chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Wound
Clinical narrative: A non-serious spontaneous report of 'administered H1N1 to pregnant female' and wound was received from a nurse/health professional concerning a 26-year-old pregnant female, subsequent to H1N1 Vaccine Live, Intranasal. The patient neither had any relevant medical history nor any concomitant medications. The obstetrical history of the patient included gravida one and para zero. The patient was nine weeks pregnant at the time of vaccination. The EDD of the patient was 15-Jun-2010. On 03-Nov-2009, the patient received H1N1 Vaccine Live, Intranasal for an unknown indication. The reporter stated that she had seen the patient on 21-Jun-2010 for a wound check. The reporter then indicated that she could give no further information but gave the name and phone number. The outcome of the event of 'administered H1N1 to pregnant female' was considered resolved and the outcome of the event of wound was unknown. Additional information was received on 22-Dec-2009 and incorporated into the narrative are patient's medical history, concomitant medications and obstetrical history. Additional information was received on 08-Jul-2010 and incorporated in the narrative: adverse event of "Wound" was added. Other additional information received was patient's full name and physician name and phone number.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever, cough and sore throat has been received from a nurse concerning a five-year-old female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. On 29-Oct-2009 the patient received H1N1, Intranasal. On 01-Nov-2009 the patient began to develop fever, cough and sore throat. The reporter stated the events were ongoing.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Dysgeusia
Clinical narrative: A non-serious spontaneous report of taste the vaccine in the back of their throat has been received from a nurse concerning ten adolescents subsequent to H1N1, Intranasal. The past medical history and concomitant medications of these patients were not reported. On 30-Oct-2009 the patients received H1N1, Intranasal. On the same day, shortly after administration of the vaccine the patients reported they could taste the vaccine in the back of their throat. The outcome of the event was not reported.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Cough, Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous reports of "tested positive for influenza A" has been received from a registered nurse concerning children of unknown age and sex subsequent to H1N1, Intranasal. The patient's medical history and concomitant medications were not reported. The patients received H1N1, Intranasal on 20-Oct-2009. A week after receiving H1N1, Intranasal, on 27-Oct-2009, the patients experienced flu like symptoms and tested positive for influenza A. The patients had fevers of 103 degrees, runny nose, and cough. The outcome of the event was unknown.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous reports of "tested positive for influenza A" has been received from a registered nurse concerning children of unknown age and sex subsequent to H1N1, Intranasal. The patient's medical history and concomitant medications were not reported. The patients received H1N1, Intranasal on 20-Oct-2009. A week after receiving H1N1, Intranasal, on 27-Oct-2009, the patients experienced flu like symptoms and tested positive for influenza A. The patients had fevers of 103 degrees, runny nose, and cough. The outcome of the event was unknown.
Age: 14.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Influenza like illness, Nausea
Clinical narrative: A non-serious, spontaneous report of "got H1N1 and now feeling like he has the flu" and nausea has been received from a consumer concerning an 14-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose of H1N1, Intranasal on 27-Oct-2009. On 27-Oct-2009, within an hour of receiving vaccine, began feeling like he had the flu and nausea. Neither outcome nor causality has been reported for these events.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Headache, Influenza, Influenza virus test positive, Nausea, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of flu and nausea has been received from a parent/non health professional concerning a forty six-month-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 31-Oct-2009, after seven days of vaccination, the patient experienced nausea and flu with symptoms of congestion, fever, headache, sore throat and nausea. In Oct-2009 nasal swab was taken which tested positive for flu. The outcome of the reported events was not resolved.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of flu and nausea has been received from a parent/non health professional concerning a forty six-month-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 31-Oct-2009, after seven days of vaccination, the patient experienced nausea and flu with symptoms of congestion, fever, headache, sore throat and nausea. In Oct-2009 nasal swab was taken which tested positive for flu. The outcome of the reported events was not resolved.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of chest pressure, dizzy, tiredness, sore throat, tickle in throat and headache has been received from a 33-year-old female patient, subsequent to H1N1, Intranasal. The patients medical history included anemia. The patient denies history of headache. No concomitant medications were reported. On 27-Oct-2009, the patient received H1N1, Intranasal for an unspecified indication. On 29-Oct-2009, the patient experienced chest pressure, sore throat, tickle in her throat and tiredness. On 03-Nov-2009, patient experienced a headache on the right side of her head that persists. As stated by reporter most of the other symptoms had resolved but she was still tired. At the time of report she was feeling dizzy when she gets up. The patient recovered from the events of chest pressure, sore throat, tickle in her throat and headache. The events of dizzy and tiredness were not resolved.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Throat irritation
