chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, HEPA, IPV, MMR
Symptoms: Lung infiltration, Lymphocyte percentage decreased, Neutrophil percentage increased, Oxygen saturation decreased, Pneumonia
Clinical narrative: A serious event of pneumonia was reported by a Study Investigator concerning a four-year-old male subject (Pat ID# 42458400) enrolled in a post-marketed study MI-MA162.  Medical history included cough and congestion with intermittent fever for three weeks.  Concomitant vaccinations included DTaP, IPV, MMR and Hep A and were received on the same day FLUMIST was received.  The subject received FLUMIST on 29-Nov-2007.  The subject had been feeling better for a few days after his vaccinations on 29-Nov-2007, he then developed a fever of 104 degrees Fahrenheit, was vomiting and taking only sips of fluid.  On 04-Dec-2007 the subject was seen by his primary physician and diagnosed with pneumonia after a chest x-ray showed a right middle lobe infiltrate.  He was prescribed amoxicillin and sent home.  The subject's condition did not improve with continued cough, occasional post-tussive emesis, fever and worsened breathing.  He was admitted to the hospital on 06-Dec-2007 with a oxygen saturation of 91% on room air and a respiratory rate of 55.  The subject was treated with intravenous fluids, ceftriaxone, albuterol nebulizers and supplemental oxygen.  A NP swab done 05-Dec-2007 was positive for RSV. On 08-Dec-2007 the subject was discharged from the hospital and per the father he was reported as doing "fine" with an occasional cough.  The pneumonia was considered resolved on 08-Dec-2007.  No additional doses of FLUMIST were received.  The Study Investigator considered the event of pneumonia as possibly related to study drug.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, HEPA, IPV, MMR
Symptoms: Post-tussive vomiting, Pyrexia, Respiratory rate increased, Respiratory syncytial virus serology positive, Vomiting
Clinical narrative: A serious event of pneumonia was reported by a Study Investigator concerning a four-year-old male subject (Pat ID# 42458400) enrolled in a post-marketed study MI-MA162.  Medical history included cough and congestion with intermittent fever for three weeks.  Concomitant vaccinations included DTaP, IPV, MMR and Hep A and were received on the same day FLUMIST was received.  The subject received FLUMIST on 29-Nov-2007.  The subject had been feeling better for a few days after his vaccinations on 29-Nov-2007, he then developed a fever of 104 degrees Fahrenheit, was vomiting and taking only sips of fluid.  On 04-Dec-2007 the subject was seen by his primary physician and diagnosed with pneumonia after a chest x-ray showed a right middle lobe infiltrate.  He was prescribed amoxicillin and sent home.  The subject's condition did not improve with continued cough, occasional post-tussive emesis, fever and worsened breathing.  He was admitted to the hospital on 06-Dec-2007 with a oxygen saturation of 91% on room air and a respiratory rate of 55.  The subject was treated with intravenous fluids, ceftriaxone, albuterol nebulizers and supplemental oxygen.  A NP swab done 05-Dec-2007 was positive for RSV. On 08-Dec-2007 the subject was discharged from the hospital and per the father he was reported as doing "fine" with an occasional cough.  The pneumonia was considered resolved on 08-Dec-2007.  No additional doses of FLUMIST were received.  The Study Investigator considered the event of pneumonia as possibly related to study drug.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, HEPA, IPV, MMR
Symptoms: White blood cell count increased
Clinical narrative: A serious event of pneumonia was reported by a Study Investigator concerning a four-year-old male subject (Pat ID# 42458400) enrolled in a post-marketed study MI-MA162.  Medical history included cough and congestion with intermittent fever for three weeks.  Concomitant vaccinations included DTaP, IPV, MMR and Hep A and were received on the same day FLUMIST was received.  The subject received FLUMIST on 29-Nov-2007.  The subject had been feeling better for a few days after his vaccinations on 29-Nov-2007, he then developed a fever of 104 degrees Fahrenheit, was vomiting and taking only sips of fluid.  On 04-Dec-2007 the subject was seen by his primary physician and diagnosed with pneumonia after a chest x-ray showed a right middle lobe infiltrate.  He was prescribed amoxicillin and sent home.  The subject's condition did not improve with continued cough, occasional post-tussive emesis, fever and worsened breathing.  He was admitted to the hospital on 06-Dec-2007 with a oxygen saturation of 91% on room air and a respiratory rate of 55.  The subject was treated with intravenous fluids, ceftriaxone, albuterol nebulizers and supplemental oxygen.  A NP swab done 05-Dec-2007 was positive for RSV. On 08-Dec-2007 the subject was discharged from the hospital and per the father he was reported as doing "fine" with an occasional cough.  The pneumonia was considered resolved on 08-Dec-2007.  No additional doses of FLUMIST were received.  The Study Investigator considered the event of pneumonia as possibly related to study drug.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Acute respiratory distress syndrome, Adenoidectomy, Bronchial wall thickening, Chest X-ray abnormal, Cyanosis
