chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with Twinrix for prophylaxis. On an unspecified date the subject completed the entire series of Twinrix. At an unspecified time following completion of the Twinrix series, the subjects titers were tested and the subject was found to have not responded to therapy. At the time of reporting the outcome of the event was unspecified.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Antimicrobial susceptibility test, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 47-year-old male subject not responding to therapy following vaccination with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included elevated blood pressure.  Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (Aventis) and tetanus toxoid (Aventis) given on 8 June 2007.  Concurrent medications included Lisinopril and Hydrochlorothiazide (HCTZ).  On 29 June 2007, 15 June 2007 and 8 June 2007 the subject received 3rd dose, 2nd dose and 1st dose of Twinrix (unknown).  On 27 July 2007, 1 month after completion of the Twinrix series, a titer was drawn and was reported as negative.  The subject had not responded to therapy with Twinrix.  At the time of reporting the event was unresolved.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of dizziness in a 58-year-old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  Concurrent medications included unspecified pain medications.  On an unspecified date in July 2007, the subject received the 2nd dose of Twinrix (unknown).  On an unspecified date in July 2007 after vaccination with Twinrix, the subject experienced dizziness.  The pharmacist reported that the subject may not take the 3rd dose in the Twinrix series.  At the time of reporting the event was resolved.  The pharmacist considered the event was possibly related to vaccination with Twinrix.
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 59-year-old male subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included allergy to erythromycin, bee sting allergy and penicillin allergy. Concurrent medications included Cipro. On 10 August 2007 at 09:00, the subject received 1st dose of Twinrix (unknown, left arm). Approximately 12 hours after vaccination with Twinrix, the subject experienced diarrhea. As of 15 August 2007, the event was resolved. On an unspecified date, the subject was scheduled to receive the 2nd dose of Twinrix, but the nurse declined to vaccinate him due to the diarrhea he experienced following the 1st dose of the vaccine.
Age: 28.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Blood sodium increased, Oedema peripheral, Rheumatoid factor negative
Clinical narrative: Information has been received from a 28 year old female consumer with urinary tract infection who on 28-FEB-2007 was vaccinated with a dose of MERUVAX II. Concomitant therapy included amoxicillin. On 02-MAR-2007 two days after vaccination, the patient experienced severe joint pain and swelling in the legs and feet. The patient reported that she received the vaccine in the hospital after giving birth and she has been nursing since she received the vaccine. On 23-MAR-2007 follow up information received from the patient's mother who is a registered nurse stated that her daughter experienced stiffness and joint pain in toes and feet. This past week of 19-Mar-2007 the symptoms accelerated with pain and swelling in feet, toes, and ankles and pain in knees and elbows. Today 23-Mar-2007 she has stiffness and pain in the neck having difficulty standing on her feet, as well as continuing with the above symptoms. On 18-Mar-2007 the patient was seen in urgent care and lab work for rheumatoid arthritis screen, lupus, and blood sugar all were negative and normal. Sodium was 3 above normal range. The family physician drew labs this week, week of 19-Mar-2007 and was waiting for the results. Baby was born on 26-Feb-2007 and the patient had been  breast feeding the infant. Baby does not have any adverse symptoms. The patient had not taken any medication for the symptoms. The patient's outcome was not known. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Blood glucose normal, Blood sodium increased, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Information has been received from a 28 year old female consumer with urinary tract infection who on 28-FEB-2007 was vaccinated with a dose of MERUVAX II. Concomitant therapy included amoxicillin. On 02-MAR-2007 two days after vaccination, the patient experienced severe joint pain and swelling in the legs and feet. The patient reported that she received the vaccine in the hospital after giving birth and she has been nursing since she received the vaccine. On 23-MAR-2007 follow up information received from the patient's mother who is a registered nurse stated that her daughter experienced stiffness and joint pain in toes and feet. This past week of 19-Mar-2007 the symptoms accelerated with pain and swelling in feet, toes, and ankles and pain in knees and elbows. Today 23-Mar-2007 she has stiffness and pain in the neck having difficulty standing on her feet, as well as continuing with the above symptoms. On 18-Mar-2007 the patient was seen in urgent care and lab work for rheumatoid arthritis screen, lupus, and blood sugar all were negative and normal. Sodium was 3 above normal range. The family physician drew labs this week, week of 19-Mar-2007 and was waiting for the results. Baby was born on 26-Feb-2007 and the patient had been  breast feeding the infant. Baby does not have any adverse symptoms. The patient had not taken any medication for the symptoms. The patient's outcome was not known. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Oedema peripheral, Rheumatoid factor
Clinical narrative: Information has been received from a 28 year old female consumer with urinary tract infection who on 28-FEB-2007 was vaccinated with a dose of MERUVAX II. Concomitant therapy included amoxicillin. On 02-MAR-2007 two days after vaccination, the patient experienced severe joint pain and swelling in the legs and feet. The patient reported that she received the vaccine in the hospital after giving birth and she has been nursing since she received the vaccine. On 23-MAR-2007 follow up information received from the patient's mother who is a registered nurse stated that her daughter experienced stiffness and joint pain in toes and feet. This past week of 19-Mar-2007 the symptoms accelerated with pain and swelling in feet, toes, and ankles and pain in knees and elbows. Today 23-Mar-2007 she has stiffness and pain in the neck having difficulty standing on her feet, as well as continuing with the above symptoms. On 18-Mar-2007 the patient was seen in urgent care and lab work for rheumatoid arthritis screen, lupus, and blood sugar all were negative and normal. Sodium was 3 above normal range. The family physician drew labs this week, week of 19-Mar-2007 and was waiting for the results. Baby was born on 26-Feb-2007 and the patient had been  breast feeding the infant. Baby does not have any adverse symptoms. The patient had not taken any medication for the symptoms. The patient's outcome was not known. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Electrocardiogram normal, Epilepsy, Full blood count normal
Clinical narrative: Initial report received on 27 November 2007 from a health care provider. A 12-year-old female patient, with a past medical history of asthma, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2862AA; a first dose, right arm, intramuscular injection of Menactra, lot number U2538AA; a seventh dose, left arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2524AA; and a first dose, right arm intramuscular injection of Gardasil, manufacturer Merck, lot number 12676; on 12 November 2007. Four days post-vaccination, the patient experienced an episode of spinning with her head tilted to the right and her whole body shaking. The episode lasted less than two minutes. The patient had no fever at the time of the event. She was transported by emergency medical services to an emergency room where she was subsequently admitted to the hospital with a diagnosis of questionable partial complex seizure versus syncopal episode. The patient was discharged following a three day hospitalization. Two days after discharge, the parent called and stated that the patient had experienced another seizure. She was re-examined and started on Depakote. Relevant diagnostic testing, (dates not provided), included a CT scan of the head which was normal, an EKG which was normal, CBC and electrolytes which were normal, a video EEG (results pending), and a MRI (results pending). Recovery status was not provided.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Posture abnormal, Syncope, Tremor, Vertigo
Clinical narrative: Initial report received on 27 November 2007 from a health care provider. A 12-year-old female patient, with a past medical history of asthma, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2862AA; a first dose, right arm, intramuscular injection of Menactra, lot number U2538AA; a seventh dose, left arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2524AA; and a first dose, right arm intramuscular injection of Gardasil, manufacturer Merck, lot number 12676; on 12 November 2007. Four days post-vaccination, the patient experienced an episode of spinning with her head tilted to the right and her whole body shaking. The episode lasted less than two minutes. The patient had no fever at the time of the event. She was transported by emergency medical services to an emergency room where she was subsequently admitted to the hospital with a diagnosis of questionable partial complex seizure versus syncopal episode. The patient was discharged following a three day hospitalization. Two days after discharge, the parent called and stated that the patient had experienced another seizure. She was re-examined and started on Depakote. Relevant diagnostic testing, (dates not provided), included a CT scan of the head which was normal, an EKG which was normal, CBC and electrolytes which were normal, a video EEG (results pending), and a MRI (results pending). Recovery status was not provided.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Blood electrolytes normal, Complex partial seizures, Computerised tomogram normal, Convulsion, Electrocardiogram normal
