chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Shoulder pain
Clinical narrative: Information  has been received from a nurse practitioner concerning a 73 year old male with dyslipidaemia and a history of coronary artery disease, cardiac pacemaker insertion, hiatus hernia, right nephrectomy and renal cancer who on 21-Nov-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651357/0391F), IM. Concomitant therapy included simvastatin, aspirin, digoxin, triamterene and desmopressin (DDAVF). On 21-Nov-2006, the patient developed pain in his right shoulder which radiated down his arm about 1-2 hours after vaccination with pneumococcal 23v polysaccharide vaccine. The pain progressed resulting in an inability to move his shoulder. The patient went to the emergency room (ER) ON 26-Nov-2006 and was admitted to the hospital the same day. The patient had orthoscopic surgery on his right shoulder to clean mucopurlent drainage from the shoulder joint. The patient received IV Vancomycin while in the hospital. The patient was discharged on 24-Nov-2006. The patient received daily antibiotics for one month. Pain in his right shoulder which radiated down his arm and inability to move shoulder were considered to be disabling, other important medical event and life threatening (OMIC). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Hyperlipidaemia, Hypertension, Injection site hypersensitivity, Injection site pain, Osteoporosis
Clinical narrative: Information has been received from a physician concerning a 75 year old female who on 31-Oct-2006 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot#651357/0391F), IM left arm. Concomitant therapy included simvastatin, alendronate sodium, ezetimibe (+) simvastatin, HCTZ/triamterence (MAXZIDE), lisinopril and ergocalciferol (DRISOL). The patient was initially vaccinated with pneumococcal 23v polysaccharide vaccine 9 years ago (in approximately 1997). On 31-Oct-2006, the patient experienced large painful local reaction with pruritis that extending from her deltoid to hand and forearm almost circumferential. Later in the evening while talking on the phone to one of her children (also reported as talking to her physician's office) she fainted. The patient was brought to the emergency room and was admitted for overnight observation. While hospitalized the patient was diagnosed with hypertension, hyperlipidemia and osteoporosis. The physician reported that there was no evidence for an acute myocardial event. The reaction appeared to be severe and local with no systemic effects. The syncopal episode was thought to be on a vagal basis due to the pain. The patient was stable the following morning and the reaction appeared to no longer be progressing. On 01-Nov-2006, the patient was discharged in improved condition (also reported as recovered) for close office follow-up. The patient was instructed to use cool compresses to the right arm 20 minutes on, 20 minutes off as often as possible. The event were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Syncope, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 75 year old female who on 31-Oct-2006 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot#651357/0391F), IM left arm. Concomitant therapy included simvastatin, alendronate sodium, ezetimibe (+) simvastatin, HCTZ/triamterence (MAXZIDE), lisinopril and ergocalciferol (DRISOL). The patient was initially vaccinated with pneumococcal 23v polysaccharide vaccine 9 years ago (in approximately 1997). On 31-Oct-2006, the patient experienced large painful local reaction with pruritis that extending from her deltoid to hand and forearm almost circumferential. Later in the evening while talking on the phone to one of her children (also reported as talking to her physician's office) she fainted. The patient was brought to the emergency room and was admitted for overnight observation. While hospitalized the patient was diagnosed with hypertension, hyperlipidemia and osteoporosis. The physician reported that there was no evidence for an acute myocardial event. The reaction appeared to be severe and local with no systemic effects. The syncopal episode was thought to be on a vagal basis due to the pain. The patient was stable the following morning and the reaction appeared to no longer be progressing. On 01-Nov-2006, the patient was discharged in improved condition (also reported as recovered) for close office follow-up. The patient was instructed to use cool compresses to the right arm 20 minutes on, 20 minutes off as often as possible. The event were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective, Haemoptysis, Injection site oedema, Injection site warmth, Pneumonia
Clinical narrative: Information has been received from a 66 year old female former nurse with BACTRIM allergy and a history of insomnia and taking alternative medicine, who was vaccainted with Pneumococcal 23v polysaccharide vaccine. Concomitant Therapy included melatonin and other meds. She reported that she began to receive Pneumococcal 23v polysaccharide vaccine in the late 1970's and at one time received it 3 years in a row. It was reported that more recently she had been receiving Pneumococcal 23v polysaccharide vaccine every 5 years. In the last 5 years she had pneumonia 3 times and mostly recently 7 weeks ago. When she had pneumonia she had blood in her sputum. When she had pneumonia she started LEVAQUIN. Whenever she received Pneumococcal 23v polysaccharide vaccine she had a severe local reaction with swelling of her arm from shoulder to elbow, heat and a low grade fever. It was also noted that whenever she received a flu shot, she developed pneumonia within 24 hours. At the time of the report the patient was recovering. The patient considered her adverse experienced to be disabling and other medical events (OMIC). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 66 year old female former nurse with BACTRIM allergy and a history of insomnia and taking alternative medicine, who was vaccainted with Pneumococcal 23v polysaccharide vaccine. Concomitant Therapy included melatonin and other meds. She reported that she began to receive Pneumococcal 23v polysaccharide vaccine in the late 1970's and at one time received it 3 years in a row. It was reported that more recently she had been receiving Pneumococcal 23v polysaccharide vaccine every 5 years. In the last 5 years she had pneumonia 3 times and mostly recently 7 weeks ago. When she had pneumonia she had blood in her sputum. When she had pneumonia she started LEVAQUIN. Whenever she received Pneumococcal 23v polysaccharide vaccine she had a severe local reaction with swelling of her arm from shoulder to elbow, heat and a low grade fever. It was also noted that whenever she received a flu shot, she developed pneumonia within 24 hours. At the time of the report the patient was recovering. The patient considered her adverse experienced to be disabling and other medical events (OMIC). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatine phosphokinase increased, Muscular weakness, Muscular weakness, Renal disorder, Renal impairment
Clinical narrative: Information has been received from a physician concerning a 70 year old female with diabetes, hypertension, coronary artery disease who two weeks ago was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, 10 days post dose the patient developed weakness in her lower limbs. She also developed rhabdomyolysis and renal dysfunction. The patient had elevated CPK. The reporter was awaiting the muscle biopsy. At the time of the report, the patient was hospitalized in the intensive care unit. At the time of the report, the patient was considered to be not recovered. The reporter considered the patient's experience to be disabling and other medical event (OMIC). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rhabdomyolysis
Clinical narrative: Information has been received from a physician concerning a 70 year old female with diabetes, hypertension, coronary artery disease who two weeks ago was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, 10 days post dose the patient developed weakness in her lower limbs. She also developed rhabdomyolysis and renal dysfunction. The patient had elevated CPK. The reporter was awaiting the muscle biopsy. At the time of the report, the patient was hospitalized in the intensive care unit. At the time of the report, the patient was considered to be not recovered. The reporter considered the patient's experience to be disabling and other medical event (OMIC). Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Cold sweat, Dehydration, Dizziness, Fatigue
Clinical narrative: Information has been received from a investigator concerning a 71 year old male with an enlarged prostate (April 2005) and an allergy to Sulfonamide who entered a study. On 29 Nov 2006, the patient was vaccinated SC in the deltoid with a 0.65 ml dose of varicella Zoster vaccine. Concomitant vaccination on 15 Nov 2006 included a dose of influenza virus vaccine (unspecified). On 29 Nov 2006, prior to vaccination with study therapy, the patient arose early and went exercising without having breakfast. The patient was then screened and vaccainted with Varicella Zoster vaccine. He was observed for 30 minutes and was released feeling well. The patient went home and had breakfast that consisted of eggs and cinnamon bread. Two hours post vaccination, the patient suddenly felt dizzy and nauseated followed by episodes of vomiting. The patient also experienced the sensation of numbness affection his arms, legs and neck. The patient felt clammy and looked pale to his wife who called the study site and spoke with the investigator and his primary care physician. The patient was taken by ambulance to the emergency room on 29 Nov 2006 for nausea, vomiting and vertigo. he was hospitalized for 24 hours in the emergency room and was discharged on 30 Nov 2006. The discharge diagnosis was rule out myocardial infarction with the additional diagnoses of benign paroxym\smal vertigo, dehydration, possible allergic reaction to varicella zoster vaccine. On 01 Dec 2006, the patient was called post release from the emergency department and he felt well. Again, he skipped breakfast and went to exercise. He arrived home to feel lightheaded and fatigues. He took a nap and felt better. On 04 Dec 2006, the patient was called again for an update. He rested over the weekend without further nausea or vomiting. He stated that he felt about 90 percent. Again, he exercised without breakfast and felt lightheaded. He stated the he has continued to have intermittent feelings of dizziness. The patient considered recovered on 30 Nov 2006. The patient's nausea, vomiting and vertigo was considered to be other important medical events (OMIC). The reporter felt that the patients nausea, vomiting and vertigo was possibly related to vaccination with varicella Zoster vaccine. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Hypoaesthesia, Lung disorder, Lymphopenia, Nausea
Clinical narrative: Information has been received from a investigator concerning a 71 year old male with an enlarged prostate (April 2005) and an allergy to Sulfonamide who entered a study. On 29 Nov 2006, the patient was vaccinated SC in the deltoid with a 0.65 ml dose of varicella Zoster vaccine. Concomitant vaccination on 15 Nov 2006 included a dose of influenza virus vaccine (unspecified). On 29 Nov 2006, prior to vaccination with study therapy, the patient arose early and went exercising without having breakfast. The patient was then screened and vaccainted with Varicella Zoster vaccine. He was observed for 30 minutes and was released feeling well. The patient went home and had breakfast that consisted of eggs and cinnamon bread. Two hours post vaccination, the patient suddenly felt dizzy and nauseated followed by episodes of vomiting. The patient also experienced the sensation of numbness affection his arms, legs and neck. The patient felt clammy and looked pale to his wife who called the study site and spoke with the investigator and his primary