chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2002-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from the mother of an 11 year old female who experienced runny nose, congestion, cough and sore throat.  At 11 years of age, the pt received a dose on 12/12/03.  The child had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The mother reported that the child only received half of a Flumist dose in one nostril.  On 12/13/03, the child experienced runny nose (rhinorrhoea), congestion (nasal congestion), cough (cough) and sore throat (pharyngolaryngeal pain).  As of 12/17/03, her symptoms persisted.  No additional information was available at the time of this report.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Pharyngolaryngeal pain
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 13 year old male pt who experienced a sore throat and cough.  At 13 years of age, the pt received a dose on 12/15/03. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 0.5mL (IN).  Pt was not taking any concomitant therapy.  On 12/16/103, 1 day post-immunization, the pt experienced a sore throat and cough.  He was being treated with Tanafed.  As of 12/17/03, the symptoms persisted.  No additional information was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a male pt who experienced fever and sore throat.  The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant medications were not reported.  The pt experienced fever (pyrexia) and sore throat (pharyngolaryngeal pain).  No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a female pt who experienced fever of 103 deg. F.  The pt received a dose on an unspecified date.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced fever of 103 deg. F (pyrexia).  No additional information was available at the time of this report.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: Follow-up information pertaining to therapy and event start dates and recovery status was received from the reporter.  Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was reported by a healthcare professional concerning a 6 year old male pt who experienced 13 hours of vomiting after receiving the vaccine on 12/12/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant medications.  The pt experienced 13 hours of vomiting (vomiting) after receiving the first dose of Flumist on 12/12/03.  The pt recovered.  It was reported that the pt received injectable flu vaccine on 02/06/04.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 7 year old son who "got the flu."  The pt received the first dose on 12/11/03. It was reported that the child had no medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The mother reported that on 12/14/03, three days post-immunization, her son "got the flu," experiencing a fever of 103 deg. F, nasal congestion, and body aches.  The symptoms persisted until 12/16/03, resolving without treatment.  No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Sinusitis, Upper respiratory tract infection
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a female pt who experienced upper respiratory infection, general sinus infection and fever.  The pt received the first dose in Dec 2003.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered in Dec 2003. Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  The pt received Flumist on an unspecified date in the beginning of December 2003.  She has been experiencing an upper respiratory infection (upper respiratory tract infection) and general sinus infection (sinusitis) every 2 weeks.  No additional information was available at the time of this report.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 43 year old male consumer who experienced a stuffy nose.  At 43 years of age, the pt received a dose on 12/11/03. The pt's concurrent illness includes anxiety.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Lexapro (escitalopram) and Xanax (alprazolam).  On 12/11/03, the pt experienced a stuffy nose after receiving Flumist.  He was treated with Claritin.  As of 12/18/03, the stuffy nose had not resolved.  No additional information was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a male consumer who experienced a cough and runny nose.  The pt received a dose on 12/13/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced a cough and runny nose several days following administration of Flumist on 12/13/03.  His wife experienced a similar reaction after receiving Flumist (see related case HQWYE887823DEC03).  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a male consumer regarding his wife who experienced a cough and runny nose.  The pt received a dose on 12/13/03. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The caller's wife experienced a cough and runny nose following administration of Flumist.  The caller himself, also experienced a similar reaction (see related case HQWYE887723DEC03).  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Fatigue, Headache, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from the father of an 8 year old male who experienced headache, fever up to 103 deg. F., fatigue and cough.  At 8 years of age, the child received a dose on 12/15/03.  The reporter indicated that the child experiences "something similar with cough and fever every winter."  Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy. The pt experienced headache (headache, fever up to 103 deg. F. (pyrexia), fatigue (fatigue) and cough (cough) on 12/20/03.  The child was treated with ibuprofen.  As of 12/22/03, the headache and fever were much better but the child is still fatigued.  