Clinical narrative: A serious event of respiratory distress syndrome was reported by a Study Investigator concerning a 39-month-old male subject (Pat ID# 42455284) enrolled in a post-marketed study MI-MA 162.  Medical history included adenotonsillar hypertrophy, obstructive sleep apnea, heavy snoring since birth and worsening gasping and choking with apneic pauses.  The patient's parents both smoke.  No concomitant medications were reported.  The subject received FLUMIST on 15-Oct-2007.  The subject was scheduled for a tonsil and adenoidectomy due to known adenotonsillar hypertrophy and obstructive sleep apnea.  On 18-Oct-2007 the subject developed symptoms of respiratory distress syndrome.  On 21-Oct-2007 the subject was seen in the emergency room for respiratory difficulty after he became pale and blue.  The subject underwent a tonsillectomy and adenoidectomy, after surgery the subject was intubated and a chest x-ray on 22-Oct-2007 showed bronchial thickening, question of mild segmental area of atelectasis or infiltrate in the right base.  On 22-Oct-2007 the subject was extubated and discharged to home on 23-Oct-2007.  The subject did not receive any further doses of FLUMIST.  The Study Investigator considered the event of respiratory distress syndrome as possibly related to study drug.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea, Endotracheal intubation, Lymphoid tissue hyperplasia, Pallor, Tonsillectomy
Clinical narrative: A serious event of respiratory distress syndrome was reported by a Study Investigator concerning a 39-month-old male subject (Pat ID# 42455284) enrolled in a post-marketed study MI-MA 162.  Medical history included adenotonsillar hypertrophy, obstructive sleep apnea, heavy snoring since birth and worsening gasping and choking with apneic pauses.  The patient's parents both smoke.  No concomitant medications were reported.  The subject received FLUMIST on 15-Oct-2007.  The subject was scheduled for a tonsil and adenoidectomy due to known adenotonsillar hypertrophy and obstructive sleep apnea.  On 18-Oct-2007 the subject developed symptoms of respiratory distress syndrome.  On 21-Oct-2007 the subject was seen in the emergency room for respiratory difficulty after he became pale and blue.  The subject underwent a tonsillectomy and adenoidectomy, after surgery the subject was intubated and a chest x-ray on 22-Oct-2007 showed bronchial thickening, question of mild segmental area of atelectasis or infiltrate in the right base.  On 22-Oct-2007 the subject was extubated and discharged to home on 23-Oct-2007.  The subject did not receive any further doses of FLUMIST.  The Study Investigator considered the event of respiratory distress syndrome as possibly related to study drug.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Antibody test positive, Asthenia, Electromyogram normal, Gait disturbance, Muscle tightness
Clinical narrative: A serious spontaneous report of Sjogren's syndrome tingling, twitching, tightness in calves, shaky and weakness, has been received from a registered nurse concerning a 40-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes dry mouth for two years. The patient's WBC (white blood cell ) count was reportedly low in 2007 so the patient had injectable vaccine; no further information was provided. The patient also had three new tooth cavities. The patient has not been taking any prior medication. The patient received FLUMIST on 09-Sep-2008. The patient began having tingling in the thighs, twitching, and tightness in calves (making it difficult to walk) on 03-Oct-2008. Two weeks prior to these events, the patient has been experiencing tingling (felt like asleep) at the tip of the nose. The patient's symptoms progressed over the weekend and by 08-Oct-2008, symptoms in the arms described as weak and shaky, and abdomen and diaphragm twitching were reported. The patient was evaluated in the physician's office and in the emergency room on an unknown date. The patient was not admitted to the hospital. The patient had laboratory tests and an MRI of the brain. On 09-Oct-2008, the patient was informed by the rheumatologist of a diagnosis of Sjogren's syndrome due to elevated SSA (Sjogren's syndrome antibodies) and RA (rheumatoid arthritis) antibodies. The patient's EMG (electromyography) was reportedly "OK." The patient was prescribed baclofen, metaxalone, clonidine and prednisone. The patient will also be placed on hydroxychloroquine. The patient was feeling better after treatment. The reporter causality assessment for the event of Sjogren's syndrome was not related to FLUMIST. The reporter further stated that in retrospect, the patient had symptoms for "quite a while." According to the reporter, the physician felt that the event was not related to FLUMIST.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging brain, Paraesthesia, Rheumatoid factor increased, Sjogren's syndrome
Clinical narrative: A serious spontaneous report of Sjogren's syndrome tingling, twitching, tightness in calves, shaky and weakness, has been received from a registered nurse concerning a 40-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes dry mouth for two years. The patient's WBC (white blood cell ) count was reportedly low in 2007 so the patient had injectable vaccine; no further information was provided. The patient also had three new tooth cavities. The patient has not been taking any prior medication. The patient received FLUMIST on 09-Sep-2008. The patient began having tingling in the thighs, twitching, and tightness in calves (making it difficult to walk) on 03-Oct-2008. Two weeks prior to these events, the patient has been experiencing tingling (felt like asleep) at the tip of the nose. The patient's symptoms progressed over the weekend and by 08-Oct-2008, symptoms in the arms described as weak and shaky, and abdomen and diaphragm twitching were reported. The patient was evaluated in the physician's office and in the emergency room on an unknown date. The patient was not admitted to the hospital. The patient had laboratory tests and an MRI of the brain. On 09-Oct-2008, the patient was informed by the rheumatologist of a diagnosis of Sjogren's syndrome due to elevated SSA (Sjogren's syndrome antibodies) and RA (rheumatoid arthritis) antibodies. The patient's EMG (electromyography) was reportedly "OK." The patient was prescribed baclofen, metaxalone, clonidine and prednisone. The patient will also be placed on hydroxychloroquine. The patient was feeling better after treatment. The reporter causality assessment for the event of Sjogren's syndrome was not related to FLUMIST. The reporter further stated that in retrospect, the patient had symptoms for "quite a while." According to the reporter, the physician felt that the event was not related to FLUMIST.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Tremor, White blood cell count normal
