chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Gastrointestinal disorder, Increased upper airway secretion, Malaise, Respiratory tract congestion, Toothache
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Jan 16, 2007. Female patient, 42 years of age, was vaccinated with FLUMIST on Jan 08, 2007. "On 12 Oct 2006, two days after receiving FLUMIST therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving FLUMIST therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on KETEK and MEDROL DOSE PAK therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FLUMIST therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FLUMIST therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with DILAUDID, hydration therapy and clear liquids. The patient indicated that she received no antibody therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to KETEK therapy. No reporter causality as it related to FLUMIST therapy was provided.". None. Mitral valve repair - 2004. Patient recovered."
Age: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased immune responsiveness, Herpes zoster, Nephrolithiasis
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Oct 23, 2007. Male patient, 34 years of age, was vaccinated with FLUMIST on Oct 23, 2007. "Patient was exposed to civilian employee who was diagnosed with the shingles prior to receiving the FLUMIST. Physician suspects the FLUMIST decreased the patient's immune response enough to have an outbreak of the shingles. He was diagnosed with Herpes Zoster on 21 October 2007. He was treated at a local emergency room, given ZOVIRAX for treatment and placed on quarters for 72 hours."...Nephrolithiasis. Patient recovered."
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Croup infectious, Stridor
Clinical narrative: This is a verbatim narrative as reported on patientsville.com, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 02, 2007. Male patient, child 8 years of age, was vaccinated with FLUMIST on Nov 02, 2007. "Croup began the evening he received the FLUMIST vaccine. 11/09/2007 MR received for DOS 10/31/2007 for D/C DX of Croup. Pt presented to ER with abrupt onset of inspiratory stridor which responded quickly to racemic epinephrine and steroids. Transferred to current facility where pt has not required any additional epi. Discharged on steroid taper. PE (+) respiratory stridor, otherwise WNL. Impression: Croup" . . "has history of ""seasonal asthma"". Patient was hospitalized. Patient recovered."
Age: 30.0
Sex: M
Vaccine: FLUN3
Symptoms: Back pain, Blood creatine phosphokinase increased, Chromaturia, Pain in extremity, Pharyngeal erythema
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported from on Nov 06, 2007. Male patient, 30 years of age, was vaccinated with FLUMIST on Oct 12, 2007. "24 hours after receiving FLUMIST patient noticed dark brown urine. Next day CK level found elevated. Did have afebrile URI symptoms starting 2 days prior to receiving FLUMIST. Received IV fluid therapy for 48 hours after 24 hrs of oral therapy until CK < 5000. No other complications. 11/27/2007 MR received DOS 10/13-16/2007. Pt reported dark brown urine 1 day following FLUMIST vax. Pt had 5 day hx of afebrile URI prior to receiving vaccine. PE (+) for pharyngeal erythema and nasal discharge. Diffuse aches noted in arms and back. DX: Rhabdomyolysis (likely due to viral illness, possibly FLUMIST). TXd with IVF. Normal urine color noted 10/16/2007. Resolution of Lab abnormalities noted on 10/16 as well.". None. NKDA; No meds. PMH: Gastroenteritis. BP elevated. Midback pain. Knee pain. Patellofemoral syndrome L. Esophagitis chronic reflux. Allergic to pollens. Recent URI.. Patient was hospitalized Patient recovered."
Age: 30.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhabdomyolysis, Rhinorrhoea, Viral infection
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported from on Nov 06, 2007. Male patient, 30 years of age, was vaccinated with FLUMIST on Oct 12, 2007. "24 hours after receiving FLUMIST patient noticed dark brown urine. Next day CK level found elevated. Did have afebrile URI symptoms starting 2 days prior to receiving FLUMIST. Received IV fluid therapy for 48 hours after 24 hrs of oral therapy until CK < 5000. No other complications. 11/27/2007 MR received DOS 10/13-16/2007. Pt reported dark brown urine 1 day following FLUMIST vax. Pt had 5 day hx of afebrile URI prior to receiving vaccine. PE (+) for pharyngeal erythema and nasal discharge. Diffuse aches noted in arms and back. DX: Rhabdomyolysis (likely due to viral illness, possibly FLUMIST). TXd with IVF. Normal urine color noted 10/16/2007. Resolution of Lab abnormalities noted on 10/16 as well.". None. NKDA; No meds. PMH: Gastroenteritis. BP elevated. Midback pain. Knee pain. Patellofemoral syndrome L. Esophagitis chronic reflux. Allergic to pollens. Recent URI.. Patient was hospitalized Patient recovered."
