chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Ear pain, Headache, Hypokinesia, Pain, Vertigo
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from 34-year-old female who received a dose of Flumist 08-Jan-2004, and experienced an inability to function, headache front and back of head and on her face, vertigo and ear pain. The patient had a sinus infection concurrent with Flumist administration. Medical History: The patient's concurrent illnesses include hypersensitivity (allergies) and sinusitis with a past history of migraines (15 years ago). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 08-Jan-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included Flonase (fluticasone propionate) and Zyrtex (cetirizine hydrochloride). Event Details: On 09-Jan-2004, the patient experienced headaches that "exploded" in the front and back of her head, and her face (headache); along with vertigo (vertigo) and she was unable to function (activities of daily living impaired) for two weeks. She was treated with Ceclor for 10 days, Biaxin for 7 days, Levaquin for 3 days along with Sudafed as treatment for her sinus condition that "there was no infection." As of 10-Feb-2004, her headaches persisted along with ear pain. She is currently being treated with Fiorinal. Test Results: Computerized tomogram (results: Negative) was done on an unspecified date. No additional information was available at the time of this report. Follow up: information received on 06APR2004 indicated that the patient had sinusitus at the time of vaccination, provied treatment medication and patient's recovery status. A recent CAT scan was performed with negative results. She indicated taht her physician stated that "there was no infection." As of 10FEB2004, her headaches persisted with pain. She is currently being treated with Fiorinal. The pt had sinusitis at the time of vaccination and was treated with Ceclor. The patient recovered.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Otitis media, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a consumer regarding a 6-year old female patient who experienced fever of 101.2, cough and phlegm. At 6 years of age, the patient received the first dose on 12-Dec-2003. Medical History: The patient's concurrent illness includes eczema. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included Elidel (pimecrolimus). Event Details: The patient received Flumist 0.5 mL on 12-Dec-2004 with no immediate adverse effects; she did not receive a booster dose. On 09-Feb-2004 the patient experienced fever of 101.2 (pyrexia) and cough (cough). She was treated with Pedia Care and Advil. On 10-Feb-2004 the patient's temperature was "normal" but she still had a little cough with "phlegm" (throat secretion increased). No additional information was available at the time of this report.  FOLLOW UP: information was received from a physician attributing the patient's fever to an ear infection and reporting administration of a second dose of Flumist with no reaction. On 24FEB2004, the pt received her second dose of Flumist with no reaction.
Sex: F
Vaccine: FLUN3
Symptoms: Infection transmission via personal contact, Malaise, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 45-year-old female who did not receive FluMist vaccine but experience subsequent accidental exposure and development of and adverse event on 28-Dec-2003. Medical History: None reported. Product Details: Indication, dose and dates of FluMist (2003-2004 Formula) therapy were not provided. The reported did not receive Flu Mist. Concomitant Therapy: Reporter was not taking concomitant therapy. Event Details: A 45-year old female reported that she developed a sore throat (pharyngolaryngeal pain) and nasal congestion (nasal congestion) on 28-Dec-2003, after six hour visit with a person who had received FluMist on an unspecified dated (accidental exposure). The reporter indicated that the FluMist recipient, "did not seem to be sick." and stated, "your product made me sick." Manufacturer's comment: The reporter declined to provide information necessary for follow-up. No additional information was available at the time of this report.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 47-year old female consumer who experienced fever, chills, body aches, abdominal pain, vomiting and nausea. The patient received a dose on 23-Dec-2003. Medical History: The patient has a past history of sarcoidosis (lung condition (not certain), working diagnosis Sarcoid, total remission). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 23-Dec-2003. Dose regiment was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included prednisone, Synthroid (levothyroxine sodium), Lasix (furosemide), multivitamins and Caltrate (calcium carbonate tablet). Event Details: On 23-Dec-2003, within 12-16 hours of receiving Flumist, the patient developed fever, chills, body aches, abdominal pain, vomiting and nausea. At the time of this report, the patient explained that she still was a "a little shaky" due to the symptoms originally reported. No additional information was available at the time of this report.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Tremor, Vomiting
Clinical narrative: Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 47-year old female consumer who experienced fever, chills, body aches, abdominal pain, vomiting and nausea. The patient received a dose on 23-Dec-2003. Medical History: The patient has a past history of sarcoidosis (lung condition (not certain), working diagnosis Sarcoid, total remission). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 23-Dec-2003. Dose regiment was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included prednisone, Synthroid (levothyroxine sodium), Lasix (furosemide), multivitamins and Caltrate (calcium carbonate tablet). Event Details: On 23-Dec-2003, within 12-16 hours of receiving Flumist, the patient developed fever, chills, body aches, abdominal pain, vomiting and nausea. At the time of this report, the patient explained that she still was a "a little shaky" due to the symptoms originally reported. No additional information was available at the time of this report.