Clinical narrative: A serious spontaneous report of Sjogren's syndrome tingling, twitching, tightness in calves, shaky and weakness, has been received from a registered nurse concerning a 40-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes dry mouth for two years. The patient's WBC (white blood cell ) count was reportedly low in 2007 so the patient had injectable vaccine; no further information was provided. The patient also had three new tooth cavities. The patient has not been taking any prior medication. The patient received FLUMIST on 09-Sep-2008. The patient began having tingling in the thighs, twitching, and tightness in calves (making it difficult to walk) on 03-Oct-2008. Two weeks prior to these events, the patient has been experiencing tingling (felt like asleep) at the tip of the nose. The patient's symptoms progressed over the weekend and by 08-Oct-2008, symptoms in the arms described as weak and shaky, and abdomen and diaphragm twitching were reported. The patient was evaluated in the physician's office and in the emergency room on an unknown date. The patient was not admitted to the hospital. The patient had laboratory tests and an MRI of the brain. On 09-Oct-2008, the patient was informed by the rheumatologist of a diagnosis of Sjogren's syndrome due to elevated SSA (Sjogren's syndrome antibodies) and RA (rheumatoid arthritis) antibodies. The patient's EMG (electromyography) was reportedly "OK." The patient was prescribed baclofen, metaxalone, clonidine and prednisone. The patient will also be placed on hydroxychloroquine. The patient was feeling better after treatment. The reporter causality assessment for the event of Sjogren's syndrome was not related to FLUMIST. The reporter further stated that in retrospect, the patient had symptoms for "quite a while." According to the reporter, the physician felt that the event was not related to FLUMIST.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Altered state of consciousness, Aphasia, Computerised tomogram normal, Dysphemia, Fall
Clinical narrative: A serious spontaneous report of stuttering, aphasia, paresthesia, feeling that all her extremities were "paralyzed," falling to the ground and not cognizant of what happened was received from a physician concerning a 42-year-old female subsequent to FLUMIST. The patient has migraine. She has no hypertension, diabetes or history of transient ischemic attack (TIA). Her past medical history included seizure twelve years ago after she bumped her head. At that time, she was on birth control pills. The patient was never diagnosed with epilepsy nor was she given maintenance anti-convulsant drugs. For the past two weeks prior to FLUMIST vaccination on 24-Sep-2008, the patient has been experiencing intermittent episodes of feeling "funny" and intense headache. The patient is on a lot of unreported medications for unknown indications. The patient received FLUMIST for the first time on 24-Sep-2008. The patient reported "feeling funny" and experiencing intense headache prior to FLUMIST vaccination on 24-Sep-2008. After receiving FLUMIST, the patient went home. While at home and about 30-45 minutes after FLUMIST administration, she began to experience stuttering, aphasia and paresthesia. She also felt that all her extremities were "paralyzed," fell to the ground and was not cognizant of what happened. It was not reported whether she had a black-out. The patient was brought by her friends to the local emergency room. At the emergency room, no focal defects were noted. A head CT scan was performed which showed no abnormality. It was determined that there was no evidence of stroke or intracranial bleed. Since FLUMIST administration, the patient's stuttering, aphasia, and paresthesia have occurred intermittently. The patient's stuttering and aphasia would come and go. The paresthesia affected her extremities alternately at various sites. The symptoms of stuttering, aphasia, and paresthesia did get better. The patient was seen in the physician's clinic on 01-Oct-2008. Her physical and neurologic examination did not reveal any abnormality except that the patient would stutter followed by inability to finish a sentence. Her physician could not be certain if she had true aphasia or whether she could not just find the words to say. Head MRI was done on the same day and was normal. A neurology consult was being considered but no appointment was scheduled. As of 01-Oct-2008, the patient's stuttering, aphasia, and paresthesia have worsened. The adverse events of feeling all her extremities were "paralyzed," Falling to the ground and not cognizant of what happened resolved on 24-Sep-2008.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging normal, Paraesthesia, Paralysis