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Asthenia, Ear pain, Influenza like illness, Joint swelling
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. FLUMIST problem was reported on Nov 07, 2007. Female patient, 47 years of age, was vaccinated with FLUMIST on Nov 07, 2007. "11/05 - Influenza, live, intranasal vaccine (vaccine record date reflects 8 Nov 05) was administered while performing (weekend duty); 2-3 weeks later (week after Thanksgiving) developed sore throat; slight fever, stuffy head & other flu-like symptoms; 12/05- Sore throat continued, noticeable rash appeared on thighs & small lymph nodes on face; 1/06 - same symptoms continued intermittently, visited ENT at Med Ctr for sore throat, ear pain & advised possible allergy; experienced joint pain in fingers, wrist, slight swelling in right knee & ankle; 02/06 - Emergency Rm visit to Med Ctr for burning rash on body; Mar 06 - Visit to Family Clinic for rash on body; Mid 4/06 - sore throat continued with high fever, body pain & swelling of fingers, wrists, knees, ankles & feet; Hospitalized: 4/17/06 at Med Ctr; Diagnosis - Undetermined, Discharged 5/9/06; Hospitalized: 5/10/06 - Hospital, 2; Diagnosis 5/25/06: adult Onset Still Disease (initially 60 mg of Prednisone, reduced to 3 mg; at present, regular visits have continued w/ treating physician since hospital discharge date - Dr. 11/9/07-records received from patient for hospital stay DCS 5/10-5/26/06-DC DX: Still disease. Temp 102.2. Bilateral axillary lymphadenopathy. Leukocytosis. Generalized body pains, weakness and extensive macular rash especially on tongue and chest." None prior. UNK. Patient was hospitalized Patient recovered.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Leukocytosis, Lymphadenopathy, Nasal congestion, Nodule, Oedema peripheral
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. FLUMIST problem was reported on Nov 07, 2007. Female patient, 47 years of age, was vaccinated with FLUMIST on Nov 07, 2007. "11/05 - Influenza, live, intranasal vaccine (vaccine record date reflects 8 Nov 05) was administered while performing (weekend duty); 2-3 weeks later (week after Thanksgiving) developed sore throat; slight fever, stuffy head & other flu-like symptoms; 12/05- Sore throat continued, noticeable rash appeared on thighs & small lymph nodes on face; 1/06 - same symptoms continued intermittently, visited ENT at Med Ctr for sore throat, ear pain & advised possible allergy; experienced joint pain in fingers, wrist, slight swelling in right knee & ankle; 02/06 - Emergency Rm visit to Med Ctr for burning rash on body; Mar 06 - Visit to Family Clinic for rash on body; Mid 4/06 - sore throat continued with high fever, body pain & swelling of fingers, wrists, knees, ankles & feet; Hospitalized: 4/17/06 at Med Ctr; Diagnosis - Undetermined, Discharged 5/9/06; Hospitalized: 5/10/06 - Hospital, 2; Diagnosis 5/25/06: adult Onset Still Disease (initially 60 mg of Prednisone, reduced to 3 mg; at present, regular visits have continued w/ treating physician since hospital discharge date - Dr. 11/9/07-records received from patient for hospital stay DCS 5/10-5/26/06-DC DX: Still disease. Temp 102.2. Bilateral axillary lymphadenopathy. Leukocytosis. Generalized body pains, weakness and extensive macular rash especially on tongue and chest." None prior. UNK. Patient was hospitalized Patient recovered.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rash, Rash macular
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. FLUMIST problem was reported on Nov 07, 2007. Female patient, 47 years of age, was vaccinated with FLUMIST on Nov 07, 2007. "11/05 - Influenza, live, intranasal vaccine (vaccine record date reflects 8 Nov 05) was administered while performing (weekend duty); 2-3 weeks later (week after Thanksgiving) developed sore throat; slight fever, stuffy head & other flu-like symptoms; 12/05- Sore throat continued, noticeable rash appeared on thighs & small lymph nodes on face; 1/06 - same symptoms continued intermittently, visited ENT at Med Ctr for sore throat, ear pain & advised possible allergy; experienced joint pain in fingers, wrist, slight swelling in right knee & ankle; 02/06 - Emergency Rm visit to Med Ctr for burning rash on body; Mar 06 - Visit to Family Clinic for rash on body; Mid 4/06 - sore throat continued with high fever, body pain & swelling of fingers, wrists, knees, ankles & feet; Hospitalized: 4/17/06 at Med Ctr; Diagnosis - Undetermined, Discharged 5/9/06; Hospitalized: 5/10/06 - Hospital, 2; Diagnosis 5/25/06: adult Onset Still Disease (initially 60 mg of Prednisone, reduced to 3 mg; at present, regular visits have continued w/ treating physician since hospital discharge date - Dr. 11/9/07-records received from patient for hospital stay DCS 5/10-5/26/06-DC DX: Still disease. Temp 102.2. Bilateral axillary lymphadenopathy. Leukocytosis. Generalized body pains, weakness and extensive macular rash especially on tongue and chest." None prior. UNK. Patient was hospitalized Patient recovered.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Skin burning sensation