Age: 46.0
Sex: M
Vaccine: FLUN3
Symptoms: Conjunctivitis, Eye oedema, Face oedema, Hypersensitivity
Clinical narrative: Follow up information received from the reported on 27-Feb-2004, provided further clarification of the event and treatment plan. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a physician regarding a 46-year-old male patient who experienced "mild" swelling of the right side of his face, lips, right periorbital swelling, mild "pink eye" and slightly swollen ear canals on 10-Dec-2003, within a "few hours" post immunization of Flumist.... Medical History: The patient's concurrent illness includes seasonal allergy (hay fever). Product Details: Indications for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant Therapy: Concomitant therapy included Paxil (paroxetine hydrochloride). Event Details: About 12 hours post immunization, on 10-Dec-2003, the patient experienced "mild" right facial and lip swelling (swelling face), "mild" right periorbital swelling (eye swelling), "pink eye" (conjuctivitis allergic), and "slightly" swollen ear canals (auricular swelling). The physician assessed the event as an "allergic reaction to Flumist." (hypersensitivity). The patient was treated with cool compresses and prescribed Benadryl 50 mg initially and ten 25 mg every 6 hours PRN; along with Naphcon A ophthalmic solution and Zyrtec 10 mg QD. The physician also noted gentamycin ophthalmic solution. The reporter stated that the symptoms resolved in 36 hours.
Age: 57.0
Sex: M
Vaccine: FLUN3
Symptoms: Dysgeusia, Nasal congestion, Nasal dryness, Parosmia, Rhinorrhoea
Clinical narrative: A 57-year-old male consumer reported that he received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date in December 2003 and developed a runny nose, stuffy nose, impaired sense of smell and impaired sense of taste. Medical History: The patient has no known drug allergies. He has a history of seasonal allergies, however, the reported indicated that he was asymptomatic prior to the Flumist vaccination. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. The product was administered approximately three weeks prior to 30-Dec-2003. Concomitant Therapy: Concomitant therapy included Atenolol. Event Details: On a unspecified date in December 2003, a male patient developed a runny nose, stuffy nose, impaired sense of smell, and impaired sense of taste after receiving a dose of Flumist. He stated he "could taste the Flumist in his mouth right away" after vaccination. The patient indicated that the runny nose, stuffy nose, impaired sense of smell and impaired sense of taste occurred almost immediately after administration. He also noticed that his sense of smell and taste was affected in "sensing fragrances associated with certain foods." Treatment included over-the counter antihistamines and Sudafed, however, the patient stated that his runny nose and congestion were not relieved with the use of these products. The patient described his nostrils as "sometimes very dry and sometimes very wet." As of 30-Dec-2003, the reported adverse events persist. The reported indicated he was in the process of contacting his physician regarding the adverse events. No additional information was available at the time of this report.
Age: 49.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug ineffective, Influenza
Clinical narrative: Follow up information received from the reporter on 01-Mar-2003 provided patient's date of birth and lot number. Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 49-year-old male who received a dose of the vaccine and subsequently developed the "flu." 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 regiment was not provide. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced the "flu" (influenza). No additional information was available at the time of this report.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Pyrexia, Rhinorrhoea
Clinical narrative: Pyrexia/ Fever. Rhinorrhoea/ Runny Nose. Headache. Information regarding Flumist 2003-2004 influenza vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a parent regarding her 9 year old daughter who received a dose of 02-Jan-2004 and later developed fever, runny nose and headache. The patient developed a fever of over 99 degrees F-pyrexia, runny nose (rhinorrhea) and headache on 04-Jan-2004. She was given Tylenol which reduced the fever. As of 05-Jan-2004, the reporter stated that the fever "came down," the headache resolved but the runny nose persisted. No additional information was available at the time of this report. The reporter declined to provide a complete address which does not permit follow investigation.
