chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Computerised tomogram normal, Cough
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 12 February 2009 (reference number 331045). A 69-year-old female patient with no reported medical history received an intramuscular injection of FLUZONE (lot number U2831) on 15 October 2008. Prior to leaving the facility where she received the vaccination, she stated that her arm felt heavy. She then began to have worsening symptoms, including joint pains, cramping, headache, elevated blood pressure, fever (102 degrees Fahrenheit), skin red and burning, and eyes red and burning. She reported a "shocky" feeling. She presented to the emergency department, where she complained of band-like chest tightness, shaking, nausea, shortness of breath, dizziness, and a cough. She underwent a CT, ultrasound of the lungs and legs, chest x-ray, ABGs, and routine bloodwork, including blood cultures; no abnormalities were found. She was treated with ATIVAN, but continued to feel weak. She also received XANAX, after which she experienced diarrhea. The event was considered to be life-threatening, requiring intervention to prevent permanent impairment/damage. She subsequently recovered.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Erythema, Eye irritation
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 12 February 2009 (reference number 331045). A 69-year-old female patient with no reported medical history received an intramuscular injection of FLUZONE (lot number U2831) on 15 October 2008. Prior to leaving the facility where she received the vaccination, she stated that her arm felt heavy. She then began to have worsening symptoms, including joint pains, cramping, headache, elevated blood pressure, fever (102 degrees Fahrenheit), skin red and burning, and eyes red and burning. She reported a "shocky" feeling. She presented to the emergency department, where she complained of band-like chest tightness, shaking, nausea, shortness of breath, dizziness, and a cough. She underwent a CT, ultrasound of the lungs and legs, chest x-ray, ABGs, and routine bloodwork, including blood cultures; no abnormalities were found. She was treated with ATIVAN, but continued to feel weak. She also received XANAX, after which she experienced diarrhea. The event was considered to be life-threatening, requiring intervention to prevent permanent impairment/damage. She subsequently recovered.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Muscle spasms, Nausea, Ocular hyperaemia, Paraesthesia
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 12 February 2009 (reference number 331045). A 69-year-old female patient with no reported medical history received an intramuscular injection of FLUZONE (lot number U2831) on 15 October 2008. Prior to leaving the facility where she received the vaccination, she stated that her arm felt heavy. She then began to have worsening symptoms, including joint pains, cramping, headache, elevated blood pressure, fever (102 degrees Fahrenheit), skin red and burning, and eyes red and burning. She reported a "shocky" feeling. She presented to the emergency department, where she complained of band-like chest tightness, shaking, nausea, shortness of breath, dizziness, and a cough. She underwent a CT, ultrasound of the lungs and legs, chest x-ray, ABGs, and routine bloodwork, including blood cultures; no abnormalities were found. She was treated with ATIVAN, but continued to feel weak. She also received XANAX, after which she experienced diarrhea. The event was considered to be life-threatening, requiring intervention to prevent permanent impairment/damage. She subsequently recovered.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sensation of heaviness, Skin burning sensation, Tremor, Ultrasound scan normal
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 12 February 2009 (reference number 331045). A 69-year-old female patient with no reported medical history received an intramuscular injection of FLUZONE (lot number U2831) on 15 October 2008. Prior to leaving the facility where she received the vaccination, she stated that her arm felt heavy. She then began to have worsening symptoms, including joint pains, cramping, headache, elevated blood pressure, fever (102 degrees Fahrenheit), skin red and burning, and eyes red and burning. She reported a "shocky" feeling. She presented to the emergency department, where she complained of band-like chest tightness, shaking, nausea, shortness of breath, dizziness, and a cough. She underwent a CT, ultrasound of the lungs and legs, chest x-ray, ABGs, and routine bloodwork, including blood cultures; no abnormalities were found. She was treated with ATIVAN, but continued to feel weak. She also received XANAX, after which she experienced diarrhea. The event was considered to be life-threatening, requiring intervention to prevent permanent impairment/damage. She subsequently recovered.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye pruritus, Ocular hyperaemia, Throat tightness
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 331154). A 49-year-old female patient had received an intramuscular injection of FLUZONE SV 2008-2009 on 03 November 2008 and approximately four hours later, she presented to the emergency room complaining of throat tightness, chest heaviness and red itchy eyes. She received DECADRON 4 mg and diphenhydramine 50 mg intramuscularly as corrective treatment with slight improvement noted. The patient was sent home with PREDNISONE and subsequently recovered (recovery date and time not reported). Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Cough, Dysphonia, Dyspnoea, Eye pruritus
