chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Febrile convulsion, White blood cell count increased
Clinical narrative: patient had approximately 30 minutes of witnessed generalized tonic clonic seizure activity. Was found to have a rectal temperature of 103.5F at that time. Subsequently awoke from post-ictal state and was behaving normally with a normal neurologic exam. The ER record and H&P received on 2/9/04 states atypical febrile seizure.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Febrile convulsion
Clinical narrative: patient had approximately 30 minutes of witnessed generalized tonic clonic seizure activity. Was found to have a rectal temperature of 103.5F at that time. Subsequently awoke from post-ictal state and was behaving normally with a normal neurologic exam. The ER record and H&P received on 2/9/04 states atypical febrile seizure.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Nausea
Clinical narrative: 11 am.-Second dose of RabAvert vaccine administered 11:45 am.- started feeling flushed, faint, lightheaded, nausea 12 noon- ate lunch 1pm- headache started, diaphoretic, continued to be lightheaded and have nausea. Taken to clinic BP 135/94 p-86 temp. 97.8 F 1:20pm-started 1000cc NS, headache 5/10 on pain scale 1:26 pm- given 125 mg of Solu Medrol 3:45pm- Feeling better, headache 2/10, discharged from Urgent care. 114/62 - 80- 12- 97.6 F.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Syncope
Clinical narrative: 11 am.-Second dose of RabAvert vaccine administered 11:45 am.- started feeling flushed, faint, lightheaded, nausea 12 noon- ate lunch 1pm- headache started, diaphoretic, continued to be lightheaded and have nausea. Taken to clinic BP 135/94 p-86 temp. 97.8 F 1:20pm-started 1000cc NS, headache 5/10 on pain scale 1:26 pm- given 125 mg of Solu Medrol 3:45pm- Feeling better, headache 2/10, discharged from Urgent care. 114/62 - 80- 12- 97.6 F.
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cellulitis, Swelling
Clinical narrative: PT. WAS GIVEN DTAP AND IPV IM TO LEFT LEG, FLU AND MMR TO RIGHT LEGON 02 FEB 04. SWELLING WAS NOTED TO LEFT LEG, MOTHER OF PATIENT BROUGHT PATIENT TO ER ON 03 FEB 04. PT HAD FOLLOW UP VISIT WITH PRIMARY DOCTOR ON 04 FEB 04 AND WAS DIAGNOSED WITH CELLULITIS TO LEFT LEG.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: A nurse reported that a 5 year old male received his 1st dose of Flumist on 12/8/03, and approximately 4 hrs later, experienced "itching, large whelps, and hives all over his body." On 12/8/03, approximately 4 hrs post-immunization, the child developed "itching, large whelps, and hives all over his body." Treatment included Aveeno topical cream and Benadryl elixir by mouth. As of 12/9/03, the events persisted. No additional info was available at the time of this report.
Age: 0.76
Sex: F
Vaccine: HEP, IPV
Symptoms: Apnoea, Asphyxia, Hypoxia
Clinical narrative: Per EMS, found face down in crib not breathing. CPR initiated. Patient intubated and received O2, epinephrine 2 times, Atropine 1 time per ER record. Autopsy Report received on 4/27/2004 states COD was suffocation.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Diabetic coma, Medication error
Clinical narrative: This case was reported by a nurse representing a law firm and described the occurrence of diabetic coma in a male child who had received hep A vaccine inactivated (Havrix). On an unspecified date, the pt received an "adult dose" of Havrix rather than recommended pediatric dose. Approximately two to three days later, the pt experienced a diabetic coma and was hospitalized. The nurse stated that the pt was "near death." Diagnostic tests revealed a glucose value of 667, and a calcium value of 11.1 (units not specified). The vaccination series was discontinued. The events, which were considered to be life threatening and jeopardized the pt/required intervention, were unresolved at the time of reporting. In the reporting nurse's opinion, the events were possibly related to vaccination with Havrix. The nurse also noted that the events may have been associated with the erroneous administration of an adult dose of Havrix. Diabetic coma was assessed as medically serious (OMIC) by manufacturer. Information from Annual Follow-up report states this report was received through the litigation process. Additional information including outcome information is being pursued through the litigation process and will be reported if obtained.
