chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Chest discomfort, Chest pain
Clinical narrative: Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Injection site pain, Myopericarditis, Troponin I increased
Clinical narrative: Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Anion gap increased, Axillary pain, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase MB increased
Clinical narrative: Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Blood glucose normal, Blood osmolarity decreased, Blood potassium decreased
Clinical narrative: Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Chest discomfort
Clinical narrative: Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram abnormal, Injection site pain, Myopericarditis, Troponin I increased
Clinical narrative: Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy
Clinical narrative: supraclavicular lymphadenopathy on same shot was given for gardasil #1 and #2
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: supraclavicular lymphadenopathy on same shot was given for gardasil #1 and #2
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood test normal, Computerised tomogram normal, Depression, Diarrhoea
Clinical narrative: UTI like symptoms, frequent urination, burning on urination beginning 11 days after initial dose, continuing sporadically to present time, 9 months later. Treated twice with Macrobid, once with Augmentin. Also treated in March 09 for yeast infection. Persistant headache, vertigo, blurry vision incapacitating, beginning two months after second dose and continuing for another two months. During these months also experienced anxiety/panic attacks/depression, diarrhea, vomiting. Blood and urine tests all normal. MRI and CT scan revealed nothing. Pap test revealed abnormal cells at the moderate level. All symptoms were beginning to improve when the last dose was given because no one had yet connected the dots....Then exactly two months after the last dose all symptoms returned in full. Headache, blurry vision, vertigo, frequent and burning urination. Patient is now 3 months from the last dose of gardasil and is now starting to feel less bad!
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dysuria, Fungal infection, Headache, Micturition urgency, Nuclear magnetic resonance imaging normal
Clinical narrative: UTI like symptoms, frequent urination, burning on urination beginning 11 days after initial dose, continuing sporadically to present time, 9 months later. Treated twice with Macrobid, once with Augmentin. Also treated in March 09 for yeast infection. Persistant headache, vertigo, blurry vision incapacitating, beginning two months after second dose and continuing for another two months. During these months also experienced anxiety/panic attacks/depression, diarrhea, vomiting. Blood and urine tests all normal. MRI and CT scan revealed nothing. Pap test revealed abnormal cells at the moderate level. All symptoms were beginning to improve when the last dose was given because no one had yet connected the dots....Then exactly two months after the last dose all symptoms returned in full. Headache, blurry vision, vertigo, frequent and burning urination. Patient is now 3 months from the last dose of gardasil and is now starting to feel less bad!
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Panic attack, Pollakiuria, Smear cervix abnormal, Urinary tract infection, Urine analysis normal
Clinical narrative: UTI like symptoms, frequent urination, burning on urination beginning 11 days after initial dose, continuing sporadically to present time, 9 months later. Treated twice with Macrobid, once with Augmentin. Also treated in March 09 for yeast infection. Persistant headache, vertigo, blurry vision incapacitating, beginning two months after second dose and continuing for another two months. During these months also experienced anxiety/panic attacks/depression, diarrhea, vomiting. Blood and urine tests all normal. MRI and CT scan revealed nothing. Pap test revealed abnormal cells at the moderate level. All symptoms were beginning to improve when the last dose was given because no one had yet connected the dots....Then exactly two months after the last dose all symptoms returned in full. Headache, blurry vision, vertigo, frequent and burning urination. Patient is now 3 months from the last dose of gardasil and is now starting to feel less bad!
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vertigo, Vision blurred, Vomiting
Clinical narrative: UTI like symptoms, frequent urination, burning on urination beginning 11 days after initial dose, continuing sporadically to present time, 9 months later. Treated twice with Macrobid, once with Augmentin. Also treated in March 09 for yeast infection. Persistant headache, vertigo, blurry vision incapacitating, beginning two months after second dose and continuing for another two months. During these months also experienced anxiety/panic attacks/depression, diarrhea, vomiting. Blood and urine tests all normal. MRI and CT scan revealed nothing. Pap test revealed abnormal cells at the moderate level. All symptoms were beginning to improve when the last dose was given because no one had yet connected the dots....Then exactly two months after the last dose all symptoms returned in full. Headache, blurry vision, vertigo, frequent and burning urination. Patient is now 3 months from the last dose of gardasil and is now starting to feel less bad!