Clinical narrative: This serious case was extracted from the VAERS database via QScan on 12 February 2009 (reference number 331421). A 50-year-old female had received a fifth dose intramuscular injection of FLUZONE SV 2008-2009, lot number U2743AA on 28 October 2008 at 11:15 am (site not reported), and at 14:30 pm, she became hoarse and began coughing with mucus and congestion, and felt her eyes swelling. The patient self medicated with BENADRYL and ROBITUSSIN and layed down. Her mouth and tongue began to feel funny and she went to the emergency room. Upon arrival, she presented with a harsh barky cough, lips swelling, itchy and red eyes, tingling in her lips, and she had trouble breathing. Unspecified medications were administered in the ER and the patient was admitted overnight for angioedema and questionable reaction to flu vaccine. The patient had no other abnormal ingested foods or medications that day except for Influenza vaccination. Oral prednisone was prescribed at discharge. In addition to hospitalization, the event outcome was reported as "required intervention to prevent permanent impairment/damage and the patient recovered from the event (date of recovery not reported).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Ocular hyperaemia, Paraesthesia oral, Productive cough
Clinical narrative: This serious case was extracted from the VAERS database via QScan on 12 February 2009 (reference number 331421). A 50-year-old female had received a fifth dose intramuscular injection of FLUZONE SV 2008-2009, lot number U2743AA on 28 October 2008 at 11:15 am (site not reported), and at 14:30 pm, she became hoarse and began coughing with mucus and congestion, and felt her eyes swelling. The patient self medicated with BENADRYL and ROBITUSSIN and layed down. Her mouth and tongue began to feel funny and she went to the emergency room. Upon arrival, she presented with a harsh barky cough, lips swelling, itchy and red eyes, tingling in her lips, and she had trouble breathing. Unspecified medications were administered in the ER and the patient was admitted overnight for angioedema and questionable reaction to flu vaccine. The patient had no other abnormal ingested foods or medications that day except for Influenza vaccination. Oral prednisone was prescribed at discharge. In addition to hospitalization, the event outcome was reported as "required intervention to prevent permanent impairment/damage and the patient recovered from the event (date of recovery not reported).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Upper respiratory tract congestion
Clinical narrative: This serious case was extracted from the VAERS database via QScan on 12 February 2009 (reference number 331421). A 50-year-old female had received a fifth dose intramuscular injection of FLUZONE SV 2008-2009, lot number U2743AA on 28 October 2008 at 11:15 am (site not reported), and at 14:30 pm, she became hoarse and began coughing with mucus and congestion, and felt her eyes swelling. The patient self medicated with BENADRYL and ROBITUSSIN and layed down. Her mouth and tongue began to feel funny and she went to the emergency room. Upon arrival, she presented with a harsh barky cough, lips swelling, itchy and red eyes, tingling in her lips, and she had trouble breathing. Unspecified medications were administered in the ER and the patient was admitted overnight for angioedema and questionable reaction to flu vaccine. The patient had no other abnormal ingested foods or medications that day except for Influenza vaccination. Oral prednisone was prescribed at discharge. In addition to hospitalization, the event outcome was reported as "required intervention to prevent permanent impairment/damage and the patient recovered from the event (date of recovery not reported).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Hypertension, Nasal congestion, Ocular hyperaemia
Clinical narrative: This case was received on 24 February 2009 via a search of the VAERS database (reference number 331596). A 53 year old female received FLUZONE (lot number U2766AA) intramuscularly on 03 November 2008 at 10:50. At approximately 17:00 the patient began having nasal congestion, a scratchy throat, and was feverish. She took a vitamin at 17:30 and returned to work. At that time she became hoarse, but felt better. At approximately 20:00 her eyes became blood shot. At 21:00 she had difficulty taking a deep breath which had improved three hours previously. She went to the emergency room at 21:15 and was noted to have high blood pressure. She received an injection of BENADRYL which made her feel worse, however her voice returned spontaneously. Her illness was deemed viral and she was sent home. At that time the patient felt fine and was reported as recovered. List of Documents held by Sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation, Viral infection
Clinical narrative: This case was received on 24 February 2009 via a search of the VAERS database (reference number 331596). A 53 year old female received FLUZONE (lot number U2766AA) intramuscularly on 03 November 2008 at 10:50. At approximately 17:00 the patient began having nasal congestion, a scratchy throat, and was feverish. She took a vitamin at 17:30 and returned to work. At that time she became hoarse, but felt better. At approximately 20:00 her eyes became blood shot. At 21:00 she had difficulty taking a deep breath which had improved three hours previously. She went to the emergency room at 21:15 and was noted to have high blood pressure. She received an injection of BENADRYL which made her feel worse, however her voice returned spontaneously. Her illness was deemed viral and she was sent home. At that time the patient felt fine and was reported as recovered. List of Documents held by Sender: none.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Ocular hyperaemia, Sensation of foreign body, Wheezing