Age: 32.0
Sex: F
Vaccine: MEN
Symptoms: Chest pain, Eye oedema, Face oedema, Throat tightness
Clinical narrative: No seriousness criteria was reported. Based upon medical judgement this case is considered serious: medically significant event (OMIC). From initial information received on 1/30/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received MENOMUNE A/C/Y/W-135, lot number UB351AB, administered SC in the left arm at 2:30 PM on 1/28/04. One to two hours post-immunization, the patient complained of swollen eyes and lips. She took Benadryl orally at home. The next morning, on 1/29/04, the patient woke up with the feeling that her throat was swollen and complained of heaviness in her chest. She called her physician, who sent her to the emergency room for evaluation. The patient was treated with Solu-medrol, Benadryl, and an antacid and was released. Reportedly the patient recovered without further complaints.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis bullous, Pruritus, Rash erythematous, Skin ulcer
Clinical narrative: 2/3/04 12:15 developed puritic, erythemous rash rapid development to bullous lesions on hands. Benadryl 50gm IM at 1515. In ED 1800 rash flat red on forearms, abdomen and inner thigh. Some bloody in appearance with min. drainage on hands. 2/4/00 0800-4 bullous-bloody lesion on hands-none elsewhere. The hospital discharge summary received on 2/17/04 states pt was in hospital less than 24 hrs and was treated with Benadryl for rash. Final diagnosis is left blank, but MD states lesions were probably a result of a vaccine reaction, though she is uncertain if it was the smallpox or anthrax vaccine.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: On the evening of 1/20/04, pt received a pneumococcal vaccination in the right deltoid. On 1/21/04, there was a raised area the size of a baseball at the site of injection. The physician on call ordered the pt to receive were compresses to the area. The pt and the nurse reported the area to be red in color and warm to the touch. The nurse manager contacted pharmacy and a recommendation was made to give the pt diphenhydramine to control a possible allergic reaction. Swelling was down by 1/22/04. By 1/26/04 the problem was resolved, area resembled a whelt.
Age: 1.32
Sex: F
Vaccine: DTAP, HBPV, PNC
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular, Red blood cell sedimentation rate increased, Stevens-Johnson syndrome
Clinical narrative: Fever of 104. Target erythematous maculopapular rash day 2 post immunization (face, trunk, back, extremities) for one week. Responded to steroids while hospitalized. Very detailed record for this admission is received and confirms a diagnosis of Steven-Johnson Syndrome for this event. Secondary diagnoses include conjunctivitis and mucositis. Of note, this record indicates that child was treated w/ penicillin one month prior to this event for URI and OM. She was discharged to home on po steroids to be followed by PMD and allergy clinic
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin ulcer
Clinical narrative: 24-48 hours after vaccine, acute onset apthor ulcers 24-48 hours later it dry whole body up in rash.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Urticaria
Clinical narrative: Redness, edema, urticaria, moderate pain, warmth to area.
Age: 0.1
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received immunization on 01/30/04.  Right lateral thigh red, warm to touch.  Erythema 11cm diameter.  Treatment: Augmentin 250/5 1/2 tsp 3 times per day for 10 days.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: 01/24/04: Right leg red, swollen, hot, giving Tylenol.  01/26/04: Leg hard knot 1/2 inch in diameter.  Red is decreasing in size.  No Tylenol.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Constant crying for approximately 24 hours after vaccines.  Stops for short periods only.  Parent took temperature, rectal 100.  Gave bath temperature after was 96 rectal.  Child then acted like self, stopped crying.  No further difficulties.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: 08/16/02: Pt was seen in ER for redness and swelling at site.  (right upper arm 10x5cm induration).  Warm to touch.  Possible cellulitis.  Pt given antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Rash, Skin discolouration, Urticaria
Clinical narrative: Mother noticed on approximately 01/19/04 that child was switching left arm, no increased temperature, on approximately 01/24/04 reddened, raised area with small whelps appeared.  Mother gave Benadryl x1 and rubbed area with alcohol.  A few days later, mother noticed a fine rash across chest and back of neck (no itching).  Pt's mother in clinic today 02/04/04, left deltoid continues with dark skin color, raised 5.5cm area with small whelped spots inside dark circle  Dark sports present on upper chest/past neck where rash occurred.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 01/30/04: Received DTAP, IPV in right arm.  Grandparents noted redness and swelling to right arm that evening.  Grandparents called ask a nurse and was told to give Tylenol. Grandparents reported no fever.  Contacted CDC with no success.  GM states no one answered.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash papular, Urticaria
Clinical narrative: 01/26/04: 10 days after administering varicella vaccine, he developed a small cluster of tiny papules  on erythematous base at site of injection.  No pruritis/discomfort.  Treatment: Ibuprofen with ice.  01/29/04: Still there.  No master change.  Urticarial hardness at base.