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. FLUMIST problem was reported on Nov 07, 2007. Female patient, 47 years of age, was vaccinated with FLUMIST on Nov 07, 2007. "11/05 - Influenza, live, intranasal vaccine (vaccine record date reflects 8 Nov 05) was administered while performing (weekend duty); 2-3 weeks later (week after Thanksgiving) developed sore throat; slight fever, stuffy head & other flu-like symptoms; 12/05- Sore throat continued, noticeable rash appeared on thighs & small lymph nodes on face; 1/06 - same symptoms continued intermittently, visited ENT at Med Ctr for sore throat, ear pain & advised possible allergy; experienced joint pain in fingers, wrist, slight swelling in right knee & ankle; 02/06 - Emergency Rm visit to Med Ctr for burning rash on body; Mar 06 - Visit to Family Clinic for rash on body; Mid 4/06 - sore throat continued with high fever, body pain & swelling of fingers, wrists, knees, ankles & feet; Hospitalized: 4/17/06 at Med Ctr; Diagnosis - Undetermined, Discharged 5/9/06; Hospitalized: 5/10/06 - Hospital, 2; Diagnosis 5/25/06: adult Onset Still Disease (initially 60 mg of Prednisone, reduced to 3 mg; at present, regular visits have continued w/ treating physician since hospital discharge date - Dr. 11/9/07-records received from patient for hospital stay DCS 5/10-5/26/06-DC DX: Still disease. Temp 102.2. Bilateral axillary lymphadenopathy. Leukocytosis. Generalized body pains, weakness and extensive macular rash especially on tongue and chest." None prior. UNK. Patient was hospitalized Patient recovered.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Anxiety disorder, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 20, 2007. Female patient, 45 years of age, was vaccinated with FLUMIST on Nov 20, 2007. "Fatigue, Anxiety, and numbness/tingling of lower extremities. Patient transferred to hospital. Epinephrine and BENADRYL given prior to transport.". None. Anxiety disorder.. Patient recovered."
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Lobar pneumonia, Pneumonitis, Pyrexia
Clinical narrative: This is a verbatim narrative as reported on a website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 20, 2007. Male patient, child 5 years of age, was vaccinated with FLUMIST on Nov 20, 2007. "24 hours after patient received FLUMIST, he developed a cough. The next day he developed fever, which persisted for 4 days. He was seen in the ER at Hospital on 19 November, 5 days after the immunization, and diagnosed with pneumonitis and RLL pneumonia. Treated with albuterol, ZITHROMAX and prednisolone.". SINGULAIR. Allergic rhinitis. Allergy to pcn. Reactive airway dx (no firm dx of asthma). Patient recovered."
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Breath sounds abnormal, Chest discomfort, Cough, Dyspnoea, Lung disorder
Clinical narrative: This is a verbatim narrative as reported on patientsville.com, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 20, 2007. Female patient, 14 years of age, was vaccinated with FLUMIST on Nov 20, 2007. "Patient received the FLUMIST on 10/24/07. She began having increased coughing shortly after the shot. She took CLARATIN as recommended by her physician. On the a.m. of 10/28/07, patient was experiencing mild wheezing but went out of town with her high school band for a contest. I was called at 3:00 p.m. and notified that patient was short of breath and wheezing to the point that she was ""squeaking"". A physician on site listened to her chest and said she was very restricted and wheezing and recommended using an inhaler. Patient was then transported to a local clinic. I was telephoned from the clinic by the physician treating patient who said her oxygen saturation was 92% and that she was very ""tight"" in her lungs with significant wheezing. I spoke with patient and she was barely able to speak. Patient was given a nebulizer breathing treatment and an injection of ROCEPHIN and SOLU MEDROL. It took over 1 hour for patient's oxygen saturation to raise to 95%." . . uncertain. Patient recovered."
