chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Parasitic test, Pneumonia aspiration, Pollakiuria, Syncope
Clinical narrative: A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Ultrasound testes normal, Varicella virus test negative, Viral test, Weight decreased, West Nile virus test negative
Clinical narrative: A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Blood alkaline phosphatase normal, Blood creatinine normal, Borrelia test negative, Constipation, Dysaesthesia
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning a 5 year old female patient. The patient's medical history included infected insect bite and ear infection. The patient's concurrent disease included congested. On 28-Oct-2009, the patient was receiving FLUMIST (intranasal) for H1N1. Seasonal FLUMIST was given on 23-Sep-2009. Extreme itching and sensitivity in toes spreading to feet, legs and hands developed over several days. She was seen in emergency room on 11-Nov-2009, referred to neurologist, told Guillain-Barre. She treated with TEGRETOL, MOTRIN. She presented with complaints of bilateral foot, toe and hand pain. Later she presented with paresthesias, toes and fingers ache at tips and constipation. Mild Guillain-Barre syndrome was a consideration, dysesthesias consistent with a peripheral neuropathy. Action taken of FLUMIST was unknown. At the time of reporting, the event of Guillain-Barre syndrome was ongoing. According to the company physician the event of Guillain-Barre syndrome was upgraded to serious with the serious criteria of important medical event. Laboratory values were available.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Guillain-Barre syndrome, Hyperaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning a 5 year old female patient. The patient's medical history included infected insect bite and ear infection. The patient's concurrent disease included congested. On 28-Oct-2009, the patient was receiving FLUMIST (intranasal) for H1N1. Seasonal FLUMIST was given on 23-Sep-2009. Extreme itching and sensitivity in toes spreading to feet, legs and hands developed over several days. She was seen in emergency room on 11-Nov-2009, referred to neurologist, told Guillain-Barre. She treated with TEGRETOL, MOTRIN. She presented with complaints of bilateral foot, toe and hand pain. Later she presented with paresthesias, toes and fingers ache at tips and constipation. Mild Guillain-Barre syndrome was a consideration, dysesthesias consistent with a peripheral neuropathy. Action taken of FLUMIST was unknown. At the time of reporting, the event of Guillain-Barre syndrome was ongoing. According to the company physician the event of Guillain-Barre syndrome was upgraded to serious with the serious criteria of important medical event. Laboratory values were available.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pruritus
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning a 5 year old female patient. The patient's medical history included infected insect bite and ear infection. The patient's concurrent disease included congested. On 28-Oct-2009, the patient was receiving FLUMIST (intranasal) for H1N1. Seasonal FLUMIST was given on 23-Sep-2009. Extreme itching and sensitivity in toes spreading to feet, legs and hands developed over several days. She was seen in emergency room on 11-Nov-2009, referred to neurologist, told Guillain-Barre. She treated with TEGRETOL, MOTRIN. She presented with complaints of bilateral foot, toe and hand pain. Later she presented with paresthesias, toes and fingers ache at tips and constipation. Mild Guillain-Barre syndrome was a consideration, dysesthesias consistent with a peripheral neuropathy. Action taken of FLUMIST was unknown. At the time of reporting, the event of Guillain-Barre syndrome was ongoing. According to the company physician the event of Guillain-Barre syndrome was upgraded to serious with the serious criteria of important medical event. Laboratory values were available.
Age: 48.0
Sex: M
Vaccine: IPV
Symptoms: Neck pain
Clinical narrative: Initial unsolicited report received from a healthcare professional on 09 January 2015. A 48-year-old male patient, whose medical history and concomitant medication was not reported, had received intramuscularly a dose of IPOL, (batch number: J1406-1, expiry date: 20-Jul-2015), (dose number was not reported) in right deltoid on 15-Dec-2014. On 19-Dec-2014, patient experienced right sided neck soreness. Illness at the time of vaccination and Pre-existing physician diagnosed allergies were denied by the reporter. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the patient was reported as recovered. Documents held by sender: none. Follow-up received from a nurse on 24 February 2015. The patient had received booster dose of IPOL. The patient did not receive any concomitant medications at the time of IPOL vaccination. No laboratory investigations were performed and corrective actions were not taken. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Initial unsolicited report received from a Nurse on 28 Jan 2015. A 4-year-old male patient, whose medical history and concomitant medications were none, had received a dose of DAPTACEL (batch number C4645AA, expiration date 05-NOV-2016, route of administration unknown on right thigh) on 23 Jan 2015 and also received a dose of IPOL (batch number K1169-2, expiration date 26-MAR-2016, route of administration unknown on right thigh) on 23 Jan 2015. The patient had not received any other vaccination 4 weeks prior to DAPTACEL and IPOL. On 24 Jan 2015 morning it began looking red and puffy and on 26 Jan 2015 seen in the office the patient had 10cm swelling with redness tenderness, but no bruising. Laboratory investigations were none and corrective treatment included treatment with BENADRYL. The outcome of the events was not resolved. The patient required ER visit. Documents held by sender: none. Followup information received from a Nurse on 20 March 2015. It was reported that patient recovered on 30 January 2015. No further redness/swelling to right thigh reported by patient.