Clinical narrative: Initial report was extracted from VAERS via QSCAN FDA report on 24 February 2009 (VAERS identification number 331719). A 50-year-old female patient, who has a lot of food allergies (type of foods not identified), but is able to eat eggs without reaction, had received an intramuscular injection of FLUZONE SV 208-2009 (lot number U2741AA) on 24 October 2008. Approximately six hours post-vaccination the patient experienced wheezing and a lump in her throat with difficulty swallowing. She also had red eyes. The patient self medicated with two doses of Benadryl 25 mg that worked to relieved the symptoms. Duration of symptoms was not provided. The patient recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Ocular hyperaemia, Oropharyngeal pain, Sensation of foreign body, Urticaria
Clinical narrative: This non-serious case was received from a health care professional on 04 December 2008. A 61-year-old female patient with a history of seasonal allergies received a left deltoid injection of FLUZONE SV 2008-2009 (lot number 2751AA) on 30 October 2008. Three hours after vaccination she experienced a sore throat"like a lump in the throat". An hour later, she developed blood shot eyes "with white pus" and the next morning she noted hives on the right side of her stomach. She notified her doctor and was instructed to take Claritin 10mg. At the time of the report, the hives were fading, and the events were considered to be recovered. The reporter in this case also reported four other patients who experienced events following receipt of FLUZONE vaccine; these events are captured in this case numbers 2008-0388, 03890, -03891, and -0392. A corrective version was created on 09 December 2008, using the receipt date from the previous version, in order to add the following statement: This case is one of a cluster of five patients who experienced adverse events following receipt of FLUZONE lot number 2751AA. Follow-up information was received from the reporter on 22 December 2008. The FLUZONE was administered intramuscularly. The patient is one of a cluster of four, not five as previously reported. The fifth patient received FLUZONE lot number U2752AA. Follow-up information was extracted from VARES reference number 331832. No additional information was provided. Documents held by sender: None
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Ocular hyperaemia, Throat tightness
Clinical narrative: Difficulty breathing. Throat tightness. Swallowing difficult. Red eye. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 332066). A 57-year-old female patient had received an intramuscular injection of Fluzone SV 2008-2009 (site not reported), lot number U2748A on 31 October 2008, and an unspecified amount of time later on the day of vaccination, her throat constricted and she had difficulty breathing and swallowing, and she developed red eyes. The outcome for the event noted the patient had a doctor's visit or an emergency room visit. The patient recovered from the event (date and time of recovery not reported). Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye pruritus, Heart rate increased, Ocular hyperaemia
Clinical narrative: This serious report was extracted via QScan on 24 February 2009 (reference number 332560). A 48-year-old female patient had received a first dose intramuscular injection of FLUZONE SV 2008-2009, lot number U2810AA on 14 November and an unspecified amount of time later, at 18:30 hours, she developed itchy and red eyes. Her symptoms worsened to include a rapid heart rate and breathing difficulties. At 23:15 hours, the patient was "seen and received epinephrine, BENADRYL and a steroid. The patient was given Prednisone 50 mg x5 to take home and recovered from the event (date of recovery not reported). Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity, Lip swelling, Ocular hyperaemia
Clinical narrative: This serious case was extracted from VAERS via QSCAN on 12 February 2009 (reference number 332695). A 51-year-old female patient, with no reported medical history, received an intramuscular injection of FLUZONE (lot number U2749AA) on 17 November 2008. Approximately 4.5 hours after vaccination, she began to complain of peri oral swelling. She was advised by her pharmacist to take 25 mg BENADRYL by mouth, but treatment was ineffective. She subsequently developed eye redness, throat tightness, shortness of breath, and chest discomfort, at which time her physician advised her to go to the emergency room. Physical exam revealed throat swelling and sinus tachycardia, and she was diagnosed with an allergic reaction. She was treated with intravenous medications and fluids, and was discharged on steroids. The event was considered to be life-threatening, and required intervention to prevent permanent impairment/damage. The patient recovered.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Sinus tachycardia, Throat tightness
Clinical narrative: This serious case was extracted from VAERS via QSCAN on 12 February 2009 (reference number 332695). A 51-year-old female patient, with no reported medical history, received an intramuscular injection of FLUZONE (lot number U2749AA) on 17 November 2008. Approximately 4.5 hours after vaccination, she began to complain of peri oral swelling. She was advised by her pharmacist to take 25 mg BENADRYL by mouth, but treatment was ineffective. She subsequently developed eye redness, throat tightness, shortness of breath, and chest discomfort, at which time her physician advised her to go to the emergency room. Physical exam revealed throat swelling and sinus tachycardia, and she was diagnosed with an allergic reaction. She was treated with intravenous medications and fluids, and was discharged on steroids. The event was considered to be life-threatening, and required intervention to prevent permanent impairment/damage. The patient recovered.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Fatigue, Injection site anaesthesia, Injection site erythema