Clinical narrative: A non-serious spontaneous report of chest pressure, dizzy, tiredness, sore throat, tickle in throat and headache has been received from a 33-year-old female patient, subsequent to H1N1, Intranasal. The patients medical history included anemia. The patient denies history of headache. No concomitant medications were reported. On 27-Oct-2009, the patient received H1N1, Intranasal for an unspecified indication. On 29-Oct-2009, the patient experienced chest pressure, sore throat, tickle in her throat and tiredness. On 03-Nov-2009, patient experienced a headache on the right side of her head that persists. As stated by reporter most of the other symptoms had resolved but she was still tired. At the time of report she was feeling dizzy when she gets up. The patient recovered from the events of chest pressure, sore throat, tickle in her throat and headache. The events of dizzy and tiredness were not resolved.
Age: 1.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of "gave H1N1 to children less than two years old and runny nose" has been received from a registered nurse concerning a 12-month year old male patient subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 29-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 29-Oct-2009, the patient experienced runny nose and was resolved on 30-Oct-2009. The outcome of the event was resolved.
Age: 1.25
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 to children less than two years old was received from a registered nurse/health professional concerning a 14-month-old male. The patient's medical history included sickle cell trait, but no disease and no concomitant medications was taken by the patient. On 29-Oct-2009, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 18-Dec-2009 and incorporated into the narrative: The patient's medical history and concomitant medications.
Age: 50.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1, Intranasal to 50-year-old male physician was received from a healthcare professional/registered nurse. Neither relevant medical history nor concomitant medications have been reported for this patient. On 29-Oct-2009, the patient received H1N1 vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of pregnant patient inadvertently given the live vaccine was received from a registered nurse concerning an adolescent female. After vaccination of the patient, the nurse was informed that the patient was four weeks pregnant. The expected delivery date is approximately 11-Jul-2010. There was no adverse event associated with this pregnancy. Additional information was received on 05-Nov-2009: start date of adverse event, reporter's address and responsible physician's address. Additional information was received on 13-Nov-2009: Expected delivery date has been updated.
Age: 72.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "inadvertently gave H1N1 vaccine to person above age 49" was received from a registered nurse concerning a 72-year-old female. On 29-Oct-2009, the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 16.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Influenza like illness, Nausea
Clinical narrative: A non-serious, spontaneous report of "got H1N1 and now feeling like she has the flu" and nausea has been received from a consumer concerning an 16-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal on 27-Oct-2009. On 27-Oct-2009, within an hour of receiving vaccine, began feeling like she had the flu and nausea. Neither outcome nor causality has been reported for these events.
Age: 19.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Influenza like illness, Nausea
Clinical narrative: A non-serious spontaneous report of "got H1N1 and now feeling like she has the flu" and nausea has been received from a consumer concerning an 19-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal on 27-Oct-2009. On 27-Oct-2009, within an hour of receiving vaccine, began feeling like she had the flu and nausea. Neither outcome nor causality has been reported for these events.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of gave pregnant woman H1N1 was received from a nurse practitioner concerning a 32-year-old female. No relevant medical history and concomitant medications was reported for the patient. The patient's obstetrical history was unknown and estimated date of delivery was 07-Dec-2009. The patient was in her third trimester at 35 weeks gestation. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments was not applicable and the event vaccine exposure during pregnancy was considered resolved. The outcome of the pregnancy in mid of Dec-2009 was birth to a beautiful, healthy and normal baby girl and both mother and child are doing very well. Additional information was received on 11-Nov-2009 and incorporated into the narrative: obstetrical history, medical history, concomitant medication and estimated date of delivery. Additional information was received on 23-Dec-2009 and incorporated into the narrative: outcome of pregnancy.
