1 tsp BID x 10 days.
Age: 0.16
Sex: U
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient developed induration and erythema at injection site and required doctors visit 5 days after injection. Antibiotics were prescribed.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: PT received Tdap and Hep A IM LD on 4/21/06. Pt developed local reaction on left deltoid area consisting of a 10 cm x 10 cm area of erythema and slight induration without any c/o pain even when palpated.
Age: 0.51
Sex: F
Vaccine: DTAP, HBPV, PNC
Symptoms: Drug ineffective, Pneumonia, Respiratory disorder, Sepsis
Clinical narrative: Info regarding Prevnar was received from a healthcare professional regarding a 15 month old female pt who experienced pneumococcal sepsis and respiratory symptoms. At 6 months of age the pt received the third dose on 5/24/05. The pt also received a dose of DTAP and a dose of Hep-B on 5/24/05. Indication for Prevnar was immunization. Product was administered on 5/24/05. Dose regimen was 1 dose 1 time per day. Event Details: A physician reported that the pt developed pneumococcal sepsis (drug ineffective) and was hospitalized on 2/22/06. Respiratory symptoms occurred prior to the sepsis. Serotyping of a sample collected was unavailable at the time of this report. Results from chest films obtained were "clear". Recovery status of pt is unknown.
Age: 0.74
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Info regarding Prevnar was received from a public health nurse regarding a 10 month old female pt who developed pneumococcal bacteremia. On 3/11/05, at 8 months of age, the pt received a third dose of Prevnar. On the same day, the pt also received a dose of Polio vaccine, a dose of Tripedia and a dose of Comvax. Indication for Prevnar was immunization. Product was administered on 3/11/05. Dose regimen was 1 dose 1 time per day. Event Details: On 3/11/05, at 8 months of age, the pt received a third dose of Prevnar. On 4/24/05, at 10 months of age, the pt developed pneumococcal bacteremia (drug ineffective) after a blood culture perform in 4/05, was positive for Streptococcal pneumoniae. The pt recovered. No additional info was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Info regarding Prevnar was received from a healthcare professional regarding a 6 year old pt who experienced urticarial rash. The pt received a dose on 3/20/05. Indication for Prevnar was immunization. Product was administered on 3/10/05. Dose regimen was 1 dose. It was reported that the pt has a history of recurrent pneumonia and sinusitis. He was referred by his pediatrician to the infectious disease department at a hospital for follow-up. The pt was given Prevnar on 3/10/05 and developed a urticarial rash. The pt was hospitalized. No additional info was available at the time of this report.
Age: 1.45
Sex: F
Vaccine: HEP, PNC, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: Info regarding Prevnar was received from a public health nurse regarding a female pt who, on 1/12/04, at 17 months of age, received a fourth dose of Prevnar, along with a dose of hepatitis B vaccine and a dose of varicella virus vaccine, live. On 5/28/05, at 33 months of age, the pt developed pneumococcal bacteremia. Indication for Prevnar was immunization. Product was administered on 1/12/04. Dose regimen was 1 dose 1 time per day. Concomitant therapy included hepatitis B, varicella live, Hib-Titer, DTAP and Polio. Event details: On 1/12/04, at 17 months of age, the pt received a fourth dose of Prevnar. On 5/28/05, at 33 months of age, the pt developed pneumococcal bacteremia, requiring hospitalization., after a blood culture performed on an unspecified date was positive for Streptococcus pneumoniae (drug ineffective). The reporter indicated the pt recovered. No additional info was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Info regarding Prevnar was received from a public health nurse regarding a male pt who on 10/08/04, at 12 months of age, received a dose of Prevnar. On 5/31/05, at 19 months of age, the pt developed pneumococcal bacteremia. Indication for Prevnar was immunization. Product was administered on 10/8/04. Dose regimen was 1 dose 1 time per day. Event Details: On 10/8/04, at 12 months of age, the pt received a dose of Prevnar. On 5/21/05, at 19 months of age, the child developed pneumococcal bacteremia (drug ineffective), after a blood culture performed on an unspecified date in 5/05, was positive for Streptococcus pneumoniae. The pt's recovery status is unknown. No additional info was available at the time of this report.