Clinical narrative: Initial report received on 27 November 2007 from a health care provider. A 12-year-old female patient, with a past medical history of asthma, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2862AA; a first dose, right arm, intramuscular injection of Menactra, lot number U2538AA; a seventh dose, left arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2524AA; and a first dose, right arm intramuscular injection of Gardasil, manufacturer Merck, lot number 12676; on 12 November 2007. Four days post-vaccination, the patient experienced an episode of spinning with her head tilted to the right and her whole body shaking. The episode lasted less than two minutes. The patient had no fever at the time of the event. She was transported by emergency medical services to an emergency room where she was subsequently admitted to the hospital with a diagnosis of questionable partial complex seizure versus syncopal episode. The patient was discharged following a three day hospitalization. Two days after discharge, the parent called and stated that the patient had experienced another seizure. She was re-examined and started on Depakote. Relevant diagnostic testing, (dates not provided), included a CT scan of the head which was normal, an EKG which was normal, CBC and electrolytes which were normal, a video EEG (results pending), and a MRI (results pending). Recovery status was not provided.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Electroencephalogram, Full blood count normal, Nuclear magnetic resonance imaging, Posture abnormal, Syncope
Clinical narrative: Initial report received on 27 November 2007 from a health care provider. A 12-year-old female patient, with a past medical history of asthma, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2862AA; a first dose, right arm, intramuscular injection of Menactra, lot number U2538AA; a seventh dose, left arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2524AA; and a first dose, right arm intramuscular injection of Gardasil, manufacturer Merck, lot number 12676; on 12 November 2007. Four days post-vaccination, the patient experienced an episode of spinning with her head tilted to the right and her whole body shaking. The episode lasted less than two minutes. The patient had no fever at the time of the event. She was transported by emergency medical services to an emergency room where she was subsequently admitted to the hospital with a diagnosis of questionable partial complex seizure versus syncopal episode. The patient was discharged following a three day hospitalization. Two days after discharge, the parent called and stated that the patient had experienced another seizure. She was re-examined and started on Depakote. Relevant diagnostic testing, (dates not provided), included a CT scan of the head which was normal, an EKG which was normal, CBC and electrolytes which were normal, a video EEG (results pending), and a MRI (results pending). Recovery status was not provided.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Tremor, Vertigo
Clinical narrative: Initial report received on 27 November 2007 from a health care provider. A 12-year-old female patient, with a past medical history of asthma, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2862AA; a first dose, right arm, intramuscular injection of Menactra, lot number U2538AA; a seventh dose, left arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2524AA; and a first dose, right arm intramuscular injection of Gardasil, manufacturer Merck, lot number 12676; on 12 November 2007. Four days post-vaccination, the patient experienced an episode of spinning with her head tilted to the right and her whole body shaking. The episode lasted less than two minutes. The patient had no fever at the time of the event. She was transported by emergency medical services to an emergency room where she was subsequently admitted to the hospital with a diagnosis of questionable partial complex seizure versus syncopal episode. The patient was discharged following a three day hospitalization. Two days after discharge, the parent called and stated that the patient had experienced another seizure. She was re-examined and started on Depakote. Relevant diagnostic testing, (dates not provided), included a CT scan of the head which was normal, an EKG which was normal, CBC and electrolytes which were normal, a video EEG (results pending), and a MRI (results pending). Recovery status was not provided.