Clinical narrative: Initial report received from a consumer on 07 November 2008. Additional information concerning this case was also received from a health professional on 07 November 2008. A 32-year-old pregnant female (27 weeks gestation) had received a left deltoid injection on FLUZONE sv 2008-2009 (lot number U2839AA), route of administration not reported) on 06 November 2008 and hours later, she experienced tenderness at the injection site, mild redness at the injection site extending to her elbow, numbness and tingling in the arm at the site of injection down to her fingers and "fatigue" in the arm. A welt at the injection site was also reported. The date of the patient's last menstrual period was in April 2008 and the estimated date of delivery was reported as 03 February "2008". At the time of the report, the patient had not yet recovered from the adverse events. Follow-up information was received 03 March 2009 from a health care professional who reported they were unable to provide additional information because they did not have the patient listed in their records. Follow-up information was received 04 May 2009 from  the patient who reported that the adverse reaction to the flu shot resolved after approximately 36 hours and she had not experienced any additional problems. The patient also reported that her estimated date of delivery was 03 February 2009 (previously reported as 03 February 2008) and that her baby was born healthy on 01 February 2009. No further information was provided. Follow-up information was received 01 June 2009 from the nurse midwife who reported that the patient was 27.5 weeks at the time of vaccination. Her estimated date of confinement was 03 February 2009 and the baby was born on 01 February 2009. The nurse midwife contacted the patient to assess the outcome of her pregnancy. According to the patient's response and the records the doctor's office received, the outcome was positive. The patient also provided information on her reaction post vaccination which was described as localized with redness and possible induration. No further information was provided. Follow-up information was received 11 September 2009 from a health care professional. The patient's last menstrual period was 29 April 2008. Twelve hours after onset, the numbness, tingling, redness, and tenderness resolved. Prenatal testing included: Alpha Feto Protein, multiple Serologies, and multiple ultrasounds were normal (dates were not specified). The patient's date of delivery was 01 February 2009. The patient delivered vaginally at 40 weeks gestation. The baby boy weighed 7 pounds 13 ounces and was 21 inches in length. The baby was without congenital anomalies. APGAR scores were not known. Neither the mother nor the baby experienced complications. No further information was provided. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site urticaria, Paraesthesia, Ultrasound scan normal
Clinical narrative: Initial report received from a consumer on 07 November 2008. Additional information concerning this case was also received from a health professional on 07 November 2008. A 32-year-old pregnant female (27 weeks gestation) had received a left deltoid injection on FLUZONE sv 2008-2009 (lot number U2839AA), route of administration not reported) on 06 November 2008 and hours later, she experienced tenderness at the injection site, mild redness at the injection site extending to her elbow, numbness and tingling in the arm at the site of injection down to her fingers and "fatigue" in the arm. A welt at the injection site was also reported. The date of the patient's last menstrual period was in April 2008 and the estimated date of delivery was reported as 03 February "2008". At the time of the report, the patient had not yet recovered from the adverse events. Follow-up information was received 03 March 2009 from a health care professional who reported they were unable to provide additional information because they did not have the patient listed in their records. Follow-up information was received 04 May 2009 from  the patient who reported that the adverse reaction to the flu shot resolved after approximately 36 hours and she had not experienced any additional problems. The patient also reported that her estimated date of delivery was 03 February 2009 (previously reported as 03 February 2008) and that her baby was born healthy on 01 February 2009. No further information was provided. Follow-up information was received 01 June 2009 from the nurse midwife who reported that the patient was 27.5 weeks at the time of vaccination. Her estimated date of confinement was 03 February 2009 and the baby was born on 01 February 2009. The nurse midwife contacted the patient to assess the outcome of her pregnancy. According to the patient's response and the records the doctor's office received, the outcome was positive. The patient also provided information on her reaction post vaccination which was described as localized with redness and possible induration. No further information was provided. Follow-up information was received 11 September 2009 from a health care professional. The patient's last menstrual period was 29 April 2008. Twelve hours after onset, the numbness, tingling, redness, and tenderness resolved. Prenatal testing included: Alpha Feto Protein, multiple Serologies, and multiple ultrasounds were normal (dates were not specified). The patient's date of delivery was 01 February 2009. The patient delivered vaginally at 40 weeks gestation. The baby boy weighed 7 pounds 13 ounces and was 21 inches in length. The baby was without congenital anomalies. APGAR scores were not known. Neither the mother nor the baby experienced complications. No further information was provided. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphonia, Dyspnoea, Eye discharge