No additional information was available at the time of this report.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 11 year old son who experienced fever.  At 11 years of age, the pt received a dose on 12/18/03.  The pt had sinusitis, cough, and congestion when he received the Flumist.  The physician began therapy with amoxicillin on 12/18/03, since the pt's nasal discharge had changed from clear to yellow.  The pt's medical history also included attention deficit/hyperactivity disorder.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/18/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Ritalin (methylphenidate hydrochloride) and amoxicillin.  The pt began "spiking" a fever (pyrexia) of 101-103 deg. F., on  12/19/03.  The mother stated that Tylenol (acetaminophen) "does not seem to help the fever very much," and ibuprofen helped more, "but you can tell when it wears off."  The mother reported that the pt's cough and congestion were "about the same" as before he received Flumist.  No additional information was available at the date of this report.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal solution (frozen)) was received from a pharmacist regarding a 5 year old female pt who experienced fever of 104 deg. F.  The pt received a dose on 12/17/03. The child received Zyrtec (cetirizine) and albuterol in the summer of 2003 for a cough.  She did not have asthma.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/17/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The pharmacist stated that on 12/19/03, 2 days post-immunization, a father reported that his daughter had a fever of 104 deg. F., when she was picked up from school.  The child's temperature was later rechecked and found to be 102 deg., F.  On follow-up (date not specified), the father reported that his daughter was "fine".  No additional information was available at the time of this report.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal nasal solution (frozen)) was received from a physician regarding a 33 year old female pt who experienced a fever of 102 deg. F., muscle aches, and upper respiratory symptoms (cough).  The pt received a dose on 12/15/03.  The pt's concurrent illness includes allergies.  The pt is otherwise healthy.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03. Dose regimen was 0.5mL (IN).  Concomitant therapy included Flonase (fluticasone propionate) and Singulair (montelukast sodium).  On 12/17/03, 2 days post-immunization, the pt developed a fever of 102 deg. F., muscle aches, and upper respiratory symptoms (cough).  No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer reporting that she experienced "flu" subsequent to receiving Flumist on an unspecified date. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date. Dose regimen was not provided.  Concomitant medications were not reported.  The pt reported that she experienced "flu" subsequent to receiving Flumist on an unspecified date.  She recovered.  No additional information was available at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Follow-up information from the physician's office provided lab results and event outcome (pt recovered).  Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding an 8 year old male pt who experienced a fever of 100.7 deg. F. and a sore throat.  The pt received a dose on 12/20/03.  The pt had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/20/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  On 12/21/03, 36 hours post-immunization, the child experienced a fever of 100.7 deg. F. and a sore throat.  On 12/22/03, he was seen by the physician.  Results of a "rapid strep test" and throat culture were negative.  On 12/24/03, the mother was called with the lab results.  The nurse reported that the child had no further problems.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Pyrexia
Clinical narrative: Follow-up information received from the physician provided illness at the time of vaccination and even outcome (patient recovered). Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a physician regarding a 9-year-old male patient who developed a cough and fever. The patient received a dose on 15-Dec-2003. Medical History: The patient's concurrent illnesses included pyrexia (fever to 101 deg. F), fatigue and pain (body aches) for 24 hours. Product Details: Indication for Flumist (2003-2004 formula) was immunization. Product was administer on 15-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event details: On 20-Dec-2003, 5 days post-immunization, the patient developed a cough and a fever. On 22-Dec-2003, the patient was seen by the physician; his fever at that time was 102.5 deg F. The patient recovered.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion
Clinical narrative: Follow-up information from the physician provided patient's birth weight, changes to concurrent illness and concomitant medication, and event outcome (recovery pending). Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal solution (frozen) was received from a mother regarding her 4-year-old daughter who experienced nasal congestion a few days post-immunization. The patient received a dose on 18-Dec-2003. Medical history: The patient has a past history of acute purulent otitis media. The patient's concurrent illnesses include otitis media and upper respiratory infection. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included Augmentin (amoxicillin sodium/clavulante potassium) and no other vaccines. Event details: A few days post-immunization with Flumist, the child experienced nasal congestion. The physician reported that recovery is "pending."