Clinical narrative: A serious spontaneous report of stuttering, aphasia, paresthesia, feeling that all her extremities were "paralyzed," falling to the ground and not cognizant of what happened was received from a physician concerning a 42-year-old female subsequent to FLUMIST. The patient has migraine. She has no hypertension, diabetes or history of transient ischemic attack (TIA). Her past medical history included seizure twelve years ago after she bumped her head. At that time, she was on birth control pills. The patient was never diagnosed with epilepsy nor was she given maintenance anti-convulsant drugs. For the past two weeks prior to FLUMIST vaccination on 24-Sep-2008, the patient has been experiencing intermittent episodes of feeling "funny" and intense headache. The patient is on a lot of unreported medications for unknown indications. The patient received FLUMIST for the first time on 24-Sep-2008. The patient reported "feeling funny" and experiencing intense headache prior to FLUMIST vaccination on 24-Sep-2008. After receiving FLUMIST, the patient went home. While at home and about 30-45 minutes after FLUMIST administration, she began to experience stuttering, aphasia and paresthesia. She also felt that all her extremities were "paralyzed," fell to the ground and was not cognizant of what happened. It was not reported whether she had a black-out. The patient was brought by her friends to the local emergency room. At the emergency room, no focal defects were noted. A head CT scan was performed which showed no abnormality. It was determined that there was no evidence of stroke or intracranial bleed. Since FLUMIST administration, the patient's stuttering, aphasia, and paresthesia have occurred intermittently. The patient's stuttering and aphasia would come and go. The paresthesia affected her extremities alternately at various sites. The symptoms of stuttering, aphasia, and paresthesia did get better. The patient was seen in the physician's clinic on 01-Oct-2008. Her physical and neurologic examination did not reveal any abnormality except that the patient would stutter followed by inability to finish a sentence. Her physician could not be certain if she had true aphasia or whether she could not just find the words to say. Head MRI was done on the same day and was normal. A neurology consult was being considered but no appointment was scheduled. As of 01-Oct-2008, the patient's stuttering, aphasia, and paresthesia have worsened. The adverse events of feeling all her extremities were "paralyzed," Falling to the ground and not cognizant of what happened resolved on 24-Sep-2008.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Migraine
Clinical narrative: This case was reported by a pharmacist and described the occurrence of migraine in a 45-year-old female subject (also a pharmacist) who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included MOTRIN. On 8 October 2008 at 11:30 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 8 October 2008, approximately 40 to 60 minutes after vaccination with FLULAVAL, the subject experienced migraine, fatigue and tiredness. The pharmacist considered the events were disabling. At the time of reporting the outcome of the events was unspecified.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of migraine in a 29-year-old female subject (a pharmacy technician) who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included paroxetine. On 8 October 2008 at 11:30 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 8 October 2008, approximately 40 to 60 minutes after vaccination with FLULAVAL, the subject experienced migraine, nausea and vomiting. The subject was hospitalized and the pharmacist considered the events were disabling. The subject was treated with ADVIL for migraine. At the time of reporting the outcome of the events was unspecified.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood product transfusion, Diplegia, Facial palsy, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: This case was reported by a physician and described the occurrence of Guillain Barre Syndrome in a 41-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. Concurrent medications included Xanax (0.25 mg, three times daily as needed). Ativan (1 mg at bedtime as needed), atenolol, Glucophage and Lotrel (5/20 mg once daily). Concurrent medical conditions included autosome dominant polycystic kidney disease with early stage renal disease and new onset diabetes. On 26 September 2008 at 09:52 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On the morning of 06 October 2008, the subject presented to the physician's office with numbness and tingling in the upper left limb that had started that morning. The subject was hospitalized on 08 October 2008 or 09 October 2008 and was paralysed including facial muscles, upper and lower limbs and respiratory muscles. The subject was on a ventilator and was unconscious. The physician stated at the time of reporting that at this point they were unsure if the subject was unconscious due to the events or due to medication she is being treated with due to having the ventilator in place. Guillain Barre Syndrome was reported. the subject was treated with intravenous immunoglobulin (dates of treatment thought to be 08 October 2008 through 10 October 2008), but the subject didn't have much response. The physician considered the events were disabling, life threatening and clinically significant or requiring intervention. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Mechanical ventilation, Monoplegia, Paraesthesia, Paralysis