Clinical narrative: This case was received on 24 February 2009 via a search of the database (reference number 332981). A 49 year old female received FLUZONE SV 2008-2009 (Lot number U2806A) intramuscularly on 06 November 2008. Approximately four hours post vaccination, the patient developed difficulty breathing where her chest became tight and heavy, coughing, hoarseness, and throat swelling. Her eyes became extremely red and filled with pus. She was treated by the paramedics with oxygen and taken to the emergency room. The patient was reported as recovered. No further information was provided. List of Documents held by Sender: none.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Oxygen supplementation, Pharyngeal oedema
Clinical narrative: This case was received on 24 February 2009 via a search of the database (reference number 332981). A 49 year old female received FLUZONE SV 2008-2009 (Lot number U2806A) intramuscularly on 06 November 2008. Approximately four hours post vaccination, the patient developed difficulty breathing where her chest became tight and heavy, coughing, hoarseness, and throat swelling. Her eyes became extremely red and filled with pus. She was treated by the paramedics with oxygen and taken to the emergency room. The patient was reported as recovered. No further information was provided. List of Documents held by Sender: none.
Age: 1.8
Sex: M
Vaccine: FLU3
Symptoms: Ketoacidosis, Type 1 diabetes mellitus
Clinical narrative: This serious case was received from a health care professional on 17 November 2008. A 22-month-old male patient received FLUZONE (lot number and date of administration not reported). Approximately 48 hours after vaccination, he developed ketoacidosis, and was subsequently diagnosed with Type I diabetes mellitus. The reporter, a physician who was a friend of the patient's parent, did not have any additional information to provide. Of note, the reporter refused to provide contact information, but did agree to contact the patient's primary care physician directly to obtain additional information. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Lymphadenitis, Mass, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report received on 24 November 2008 from a physician. A 53-year-old female patient, had received an intramuscular right arm injection of Fluzone SV 2008-2009 on 12 November 2008 at 15:10pm. The following day around 18:00 pm after the patient threw a baseball, she noted an ovoid swollen mass 7 cm high and 3 cm wide across the mid right clavicle. The patient was evaluated by her physician the following day and a magnetic resonance imaging (MRI) test with dye, and a chest x-ray lead to the conclusion of infected lymph node. It was not reported whether the patient had received any treatment, or if any other diagnostic tests were performed. At the time of this report, it was "unknown" if the patient had recovered. Follow up information was received on 14 January 2009 from a health care professional. After discussion with the patient, the reporter state that the causuality of the event wad undetermined. No further information was available at the time.
Sex: U
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Oropharyngeal pain, Throat tightness, X-ray
Clinical narrative: This serious case was extracted from the VARES database via QScan on 24 February 2009 (VAERS identification number 333565). A 43-year-old female patient, whose past medical history was not provided, had received on 19 November 2008 a first intramuscular injection of Fluzone SV 2008-2009 (lot number U2808AA). Approximately three hours post-vaccination, the patient complained of a cough, throat tightness, sore throat and eye redness. The patient was evaluated in the emergency room and was administered intravenous steroids and intravenous Benadryl. An x-ray (type not provided) was completed; however the result were not provided. The patient recovered (date not provided).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye pruritus, Eye swelling, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Initial report extracted from VAERS via QSCAN FDA report on 24 February 2009 (VAERS identification number 334166). A 30-year-old female patient whose past medical history was not provided, had received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2848AA) on 12 November 2008. Approximately four hours post-vaccination the patient developed red swollen eyes, eyes with yellow discharge that were itchy, slight fever and sore throat. No treatment was provided. The recovery status of the patient was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report extracted from VAERS via QSCAN FDA report on 24 February 2009 (VAERS identification number 334166). A 30-year-old female patient whose past medical history was not provided, had received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2848AA) on 12 November 2008. Approximately four hours post-vaccination the patient developed red swollen eyes, eyes with yellow discharge that were itchy, slight fever and sore throat. No treatment was provided. The recovery status of the patient was not reported. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Miosis, Ocular hyperaemia