Age: 0.98
Sex: F
Vaccine: PNC
Symptoms: Drug ineffective, Medication error, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Info regarding Prevnar was received from a healthcare professional regarding a 2 year old female pt who developed right lower lobe pneumonia. At 11 months of age, the pt received the fourth dose on 10/28/03. Indication for Prevnar was immunization. Product was administered on 10/28/2003. Dose regimen was 1 dose IM. Event Details: The pt developed right lower lobe pneumonia (drug ineffective) on 1/31/05. The pt was treated with Zithromax. A culture was not performed. On an office visit of 2/2/05, the pt's lungs were clear. It was additionally noted that the pt had received the 4th dose of Prevnar, 8 days before her first birthday (medication error). No additional info was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Bacterial infection, Drug ineffective, Pneumonia, Pyrexia, Vomiting
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 year old female patient who experienced streptococcal pneumonia and drug ineffective. At 6 months of age, the patient received the third dose on 4/18/2002. Relevant medical history was not provided. Indication for Prevenar was immunization. Product was administered on 4/18/2002. Dose regimen was 1 dose. Concomitant therapy included IPV, Engerix B and Infanrix. On 2/4/2005, the patient developed an acute febrile illness with vomiting. The patient was hospitalized with streptococcal pneumonia, drug ineffective on 2/6/2005. It was reported the the patient recovered date unspecified. Culture results revealed streptococcus pneumoniae, serotype 4, was done on 2/9/2005. No additional information was available at the time of this report.
Age: 1.5
Sex: U
Vaccine: PNC
Symptoms: Anaphylactic shock
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding an 18 month old patient who experienced anaphylactic shock. The patient received the second 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 intramuscular. Concomitant medications were not reported. The patient experienced anaphylactic (anaphylactic shock) on an unspecified date. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: Follow up information received from a physician, provided the lot number and date of administration of the child's fourth dose of Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a Epidemiologist regarding a 35 month old male patient who received a fourth dose of Prevnar on 7/19/2003, In 3/15/2005, the patient developed pneumococcal pneumonia and on 3/21/2005, developed pneumococcal bacteremia. Reported as none. Indication for Prevnar was immunization. Product was administered on 7/19/2003. Dose regimen was 1 dose. Concomitant medications were not reported. On 7/19/2003, the patient received a fourth dose of Prevenar. On 3/15/2005, the child developed pneumonia. On 3/21/2005, he was hospitalized. A blood culture was performed which positive for streptococcus pneumonia, serotype not included (pneumococcal bacteraemia) (drug ineffective). A pleural fluid culture was performed, which also revealed streptococcus pneumoniae, serotype not included (pneumonia pneumococcal) (drug ineffective). Susceptibility cultures were not reported. As of 3/28/2005, the patients recovery status is unknown. Blood culture (results positive for streptococcus pneumonia, no serotype was included in report) and Culture (results Pleural fluid was examined. Reported as positive for streptococcus pneumonia, serotype not included. Were done in 3/2005. No additional information was available at the time of this report.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC
Symptoms: Bacterial infection, Drug ineffective, Meningitis, Pneumonia
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 15 month old male patient who developed pneumococcal meningitis. At 12 months of age, the patient received the fourth dose on 12/2/2004. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 12/2/2004. Dose regimen was 1 dose intramuscular. Concomitant therapy included Haemophilus B conjugate vaccine (manufacturer unknown). The patient was hospitalized with Pneumococcal meningitis (meningitis pneumococcal) (drug ineffective) on 3/9/2005. He was discharged on 3/15/2005 and considered recovered. CSF culture results positive for streptococcus pneumonia, serotype not listed, was done on 3/9/2005.
Age: 5.0
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Meningitis, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 year old female patient who developed pneumococcal meningitis and exhibited a negative antibody titer. The patient received the third dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. The patient developed pneumococcal meningitis, drug ineffective in Oct 2005. Test results also showed that the patient exhibited a negative antibody titer (antibody test negative). The patient has since recovered. No further information was provided. The following test were done on an unspecified date, antibody test results no antibodies to PRP Hib, varicella and streptococcus pneumonia serotypes, culture results serotype pending, and blood immunoglobulin G results normal. See related case HQWYE686506FEB06 in which the same reporter revealed this patient had no antibody response to Hib vaccine.