care physician. The patient was taken by ambulance to the emergency room on 29 Nov 2006 for nausea, vomiting and vertigo. he was hospitalized for 24 hours in the emergency room and was discharged on 30 Nov 2006. The discharge diagnosis was rule out myocardial infarction with the additional diagnoses of benign paroxym\smal vertigo, dehydration, possible allergic reaction to varicella zoster vaccine. On 01 Dec 2006, the patient was called post release from the emergency department and he felt well. Again, he skipped breakfast and went to exercise. He arrived home to feel lightheaded and fatigues. He took a nap and felt better. On 04 Dec 2006, the patient was called again for an update. He rested over the weekend without further nausea or vomiting. He stated that he felt about 90 percent. Again, he exercised without breakfast and felt lightheaded. He stated the he has continued to have intermittent feelings of dizziness. The patient considered recovered on 30 Nov 2006. The patient's nausea, vomiting and vertigo was considered to be other important medical events (OMIC). The reporter felt that the patients nausea, vomiting and vertigo was possibly related to vaccination with varicella Zoster vaccine. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pallor, Vertigo, Vomiting
Clinical narrative: Information has been received from a investigator concerning a 71 year old male with an enlarged prostate (April 2005) and an allergy to Sulfonamide who entered a study. On 29 Nov 2006, the patient was vaccinated SC in the deltoid with a 0.65 ml dose of varicella Zoster vaccine. Concomitant vaccination on 15 Nov 2006 included a dose of influenza virus vaccine (unspecified). On 29 Nov 2006, prior to vaccination with study therapy, the patient arose early and went exercising without having breakfast. The patient was then screened and vaccainted with Varicella Zoster vaccine. He was observed for 30 minutes and was released feeling well. The patient went home and had breakfast that consisted of eggs and cinnamon bread. Two hours post vaccination, the patient suddenly felt dizzy and nauseated followed by episodes of vomiting. The patient also experienced the sensation of numbness affection his arms, legs and neck. The patient felt clammy and looked pale to his wife who called the study site and spoke with the investigator and his primary care physician. The patient was taken by ambulance to the emergency room on 29 Nov 2006 for nausea, vomiting and vertigo. he was hospitalized for 24 hours in the emergency room and was discharged on 30 Nov 2006. The discharge diagnosis was rule out myocardial infarction with the additional diagnoses of benign paroxym\smal vertigo, dehydration, possible allergic reaction to varicella zoster vaccine. On 01 Dec 2006, the patient was called post release from the emergency department and he felt well. Again, he skipped breakfast and went to exercise. He arrived home to feel lightheaded and fatigues. He took a nap and felt better. On 04 Dec 2006, the patient was called again for an update. He rested over the weekend without further nausea or vomiting. He stated that he felt about 90 percent. Again, he exercised without breakfast and felt lightheaded. He stated the he has continued to have intermittent feelings of dizziness. The patient considered recovered on 30 Nov 2006. The patient's nausea, vomiting and vertigo was considered to be other important medical events (OMIC). The reporter felt that the patients nausea, vomiting and vertigo was possibly related to vaccination with varicella Zoster vaccine. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Diplopia, Vision blurred
Clinical narrative: Information has been received from a health professional concerning a 28 year old female speech language assistant with no illness at the time of the vaccination and a history of cardiac murmur and migraine who on 07 Nov 2006 was vaccinated with first dose of HPV vaccine (lot 653735/0688F) in the right deltoid at approximately 1100 hours. On 08 Nov 2006, the patient called the medical facility and complained of experiencing blurred vision. On 09 Nov 2006, the patient experienced seeing double. The patient was told to go to the emergency room immediately. On 12 Nov 2006, the patient recovered. It was reported that the events required medical/surgical intervention (other important medical Events) (OMIC). No further information is available.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Information has been received from a physician concerning a 56 year old female who on 18 Oct 2006 at 4:15 pm was vaccinated with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 651400/0618F) (0.5ml), intramuscularly in the right deltoid. Concomitant therapy that day and time included a dose of influenza virus vaccine (lot 69898), intramuscularly in the left deltoid. There was no illness at the time of vaccination. Subsequently, a few hours after receiving the injection the patient was complaining of pain. The patient was unable to move her right arm where the injection was given. It was also reported that on 19 Oct 2006 at 8:00 am the patient's right arm extremely sore unable to move, decreased range of motion. Subsequently, the patient recovered. It was noted that the patient had no adverse events following prior vaccination. The reporter considered the patients experience to be disabling. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Purpura, Rash erythematous
Clinical narrative: A 67 year old male patient, with no illness at the time of vaccination, had received a first dose of Fluzone, lot number U2273AA, on 05 October 2006. The following day, the patient developed a full body rash described as pruritic and erythematous. he was treated with Atarax and DepoMedrol. On 11 October 2006, the patient was referred to a dermatologist and was treated with steroids and antibiotics. He was subsequently hospitalized on 13 October 2006 and discharged on 17 October 2006. results of a skin biopsy were pending. The patient recovered from the event.