Clinical narrative: This non serious case was received on 24 February 2009 from VAERS (reference number 334283) via a search of the QScan database. A 34 year old female received ADACEL (lot number not reported) and FLUZONE SV 2008-2009 (lot number U2810AA) on 05 November 2008. At 1:10 pm that day, the patient developed a headache, pinpoint pupils, blood shot eyes, and slept. No symptoms remained upon awakening. the patient reported that she gets severe headaches once a month. The patient was reported as recovered.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Conjunctivitis, Cough, Pyrexia, Wheezing
Clinical narrative: This non serious case was received on 24 February 2009 from VAERS (reference number 334428) via a search of the QSCAN data base. A 49 year old male patient received FLUZONE SV 2008-2009 (lot number U2831AA) intramuscularly on 21 November 2008. On 21 November 2008 the patient developed conjunctivitis, fever, rigors, cough, and wheezing. The patient was reported as recovered. No further information was provided. List of Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Eye discharge, Eye pruritus, Ocular hyperaemia, Sensation of foreign body
Clinical narrative: This non-serious case was received from a health care professional on 04 December 2008. A 63-year-old female patient, with a history of mild seasonal allergies and bronchial asthma, received a left deltoid injection of FLUZONE SV 2008-2009 (lot number 2751AA) on 04 November 2008. Within one hour of vaccination she developed a lump in her throat and had difficulty swallowing; this resolved the morning following vaccination. In addition, her eyes began to itch, became blood shot, and "crusty". She saw a physician on 06 November 2008 who diagnosed her with a possible sensitvity to thimerosal. By day 3 post-vaccination, all events had resolved. The reporter in this case also reported four other patients who experienced events following receipt of FLUZONE vaccine; these events are captured in case numbers 2008-03888, -03889, -03890, and -03892. A corrective version was created on 09 December 2008, using the receipt date from the previous version, in order to add the following statement: This case is one of a cluster of five patients who experienced adverse events following receipt of FLUZONE lot number 2751AA. Follow-up information was received from the reporter on 22 December 2008. The FLUZONE was administered intramuscularly. The patient is one of a cluster of four, not five as previously reported. The fifth patient received FLUZONE lot number U2752AA. Follow-up information was extracted from VAERS via QSCAN FDA report on 24 February 2009 (VAERS number 334443). The patient has no previous allergy to thimerosal. The patient was considered to be recovered on day three of symptoms (06 November 2008). Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood culture negative, Cardiac enzymes, Chest X-ray, Chills
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 334557). A 61-year-old female patient had received a first dose injection of FLUZONE SV 2008-2009 (route unknown), lot number U2740AA, on 14 November 2008 and an unspecified amount of time later, the patient reported to the emergency room at "10:30" on 14 November 2008 complaining of chills, fever (101.9), red and burning eyes, dizziness, shortness of breath, sensitivity to touch (pin-prickly feeling), mild cough, nasal congestion, weakness, and headache. Diagnostic and laboratory testing included a chest x-ray, EKG, CBC; BMP; cardiac enzymes; and blood cultures which were essentially normal (WBC- 1200). Corrective treatments included IV, Tylenol. The patient's symptom of weakness had been diminishing, but was still present on 17 November 2008. The patient subsequently recovered (recovery date not reported). Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Dyspnoea, Electrocardiogram, Eye irritation
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 334557). A 61-year-old female patient had received a first dose injection of FLUZONE SV 2008-2009 (route unknown), lot number U2740AA, on 14 November 2008 and an unspecified amount of time later, the patient reported to the emergency room at "10:30" on 14 November 2008 complaining of chills, fever (101.9), red and burning eyes, dizziness, shortness of breath, sensitivity to touch (pin-prickly feeling), mild cough, nasal congestion, weakness, and headache. Diagnostic and laboratory testing included a chest x-ray, EKG, CBC; BMP; cardiac enzymes; and blood cultures which were essentially normal (WBC- 1200). Corrective treatments included IV, Tylenol. The patient's symptom of weakness had been diminishing, but was still present on 17 November 2008. The patient subsequently recovered (recovery date not reported). Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Headache, Metabolic function test, Nasal congestion, Ocular hyperaemia