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Depression, Vaccine positive rechallenge
Clinical narrative: HPV #1, 8/18/08; HPV #2, 10/20/08; HPV #3, 3/3/09. Hospitalized within 2 weeks of each vaccine for severe depression exacerbation.  3/23/09 Received PCP vaccine records & medical records of 8/18/08-3/17/2009. FINAL DX: OCD, depression, suicidal ideation Records reveal patient experienced good health on 8/18/08 when received HPV #1.  RTC 10/20 s/p hospitalization x 2 wks for depression & was continued psych meds & care.  Had nasal congestion, HA & sleep disturbance x 3-4 days.  No dx provided & received HPV #2.  RTC 3/3/09 w/rhinitis, cough, fever x 4 days.  Dx w/viral URI & received HPV #3.  3/26/09 Received multiple ER medical records:  9/5/2008 ER visit FINAL DX: Depression w/suicidal ideation Records reveal patient having SI.  Meds given for UTI.  Psych eval in ER & transfer to psych hospital.  11/8/2008 ER visit FINAL DX: Depression w/suicidal ideation Records reveal patient w/SI x 1-2 wks.  Psych eval in ER & transferred to psych hospital.  3/10/2009 ER visit FINAL DX:Depression w/suicidal ideation Records reveal patient w/SI intermittently since 11/08, on multiple psych meds & seeing psychiatrist 2x/wk & was in outpatient program.  Had dx at psych hospital recently of depression, OCD & anxiety disorder.  Had 30# wt gain w/increased appetite.  Parental divorce in process.  Psych eval in ER & transferred to psych hospital.  3/16/2009 ER visit FINAL DX: Depression w/suicidal ideation Records reveal patient w/SI & plan for self harm, racing thoughts, insomnia.  Psych eval in ER & transferred to psych hospital.  4/6/09 Received D/C summaries for 3 admissions: 9/6-9/17/2008 Final dx: OCD; major depressive disorder, recurrent. Records reveal s/s had been progressing since summer w/suicidal ideation, anxiety, panic attacks, OCD repetitive behaviors.  Initial psych hospitalization.  Parents had separated 1 yr prior & had multiple family/friend losses.  Required constant attention while hospitalized due to anxiety.  Tx w/multiple meds as well as psychotherapy.  Slowly improved & d/c to home on continued meds & w/outpatient therapy.  11/9-11/16/2008 Final dx: major depressive disorder, recurrent; OCD. Records reveal patient had initially done well s/p hospitalization 9/08 then gradually began to have recurrent s/s that increased severely 4 days prior to admit w/suicidal ideation.  Had been seeing therapist weekly & was on meds.  Meds adjusted & changed.  Improved & d/c to home on continued meds & therapy.  3/11-3/14/2009 Final dx: major depressive disorder, recurrent; OCD; panic disorder w/agoraphobia. Records reveal patient had attended partial hospital program for couple of mo & had done OK but depression, anxiety & SI returned.  Having academic & social difficulties.  Gained 35#.  Meds adjusted.  Slowly improved & d/c to home w/continued meds & therapy.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Auricular swelling, Erythema, Rash papular, Rash vesicular
Clinical narrative: Red, papular, vesicular, asymptomatic chin, upper/lower extremities left ear very red, swollen 2/7/09
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left & right thigh swollen, red, pain.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash rubelliform
Clinical narrative: Fever started 03/16/09 and developed generalized rubelliform rash- continues to today though now defervesced.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient was given MMR vaccine on 3/16/09. Route IM the right lower thigh, Mom noticed reaction next day. Swollen. Warm to touch. Large ring around the injection site. Tx, cold compress. TYLENOL for pain.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Child started with redness to right thigh at around 10am 3/18/09.  Redness worse & area getting swollen leg looks more swollen.  Child seen at 8am on 3/19/09.  Mom also took child to ER 3/18/09 at 1800.  Pt treated with BENADRYL & CEPHALEXIN by Dr.