Age: 1.0
Sex: M
Vaccine: PNC, HEP, PNC
Symptoms: Eye oedema
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a 12 month old male pt who experienced puffy eyes. A 12 months of age, the pt received the fifth dose on 6/29/05. Indication for Prevnar was immunization. Product was administered on 6/29/05. Dose regimen was 1 dose, IM. Additional suspect medication included Pentacel (diphtheria vaccine/haemophilus influenzae b/acellular pertussis vaccine/poliomyelitis vaccine inactivated/tetanus vaccine). Concomitant medications were not reported. Event Details: The pt developed puffy eyes (eye swelling) on either 6/30/05 or 7/1/05. Around this same time, the child had eaten Bing cherries and popsicle which he had not eaten before. The child also had sunscreen applied; the physician thought that the sunscreen was the possible cause of the puffy eyes; food allergy testing was not done. The eyes cleared by 7/3/05. No more info was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: PNC, HEP, PNC
Symptoms: Condition aggravated, Cough, Gastroenteritis, Laboratory test abnormal, Lethargy
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a 12 month old male pt who experienced puffy eyes. A 12 months of age, the pt received the fifth dose on 6/29/05. Indication for Prevnar was immunization. Product was administered on 6/29/05. Dose regimen was 1 dose, IM. Additional suspect medication included Pentacel (diphtheria vaccine/haemophilus influenzae b/acellular pertussis vaccine/poliomyelitis vaccine inactivated/tetanus vaccine). Concomitant medications were not reported. Event Details: The pt developed puffy eyes (eye swelling) on either 6/30/05 or 7/1/05. Around this same time, the child had eaten Bing cherries and popsicle which he had not eaten before. The child also had sunscreen applied; the physician thought that the sunscreen was the possible cause of the puffy eyes; food allergy testing was not done. The eyes cleared by 7/3/05. No more info was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: PNC, HEP, PNC
Symptoms: Medication error, Otitis media, Pyrexia, Somnolence, Vomiting
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a 12 month old male pt who experienced puffy eyes. A 12 months of age, the pt received the fifth dose on 6/29/05. Indication for Prevnar was immunization. Product was administered on 6/29/05. Dose regimen was 1 dose, IM. Additional suspect medication included Pentacel (diphtheria vaccine/haemophilus influenzae b/acellular pertussis vaccine/poliomyelitis vaccine inactivated/tetanus vaccine). Concomitant medications were not reported. Event Details: The pt developed puffy eyes (eye swelling) on either 6/30/05 or 7/1/05. Around this same time, the child had eaten Bing cherries and popsicle which he had not eaten before. The child also had sunscreen applied; the physician thought that the sunscreen was the possible cause of the puffy eyes; food allergy testing was not done. The eyes cleared by 7/3/05. No more info was available at the time of this report.
Age: 0.75
Sex: M
Vaccine: PNC, HEP, PNC
Symptoms: Eye oedema
Clinical narrative: Follow up information has been received upgrading this case from non serious to serious status. Information has been received regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) from a healthcare professional regarding a 9 month old male patient who was hospitalized with gastroenteritis and otitis media. The patient additionally developed a temperature of 99.3 degrees F, occasional cough and exhibited increased sleep. He received his 4 dose of Prevnar of 3/29/2005 at 9 months of age. The patient also received the third dose of Recombivax Hb (hepatitis B vaccine) on 3/29/2005. The patients concurrent illness include otitis media (has occurred seven times. Reported as persistent) and eczema. Indication for Prevnar was immunization. Product was administered on 3/29/2005. Dose regimen was 1 dose. Concomitant therapy included Recombivax HB Hepatitis b vaccine, Vantin (Cefpodoxime proxetil) and Elidel (Pimecrolimus). During a routine office visit on 3/29/2005, the patient at 9 months of age, received a 4ht dose of Prevnar (inappropriate schedule of drug administration). At this time he was started on prophylactic Vantin (Cefpodoxime proxetil) due to his history of persistent otitis media. The patients mother reported that shortly after this visit the child began to experienced frequent episodes of emesis, became lethargic and had an increased in his sleep pattern (Somnolence). On one occasion he  reportedly had a temperature of 99.3 deg F (Pyrexia) and developed an occasional cough. The patient was seen by his physician on 4/7/2005 for the vomiting and recurrent otitis media. He was treated with intramuscular Rocephin (Ceftriaxone sodium) for three days. On 4/9/2005 the patient was hospitalized for gastroenteritis and his recurrent otitis media. He was treated with intravenous maintenance fluids and Tylenol Paracetamol. The patient subsequently began to tolerate all oral intake. The patient recovered his vital signs were stable and he was discharged to home on 4/13/2005 with a pediatric follow up scheduled for 4/15/2005. Full blood count WBC 6300, hemoglobin 10.9, hematocrit 33.9, platelets 336,000, neutrophils 61 percent, lymphocytes 35 percent, monocytes 4 percent. And metabolic function test results sodium 138, potassium 4.6, chloride 99, bicarbonate 14, blood urea nitrogen 21, creatinine 0.2, glucose 64, were done in Apr 2005. Culture stool results rotavirus antigen: rotavirus detected, was done on 4/10/2005. See related cases HQWYE052008JUL05 (adverse event, non expedited). No additional information was available at the time of this report.