Age: 15.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Malaise
Clinical narrative: A non-serious, spontaneous report of "daughter got H1N1 and now she is sick" has been received from a physician concerning a 15-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal in Oct-2009. On an unknown date the patient became very sick. Neither outcome nor causality has been reported for this event.
Age: 60.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1, Intranasal to a 60-year-old female was received from a healthcare professional/medical assistant. Neither relevant medical history nor concomitant medications have been reported for this patient. On 02-Nov-2009, the patient received H1N1 vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Headache, Influenza virus test negative, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of congestion, fever, headache, sore throat and nausea has been received from a parent/non health professional concerning a seven-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 28-Oct-2009, after four days of vaccination, the patient experienced congestion, fever, headache, sore throat and nausea. Nasal swab was taken which tested negative for flu. The outcome of the reported events was not resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of congestion, fever, headache, sore throat and nausea has been received from a parent/non health professional concerning a seven-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 28-Oct-2009, after four days of vaccination, the patient experienced congestion, fever, headache, sore throat and nausea. Nasal swab was taken which tested negative for flu. The outcome of the reported events was not resolved.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 07 October 2009 from a health professional. A 36 year old female, with no known allergies and a history of hypertension, received at left deltoid intramuscular injection of FLUZONE (lot number U3184AA) on 05 October 2009. Concomitant medication included unspecified blood pressure medication. The patient had no illness at the time of vaccination and had received no other vaccinations within four previous weeks. On the evening of vaccination, the area from the left deltoid to the elbow became red, hot and tender to touch, there was swelling, decreased mobility in the arm, and it was was painful to move. At the time of the report, the patient had not recovered and was to be seen by a health care professional later that day. Follow-up report received on 03 December 2009 from a health care professional. The patient had received no previous doses of any influenza vaccine. The patient's concomitant medication included Triamterene-HCTZ (37.5-25 milligrams) for high blood pressure. The patient's symptoms were treated with MORTIN (600 milligrams, oral, TID for 4 days) and cold compresses (QID). The patient was monitored daily, the symptoms improved daily beginning 07 October 2009 and resolved by 12 October 2009. List of documents held by sender (as of 03 December 2009): none.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report received on 07 October 2009 from a health professional. A 36 year old female, with no known allergies and a history of hypertension, received at left deltoid intramuscular injection of FLUZONE (lot number U3184AA) on 05 October 2009. Concomitant medication included unspecified blood pressure medication. The patient had no illness at the time of vaccination and had received no other vaccinations within four previous weeks. On the evening of vaccination, the area from the left deltoid to the elbow became red, hot and tender to touch, there was swelling, decreased mobility in the arm, and it was was painful to move. At the time of the report, the patient had not recovered and was to be seen by a health care professional later that day. Follow-up report received on 03 December 2009 from a health care professional. The patient had received no previous doses of any influenza vaccine. The patient's concomitant medication included Triamterene-HCTZ (37.5-25 milligrams) for high blood pressure. The patient's symptoms were treated with MORTIN (600 milligrams, oral, TID for 4 days) and cold compresses (QID). The patient was monitored daily, the symptoms improved daily beginning 07 October 2009 and resolved by 12 October 2009. List of documents held by sender (as of 03 December 2009): none.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injected limb mobility decreased, Joint swelling, Local swelling, Vaccine positive rechallenge