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Otitis media
Clinical narrative: Ear information, Condition aggravated. Information regarding Flumist 2003-4 formula influenza virus vaccne live intranasal 2003-4 formula nasal solution frozen was received from a consumer regarding a ten year old male patient who experienced more frequent ear infections. The patient received a dose on an unspecified date. The pt experienced more frequent ear infections and conditioned aggravated since receiving Flumist (date unspecified). No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Respiratory disorder, Unevaluable event
Clinical narrative: Nasal congestion; Unevaluable event. Information regarding Flumist 2003-4 Formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a female consumer who received a dose on an unspecified date and experienced an adverse event. A consumer reported that she developed a stuffy nose, nasal congestion and upper respiratory symptoms (unevaluable event) after receiving a dose of Flumist on an unspecified date. No additional information was available at the time of this report.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pharyngolaryngeal pain
Clinical narrative: Cough/Persistent non-productive cough; Throat irritation. A 30 year old female consumer reported that she received a dose of Flumist influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen on 12-Dec-2003 and developed a persistent cough and scratchy throat. on 01-Jan-2004, the patient experienced a perisistent cough and scratchy throat/ throat irritation. At the end of January 2003, she was examined by a physician, a diagnosis of allergies was made. She was treated with Claritan (loratadine) and Entuss (guifenesin/hydrocodone bitartrate) cough syrup. The reporter indicated that these medications helped the throat problem, however she continued taking Entuss. The reporter indicated that her physician is not aware that she received Flumist. As of 26-Feb-2004, the cough persists. No further information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Anorexia, Difficulty in walking, Drug ineffective, Influenza, Laboratory test abnormal
Clinical narrative: Influenza. Tremor. Anorexia. Difficulty in walking. Unevaluable event. Information regarding flumist 2003-4 formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a mother regarding her 4 year old son who experienced the flue. At four years of age, the patient received the first dose on 15-Dec-2003. On 20-Dec-2003, the mother reported that her son "had a fever of 103.6 F and was shaking/tremor, couldn't get up/unevaluable event or walk/difficulty walking and wouldn't eat/anorexia. " He was treated with Children's Motrin (ibuprofen), "which would reduce the fever a little, but still over 101 F. On 22-Dec-2003, the child was seen by a physician. A nasal swab was taken, which showed that he had the flu. The child was treated with Tamiflu (oseltamivir). The mother stated that the patient "was much better after six days" of Tamiflu therapy. However, the child remained "sick and weak for at lest three weeks, " before all symptoms completely resolved. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Tremor, Viral infection
Clinical narrative: Influenza. Tremor. Anorexia. Difficulty in walking. Unevaluable event. Information regarding flumist 2003-4 formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a mother regarding her 4 year old son who experienced the flue. At four years of age, the patient received the first dose on 15-Dec-2003. On 20-Dec-2003, the mother reported that her son "had a fever of 103.6 F and was shaking/tremor, couldn't get up/unevaluable event or walk/difficulty walking and wouldn't eat/anorexia. " He was treated with Children's Motrin (ibuprofen), "which would reduce the fever a little, but still over 101 F. On 22-Dec-2003, the child was seen by a physician. A nasal swab was taken, which showed that he had the flu. The child was treated with Tamiflu (oseltamivir). The mother stated that the patient "was much better after six days" of Tamiflu therapy. However, the child remained "sick and weak for at lest three weeks, " before all symptoms completely resolved. No additional information was available at the time of this report.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Pyrexia/Fever; Paryngolaryngeal pain/ Throat sore; Pain/Generalized aching. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 23 year old male patient who experienced fever of 102 degrees, sore throat and body aches. At 23 years of age, the patient received the first dose on 18-Dec-2003. The patient received flumist on 18-DEC-2003 and did not experience any symptoms immediately following administration of the vaccine. On 18-Jan-2004 the patient experienced fever of 102 degrees (pyrexia), sore throat (pharyngolaryngeal pain) and body aches (pain). He was treated with Tylenol but low-grade fever, sore throat and body aches persisted as of 22-Jan-2004.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental overdose, Medication error, Tongue discolouration