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Diarrhoea, Influenza like illness, Pyrexia, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse practitioner regarding a 6 year old male pt who experienced flu-like symptoms and diarrhea.  At 6 years of age, the pt received a dose on 12/18/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/18/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy.  On 12/22/03, 4 days post-immunization, the child presented to the clinic for treatment of flu-like symptoms, characterized by nasal discharge, cough, fever of 102.9 degrees F., and diarrhea.  No additional information was available at the time of this report.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 7 year old daughter who, at the time of administration, experienced nasal congestion and later a sore throat.  The pt received a dose on 12/20/03.  The reporter indicated that the pt had no medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/20/2003.  Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  On the day of administration (12/20/03), the pt, as reported by her mother, experienced nasal congestion (nasal congestion).  Two days later, on 12/22/03, she developed a sore throat (pharyngolaryngeal pain).  On 12/23/03, both the nasal congestion and sore throat persisted.  No additional information was available at the time of this report.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Headache
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 15 year old son who experienced a "bad headache" and was "very fatigued".  At 15 years of age, the pt received a dose on 12/23/03. The pt's concurrent illness includes ADHD. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/23/03.  Dose regimen was 0.5mL (IN). Concomitant therapy included Concerta (methylphenidate).  After receiving Flumist at 9:20am on 12/23/03, the pt developed a "bad headache" and became "very fatigued" that afternoon.  No additional information was available at the time of this report.
Sex: U
Vaccine: FLUN3
Symptoms: Nasal congestion
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a pt who developed nasal congestion. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was not provided.  Concomitant medications were not reported.  The pt developed nasal congestion (nasal congestion). The reporter indicated that this event occurred with "several" pt's; however, they are not presently identifiable.  Additional reports will be generated when identifying information is received.  No additional information was available at the time of this report.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 5 year old female pt who experienced fever 102 deg F..At 5 years of age, the pt received a dose on 12/16/03. The child had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/16/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy. The pt experienced fever 102 deg F (pyrexia) on 12/18/03.  The pt was treated with Tylenol (acetaminophen) and recovered after 4 days.  The physician was not notified.  No additional information was available at the time of this report.Follow UP: follow up informaiton received from the physician medically confirmed events.
Age: 21.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A consumer reported that her 21 year old son received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/11/03 and developed a fever of 99.7 deg. F. and a runny , watery, yellow discharge from his right nostril. The reporter indicated that the pt has allergies.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose. The pt was not taking concomitant medications.  The pt received a dose of Engerix-B (hepatitis B vaccine) on 11/11/03 and 12/11/03.  On 12/11/03, a male pt received a dose of Flumist and developed a fever of 99.7 deg. F.  On 12/25/03, the pt developed a runny, watery, yellow discharge from his right nostril.  He was treated with Cefzil (cefprozil) for the "infection".  As of 12/29/03, the fever has resolved, however, the nasal discharge persists.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood urine, Postnasal drip
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 39 year old female pt who experienced blood in her urine.  At 39 years of age, the pt received a dose on 12/15/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN). Pt was not taking concomitant therapy.  On 12/18/03, the pt had two occurrences of blood in her urine (blood urine).  She stated that when the Flumist was administered in her left nostril, it all came out as a stream (pharmaceutical product complaint) and "all drained down the throat and was swallowed."  When it was administered in the right nostril, it came out as a spray, but some of it drained down her throat.  She wanted to know if swallowing Flumist could cause blood in the urine.  The pt indicated that she did not have any blood in her urine on 12/19/03. She stated that she has scheduled an appointment to see her physician.  No additional information was available at the date of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Bronchitis, Sinusitis
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a female pt who experienced sinusitis and bronchitis.  The pt received a dose on an unspecified date. The pt has a past history of influenza (The pt developed the flu following administration of a "flu shot" 25 years ago).  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose. Concomitant medications were not reported.  The pt experienced sinusitis (sinusitis) and bronchitis (bronchitis) on an unspecified date.  No additional information was available at the time of this report.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 6 year old daughter who experienced a runny nose and rash on her back.  At 6 years of age, the pt received a dose on 12/12/03. The pt had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy.  On 12/13/03, 1 day post-immunization, the child experienced a runny nose which lasted for 2 days.  On 12/17/03, she developed a rash on her back. The rash persisted as of 12/19/03.  No additional information was available at the time of this report.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding several nursing home pt's who experienced influenza-like symptoms, after possible accidental exposure to health care workers or family members who received Flumist.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) therapy were not provided. Concomitant medications were not reported.  Several nursing home pt's became sick with "influenza-like symptoms," after possible accidental exposure to health care workers or family members who received Flumist.