Sex: F
Vaccine: HEPA, YF
Symptoms: Migraine
Clinical narrative: Violent migraine treated with Morphine at hospital ER, lumbar puncture did not heal.  Unable to return to work for 4 weeks.
Sex: M
Vaccine: FLUN3
Symptoms: Infection transmission via personal contact, Pyrexia, Rhinitis
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 6-month-old male patient who experienced runny nose after being in close contact with his brother, who had received the Flumist. Medical history: Relevant medical history was noT provided. Product details: Additional suspect medication included influenza virus vaccine injection (manufacturer unknown), which he received on 06-Nov-2003. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced runny nose (rhinorrhea) on 11-Nov-2003, after being in close contact with his brother who had been vaccinated with Flumist (accidental exposure). The infant had also received an influenza virus vaccine injection (manufacturer unknown) on 06-Nov-2003. Related case(s): The patient's brother developed the cold symptoms of a runny nose and fever following receipt of Flumist on 06-Nov-2003 (see MCN HQWYE0195). No additional information was available at the date of this report.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Headache, Nausea, Tachycardia
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 43-year-old female patient who experienced headache, nausea, tachycardia and erythema on her cheeks, forehead, and neck. At 43 years of age, the patient received her first dose on 07-Oct-2003. Medical history: The patient's concurrent illnesses include seasonal allergies and a "serum-sickness like allergy" to penicillin and sulfa. The reporter indicated that the patient had no history of adverse reaction to "TIV flu vaccines." Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 07-Oct-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: Concomitant medications were not reported. Event details: Three hours post-immunization, she experienced headache, nausea, tachycardia and erythema on her cheeks, forehead and neck. She returned to the physician's office where her vital signs were reported to be normal. She left the physician's office after lying down for a period of time. A the time she left the office, "everything had resolved except the erythema." No additional information was available at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Sneezing
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 patient who experienced sneezing and congestion. At 8 years of age, the patient received a dose of 01-Oct-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 01-Oct-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: The patient was not receiving concomitant medications. Event details: the patient developed sneezing and congestion on 04-Oct-2003. As of 06-Oct-2003, the symptoms persisted. The patient's brother experienced sneezing and congestion following receipt of Flumist on 01-Oct-2003 at 11 years of age (see MCN HQWYE094909OCT03). No additional information was available at the date of this report.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Sneezing
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 11-year-old male patient who experienced sneezing and congestion. At 11 years of age, the patient received a dose on 01-Oct-2003. Medical history: The patient's concurrent illness includes being overweight. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 01-Oct-2003. Dose regimen was 0.5 ml (intranasal). Concomitant therapy: The patient was not receiving concomitant medications. Event details: The patient developed sneezing (sneezing) and congestion (nasal congestion) on 04-Oct-2003. As of 06-Oct-2003, his symptoms persisted. The patient's brother developed sneezing and congestion following receipt of Flumist on 01-Oct-2003 at 8 years of age (See MCN HQWYE0948). No additional information was available at the date of this report.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Dysgeusia, Headache, Lacrimation increased, Retching
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 her 12 year old daughter who experienced gagging, eyes watered, awful taste, headache, stomach ache and runny nose. At 12 years of age, the patient received a dose on 07-Nov-2003. Medical history: relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 07-Nov-2003. Dose regimen was 0.5 mL 1 time per day (nasal). Concomitant therapy: Concomitant therapy included Motrin (ibuprofen). Event details: The patient experienced gagging (retching), eyes watered (lacrimation increased) and awful taste (dysgeusia) on 07-Nov-2003. Two days later she developed headache (headache), stomach ache (abdominal pain upper) and runny nose (rhinorrhea) on 09-Nov-2003. Related Case (s): See related case(s): HQWYE944711NOV03 (adverse even, non-expedited) and HQWYE956611NOV03 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
