chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 31 year old female pt who experienced mouth numbness, tingling of mouth and headache. At 31 years of age, the pt received the first dose on 12/10/03. Five minutes post-immunization, the pt experienced mouth numbness, tingling of mouth and headache. The reporter indicated that the pt was not allergic to eggs and has no history of reactive airway disease. The reporter also indicated that the pt has never had influenza vaccine prior to this event. No additional info was available at the time of this report.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A 48 year old female report that she received a dose of Flumist and on 12/10/03, experienced a severe bloody nose. On 12/10/03, the reporter experienced a severe bloody nose, after receiving a dose of Flumist. No additional info was available at the time of this report.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Dry throat, Nasal congestion, Pharyngitis, Rhinitis, Sneezing
Clinical narrative: A 32 year old female reported that she received a dose of Flumist on 12/8/03, and experienced "feeling like I was coming down with a cold" afterward. On 12/10/03, 2 days post-immunization, the reporter experienced "feeling like I was coming down with a cold," characterized by sneezing, nasal congestion, and dry throat. As of 12/11/03, all symptoms were unresolved. No additional info was available at the time of this report.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Musculoskeletal stiffness, Sinusitis
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 6 year old male pt who experienced sinus symptoms and a stiff neck. At 6 years of age, the pt received a dose on 12/10/03. The pt developed sinus symptoms and a stiff neck during the night on 12/10/03. The reporter noted that the physician did not feel that the events were related to Flumist. No additional info was available at the date of this report.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 6 year old female pt who experienced redness in the neck. The pt received a dose on 12/11/03. The patient's neck turned red immediately after receiving the Flumist on 12/11/03. The nurse stated that the tp said she felt fine. The nurse indicated that there was no sign of a rash, just redness. No additional info was available at the date of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Myalgia, Nausea
Clinical narrative: A physician reported that she administered Flumist to 3 students on 12/11/03 and later experienced flu-like symptoms characterized by myalgias, chills, sweats and nausea. On 12/11/03, the reporter (a physician), administered Flumist to 3 students at the student health center, and then stayed with the students in the same room for about an hour. At 7pm that night, she started to get flu-like symptoms, experiencing myalgias, chills, sweats and nausea. She took no medications to treat her symptoms. The next morning, she was still not feeling better and was not able to go to work. She was feeling a lot better at the time of this report. She was concerned about whether she developed her flu-like symptoms as a result of administering Flumist. No additional info was available at the time of this report.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
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 22 year old male pt who experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness.  At 22 years of age, the pt received a dose on 12/11/03.  The pt has a past history of syncope vasovagal.  The pt had no history of egg allergy.  He had passed out previously when having blood drawn.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Zirtec (cetirizine hydrochloride).  The pt experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness on 12/11/03.  No additional information was available at the date of this report.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
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 22 year old male pt who experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness.  At 22 years of age, the pt received a dose on 12/11/03.  The pt has a past history of syncope vasovagal.  The pt had no history of egg allergy.  He had passed out previously when having blood drawn.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Zirtec (cetirizine hydrochloride).  The pt experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness on 12/11/03.  No additional information was available at the date of this report.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A pharmacist reported that an 11 year old female pt inadvertently received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 Formula) nasal solution (frozen)) into a single nostril on 12/12/2003.  The reporter indicated that the pt does not have any relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Concomitant medications were not reported.  Concomitant vaccines were not administered.  On 12/12/03, a female pt inadvertently received a dose of Flumist into a single nostril.  The reporter indicated that the pt stated the Flumist "tasted sweet" right after administration.  No additional information was available at the time of this report.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye oedema