Clinical narrative: Initial case was received from a physician, who is also the patient's parent, on 09 October 2009. The physician reported that this patient experienced a similar event following FLUZONE vaccination in 2008; this event is captured in case number 2009-04270. An eight-year-old male patient experienced localized swelling and redness, and diminished abduction of the shoulder, after receiving an intramuscular injection of FLUZONE (lot not reported) on 06 October 2009. The patient had a history of allergies to AUGMENTIN, Penicillin, and Amoxicillin, and had previously experienced similar adverse events following FLUZONE injection. The day of vaccination, the patient developed swelling and redness localized in the shoulder. He was unable to abduct his shoulder greater than 30 degrees. At the time of the event, the events had not yet recovered. Follow-up information received on 18 December 2009 from the patient's parent who is a physician. The patient had no concurrent illnesses at time of vaccination, and does not take any concomitant medications. The patient recovered; however a recovery date was not provided. No further information is expected. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: Initial report received from a health care professional on 12 October 2009. The same health care professional reported another case which is described in case 2009-04286. A patient whose age and gender were not reported received an injection in the left deltoid of FLUZONE (lot number not reported). One day after vaccination, the patient developed nausea, decreased appetite, fever greater than 101 degrees Fahrenheit, chills, headache and body aches. Illness at the time of vaccination and pre-existing conditions were reported as none. No additional information was provided. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received from a health care professional on 12 October 2009. The same health care professional reported another case which is described in case 2009-04286. A patient whose age and gender were not reported received an injection in the left deltoid of FLUZONE (lot number not reported). One day after vaccination, the patient developed nausea, decreased appetite, fever greater than 101 degrees Fahrenheit, chills, headache and body aches. Illness at the time of vaccination and pre-existing conditions were reported as none. No additional information was provided. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Body temperature increased, Diarrhoea, Nausea
Clinical narrative: Initial report received from a health care professional on 12 October 2009. The same health care professional reported another case which is described in case 2009-04285. A 44 year old female patient received an injection in the left deltoid of FLUZONE (lot number not reported). One day after vaccination, the patient developed nausea, diarrhea, abdominal pain and temperature of 101.2 degrees Fahrenheit. Illness at the time of vaccination was re ported as none. The patient's concomitant medications include XANAX for anxiety, CLARINEX and birth control. The patient's recovery status was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial non-serious case received from a health care professional on 09 October 2009. A female patient (age not reported) had a possible reaction (not otherwise specified) to FLUZONE (lot number U1881AA) in 2005. No further information was provided. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Initial report received from a health care professional on 12 October 2009. A female of unknown age received an injection of FLUZONE (lot number not reported). The site of vaccination was reported as the shoulder joint. The date and route of vaccination were not reported. The patient experienced shoulder pain. The date of onset was not reported, however the patient's shoulder pain was ongoing at 3 weeks post vaccination. The patient was seen by a health care provider. No additional information was provided. List of documents held by sender: none.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Feeling abnormal, Headache, Vomiting
Clinical narrative: Initial report received from a health care professional on 12 October 2009. A 39 year-old male patient was vaccinated with H1N1 (sanofi pasteur, lot # UP001A) on 11 October 2009 and was previously vaccinated with  FLUZONE (sanofi pasteur, Lot # U3213AA) on 26 September 2009. The patient reported receiving the H1N1 vaccine in the morning, ate lunch at approximately 12:30 PM and at approximately 3:15 PM developed a left-sided occipital headache which was unrelieved by EXCEDRIN. The patient also had two episodes of vomiting that evening. The following morning, the patient reported that the headache was resolved, but reported feeling very rundown. Two days post vaccination, the patient was recovered and returned to work reporting that he was "feeling fine". The patient reported having seasonal allergies treated with ALLEGRA and NASACORT at the time of vaccination. No further information is expected. List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoglycaemia
