chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST, INTRANASAL), 0.2 Millilitres, Unknown. FLUMIST (INTRANASAL) started on 17-Nov-2015. Nurse inadvertently administered FLUMIST to child 18 months old two days ago. FLUMIST was administered in a family health team clinic. The outcome of the event of INADVERTENT ADMINISTRATION TO CHILD <2 YEARS is unknown. The reporter's description of the event (s) was as follows: no asthma. The report was considered to be non-serious. The reporter considered that there was no casual relationship between INADVERTENT ADMINISTRATION TO CHILD <2 YEARS and FLUMIST.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Dizziness, Drug screen
Clinical narrative: Found passed out on bathroom floor at school. Minimally responsive when found by fellow student. Dizzy and lightheaded prior to going to bathroom. Pt was found sleepy but arousable. Pt does not have recollection of passing out once in bathroom.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Electrocardiogram, Hyporesponsive to stimuli, Loss of consciousness, Somnolence
Clinical narrative: Found passed out on bathroom floor at school. Minimally responsive when found by fellow student. Dizzy and lightheaded prior to going to bathroom. Pt was found sleepy but arousable. Pt does not have recollection of passing out once in bathroom.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram normal, Electrocardiogram, Excessive eye blinking
Clinical narrative: Tried to wake up about 7-730 am, left eye very watery, constant blinking, or trying to blink, ate bowl of cereal, something didn't feel right inside my mouth, after eating brushed teeth, went to spit water and is dribbled out on the left side of my mouth, looked in mirror couldn't smile only on right side, left side paralyzed, suspected stroke, went to ER, all CAT, MRI tests show no stroke, it was diagnosed as Bell Palsy. Sent home with anti inflammatory, antibiotic and eye ointment.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Hemiplegia, Lacrimation increased, Nuclear magnetic resonance imaging normal, Urine analysis, VIIth nerve paralysis
Clinical narrative: Tried to wake up about 7-730 am, left eye very watery, constant blinking, or trying to blink, ate bowl of cereal, something didn't feel right inside my mouth, after eating brushed teeth, went to spit water and is dribbled out on the left side of my mouth, looked in mirror couldn't smile only on right side, left side paralyzed, suspected stroke, went to ER, all CAT, MRI tests show no stroke, it was diagnosed as Bell Palsy. Sent home with anti inflammatory, antibiotic and eye ointment.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Albumin CSF increased, CSF immunoglobulin increased, CSF protein increased, Electromyogram abnormal, Gait disturbance
Clinical narrative: Tingling in toes which progressed over the next few days to muscle aches in the patient's calves, legs, and arms.  This gradually progressed to muscle weakness and difficulty going up stairs.  An EMG was done as an outpatient and was highly suspicious for Guillain-Barre, at which point patient was referred to the hospital for definitive diagnosis and treatment. Spinal tap was positive for high protein levels.  Patient received IVIG (Carimune 96 gm daily x 2 days).
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: Tingling in toes which progressed over the next few days to muscle aches in the patient's calves, legs, and arms.  This gradually progressed to muscle weakness and difficulty going up stairs.  An EMG was done as an outpatient and was highly suspicious for Guillain-Barre, at which point patient was referred to the hospital for definitive diagnosis and treatment. Spinal tap was positive for high protein levels.  Patient received IVIG (Carimune 96 gm daily x 2 days).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Condition aggravated, Febrile convulsion, Pyrexia
Clinical narrative: Seizure due to fever of 103.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: High heat at injection site, soreness of whole upper arm, swelling of whole upper arm.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a infant patient of unknown gender. Patient relevant history, concomitant diseases and concomitant medications were not reported. Patient received FLUMIST (intranasal) on 18-Nov-2015. Mother of an infant (6 months old) called a Public Health Nurse to discuss administration of FLUMIST to her child by their physician, RN called Med Info to inquire about administration to children less than 2 years of age as this was not indicated. The dose was administered today to an infant and no adverse events were reported at time of the call. Unsure if this was an intentional administration to this age group by the physician. The outcome of potential inadvertent administration was unknown. Reporter assessed potential inadvertent administration to be serious with the criteria of important medical event.