Age: 17.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: "Blacked out" for a few seconds then felt dizzy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth to deltoid site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site warmth
Clinical narrative: Immus given 03-16-09.  Called by mom about red hot areas on arm.  Came in for eval.  No resp. problems.  Relaxed and reading book.  R arm (deltoid) red and hot to touch.  Area is 11cc. L arm (deltoid) red & hot.  2.5cm area.  Small bumps at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Patient with local reaction, left upper thigh. Warmth and redness about 10x6 inches.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Left thigh 8x10cm red oval. mild edema and tender to exam.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Herpes zoster
Clinical narrative: For the past 15 yrs, pt has had single spot zoster breakouts on her gluteal area approx every year. She received ZOSTAVAX 11-7-08. Since that time, breakout frequency has increased to every week. A spot will develop, last approx 7 days, heal then another spot appears in close proximity soon after. She experiences a severe burning pain with each outbreak, all with the same intensity. She admits to many stressors in her life during this time frame also.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives developed on entire torso 7 hrs after MMR #1 given-
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Irritability, Pyrexia, Rash macular, Rash papular, Rhinorrhoea
Clinical narrative: Head to toe macular papular rash. Purplish face coloring, fussiness, fever, runny nose and swollen face.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Skin discolouration, Swelling face
Clinical narrative: Head to toe macular papular rash. Purplish face coloring, fussiness, fever, runny nose and swollen face.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: 2 cm in diameter erythematous lesion on the (R) upper arm.  Site of varicella shot 24 hrs after injection.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox 3/18/09 after 2 vaccinations for VARIVAX 9/26/05 12/9/08.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Injection site reaction, Pyrexia, Vomiting
Clinical narrative: 3/14/09- Experienced diarrhea, vomiting and fever (102.0) for 24 hrs. Had same reaction to Hep B # 1 of 3 on 11/17/2008.
Sex: U
Vaccine: RV5, RV5
Symptoms: Adenosine deaminase deficiency, Adenovirus infection, Dehydration, Diarrhoea, Failure to thrive
Clinical narrative: Information has been received from the author of a literature article, titled stated above, that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). One patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (IL2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the presence of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ. Administration of rotavirus vaccines resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as can occur with other live viral vaccines, in severely immunocompromised hosts. Screening for immunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with the ROTATEQ vaccine (WAES#0903USA02190). No further information was provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Giardiasis, Rotavirus infection, Stool analysis abnormal
Clinical narrative: Information has been received from the author of a literature article, titled stated above, that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). One patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (IL2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the presence of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ. Administration of rotavirus vaccines resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as can occur with other live viral vaccines, in severely immunocompromised hosts. Screening for immunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with the ROTATEQ vaccine (WAES#0903USA02190). No further information was provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Adenovirus infection, Dehydration, Diarrhoea, Failure to thrive, Giardiasis
Clinical narrative: Information has been received from the author of a literature article, titled stated above, that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). One patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (IL2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the presence of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ. Administration of rotavirus vaccines resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as can occur with other live viral vaccines, in severely immunocompromised hosts. Screening for immunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with the ROTATEQ vaccine (WAES#0903USA02190). No further information was provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Rotavirus infection, Stool analysis abnormal
Clinical narrative: Information has been received from the author of a literature article, titled stated above, that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). One patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (IL2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the presence of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ. Administration of rotavirus vaccines resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as can occur with other live viral vaccines, in severely immunocompromised hosts. Screening for immunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with the ROTATEQ vaccine (WAES#0903USA02190). No further information was provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Adenosine deaminase deficiency, Adenovirus infection, Dehydration, Diarrhoea, Failure to thrive
Clinical narrative: Information has been received from the author of a literature article that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). The patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (1L2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the pressure of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ sequences. Administration of ROTATEQ resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as occur with other live viral vaccines, in severely immunocompromised hosts. Screening for imniunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with ROTATEQ (WAES #0903USA02889). No further information was provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Giardiasis, Rotavirus infection, Stool analysis abnormal
Clinical narrative: Information has been received from the author of a literature article that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). The patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (1L2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the pressure of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ sequences. Administration of ROTATEQ resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as occur with other live viral vaccines, in severely immunocompromised hosts. Screening for imniunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with ROTATEQ (WAES #0903USA02889). No further information was provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Adenovirus infection, Dehydration, Diarrhoea, Failure to thrive, Giardiasis
Clinical narrative: Information has been received from the author of a literature article that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). The patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (1L2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the pressure of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ sequences. Administration of ROTATEQ resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as occur with other live viral vaccines, in severely immunocompromised hosts. Screening for imniunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with ROTATEQ (WAES #0903USA02889). No further information was provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Rotavirus infection, Stool analysis abnormal
Clinical narrative: Information has been received from the author of a literature article that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodeficiency (SCID). The patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (1L2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the pressure of genes 6 and 10, both of bovine rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ sequences. Administration of ROTATEQ resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with ROTATEQ, as occur with other live viral vaccines, in severely immunocompromised hosts. Screening for imniunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of another infant who had a similar experience after therapy with ROTATEQ (WAES #0903USA02889). No further information was provided.