Clinical narrative: This case was reported by a physician and described the occurrence of Guillain Barre Syndrome in a 41-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. Concurrent medications included Xanax (0.25 mg, three times daily as needed). Ativan (1 mg at bedtime as needed), atenolol, Glucophage and Lotrel (5/20 mg once daily). Concurrent medical conditions included autosome dominant polycystic kidney disease with early stage renal disease and new onset diabetes. On 26 September 2008 at 09:52 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On the morning of 06 October 2008, the subject presented to the physician's office with numbness and tingling in the upper left limb that had started that morning. The subject was hospitalized on 08 October 2008 or 09 October 2008 and was paralysed including facial muscles, upper and lower limbs and respiratory muscles. The subject was on a ventilator and was unconscious. The physician stated at the time of reporting that at this point they were unsure if the subject was unconscious due to the events or due to medication she is being treated with due to having the ventilator in place. Guillain Barre Syndrome was reported. the subject was treated with intravenous immunoglobulin (dates of treatment thought to be 08 October 2008 through 10 October 2008), but the subject didn't have much response. The physician considered the events were disabling, life threatening and clinically significant or requiring intervention. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed warmth, redness and swelling of entire RUE to elbow and shoulder. Started about 1-2 hrs after injection. 10/22/08-records received for DOS 10/17-10/18/08-DC DX: Right upper arm erythema, swelling and pain. Admitted with right painful upper right arm. Arm became erythematous, swollen, warm and tender, rash and pain.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Syncope
Clinical narrative: Syncopal episode following administration of HPV# 1 vaccine
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Alopecia, Regressive behaviour
Clinical narrative: Change in behavior (inappropriate laughing, maturity regression), hair loss.  Reported to us 10-21-08.  Status changes were noted approximately 2 weeks after vaccine administration.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Back pain, Cold sweat, Erythema, Local reaction
Clinical narrative: Received vaccines (Flu and Pneumovax) 10/15/08. 10/16/08 Woke up with extreme lower back pain and joint pain. Also started with fever 103 F that day. Sick all day 10/16/08. 10/17/08 - Still had fever 99-100, nausea, clammy, joint pain. (L) arm local reaction. Red/hot/tender 3x5 inches. 10/18/08 Woke up with no problems - back to normal.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, Skin warm, Tenderness
Clinical narrative: Received vaccines (Flu and Pneumovax) 10/15/08. 10/16/08 Woke up with extreme lower back pain and joint pain. Also started with fever 103 F that day. Sick all day 10/16/08. 10/17/08 - Still had fever 99-100, nausea, clammy, joint pain. (L) arm local reaction. Red/hot/tender 3x5 inches. 10/18/08 Woke up with no problems - back to normal.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Fall, Rhinorrhoea, Upper respiratory tract infection, Visual impairment
Clinical narrative: Patient presented 10/17/08 to c/o "fainting" on 10/10/08 pm - 2 days following GARDASIL 10/08/08.  On 10/09/08 patient had URI type.  Symptoms of runny nose - o/w well.  On 10/10/08 patient was in bathroom, standing and starting to feel faint; she saw "stars" and fell to the floor.  Negative LOC.  Appeared "lost" for few minutes.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Heart rate increased, Hypoventilation
Clinical narrative: Patient reports achiness, weakness, dizziness, rapid heart rate, chills and shallow breathing 4 1/2 hrs after receiving flu shot. 22 hours after shot symptoms improving, but not gone.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient reports achiness, weakness, dizziness, rapid heart rate, chills and shallow breathing 4 1/2 hrs after receiving flu shot. 22 hours after shot symptoms improving, but not gone.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills
Clinical narrative: Chills, rigors, weakness x 2 days.
Age: 63.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Wrong drug administered
Clinical narrative: No adverse effects noticed.  Patient given Prevnar instead of Pneumovax, accidentally given by fill in nurse helping that morning.
Age: 64.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Wrong drug administered
Clinical narrative: No adverse effects noted. Pt. given PREVNAR instead of PNEUMOVAX accidently given by fill-in nurse helping that morning
Age: 56.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Wrong drug administered
Clinical narrative: No adverse effect noted; Patient given PREVNAR instead of PNEUMOVAX accidentally given by fill-in nurse helping that morning
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye pain, Flushing, Headache, Pain in extremity
Clinical narrative: Employee states that she received vaccine at 4PM.  That evening around 7PM, she was in a drug store.  Her throat started closing, chest started filling up.  Face got hot.  Vaccinated arm, head and eyes were hurting.  Pharmacist told her to take Benadryl and she did.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Employee states that she received vaccine at 4PM.  That evening around 7PM, she was in a drug store.  Her throat started closing, chest started filling up.  Face got hot.  Vaccinated arm, head and eyes were hurting.  Pharmacist told her to take Benadryl and she did.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Candidiasis, Mouth ulceration, Rash
Clinical narrative: Developed rash on back + buttocks + breast the day after injection per patient.  Pt continues to be treated with magic mouth wash for sores she developed in mouth.  She reports she developed in mouth.  She reports she developed Thrush the day after as well.  but they continued to worsen.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Livedo reticularis, Pruritus
Clinical narrative: 18 hours past vaccination, developed skin mottling, itching, and headache persisted for 3 days. Improved after Prednisone IM, Hydroxyzine and benedryl.