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory disorder, Speech disorder, Wheezing
Clinical narrative: This is a verbatim narrative as reported on patientsville.com, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 20, 2007. Female patient, 14 years of age, was vaccinated with FLUMIST on Nov 20, 2007. "Patient received the FLUMIST on 10/24/07. She began having increased coughing shortly after the shot. She took CLARATIN as recommended by her physician. On the a.m. of 10/28/07, patient was experiencing mild wheezing but went out of town with her high school band for a contest. I was called at 3:00 p.m. and notified that patient was short of breath and wheezing to the point that she was ""squeaking"". A physician on site listened to her chest and said she was very restricted and wheezing and recommended using an inhaler. Patient was then transported to a local clinic. I was telephoned from the clinic by the physician treating patient who said her oxygen saturation was 92% and that she was very ""tight"" in her lungs with significant wheezing. I spoke with patient and she was barely able to speak. Patient was given a nebulizer breathing treatment and an injection of ROCEPHIN and SOLU MEDROL. It took over 1 hour for patient's oxygen saturation to raise to 95%." . . uncertain. Patient recovered."
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Dermatitis contact, Fall, Syncope
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 26, 2007. Female patient, child 11 years of age, was vaccinated with FLUMIST on Nov 16, 2007. After immunization patient had brief episode of syncope. Resolved completely; Fell to floor but no head injury. None. Diagnosed contact dermatitis. Patient recovered."
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Asthma, Atelectasis, Bronchoscopy abnormal, Cough
Clinical narrative: This is a verbatim narrative as reported on a website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 29, 2007. Female patient, child 8 years of age, was vaccinated with FLUMIST on Nov 21, 2007. "Right upper lobe of lung collapsed. 12/7/07 Reviewed hospital medical records which reveal patient experienced 2 week of persistent nonproductive cough w/intermittent SOB, wheezing & sharp stabbing right neck pain beginning 1 week s/p vax. Persistent RUL collapse & possible foreign body aspiration which was ruled out. Admitted 11/14-11/18/2007. Tx w/antibiotics, PPD & aggressive pulmonary toilet. Pulmonary consult done. FINAL DX: no d/c summary available, admit & d/c dates obtained from ROI. Bronchoscopy revealed asthma w/RUL collapse.". None. "chronic abdominal pain, no specific cause identified PMH: PE tubes in infancy, urinary leakage. Family Hx: siblings w/allergies. Parent w/pneumonia 1-1 1/2 mos prior to patient admit.". Patient was hospitalized. Patient recovered."
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Dyspnoea, Neck pain, Wheezing
Clinical narrative: This is a verbatim narrative as reported on a website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 29, 2007. Female patient, child 8 years of age, was vaccinated with FLUMIST on Nov 21, 2007. "Right upper lobe of lung collapsed. 12/7/07 Reviewed hospital medical records which reveal patient experienced 2 week of persistent nonproductive cough w/intermittent SOB, wheezing & sharp stabbing right neck pain beginning 1 week s/p vax. Persistent RUL collapse & possible foreign body aspiration which was ruled out. Admitted 11/14-11/18/2007. Tx w/antibiotics, PPD & aggressive pulmonary toilet. Pulmonary consult done. FINAL DX: no d/c summary available, admit & d/c dates obtained from ROI. Bronchoscopy revealed asthma w/RUL collapse.". None. "chronic abdominal pain, no specific cause identified PMH: PE tubes in infancy, urinary leakage. Family Hx: siblings w/allergies. Parent w/pneumonia 1-1 1/2 mos prior to patient admit.". Patient was hospitalized. Patient recovered."
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Convulsion, Loss of consciousness, Syncope
Clinical narrative: This is a verbatim narrative as reported on patientsville.com, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. FLUMIST problem was reported from on Dec 06, 2007. Female patient, child 12 years age, was vaccinated with FLUMIST on Nov 27, 2007. Syncope with questionable brief (seconds) seizure that resolved in 10-15 seconds total. Patient rested in office for 15-20 min and drank some water. Had normal vital signs after event. She passed out 15 min after injection.. Multivitamin. None. Patient recovered."