Age: 38.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Computerised tomogram normal, Facial palsy
Clinical narrative: This serious case was received on 16 March 2009 from a physician. A 38 year old female with a history of hyperlipidemia, panic disorder, and anxiety disorder received ADACEL and MENACTRA (lot numbers not provided) on 27 February 2009. On 13 March 2009 (also reported as 17 March 2009) the patient complained of a tingling sensation of the tongue which progressed to entire left sided facial weakness. The patient went to the emergency room. A CT scan (Computed tomography) of the head was negative. The patient was treated with PREDNISONE and ACYCLOVIR. The patient was evaluated by a physician and was diagnosed with Bell's Palsy. The patient has not had any improvement and was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 38.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Computerised tomogram normal, Facial palsy, Facial paresis, Paraesthesia oral
Clinical narrative: This serious case was received on 16 March 2009 from a physician. A 38 year old female with a history of hyperlipidemia, panic disorder, and anxiety disorder received ADACEL and MENACTRA (lot numbers not provided) on 27 February 2009. On 13 March 2009 (also reported as 17 March 2009) the patient complained of a tingling sensation of the tongue which progressed to entire left sided facial weakness. The patient went to the emergency room. A CT scan (Computed tomography) of the head was negative. The patient was treated with PREDNISONE and ACYCLOVIR. The patient was evaluated by a physician and was diagnosed with Bell's Palsy. The patient has not had any improvement and was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site irritation, Injection site pain, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a manager concerning a 46 year old female hospital employee with allergy to LIPITOR, diabetes, hypertension, hyperlipidaemia, obesity and hypothyroidism who on 12-FEB-2009 was vaccinated with PNEUMOVAX IM into deltoid (lot # 662599/1076X at 0945.  There was no illness at time of vaccination.  On 12-FEB-2009 the patient experienced severe edema, redness, hot extended entire length of arm, severe burning and pain at site and "arm swelled 2 * normal size".  The patient was treated in office with KEFLEX and BENADRYL.  Subsequently, the patient recovered from the events.  The reporter considered the events as an other important medical event.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, High risk pregnancy, Pre-eclampsia
Clinical narrative: Initial information has been received through the Merck Pregnancy Registry from a medical assistant concerning a 19 year old female with asthma who on 22-OCT-2007 was vaccinated intramuscularly with the 0.5 ml first dose of GARDASIL and on 26-FEB-2008 was vaccinated intramuscularly with the 0.5 ml second dose of GARDASIL. On 19-JUN-2008 the patient was vaccinated intramuscularly with the 0.5 ml third dose of GARDASIL and she was pregnant at that time. The date of her last menstrual period was 28-APR-2008 and her estimated delivery date is 02-FEB-2009. No adverse events reported. The patient's outcome was unknown. The patient called the physician's office. Follow-up information has been received from a physician concerning a 19 year old female with moderate persistent asthma (better past couple of years) and allergies and a history of hospitalization due to her asthma prior to 1996. There was no history of pregnancy. It was reported that the patient received a prior dose of GARDASIL on 28-FEB-2007. Concomitant therapy included fluticasone nasal spray (during allergy season), montelukast sodium (MSD) and QVAR (since before pregnancy). On approximately 26-AUG-2008, during pregnancy, the patient experienced sinus infection. AUGMENTIN and amoxicillin were prescribed. The patient also used other medications for asthma including prednisone and ADVAIR. Ultrasounds were done in 4 times due to the patient was in high risk. All the results were normal. On 22-FEB-2009 the patient delivered a normal, healthy female baby weighing 7 pounds 2 ounces. The baby's length was 19.25 inches and head circumference was 13 inches with Apgar score 8/9. There were no congenital anomalies and other complications/abnormalities. On approximately 22-FEB-2009, during labor, the patient experienced pre-eclampsia and uterine infection. The patient underwent c-section and had meconium birth. The patient's outcomes were unknown. Upon internal review, c-section was determined to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Sinusitis, Ultrasound scan normal, Uterine infection