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Based on additional information received on 19 January 2016, this case became medically confirmed. Initial unsolicited report received from non-healthcare professional on 23 October 2015. This case involves a 66-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number: UI458AA, expiration date: 24 April 2016, dose, dose number and route were not reported) in left arm on 16 October 2015. The patient's medical history includes allergy of spinach, kale and marijuana and the patient had previously received vaccination with Fluzone HD which was well tolerated. Patient's concomitant medication was not reported. On 16 October 2015 same day following the vaccination, the patient experienced reddened, hot to touch, area with burning sensation extended to below her elbow of her left arm. Then the red, hot to touch, burning sensation extended to below her elbow to wrist and her elbow was very swollen and skin felt hard. Then over next few days her right arm also became red, hot to touch, swollen, and same burning sensation from her upper arm to her wrist. The patient required ER/doctor visit. Laboratory investigations were not reported. The patient received Benadryl as a corrective treatment. The outcome of the events were not recovered. Patient's arms were much less hot with burning sensation, stated "almost back to normal", although skin still feels rough. As of 23 October 2015, the swelling and redness had resolved. List of documents held by sender: none. Follow up information received from a health care professional on 19 January 2016. It was reported that patient had a medical history of tobacco use disorder -1/2 ppd since 10 years of age, back pain due to work related injury, depression, asthma, RT torn rotator cuff, overweight. Patient had concomitant medications of aspirin lite coat 325 mg tablet 1 tablet once a day, Cymbalta 60 delayed release capsule taken one capsule by mouth every day, albuterol sulfate CFC free 90mcg/inh aerosol 2 puffs q4h prn, Ambien 10 mg tablet 1 tab qhs prn insomnia, chondroitin- glucosamine 1500/1200 mg 2 tabs once a day, lorazepam 0.5 mg tablet 1 tab TID prn, hydrochlorothiazide 12.5 mg capsule 1 cap once a day, Soma 350 mg tablet 1 tab QID, Norco 325 mg-7.5 mg tablet 1 tab every 6 hours prn, Ambien 10 mg tab 1 tab qhs prn insomnia on 16 October 2015. It was also reported that patient received dose 1 of 0.5 ml of FLUZONE HD vaccine and had allergic reaction and her arm was red and swollen by the afternoon of 16th October 2015. Patient was treated with refill soma tablet 350 mg, 1 tab, orally, QID, 30 days, 120 tablets, refill gave 3 rx's, refill Norco tablet, 325 mg-7.5 mg, 1 tab, orally, every 6 hours prn, 30 days, 90, refills gave 3 rx's.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Based on additional information received on 19 January 2016, this case became medically confirmed. Initial unsolicited report received from non-healthcare professional on 23 October 2015. This case involves a 66-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number: UI458AA, expiration date: 24 April 2016, dose, dose number and route were not reported) in left arm on 16 October 2015. The patient's medical history includes allergy of spinach, kale and marijuana and the patient had previously received vaccination with Fluzone HD which was well tolerated. Patient's concomitant medication was not reported. On 16 October 2015 same day following the vaccination, the patient experienced reddened, hot to touch, area with burning sensation extended to below her elbow of her left arm. Then the red, hot to touch, burning sensation extended to below her elbow to wrist and her elbow was very swollen and skin felt hard. Then over next few days her right arm also became red, hot to touch, swollen, and same burning sensation from her upper arm to her wrist. The patient required ER/doctor visit. Laboratory investigations were not reported. The patient received Benadryl as a corrective treatment. The outcome of the events were not recovered. Patient's arms were much less hot with burning sensation, stated "almost back to normal", although skin still feels rough. As of 23 October 2015, the swelling and redness had resolved. List of documents held by sender: none. Follow up information received from a health care professional on 19 January 2016. It was reported that patient had a medical history of tobacco use disorder -1/2 ppd since 10 years of age, back pain due to work related injury, depression, asthma, RT torn rotator cuff, overweight. Patient had concomitant medications of aspirin lite coat 325 mg tablet 1 tablet once a day, Cymbalta 60 delayed release capsule taken one capsule by mouth every day, albuterol sulfate CFC free 90mcg/inh aerosol 2 puffs q4h prn, Ambien 10 mg tablet 1 tab qhs prn insomnia, chondroitin- glucosamine 1500/1200 mg 2 tabs once a day, lorazepam 0.5 mg tablet 1 tab TID prn, hydrochlorothiazide 12.5 mg capsule 1 cap once a day, Soma 350 mg tablet 1 tab QID, Norco 325 mg-7.5 mg tablet 1 tab every 6 hours prn, Ambien 10 mg tab 1 tab qhs prn insomnia on 16 October 2015. It was also reported that patient received dose 1 of 0.5 ml of FLUZONE HD vaccine and had allergic reaction and her arm was red and swollen by the afternoon of 16th October 2015. Patient was treated with refill soma tablet 350 mg, 1 tab, orally, QID, 30 days, 120 tablets, refill gave 3 rx's, refill Norco tablet, 325 mg-7.5 mg, 1 tab, orally, every 6 hours prn, 30 days, 90, refills gave 3 rx's.