Clinical narrative: A consumer reported that a 49 year old female pt received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 Formula) nasal solution (frozen)) on 12/11/03.  The pt's concurrent illnesses include hypersensitivity (allergy to PCN and Ceftin), depression (dysthymia), ADHD and mitral valve prolapse with a past history of hysterectomy (five years ago).  The pt has no known food allergies.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL 1 time per day (IN).  Concomitant therapy included Premarin, Paxil and Adderall.  Concomitant vaccine were not administered.  On 12/12/03, a 49 year old female experienced a "puffed up left eye" after receiving a dose of Flumist.  The reporter stated that her left eye was "swollen, but with no redness, drainage, or itching".  The adverse event has not resolved.  No additional information was available at the time of this report.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Inflammation, Rash
Clinical narrative: A 40 year old male pt reported that he received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/10/03.  The pt has no known drug allergies.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/10/03.  Dose regimen was 1 dose 1 time per day (intranasal).  Concomitant medications were not reported.  On 12/11/03, a 40 year old pt developed a rash in and around the right nostril after receiving a dose of Flumist.  The reporter states that the rash is red and raised and hurts when touched.  The rash covers 1/16 inch on the inside of the right nostril and 1/4 inch on the outside of the right nostril.  The rash extends up and around the right nostril, and the nose is inflamed on the right side.  No additional information was available at the time of this report.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Lethargy, 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 consumer regarding a 7 year old female pt who experienced nasal congestion, feeling lethargic and cough.  At 7 years of age, the pt received a dose on 10/16/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 10/16/03.  Dose regimen was 1 dose intranasal.  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion), feeling lethargic (lethargy), and cough (cough) on 10/16/03.  The pt's mother stated that she doesn't know if these events are related to Flumist or seasonal allergy or cold. As of 10/29/03, the pt's symptoms persisted.  No additional information was available at the date of this report.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Lethargy, 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 consumer regarding a 5 year old male pt who experienced nasal congestion, feeling lethargic and cough.  At 5 years of age, the pt received a dose on 10/16/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 10/16/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion), feeling lethargic (lethargy) and cough (cough) on 10/16/03.  The pt's mother stated that she did not know if the events were related to Flumist or to seasonal allergy or cold.  As of 10/29/03, the pt's symptoms persisted.  No additional information was available at the time of date report.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Headache, Pharyngolaryngeal pain, Pyrexia, Respiratory disorder
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 fever of 99-100, sore throat, headache, coughing and more raspy breathing.  At 8 years of age, the pt received a dose on 12/08/03.  The pt's concurrent illness includes seasonal asthma (October to April).  Indication for Flumist (2003-2004 formula) was immunization. Product was administered on 12/08/03.  Dose regimen was 0.5mL (IN).  Concomitant therapy included Albuterol.  On the evening of 12/11/03, 3 days post-immunization, the child experienced coughing, "more raspy breathing", fever of 99-100, sore throat and headache.  He was treated with albuterol nebulizer and given Children's Advil.  No additional information was available at the time of this report.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood glucose increased, Dizziness, Gait disturbance, Vomiting
Clinical narrative: Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 16 year old son who experienced leg buckling, felt like passing out, vomiting and blood sugar increased.  At 16 years of age, he received a dose on 12/11/03.  The pt's concurrent illness include diabetes melllitus since 4 years of age.  The reporter indicated that her son's blood sugar goes up and down routinely.  The reporter indicated that her 8 year old daughter developed a "stomach bug" on 12/10/03.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL 1 time per day IN.  Concomitant therapy included Lantus and Novolog.  The pt woke up on the morning of 12/12/03, and experienced leg buckling, vomiting, and he felt like passing out.  A blood sugar reading of 392 was "higher than normal" (blood glucose increased)(condition aggravated).  He was given 8 units of Novolog.  Later that same day, another fasting blood sugar reading was 145.  The reporter indicated that her son was resting in bed and "felt better". Follow-up information received from the reporter on 05-Jan-2004 provided the lot number and information on previous doses of vaccines. The reported stated that the patient recovered.