Age: 1.6
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Eye movement disorder, Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: Seriousness criteria other medically significant (OMIC). initial report received on 07 December 2006 from a health care professional. A 19 month old male patient had received a first dose, left thigh injection of Fluzone, lot number 2191AA, on 01 December 2006. Approximately ten hours later, the patient experienced a fever of 102.6 degrees F, seizure, body shaking, eyes rolled back which lasted for two minutes. He was examined in an emergency room and treated with Rocephin. Additional symptoms included runny nose. Blood cultures obtained in the emergency room were pending. He was re examined the following day by his personal physician to determine if the seizure was due to fever. Information related to this exam was not provided. The patient recovered from the event.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 08 December 2006 from a health care professional. A 46 year old female patient had received an intramuscular injection of Fluzone, lot number U2215AA, on a date between 14 November 2006 and 18 November 2006. There was no illness at the time of vaccination. the reporter was unsure of past medical history, but the patient dose take Singulair and Effexor. on 18 November 2006, the patient was diagnosed with Bell's Palsy. The event required examination by a physician. She was treated with prednisone and Lacrilube. relevant diagnostic testing included CBC, sedimentation rate, and Lyme test. Results were not provided. Recovery status was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial information received on 11 December 2006 from another manufacturer (no reference number provided). The information was originally provided to the other manufacturer by a health care professional. A patient (gender and birth date not reported) received a dose of influenza vaccine 20 years ago. The trade number, manufacturer and lot number were not reported. An unspecified amount of time later, the patient experienced an anaphylactic reaction. Per the reporter, no other information was available at the time of this report. It was not reported whether the patient recovered from the event.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Balance disorder, Coordination abnormal, Dizziness, Vertigo
Clinical narrative: Initial report received on 29 November 2006 from another manufacturer, report number WAES0610USA05056. The initial reporter to this manufacturer had been a health care professional. A 19 year old male patient, with no preexisting medical conditions, had received a first dose, left deltoid, intramuscular injection of Decavac, lot number U1637A, (lot number matches Decavac although the product as reported as Tripedia, on 20 May 2006. On 22 June 2006 he also received a third dose, left deltoid, intramuscular injection of Recombivax HB, lot number 652093/1099R, and a second dose, left triceps, subcutaneous injection of Varivax, lot number 653516/0347F. Sixty eight days post vaccination with Decavac and 35 days after Recombivax Hb and Varivax, the patient experienced dizziness, vertigo and ataxia. The following day his symptoms included dizziness, gait ataxia, and inability to keep balance. Reportedly MRI and spinal tap results were normal. The event required hospitalization of an unknown number of days. Gait ataxia was considered to be disabling. The patient recovered from the events.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 05 December 2006 from a health care professional. A three year old male patient, with no pre existing medical history, had received an intramuscular, left thigh injection of Fluzone, lot number U2239AA, on 03 November 2006. He had previously received four doses of influenza vaccine with no reported adverse effect. Other medications included Claritin as needed. Two weeks post vaccination, the patient developed bruising. Seventeen days later, laboratory testing showed a decreased platelet count of 19,000. The patient was diagnosed with idiopathic thrombocytopenic purpura. At the time of this report, the patient had not recovered. Additional medically relevant information was not provided.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Pt deceased 12/17/2006.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cough, Decreased appetite, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Received immunization 10/12/06 DTaP, HIB, IPV, Pneumococcal.  Seen in office 10/13/06 with extreme fussiness, cough, nasal congestion, decreased oral intake, temp 102.8 rectally.  Mild head lag.  Admitted to hospital.  Nasopharyngeal swab negative.  Inf A/B and RSV, lumbar puncture done.  Blood and urine cultures neg.  Patient also had URI signs/symptoms.  Follow up with immunology for allergy to acellular pertussis.  Hospital MR received for a direct admit for this 4 month old for c/o extreme fussiness, cough, fever, and nasal congestion on the day following vax. PE: Mild head lag noted. Nasal congestion and turbinate hypertrophy with green nasal discharge..  Slightly coarse breath sounds bilaterally.  Otherwise normal. Txd with IV fluids and antibiotics.  Discharge home after 2 days. Discharge Instructions and Disposition: Upper Respiratory Tract symptoms, resolved irritablility, and head lag that was likely due to an immunization reaction. 02/22/2007 MR received from immunology consult in F/u to the head lagging, floppiness, and moaning the infant experienced with fever after his 4 month vax. PE: WNL. Parents report child has fully recovered. Impression:  Floppy baby syndrome which has been seen with the pertussis componant of the immunization.  It is not believed that this is a true allergy to the vaccine.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Upper respiratory tract infection