Age: 64.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Anorexia, Asthenia, Diarrhoea, Headache, Heart rate increased
Clinical narrative: 2-3 days following vaccination right arm swelling for several days.  Resolved, felt weak with headache.  Nausea; emesis x2; diarrhea; no appetite 2 days after vaccination.  Continues with diarrhea.  Was given Phenergan by FNP on visit on 12/3/2007.  Blood pressure 78/56; pulse 100; no fever.
Age: 64.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Hypotension, Nausea, Oedema peripheral, Vomiting
Clinical narrative: 2-3 days following vaccination right arm swelling for several days.  Resolved, felt weak with headache.  Nausea; emesis x2; diarrhea; no appetite 2 days after vaccination.  Continues with diarrhea.  Was given Phenergan by FNP on visit on 12/3/2007.  Blood pressure 78/56; pulse 100; no fever.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Full blood count, Injection site erythema, Laboratory test, Skin exfoliation
Clinical narrative: Red circle appeared 2-3 days after vaccine administration on Left Deltoid where vaccine was given.  Skin changes noted and still evident 6 weeks later.  Skin is rough and scaly, no masses or thickening noted at site. No enlarged L axillary nodes.  Patient c/o feeling weak for last month.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Nasal discomfort, Proctalgia, Pruritus
Clinical narrative: Now presents with erythemia to outer nasal area; nasal pharyngeal and anal discomfort. c/o of swelling and itching of nose. States 24 hours after injection had local redness and itching locally. Dis(?) within a few days.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Now presents with erythemia to outer nasal area; nasal pharyngeal and anal discomfort. c/o of swelling and itching of nose. States 24 hours after injection had local redness and itching locally. Dis(?) within a few days.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Infection, Injury, Pruritus, Rash pruritic, Skin lesion
Clinical narrative: Patient returned to pharmacy on 12/03/07 presenting an intense rash reaction on the lefty arm.  The condition of the lesions reflects trauma and secondary infection potentially due to intense itching.  Recommended patient to see his PCP ASAP.  Patient was stable.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Angiogram, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Cardiac enzymes increased, Chest pain
Clinical narrative: Patient given TDaP and meningococcus vaccines on 11/27/07.  The next day, he developed muscle aches, malaise and low grade fever.  That night, he had chest pain.  The chest pain worsened over 24 hours.  He was admitted to the hospital on 11/29/07 with myocarditis.  His function was normal on echo and CT angio.  His ekg showed inferior lead ST elevation.  His troponin peaked at about 9 and his CPK and CK-MB were both quite elevated.  He was treated with IVIG and NSAIDs.  His chest pain resolved over 24 hours and his cardiac enzymes returned to normal over about 72 hours.  He had no ectopy.  12/06/2007 MR received for OV 11/27/07 for 15yr WCC and hospital DOS 11/30-12/03/2007 with D/C DX:  Myocarditis. Child presented to ER on 11/30/07 with chest pain/heaviness x 2 days.  Pt developed muscle aches and fever 1 day after receiving Menactra and Adacel vax. That night pt developed squeezing chest pain which was worsening.  Pain increased on laying down.  ROS (+) for chest pain and near syncope. Cardiac Consult with DX:  Likely vaccination related myopericarditis. Txd with IVIG and Indocin.  By D/C Chest pain resolved EKG and Echo WNL
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Immunoglobulins, Laboratory test normal