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Fatigue, Pharyngolaryngeal pain, 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 father regarding his 5 year old daughter who experienced fever, weakness, tiredness, runny nose, sore throat, and swollen throat.  At 5 years of age, the pt received a dose on 12/10/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/10/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  On 12/11/03, the pt was sent home from school due to weakness and tiredness.  Later that same day, she developed a runny nose, sore throat, and swollen throat.  That night she woke up with a fever of 103 deg F.  As of 12/12/03, she still had a fever of 99 deg F, runny nose and sore, swollen throat.  No additional information was available at the date of this report. Follow-up information received on 16-Jan-2004 from the reporter provided the child's birth weigh, sibling information, previous vaccine adverse event history, and recovery status. The child's father indicated that more than half of the patient's classmates had become ill with the flu at the time his daughter was ill. The reporting father indicated that his daughter's pediatrician commented that it was likely she had already been exposed to the flu prior to FluMist adminstration. Through the course of her illness she experienced high fevers of 104 deg. F. for several days, and was well by the fifth day.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Tracheal oedema
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 5 year old daughter who experienced fever, weakness, tiredness, runny nose, sore throat, and swollen throat.  At 5 years of age, the pt received a dose on 12/10/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/10/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  On 12/11/03, the pt was sent home from school due to weakness and tiredness.  Later that same day, she developed a runny nose, sore throat, and swollen throat.  That night she woke up with a fever of 103 deg F.  As of 12/12/03, she still had a fever of 99 deg F, runny nose and sore, swollen throat.  No additional information was available at the date of this report. Follow-up information received on 16-Jan-2004 from the reporter provided the child's birth weigh, sibling information, previous vaccine adverse event history, and recovery status. The child's father indicated that more than half of the patient's classmates had become ill with the flu at the time his daughter was ill. The reporting father indicated that his daughter's pediatrician commented that it was likely she had already been exposed to the flu prior to FluMist adminstration. Through the course of her illness she experienced high fevers of 104 deg. F. for several days, and was well by the fifth day.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
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 9 year old daughter who experienced bleeding and watery discharge from the right nostril.  At 9 years of age, the pt received a dose on 12/12/03.  The pt had no history of nose bleeds.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  On 12/12/03, about thirty minutes after Flumist administration, the pt started bleeding from the right nostril (epistaxis).  A compress was applied and after about three minutes the bleeding stopped.  The father stated that since then, the pt has had some watery discharge from the right nostril.  No additional information was available at the date of this report. Follow-up information received from the patient's physician provided vaccine lot number and concomitant medications. Concomitant Therapy: Concomitant therapy included Poly-Vi-Flor (ascorbic acid/ergocalciferol/nicotinamide/potassium flouride/retinol/riboflavin/thiamine hydrochloride). Event Details: On 12-Dec-2003, about thirty minutes after Flumist administration, the patient started bleeding from the right nostril (epistaxis). A compress was applied after about three minutes the bleeding stopped. The father stated that since the, the patient has had some watery discharge (rhinorrhoea) from the right nostril.
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Lymphadenopathy, Nasal congestion, 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 female student who experienced fever, headache, nasal congestion, swollen tonsilar glands, sore throat and vomiting.  The pt received a dose on 12/11/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  The pt experienced fever "subjectively higher over the weekend" than a temperature of 99.1 deg F on 12/16/03.  She also developed headache, nasal congestion, swollen tonsilar glands, sore throat and two episodes of vomiting on 12/13/03.  No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
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 student who experienced fever, headache, nasal congestion, swollen tonsilar glands, sore throat and vomiting.  The pt received a dose on 12/11/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  The pt experienced fever "subjectively higher over the weekend" than a temperature of 99.1 deg F on 12/16/03.  She also developed headache, nasal congestion, swollen tonsilar glands, sore throat and two episodes of vomiting on 12/13/03.  No additional information was available at the time of this report.