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Adverse reaction, Blood test abnormal, Headache, Inflammation, Injected limb mobility decreased
Clinical narrative: Initial report received from the patient's parent on 01 August 2011. A 14-year-old female patient received a left deltoid intramuscular injection (dose 1) of ADACEL, sanofi pasteur Ltd. lot number C3922AA, on 18 June 2011. The patient had no other vaccinations within 4 weeks of the ADACEL. The patient's medical history was not reported. The patient had no adverse events following prior vaccinations. On 18 June 2011, one hour later, the patient who was a competitive gymnast developed a headache, feeling tired and had a temperature of 101 Fahrenheit (F). On 19 June 2011, her left arm started to swell and for 3 days she could not lift the left arm. On 22 June 2011, the patient was seen at an urgent care center with no treatment given. The left arm was better within 2 weeks. On 28 June 2011, the patient was seen by the family physician for persistent headache. The patient had blood work done and a diagnosis of systemic inflammation in blood was reported. Laboratory studies were performed; however, no specific testing or results were reported. A week or so later the patient was seen by a pediatric neurologist. The mother reported that she was told "No permanent brain damage" and "Fatigue may last 6 months". The patient was given 60 milligrams (mg) of prednisone for 7 days. She was also given ondanestron HCL which "made her sick" and then promethazine which she tolerated better. The patient's headache became "lighter" and the 14-year-old did not want to take the next medications that the neurologist wanted to prescribe. The outcome was reported as not recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Reaction to preservatives, Vaccination site swelling
Clinical narrative: Initial report received from the patient's parent on 01 August 2011. A 14-year-old female patient received a left deltoid intramuscular injection (dose 1) of ADACEL, sanofi pasteur Ltd. lot number C3922AA, on 18 June 2011. The patient had no other vaccinations within 4 weeks of the ADACEL. The patient's medical history was not reported. The patient had no adverse events following prior vaccinations. On 18 June 2011, one hour later, the patient who was a competitive gymnast developed a headache, feeling tired and had a temperature of 101 Fahrenheit (F). On 19 June 2011, her left arm started to swell and for 3 days she could not lift the left arm. On 22 June 2011, the patient was seen at an urgent care center with no treatment given. The left arm was better within 2 weeks. On 28 June 2011, the patient was seen by the family physician for persistent headache. The patient had blood work done and a diagnosis of systemic inflammation in blood was reported. Laboratory studies were performed; however, no specific testing or results were reported. A week or so later the patient was seen by a pediatric neurologist. The mother reported that she was told "No permanent brain damage" and "Fatigue may last 6 months". The patient was given 60 milligrams (mg) of prednisone for 7 days. She was also given ondanestron HCL which "made her sick" and then promethazine which she tolerated better. The patient's headache became "lighter" and the 14-year-old did not want to take the next medications that the neurologist wanted to prescribe. The outcome was reported as not recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test abnormal, Body temperature increased, Fatigue, Headache, Inflammation
Clinical narrative: Initial report received from the patient's parent on 01 August 2011. A 14-year-old female patient received a left deltoid intramuscular injection (dose 1) of ADACEL, sanofi pasteur Ltd. lot number C3922AA, on 18 June 2011. The patient had no other vaccinations within 4 weeks of the ADACEL. The patient's medical history was not reported. The patient had no adverse events following prior vaccinations. On 18 June 2011, one hour later, the patient who was a competitive gymnast developed a headache, feeling tired and had a temperature of 101 Fahrenheit (F). On 19 June 2011, her left arm started to swell and for 3 days she could not lift the left arm. On 22 June 2011, the patient was seen at an urgent care center with no treatment given. The left arm was better within 2 weeks. On 28 June 2011, the patient was seen by the family physician for persistent headache. The patient had blood work done and a diagnosis of systemic inflammation in blood was reported. Laboratory studies were performed; however, no specific testing or results were reported. A week or so later the patient was seen by a pediatric neurologist. The mother reported that she was told "No permanent brain damage" and "Fatigue may last 6 months". The patient was given 60 milligrams (mg) of prednisone for 7 days. She was also given ondanestron HCL which "made her sick" and then promethazine which she tolerated better. The patient's headache became "lighter" and the 14-year-old did not want to take the next medications that the neurologist wanted to prescribe. The outcome was reported as not recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Laboratory test, Malaise, Oedema peripheral