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 her 12 year old daughter who experienced gagging, eyes watered, awful taste, headache, stomach ache and runny nose. At 12 years of age, the patient received a dose on 07-Nov-2003. Medical history: relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 07-Nov-2003. Dose regimen was 0.5 mL 1 time per day (nasal). Concomitant therapy: Concomitant therapy included Motrin (ibuprofen). Event details: The patient experienced gagging (retching), eyes watered (lacrimation increased) and awful taste (dysgeusia) on 07-Nov-2003. Two days later she developed headache (headache), stomach ache (abdominal pain upper) and runny nose (rhinorrhea) on 09-Nov-2003. Related Case (s): See related case(s): HQWYE944711NOV03 (adverse even, non-expedited) and HQWYE956611NOV03 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: FLUN3
Symptoms: Irritability, 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 healthcare professional regarding a pt who experienced liquid running down the back of the throat that tasted bad and was irritating.  The pt received a dose on 10/07/03.  The reporter indicated that two pt's experienced this event; however, they are not presently identifiable.  Additional reports will be generated when identifying information is provided.  No additional information was available at the date of this report.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Postnasal drip, Rhinorrhoea
Clinical narrative: A 39 year old female consumer reported that she received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 11/09/03.  The reporter indicated that the vaccine "ran out of her nose like water."  She was instructed by the nurse to "tilt her head back" and the vaccine subsequently "ran down her throat and she almost threw up."  No additional information was available at the time of this report.  See related case HQWYE136817NOV03.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Anorexia, Cough, Influenza like illness, Lacrimation increased, Pallor
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 9 year old female pt who experienced symptoms just like the flu, fever (102 deg F), sallow skin, watery eyes, loss of appetite, hacking cough and mild sore throat.  At 9 years of age, the pt received a dose on 11/04/03.  The pt experienced symptoms just like the flu (influenza like illness), fever (102 deg. F), sallow skin, watery eyes, loss of appetite, hacking cough and mild sore throat on 11/12/03. She was seen by a physician that same day.  As of 11/12/03, the pt's symptoms have not resolved.  Follow-up received from the patient's physician provided information regarding vaccines received within four weeks (none), illness at the time of vaccination (none), and duration of symptoms. She was seen by a physician the same day. The patient's mother reported that the symptoms lasted for 6 to 7 days.
Age: 9.0
Sex: F
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 consumer regarding a 9 year old female pt who experienced symptoms just like the flu, fever (102 deg F), sallow skin, watery eyes, loss of appetite, hacking cough and mild sore throat.  At 9 years of age, the pt received a dose on 11/04/03.  The pt experienced symptoms just like the flu (influenza like illness), fever (102 deg. F), sallow skin, watery eyes, loss of appetite, hacking cough and mild sore throat on 11/12/03. She was seen by a physician that same day.  As of 11/12/03, the pt's symptoms have not resolved.  Follow-up received from the patient's physician provided information regarding vaccines received within four weeks (none), illness at the time of vaccination (none), and duration of symptoms. She was seen by a physician the same day. The patient's mother reported that the symptoms lasted for 6 to 7 days.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: A 52 year old female reported that she received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) on 09/15/03.  The pt's concurrent illnesses include pernicious anaemia, allergies (nonspecified) and a past history of lung cancer (diagnosed in Aug 2002, currently in remission).  The pt experienced a sore throat and sniffles for 2 days following Flumist administration on 09/15/03.  She also expressed concern regarding the administration of Flumist to people with compromised immune systems and those who are over 50 years of age.  No additional information was available at the time of this report.