Clinical narrative: Patient given TDaP and meningococcus vaccines on 11/27/07.  The next day, he developed muscle aches, malaise and low grade fever.  That night, he had chest pain.  The chest pain worsened over 24 hours.  He was admitted to the hospital on 11/29/07 with myocarditis.  His function was normal on echo and CT angio.  His ekg showed inferior lead ST elevation.  His troponin peaked at about 9 and his CPK and CK-MB were both quite elevated.  He was treated with IVIG and NSAIDs.  His chest pain resolved over 24 hours and his cardiac enzymes returned to normal over about 72 hours.  He had no ectopy.  12/06/2007 MR received for OV 11/27/07 for 15yr WCC and hospital DOS 11/30-12/03/2007 with D/C DX:  Myocarditis. Child presented to ER on 11/30/07 with chest pain/heaviness x 2 days.  Pt developed muscle aches and fever 1 day after receiving Menactra and Adacel vax. That night pt developed squeezing chest pain which was worsening.  Pain increased on laying down.  ROS (+) for chest pain and near syncope. Cardiac Consult with DX:  Likely vaccination related myopericarditis. Txd with IVIG and Indocin.  By D/C Chest pain resolved EKG and Echo WNL
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Malaise, Myalgia, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: Patient given TDaP and meningococcus vaccines on 11/27/07.  The next day, he developed muscle aches, malaise and low grade fever.  That night, he had chest pain.  The chest pain worsened over 24 hours.  He was admitted to the hospital on 11/29/07 with myocarditis.  His function was normal on echo and CT angio.  His ekg showed inferior lead ST elevation.  His troponin peaked at about 9 and his CPK and CK-MB were both quite elevated.  He was treated with IVIG and NSAIDs.  His chest pain resolved over 24 hours and his cardiac enzymes returned to normal over about 72 hours.  He had no ectopy.  12/06/2007 MR received for OV 11/27/07 for 15yr WCC and hospital DOS 11/30-12/03/2007 with D/C DX:  Myocarditis. Child presented to ER on 11/30/07 with chest pain/heaviness x 2 days.  Pt developed muscle aches and fever 1 day after receiving Menactra and Adacel vax. That night pt developed squeezing chest pain which was worsening.  Pain increased on laying down.  ROS (+) for chest pain and near syncope. Cardiac Consult with DX:  Likely vaccination related myopericarditis. Txd with IVIG and Indocin.  By D/C Chest pain resolved EKG and Echo WNL
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: extreme redness and warmth of posterior(inside below armpit to elbow)arm
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The evening after vaccination child developed redness, warmth and swelling measuring 7.25 cm horizontally and 9 cm vertically in upper arm where vaccination occured.  The child also had itching and benadryl was given.  Benadryl helped with itching, but the redness, and swelling increased.  Child was seen in office the following morning, 16 hours after first measurement and area of redness, swelling and warmth now measured 12.5 cm vertically and 12.75 cm horizontally.  Plan of care was for Motrin 3 times a day for next two days, and benadryl as needed for itching.  Will plan for further follow-up if increases redness, pain, or changes in sensation occur.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Device failure, Injection site swelling
Clinical narrative: Upon injection into patient's left arm, administrator felt resistance.  No vaccine was injected.  Needle was withdrawn and swelling was observed.  No pain or itching was observed by patient.  Administrator observed patient for several minutes and noticed that swelling decreased.  Patient was sent home for follow-up appointment 3 days later.  Vaccine was administered in right arm with no incidence.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: NONE
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature fluctuation, Body temperature increased, Diarrhoea, Myalgia
Clinical narrative: Day 1 shot administered 2 hrs later joint pain. Day 2 all over muscle aches. Day 3 101.5 temp muscular aches. Diarrhea. Day 4 same as day 3. Day 5 temp. fluctuated between norm and 100+. Minor muscles aches diarrhea. Day 6 better, similar to day 5. Day 7 back to work.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Felt electrical "zing" when vaccine administered. Has had a chronic deep ache in deltoid for the following month. painful, but not limited range of motion.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Diet refusal, Vomiting