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test abnormal, Ear infection, Fall, Fibromyalgia, Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a consumer via partner company (Pfizer) (manufacturer reference number- 2015362182) on 17 February 2016. This case involves 75-year-old female patient who was vaccinated with a dose of Flu shot (batch number, route and site of administration not reported) on an unspecified date in October 2014. The patient had also received capsule of Lyrica (150 mg, once a day, orally) for fibromyalgia from an unspecified date to 08 February 2016. The patient's medical history includes allergy, compromised immune system, respiratory illness, genetic/ chromosomal abnormalities, endocrine abnormalities, obesity and concomitant medications were not reported. On an unspecified date in October 2014, few days following the vaccination, the patient had experienced Guillain Barre Syndrome (diagnosed on March 2015). On an unspecified date in December 2015, few months following the vaccination, the patient had experienced urinary tract infection, Fell and hit her head. The patient's concurrent conditions includes well controlled diabetes from 2010. The patient was hospitalized on an unspecified date in December 2015. Laboratory data includes test (needles placed in feet and back) was performed and platelet was 14 times than normal. MRI and X-ray was performed in December 2015, no abnormalities found. On December 2015, blood test was performed, diagnosed with ear infection. The patient had received antibiotic (unspecified) for urinary tract infection as corrective treatment. The outcome of event Guillain Barre Syndrome was reported as recovering. The patient was not recovered from event urinary tract infection and outcome of event Fell and hit my head was not reported. The patient was discharged from hospital on an unspecified date in first week of January 2016. List of documents held by sender: none. Sender's Comments: The patient experience Guillain Barre Syndrome and Urinary tract infection with INFLUENZA VACCINE (unknown manufacture). Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details ruling out any congenital condition metabolic disorders, maternal pre and postnatal history would help assess the events better. The patient received other vaccines so making it difficult to assess the role of each vaccine in particular based on the information available, the role of the vaccine cannot be assessed.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Head injury, Nuclear magnetic resonance imaging normal, Platelet count increased, Urinary tract infection, X-ray normal
Clinical narrative: Initial unsolicited report received from a consumer via partner company (Pfizer) (manufacturer reference number- 2015362182) on 17 February 2016. This case involves 75-year-old female patient who was vaccinated with a dose of Flu shot (batch number, route and site of administration not reported) on an unspecified date in October 2014. The patient had also received capsule of Lyrica (150 mg, once a day, orally) for fibromyalgia from an unspecified date to 08 February 2016. The patient's medical history includes allergy, compromised immune system, respiratory illness, genetic/ chromosomal abnormalities, endocrine abnormalities, obesity and concomitant medications were not reported. On an unspecified date in October 2014, few days following the vaccination, the patient had experienced Guillain Barre Syndrome (diagnosed on March 2015). On an unspecified date in December 2015, few months following the vaccination, the patient had experienced urinary tract infection, Fell and hit her head. The patient's concurrent conditions includes well controlled diabetes from 2010. The patient was hospitalized on an unspecified date in December 2015. Laboratory data includes test (needles placed in feet and back) was performed and platelet was 14 times than normal. MRI and X-ray was performed in December 2015, no abnormalities found. On December 2015, blood test was performed, diagnosed with ear infection. The patient had received antibiotic (unspecified) for urinary tract infection as corrective treatment. The outcome of event Guillain Barre Syndrome was reported as recovering. The patient was not recovered from event urinary tract infection and outcome of event Fell and hit my head was not reported. The patient was discharged from hospital on an unspecified date in first week of January 2016. List of documents held by sender: none. Sender's Comments: The patient experience Guillain Barre Syndrome and Urinary tract infection with INFLUENZA VACCINE (unknown manufacture). Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details ruling out any congenital condition metabolic disorders, maternal pre and postnatal history would help assess the events better. The patient received other vaccines so making it difficult to assess the role of each vaccine in particular based on the information available, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning multiple patients who had been receiving Nasal FLUMIST, INTRANASAL), 0.2 Millilitres, Unknown, which was given when it was out of temperature range which was off label. The FLUMIST was out of temperature range on different occasions between 02-Nov-2015 and 02-Dec-2015. FLUMIST (INTRASNASAL) started on an unknown date. FLUMIST (INTRANASAL) was continued. The outcome of the event TEMPERATURE EXCURSION and OFF LABEL is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (INTRANASAL) started on an unknown date for INFLUENZA. Nurse reported at 17 month old patient accidentally received FLUMIST. The outcome of the event of FLUMIST TO A 17 MONTH OLD INFANT is unknown. The report was considered to be non-serious.