Clinical narrative: Initial report received from the patient's parent on 01 August 2011. A 14-year-old female patient received a left deltoid intramuscular injection (dose 1) of ADACEL, sanofi pasteur Ltd. lot number C3922AA, on 18 June 2011. The patient had no other vaccinations within 4 weeks of the ADACEL. The patient's medical history was not reported. The patient had no adverse events following prior vaccinations. On 18 June 2011, one hour later, the patient who was a competitive gymnast developed a headache, feeling tired and had a temperature of 101 Fahrenheit (F). On 19 June 2011, her left arm started to swell and for 3 days she could not lift the left arm. On 22 June 2011, the patient was seen at an urgent care center with no treatment given. The left arm was better within 2 weeks. On 28 June 2011, the patient was seen by the family physician for persistent headache. The patient had blood work done and a diagnosis of systemic inflammation in blood was reported. Laboratory studies were performed; however, no specific testing or results were reported. A week or so later the patient was seen by a pediatric neurologist. The mother reported that she was told "No permanent brain damage" and "Fatigue may last 6 months". The patient was given 60 milligrams (mg) of prednisone for 7 days. She was also given ondanestron HCL which "made her sick" and then promethazine which she tolerated better. The patient's headache became "lighter" and the 14-year-old did not want to take the next medications that the neurologist wanted to prescribe. The outcome was reported as not recovered. Documents held by sender: None.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 19 week old female infant with no known drug allergies and a history of reflux who was vaccinated orally with the first and second doses of ROTATEQ on 18-MAY-2011 and 22-JUL-2011 respectively (Lot # not provided). Concomitant therapy included ZANTAC. The nurse reported that on 25-JUL-2011 the infant experienced intussusception after administration of her second dose of ROTATEQ on 22-JUL-2011. ROTATEQ series would not be completed. The infant experienced pain, vomiting, lethargy, and a lot of blood in her stools. Pediatrician examined her on 25-JUL-2011 and sent her to hospital. The infant was admitted to hospital for comprehensive blood work, blood cultures and initial X-rays and results were not reported. Physician from hospital stated she was experiencing a serious side effect from a medication. Physician could not determine diagnosis from X-ray results. The infant was given a barium enema for 4 hours. Physician stated the infant could die within 2-3 days. She was lethargic and vomiting after procedure. Emergency surgery was performed to treat intussusception. The procedure was successful. The infant was admitted in ICU with nasogastric tube. She experienced pain all night. The next day the nasogastric tube was removed and feeding was attempted. After a few hours the infant experienced projectile vomiting of bile. The next day, on approximately 27-JUL-2011, a second emergency surgery was performed to treat an adhesion which had formed. The infant was discharged from hospital on 02-AUG-2011. At the time of reporting, the infant was recovering. Intussusception and adhesion were considered to be disabling, immediately life-threatening and other important medical events by the nurse. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Ileus paralytic, Intestinal operation, Intussusception, Procedural complication, Rectal haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 19 week old female infant with no known drug allergies and a history of reflux who was vaccinated orally with the first and second doses of ROTATEQ on 18-MAY-2011 and 22-JUL-2011 respectively (Lot # not provided). Concomitant therapy included ZANTAC. The nurse reported that on 25-JUL-2011 the infant experienced intussusception after administration of her second dose of ROTATEQ on 22-JUL-2011. ROTATEQ series would not be completed. The infant experienced pain, vomiting, lethargy, and a lot of blood in her stools. Pediatrician examined her on 25-JUL-2011 and sent her to hospital. The infant was admitted to hospital for comprehensive blood work, blood cultures and initial X-rays and results were not reported. Physician from hospital stated she was experiencing a serious side effect from a medication. Physician could not determine diagnosis from X-ray results. The infant was given a barium enema for 4 hours. Physician stated the infant could die within 2-3 days. She was lethargic and vomiting after procedure. Emergency surgery was performed to treat intussusception. The procedure was successful. The infant was admitted in ICU with nasogastric tube. She experienced pain all night. The next day the nasogastric tube was removed and feeding was attempted. After a few hours the infant experienced projectile vomiting of bile. The next day, on approximately 27-JUL-2011, a second emergency surgery was performed to treat an adhesion which had formed. The infant was discharged from hospital on 02-AUG-2011. At the time of reporting, the infant was recovering. Intussusception and adhesion were considered to be disabling, immediately life-threatening and other important medical events by the nurse. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Screaming, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 19 week old female infant with no known drug allergies and a history of reflux who was vaccinated orally with the first and second doses of ROTATEQ on 18-MAY-2011 and 22-JUL-2011 respectively (Lot # not provided). Concomitant therapy included ZANTAC. The nurse reported that on 25-JUL-2011 the infant experienced intussusception after administration of her second dose of ROTATEQ on 22-JUL-2011. ROTATEQ series would not be completed. The infant experienced pain, vomiting, lethargy, and a lot of blood in her stools. Pediatrician examined her on 25-JUL-2011 and sent her to hospital. The infant was admitted to hospital for comprehensive blood work, blood cultures and initial X-rays and results were not reported. Physician from hospital stated she was experiencing a serious side effect from a medication. Physician could not determine diagnosis from X-ray results. The infant was given a barium enema for 4 hours. Physician stated the infant could die within 2-3 days. She was lethargic and vomiting after procedure. Emergency surgery was performed to treat intussusception. The procedure was successful. The infant was admitted in ICU with nasogastric tube. She experienced pain all night. The next day the nasogastric tube was removed and feeding was attempted. After a few hours the infant experienced projectile vomiting of bile. The next day, on approximately 27-JUL-2011, a second emergency surgery was performed to treat an adhesion which had formed. The infant was discharged from hospital on 02-AUG-2011. At the time of reporting, the infant was recovering. Intussusception and adhesion were considered to be disabling, immediately life-threatening and other important medical events by the nurse. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Barium enema, Blood culture, Blood test, Gastrointestinal tube insertion, Gastrointestinal tube removal
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 19 week old female infant with no known drug allergies and a history of reflux who was vaccinated orally with the first and second doses of ROTATEQ on 18-MAY-2011 and 22-JUL-2011 respectively (Lot # not provided). Concomitant therapy included ZANTAC. The nurse reported that on 25-JUL-2011 the infant experienced intussusception after administration of her second dose of ROTATEQ on 22-JUL-2011. ROTATEQ series would not be completed. The infant experienced pain, vomiting, lethargy, and a lot of blood in her stools. Pediatrician examined her on 25-JUL-2011 and sent her to hospital. The infant was admitted to hospital for comprehensive blood work, blood cultures and initial X-rays and results were not reported. Physician from hospital stated she was experiencing a serious side effect from a medication. Physician could not determine diagnosis from X-ray results. The infant was given a barium enema for 4 hours. Physician stated the infant could die within 2-3 days. She was lethargic and vomiting after procedure. Emergency surgery was performed to treat intussusception. The procedure was successful. The infant was admitted in ICU with nasogastric tube. She experienced pain all night. The next day the nasogastric tube was removed and feeding was attempted. After a few hours the infant experienced projectile vomiting of bile. The next day, on approximately 27-JUL-2011, a second emergency surgery was performed to treat an adhesion which had formed. The infant was discharged from hospital on 02-AUG-2011. At the time of reporting, the infant was recovering. Intussusception and adhesion were considered to be disabling, immediately life-threatening and other important medical events by the nurse. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Haematochezia, Intensive care, Intestinal operation, Intussusception, Lethargy
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 19 week old female infant with no known drug allergies and a history of reflux who was vaccinated orally with the first and second doses of ROTATEQ on 18-MAY-2011 and 22-JUL-2011 respectively (Lot # not provided). Concomitant therapy included ZANTAC. The nurse reported that on 25-JUL-2011 the infant experienced intussusception after administration of her second dose of ROTATEQ on 22-JUL-2011. ROTATEQ series would not be completed. The infant experienced pain, vomiting, lethargy, and a lot of blood in her stools. Pediatrician examined her on 25-JUL-2011 and sent her to hospital. The infant was admitted to hospital for comprehensive blood work, blood cultures and initial X-rays and results were not reported. Physician from hospital stated she was experiencing a serious side effect from a medication. Physician could not determine diagnosis from X-ray results. The infant was given a barium enema for 4 hours. Physician stated the infant could die within 2-3 days. She was lethargic and vomiting after procedure. Emergency surgery was performed to treat intussusception. The procedure was successful. The infant was admitted in ICU with nasogastric tube. She experienced pain all night. The next day the nasogastric tube was removed and feeding was attempted. After a few hours the infant experienced projectile vomiting of bile. The next day, on approximately 27-JUL-2011, a second emergency surgery was performed to treat an adhesion which had formed. The infant was discharged from hospital on 02-AUG-2011. At the time of reporting, the infant was recovering. Intussusception and adhesion were considered to be disabling, immediately life-threatening and other important medical events by the nurse. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: Pain, Post procedural complication, Postoperative adhesion, Vomiting, Vomiting projectile