Age: 68.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Rhinitis
Clinical narrative: A female reported that her 68-year-old husband received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) 0n 15-Sep-2003. Medical history: The patient's concurrent illness includes pernicious anaemia. Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 15-Sep-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: Concomitant therapy included Vitamin B12 (Cyanocobalamin and Derivatives). Event details: The caller's husband experienced "sniffles and sore throat" for 2 days following Flumist administration on 15-Sep-2003. The caller also expressed concern regarding the administration of Flumist to people with compromised immune systems and those who are over 50 years of age. No additional information was available at the time of this report.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Pneumonia, Respiratory tract infection
Clinical narrative: A physician reported that a 52-year-old female patient received a dose of FLUMIST (2003-2004 Formula) on 05-NOV-2003 and experienced a respiratory infection which led to pneumonia.  On 07-Nov-2003, the patient developed a respiratory infection  which progressed to pneumonia . The patient was treated with intramuscular LEVAQUIN. The patient has not recovered. No additional information was available at the time of this report.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Retching
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 5-year-old female patient who experienced gagging. At 5 years of age, the patient received the first dose of 14-Oct-2003. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 14-Oct-2003. Dose regimen was 0.5 mL 1 times per day (intranasal). Concomitant therapy: Concomitant therapy included Tavist (clemastine fumarate). Event details: The patient gagged (retching) and some of the Flumist ran out of her nose on 14-Oct-2003. The patient is scheduled for her second dose. No additional information was available at the time of this report.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Pyrexia, Urticaria
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 27-year-old white female patient who experienced hives, fever and sore throat. 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 not provided. Concomitant therapy: Concomitant medications were not reported. Event details: On 14-Nov-2003, the patient developed hives (urticaria), a fever (pyrexia) and sore throat (pharyngolaryngeal pain). She was treated with Benadryl. On a unspecified date, the patient recovered. No additional information was available at the time of this report.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Dysgeusia, Lacrimation increased, Retching
Clinical narrative: Information regarding Flu Mist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 10-year-old son who experienced an "awful" tasted, watery eyes and gagging. Product was administered on an unspecified date. The reported also noted that the product did not come out as a spray, rather it squirted out. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced taste (dysgeusia), eyes watery (lacrimation increased) and gag (retching) in Nov-2003. No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Skin ulcer
Clinical narrative: Information regarding Flu Mist (2003-2004 Formula) (influenza virus vaccine. live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a female patient who received a dose of vaccine on an unspecified date and developed an "ulcer under nostril." Medical history: Relevant medical history is not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was 0.5 mL 1 time per day. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced an ulcer under the nostril (ulcer) on the day of administration in 2003. He recovered. No additional information was available at the time of this report.
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Vision blurred
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 male who experienced blurred vision after receiving a dose on 12-Nov-2003. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Nov-2003. Dose regimen was 1 dose 1 time per day (nasal). Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced blurred vision (vision blurred) after receiving a dose on 12-Nov-2003. No additional information was available at the time of this report.
Age: 70.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Medication error, Nasal congestion
Clinical narrative: A 70-year-old female reported that she inadvertently received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) on 11-Oct-2003, and since then has had a "stuffy nose and a headache". Medical History: relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Oct-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Concomitant therapy included Evista (raloxifene hydrochloride). Event details: On 11-Oct-2003, subsequent to Flumist administration, she developed stuffy nose (nasal congestion) and headache (headache). As of 15-Oct-2003, the events had not resolved. No additional information was available at the time of this report.
Sex: U
Vaccine: FLUN3
Symptoms: Dysgeusia
Clinical narrative: Information regarding Flumist nasal solution was received from a healthcare professional regarding a patient who received a dose on an unspecified day and month in 2003. It was reported the patient experienced a bad taste in the back of their mouth for a short while and product ran back out of both nostrils. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified day and month in 2003. Dose regimen was 0.5mL 1 time per day (nasal). Concomitant medications were not reported. The patient experienced bad taste in mouth in 2003. The reporter indicated that 8-9 patients between the ages of 5-18, experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.  No additional information was available at the time of this report.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Dysgeusia
Clinical narrative: A 39 year old female reported that she received a dose of Flumist nasal solution on 10/16/03 and experienced a strange taste in her mouth after vaccine administration. The patient's concurrent illnesses included hypothyroidism and post-nasal drip. Indication for Flumist was immunization. Product was administered on 10/16/03. Dose regimen was 0.5mL (IN). Concomitant therapy included Synthroid. Subsequently to Flumist administration, the patient reported that the Flumist tasted strange, and she continued to taste it for 30 minutes, up to the time of calling in this report. No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Otitis media, Pharyngitis, Rhinitis, Sinusitis
Clinical narrative: A consumer reported that she received a dose of Flumist a couple of weeks ago and recently has developed a cold, productive cough, infected sinuses and ears. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered in 2003. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced cold, infected sinuses, ear infection, and productive cough in 2003. No additional information was available at the time of this report.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Dry throat, Migraine, Pain, Sneezing
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 46 year old female pt who experienced lightheadedness, migraine headaches, blurred vision, body ache, sneezing and scratchy throat. At 46 years of age, the pt received a dose on 10/16/03. The pt's concurrent illness include migraine headaches, chronic back pain, hypothyroidism, and arthritis with a past history of sinusitis (frequent) and hysterectomy. The pt became lightheaded, and started having migraine headaches and blurred vision on 10/16/03. She then developed body aches, sneezing and a scratchy throat on 10/17/03. She recovered.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Vision blurred
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 46 year old female pt who experienced lightheadedness, migraine headaches, blurred vision, body ache, sneezing and scratchy throat. At 46 years of age, the pt received a dose on 10/16/03. The pt's concurrent illness include migraine headaches, chronic back pain, hypothyroidism, and arthritis with a past history of sinusitis (frequent) and hysterectomy. The pt became lightheaded, and started having migraine headaches and blurred vision on 10/16/03. She then developed body aches, sneezing and a scratchy throat on 10/17/03. She recovered.