Age: 0.96
Sex: M
Vaccine: IPV
Symptoms: Flushing, Pyrexia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 08 January 2015. An 11-month-old male patient, whose concomitant medication was not reported, had received intramuscularly a dose of IPOL, (batch number: J1561) (number of dose not reported) in left thigh on 04-Feb-2014. Medical history was reported as allergy to formaldehyde and polymixin B. On 04-Feb-2014, patient experienced flushing of his facial cheeks and fever of 101.8 degree C. Illness at the time of vaccination and Pre-existing physician diagnosed allergies were denied by the reporter. Corrective treatment was reported as ibuprofen. Laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from nurse (NP) on 25 February 2015. A 05-year-old male patient, whose concomitant medications were not reported, had received a fifth intramuscular dose of DAPTACEL (batch number- C4709AA) and intramuscular and third intramuscular dose of IPOL (batch number- K1649-1) (site of administration was left deltoid for both vaccines) on 24 February 2015. The patient had medical history of no know allergy. And had no illness at the time of vaccination. On 24 February 2015 same day after vaccination, the patient's left arm at injection was OK and experienced indurated and warm just below the injection site to a few inches below the elbow. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of events were not reported. List of Documents held by sender: None. Follow-up report received from a nurse on 10 April 2015. Patient was prescribed to take BENADRYL. On an unspecified date, patient had swelling. It was reported that patient was further needed testing and treatment. At the time of this report the outcome of the event swelling was reported as resolved and the outcome for other events were reported as unknown. List of Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, PNC13, TDAP
Symptoms: Blood test normal, Lymphadenopathy, Pyrexia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 08 April 2015. A 11-year-old male patient, whose medical history was reported as none and concomitant medications were not reported received a second dose of ADACEL (batch number C4713AA) (expiry date, dose, route and site of administration were not reported), a second dose of PNEUMOCOCCAL VACCINE (batch number, expiry date, dose, route and site of adminsitration were not reported), a dose of HEPATITIS A vaccine (batch number, expiry date, dose, route and site of administration were not reported) and a dose of HEPATITIS B VACCINE whose batch number, expiry date, dose, route and site of adminsitratiton were not reported on 03 April 2015. On 06 March 2015, the patient received a second dose of IPOL and also a second dose of MMR II whose batch number, expiry date, dose, route and site of administration were not reported. It was reported that after the vaccination the patient experienced fever of 103 degrees F and swollen lymph nodes of axilla of arm in which had received ADACEL vaccination. It was reported that previously the patient had received first dose of ADACEL (batch number U4963AA) (expiry date, dose, route and site of administration were not reported), IPOL, MMR II and Pneumococcal vaccine (whose expiry date, batch number, dose, route and site of administration were not reported for all the vaccines) on 05 Februray 2015. It was reported that several days after vaccination, patient experienced fever of 103 degrees F and swollen lymph nodes at axillary area of arm in which ADACEL was given. Corrective treatments and other lab test reports were not reported. At the time of this report the patient outcome was unknown. It was reported that patient required Emergency Room/doctor visit. Documents held by sender: none. Follow up information received from a physician on 08 May 2015. It was reported that, patient had received 0.5 ml dsoe of Pneumococcal Vaccine (Batch number: LI3063, Mfr: - Pfizer) and 0.5 ml dose of IPOL (Batch number: K007827)), 0.5 ml dose of HEPATITIS A VACCINE (Batch number: K007827, Mfr: - Merck) and HEPATITIS B VACCINE (Batch number: K02144, Mfr: - Merck). All the vaccines were administered intramuscularly. No new additional information reported. Documents held by sender: none. Follow-up information received from a physician on 06 July 2015. Patient had previously experienced fever and lymphadenopathy when he received first dose of ADACEL, IPOL, MMR II and pneumococcal vaccine. Patient had received antibiotics previously as corrective treatments. A CXR (chest X-ray) and blood tests were conducted which were found to be negative. Patient has visited the office twice. It was reported that the patient was doing well with no further symptoms and recovered from the events on unspecified date. List of Documents held by Sender: none.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Dermatitis contact, Extra dose administered