Clinical narrative: Non-serious case received from a health care professional (pharmacist) on 16 October 2009. A 50-year-old male patient with history of diabetes and hypertension reported having problems with "blood sugars running low at night" since receiving a FLUZONE vaccination (lot number unknown; route/site of administration not reported) on 08 October 2009. Patient outcome was unknown. The reporter indicated that the patient had received the FLUZONE vaccination at his physician's office. No further details were provided. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity
Clinical narrative: Initial report received on 20 October 2009 from a consumer who is a health care professional. A 47-year-old female patient, who has allergy to Codeine, had received a dose of FLUZONE (lot number unknown) two weeks prior to 20 October 2009; and subsequently received a right deltoid dose of H1N1 (lot number unknown) on 16 October 2009. Concomitant medications included IMITREX; "Amitryptyline", and SYNTHROID. The following day after receiving the H1N1, the patient experienced pain in both legs from her hips to feet, which persists. The patient required medical attention; however no relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient received any treatment. It is worthy to note the patient indicated that she experienced the "same" type of adverse events with prior flu vaccinations; however the dates of administration, trade names, manufacturer names, lot numbers, routes and sites of administration were not reported for those vaccines. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Discomfort, Injection site pain, Myalgia
Clinical narrative: Cluster of two cases of muscular pain at the site of injection and discomfort when moving arm which was vaccinated who had received FLUZONE (lot number U3198AA). Follow-up information received on 16 November 2009 from a healthcare professional. Information was provided for one of the patients, who was a 45 year old female. The patient consulted a physician and was found to have bursitis. The patient recovered. No other information was provided. Follow-up information was received from the pharmacist on 28 April 2010. Both patients fully recovered from the events. The reporter had no additional information to provide.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: A cluster of 2 female patients who received FLUZONE (lot number UT3172BA) and developed injection site redness, lump, and burning one day after vaccination. Initial report received on 24 September 2009 from a healthcare professional. A 50+ year old female patient, whose medical history was not reported, received a left deltoid intramuscular injection of FLUZONE (lot number UT3172BA) on 23 September 2009. Concomitant medications and illness at the time of vaccination were not reported. She had received no other vaccinations within the four previous weeks. She has received previous flu shots and had no adverse event following prior vaccination. One day after vaccination, 24 September 2009, the patient developed redness, a lump, and burning at the injection site. Corrective treatment was not reported. At the time of the report, the patient had not recovered. Follow-up information was received from the health care professional, who is also the patient, on 13 October 2009. The patient was 55 years old at the time of the event. She did not receive any other vaccines on 23 September 2009, and the events subsequently recovered. Case 2009-04080, with the same reporter and same FLUZONE lot number, contains the events for the second patient.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: A cluster of 2 female patient who received FLUZONE (lot number UT3172BA) and developed injection site redness, lump, and burning one day after vaccination. Initial report received on 24 September 2009 from a healthcare professional. A 28+ year old female patient, whose medical history was not reported, received a left deltoid intramuscular injection of FLUZONE (lot number UT3172BA) on 23 September 2009. Concomitant medications and illness at the time of vaccination were not reported. She had received no other vaccinations within the four previous weeks. She had received previous flu shots and had no adverse event following prior vaccination. One day after vaccination, 24 September 2009, the patient developed redness, a lump, and burning at the injection site. Corrective treatment was not reported. At the time of the report, the patient had not recovered. Follow-up information was received from a health care professional on 13 October 2009. Patient identifying information was provided. It was indicated that the patient did not require an emergency room or doctor visit and that the patient recovered. No further details were provided. Case 2009-04079, with the same reporter and same FLUZONE lot number, describes the events for the second patient.