Clinical narrative: Vomited a few times and did not want to eat
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Chest X-ray normal, Cold sweat, Cyanosis, Diarrhoea
Clinical narrative: 11/19/07  Received 4 month vaccinations (DTaP, Hib,Polio and Prevnar).  The same evening became diaphoretic and clammy with diarrhea and projectile vomiting.  Respirations were shallow with periods of apnea.  Cyanosis worsened as apneic periods increased.  Mom gave 2 rescue breaths. Became slightly more responsive. Was transported by squad to local hospital.  12/31/2007 MR received for DOD 11/20-21/2007 with D/C Dx:  Acute apneic episode likely 2' to esophageal reflux. Infant found lethargic, limp, diaphoretic and apneic by mom. Pt had an episode of projectile emesis and a loose, watery stool. Able to restore normal breathing with rescue breaths and stimulation.  Upon arrival in ED pt had revovered although had some desats to 92% while nursing. Admission PE WNL. No further incidents.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hyperhidrosis, Hypoventilation, Sleep study normal, Vomiting projectile
Clinical narrative: 11/19/07  Received 4 month vaccinations (DTaP, Hib,Polio and Prevnar).  The same evening became diaphoretic and clammy with diarrhea and projectile vomiting.  Respirations were shallow with periods of apnea.  Cyanosis worsened as apneic periods increased.  Mom gave 2 rescue breaths. Became slightly more responsive. Was transported by squad to local hospital.  12/31/2007 MR received for DOD 11/20-21/2007 with D/C Dx:  Acute apneic episode likely 2' to esophageal reflux. Infant found lethargic, limp, diaphoretic and apneic by mom. Pt had an episode of projectile emesis and a loose, watery stool. Able to restore normal breathing with rescue breaths and stimulation.  Upon arrival in ED pt had revovered although had some desats to 92% while nursing. Admission PE WNL. No further incidents.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: one hour after shots were administered, patient cried continuously until taken to Hospital E.R. for 3-4 hours stay.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature increased, Hypotonic-hyporesponsive episode, Listless, Pallor, Screaming
Clinical narrative: 4-5 hrs after vaccination pt w/ extreme pallor/listlesness; alternating periods betw. sleeping and screaming.  child's color was "dead-baby white" per mother.  (very reliable parents).  also had temp of 99.1 but was given tylenol 2 hrs before event.  overall, consistent w/ hypotonic-hyporesponsive episode.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Chills, Oedema peripheral, Pyrexia
Clinical narrative: pt immunized at 12 noon and that same evening developed sweeling of left extremity and c/o chills and inability to walk. Pt to the ED and admitted to Hospital. Fever was a one point up to 103.9. Pt was discharge from hospital with diagnosis of bronchitis and a prescription for an antibiotic. Unknown reason for neurological symptoms.  12/18/07 Reviewed hospital medical records which reveal patient experienced cough, congestion, dizziness, chills/fever, SOB, ataxia, swelling & redness of left arm.  Admitted 12/1-12/4/2007. Tx w/IV antibiotics & nebs.  Improved & swelling/redness also improved.  D/C to home w/continued oral antibiotics. FINAL DX: Acute bronchitis, query reaction to pneumo shot.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: The patient experienced pain, swelling and cellulitis at the site of injection the evening of the injection. The reaction became worse and the patient was called in the clinic for an evaluation and antibiotics were ordered.(The clinic called this in because this was the third case of this type of reaction with this lot#).
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: The patient experienced pain, swelling, fevers, chills and cellulitis in the affected arm starting within 24 hours of the IM Pneumovax in the same arm. The patient is a physician began antibiotics because of streaking on the skin(amoxicillin, then levofloxaxin and finally bactrim).