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 09 June 2015. A five months old male patient, whose medical history and concomitant medications were not reported, had received first dose of PENTACEL (batch number C4828AA and expiry date, site of administration was unknown) via intramuscular route on 24 April 2015. The patient also received the first dose of IPOL (batch number K1694 and expiry date, route and site of administration was unknown) on the same day on 24 April 2015. Thus it was an overdose for IPV. It was reported that patient had no reactions post vaccination, however two months after vaccination, the patient developed contact dermatitis and the patient's mother was trying to claim the two doses of IPV administered in April as the cause. It was reported that patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Based on additional information received on 23-Jul-2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 04 June 2015. A 54-year month-old female patient, had received a first dose of ADACEL (batch number U5095AA, expiry date, dose were not reported) intramuscularly in left deltoid on 01 June 2015 (15:00 hours). Patient had also received a dose of POLIO VACCINE (batch number U001-1, expiry date, dose, dose number were not reported) intramuscularly in left deltoid on 12 May 2015. Illness at the time of vaccination was reported as urinary tract infection (UTI). Pre-existing physician diagnosed allergies birth defects, medical conditions were reported as hypertension (HTN), neuropathy feet and there was no known drug allergy (NKDA). Concomitant medications were lisinopril, gabapentin, NASONEX, CLARITIN, mvi, BIOTIN, vitamin D, calcium. On 01 June 2015 (18:30 hours), i.e. 3.5 hours post vaccination, patient developed low grade temperature (temperature 98 degree celsius) and experienced headache after unspecified time on the same day. Patient had tiredness and muscle aches on 02 June 2015. Other laboratory investigations were reported as none and corrective treatment was not reported. At the time of this report, patient was recovered from the event of low grade temperature on 03 June 2015 and was not recovered from tiredness, muscle aches and headache. Documents held by sender: none. Follow up information received from a nurse on 23-Jul-2015. On 01 June 2015, the patient developed headache. On 02-Jun-2015, he had tiredness and muscle aches. On 05 June 2015, the patient recovered from the above mentioned events. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Completed suicide, Death, Gun shot wound
Clinical narrative: A report has been received from a Study investigator concerning a 15 year old, female subject, Height: 5.1 inches; Weight: 140.0 Pounds, enrolled in study. FLUMIST QUADRIVALENT (intranasal) started on 19-Oct-2013. The patient experienced suicide/intentional self-harm with a firearm which started on 04-May-2014. The patient died from the event of suicide/intentional self-harm with a firearm on 04-May-2014. Assessment of the Serious criteria for the report was as follows: Death. The patient died on 04-May-2014. The cause(s) of death was/were suicide/intentional self-harm with a firearm and gunshot wound of head. The investigator considered that there was no causal relationship between suicide/intentional self-harm with a firearm and FLUMIST QUADRIVALENT.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A report from a physician concerns a patient of unknown gender. No relevant history or concomitant medications provided. The patient received FLUMIST (intranasal) on an unknown date. MD reported that a patient received FLUMIST then tested positive for the flu later that season and was hospitalized, MD stated the patient received FLUMIST again another season and also tested positive for the flu again. MD reported both these occurrences were a few years ago-he did not remember exact season. The outcome of patient tested positive for flu was unknown. The reporter assessed the event of patient tested positive for flu to be serious due to hospitalisation. Laboratory values are available.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Arthralgia, Guillain-Barre syndrome, Lethargy, Pain in extremity, VIIth nerve paralysis
Clinical narrative: A spontaneous consumer report received via regulatory authority concerns a 3 year old male patient. The patient's medical history and concomitant medications were not reported. On 16-Aug-2013, the patient received nasal FLUMIST quadrivalent (intranasal). Patient had leg pain on 25-Aug-2013 and knee pain on 27-Aug-2013. Patient had lethargy and facial droop on 02-Sep-2013. Patient diagnosed with Guillain-Barre syndrome on 03-Sep-2013 and Patient also had VIIth nerve paralysis. The outcome of the events of VIIth nerve paralysis and Guillain-Barre syndrome were unknown. Reporter assessed the Guillain-Barre syndrome to be serious as hospitalization. The event of VIIth nerve paralysis have been identified by the company physician from the source documents and added as serious adverse events as important medical event.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Computerised tomogram normal, Electromyogram normal, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture normal
Clinical narrative: This report to VAERS provides the following narrative: A spontaneous report received from consumer via regulatory authority (VAERS), concerns a 15 year old male patient. The patient's concurrent disease included asthenia. The patient's concomitant medications were not provided. On unspecified date, the patient received FLUMIST (intranasal) Lot Number AH2193 and HPV4. The patient experienced VIIth nerve paralysis/facial droop and Guillain-Barre syndrome. The outcome of the VIIth nerve paralysis/facial droop was unknown and at the time of reporting, the Guillain-Barre syndrome was ongoing. CT, MRI, spinal tap, EMG, labs all essentially normal; given 2 doses IVIG. Reporter assessed the Guillain-Barre syndrome to be serious based on hospitalization. Company physician assessed the VIIth nerve paralysis/facial droop to be serious based on hospitalization.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, VIIth nerve paralysis