Age: 0.75
Sex: M
Vaccine: PNC, HEP, PNC
Symptoms: Condition aggravated, Cough, Gastroenteritis, Laboratory test abnormal, Lethargy
Clinical narrative: Follow up information has been received upgrading this case from non serious to serious status. Information has been received regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) from a healthcare professional regarding a 9 month old male patient who was hospitalized with gastroenteritis and otitis media. The patient additionally developed a temperature of 99.3 degrees F, occasional cough and exhibited increased sleep. He received his 4 dose of Prevnar of 3/29/2005 at 9 months of age. The patient also received the third dose of Recombivax Hb (hepatitis B vaccine) on 3/29/2005. The patients concurrent illness include otitis media (has occurred seven times. Reported as persistent) and eczema. Indication for Prevnar was immunization. Product was administered on 3/29/2005. Dose regimen was 1 dose. Concomitant therapy included Recombivax HB Hepatitis b vaccine, Vantin (Cefpodoxime proxetil) and Elidel (Pimecrolimus). During a routine office visit on 3/29/2005, the patient at 9 months of age, received a 4ht dose of Prevnar (inappropriate schedule of drug administration). At this time he was started on prophylactic Vantin (Cefpodoxime proxetil) due to his history of persistent otitis media. The patients mother reported that shortly after this visit the child began to experienced frequent episodes of emesis, became lethargic and had an increased in his sleep pattern (Somnolence). On one occasion he  reportedly had a temperature of 99.3 deg F (Pyrexia) and developed an occasional cough. The patient was seen by his physician on 4/7/2005 for the vomiting and recurrent otitis media. He was treated with intramuscular Rocephin (Ceftriaxone sodium) for three days. On 4/9/2005 the patient was hospitalized for gastroenteritis and his recurrent otitis media. He was treated with intravenous maintenance fluids and Tylenol Paracetamol. The patient subsequently began to tolerate all oral intake. The patient recovered his vital signs were stable and he was discharged to home on 4/13/2005 with a pediatric follow up scheduled for 4/15/2005. Full blood count WBC 6300, hemoglobin 10.9, hematocrit 33.9, platelets 336,000, neutrophils 61 percent, lymphocytes 35 percent, monocytes 4 percent. And metabolic function test results sodium 138, potassium 4.6, chloride 99, bicarbonate 14, blood urea nitrogen 21, creatinine 0.2, glucose 64, were done in Apr 2005. Culture stool results rotavirus antigen: rotavirus detected, was done on 4/10/2005. See related cases HQWYE052008JUL05 (adverse event, non expedited). No additional information was available at the time of this report.