Age: 6.0
Sex: M
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Malaise, Pallor
Clinical narrative: Administered vaccines and when patient stood up he became pale and c/o not feeling well.  Told patient to lay down on exam bed and gave apple juice, took vital signs - BP 96/58, P 77, Sat 98%.
Age: 30.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: Employee was given vaccination 10 am began feeling lightheaded,dizzy and nausea 30 minutes after, then vomited x3 over next 30 min, denied ever having headache, chest pain, difficulty breathing, abdominal pain, swelling, redness or hives.  Employee left work for the day, contacted at home 2 hours later still feeling weak and dizzy.
Age: 30.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: Employee was given vaccination 10 am began feeling lightheaded,dizzy and nausea 30 minutes after, then vomited x3 over next 30 min, denied ever having headache, chest pain, difficulty breathing, abdominal pain, swelling, redness or hives.  Employee left work for the day, contacted at home 2 hours later still feeling weak and dizzy.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Phlebitis, Swelling
Clinical narrative: 2 days after shot patient presented, complaining of swelling, redness, pain.  Doctor prescribed Levaquin 500mg once qd x 10 days, thought it might be Phlebitis.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Vertigo, Vomiting
Clinical narrative: Within 15 minutes of vaccine - vertigo, cold sweats, chills.  After 30 minutes came to pharmacy.  Given 25mg Benadryl.  After 45 minutes emesis x 2.  Stayed with patient til husband picked her up from work.  Would not allow us to call 911 - no insurance.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood electrolytes normal, Blood glucose increased, Blood urea normal, Computerised tomogram normal
Clinical narrative: pt got up to go to bathroom early am, did not feel well and felt weak and dizzy.  She sat and vomited and felt faint- called for help and husband found her on floor- he call 911.  The ambulance took her to BRMC ER where she was Tx Dx and release
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Malaise, Urine analysis normal, Vomiting
Clinical narrative: pt got up to go to bathroom early am, did not feel well and felt weak and dizzy.  She sat and vomited and felt faint- called for help and husband found her on floor- he call 911.  The ambulance took her to BRMC ER where she was Tx Dx and release
Age: 1.6
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Expired Pediarix given.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dry skin, Fear, Muscle tightness, Pallor
Clinical narrative: 11:45am: Patient feels faint and dizzy, pulse 70 regular, strong: pale, BP 98/62: patient sitting with head down.  12:00 noon: called 911 c/o tightness in neck, pale.  12:03pm: EPI 0.2 cc: assisted to another room.  12:08pm: scared, pulse 80 regular strong: skin dry: BP 110/68: color improving.  12:10pm: Life squad on scene, pulse 80: always verbal: color improving: wife called.  12:15pm: Transported to hospital.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Pain in extremity, Tremor, Vomiting
Clinical narrative: had vaccine at 0140,  went home had supper.  At 0515 started with the chills & shaking.  Shaking continued with full body involvement.  No temp.  No diaphoresis. Went to bed.   Vomited x1.  Slept for a while-  next arm felt weak all over legs ached.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Radiculitis brachial
Clinical narrative: Left shoulder soreness worsening over 7 days after vaccine with severe pain starting at night.  Day 7 left brachial neuritis.  RX Medrol dose pak.  RX Amitriptylizine.  RX Vicodisine.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Client c/o redness, soreness, itchiness and slight  rash at injection site on arm began evening of 10/14. Pt called 10/17.  advised to take ADVIL and ice pack and Flu with primary Dr if worsening occurred.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Client c/o redness, soreness, itchiness and slight  rash at injection site on arm began evening of 10/14. Pt called 10/17.  advised to take ADVIL and ice pack and Flu with primary Dr if worsening occurred.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Immediate post-injection reaction, Muscle tightness, Respiratory distress, Tachypnoea
Clinical narrative: Patient noted to develop complaints of chest and neck tightness approximately 5-6 minutes after flu shot, no known prior flu shot reactions, had associated tach apnea and respiratory distress, required albuterol 120 b x 2 with eventual improvement in symptoms, increase pulse flow from 150 to 370, 98% 02 Sat, negative EKG.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dry eye, Eye discharge, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Very dry eyes - developed watery eyes of a puss like fluid that made eyes stick - enlarged throat.  Heaviness in chest with congestion.  Face swelling and puffiness with red eyes by morning.  Still have puffy face and red eyes.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Swelling face
Clinical narrative: Very dry eyes - developed watery eyes of a puss like fluid that made eyes stick - enlarged throat.  Heaviness in chest with congestion.  Face swelling and puffiness with red eyes by morning.  Still have puffy face and red eyes.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, International normalised ratio, Prothrombin time prolonged