Clinical narrative: This report to VAERS provides the following narrative: A spontaneous report received from consumer via regulatory authority (VAERS), concerns a 15 year old male patient. The patient's concurrent disease included asthenia. The patient's concomitant medications were not provided. On unspecified date, the patient received FLUMIST (intranasal) Lot Number AH2193 and HPV4. The patient experienced VIIth nerve paralysis/facial droop and Guillain-Barre syndrome. The outcome of the VIIth nerve paralysis/facial droop was unknown and at the time of reporting, the Guillain-Barre syndrome was ongoing. CT, MRI, spinal tap, EMG, labs all essentially normal; given 2 doses IVIG. Reporter assessed the Guillain-Barre syndrome to be serious based on hospitalization. Company physician assessed the VIIth nerve paralysis/facial droop to be serious based on hospitalization.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Computerised tomogram head normal, Coordination abnormal, Guillain-Barre syndrome, Nuclear magnetic resonance imaging normal
Clinical narrative: A spontaneous report received from health professional via regulatory authority (VAERS), concerns a 5 year old male patient. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). It was reported that patient experienced Guillain-Barre syndrome. The outcome of the event of Guillain-Barre syndrome was unknown. Company physician assessed the Guillain-Barre syndrome to be serious as hospitalization. Summary of follow-up information received by AstraZeneca/MedImmune on 16-Jan-2015 from health professional via VAERS: Lab data were added. Narrative updated. Correction in database only: Reporter's information updated. Vaccine field added.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative, Guillain-Barre syndrome
Clinical narrative: A spontaneous report received from consumer via Regulatory Authority (VAERS) concerning a 3 year old female patient. Concomitant medications were not provided. The patient's medical history included hives. The patient's concurrent disease(s) included tachycardia and shellfish causing hives. The patient had been receiving FLUMIST (intranasal), started on 31-Jan-2014. Lot number was unknown. It was reported that the patient developed Guillain-Barre syndrome approximately 1 week after vaccination with nasal flu vaccine. She required admission to PICU and received IVIG but was recovering nicely, should make full recovery. Never required intubation but had tachycardia requiring monitoring. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. MRI brain contrast done and per report normal. LP contrast done and CSF showed WBC 1, RBC 12, glucose 57, protein 277. The reporter assessed the event of Guillain-Barre syndrome to be serious with the seriousness criteria of life threatening and hospitalization. Laboratory values and diagnostic test details are available.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Immunoglobulin therapy, Intensive care, Nuclear magnetic resonance imaging brain normal, Tachycardia
Clinical narrative: A spontaneous report received from consumer via Regulatory Authority (VAERS) concerning a 3 year old female patient. Concomitant medications were not provided. The patient's medical history included hives. The patient's concurrent disease(s) included tachycardia and shellfish causing hives. The patient had been receiving FLUMIST (intranasal), started on 31-Jan-2014. Lot number was unknown. It was reported that the patient developed Guillain-Barre syndrome approximately 1 week after vaccination with nasal flu vaccine. She required admission to PICU and received IVIG but was recovering nicely, should make full recovery. Never required intubation but had tachycardia requiring monitoring. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. MRI brain contrast done and per report normal. LP contrast done and CSF showed WBC 1, RBC 12, glucose 57, protein 277. The reporter assessed the event of Guillain-Barre syndrome to be serious with the seriousness criteria of life threatening and hospitalization. Laboratory values and diagnostic test details are available.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Areflexia, Asthenia, Guillain-Barre syndrome
Clinical narrative: A spontaneous consumer report received via regulatory authority (VAERS), concerns a 2 year old female patient. Her medical history and concurrent diseases were not reported. Concomitant medications were not reported. On 04-Oct-2012, the patient received FLUMIST (intranasal). Patient was admitted to hospital for symptoms of weakness and areflexia consistent for Guillain-Barre Syndrome which started on 06-Oct-2012. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the Guillain-Barre syndrome to be serious as hospitalization.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Aphonia, Chest X-ray abnormal, Chills, Computerised tomogram head normal, Dysphagia
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Echocardiogram normal, Electromyogram abnormal, Guillain-Barre syndrome, Haemolysis, Hyperbilirubinaemia
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Hypertension, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Mechanical ventilation complication, Motor dysfunction, Muscular weakness, Nausea, Neurological symptom
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging brain normal, Orchitis, Oropharyngeal pain, Paraesthesia, Paraesthesia oral
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Plasmapheresis, Pneumonia aspiration, Polyneuropathy idiopathic progressive, Productive cough, Pyrexia
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Respiratory failure, Respiratory tract congestion, Reticulocyte count increased, Rhinorrhoea, Sensory loss
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.