Age: 5.0
Sex: F
Vaccine: FLU3, FLUN3
Symptoms: Bronchitis, Incorrect dose administered, Pyrexia
Clinical narrative: Non-serious case received 09 October 2009 from a health care professional. A six-year-old female patient had received an intramuscular injection of FLUZONE (lot not reported) on 29 September 2009, even though she was diagnosed with an upper respiratory infection on that date. There was no adverse events immediately following the FLUZONE injection. On 08 October 2009, the patient was inadvertently given FLUMIST at school. The following day, the patient developed a fever and was evaluated by a nurse practitioner. The patient was diagnosed with bronchitis, and treatment with ZITHROMAX was initiated. At the time of the report, the patient had not recovered. No further information was provided. Follow-up information received on 09 November 2009 from a health care professional. The patient received FLUZONE (lot number U3174EA) in the left deltoid. The patient was seen on 28 October 2009 and had made a full recovery from the bronchitis. No additional information was reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site discomfort
Clinical narrative: Initial report received from a health care provider on 12 October 2009. A female patient (age not reported) was vaccinated with FLUZONE (Sanofi Pasteur, Lot # U3173BA) via an intramuscular injection to the left deltoid on 13 September 2009. Post vaccination, the patient reported discomfort at the injection site and difficulty lifting the left arm. One month later, the patient continues to experience these symptoms. The patient also stated that the site of vaccination may have been a little higher on the arm than the deltoid (more toward shoulder area). The patient reported no known allergies. No further information is expected. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Initial report received on 26 October 2009 from a consumer, who is  physician. A male patient (age not known) with a history of asthma developed a red, swollen, watery right eye on the same day of vaccination after he received FLUZONE (lot number U3173DA) on 06 October 2009. The patient self treated with topical steroids and cold compresses to the eye. The symptoms resolved within 48 hours. The patient declined to provide further information. List of Documents held by Sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial case received from a health care professional on 06 November 2009. This case contains information for one of a cluster of four patients who experienced similar events following FLUZONE administration. Information for the other patients is captured in 2009-04184 (serious), 2009-04795 (non-serious) and 2009-04509 (non-serious).
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Initial report was received 07 September 2010 from a health care professional. A 71-year-old male patient with no concurrent illness, had received an intramuscular left deltoid injection of FLUZONE High-Dose, lot number U3599AA on 06 September 2010 at 09:30 and four hours later at 13:30 hours, the patient developed a fever of 104 degrees Fahrenheit, body aches, and a headache and a "stiff neck". The following day, the patient's fever was down to 101 degrees Fahrenheit and his symptoms of body aches, headache and stiff neck had decreased, but still persisted. Outcome was not recovered. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Neck pain, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Initial report was received from a health care professional on 16 November 2009. It involves one patient in a cluster of seven patients who experienced adverse events following vaccination with FLUZONE, lot number U3193AA. The other events are found in case numbers 2009-04035, 2009-05006, 2009-05007, 2009-05008, 2009-050109, 2009-05010. A 36-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U3193AA) on 30 September 2009. Six hours post-vaccination, she experienced neck pain, back pain, a sore throat, and noted that her throat felt swollen. The events recovered after approximately 18 hours.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Swelling
Clinical narrative: Initial report received on 16 November 2009 from a health care professional. A 50 year old female patient developed soreness in the left axillary area with some swelling noted upon examination one day after receiving FLUZONE (lot number U3214AA) intramuscularly in the left deltoid on 12 November 2009. No reaction was present at the site of the injection. The patient's symptoms were progressing at the and the patient had not recovered by the time of the report. Follow-up information received 22 December 2009 from a health care professional. The dose of FLUZONE received by the patient had been a first dose injection. The patient had no significant medical history and she had not received any other vaccinations within four weeks of FLUZONE. The patient had been seen at the health sciences center and was diagnosed with "normal side effect of immunization". According to the reporter, the patient no longer experienced any difficulties and she had no further symptoms or complaints. The patient recovered. List of Documents held by Sender: none.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus, Rash generalised, Urticaria