Age: 0.75
Sex: M
Vaccine: PNC, HEP, PNC
Symptoms: Medication error, Otitis media, Pyrexia, Somnolence, Vomiting
Clinical narrative: Follow up information has been received upgrading this case from non serious to serious status. Information has been received regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) from a healthcare professional regarding a 9 month old male patient who was hospitalized with gastroenteritis and otitis media. The patient additionally developed a temperature of 99.3 degrees F, occasional cough and exhibited increased sleep. He received his 4 dose of Prevnar of 3/29/2005 at 9 months of age. The patient also received the third dose of Recombivax Hb (hepatitis B vaccine) on 3/29/2005. The patients concurrent illness include otitis media (has occurred seven times. Reported as persistent) and eczema. Indication for Prevnar was immunization. Product was administered on 3/29/2005. Dose regimen was 1 dose. Concomitant therapy included Recombivax HB Hepatitis b vaccine, Vantin (Cefpodoxime proxetil) and Elidel (Pimecrolimus). During a routine office visit on 3/29/2005, the patient at 9 months of age, received a 4ht dose of Prevnar (inappropriate schedule of drug administration). At this time he was started on prophylactic Vantin (Cefpodoxime proxetil) due to his history of persistent otitis media. The patients mother reported that shortly after this visit the child began to experienced frequent episodes of emesis, became lethargic and had an increased in his sleep pattern (Somnolence). On one occasion he  reportedly had a temperature of 99.3 deg F (Pyrexia) and developed an occasional cough. The patient was seen by his physician on 4/7/2005 for the vomiting and recurrent otitis media. He was treated with intramuscular Rocephin (Ceftriaxone sodium) for three days. On 4/9/2005 the patient was hospitalized for gastroenteritis and his recurrent otitis media. He was treated with intravenous maintenance fluids and Tylenol Paracetamol. The patient subsequently began to tolerate all oral intake. The patient recovered his vital signs were stable and he was discharged to home on 4/13/2005 with a pediatric follow up scheduled for 4/15/2005. Full blood count WBC 6300, hemoglobin 10.9, hematocrit 33.9, platelets 336,000, neutrophils 61 percent, lymphocytes 35 percent, monocytes 4 percent. And metabolic function test results sodium 138, potassium 4.6, chloride 99, bicarbonate 14, blood urea nitrogen 21, creatinine 0.2, glucose 64, were done in Apr 2005. Culture stool results rotavirus antigen: rotavirus detected, was done on 4/10/2005. See related cases HQWYE052008JUL05 (adverse event, non expedited). No additional information was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician regarding a 24 month old female patient who received a third dose on an unspecified date and subsequently, developed invasive pneumococcal disease. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. On an unspecified date, the patient received a third dose of Prevnar. In Jun 2005, the patient developed invasive pneumococcal disease (pneumococcal infection) (drug ineffective). A culture was performed (date unspecified) identifying the causative organism as Streptococcus pneumoniae, serotype 19A. The patients outcome is unknown. Culture results streptococcus Pneumonia, serotype 19A was done on an unspecified date. No additional information was available at the time of this report.
Age: 0.75
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Follow up information was received pertaining to patient demographics, medical history and product details including additional vaccines, dates of administration and lot numbers. Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from healthcare professional regarding a male patient who on 4/18/2005, at 9 months of age, received a third dose of Prevnar. The patient also received the third dose of Tripedia (diphtheria tetanus toxoid acellular pertussis vaccine), the third dose of Act Hib Haemophilus B conjugate vaccine (tetanus) and the third dose of Recombivax HB (hepatitis B vaccine) on 4/18/2005. On 5/14/2005, at 9 months of age, he developed pneumococcal bacteremia. The patient has a past history of ventricular septal defect, reported by the child's mother as hole in heart. Indication for Prevnar was immunization. Product was administered on 4/18/2005. Dose regimen was 1 dose 1 time per day. Concomitant medications were reported as none. On 4/18/2005, 9 month old male patient received a third dose Prevnar. On 5/14/2005, the patient developed pneumococcal bacteraemia (drug ineffective, after a blood culture, done in May 2005, was positive for streptococcus pneumoniae. The reporter indicated the child recovered. Blood culture positive for streptococcus pneumoniae was done in May 2005. See related cases HQWYE165812JUN05, HQWYE164812JUL05, HQWYE165012JUL05, HQWYE165112JUL05, AND HQWYE165212JUL05 (adverse event, expedited)
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Meningitis
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 month old male patient who experienced pneumococcal meningitis and drug ineffective. The patient received the second dose at 4 months of age, on an unspecified date in 2005. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on an unspecified date in 2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. The patient developed pneumococcal meningitis, drug ineffective in Nov 2005. The reporter considered the event to be life threatening and required hospitalization. Recovery status is unknown. Blood culture results confirmed pneumococcal meningitis, serotype pending, was done in Nov 2005. No additional information was available at the time of this report.