Sex: F
Vaccine: FLUN3
Symptoms: Condition aggravated, Cough, Nasal congestion
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a nurse who experienced coughing, congestion, exposure to vaccine and condition aggravated.  The pt's concurrent illness includes asthma. Flumist (2003-2004 Formula) therapy was not indicated for the nurse.  Concomitant medications were not reported.  A nurse, with a history of asthma, experienced increased coughing (cough) and congestion (nasal congestion) beginning on 12/16/03.  The nurse did not receive the vaccine.  She administers Flumist (accidental exposure) and experienced an increase in her coughing (condition aggravated) and congestion (nasal congestion).  No additional information was available at the time of this report.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Dizziness, Lacrimation increased, Nasal congestion, Ocular hyperaemia
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a pharmacist regarding a 43 year old male pt who experienced a runny nose, congestion, red/watery eyes, sneezing, cough, fever (about 100 degrees), feeling achy and dizziness.  The pt received a dose on 12/08/03.  Pt stated that he had no medical history.  He signed a Vaccine Information Statement for Flumist questionnaire provided by the pharmacy flu vaccine program, stating he had no contraindications to receiving Flumist.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/08/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy. On 12/08/03, the pt experienced a runny nose immediately following Flumist administration.  He subsequently developed congestion, red/watery eyes, sneezing, a cough, fever (about 100 degrees), and felt achy and dizzy.  Between 12/11/03 and 12/12/03, his "symptoms peaked" and continued through 12/15/03.  He took Theraflu (caffeine, codeine phosphate, paracetamol, piperylone maleate) for symptom relief.  As of 12/19/03, the pt reported that he was "over it".  No additional information was available at the time of this report.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain, Pyrexia, Sneezing
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a pharmacist regarding a 43 year old male pt who experienced a runny nose, congestion, red/watery eyes, sneezing, cough, fever (about 100 degrees), feeling achy and dizziness.  The pt received a dose on 12/08/03.  Pt stated that he had no medical history.  He signed a Vaccine Information Statement for Flumist questionnaire provided by the pharmacy flu vaccine program, stating he had no contraindications to receiving Flumist.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/08/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy. On 12/08/03, the pt experienced a runny nose immediately following Flumist administration.  He subsequently developed congestion, red/watery eyes, sneezing, a cough, fever (about 100 degrees), and felt achy and dizzy.  Between 12/11/03 and 12/12/03, his "symptoms peaked" and continued through 12/15/03.  He took Theraflu (caffeine, codeine phosphate, paracetamol, piperylone maleate) for symptom relief.  As of 12/19/03, the pt reported that he was "over it".  No additional information was available at the time of this report.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal nasal solution (frozen) was received from a 41-year-old female consumer who experienced severe joint pain. At 41 years of age, the patient received a dose on 18-Dec-2003. Medical History: The patient's concurrent illness includes rheumatoid arthritis. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included ibuprofen (manufacturer unknown). Event Details: on 18-Dec-2003, hours after receiving Flumist, the patient developed severe joint pain. She took ibuprofen with no relief. As of 19-Dec-2003, the pain continued. Related case(s): See related case(s): HQWYE914824DEC03 (In 2002, the patient received a flu shot (manufacturer unknown), and in the first 24 hours, she experienced severe joint pain.) No additional information was available at the time of this report.
Age: 36.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest pain
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal nasal solution (frozen)) was received from a nurse regarding a 36-year-old male patient who experienced feeling like his "chest is on fire." At 36 years of age, the patient received a dose on 16-Dec-2003. Medical History: The patient had no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 16-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event details: On 19-Dec-2003, 3 days post-immunization, the patient experienced a feeling like his "chest is on fire." The patient was advised to see the physician at the office. No additional information was available at the time of this report.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 7-year-old daughter who experienced a severe red, sore throat and a fever of 100 degrees. At 7 years of age, the patient received a dose on 15-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regiment was 0.5 mL (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, 3 days post-immunization, the child experienced a severe red, sore throat and a fever of 100 degrees. As of 19-Dec-2003, her symptoms persisted. Of note, the patient's brother had "strep throat", and had tested positive for strep on the day of his sister's vaccination. No additional information was available at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Follow-up information from the physician revealed that the child received no other vaccines within 4 weeks of Flumist administration. Information regarding Flumist (2003-2004 Formula) (Influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 8-year-old son who experienced vomiting, diarrhea and nausea. The patient received a dose on 18-Dec-2003. Medical History: The child had no medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.25 mL in each nostril. Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, 5 hours after receiving Flumist, the child developed nausea, vomiting and diarrhea. The nausea continued through the night until 5:00 am on 19-Dec-2003. As of 19-Dec-2003, the diarrhea was subsiding and the child was "experiencing very loose stools".  No medications were taken for the diarrhea or vomiting. Of note, the child's mother developed severe joint pain after receiving a dose of Flumist (2003-2004 formula) on 18-Dec-2003 (see MCN: HQWYE893323DEC03).