Age: 1.3
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 24-Nov-2015. She had administered the FLUMIST to a 16 months old patient. The outcome of the event of VACCINE GIVEN TO A CHILD UNDER 2 YEARS OF AGE was unknown. The reporter's description of the event (s) was as follows: healthy child. The report was considered to be non-serious. The reporter considered that there was no causal relationship between VACCINE GIVEN TO A CHILD UNDER 2 YEARS OF AGE and FLUMIST. The company physician agreed to it.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction to Zostavax-redness and swelling.
Age: 25.0
Sex: M
Vaccine: HPV4, RAB
Symptoms: Cold sweat, Eye movement disorder, Muscle twitching, Nasopharyngitis
Clinical narrative: Patient received 3rd dose and final dose of pre-exposure rabies vaccine, 3rd dose of HPV4 vaccine about 25 minutes apart. Immediately of HPV administration patient had generalized muscle twitching, no rigidity, eyes rolled back, he was cold and clammy, no loss of consciousness.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Blood test, Pyrexia, Rash, Stevens-Johnson syndrome
Clinical narrative: Client started developing symptoms of fever, facial swelling, hives and rash. She was seen in an express care clinic on 1/13/16 and was given Benadryl and a shot if steroids. Symptoms continued to worsen and she returned to express care on 1/15 and received same rx. She continued to worsen and ultimately went to ED on 1/21/16 and was admitted for 2 days.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: Client started developing symptoms of fever, facial swelling, hives and rash. She was seen in an express care clinic on 1/13/16 and was given Benadryl and a shot if steroids. Symptoms continued to worsen and she returned to express care on 1/15 and received same rx. She continued to worsen and ultimately went to ED on 1/21/16 and was admitted for 2 days.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site infection, Injection site reaction, Soft tissue infection, Ultrasound scan
Clinical narrative: Right deltoid skin and soft tissue infection with likely extension into the muscle following influenza and pneumococcal vaccines.
Age: 77.0
Sex: F
Vaccine: IPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Musculoskeletal stiffness, Pain
Clinical narrative: Large (2") bruise, pain, severe stiffness - pain/stiffness still existing after 14 days, while bruise is now beginning to fade, on 2/23/16.
Age: 44.0
Sex: F
Vaccine: IPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.42
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year 22 weeks 7 days old, Male patient, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 25-NOV-2015. Patient was administered FLUMIST yesterday. Patient does not have any known medical conditions and was currently not on any other medications. Parents of patient had not reported any symptoms post administration. FLUMIST (INTRANASAL) was discontinued on 25-Nov-2015. The outcome of the event of INADVERTENT ADMINISTRATION was unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between INADVERTENT ADMINISTRATION and FLUMIST.
Sex: F
Vaccine: FLUN4
Symptoms: Contraindication to vaccination
Clinical narrative: A report has been received from a Health Professional concerning a, Female subject, who had been receiving FLUMIST (INTRANASAL), 0.2 Millilitres (frequency not reported), for INFLUENZA. Concomitant medications included METHOTREXATE. FLUMIST (INTRANASAL) started on an unknown date for INFLUENZA. The reporter stated that mistakenly FLUMIST was administered to immunosuppression patient. The outcome of the event of FLUMIST MISTAKENLY GIVEN TO IMMUNOSUPPRESSED PATIENT is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning multiple patients of unknown gender, who had been receiving Nasal FLUMIST, INTRANASAL), 0.2 Millilitres, Once/Single administration. FLUMIST (INTRANASAL) started on 13-Nov-2015. It was reported that 10 patients received FLUMIST with temperature excursion. FLUMIST (INTRANASAL) was discontinued on 13-Nov-2015. The outcome of the event of 10 PATIENTS RECEIVED FLUMIST WITH TEMPERATURE EXCURSION is unknown. The report was considered to be non-serious.