Clinical narrative: Tongue Discoloration; Accidental overdose (therapeutic agent); Medication error; Drug maladministration. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 9 year old male patient who experienced tongue discoloration after he received a second dose of Flumist on 17-Feb-2004. The patient received the first dose on 05/Jan/2004. On 17-Feb-2004 the patient received a second dose of flumist (accidental overdose)/medication error. The first dose of vaccine was given on 05-Jan-2004. The doctor's office misread the flyer that accompanied the flumist and administered the second dose since the patient had not been given a flu shot in the past. Immediately after administration of the second dose, the patient's tongue turned blue/ tongue discoloration. See related case HQWYE666209MAR04 (adverse event, non expedited) and HQWYE666309MAR09 (adverse event, non-expedited. No additional information was available at the time of this report. Follow Up: information pertaining to the reported event of tongue discoloration was received from the reporter.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Medication error, Vomiting
Clinical narrative: Vomiting; Medication Error/ Maladministration; Diarrhea. Follow-up information received from the pediatrician provided adverse event details, recovery status, patient date of birth, revised physician address, count of vaccine adminsitration and vaccine lot number. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding 4 year old male who developed vomiting and diarrhea after he was given Flumist inadvertently, due to human error. At 4 years of age, the patient received a dose on 24-Oct-2003. On 26-Oct-2003, two days post vaccination, the child developed vomiting and diarrhea, which lasted about 24 hours. He recovered. The patient was given Flumist inadvertently, due to human error /medication error.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Ear pain, Influenza like illness, Pain, Pharyngolaryngeal pain
Clinical narrative: Influenza like illness/Flu-like symptoms; Pharygolaryngeal pain/ Sore throat; Ear pain/Ear ache; Rigors/chills; Pain/Ache NOS; Pyrexia/Fever. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a 35 year old female consumer who experienced flu-like sympttoms, sore throat, earache, chills, body aches and fever between 100-101. At 35 years of age, the patient received a dose on 15-Jan-2004. On 21-Jan-2004, 6 days post-immunization, the patient experienced flu-like symptoms (influenza like illness) characterized by sore throat (pharyngolaryngeal pain); earache/pain, chills/rigors,  body aches/pain and fever between 100-101 degrees/pyrexia. As of 26-Jan-2004, the patient's symptoms were "getting worse".
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Influenza like illness/Flu-like symptoms; Pharygolaryngeal pain/ Sore throat; Ear pain/Ear ache; Rigors/chills; Pain/Ache NOS; Pyrexia/Fever. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a 35 year old female consumer who experienced flu-like sympttoms, sore throat, earache, chills, body aches and fever between 100-101. At 35 years of age, the patient received a dose on 15-Jan-2004. On 21-Jan-2004, 6 days post-immunization, the patient experienced flu-like symptoms (influenza like illness) characterized by sore throat (pharyngolaryngeal pain); earache/pain, chills/rigors,  body aches/pain and fever between 100-101 degrees/pyrexia. As of 26-Jan-2004, the patient's symptoms were "getting worse".
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Influenza like illness, Medication error, Nasal congestion, Pain
Clinical narrative: Pyrexia/ Slight Fever; Medicaiton error/Inappropriate dose of drug administered; Influenza like illness (flu-like symptoms). Follow up information received form the healthcare provider, on 15-Mar-2003, provided additional demographics, vaccination details, including date and lot number, additional details of adverse event, including date, and recovery status, and reported previous history, allergies and birth defects as none. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding a 23 year old female patient who received a partial dose on 21-Jan-2004 developed a mild fever and flu like symptoms. A nurse reported that a 23 year old female patient refused the second half of a divided dose of flumist (medication error) on 21-Jan-2004. On 24-Jan-2004, she developed a mild fever/ pyrexia and flulike symptoms (influenza like illness) which were described as stuffy nose, aches and tiredness. The reporter indicated that the patient received "over the counter treatment for mild fever and aches." The reporter also indicated, that the patient's signs and symptoms lasted 4 days and she recovered.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Pyrexia/ Slight Fever; Medicaiton error/Inappropriate dose of drug administered; Influenza like illness (flu-like symptoms). Follow up information received form the healthcare provider, on 15-Mar-2003, provided additional demographics, vaccination details, including date and lot number, additional details of adverse event, including date, and recovery status, and reported previous history, allergies and birth defects as none. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding a 23 year old female patient who received a partial dose on 21-Jan-2004 developed a mild fever and flu like symptoms. A nurse reported that a 23 year old female patient refused the second half of a divided dose of flumist (medication error) on 21-Jan-2004. On 24-Jan-2004, she developed a mild fever/ pyrexia and flulike symptoms (influenza like illness) which were described as stuffy nose, aches and tiredness. The reporter indicated that the patient received "over the counter treatment for mild fever and aches." The reporter also indicated, that the patient's signs and symptoms lasted 4 days and she recovered.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, Tongue discolouration