Clinical narrative: large ant. of bruising along entire L arm.  Denies pain of L arm.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Expired drug administered
Clinical narrative: Expired Pediarix given.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Expired drug administered
Clinical narrative: Expired PEDIARIX given.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Expired drug administered
Clinical narrative: Expired PEDIARIX given.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Dark circles under eyes, Dehydration, Diarrhoea
Clinical narrative: I received a call from pt, dob:5/14/55 on Thursday 10/16/08 at 1 pm, regarding an adverse reaction that occurred to her following an influenza vaccine injection on Monday 10/13/08 between 10:30 and 11:30 am. . The nurse on-site, had administered the vaccine between the hours of 10:30 and 11:30 and had left the clinic shortly after 11:30. Pt reported that she ate her lunch, at 11 am, it consisted of yogurt and fried chicken that she had brought with her from home that morning. Pt reported that at approximately 1 pm she became violently ill with vomiting, diarrhea, chills and shaking. She reported that she spiked a temp of 103 degrees farenheit. She reported 4 episodes of vomiting that continued into the evening. she remained at work until 4:30 pm at which time an associate offered to drive her home. She refused the offer and states "I drove herself home with much difficulty". She stated that she had dark circles under her eyes the following morning from dehydration. On Thursday at the time of report, she was feeling much better. She was offered an appointment with a physician. Pt refused the appointment. She reports that her family physician and Neurologist in the office where she is employed stated that she should not have received the flu shot due to recent illness. Pt stated that she was on her final day of antibiotics following an episode of pneumonia. She states that she reported the recent illness to the nurse administering the vaccine and was told by that nurse there was no problem with having the vaccine administered at that time. Pt completed and signed a standard on-site vaccine consent form prior to receiving the vaccine. Sanofi/Avenis vaccine lot #U2807AA. Please add an additional page if necessary.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Tremor, Vomiting
Clinical narrative: I received a call from pt, dob:5/14/55 on Thursday 10/16/08 at 1 pm, regarding an adverse reaction that occurred to her following an influenza vaccine injection on Monday 10/13/08 between 10:30 and 11:30 am. . The nurse on-site, had administered the vaccine between the hours of 10:30 and 11:30 and had left the clinic shortly after 11:30. Pt reported that she ate her lunch, at 11 am, it consisted of yogurt and fried chicken that she had brought with her from home that morning. Pt reported that at approximately 1 pm she became violently ill with vomiting, diarrhea, chills and shaking. She reported that she spiked a temp of 103 degrees farenheit. She reported 4 episodes of vomiting that continued into the evening. she remained at work until 4:30 pm at which time an associate offered to drive her home. She refused the offer and states "I drove herself home with much difficulty". She stated that she had dark circles under her eyes the following morning from dehydration. On Thursday at the time of report, she was feeling much better. She was offered an appointment with a physician. Pt refused the appointment. She reports that her family physician and Neurologist in the office where she is employed stated that she should not have received the flu shot due to recent illness. Pt stated that she was on her final day of antibiotics following an episode of pneumonia. She states that she reported the recent illness to the nurse administering the vaccine and was told by that nurse there was no problem with having the vaccine administered at that time. Pt completed and signed a standard on-site vaccine consent form prior to receiving the vaccine. Sanofi/Avenis vaccine lot #U2807AA. Please add an additional page if necessary.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Expired drug administered
Clinical narrative: Expired PEDIARIX given
Age: 0.2
Sex: F
Vaccine: HIBV, PNC, RV5, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Child received BOOSTERIX instead of PEDIARIX per MD order.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: As per mother fever the night of 8/29/07.  Temp 100.5 F.  Stomach pains on 8/30/07.  On 8/31/07 no problems noted.  Child is feeling well.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling of R upper arm.  Warmth to touch noted mother also reports Pt had stomach pains.  Pt was taken to ER on 9/19/2007.  BENADRYL and AMOXICILLIN Q6 hour X 7 days were prescribed.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Culture throat negative, Pyrexia
Clinical narrative: Patient had high fever to 104 within 24 hrs of the Flu Shot
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, Eye pain
Clinical narrative: While pushing FLUMIST in the 2nd nostril, child jerked head backwards and said "some got in my eye - it hurts." Called Medimmune - flushed child's eye with sterile water 5 min. later.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Expired drug administered
Clinical narrative: Expired PEDIARIX given.
Age: 1.9
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Expired PEDIARIX given
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Local swelling, erythema, induration and warmth of (L) leg about 3 x 3" diameter.