Age: 62.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye oedema, Lacrimation increased, Rhinorrhoea, Sneezing, Toothache
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 62 year old female pt who experienced sneezing, runny nose, aching teeth, swollen left eye and watery left eye.  At 62 years of age, the pt received a dose on 12/12/03.  The pt has a past history of migraine headaches.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced sneezing on 12/12/03, and runny nose on 12/13/03.  On 12/16/03, her nose was extremely runny, her left eye was swollen and watery and her teeth on the left side ached.  No additional information was available at the time of this report.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error, Myalgia, 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 consumer regarding a 38 year old male pt who experienced Flumist administered incorrectly and both biceps mildly sore.  At 38 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 12/15/03, the caller reported that after Flumist was administered to him, the liquid ran down his cheeks and upper lip and into his mouth, and some drained down his throat.  He stated the administration was incorrect.  On 12/16/03, 15 hours post-immunization, both of his biceps were mildly sore, and the continued to be mildly sore at the time of this report.  No additional information was available at the time of this report. Follow-up information received from the physician confirmed a problem with administration. He stated the administration was incorrect and he did not receive a half dose in each nostril. On 16-Dec-2003, 15 hours post-immunization, both of his biceps were mildly sore. On follow-up, the physician confirmed the "problem with administration." No additional information was available at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Psychomotor hyperactivity, Pyrexia, Rash
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 an 8 year old male pt who experienced fever of 101 deg F, stuffy nose, cough and acting "hyper".  At 8 years of age, the pt received a dose on 12/13/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  On 12/15/03, 2 days post-immunization, the child had a low grade fever and was sent home from school on 12/16/03, with a fever of 101 deg F, stuffy nose, acting "hyper" and cough.  He was treated with Tylenol.  No additional information was available at the time of this report. Follow-up information received from the child's mother provided an additional symptom of a rash behind her son's knees which started on 19-Dec-2003. On 19-Dec-2003, the child developed a rash behind his knees, which appeared worse on 21-Dec-2003. The rash is currently being treated with Benedryl cream (diphenhydramine). No additional information was available at the time of this report.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Influenza like illness, Nasal congestion, Rhinorrhoea, Somnolence
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 17 year old daughter who experienced chills, nasal congestion, nasal drainage, and sleeping longer.  At 17 years of age, the pt received a dose on 12/13/03.  The pt's concurrent illness includes seasonal allergy.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose 1 (IN).  Concomitant therapy included Claritin.  The pt experienced chills, nasal congestion, nasal drainage, and sleeping longer on 12/15/03.  The mother reported that her daughter slept twelve hours on the night on 12/15/03 and had to stay home from school on 12/16/03.  The mother indicated that Sudafed and Claritin have not helped with the congestion and drainage.  No additional information was available at the date of this report. Follow-up information received from the patient's mother provided additional event details and physician information. On 15-Dec-2003, the patient developed a "flu like cold" (influenza like illness), chills (rigors), nasal congestion (nasal congestion), nasal drainage (nasal sinus drainage) and sleeping longer (somnolence). The mother reported that her daughter slept twelve hours on the night of 15-Dec-2003 and had to stay home from school on 16-Dec-2003. The mother indicated that Sudafed (psudoephedrine) and Claritin have not helped with the congestion and drainage. The mother reported that the symptoms lasted for three days, and the patient did not see a physician. No additional information was available at the date of this report.  The physician reported taht the patient recovered.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Cough, Dizziness, Feeling abnormal
Clinical narrative: Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 26 year old female consumer who received a dose on 12/13/03.  The pt has a past history of nasopharyngitis.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 0.5mL 1 time per day (IN).  Pt was not taking concomitant therapy.  It was reported by a 26 year old female consumer that on 12/13/03, she received a dose of Flumist.  On 12/15/03, she developed fever, coughing, feeling bad and head feeling foggy (feeling abnormal), chills, cold sweats, weakness and felt woozy.  By approximately 1-2am on 12/16/03, she reported that her "fever broke".  As of 12/16/03, the cough persists.  No additional information was available at the time of this report. Follow-up information received from a healthcare professional on 13-Jan-2004 states, "Patient recovered without complications."