Age: 0.92
Sex: F
Vaccine: FLUN4
Symptoms: Off label use
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject who had been receiving Unknown FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 17-Nov-2015. It was reported that the patient experienced inadvertent off-label administration of FLUMIST. The outcome of the event of INADVERTENT OFF-LABEL ADMINISTRATION OF FLUMIST was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a, patients of unknown gender, who received Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (INTRANASAL) was started on an unknown date for INFLUENZA. It was reported that FLUMIST underwent bi-directional temperature excursions. The outcome of the event of TEMPERATURE EXCURSION was unknown. The report was considered to be non-serious.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 12 year old, Female patient, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown. Pharmacist realized that only around half of the FLUMIST volume was delivered to the 12 years old patient after the patient had left the pharmacy. The outcome of ONLY A PARTIAL DOSE DELIVERED TO THE PATIENT was unknown. The report was considered to be non-serious.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that patient was 9 years old and received the FLUMIST vaccine with the second half of the dose not administered fully into the second nostril which started on 18-Nov-2015. The outcome of the event of INAPPROPRIATE ADMINISTRATION was unknown. The report was considered to be non-serious.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Croup infectious, Respiratory syncytial virus test negative, Wheezing
Clinical narrative: Patient received his 2nd dose of flu vaccine for this season and his dad noticed he was wheezing a few minutes afterwards when he arrived home. Dad brought him back to the office and administered a nebulizer  treatment of albuterol sulfate inhalation. 2-23-16 This is a 9 month old here for check-up. Is doing quite well with his molding helmet per Dr. PE is otherwise normal. Immunizations up to date. Recheck in 3 months. 2-23-16 This is a 9 month old here for check-up. We just saw him earlier this morning here for his 9 month check-up. Had a molding helmet on but his exam was normal. We gave him the second flu shot and upon arriving home about half an hour later he started having a little bit of wheezing. Neither of his parents are allergic to eggs. He did not have any problems at all with his first flu shot in November 2015. Upon examination he has more of a croupy sounding voice with very, very minimal wheezing in the lower lung fields. I gave him a neb mask treatment and the wheezing cleared up. I went ahead and did an RSV test but this was negative. Thus may just be the onset of some croup. However it was certainly related from a time point of view within an hour of giving him his flu shot so it could also be a flu shot reaction but he responded well to the breathing treatment. I am going to go ahead and put him on PRELONE syrup 4 ml. Once a day for the next 3 days. They will elevate the head of the bed, use a vaporizer. They will call if symptoms worsen. 6-11-15 This is an extended visit for this 2 week old that was born at 37 weeks. Had an induced vaginal delivery because of maternal preeclampsia. Was admitted directly to the NICU where certainly after birth started having some seizure activity. We don't have the complete dictated records yet. Was sent home with the diagnosis of hypoxic ischemic encephalitis and is on KEPPRA and also Phenobarbital which are being monitored by the neonatology service. We are going to try to get an appointment in the near future with neurology. The child otherwise is taking pumped breast milk 60-90 cc's every 3 hours and is gaining weight. The child's exam does have a right turn of his head but will work with this over the next couple of weeks. May need physical therapy if it does not resolve. Neurological evaluation is normal. HEENT is negative. Neck is supple. Chest is supple to auscultation. Cardiac exam is normal. Abdominal exam is unremarkable. IMP: Seizure disorder secondary to hypoxic encephalopathy. Will get an appointment as soon as we can. Will also recheck in 1-2 weeks to make sure that his weight gain is going well. Answered numerous questions for this very nice family.
Sex: M
Vaccine: FLUN4
Symptoms: Nasal discomfort, Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 6 month old Male patient, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient when the first half dose was given in the first nostril the child reported irritation in his nostrils. and did not left her give the second half of the dose. The outcome of the event of irritation in the nostril when FLUMIST administered led to only giving one half the dose of FLUMIST was unknown. The report was considered to be non-serious The reporter considered that the irritation in the nostril when FLUMIST administered led to only giving half the dose to be unrelated with suspect drug FLUMIST Quadrivalent.
Age: 67.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: CD4 lymphocytes, Rash, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: Received varicella vaccine on 11/3/15, presented with rash on 11/23/15. VZV DFA positive for VZV. Treated with valacyclovir, resolved. Prior to this, he was removed from all immunosuppression for a full years time, and CD4 count was >1000 prior to vaccination with live vaccine.
Age: 0.83
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: A spontaneous report has been received from a health professional via Med rep. concerning a 46 weeks 1 day old female patient. Patient concomitant medications and relevant history was not reported. It was reported that the patient was 11 months old and had administered nasal FLUMIST Vaccine on 10-Nov-2015. Patient since administration has not experienced any symptoms. It was patient's first flu vaccination. At the time of administration, patient was not taking any other medications. The outcome of the event of inadvertent administration was unknown. The reporter assessed the event of inadvertent administration to be non-serious. The reporter and company physician considered that there was no causal relationship between the event inadvertent administration and FLUMIST.