Clinical narrative: Initial information has been received through the Merck Pregnancy Registry from a medical assistant concerning a 19 year old female with asthma who on 22-OCT-2007 was vaccinated intramuscularly with the 0.5 ml first dose of GARDASIL and on 26-FEB-2008 was vaccinated intramuscularly with the 0.5 ml second dose of GARDASIL. On 19-JUN-2008 the patient was vaccinated intramuscularly with the 0.5 ml third dose of GARDASIL and she was pregnant at that time. The date of her last menstrual period was 28-APR-2008 and her estimated delivery date is 02-FEB-2009. No adverse events reported. The patient's outcome was unknown. The patient called the physician's office. Follow-up information has been received from a physician concerning a 19 year old female with moderate persistent asthma (better past couple of years) and allergies and a history of hospitalization due to her asthma prior to 1996. There was no history of pregnancy. It was reported that the patient received a prior dose of GARDASIL on 28-FEB-2007. Concomitant therapy included fluticasone nasal spray (during allergy season), montelukast sodium (MSD) and QVAR (since before pregnancy). On approximately 26-AUG-2008, during pregnancy, the patient experienced sinus infection. AUGMENTIN and amoxicillin were prescribed. The patient also used other medications for asthma including prednisone and ADVAIR. Ultrasounds were done in 4 times due to the patient was in high risk. All the results were normal. On 22-FEB-2009 the patient delivered a normal, healthy female baby weighing 7 pounds 2 ounces. The baby's length was 19.25 inches and head circumference was 13 inches with Apgar score 8/9. There were no congenital anomalies and other complications/abnormalities. On approximately 22-FEB-2009, during labor, the patient experienced pre-eclampsia and uterine infection. The patient underwent c-section and had meconium birth. The patient's outcomes were unknown. Upon internal review, c-section was determined to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Repetitive speech, Social avoidant behaviour
Clinical narrative: Information has been received from a consumer reported that "her former student's sibling was diagnosed with autism after receiving MMR II the patient was withdrawn, did not want to be cuddled, several behavioral problems and perseverating. The patient was in a special needs school". No further adverse event information provided. The patient sought unspecified medical attention. Upon internal review, the patient's autism was considered an other important medical event. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant for the pregnancy registry for GARDASIL concerning a 22 year old female who on 21-SEP-2007 was vaccinated intramuscularly with the first dose of GARDASIL (658490/0802U). Subsequently, the patient discovered that she was pregnant (LMP=10-AUG-2007). The patient returned to the physician's office on 05-DEC-2007 because her cycle was late and the office performed a pregnancy test that was positive. During the 05-DEC-2007 office visit, the patient was asked to have an ultrasound obtained. The patient was seen in the office again on 26-DEC-2007 and had not yet had the ultrasound completed. The scheduled date for the ultrasound was unknown. Per the reporter, the pregnancy has been unremarkable thus far. No additional information was available. Patient outcome was not reported. Follow up information received on 13-MAR-2009 from an initial and an outcome pregnancy questionnaire stated that the patient had no concurrent medical conditions reported. Medication used during the pregnancy includes ZOFRAN in January 2008 through February for the treatment of nausea. The patient was also taken prenatal vitamins. There were not birth defects and infant complications in previous pregnancies, the patient had a previous full term delivery and no fetal deaths, spontaneous abortions and pre term deliveries. The patient had an elective pregnancy termination in May 2007 at 7 weeks from LMP. The products of the conception were examined. The patient did not experience infections or illness during pregnancy. The patient had an ultrasound and a serum alpha-fetoprotein test (MSAFP), both were normal. Upon internal review, elective termination was determined to be an other important medical event. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant for the pregnancy registry for GARDASIL concerning a 22 year old female who on 21-SEP-2007 was vaccinated intramuscularly with the first dose of GARDASIL (658490/0802U). Subsequently, the patient discovered that she was pregnant (LMP=10-AUG-2007). The patient returned to the physician's office on 05-DEC-2007 because her cycle was late and the office performed a pregnancy test that was positive. During the 05-DEC-2007 office visit, the patient was asked to have an ultrasound obtained. The patient was seen in the office again on 26-DEC-2007 and had not yet had the ultrasound completed. The scheduled date for the ultrasound was unknown. Per the reporter, the pregnancy has been unremarkable thus far. No additional information was available. Patient outcome was not reported. Follow up information received on 13-MAR-2009 from an initial and an outcome pregnancy questionnaire stated that the patient had no concurrent medical conditions reported. Medication used during the pregnancy includes ZOFRAN in January 2008 through February for the treatment of nausea. The patient was also taken prenatal vitamins. There were not birth defects and infant complications in previous pregnancies, the patient had a previous full term delivery and no fetal deaths, spontaneous abortions and pre term deliveries. The patient had an elective pregnancy termination in May 2007 at 7 weeks from LMP. The products of the conception were examined. The patient did not experience infections or illness during pregnancy. The patient had an ultrasound and a serum alpha-fetoprotein test (MSAFP), both were normal. Upon internal review, elective termination was determined to be an other important medical event. No further information is available.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her 4 year old granddaughter who on an unspecified date was vaccinated with a dose of MMR II. In approximately September 2008, the patient was diagnosed with autism. The consumer did mention that her granddaughter received vaccines, but did not blame any specific vaccine. It was unspecified if the patient sought medical attention. As of 16-MAR-2009, the patient had not recovered from the event. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Autism, Ear haemorrhage, Encephalopathy, Opisthotonus, Screaming
Clinical narrative: Information has been received from a consumer concerning her approximately 26 month old daughter who in April 2000, was vaccinated with a dose of MMR II (lot not reported). A week after received MMR II and other vaccines which were unspecified, the patient started to arch her back, high pitched screaming and had dry blood coming out of her ears. The screaming stopped and the patient just started to pick fuzz out of the carpet and did not look up. The patient was the diagnosed with encephalopathy and autism. The consumer reported that the patient had improved some because she now makes eye contact, smiles and responds using single words. The consumer reported no laboratory diagnostic studies were performed. Upon internal review, encephalopathy and autism were considered to be an other Important Medical Event. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Aphasia
Clinical narrative: Information has been received from a consumer concerning her friend's son who on an unspecified date was vaccinated with a dose of MMR II.  It was reported that the patient became non verbal.  At the time of this report, the outcome was unknown.  It was not specified if the patient sought medical attention or not.  Upon internal review, non verbal was considered to be other important medical event.  This is one of several reports received from the same source.  No further information is available.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Autism, Malaise, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 16 month old son with no pertinent medical history and no allergies reported, who in approximately September 2005, was vaccinated with a 0.5mL dose of MMR II (route and lot number not provided). There was no concomitant medication. Two days after being administered with the vaccine (approximately September 2005), the patient experienced fever and became very sick. The patient's mother reported that her son then became autistic. The patient's status was listed as not recovered. No lab tests were performed. The patient sought unspecified medical attention. Upon internal review, patient became autistic was determined to be an other important medical event. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her grandson who on an unknown date was vaccinated with MMR II. It was reported that after having gotten MMR II vaccine when the patient was between 18 months to 2 years old, he developed autism. The patient's outcome was not reported. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.