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 26 year old female consumer who received a dose on 12/13/03.  The pt has a past history of nasopharyngitis.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 0.5mL 1 time per day (IN).  Pt was not taking concomitant therapy.  It was reported by a 26 year old female consumer that on 12/13/03, she received a dose of Flumist.  On 12/15/03, she developed fever, coughing, feeling bad and head feeling foggy (feeling abnormal), chills, cold sweats, weakness and felt woozy.  By approximately 1-2am on 12/16/03, she reported that her "fever broke".  As of 12/16/03, the cough persists.  No additional information was available at the time of this report. Follow-up information received from a healthcare professional on 13-Jan-2004 states, "Patient recovered without complications."
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Nasal dryness
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 23 year old daughter who experienced dry nostrils that felt like they were scabbing, and bleeding from both nostrils.  At 23 years of age, the pt received a dose on 12/15/03.  The pt had no history of nose bleeds.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  On 12/16/03, the pt experienced dry nostrils (nasal dryness) that felt like they were scabbing (scab).  When she blew her nose, there was a lot bleeding from both nostrils (epistaxis).  The mother reported that the bleeding soon stopped.  No additional information was available at the date of this report. Follow-up information received from the patient provided physician name and address.
Age: 60.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Fatigue, Headache, Malaise, Medication error
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 60 year old female pt who experienced a bad headache immediately following inadvertent administration.  She also developed muscle pain, fatigue, chills, a cold, and a runny nose. The pt received a dose on 10/31/03.  The pt's concurrent illnesses include increased intraocular pressure and osteoporosis.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 10/31/03.  Dose regimen was 0.25mL each nostril (IN).  Concomitant therapy included Evista, Paxil, Aciphex, Metamucil, Vitamin C, Vitamin E, Vitamin A, Vitamin D and calcium plus Vitamin D.  On 10/31/03, the pt developed a bad headache, which she described as severe, that began immediately after she "sniffed" the Flumist.  She indicated that she could taste the Flumist, but this only lasted a few minutes.  She also developed muscle pain (myalgia), fatigue, chills and runny nose and a cold which lasted a few days.  She recovered from all of the events.  The pt stated that Flumist was inadvertently administered (medication error) because she was not aware that it was a live virus vaccine or that it was not indicated for pt's her age.
Age: 60.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Rhinorrhoea
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 60 year old female pt who experienced a bad headache immediately following inadvertent administration.  She also developed muscle pain, fatigue, chills, a cold, and a runny nose. The pt received a dose on 10/31/03.  The pt's concurrent illnesses include increased intraocular pressure and osteoporosis.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 10/31/03.  Dose regimen was 0.25mL each nostril (IN).  Concomitant therapy included Evista, Paxil, Aciphex, Metamucil, Vitamin C, Vitamin E, Vitamin A, Vitamin D and calcium plus Vitamin D.  On 10/31/03, the pt developed a bad headache, which she described as severe, that began immediately after she "sniffed" the Flumist.  She indicated that she could taste the Flumist, but this only lasted a few minutes.  She also developed muscle pain (myalgia), fatigue, chills and runny nose and a cold which lasted a few days.  She recovered from all of the events.  The pt stated that Flumist was inadvertently administered (medication error) because she was not aware that it was a live virus vaccine or that it was not indicated for pt's her age.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Laboratory test abnormal, Unintended pregnancy
Clinical narrative: A 27 year old female pt reported that she received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) 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 therapy included Protonix.  Lab test results: influenza test positive was done on an unspecified date.  On an unspecified date in Dec 03, a 27 year old female pt developed influenza after receiving a dose of Flumist.  Treatment consisted of Tylenol and Levall.  The reporter indicated that she "found out she was pregnant" soon after the administration of the Flumist vaccine.  No additional information was available at the time of this report. As of 14-Jan-2004, she has recovered from influenza.