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Infection transmission via personal contact, Pyrexia
Clinical narrative: Information regarding Flu Mist was received from a healthcare professional regarding her 4 year old son who experienced accidental exposure and developed a fever and dry cough. The mother, a pharmacist, reported that she administered the Flumist to patients in November, 2003. Two days later, she developed a cough. Three days after she developed a cough, her son developed fever and a dry cough. The mother reported that her 8 year old son also developed fever and cough at the same time. Neither the sons nor his mother received Flumist. Related cases: See HQWYE460108DEC03, and HQWYE460208DEC03. No additional info was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Infection transmission via personal contact, Pyrexia
Clinical narrative: Information regarding Flu Mist was received from a healthcare professional regarding her 8 year old son who experienced accidental exposure and developed a fever and dry cough. The mother, a pharmacist, reported that she administered the Flumist to patients in November, 2003. Two days later, she developed a cough. Three days after she developed a cough, her son developed fever and a dry cough. The fever resolved after 1 day the cough lasted several days. The mother reported that her 4 year old son also developed fever and cough at the same time. Neither the sons nor his mother received Flumist. Related cases: See HQWYE46008DEC03 and HQWYE460208DEC03. No additional info was available at the time of this report.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough
Clinical narrative: Information regarding Flu Mist was received from a healthcare professional regarding herself, a 37 year old female, who experienced accidental exposure and developed a dry "hacky" cough after administering Flu Mist. The pt experienced accidental exposure and developed a dry "hacky" cough in November, 2003. She reported that this occurred approximately 2 days after she administered Flu Mist to several people. she did not receive Flu Mist. Related cases: See HQWYE460108DEC03 and HQWYE46008DEC03. No additional info was available at the time of this report.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Nasal congestion, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Follow up information received from the physician included additional events, medical history, patient date of birth, vaccines received within four weeks, and illnesses at the time of vaccination. Information regarding Flumist nasal solution was received from a healthcare professional regarding a 13 year old female patient who experienced a stuffy nose, a runny nose, abdominal pain, fever, and a sore throat. The patient also received product that was stored at a temperature that was higher than allowable and was not frozen. At 13 years of age, the patient received a dose on 10/18/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 10/18/03. Dose regimen was 1 dose 1 time per day (IN). Patient was not taking any concomitant therapy. The patient experienced a stuffy nose, a runny nose and abdominal pain on 10/19/03. She was treated with Triaminic. The patient also developed a temperature of 100.2 degrees F. The physician indicated that the patient received product that was stored by the pharmacy at a temperature that was higher than allowable and was not frozen.