Clinical narrative: Received immunization 10/12/06 DTaP, HIB, IPV, Pneumococcal.  Seen in office 10/13/06 with extreme fussiness, cough, nasal congestion, decreased oral intake, temp 102.8 rectally.  Mild head lag.  Admitted to hospital.  Nasopharyngeal swab negative.  Inf A/B and RSV, lumbar puncture done.  Blood and urine cultures neg.  Patient also had URI signs/symptoms.  Follow up with immunology for allergy to acellular pertussis.  Hospital MR received for a direct admit for this 4 month old for c/o extreme fussiness, cough, fever, and nasal congestion on the day following vax. PE: Mild head lag noted. Nasal congestion and turbinate hypertrophy with green nasal discharge..  Slightly coarse breath sounds bilaterally.  Otherwise normal. Txd with IV fluids and antibiotics.  Discharge home after 2 days. Discharge Instructions and Disposition: Upper Respiratory Tract symptoms, resolved irritablility, and head lag that was likely due to an immunization reaction. 02/22/2007 MR received from immunology consult in F/u to the head lagging, floppiness, and moaning the infant experienced with fever after his 4 month vax. PE: WNL. Parents report child has fully recovered. Impression:  Floppy baby syndrome which has been seen with the pertussis componant of the immunization.  It is not believed that this is a true allergy to the vaccine.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intestinal obstruction, Intussusception, Laboratory test abnormal, Lethargy, Vomiting
Clinical narrative: Small Bowel Obstruction possibly intussusception 12/11/2006 (approximately 7 week after Rotateq). Report came in with MR attached documenting an almost 4 month old's admission for bilious vomiting and lethargy. PMH previously healthy infant with hx. of hyperbilirubinemia after birth which required phototherapy. Mother noticed infant to be more irritable than usual but with no other symptoms initially.  The following day she noticed yellowish-green emesis and continued vomiting as well as lethargy. 911 was called and an IV was started in the field which caused the child to perk up some. PE was unremarkable with 1 episode of emesis during exam. PE at this time showed voluntary guarding and mild distension.   NG tube was placed and patient did well and was d/c'd home after 2 days.  Working DX is transient intussusception reduced with contrast enema. Addendum: spoke with office RN/reporter who confirmed final dx. is the same as primary dx.: bilious emesis, probable intussusception and that Rotateq was given, lot # 0849F./
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: Small Bowel Obstruction possibly intussusception 12/11/2006 (approximately 7 week after Rotateq). Report came in with MR attached documenting an almost 4 month old's admission for bilious vomiting and lethargy. PMH previously healthy infant with hx. of hyperbilirubinemia after birth which required phototherapy. Mother noticed infant to be more irritable than usual but with no other symptoms initially.  The following day she noticed yellowish-green emesis and continued vomiting as well as lethargy. 911 was called and an IV was started in the field which caused the child to perk up some. PE was unremarkable with 1 episode of emesis during exam. PE at this time showed voluntary guarding and mild distension.   NG tube was placed and patient did well and was d/c'd home after 2 days.  Working DX is transient intussusception reduced with contrast enema. Addendum: spoke with office RN/reporter who confirmed final dx. is the same as primary dx.: bilious emesis, probable intussusception and that Rotateq was given, lot # 0849F./
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Tenderness
Clinical narrative: Right thigh firm, tender with erythema
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Area of redness 5 1/2" x 5 1/2" surrounding injection site for 2 days. Treatment with Augmentin (600/g) for 10 days.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Upper respiratory tract infection
Clinical narrative: Childe has history of asthma and inadvertently received FluMist vaccine on 10/26/06 during a school based immunization. No immediate adverse effects. Child did develop Upper Respiratory symptoms about 11/11/2006. Did not require physician visit or school absence. Treated with Albuterol inhaler.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Inflammation
Clinical narrative: Inflammation of both legs.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Anorexia, Lethargy, Pyrexia, Rash, Skin ulcer