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 19 week old female infant with no known drug allergies and a history of reflux who was vaccinated orally with the first and second doses of ROTATEQ on 18-MAY-2011 and 22-JUL-2011 respectively (Lot # not provided). Concomitant therapy included ZANTAC. The nurse reported that on 25-JUL-2011 the infant experienced intussusception after administration of her second dose of ROTATEQ on 22-JUL-2011. ROTATEQ series would not be completed. The infant experienced pain, vomiting, lethargy, and a lot of blood in her stools. Pediatrician examined her on 25-JUL-2011 and sent her to hospital. The infant was admitted to hospital for comprehensive blood work, blood cultures and initial X-rays and results were not reported. Physician from hospital stated she was experiencing a serious side effect from a medication. Physician could not determine diagnosis from X-ray results. The infant was given a barium enema for 4 hours. Physician stated the infant could die within 2-3 days. She was lethargic and vomiting after procedure. Emergency surgery was performed to treat intussusception. The procedure was successful. The infant was admitted in ICU with nasogastric tube. She experienced pain all night. The next day the nasogastric tube was removed and feeding was attempted. After a few hours the infant experienced projectile vomiting of bile. The next day, on approximately 27-JUL-2011, a second emergency surgery was performed to treat an adhesion which had formed. The infant was discharged from hospital on 02-AUG-2011. At the time of reporting, the infant was recovering. Intussusception and adhesion were considered to be disabling, immediately life-threatening and other important medical events by the nurse. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAP, HIBV, OPV, PPV, RVX, RV5
Symptoms: X-ray
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 19 week old female infant with no known drug allergies and a history of reflux who was vaccinated orally with the first and second doses of ROTATEQ on 18-MAY-2011 and 22-JUL-2011 respectively (Lot # not provided). Concomitant therapy included ZANTAC. The nurse reported that on 25-JUL-2011 the infant experienced intussusception after administration of her second dose of ROTATEQ on 22-JUL-2011. ROTATEQ series would not be completed. The infant experienced pain, vomiting, lethargy, and a lot of blood in her stools. Pediatrician examined her on 25-JUL-2011 and sent her to hospital. The infant was admitted to hospital for comprehensive blood work, blood cultures and initial X-rays and results were not reported. Physician from hospital stated she was experiencing a serious side effect from a medication. Physician could not determine diagnosis from X-ray results. The infant was given a barium enema for 4 hours. Physician stated the infant could die within 2-3 days. She was lethargic and vomiting after procedure. Emergency surgery was performed to treat intussusception. The procedure was successful. The infant was admitted in ICU with nasogastric tube. She experienced pain all night. The next day the nasogastric tube was removed and feeding was attempted. After a few hours the infant experienced projectile vomiting of bile. The next day, on approximately 27-JUL-2011, a second emergency surgery was performed to treat an adhesion which had formed. The infant was discharged from hospital on 02-AUG-2011. At the time of reporting, the infant was recovering. Intussusception and adhesion were considered to be disabling, immediately life-threatening and other important medical events by the nurse. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient stated that she received the ZOSTAVAX vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot pain. Patient was referred to her primary health care provider for suspected shingles.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Patient stated that she received the ZOSTAVAX vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot pain. Patient was referred to her primary health care provider for suspected shingles.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site erythema, Injection site vesicles, Pain
Clinical narrative: Patient stated that she received the ZOSTAVAX vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot pain. Patient was referred to her primary health care provider for suspected shingles.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Patient stated that she received the ZOSTAVAX vaccine on Tuesday, 08/02/11 at 3pm. She felt fine on the day she received the vaccine, but she began to feel some flu-like symptoms when she woke up the next day. Patient also stated that the injection area was slightly red but it was not bothersome initially. It was Thursday morning, when she started to itch the area, and the pain had intensified. By the time she went to bed that night, the redness had spread further down her lower back arm. The patient came to the pharmacy on 08/05. She had developed tiny little blisters in the center of the injection site and she was in a lot pain. Patient was referred to her primary health care provider for suspected shingles.
Age: 16.0
Sex: F
Vaccine: FLUN3, MNQ
Symptoms: Fall, Headache, Moaning, Posture abnormal
Clinical narrative: After leaving examination room went to waiting room to wait for sibling. Daughter started moaning and slumped over on my shoulder and then started slipping out of chair and onto floor. When woke up a minute later was unaware of what happened. Nurses came to our aid and laid her on the floor, raised her legs, gave her a wet washcloth and some water. She stayed on the floor for about ten minutes before they would let her get up. She came home and had a headache the rest of the day.