Sex: U
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 healthcare professional regarding a pt who experienced rash on neck.  The pt received vaccine 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 experienced rash on neck (rash).  The reporter declined to provide information in order to conduct follow-up.  No additional information was available at the time of this report.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Dizziness, Drug ineffective, 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 consumer regarding a 36-year-old female patient who experienced flu-like symptoms. At 36 years of age, the patient received a dose on 15-Dec-2003. Medical history: The patient had no relevant medical history. She reported she does not have an egg allergy. 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 Yasmin (drospirenone/ethinyl estradiol). Event details: The patient experienced flu-like symptoms (influenza like illness) characterized by dizziness (dizziness), weakness (asthenia) and chills (rigors) on 15-Dec-2003. She went to the emergency room but was not seen. As of 15-Dec-2003, the events had not resolved. No additional information was available at the time of this report.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Diarrhoea, Nausea
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 40-year-old female patient who experienced abdominal pain and cramping, diarrhea and nausea. At 40 years of age, the patient received a dose on 08-Dec-2003. Medical history: The patient's concurrent illness includes back pain. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 08-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Concomitant therapy included Celebrex (celecoxib) and Wellbutrin XL (amfebutamone hydrochloride). Event details: The patient experienced abdominal pain and cramping (abdominal pain), diarrhea (diarrhoea) and nausea (nausea) on 15-Dec-2003. As of 15-Dec-2003, her symptoms continued. No additional information was available at the date of this report.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Diarrhoea, Nausea
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 13-year-old female patient who experienced diarrhea, abdominal pain and cramping and nausea. At 13 years of age, the patient received a dose on 08-Dec-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004) was immunization. Product was administered on 08-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event details: the patient experienced diarrhea (diarrhoea), abdominal pain and cramping (abdominal pain) and nausea (nausea) on 14-Dec-2003. As of 15-Dec-2003, her frequent bowel movements have continued. No additional information was available at the date of this report.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Cough, Dizziness, Eye pain, Nausea
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 49-year-old female patient who experienced pain in her eyeball, dizziness, unable to get out of bed, dry cough and nausea. At 49 years of age, the patient received a dose on 10-Dec-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 10-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event details: The patient experienced pain in her eyeball (eye pain) immediately after receiving Flumist on 10-Dec-2003. That same night the patient was dizzy (dizziness), unable to get out of bed (asthenia), and developed a dry cough (cough) and nausea (nausea). As of 15-Dec-2003, her dry cough and nausea persisted. No additional information was available at the date of this report.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Drug ineffective, Headache, Influenza, Myalgia
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 9-year-old daughter who developed the flu. At 9 years of age, the patient received a dose on 11-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 11-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: A mother reported that on 13-Dec-2003, 2 days post-immunization, her daughter developed the flu. the child developed "a wicked headache", muscle aches, clear runny nose, sneezing and a fever of 102.5 deg. F. On 14-Dec-2003, her temperature increase to 103.5 deg F. The headache resolved with Tylenol (acetaminophen) and cool packs, but the other symptoms continued. Later on 14-Dec-2003, her fever was 101.7 and the runny nose continued. No additional information was available at the date of this report.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
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 9-year-old daughter who developed the flu. At 9 years of age, the patient received a dose on 11-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 11-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: A mother reported that on 13-Dec-2003, 2 days post-immunization, her daughter developed the flu. the child developed "a wicked headache", muscle aches, clear runny nose, sneezing and a fever of 102.5 deg. F. On 14-Dec-2003, her temperature increase to 103.5 deg F. The headache resolved with Tylenol (acetaminophen) and cool packs, but the other symptoms continued. Later on 14-Dec-2003, her fever was 101.7 and the runny nose continued. No additional information was available at the date of this report.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Malaise, 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 nurse regarding a 33-year-old female patient who experienced fever of 103 F., her body ached and nasal congestion. At 33 years of age, the patient received a dose on 12-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Dec-2003. Dose regimen was 1 dose (nasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On the evening of 12-Dec-2003, after receiving Flumist, the patient started to feel sick. During the night, she developed a fever of 103 degrees F., her body ached and she had nasal congestion. On 14-Dec-2003, her fever was 101 degrees F. On the morning of 15-Dec-2003, the patient no longer had a fever and she began to feel better. It is unknown if any treatment medications were taken. No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Eye irritation, Pruritus