Clinical narrative: Tongue Discoloration; Accidental Overdose; Medication error/ Drug mal-administration. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a health professional regarding a 15 year old female patient who experienced tongue discoloration after receiving a second dose of Flumist on 17-Feb-2004. On 17-Feb-2004 the patient received a second dose of Flumist (accidental overdose/medication error). The first dose of vaccine was given on 05-Jan-2004. The doctor's office misread the flyer that accompanied the Flumist and administered the second dose since the patient had not been given a flu shot in the past. Immediately after administration of the second dose, the patient's tongue turned pink/tongue discoloration. See related cases HQWYE568304MAR04 AND HQWYE666309MAR04 BOTH (ADVERSE EVENT, NON-EXPEDITED). No additional information was available at the time of this report. Follow Up: The reporter disclosed that a supply of lollipops of various colors, including the color of the patient's reported tongue discoloration, was availabe inteh room where the patient waited after immediately receiving the vaccine.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental overdose, Medication error, Tongue discolouration
Clinical narrative: Tongue discoloration; Accidental overdose (therapeutic agent); Medication error/ Drug mal-administration. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 12 year old male patient who experienced tongue discoloration after he received a second dose of Flumist on 17-Feb-2004. The pt received the first dose of vaccine on 05-Jan-2004. On 17-Feb-2004 the patient received a second dose of Flumist (accidental overdose/medication error). The first dose of vaccine was given on 05-Jan-2004. The doctor's office misread the flyer that accompanied the Flumist and administered the second dose since the patient had not been given a flu shot in the past. Immediately after administration of the second dose, the patient's tongue turned blue (tongue discoloration). No additional information was available at the time of this report. See related cases HQWYE568304MAR04 and HQWYE666209MAR04 both (adverse even, non-expedited). Follow Up: The reporter disclosed that a supply of lollipops of various colors, including the color of the patient's reported tongue discoloration, was available in the room where the patient waited after immediately receiving the vaccine.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Cough, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Pyrexia/Fever; Rhinorrhea/Runny Nose; Cough/Dry cough; Rigors/chills; Pain/Generalized Aching. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 36 year old female patient who experienced runny nose, dry cough, chils, body aches and fever. At 36 years of age, th patient received a dose on 12-Dec-2003/ The patient experienced runny nose (rhinorrhea), dry cough/cough, chills/rigors and body aches/pain on 13-Dec-2003. On 17-Dec-2003, she developed a fever (pyrexia) of 100.7 deg F. No additional information was available at the time of this report.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Periorbital oedema, Pyrexia
Clinical narrative: Orbital Oedema; Pyrexia/Fever. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 20 year old female patient who experienced peri-orbital edema and fever. At 20 years of age, the patient received a dose on 10-Dec-2003. The patient experienced peri-orbitla edema on 12-Dec-2003. Treatment included zyrtec (certirizine hydrochloriede) but this "did not help". On 17-Dec-2003, the patient developed a "low grade" fever/pyrexia. No additional information was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Pharyngolaryngeal pain, Pyrexia, Sneezing
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; SNEEZING; PYREXIA; HEADACHE; PHARYNGOLARYNGEAL PAIN; SORE THROAT. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a female patient who experienced sneezing, fever, headache, sore throat and vaccine exposure during pregnancy. The patient received a dose on 13-Dec-2003. On 13-Dec-2003, a pregnant female patient received Flumist 2003-4 formula (vaccine exposure during pregnancy) and developed fever (pyrexia), sneezing, headache and sore throat  (pharyngolaryngeal pain). As of 17-Dec-2003, her symptoms were improving. The outcome of the pregnancy is unknown. No additional information was available at the time of this report.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Pain, Vomiting