Sex: F
Vaccine: FLUN4
Symptoms: Allergy to vaccine, Drug hypersensitivity, Hyperlipidaemia
Clinical narrative: A solicited report has been received from consumer via Patient Assistance Program concerning a Female patient, enrolled in Non-interventional/Post-marketing study. The patient's concurrent disease included allergy to cipro, allergy to iodines and allergy to sulfa drugs. Concomitant medications included rosuvastatin calcium for hyperlipidemia. Patient had been received nasal FLUMIST (intranasal) and oral Lisinopril, on an unknown date. The patient had documented allergy to flu vaccine and documented allergy to lisinopril and also diagnosed with hyperlipidemia. Action taken with Lisinopril was unknown. The outcome of the event of documented allergy to flu virus vaccine, documented allergy to lisinopril and hyperlipidemia was unknown. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event documented allergy to flu virus vaccine to be related to FLUMIST. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event documented allergy to lisinopril to be related to Lisinopril. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event hyperlipidemia to be not related to FLUMIST and Lisinopril.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain was immediate after administration of injection. Injection was administered to the back of the upper left arm by a an unsupervised nursing student. I have weakness, constant pain on upper left arm and left shoulder.   I have limited range of motion of left arm and shoulder. I have received physical therapy but no relief.  Currently on Gabapentin for possible nerve damage to injected arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching around the site of injection spreading about in a 3 inch area, resolved after treatment with antihistamines.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Headache, Red/Swollen/Warm at the injection site. Temperature of 100.6. Patient was treated with acetaminophen 1 g.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Device malfunction, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Arm became very sore, but not the usual soreness from past flu shots, within two hours.  The first injection given malfunctioned so the nurse repeated it a bit higher on the arm.  The shoulder was very sore and it radiated down the arm to the elbow.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: Arm became very sore, but not the usual soreness from past flu shots, within two hours.  The first injection given malfunctioned so the nurse repeated it a bit higher on the arm.  The shoulder was very sore and it radiated down the arm to the elbow.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Right arm pain and swelling.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Cyanosis, Respiratory arrest, Sudden infant death syndrome
Clinical narrative: I saw him turning blue and not breathing. I immediately picked him up and rubbed his back and patted his back to get him to breathe and immediately called the nurse. They came in 10 minutes later but they did not check him out and said he was fine.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Audiogram abnormal, Deafness, Deafness neurosensory, Ear discomfort, Hypoacusis
Clinical narrative: Acute hearing loss as 1/21/2016 - began in AM. Had PREVNAR 1/20. Treated with decongestants, nasal and oral steroids and valacyclovir without improvement. Saw me for routine physical 1/20/2016. Came in with acute onset "blocked ear" on 1/21/2016. Decreased hearing reported. On 1/20 at her physical, review of system revealed no ear complaints. She was treated empirically for suspected serous otitis; Fluticasone and AFRIN recommended. She used the AFRIN. She contacted me 1/25/16 saying hearing had not changed. I prescribed a nasal steroid and recommended ENT eval. She saw ENT specialist 1/25/2016 - report states she had a "sudden profound SNHL AS". Empiric steroids and valacyclovir were given. She had MRI brain/internal auditory canal which was negative. She's had no improvement in loss of hearing.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging brain normal, Otitis media, Ultrasound Doppler normal
Clinical narrative: Acute hearing loss as 1/21/2016 - began in AM. Had PREVNAR 1/20. Treated with decongestants, nasal and oral steroids and valacyclovir without improvement. Saw me for routine physical 1/20/2016. Came in with acute onset "blocked ear" on 1/21/2016. Decreased hearing reported. On 1/20 at her physical, review of system revealed no ear complaints. She was treated empirically for suspected serous otitis; Fluticasone and AFRIN recommended. She used the AFRIN. She contacted me 1/25/16 saying hearing had not changed. I prescribed a nasal steroid and recommended ENT eval. She saw ENT specialist 1/25/2016 - report states she had a "sudden profound SNHL AS". Empiric steroids and valacyclovir were given. She had MRI brain/internal auditory canal which was negative. She's had no improvement in loss of hearing.