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 an adult female patient who experienced itchy eyes about 5 minutes after receiving Flumist. The patient received a dose on an unspecified date. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced itchy eyes about 5 minutes after receiving Flumist. As soon as she itched her eyes, there were fine. The reporter indicated that the patient's son also experienced this same event. Related case(s): See related case: HQWYE753718DEC03 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Headache, Pain, 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 consumer regarding a 53-year-old female patient who experienced stuffy head (feeling like her head was packed with cotton), feeling achy, chills and sore throat. At 53 years of age, the patient received a dose on 11-Dec-2003. Medical History: The patient's concurrent illness includes unspecified allergies. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included Claritin (loratadine). Event Details: On 14-Dec-2003, 3 days post-immunization, the patient developed symptoms of stuffy head (feeling like her head was packed with cotton), feeling achy, chills, and sore throat. No additional information was available at the time of this report.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Information regarding Flumist (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 headache, feeling tired and achy. At 33 years of age, the patient received a dose on 09-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 09-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 10-Dec-2003, 1 day post-immunization, the patient experienced headache and was feeling tired. On 15-Dec-2003, he was tired and achy. No additional information was available at the time of this report.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Nausea, 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 7-year-old male patient who experienced nasal congestion, sore throat, fever and nausea. At 7 years of age, the patient received the first dose on 12-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 12-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 14-Dec-2003, 2 days post-immunization, the child developed nasal congestion and a sore throat. On 16-Dec-2003 he experienced a fever and nausea. Phenergan (promethazine hydrochloride) (manufacturer unknown) was prescribed for the nausea. No additional information was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Eye disorder, Pruritus
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a male child who experienced itchy eyes about five minutes after receiving Flumist. The pt received a dose on an unspecified date. The pt experienced itchy eyes about 5 minutes after receiving Flumist. The reporter indicated that the pt's mother also experienced the same event. The reporter stated that she doesn't know if the child "just itched his eyes because he saw his mom itch her eyes." No additional info was available at the time of this report.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug interaction, Metrorrhagia
Clinical narrative: Follow-up info received from the pt's physician provided the following: concomitant vaccine; illnesses at time of vaccination; relevant diagnostic tests/ lab data; and medical history. A health care professional reported that a 42 year old female pt received a dose of Flumist on 10/27/03 and experienced a drug interaction and menstrual spotting. The pt experienced a drug interaction and menstrual spotting. On 10/29/03, the pt indicated she "started menstrual spotting and got her period on 11/3/03." This event occurred one week early. The pt stated that she is currently continuing the Nordette-21 and should not have her period. She indicated that this has never happened before. No additional info was available at the time of this report.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Myalgia, Pulmonary congestion, Pyrexia
Clinical narrative: A health care professional reported that a 44 year old male pt received a dose of Flumist on 10/16/03 and experienced muscle aches, fever and chest congestion. The pt experienced muscle aches (myagia) on 10/17/03, fever on 10/21/03 and chest congestion on 10/26/03. The pt was treated with erythromycin, prednisone and Mucinex. The pt has recovered. No additional info was available at the time of this report.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Myalgia, Nasal congestion, Nasal discomfort, Paraesthesia
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 30 year old female pt who experienced muscle aches, nasal burning, nasal tingling, nasal congestion and nasal bleeding. At 30 years of age, the pt received the first dose on 10/28/03. The pt experienced muscle aches, nasal burning, nasal tingling, nasal congestion and nasal bleeding on 10/28/03. At the date of the report, muscle aches and nasal bleeding has resolved; however, nasal burning, nasal tingling and nasal congestion had not resolved. The pt was being treated with Sudafed and Nasonex. No additional info was available at the time of this report.
Age: 48.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 48 year old male tp who experienced nasal congestion and drainage down his throat. The pt received a dose on 11/6/03. The pt experienced nasal congestion, and drainage down his throat immediately after receipt of the vaccine on 11/6/03. He then blew his nose to relieve the congestion in his left nostril. The reporter indicated that the pt did not have a cold prior to administration. No additional  info was available at the time of this report.