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Blister
Clinical narrative: Clusters of small vesicles with much crusting on posterior (R) thigh in dermatomal distribution. Signs and symptoms 5 days
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Cried for 2.5 hour straight with fever to 101.5, screaming very to move either leg. Seen in Emergency Room continued screaming crying intermittently x 12 hrs, still f/u - on 10/4.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Disorientation, Flushing, Headache
Clinical narrative: A Patient that received an on-site flu shot on 10/14/08 between 9am and 10am at the Clinic called 10/20/08 to report an adverse reaction to the flu vaccine that was administered that morning by Clinic Nurse. Patient reported that she received her flu shot at approximately 9:15am that morning. Two hours post vaccination she started with a dry cough, tightness in her chest and throat, headache, malaise and general flu like symptoms. At that time she took at ALAVERT tablet. She ate her lunch which she brought from home despite feeling ill. She states that she continued to experience tightness in her throat, became flushed and pale and vomited. At that time, she was taken to the hospital by squad. At the hospital she was treated for an allergic reaction and given STEROIDS, BENADRYL, PHENERGAN and IV fluids. Labs were drawn. The patient ha no lab results to report. She then stated that she was feeling achy and was administered TORADOL. She was discharged to home at 5:30pm at which time she was extremely groggy. At home she was unable to sleep and experienced twitching in her lower limbs. She took ADVIL PM and states that she fell asleep between 3 and 4am. She complained of feeling congested and disorinte and had a sore throat the following day. She remained off work on Wednesday 10/15 and 10/16 and returned to work on Friday 10/17. She reported that she is feeling much better today, 10/20/08. Flu vaccine - Sanofi Aventis Lot #U2767AA
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Influenza like illness, Insomnia, Malaise, Muscle twitching
Clinical narrative: A Patient that received an on-site flu shot on 10/14/08 between 9am and 10am at the Clinic called 10/20/08 to report an adverse reaction to the flu vaccine that was administered that morning by Clinic Nurse. Patient reported that she received her flu shot at approximately 9:15am that morning. Two hours post vaccination she started with a dry cough, tightness in her chest and throat, headache, malaise and general flu like symptoms. At that time she took at ALAVERT tablet. She ate her lunch which she brought from home despite feeling ill. She states that she continued to experience tightness in her throat, became flushed and pale and vomited. At that time, she was taken to the hospital by squad. At the hospital she was treated for an allergic reaction and given STEROIDS, BENADRYL, PHENERGAN and IV fluids. Labs were drawn. The patient ha no lab results to report. She then stated that she was feeling achy and was administered TORADOL. She was discharged to home at 5:30pm at which time she was extremely groggy. At home she was unable to sleep and experienced twitching in her lower limbs. She took ADVIL PM and states that she fell asleep between 3 and 4am. She complained of feeling congested and disorinte and had a sore throat the following day. She remained off work on Wednesday 10/15 and 10/16 and returned to work on Friday 10/17. She reported that she is feeling much better today, 10/20/08. Flu vaccine - Sanofi Aventis Lot #U2767AA
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pallor, Respiratory tract congestion, Somnolence
Clinical narrative: A Patient that received an on-site flu shot on 10/14/08 between 9am and 10am at the Clinic called 10/20/08 to report an adverse reaction to the flu vaccine that was administered that morning by Clinic Nurse. Patient reported that she received her flu shot at approximately 9:15am that morning. Two hours post vaccination she started with a dry cough, tightness in her chest and throat, headache, malaise and general flu like symptoms. At that time she took at ALAVERT tablet. She ate her lunch which she brought from home despite feeling ill. She states that she continued to experience tightness in her throat, became flushed and pale and vomited. At that time, she was taken to the hospital by squad. At the hospital she was treated for an allergic reaction and given STEROIDS, BENADRYL, PHENERGAN and IV fluids. Labs were drawn. The patient ha no lab results to report. She then stated that she was feeling achy and was administered TORADOL. She was discharged to home at 5:30pm at which time she was extremely groggy. At home she was unable to sleep and experienced twitching in her lower limbs. She took ADVIL PM and states that she fell asleep between 3 and 4am. She complained of feeling congested and disorinte and had a sore throat the following day. She remained off work on Wednesday 10/15 and 10/16 and returned to work on Friday 10/17. She reported that she is feeling much better today, 10/20/08. Flu vaccine - Sanofi Aventis Lot #U2767AA
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Vomiting
Clinical narrative: A Patient that received an on-site flu shot on 10/14/08 between 9am and 10am at the Clinic called 10/20/08 to report an adverse reaction to the flu vaccine that was administered that morning by Clinic Nurse. Patient reported that she received her flu shot at approximately 9:15am that morning. Two hours post vaccination she started with a dry cough, tightness in her chest and throat, headache, malaise and general flu like symptoms. At that time she took at ALAVERT tablet. She ate her lunch which she brought from home despite feeling ill. She states that she continued to experience tightness in her throat, became flushed and pale and vomited. At that time, she was taken to the hospital by squad. At the hospital she was treated for an allergic reaction and given STEROIDS, BENADRYL, PHENERGAN and IV fluids. Labs were drawn. The patient ha no lab results to report. She then stated that she was feeling achy and was administered TORADOL. She was discharged to home at 5:30pm at which time she was extremely groggy. At home she was unable to sleep and experienced twitching in her lower limbs. She took ADVIL PM and states that she fell asleep between 3 and 4am. She complained of feeling congested and disorinte and had a sore throat the following day. She remained off work on Wednesday 10/15 and 10/16 and returned to work on Friday 10/17. She reported that she is feeling much better today, 10/20/08. Flu vaccine - Sanofi Aventis Lot #U2767AA