Clinical narrative: RIGORS/CHILLS; VOMITING; PAIN/GENERALIZED ACHING. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a 45 year old female who experienced chills, vomiting and body aches, approximately 2.5 hours after administration. At 45 years of age, the patient received a dose on 17-Dec-2003. On 17-Dec-2003, approximately 2.5 hrs after Flumist administrtion, the patient experienced chills, vomiting and body aches. All symptoms were resolved at the time of this report. No additional information was available at the time of this report.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Otitis media, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Ear infection; Pyrexia/Fever; Pharyngolaryngeal Pain/ Sore throat. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from the father of a 7 year old female who experienced fever 103 deg F, sore throat and ear infection. At 7 years of age, the child received a dose on 09-Dec-2003. The child experienced fever 103 deg F/ pyrexia and sore throat/ pharyngolaryngeal pain on 12-Dec-2003. On 13-Dec-2003, the child was diagnosed with an ear infection. The child was treated with Lorabid (loracarbef). As of 18-Dec-2003, the fever had resolved and the child was "better". The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Pain/Generalized Aching, Rhinorrhea/Runny Nose; Pharyngolaryngeal pain/ Sore throat. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a mother of a 10 year old female who experienced runny nose, sore throat and aches. At 10 years of age, the patient received a dose on 13-Dec-2003. The patient experienced runny nose (rhinorrhea), sore throat (pharyngolaryngeal pain) and aches (pain) on 16-Dec-2003. No additional information was available at the time of this report.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Rhinorrhoea
Clinical narrative: Rhinorrhea/ Runny Nose; Pain/ Generalized Aching. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a consumer regarding a 35 year old female patient who experienced runny nose and became achy. At 35 years of age, the patient received a dose on 13-Dec-2003. The patient experienced runny nose (rhinorrhea) on 13-Dec-2003 and became achy (pain) on 16-Dec-2003. No additional information was available at the time of this report.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Rhinorrhoea
Clinical narrative: Rhinorrhea/Runny Nose; Unevaluable event. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a father regarding his 7 year old son who developed a runny nose and "felt run down." The patient received the first dose on an unspecified date. The father reported that within 3 days of receiving Flumist (2003-4 Formula), his son developed a runny nose and "felt run down". The events lasted several days. The patient's nine year old brother experienced a similar reaction (see MCN: HQWYE812504FEB04). No additional information was available at the time of this report
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Rhinorrhoea
Clinical narrative: Rhinorrhea/ Runny Nose; Unevaluable event. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a father regarding his 9 year old son who developed a runny nose and "felt run down" . The patient received the first dose on an unspecified date. The patient's 7 year old brother experienced a similar reaction (see MCN: HQWYE812104FEB04). No additional information was available at the time of this report.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Dysgeusia, Medication error
Clinical narrative: Medication error/ Drug maladministration; Dysgeusia/Bad taste. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a healthcare professional regarding a 6 year old female. On 05-Feb-2004 during vaccine administration, part of the Flumist dose was accidentally sprayed onto the patient's cheek and possibly into her eye. The patient experienced a bad taste in her throat. On 05-Feb-2004 during the administration of Flumist, the patient  reared back because of a "bad taste"/ Dysgeusia in her throat. Part of the dose was accidentally sprayed onto patient's cheek and possibly into her eye/ medication error. The patient's eye (reporter did not specify which eye) was flushed with water and no eye irritation was observed. No additional information was available at the time of this report.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Influenza. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a healthcare professional regarding an 11 year old female patient who received a dose on December 12, 2003 and subsequently developed influenza.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Pyrexia. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding his 5 year old son who received a dose in Dec 2003 and developed fever. The child's father reported that his son received a dose of Flumist (2003-4) in Dec-2003, and two days later, developed a fever (pyrexia) which has been "up and down" and as high as 102 degrees F. The child was seen by the physician but according to the father, his son did not have a fever that day. No additional information was available at the time of this report.