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Diarrhoea, Gait disturbance, Nausea, Restless legs syndrome
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a physician regarding a 22-year-old male patient who experienced cough, nausea, diarrhea and an uncomfortable feeling in his legs, from his hips down to his toes. At 22 years of age, the patient received a dose on 12-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Dec-2003, at a pharmacy. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 13-Dec-2003, 1 day post immunization, the patient developed a cough. The next day he experienced nausea and diarrhea. On 15-Dec-2003, he developed "this sensation from his hips down to his toes". The patient explains it as "an uncomfortable feeling; he is not comfortable standing, sitting or walking." He feels "as if he has to change his position to get comfortable, but can not". He presented to an urgent care facility with this chief complaint, while traveling. No additional information was available at the time of this report.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Medication error, Pain, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 32-year-old nursing mother who experienced headache, runny nose, body aches and feeling tired. At 32 years of age, the patient received a dose on 17-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 17-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, the patient, a nursing mother, experienced headache, runny nose, body aches and was "feeling tired". As of 19-Dec-2003, all events were unresolved. The subject stated "I wasn't supposed to have Flumist because I'm breastfeeding." Related Case: See related caseHQWYE871922DEC03 (baby case). No additional information was available at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 8-year-old son who experienced a rash, described by a nurse as Fifth disease. At 8 years of age, the patient received a dose on (date not specified). Medical History: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on (date not specified). Dose regimen was 1 dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: On 19-Dec-2003, post-immunization, the child developed a rash, first on his cheeks, and then on the rest of his body, mainly his arms and legs. The rash was described by a nurse as "Fifth disease". No additional information was available at the time of this report.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, Nasal congestion
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a healthcare professional regarding a 20-year-old female patient with systemic lupus erythematosus, who experienced nasal irritation and nasal dryness. The patient received a dose on 15-Dec-2003. Medical History: The patient's concurrent illness includes systemic lupus erythematosus (not currently receiving medication for Lupus). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included tetanus and diptheria toxoids (manufacturer unknown) administered on 16-Dec-2003. Event Details: On 15-Dec-2003, subsequent to Flumist administration, the patient experienced nasal irritation (nasal passage irritation), including dryness (nasal dryness). The reported wanted to know if the patient was at risk for any specific complications due to the fact that she has a history of lupus. The patient's rhematologist is upset that FluMist was given to a patient with lupus (medication error). No additional information was available at the time of this report.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug ineffective, Infection, Influenza, Nasal congestion, Sinus congestion
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 33-year old male consumer who experienced 24 hour flu, nose, sinus and ear congestion. At 33 years of age, the patient received a dose on 15-Dec-2003. Medical History: The patient had a "slight cold" prior to receiving Flumist on 15- Dec-2003, with a past history of ear infections. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details : On 22-Dec-2003, 1 week post-immunization, the patient experienced a "24 hour flu", for which he took Nyquil (detromethorphan hydrobromide and doxylamine succinate and ephedrine sulfate and ethanol and paracetamol). The "24 hour flu" continued as nose, sinus and ear congestion. He was scheduled to see the physician in 1 week. No additional information was available at the time of this report.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Bacterial infection, Malaise, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother (a nurse) regarding her 20-year-old son who felt sick immediately following Flumist and later developed a fever. At 20 years of age, the patient received a dose the week of 08-Dec-2003. Medical History: The patient had a slight cold and little runny nose before receiving Flumist. Product Details: Indication for Flumist (2003-2004) was immunization. Product was administered the week of 08-Dec-2003 at health center. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: the patient "felt sick" immediately following Flumist administration. On 20-Dec-2003, he reported "feeling terrible", developing a fever of 102.6, which increased to 104.4 on the night of 21-Dec-2003. He was treated with Tylenol (acetaminophen) and Advil (ibuprofen), but the fever continued to rise. On the evening of 21-Dec-2003, he was taken to the emergency room at the hospital. He was prescribed Avelox (moxifloxacin) for a possible bacterial infection, and sent home. As of 23-Dec-2003, he was beginning to feel better. Test results: On 21-Dec-2003, chest x-ray results were negative for pneumonia. No additional information was available at the time of this report.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Anorexia, Cough, Ocular hyperaemia, Pharyngitis, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 6-year-old son who experienced fever up to 104.3 F, cold symptoms, runny nose, cough, loss of appetite and eye redness. At 6 years of age, the patient received a dose on 13-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 13-Dec-2003. Dose regiment was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medication were not reported. Event Details: On 16-Dec-2003, 3 days post-immunization, the child began to have a high fever 101-102 F., cold symptoms, runny nose, cough, and his eyes became red. His fever went as high as 104.3 F. He was seen by the pediatrician, and diagnostic test (see below) were within normal limits. As of 23-Dec-2003, the child's fever was 102 F., his eyes had cleared, but he still had a cough, runny nose and loss of appetite. Test results: His chest x-rays and complete blood count were clear and strep test was negative. No additional information was available at the time of this report.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinitis, Rhinorrhoea
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 6-year-old son who experienced fever up to 104.3 F, cold symptoms, runny nose, cough, loss of appetite and eye redness. At 6 years of age, the patient received a dose on 13-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 13-Dec-2003. Dose regiment was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medication were not reported. Event Details: On 16-Dec-2003, 3 days post-immunization, the child began to have a high fever 101-102 F., cold symptoms, runny nose, cough, and his eyes became red. His fever went as high as 104.3 F. He was seen by the pediatrician, and diagnostic test (see below) were within normal limits. As of 23-Dec-2003, the child's fever was 102 F., his eyes had cleared, but he still had a cough, runny nose and loss of appetite. Test results: His chest x-rays and complete blood count were clear and strep test was negative. No additional information was available at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Gastrointestinal disorder, Headache, Infection, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 8-year-old male patient who experienced fever 102 deg F., secondary sinus infection, headache and GI symptoms. At 8 years of age, the patient received the second dose on 18-Feb-2004. Medical History: the child had no relevant medical history. The child was reported as "fine" following receipt of her first dose of Flumist on 16-Dec-2003. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Feb-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 20-Feb-2004, he developed a fever of 102 deg F. (pyrexia) for 2 days followed by a secondary sinus infection (sinusitis). He was treated with Tylenol (acetaminophen) and recovered. In March 2004, he again developed a fever of 102 deg F. with headache (headache) and GI symptoms (gastrointestinal disorder). He was treated with Tylenol (acetaminophen) and recovered by 16-Mar-2004. The reported indicated that the physician was not notified of these events. No additional information was available at the time of this report. Follow up: follow up information received from the physician provided sibling immunization history and medically confirmed the event.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Gastrointestinal disorder, Headache, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a consumer regarding a 7-year-old female patient who experienced fever 102 deg. F., headache and GI symptoms. At 7 years of age, the patient received the second dose on 18-Feb-2003. Medical History: The child had no relevant medical history. The child was reported as "fine" following receipt of her first dose of Flumist on 16-Dec-2003. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Feb-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The patient developed a fever of 102 deg. F. (pyrexia) on 20-Feb-2004. She was treated with Tylenol (acetaminophen) and recovered after 3 days. In March 2004, she again developed a fever of 102 deg. F. with headache (headache) and GI symptoms (gastrointestinal disorder). She was treated with Tylenol (acetaminophen) and recovered by 16-Mar-2004. The reporter indicated that the physician was not notified of these events. No additional information was available at the time of this report.  Follow up: information received from the physician provided sibling immunization history and medically confirmed the event.