Age: 5.0
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Oral intake reduced
Clinical narrative: Info regarding Prevnar injection was received from a consumer regarding a 4 year old male pt who received Prevnar without parental knowledge. He reportedly would not eat for 3 days and developed diarrhea. At 4 years of age, the pt received the first dose on 8/12/05. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 8/12/05. Dose regimen was 1 dose, IM. Event Details: A mother reported that on 8/12/05, her son received Prevnar (first dose) without her knowledge (drug administration error). On 8/13/05, he developed diarrhea and would not eat (decreased appetite). She gave the child a "brat diet". The child's BCP was contacted and no further treatment was prescribed. On 8/15/05, all symptoms had abated. No additional info was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Info regarding Prevnar injection was received from a consumer regarding a male pt who experienced redness entire length of leg and swelling entire length of leg. 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 not provided. Concomitant medications were not reported. Event Details: The pt's mother reported that her son developed redness and swelling in his leg (site unspecified) that multiple vaccinations had been given in. No additional info was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a 12 month male pt who experienced injection site swelling measuring 2" by 2" injection site irritation and injection site hives. At 12 months of age, the pt received the fourth dose on 2/21/06. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 2/21/06. Dose regimen was not provided. Concomitant medications were not reported. Event Details: The pt experienced injection site swelling, an area measuring 2" by 2", injection site irritation and injection site hives on 2/21/06. The pt remained in the physician's office for thirty minutes post/vax for observation. No treatment medications were given. The date of recovery was not provided. No additional info was available at the time of this report.
Age: 0.1
Sex: U
Vaccine: PNC
Symptoms: Erythema, Rash macular
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a 2 month old pt who experienced diffused redness from head to toe, cherry red in color and blotchiness on face and scalp. 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. Concomitant medications were not reported. Event Details: The pt experienced diffuse redness from head to toe, cherry red in color two to three minutes after the administration of the Prevnar vaccine. The redness started to fade away within five minutes. However, the baby was still blotchy on face and scalp (rash Macular) for an unknown period of time. No additional info was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Neurodevelopmental disorder
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a male pt who received a dose of Prevnar on an unspecified date and experienced developmental issues. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. Event Details: The pt received a dose of Prevnar on an unspecified date and experienced "developmental issues" (developmental delay). The pt's recovery status is unknown. No additional info was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a 24 month old female pt who experienced a large red and warm and swollen area at the injection site. The pt received the third dose on 8/2/05. The patient previously experienced no reaction on previous exposure to Prevnar on 12/8/02 and 2/24/04. Indication for Prevnar was immunization. Product was administered on 8/2/05. Dose regimen was 1 dose, IM. Concomitant medications were not reported. Event Details: The pt experienced a large red (injection site erythema), warm and swollen area at the injection site on 8/4/05. Site of administration was not provided. Outcome was unknown. No additional info was available at the time of this report.
Age: 0.62
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a 7 month old male pt who experienced a fever of 100.1 F, rectally, and a large red, swollen and warm area at the injection site. The pt received the second dose on 8/2/05. The pt previously experienced no reaction on Prevnar exposure to Prevnar on 4/29/05. Indication for Prevnar was immunization. Product was administered on 8/2/05. Dose regimen was 1 dose, IM. Concomitant medications were not reported. Event Details: The pt experienced a fever of 100.1 F, rectally and a large red, swollen and warm area at the injection site on 8/4/05. The site of administration was not provided. Outcome was unknown. No additional info was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Drug ineffective
Clinical narrative: Info regarding Prevnar injection was received from a healthcare professional regarding a pt, now 2 years old, who received four doses of Prevnar and experienced "low or no titer levels for Prevnar". 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. Event Details: The pt received four doses of Prevnar and subsequently experienced "low or no titer levels for Prevnar (antibody test abnormal). No additional info was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Arthralgia, Influenza, Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Info regarding Prevnar injection was received from a 36 year old male healthcare professional who experienced flu-like syndrome after Prevnar was accidentally splashed on his face. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in 9/05. Dose regimen was 0.5cc. Pt was not taking concomitant therapy. Event Details: On 9/26/05 or 9/27/05, the physician inadvertently splashed the contents of a syringe of Prevnar on his face (accidental exposure). On 9/28/05, he developed a flu-like syndrome described as muscle and joint aches, low-grade fever, and a sore throat. Treatment included Aleve (naproxen sodium) and the fever had decreased. Outcome is unknown. No additional info was available at the time of this report.