Age: 24.0
Sex: F
Vaccine: HEP, RAB, TTOX
Symptoms: Erythema, Eye pain, Headache, Lethargy, Oedema
Clinical narrative: Employee called at 9 am stated she felt lethargic, feverish and her left arm was red & swollen. Complains of severe headache, stated that her eyeballs feel like they there going to pop out of socket. Will refer to PCP for further vaccine recommendations on Hep B & Rabies.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: L. arm sore @ vx site.  Hot, red, hurts to touch.  No fever.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Erythema, Lymphadenopathy, Pharyngitis, Pyrexia, Rash
Clinical narrative: Day or two after shot had slight cold symptoms. Two days after shot had a fever of 103 and it lasted for a few days. Developed large lymph nodes at base of skull right before rash. Broke out in a rash a day or two later. First day of rash, was on the back of the neck. It was not a mild rash by any means. Following day rash worsened, bright red small dots all over body from head to toe. My daughter seemed to be slightly itchy. Doctor said it was not necessary to see her. I waited a day and when the rash worsened I brought her in anyway. They diagnosed her as having rubella which had been contagious. The nurse who had administered the injection and doctor told me that it was not necessary for them to report this to you. I am reporting it because of that.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Rhinitis
Clinical narrative: Day or two after shot had slight cold symptoms. Two days after shot had a fever of 103 and it lasted for a few days. Developed large lymph nodes at base of skull right before rash. Broke out in a rash a day or two later. First day of rash, was on the back of the neck. It was not a mild rash by any means. Following day rash worsened, bright red small dots all over body from head to toe. My daughter seemed to be slightly itchy. Doctor said it was not necessary to see her. I waited a day and when the rash worsened I brought her in anyway. They diagnosed her as having rubella which had been contagious. The nurse who had administered the injection and doctor told me that it was not necessary for them to report this to you. I am reporting it because of that.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pallor, Somnolence, Subcutaneous nodule
Clinical narrative: Excessive sleepiness and fussiness for three days, paleness for two days, and large (4cm) nodule in thigh for three WEEKS.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Disturbance in attention, Dizziness, Dysgeusia, Fatigue, Headache
Clinical narrative: 24 hours after my most recent vaccination I have the following side effects: dizziness and slight vertigo trouble focusing my vision sleepiness (I slept from 10:30 PM till 6:00 AM, and I slept again from 12 noon to 5:00 today and I still feel sleepy) bad fatigue headache trouble concentrating, like I'm a haze I felt heart palpitations when lying down occasional tingling sensation in both hands and forearms  occasionally have strange taste in mouth  so far I haven't had any treatment, I will if these symptoms persist. I feel the need to report this as an adverse reaction because this is the worst I've felt after getting this vaccination.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Palpitations, Somnolence, Vertigo, Vision blurred
Clinical narrative: 24 hours after my most recent vaccination I have the following side effects: dizziness and slight vertigo trouble focusing my vision sleepiness (I slept from 10:30 PM till 6:00 AM, and I slept again from 12 noon to 5:00 today and I still feel sleepy) bad fatigue headache trouble concentrating, like I'm a haze I felt heart palpitations when lying down occasional tingling sensation in both hands and forearms  occasionally have strange taste in mouth  so far I haven't had any treatment, I will if these symptoms persist. I feel the need to report this as an adverse reaction because this is the worst I've felt after getting this vaccination.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Laboratory test abnormal, Medication error, Unintended pregnancy
Clinical narrative: Information has been received from a physician through a pregnancy registry concerning a 28 year old female with a history of one previous full term pregnancy with no birth defects and no stillbirths or miscarriages in any previous pregnancy who on 2/12/04 was vaccinated with a first 0.5mL dose of varicella virus vaccine live (lot # 931150P). There was no local reaction at the vaccination site. There were no varicella or herpes zoster symptoms post vaccination. The physician reported that he gave the vaccination during the patient's menstrual period (LMP 2/11/04; EDD 11/17/04). Although the patient did not intend to become pregnant, the physician gave a urine pregnancy test prior to her second dose. The test was positive. The physician thought that the patient became pregnant within two weeks of her vaccination. The patient did not receive the second dose. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Follow up information was received from the physician who indicated that the patient voluntarily terminated her pregnancy on approximately 3/19/04 after discussing it with her gynecologist. It was also noted that the patient terminated her pregnancy within a month. An ultrasound on 3/19/04 was negative and was a normal test. No further information is available.
Age: 3.0
Sex: M
Vaccine: MU
Symptoms: Anaphylactic reaction, Cough, Laryngospasm, Paraesthesia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 3 year old male with latex allergy and a history of urinary bladder atrophy with multiple procedures who was vaccinated with the mumps virus vaccine live in approximately March 2004, the patient developed an anaphylactic reaction within minutes of receiving the vaccine with tingling of the tongue, vomiting and hives. He was given epinephrine and diphenhydramine hydrochloride in the office. He then experienced a laryngospasm and a croupy cough. The patient went to the emergency room and received another dose of epinephrine. Subsequently, the patient recovered from the anaphylactic reaction. The reporter felt that the anaphylactic reaction was related to therapy with the mumps virus vaccine live. The anaphylactic reaction was considered to be immediately life threatening. Follow up on 05/24/04 states: "On 04/16/04 an allergen skin test result was positive for a class 3 rash. The reporting physician stated that the mumps vaccine and gelatin were positive in triggering the generalized urticaria. The reporter felt that the anaphylactic reaction was related to therapy with the mumps virus vaccine live. The anaphylactic reaction was considered to be immediately life-threatening. This report no longer meets criteria for submission because the unexpected adverse experience of 'laryngospasm' has been deleted."