Clinical narrative: Fever, rash, vomiting, infection of blood, lesions of the skin, lethargic, loss of appetite.  3/2/07 Received medical records from hospital which reveal patient experienced croupy barky cough, mild low grade fever & rhinorrhea on day of vax.  Continued w/fever for next 10 days, decreased oral intake.  Itchy lesions started forming on head, then trunk & diaper area approx 2 days prior to hospital admission on 6/20/06 for observation & w/u for sepsis.  Temp in ER was 104.7.  Continued to have nasal congestion & clear discharge.  Exam revealed shotty adenopathy greater in the posterior triangles.  Well scabbed lesions of forehead, neck, thorax & diaper area.  Left thigh injection site had erythema w/vesicle overlying it & a fresh vesicle over dorsum of right foot.  D/C to home on continued antibiotics & f/u w/PCP.  Parents advised patient remains infective until all lesions crusted over. FINAL DX: vaccine induced varicella & possible streptococcus/scarlet fever.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Fever, rash, vomiting, infection of blood, lesions of the skin, lethargic, loss of appetite.  3/2/07 Received medical records from hospital which reveal patient experienced croupy barky cough, mild low grade fever & rhinorrhea on day of vax.  Continued w/fever for next 10 days, decreased oral intake.  Itchy lesions started forming on head, then trunk & diaper area approx 2 days prior to hospital admission on 6/20/06 for observation & w/u for sepsis.  Temp in ER was 104.7.  Continued to have nasal congestion & clear discharge.  Exam revealed shotty adenopathy greater in the posterior triangles.  Well scabbed lesions of forehead, neck, thorax & diaper area.  Left thigh injection site had erythema w/vesicle overlying it & a fresh vesicle over dorsum of right foot.  D/C to home on continued antibiotics & f/u w/PCP.  Parents advised patient remains infective until all lesions crusted over. FINAL DX: vaccine induced varicella & possible streptococcus/scarlet fever.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Chest discomfort, Chest pain, Condition aggravated, Dyspnoea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female with asthma, no allergies and a history of vomiting, fever and abdominal cramps after a flu vaccination each time she was vaccinated. The nurse reported that the patients asthma was under good control for more than six months. She also noted that due to the side effects of the flu vaccination, the patient refused to received any more flu shots. On 31 Oct 2006 the patient was vaccinated intramuscularly with a first dose of HPV vaccine (lot 653938/0954F). concomitant therapy included Advair and albuterol inhaler prn. On 02 Nov 2006 the patient had an asthma attack. She developed chest tightening, wheezing and chest pain. The symptoms began after playing basketball. She used her albuterol inhaler with no relief. She went to the ER and was given albuterol and Advair. An EKG and chest X ray were preformed. The patient was not hospitalized. The nurse felt that this asthma attack was an isolated event. She noted that the patients physician felt that it was probably a coincidence that it was after the HPV vaccination. On 04 Nov 2006 the patient recovered. No product quality complaint was involved. The reporter did not considered this asthma attack to be permanently disabling, but that it was disabling because the patient missed school and the shortness of breath during the attack would be considered disabling. Asthma attack was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female with asthma, no allergies and a history of vomiting, fever and abdominal cramps after a flu vaccination each time she was vaccinated. The nurse reported that the patients asthma was under good control for more than six months. She also noted that due to the side effects of the flu vaccination, the patient refused to received any more flu shots. On 31 Oct 2006 the patient was vaccinated intramuscularly with a first dose of HPV vaccine (lot 653938/0954F). concomitant therapy included Advair and albuterol inhaler prn. On 02 Nov 2006 the patient had an asthma attack. She developed chest tightening, wheezing and chest pain. The symptoms began after playing basketball. She used her albuterol inhaler with no relief. She went to the ER and was given albuterol and Advair. An EKG and chest X ray were preformed. The patient was not hospitalized. The nurse felt that this asthma attack was an isolated event. She noted that the patients physician felt that it was probably a coincidence that it was after the HPV vaccination. On 04 Nov 2006 the patient recovered. No product quality complaint was involved. The reporter did not considered this asthma attack to be permanently disabling, but that it was disabling because the patient missed school and the shortness of breath during the attack would be considered disabling. Asthma attack was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Lymphoedema
Clinical narrative: Chills, sweats, erythema at shot site and lymphedema of entire Right upper arm.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe swelling, redness, pain at injection site accompanied by shaking rigors. (I did not see the patient, he described these symptoms to me on 12/8/06).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Livedo reticularis, Pain