Clinical narrative: Initial case received from a health care professional on 16 December 2009. An 8-year-old female patient received an influenza vaccine reported as possibly FLUZONE (lot not reported) on 12 November 2001. The patient had a history of asthma and an allergy to CECLOR, and was taking Albuterol concomitantly. At the time of vaccination she had a sore throat and congestion. The day after vaccination, on 13 November 2009, she developed a generalized rash, itching, hives and swollen feet lasting 1/2 of the day. The reporter was unsure if the influenza vaccine was FLUZONE. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Erythema, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Initial case received on 20 January 2010 from a healthcare professional. A 47 year old female patient with a medical history of diabetes, received a right deltoid intramuscular injection of FLUZONE (lot number U3377AA) and a right arm intradermal injection of TURBERSOL 5 TU (lot number C3266AA) on 18 January 2010. A few hours post vaccination on 18 January 2010, the patient experienced a local reaction of redness and swelling of the right deltoid. She also had red raised welts appear on her face, felt clammy and reported not feeling well on 18 January 2010 at an unspecified time. The patient was reported to have no illness at the time of the vaccination. The patient recovered from the adverse events. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial case received on 20 January 2010 from a healthcare professional. A 47 year old female patient with a medical history of diabetes, received a right deltoid intramuscular injection of FLUZONE (lot number U3377AA) and a right arm intradermal injection of TURBERSOL 5 TU (lot number C3266AA) on 18 January 2010. A few hours post vaccination on 18 January 2010, the patient experienced a local reaction of redness and swelling of the right deltoid. She also had red raised welts appear on her face, felt clammy and reported not feeling well on 18 January 2010 at an unspecified time. The patient was reported to have no illness at the time of the vaccination. The patient recovered from the adverse events. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Breath sounds abnormal, Rash generalised
Clinical narrative: Initial case received on 27 January 2010 from a healthcare professional. A male patient (age and date of birth unknown) received an injection (unknown route and site) of "pediatric" FLUZONE on an unknown date. The patient experienced a full body rash and noisy breathing several hours post vaccination and was seen in the pediatric clinic. The patient had no history of an egg allergy. The chart was not available to the reporter. The patient was to have skin testing done. It was unknown if the patient recovered. Documents held by sender: None.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of '2 children each received a dose of expired H1N1 LAIV' was received from a pharmacist concerning a eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-jan-2010. On 26-Feb-2010, the patient received expired H1N1, intranasal for an unknown indication. There was no adverse event associated with this medication error therefore treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of '2 children were each inadvertently administered an expired dose of H1N1 as the second dose' was received from a registered nurse/health professional concerning a 43-month-old female child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 23-Feb-2010. On an unknown date, the patient received first dose of H1N1 vaccine. On 24-Feb-2010, the patient received second dose of expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever of 104 has been received from parent/health professional concerning a six-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. On 13-Nov-2009, after 12 hours of vaccine administration, the patient developed a high fever of 104. Ibuprofen was administered, fever subsided, with no problem or symptoms to report. The outcome for the reported adverse events was resolved.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Epistaxis
Clinical narrative: A serious spontaneous report of bloody nose had been received from a father/consumer concerning his child, a 36-month-old male, subsequent to H1N1 vaccine, intranasal. The patient has no relevant medical history. the patient was neither on any concomitant medications nor vaccinated previously. On 23-Mar-2010, the patient received H1N1 vaccine, Intranasal via nasal route for an unspecified indication. On 24-Mar-2010, in the morning, the patient woke up with bloody nose which occurred less than ten hours after receiving the H1N1 nasal vaccine. The patient experienced two nose bleeds the first one was heavy, the second bleed was not as heavy. Parent did call the patient's PCP, but no treatment was given. The child recovered in 48 hours. The outcome of bloody nose was recovered on 26-Mar-2010.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "inadvertent administration of expired H1N1 LAIV" was received from a non-healthcare professional concerning a child of an unknown gender. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Feb-2010. In mid March-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 LAIV to a patient" was received from a registered nurse/health professional concerning a 36-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 40.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 40-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date of the product was 06-Apr-2010 which was reassigned to 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 29.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse/health professional concerning a 29-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 15.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a nurse practitioner/health professional concerning a 15-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 29-Mar-2010. On 31-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse/health professional concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serous spontaneous report of administration of expired product was received from a health professional concerning a nine-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 01-Apr-2010, the patient received expired H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 11-year-old male. Neither relevant medical history nor concomitant medications have been reported fro this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 and patient was given 2nd dose was received from a registered nurse/health professional concerning a ten-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.