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 334557). A 61-year-old female patient had received a first dose injection of FLUZONE SV 2008-2009 (route unknown), lot number U2740AA, on 14 November 2008 and an unspecified amount of time later, the patient reported to the emergency room at "10:30" on 14 November 2008 complaining of chills, fever (101.9), red and burning eyes, dizziness, shortness of breath, sensitivity to touch (pin-prickly feeling), mild cough, nasal congestion, weakness, and headache. Diagnostic and laboratory testing included a chest x-ray, EKG, CBC; BMP; cardiac enzymes; and blood cultures which were essentially normal (WBC- 1200). Corrective treatments included IV, Tylenol. The patient's symptom of weakness had been diminishing, but was still present on 17 November 2008. The patient subsequently recovered (recovery date not reported). Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 334557). A 61-year-old female patient had received a first dose injection of FLUZONE SV 2008-2009 (route unknown), lot number U2740AA, on 14 November 2008 and an unspecified amount of time later, the patient reported to the emergency room at "10:30" on 14 November 2008 complaining of chills, fever (101.9), red and burning eyes, dizziness, shortness of breath, sensitivity to touch (pin-prickly feeling), mild cough, nasal congestion, weakness, and headache. Diagnostic and laboratory testing included a chest x-ray, EKG, CBC; BMP; cardiac enzymes; and blood cultures which were essentially normal (WBC- 1200). Corrective treatments included IV, Tylenol. The patient's symptom of weakness had been diminishing, but was still present on 17 November 2008. The patient subsequently recovered (recovery date not reported). Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Heart rate increased, Movement disorder, No reaction on previous exposure to drug, Pain in extremity
Clinical narrative: Initial report received on 20 November 2008 from a consumer, who is the patient. A 67 year old female, whose medical history was not reported, received on 12 November 2008 an upper right arm injection of FLUZONE (lot number U220AA) and a left arm injection of pneumonia vaccine (manufacturer and lot number unknown). The patient's concomitant medication was propanolol and she had no illness at the time of vaccination. She had previously received several doses of FLUZONE in the past and had no prior adverse events. On 12 November 2008, four hours after vaccination, the patient had a rapid heart rate to 100 or above, an increase in blood pressure, a sore arm from the shoulder to the elbow, and she had difficulty moving her arm. Corrective treatment was not reported, The patient's recovery status was not reported. However, she still had some soreness in the arm at the time of reporting. Follow-up information received 09 March 2009 from healthcare professional in the United States. The arm soreness from the shoulder to the elbow experienced by the patient, occurred in the patient's right arm and lasted for three weeks. The patient's max blood pressure reading had been 144/74. According to the reporter, the patient recovered. Follow-up information received 17 April 2009 from a healthcare professional. The patient had a history of rapid heart rate and increased blood pressure. The reported events of increased heart rate and increased blood pressure lasted 1-2 days.  According to the reporter, an etiology and diagnosis were unknown. No additional information was provided.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac enzymes, Chest pain, Electrocardiogram, Influenza like illness, Pain
Clinical narrative: Initial report received from a health care professional on 03 December 2008. A 60-year-old male patient received a left deltoid injection of FLUZONE SV 2008-2009 (lot number U2764AA, route of administration not reported) on 20 November 2008. The patient started having flu-like symptoms of generalized achiness and congestion that evening (onset date of events was also reported as 21 November 2008). The patient then developed chest pain that worsened over the next two-to-three days, sending the patient to the emergency room for treatment. The patient was admitted to the hospital three days after receiving FLUZONE. Length of hospitalization was also reported as three days. The patient underwent an EKG, Stress Echo and lab work of cardiac enzymes and was diagnosed with pericarditis. Treatment during hospitalization was not reported. Patient outcome was reported to be unknown. Document held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Pericarditis, Stress echocardiogram, Upper respiratory tract congestion
Clinical narrative: Initial report received from a health care professional on 03 December 2008. A 60-year-old male patient received a left deltoid injection of FLUZONE SV 2008-2009 (lot number U2764AA, route of administration not reported) on 20 November 2008. The patient started having flu-like symptoms of generalized achiness and congestion that evening (onset date of events was also reported as 21 November 2008). The patient then developed chest pain that worsened over the next two-to-three days, sending the patient to the emergency room for treatment. The patient was admitted to the hospital three days after receiving FLUZONE. Length of hospitalization was also reported as three days. The patient underwent an EKG, Stress Echo and lab work of cardiac enzymes and was diagnosed with pericarditis. Treatment during hospitalization was not reported. Patient outcome was reported to be unknown. Document held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Disorientation, Nausea, Rash, Vomiting