Age: 8.0
Sex: U
Vaccine: FLUN4
Symptoms: Overdose
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown. It was reported that the patient was given 2 doses of the FLUMIST on the same day. FLUMIST (INTRANASAL) was continued. The patient recovered from the event of TWO DOSES ON THE SAME DAY on an unspecified date. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Female subject, Height: 44.0 IN; Weight 49.0 Pounds, who had received FLUMIST quadrivalent, (intranasal), 0.2 Millilitres, Once/Single administration. The patient's medical history included wheezing. FLUMIST quadrivalent, (intranasal) started on 16-Nov-2015. It was reported that the patient received FLUMIST quadrivalent on 16-Nov-2015 after a temperature excursion of 34.7 degrees Fahrenheit for 20 hours. FLUMSIT quadrivalent (intranasal) was discontinued on 16-Nov-2015. The outcome of the event of consumer received FLUMIST quadrivalent on 16Nov2015 after a temperature excursion of 34.7 degrees Fahrenheit for 20 hours is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. Patients were administered FLUMIST that underwent multiple temperature excursion. The outcome of the event of PATIENTS ADMINISTERED IMPROPERLY STORED FLUMIST was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender. Relevant history, concurrent diseases and concomitant medications of the patient not reported. Health professional reported that patient received FLUMIST quadrivalent, (intranasal) vaccine 0.2ml, date of administration not provided. Health professional reported that patient received the whole 0.2ml dosage of FLUMIST quadrivalent vaccine in one nostril. The outcome of the event 0.2ml dosage of FLUMIST quadrivalent vaccine in one nostril was unknown. The company physician assessed event to be non-serious. Corrected report on 10-Dec-2015: Medical advice step added for LOT analysis.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Physician concerning a 7 year old, male patient, who had been receiving Nasal FLUMIST (Intranasal), 0.2 Millilitres, Once/Single administration for VACCINATION. FLUMIST (Intranasal) started on an unknown date for vaccination. The patient experienced 102.1 fever. FLUMIST (Intranasal) was continued. The outcome of the event of 102.1 fever was unknown. The report was considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error, Crying, Exposure via direct contact, Eye pain
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Once/Single administration for recommended by the CDC. FLUMIST (intranasal) started on 16-Nov-2015 for recommended by the CDC. It was reported that on 16-Nov-2015, the patient jerked and a drop got into the patients eye. It looked like the FLUMIST stung her eye and she began to cry. FLUMIST (intranasal) was discontinued on 16-Nov-2015. The patient recovered from the event of STUNG HER EYE and PATIENT JERKED AND A DROP GOT INTO THE PATIENT'S EYE on 16-Nov-2015. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error, Drug administration error
Clinical narrative: A report received from a pharmacist concerning a 15 year old, male patient. Patient has received the Flu shot vaccination in the past (not FLUMIST). Patient had received nasal FLUMIST, (intranasal) started on an unknown date. On Saturday, Nov 14, 2015, patient was administered by a pharmacist FLUMIST quadrivalent. Thirty seconds after the second half of the vaccine was administered into the second nostril, the patient experience a drop coming out of his nostril onto his pants and then some more dripping occurred onto his lips area which the pharmacist wiped with a tissue. Action taken of FLUMIST was unknown. The outcome of inappropriate administration was unknown. The report was considered to be non-serious by reporter.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, No adverse event
Clinical narrative: A spontaneous report has been received from a pharmacist concerning a 10 year old, female patient. No medical history or concomitant medications taken. On 13-Nov-2015, nasal FLUMIST (intranasal) was administered in a pharmacy by a pharmacist for influenza vaccination. Lot number unknown. Pharmacist removed stopper by mistake and 0.2 ml went into one nostril. Pharmacist described that he was in a rush and when going to administer in the second nostril, realized he had accidentally given it all in one nostril. No adverse reactions were reported. The report was considered to be non-serious by the reporter.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional via medical representative concerning an 11 years 26 weeks old, male patient. No medical history and concomitant medications provided. The patient received FLUMIST (intranasal), 0.2 millilitres, one time administration, nasally, on 03-Nov-2015 for vaccination. The patient was diagnosed on 14-Nov-2015 with influenza by the emergency room. FLUMIST was continued. The outcome of the event of diagnosis of influenza was unknown. The company physician considered diagnosis of influenza to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report received from a Health Professional via medical rep. concerning a female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received nasal FLUMIST Quadrivalent, 0.2 milliliters on 03-NOV-2015. The patient had influenza which started on 14-NOV-2015. FLUMIST Quadrivalent was continued. The outcome of influenza was unknown. The report was considered to be non-serious by company physician.