Age: 3.0
Sex: M
Vaccine: MU
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 3 year old male with latex allergy and a history of urinary bladder atrophy with multiple procedures who was vaccinated with the mumps virus vaccine live in approximately March 2004, the patient developed an anaphylactic reaction within minutes of receiving the vaccine with tingling of the tongue, vomiting and hives. He was given epinephrine and diphenhydramine hydrochloride in the office. He then experienced a laryngospasm and a croupy cough. The patient went to the emergency room and received another dose of epinephrine. Subsequently, the patient recovered from the anaphylactic reaction. The reporter felt that the anaphylactic reaction was related to therapy with the mumps virus vaccine live. The anaphylactic reaction was considered to be immediately life threatening. Follow up on 05/24/04 states: "On 04/16/04 an allergen skin test result was positive for a class 3 rash. The reporting physician stated that the mumps vaccine and gelatin were positive in triggering the generalized urticaria. The reporter felt that the anaphylactic reaction was related to therapy with the mumps virus vaccine live. The anaphylactic reaction was considered to be immediately life-threatening. This report no longer meets criteria for submission because the unexpected adverse experience of 'laryngospasm' has been deleted."
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 30 year old male patient with a history of hepatitis C who on 3/16/04 was vaccinated with a dose of varicella virus vaccine live (lot # 646533/0830N). On 4/1/04, the patient appeared with break through chicken pox. Unspecified medical attention was sought. On 4/5/04, the reporter stated the patient has several health issues and is currently hospitalized. The reporter noted the patient was not hospitalized because of chicken pox, nor hepatitis C. A product quality complaint was not involved. Additional information has been requested. Follow Up: On 07apr2004, the patient recovered from chickenpox. Subsequently, the patient was discharged. A product quality complaint was not involved. Additional information is not available.
Age: 1.8
Sex: M
Vaccine: MMR
Symptoms: Rash, Thrombocytopenic purpura
Clinical narrative: Child received MMR on 10/20/03. Developed diffuse rash on 10/31/03 which resolved. Subsequently developed immune thrombocytopenic purpura, diagnosed on 2/21/04. Required oral steroids, immune globulin and bone marrow biopsy/aspiration.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthropathy, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: JOINT PAIN-ALL JOINTS (ALTHRALGIA, ARTHRALGIA). JOINT STIFFNESS/JOINT DISORDER. PAIN AT SITE OF INJECTION. SWELLING AT SITE OF INJECTION. INJECTION SITE EDEMA. A report was received from a health care professional on 28 October 2003 concerning a 39 year old female vaccinee who experienced pain and swelling at the site of injection on the same day of receiving Fluvirin and pain in all of her joints and joint stiffness 2 days after receiving Fluvirin on 23 October 2003. On 23 October 2003, the vaccinee experienced pain and swelling at the site of inject on which continued until the next day. On 25 October 2003, the vaccinee experienced pain in all her joints (including her toes), and joint stiffness. The reporter indicated that the vaccinee has received influenza vaccines annually for the past 11 years and has not experienced this type of adverse reaction. At the time of reporting the vaccines had not recovered. The vaccinee plans to be evaluated by her physician. There was insufficient information to determine the reporter's causality assessment. Update 1, 09 January 2004: Futher information was received from a health care professsional indicating that the vaccinee experienced joint pain ina ll her joints on 24 October 2003 after receiving Flurin on 22 October 2003. The joint pain made it difficult for the vaccinee to move. The vaccinee had no relief despite treatment with ibuprofen following one week without improvement and off work the vaccinee consulted her physician who prescribed 40 mg daily of prednisone for 5 days. The vaccinee started to improve within 2 days. However, two weeks later the vaccinee still had some joint pain in her arms, shoulders and hands. The vaccinee recovered in an unspecified date The reporter has asssesed the relationship of the vaccine to the joint pain as probable. Update 2, 07 April 2001: Following medical review this case was upgraded to serious in view of the nature and persistence of the joint pain and stiffness, the lack of response to NSAID and the requirement for prednisoe. Follow up pending.  Follow up on 07/19/04 states: "The reporter confirms that the joint pain and stiffness started on 10/23/03 and had resolved by 12/01/03. The vaccinee had consulted her physician, has stayed off work for one week and had taken corticosteroids to decrease the pain. She had received influenza vaccines previously, but had not experienced any problems before. The reporter considers the events probably related to Fluvirin. No further information is expected."