Clinical narrative: Initial report was received 18 November 2008 from a health care professional. A 67-year-old male patient with a history of grass, mold and shellfish allergies, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2849AC on 14 November 2008 and 30 minutes later, he developed weakness, nausea and vomiting which persisted at the time of the report. The patient was scheduled to be evaluated by their physician on 18 November 2008. At the time of the report, the patient had not recovered from the event. Follow-up information received on 08 December 2008 from a nurse. Per the reporter, their staff spoke with the patient on 24 November 2008 and he was continuing to feel disoriented. The patient went to the emergency room (date not provided) and reported "no organ damage." The patient reported he had lost 25 pounds since 14 November 2008. He also reported a rash on his elbow below the injection site. The patient is currently on a bland diet at home. The reporter stated "contact patient for additional information." Per this new information, this case was upgraded to serious. The reporter for this case is the same as case number 2008-03659. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: Initial report was received 18 November 2008 from a health care professional. A 67-year-old male patient with a history of grass, mold and shellfish allergies, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2849AC on 14 November 2008 and 30 minutes later, he developed weakness, nausea and vomiting which persisted at the time of the report. The patient was scheduled to be evaluated by their physician on 18 November 2008. At the time of the report, the patient had not recovered from the event. Follow-up information received on 08 December 2008 from a nurse. Per the reporter, their staff spoke with the patient on 24 November 2008 and he was continuing to feel disoriented. The patient went to the emergency room (date not provided) and reported "no organ damage." The patient reported he had lost 25 pounds since 14 November 2008. He also reported a rash on his elbow below the injection site. The patient is currently on a bland diet at home. The reporter stated "contact patient for additional information." Per this new information, this case was upgraded to serious. The reporter for this case is the same as case number 2008-03659. Documents held by sender: None.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Cough, Lymphadenopathy, Ocular hyperaemia, Throat tightness
Clinical narrative: Initial report extracted from VAERS via QScan FDA report on 24 February 2009 (VAERS identification number 335863). A 46-year-old male patient, who has no other allergies, had received on 10 December 2008 a first intramuscular injection of FLUZONE SV 2008-2009 (lot number U2760AA). The route and site of administration was no provided. At an unspecified amount of time later, on the same day, the patient developed a deep chest cough, throat seemed a little tight, glands seemed puffy and tight and his eyes became "very" reddened and "mattery." Everything was fine the next morning. The patient was considered to be recovered.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Adverse reaction, CSF culture negative, Chills, Conjunctivitis, Cough
Clinical narrative: This serious event was received from an extraction of the VAERS database on 12 February 2009 (reference number 336301).  A 47-year-old male patient received intramuscular right arm injections of FLUZONE (lot number U2749AA) and PNEUMOVAX (Merck, lot number 0980X) on 10 December 2008.  The patient had a history of allergies to penicillin, CIPRO, and bee stings, and had previously been in a motor vehicle collision.  Medical history included hypertension, chronic obstructive pulmonary disease (COPD), alcohol abuse, tobacco abuse, anal fistula, H. pylori, and "temper".  On the evening of vaccination, the patient had pain in the right shoulder and fever up to 104 degrees Fahrenheit.  Over the next four days, he experienced a frontal headache and progressive pain, redness, and swelling at the injection site.  On 14 December 2008 he was admitted to the hospital with fever, headache, nuchal rigidity, photophobia, chills, malaise, fatigue, diaphoresis, eye pain and redness, cough, nausea, diarrhea, neck pain, dizziness, and tingling.  Physical exam was positive for bilateral injected dilated veins in the right chest.  The patient initially was started on antibiotics, however they were discontinued when a CSF culture was found to be negative.  He showed improvement after being treated with intravenous fluids and NSAIDs, and was discharged on 16 December 2008.  Discharge diagnosis was "adverse reaction to pneumococcal vaccine; aseptic meningitis; and local reaction at site of injection".
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Crepitations, Diarrhoea, Dizziness, Erythema, Eye pain
Clinical narrative: This serious event was received from an extraction of the VAERS database on 12 February 2009 (reference number 336301).  A 47-year-old male patient received intramuscular right arm injections of FLUZONE (lot number U2749AA) and PNEUMOVAX (Merck, lot number 0980X) on 10 December 2008.  The patient had a history of allergies to penicillin, CIPRO, and bee stings, and had previously been in a motor vehicle collision.  Medical history included hypertension, chronic obstructive pulmonary disease (COPD), alcohol abuse, tobacco abuse, anal fistula, H. pylori, and "temper".  On the evening of vaccination, the patient had pain in the right shoulder and fever up to 104 degrees Fahrenheit.  Over the next four days, he experienced a frontal headache and progressive pain, redness, and swelling at the injection site.  On 14 December 2008 he was admitted to the hospital with fever, headache, nuchal rigidity, photophobia, chills, malaise, fatigue, diaphoresis, eye pain and redness, cough, nausea, diarrhea, neck pain, dizziness, and tingling.  Physical exam was positive for bilateral injected dilated veins in the right chest.  The patient initially was started on antibiotics, however they were discontinued when a CSF culture was found to be negative.  He showed improvement after being treated with intravenous fluids and NSAIDs, and was discharged on 16 December 2008.  Discharge diagnosis was "adverse reaction to pneumococcal vaccine; aseptic meningitis; and local reaction at site of injection".