Clinical narrative: Received 1.0ml of flu vaccine. Increased pain and discomfort at injection site more than she usually experiences. She states gets the flu shot every year. Complained of mottling at site. Sore arm for 4 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Received 1.0 flu vaccine IM mild soreness and injection site.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Dose 1.0 ml Fluzone administered IM, denies any adverse reaction.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Received 1.0 ml Flu vaccine. Soreness arm for 2 days took Ibuprofen.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Received 1.0 ml of Flu vaccine. Complain of rather severe pain in arm for 3 days, much more severe than usual took Ibuprofen. Bruise large injection site. Arm ached- resolve after 3 days.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Received 1.0 ml Flu vaccine IM, injection site "sore" for 2 days.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Injection site pain
Clinical narrative: 1.0 ml administered IM, low grade temperature less than 24 hours. She did not measure her temperature, mild muscle soreness at site of injection.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain
Clinical narrative: Received 1.0 ml Flu vaccine IM. Complain of throat felt "scratchy" for 24 hours. Sore arm- more than usual 2-3 days. Headache for 2 days (went to bed used Tylenol).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Pain
Clinical narrative: Received 1.0 ml Flu vaccine IM. Arm - more sore- lasted 4-5 days, low grade temperature for 1 day (took Tylenol) better on 5th day (felt better).
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Received 1.0 ml flu vaccine IM. Complain of soreness at injection site for 2 days and took Ibuprofen.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Received 1.0 ml Flu vaccine IM. Usual soreness at injection site for 2-3 days. No complain of unusual adverse symptoms.
Age: 1.45
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Petechiae, Rash maculo-papular
Clinical narrative: PA-C who was seen child today stating child has maculopapular rash interior, posterior trunk extended to neck and upper extremities. No fever. Petechiae in oropharynx.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Injection site swelling, Paraesthesia, Skin discolouration
Clinical narrative: Immediate swelling and discoloring at the injection site. Swelling continued for about 40 minutes. Entire upper arm from shoulder to elbow swollen. Face and neck flushed bright red. Tingling sensation of arm and fingers. Patient felt light-headed. All symptoms resolved within 90 minutes.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: Phone call from client- Tdap immunization on 09/21/06 states felt "fine" yesterday woke today with mild fever, chills, emesis, headache, body aches, "can't keep my eyes open", redness and sore at site of Tdap injection states spoke with provider told her she had the flu and was unrelated to Tdap immunization.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Phone call from client- Tdap immunization on 09/21/06 states felt "fine" yesterday woke today with mild fever, chills, emesis, headache, body aches, "can't keep my eyes open", redness and sore at site of Tdap injection states spoke with provider told her she had the flu and was unrelated to Tdap immunization.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Appearance of rash noted 9-13-06, located on left knee. Described as "lots of tiny dots clumped together to make large red area:. On 9-14-06, she noticed the rash had spread to bilateral tops of hands and forearms. Also located on stomach and back. Describes as very itchy. Complain of "electric sensation" occasionally along back- "similar to shingles pain". Denies fluid or blisters with rash. Afebrile.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None. Pt had usual side effects after immunization. I called checked with parent for follow up appointment did fine.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: None. Pt should have received .5 ml of Flu vaccine but was given .25 ml by mistake. (Pt turned 3 years old on 12/3/06)
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea, presumed
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Injection site induration
Clinical narrative: Arm red, indurated
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Collapse of lung, Joint swelling, Paralysis, Serum sickness, Tenderness
Clinical narrative: "Paralyzed waist down for 3 days" "Collapsed lung" currently 12/27/06-records received and reviewed from Dr. DX: serum sickness. Multiple joint deformity swelling and tenderness
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Patient awoke the day after vaccination with reddened, swollen, tender, warm injection site. At 42 hours post injection site red, swollen, warm to touch and 6.5x4.5cm in size of reddened area. Treatment: Baby Motrin and if needed Augmentin solution to start tomorrow.
Age: 1.27
Sex: F
Vaccine: DTAPH, FLU3, PNC
Symptoms: Urticaria
Clinical narrative: Urticarial rash (vaccine reaction?)