Age: 60.0
Sex: M
Vaccine: FLUN3
Symptoms: Dysarthria, Visual disturbance
Clinical narrative: Information regarding Flumist nasal solution was received from a healthcare professional regarding a 60 year old male who experienced slurred speech and saw spots before his eyes. At 60 years of age, the patient received a dose of 10/22/2003. The patient's concurrent illnesses include cardiac failure congestive, chronic obstructive airways disease, alcoholism, and alcohol intoxication. Indication for Flumist was immunization. Product was administered on 10/22/03. Dose regimen was 0.5mL 1 time per day (IN). Concomitant therapy included Lipitor, Vasotec, Acetylsalicylic Acid, Tenormin and sublingual NTG. The patient developed slurred speech and saw spots before his eyes on 10/22/03. No additional information was available at the date of this report.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Bronchitis, Chills, Cough, Influenza like illness, Laryngitis
Clinical narrative: Information regarding Flumist was received from a physician regarding his 44 year old wife who developed flu-like symptoms, nausea, stiffness, chills, low grade fever, laryngitis and cough following vaccine administration on 11/27/03. On 11/29/03, she developed flu-like symptoms characterized by nausea, stiffness (musculoskeletal stiffness), chills and low grade fever. On 12/3/03, she developed laryngitis. As of 12/4/03, the laryngitis, cough, and "mild bronchitis symptoms" persisted. No additional info was available at the time of this report.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Information regarding Flumist was received from a physician regarding his 44 year old wife who developed flu-like symptoms, nausea, stiffness, chills, low grade fever, laryngitis and cough following vaccine administration on 11/27/03. On 11/29/03, she developed flu-like symptoms characterized by nausea, stiffness (musculoskeletal stiffness), chills and low grade fever. On 12/3/03, she developed laryngitis. As of 12/4/03, the laryngitis, cough, and "mild bronchitis symptoms" persisted. No additional info was available at the time of this report.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error, Nasal congestion, Rhinorrhoea
Clinical narrative: Follow-up info received provided the pt's date of birth, vaccinations receive within four weeks, medical history, and illness at the time of vaccination. Information regarding Flumist was received from a healthcare professional regarding a 9 year old male pt who experienced stuffy nose, runny nose. The pt received product that was stored at a temp that was higher than allowable and was not frozen. At 9 years of age, the pt received a dose on 10/18/03. The pt experienced stuffy nose and runny nose on 10/19/03. The pt's symptoms were treated with Triaminic. On 10/20/03, the pt had no complaints. The reporter indicated that the pt received product that was stored by the pharmacy at a temp that was higher than allowable and was not frozen.
Sex: F
Vaccine: FLUN3
Symptoms: Postnasal drip
Clinical narrative: Information has been received from a health care professional concerning a female pt who experienced postnasal sensation after receiving Flumist on 10/21/03. The pt experienced postnasal sensation on 10/21/03. No additional info was available at the time of this report.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information regarding Flumist was received from consumer regarding a 49 year old female pt who experienced sore throat with phlegm and fever < 100 deg. At 49 years of age, the pt received a dose on 12/2/03. The pt experienced sore throat with phlegm and fever < 100 deg on 12/3/03. The pt was treated with Tylenol but as of 12/3/03 the symptoms persisted. No additional info was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Face oedema, Lacrimal disorder, Lacrimation increased, Pruritus, Rash
Clinical narrative: Information regarding Flumist was received from a male consumer, a physician, who received a dose on an unspecified date. The pt's physician, reported that he developed a rash, lower lip edema, and itchy watery eyes and lacrimation increased. No additional info was available at the time of this report.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Insomnia, Nasal congestion, Pulmonary congestion
Clinical narrative: A 29 year old female consumer reported that she received a dose of Flumist on 10/20/03. The pt experienced stuffy nose, chest congestion, and sleeplessness on 10/22/03. As of the date of this report, the reporter indicated that she has recovered from "chest congestion" and has not recovered from "stuffy nose" and "sleeplessness." No additional info was available at the time of this report.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Cough, Eye inflammation, Fatigue
Clinical narrative: A 38 year old male pt reported that he received a dose of Flumist on 12/5/03. On 12/8/03, a 38 year old male pt developed dry, hacking cough, sinus congestion, slight headache, sore throat, muscle aches, chills, and burning eyes, tiredness and weakness following receipt of Flumist. As of 12/10/03, the pt's symptoms persisted. As of the date of this report, the prescribing physician has not been contacted. No additional info was available at the time of this report.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Myalgia, Pharyngolaryngeal pain, Sinus congestion
Clinical narrative: A 38 year old male pt reported that he received a dose of Flumist on 12/5/03. On 12/8/03, a 38 year old male pt developed dry, hacking cough, sinus congestion, slight headache, sore throat, muscle aches, chills, and burning eyes, tiredness and weakness following receipt of Flumist. As of 12/10/03, the pt's symptoms persisted. As of the date of this report, the prescribing physician has not been contacted. No additional info was available at the time of this report.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness
Clinical narrative: Information regarding Flumist was received from a medical technician regarding a 49 year old female co-worker who expereinced dizziness 10 minutes after receiving Flumist. At 49 years of age, the pt received a dose on 12/8/03. On 12/8/03, a female co-worker experienced dizziness about 10 minutes after receiving Flumist. She was feeling better a short time later. No additional info was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Erythema, Fatigue, Hypersensitivity, Pruritus
Clinical narrative: Information regarding Flumist was received from a female pt who experienced an allergic reaction described as itching, redness on chest or hives, and light-headedness following receipt of Flumist. The pt indicated that Flumist was administered "concomitantly with a cyst removal using lidocaine." The pt experienced allergic reaction, itching, redness on chest or hives, fatigue and light-headed. The pt indicated that Flumist was administered "concomitantly with a cyst removal using lidocaine." No additional info was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Information regarding Flumist was received from a female pt who experienced an allergic reaction described as itching, redness on chest or hives, and light-headedness following receipt of Flumist. The pt indicated that Flumist was administered "concomitantly with a cyst removal using lidocaine." The pt experienced allergic reaction, itching, redness on chest or hives, fatigue and light-headed. The pt indicated that Flumist was administered "concomitantly with a cyst removal using lidocaine." No additional info was available at the time of this report.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Heart rate increased, Influenza like illness
Clinical narrative: A 39 year old female pt reported that she received a dose of Flumist on 12/8/03. The pt's concurrent illness includes hypersensitivity (allergic to Sudafed). The pt previously experienced heart rate increased, influenza like illness and headache while taking Sudafed. On 12/8/03, a 39 year old female pt reported that she experienced heart racing, flu-like symptoms and headache within minutes of receiving a dose of Flumist. The reporter stated that she experienced a similar reaction after receiving a dose of Sudafed in the past. The adverse events have not resolved. No additional info was available at the time of this report. Follow-up information was received on 09-Jan-2004 from the reported which provided additional adverse event information. A 39-year old female patient reported that she recieved a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 08-Dec-2003 and experienced flu-like symtpoms, heart palpitations, headache, sweating, shortness of breath, and shaking. According to the reporter, the adverse events resolved withing twenty minutes after the receipt of Flumist. She stated that she experienced a similar reaction after receiving Sudafed. The patient reported that on two previous occassions, after the adminstration of Sudafed, she was seen in an emergency room for her allergy. She reported that she did not seek treatment for the adverse events related to the administration FluMist.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Information regarding Flumist was received from a healthcare professional regarding a 20 year old female pt who experienced nausea, vomiting, and headache. At 20 years of age, the pt received a dose on 12/9/03. On 12/9/03, approximately one hour post vaccination, the pt experienced nausea, vomiting, and a headache. The pt still had a headache about four hours after vaccine administration. No additional info was available at the date of this report.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Diarrhoea, Influenza like illness, Nasal congestion, Nausea
Clinical narrative: Follow-up info received from the pt's physician provided the following: adverse event info including symptoms, onset, and recovery status; pt's gender and date of birth; concomitant medications; illnesses at the time of vaccination; and medical history. A health care professional reported that a 9 year old male pt received a dose of Flumist on an unspecified date in Oct 2003, and experienced flu-like symptoms, sore throat, ear congestion, runny nose, cough, nausea, vomiting, and loose stools. Within 24 hrs of vaccination, the pt experienced flu-like symptoms, sore throat, ear congestion, runny nose, cough, nausea, vomiting and loose stools. The symptoms lasted more than five days. The pt has recovered.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Rhinorrhoea, Vomiting
Clinical narrative: Follow-up info received from the pt's physician provided the following: adverse event info including symptoms, onset, and recovery status; pt's gender and date of birth; concomitant medications; illnesses at the time of vaccination; and medical history. A health care professional reported that a 9 year old male pt received a dose of Flumist on an unspecified date in Oct 2003, and experienced flu-like symptoms, sore throat, ear congestion, runny nose, cough, nausea, vomiting, and loose stools. Within 24 hrs of vaccination, the pt experienced flu-like symptoms, sore throat, ear congestion, runny nose, cough, nausea, vomiting and loose stools. The symptoms lasted more than five days. The pt has recovered.
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Skin irritation, Skin warm
Clinical narrative: Information regarding Flumist was received from a consumer regarding a female pt who experienced a slight rash and a heat-type rash, which she scratched until it bled. Also, the tops of legs and groin area had become irritated and inflamed. The pt received a dose on 12/9/03. On 12/9/03, about two hours post vaccination, the pt developed a "slight rash" on the inside of her elbow joint. Three hrs post vaccination she developed a "heat-type rash" under her breasts. Then, about four hrs post vaccination, the tops of her legs and groin area had become irritated and inflamed. The pt stated that she has scratched until she bled in some parts. As of 12/10/03, the pt had not recovered. No additional info was available at the date of this report.