Sex: M
Vaccine: FLUN4
Symptoms: Fear of injection
Clinical narrative: A consumer report has been received. The report concerns a Male patient who received FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown. FLUMIST (INTRANASAL) was started on an unknown date. The patient experienced TRYPANOPHOBIC. The outcome of the event of TRYPANOPHOBIC was unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, Product quality issue
Clinical narrative: A report received from a health professional concerning a 15 year old female patient, height 63.0 inches, weight 110.0 pounds. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received Nasal FLUMIST Quadrivalent, 0.2 milliliters, once/single administration started on 16-NOV-2015. The HCP reported that the spacer came off the FLUMIST sprayer and because of this the entire 0.2ml dose of FLUMIST Quadrivalent was administered to the patients one nostril on 16-NOV-2015. And also product quality complaint was reported. FLUMIST Quadrivalent was discontinued on 16-NOV-2015. But action taken FLUMIST Quadrivalent was reported as none. The patient recovered from 0.2ml dose of FLUMIST was received in one nostril on 16-NOV-2015. And outcome of product quality company was unknown. The report was considered to be non-serious by company physician.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a female patient, Height: 118.1 Centimeter; Weight: 43.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent, 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on 16-NOV-2015. The patient received FLUMIST Quadrivalent on 16NOV2015 after temperature excursion of 34.7 Fahrenheit for 20 hours. FLUMIST Quadrivalent was discontinued on 16-NOV-2015. The outcome of the event of consumer received FLUMIST Quadrivalent on 16NOV2015 after temperature excursion of 34.7 degrees Fahrenheit for 20 hours was unknown. The report was considered to be non-serious.
Age: 50.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 50 year old, Male subject, who had been receiving Nasal FLUMIST Quadrivalent, 0.2 milliliters. FLUMIST Quadrivalent started on 26-OCT-2015. Physician Assistant reported that FLUMIST was administered to 50 year old male on OCT 26, 2015. This information was considered as Drug use in unapproved age group. The outcome of the event of administration to 50 year old is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a pharmacist, concerning a female patient. The patient's relevant medical history, concomitant medications and concurrent diseases were unknown. On an unknown date, the patient received nasal FLUMIST Quadrivalent, 0.2 milliliters. Single nostril administration was reported. The outcome of the event of single nostril administration was unknown. The report was considered to be non-serious by the company physician.
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product, Malaise, Nasopharyngitis
Clinical narrative: A solicited report has been received from a Health Professional enrolled in non-interventional/post-marketing study, concerning herself, who had been receiving Nasal FLUMIST Quadrivalent for patient exposed to FLUMIST while administering it. FLUMIST Quadrivalent started on an unknown date for patient exposed to FLUMIST while administering it. The nurse reported that she was feeling sick today and every time she administered FLUMIST she got sick. The first time she administered it within a week, she got a cold but normally she does not get cold easily. Then after 6 weeks, within 6 hours administering it again she started getting cold. The outcome of the event of the first time she administered it within a week, she got a cold but normally she doesn't get cold easily/within 6 hours administering it again she started getting a cold and every time she administers FLUMIST she gets sick is unknown. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the events every time she administers FLUMIST she gets sick and the first time she administered it within a week, she got a cold but normally she doesn't get cold easily/within 6 hours administered it again she started getting a cold with the suspect drug of FLUMIST quadrivalent to be related.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: A report was received from a physician concerning a 3 year old female patient with height of 78 centimeters and with weight of 11 kilograms. The patient's concurrent disease included congenital hypothyroidism. Concomitant medications included lidocaine, prilocaine, ipratropium bromide, levothyroxine and salbutamol. On 143-NOV-2015, the patient was administered  with nasal influenza virus. Report provided no information about the influenza vaccine manufacturer, brand, lot or route of administration. Patient had the flu vaccination. Soon after developed hives on the trunk and limbs. It was considered as an allergic reaction. At the time of reporting, the event of allergic reaction and hives was improving. According to the reporter the adverse events was considered to be serious with the serious criteria of important medical event.
Sex: U
Vaccine: FLUN4
Symptoms: Diarrhoea, Influenza A virus test positive, Influenza B virus test positive, Pyrexia
Clinical narrative: A report has been received from a Physician via Medical Rep concerning a patient of unknown gender, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMSIT quadrivalent (intranasal) started on 03-Dec-2015. The patient experienced high temperature and diarrhea which started on 04-Dec-2015 and tested positive for A and B strains of the Flu. The outcome of the event of high temperature diarrhea and tested positive for A and B strains of the Flu is unknown. The report was considered to be non-serious.