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Fatigue, Headache, Inflammation, Joint stiffness
Clinical narrative: 11/21 and 11/22-headache, stiff neck, low grade fever; 11/23 felt fatigued, neck and back pain; 11/24 "night sweats"-joints ached, felt warm and knees became swollen. Temp 101.5; 11/26 difficulty walking-went to emergency room. Treated with IV fluid and anti- flammatory med. Discharged with Doxyclyine and Naprocyn; 11/28 went to primary care physician-had urinary tract infection, given Cipro and cortisone shot; 12/1 inflammation decreased and saw a rheumatologist. Blood work drawn.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Urinary tract infection
Clinical narrative: 11/21 and 11/22-headache, stiff neck, low grade fever; 11/23 felt fatigued, neck and back pain; 11/24 "night sweats"-joints ached, felt warm and knees became swollen. Temp 101.5; 11/26 difficulty walking-went to emergency room. Treated with IV fluid and anti- flammatory med. Discharged with Doxyclyine and Naprocyn; 11/28 went to primary care physician-had urinary tract infection, given Cipro and cortisone shot; 12/1 inflammation decreased and saw a rheumatologist. Blood work drawn.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large (6 cm) area red and swollen at injection site.
Age: 12.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: 11/16 p.m. rash noted around injection site - rash pruritic
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient had flu shot on 11/28/2006. On 12/02/2006 developed intermittent tremor on left arm that became constant 12/03/2006 (same arm as vaccinated).
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site pain, Rash
Clinical narrative: Left upper arm turned red, hot to the touch, then the whole body was covered in a non-itchy rash. Child's arm hurt very badly. Took her to hospital and to her doctor, who diagnosed her with cellulitis from the flu shot.
Age: 1.25
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Choking, Convulsion, Pyrexia
Clinical narrative: Temp 100F- possible seizure/ choking while sitting in car seat foaming at mouth-mouth clenched shut.  12/20/06 Received medical records from PCP which included ER records which reveal patient seen in ER for febrile seizure following a week long hx of cough & congestion.  Temp 102.7 in ER.  PCP record on 11/28 day of vax reveals patient was well. Final DX: benign febrile seizure & URI per ER physician.  PCP note stated probable MMR febrile reaction.
Age: 1.33
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever-seizure
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed hives / urticaria on 14-DEC-2006.
Age: 1.26
Sex: M
Vaccine: FLU3, HIBV, PNC
Symptoms: Crying, Difficulty in walking, Pyrexia
Clinical narrative: Fever 102 degrees F, crying, difficulty walking
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 2 month old female who on 30 Oct 2006 was vaccinated PO with the first 2.0mL dose of Rotateq (human bovine) (lot #655296/0979F). Concomitant vaccinations administered on that same day included a dose of Pediarix, a dose of HIBTiter and a dose of Prevnar. The nurse reported that on 31 Oct 2006 the patient developed green, strong odor diarrhea which "smelled liked rotavirus" and a fever between 101 and 102.6F. The patient was noted to have gone to the Emergency Room (ER) twice but was not hospitalized. On 04 Nov 2006, the patient's diarrhea and fever resolved. Additional information has been requested.
Age: 0.44
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 month old female, with no medical history, who on 03 Oct 2006 was vaccinated with one 2ml oral dose of Rotavirus vaccine (lot 655050/0778F). There was no concomitant medication. On 30 Oct 2006 the patient experienced diarrhea. It was reported that it was later determined that she had rotavirus. It was unknown of it was wild type rotavirus or vaccine strain. At the time of the  report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a first and second oral dose of rotavirus vaccine on 24 Jul 2006 and 06 Nov 2006. No adverse events were involved. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old female with on medical history or allergies who on 11 Aug 2006 was vaccainted with a PO first dose of Rotavirus vaccine (lot 654248/0577F). Concomitant vaccination included a dose of Hib vaccine, a dose of Pediarix and a dose of Prevnar. On 11 Aug 2006, two hours after vaccination, the patient developed diarrhea. On 13 Oct 2006 she vomited once. The diarrhea continued to some degree to the present, however the child continued to gain weight. Medical attention was sought. She was negative for rotavirus, shigella, salmonella and Campylobacter coli. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 4-month-old patient who was vaccinated with the first dose of ROTATEQ. Unspecified medical attention was sought and no problems were reported. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4 month old female with no medical history or allergies who the morning of 14 Sep 2006 was vaccinated with a first PO dose of rotavirus vaccine s(lot 653754/0139F). Concomitant vaccination administered that day included a dose of Hib vaccine. A dose of poliovirus vaccine, and a dose of Dtap. There was no illness at the time of vaccination. On 15 Sep 2006 the patient developed severe diarrhea. The diarrhea episodes were every twenty minutes through the night. It was reported that the patient had eleven days of frequent watery non bloody diarrhea without a temperature, vomiting, emergency room or hospital visit. The patient recovered on 26 Sep 2006. Medical attention was sought. No laboratory diagnostic tests were performed. There was no product quality complaint involved.