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Dizziness, Dysphonia, Glossodynia, Pallor
Clinical narrative: Patient woke-up up with a fever of 103.1.  She was shaking and was weak, dizzy, & a little pale.  She complained that her tongue was burning.  This was on the 1st of December.  I took her to the weekend doctor and had forgot that she had this vaccination, so did not inform them of it. They said they found nothing wrong with her, but again, I did not inform them of this vaccination, because I forgot that she had it. On Sunday, December 2nd, she was hoarse the whole day.  To my knowledge she is ok, but I will call to possibly set up another appointment, if they want to see her.  She had this vaccine done at her school.  They sent home a note with the vaccine information, but I cannot tell the name of the person who administered it.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient woke-up up with a fever of 103.1.  She was shaking and was weak, dizzy, & a little pale.  She complained that her tongue was burning.  This was on the 1st of December.  I took her to the weekend doctor and had forgot that she had this vaccination, so did not inform them of it. They said they found nothing wrong with her, but again, I did not inform them of this vaccination, because I forgot that she had it. On Sunday, December 2nd, she was hoarse the whole day.  To my knowledge she is ok, but I will call to possibly set up another appointment, if they want to see her.  She had this vaccine done at her school.  They sent home a note with the vaccine information, but I cannot tell the name of the person who administered it.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: After receiving the pneumovax 23 the patient complained of pain, swelling, redness (syptoms of cellulitis)of the arm that was injected. The physician put the patient on antibiotics
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: localized red, hard, indurated, painful area at site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Rash
Clinical narrative: Pt called stated she had a 3x4 inch red spot firm and itchy at insertion site of vaccine. Pt also stated she had another raised area similar  on the L scapula. no open vesicules. She saw a local Physician. She applied Benedryl to the affected areas.
Age: 81.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Pharmaceutical product complaint, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 81-year-old subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Pharmaceutical product complaint, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 73-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 73 year old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, No reaction on previous exposure to drug, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 79-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 79-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subject recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, No reaction on previous exposure to drug, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 76-year-old subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 76-year-old subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Pharmaceutical product complaint, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 77-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specific s on each individual subject were not provided.
Age: 84.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Pharmaceutical product complaint, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 84-year-old subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Pharmaceutical product complaint, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 74-year-old subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis.  On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date of March 2008.  In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting.  The reaction was classified as systemic.  The healthcare professional considered the events were disabling.  The reporter suspected a safety and quality issue (product complaint) with the vaccine.  At the time of reporting the outcome of the events was unspecified.  It was indicated that these events occurred with multiple subjects.  Nine specified at the time of the report.  It was noted that 2 or 3 subjects had to be treated in the emergency room for these events.  Most of the subjects recovered from the events after 2 to 4 days.  Some subjects had not yet recovered at the time of reporting.  Specifics on each individual subject were not provided.
Sex: F
Vaccine: MMR
Symptoms: Malaise, Pain, Pyrexia, Rhinorrhoea, Tenderness
Clinical narrative: Information has been received from a health authority concerning a female who on 02-NOV-2007 was vaccinated intramuscularly with a dose of MMR (batch # NE49230). On 03-NOV-2007, one day post immunization, the patient developed symptoms of fever, generalized aches and pains coated tongue, tenderness of glands, runny nose and feeling generally unwell. At the time of reporting the patient had not recovered. The reporter considered this to be a non serious reaction, however, the agency considered the events to be serious due to other medically significant reason. No further information is available, the case is closed. Other business partner numbers include: E2007-08574.
Sex: F
Vaccine: MMR
Symptoms: Tongue coated
Clinical narrative: Information has been received from a health authority concerning a female who on 02-NOV-2007 was vaccinated intramuscularly with a dose of MMR (batch # NE49230). On 03-NOV-2007, one day post immunization, the patient developed symptoms of fever, generalized aches and pains coated tongue, tenderness of glands, runny nose and feeling generally unwell. At the time of reporting the patient had not recovered. The reporter considered this to be a non serious reaction, however, the agency considered the events to be serious due to other medically significant reason. No further information is available, the case is closed. Other business partner numbers include: E2007-08574.
Sex: M
Vaccine: FLU3
Symptoms: Thrombotic thrombocytopenic purpura
Clinical narrative: We received the following information on 20 NOV 2007: An adult male patient was vaccinated with an influenza virus vaccine, batch-no. and manufacturer unknown in October 2007. A thrombotic thrombocytopenic purpura was reported one week after the vaccination in October 2007 and the patient was hospitalised. The patient has not yet recovered on date of report. It seems to be unlikely that Fluvirin was used as this vaccine was not distributed to the market in this season.