chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Initial information received from a health care professional on 15 October 2010. A 75-year-old male patient with a history of severe cardiopulmonary issues (unspecified), cataracts, and who was "crippled", received a dose of FLUZONE HIGH-DOSE, lot number U3635AA, on 13 October 2010 at 10:00 a.m. The route and site of vaccination were not reported. Following vaccination, the patient experienced no adverse events or reactions and was reported to be "fine" at 8:30 p.m. that evening. The following day, on 14 October 2010 at 11:00 a.m., he was found dead by his sister. Autopsy status is unknown and no cause of death was reported. Per the reporter, the patient had been very ill prior to vaccination and his quality of life was poor. Follow-up information received on 18 October 2010 from a health care professional. The reporter stated that it is unknown if an autopsy was planned for the patient, but that if the patient had been seen by one of their physicians during the month prior to the event it is unlikely an autopsy would be performed. In addition, the reporter stated that the patient's past medical history of cardiopulmonary issues (unspecified) were "more cardiac rather than pulmonary", but no specifics were provided. Follow-up information was received 05 November 2010 from a health care professional. In addition to providing contact information for the patient's attending physician and cardiologist, the reporter noted the following: The patient did not have an autopsy performed; however, the patient's death certificate listed both coronary artery disease and arteriosclerosis as pre-existing medical conditions. Concomitant medications included LISINOPRIL and METOPROLOL. The reporter also contacted the patient's sister who stated the patient had a history of a CVA (cerebrovascular accident) in 2001 and a MI (myocardial infarction) in 2006. He also had a pre-existing nerve condition in his neck for 30+ years which caused limited mobility with his right arm and hand. He was also mildly mentally challenged, but had been functional through his life; he was able to drive an automobile when he was younger and had been employed as a sheep rancher. His health had been failing since his heart attack in 2006 and he had failed a stress test one year prior to his death. He had been scheduled for cataract surgery, but surgery was cancelled because he failed the stress test. The patient's sister had called the patient at 8:30 PM on 13 October 2010 (the evening of vaccination) and her brother had not complained of any problem at that time. The next day at approximately 11:00 am, the sister found the patient deceased. No additional information was provided. List of documents held by sender: none.
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Febrile convulsion, Resuscitation
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number (VAERS ID 404993). A male patient with no current illness, a possible amoxicillin allergy and a reported age of 2.0 (months or years were not reported), had received an third dose intramuscular left arm injection of FLUZONE, lot number U3581BA and a second dose intramuscular right arm injection of PREVNAR 13, Pfizer/Wyeth lot number E80082 on 20 October 2010 and one day later on 21 October 2010 experienced a febrile seizure for "10 seconds". He required mouth-to-mouth resuscitation and was evaluated in the emergency department (ED). The patient was treated with TYLENOL. No further information was provided at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Acute respiratory failure, Dyspnoea, Eye pruritus
Clinical narrative: Initial report was received from a health care professional on 18 October 2010. A 74 year-old female patient with a UTI and yeast infection at the time of vaccination and a past medical history of hyperthyroidism, diabetes, hyperlipidemia and angina pectoris, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3609AA between 11:45am and 12:30pm on 14 October 2010. The evening of 14 October 2010 the patient experienced shortness of breath and itchy eyes. The patient was hospitalized (dates unspecified) and treatments for the adverse events were not provided. The patient was on concomitant medications of CIPRO, Nystatin, MIRAPEX, COZAAR, LOVENOX, LASIX, metformin HCL, LIPITOR, ferrous gluconate, naproxen sodium, NEXIUM, QVAR, KAPIDEX, LIBRIUM, SPIRIVA, IMDUR, nitro, MIRALAX, COLACE, DULCOLAX, oxygen and albuterol. It was noted the CIPRO was used to treat the patient's UTI. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received 03 November 2010 from a health care professional. The patient developed "acute on chronic resp. failure" and was stabilized in the hospital. She was hospitalized for 5 days and discharged to home. Outcome was recovered. Documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Initial report was received from a health care professional on 18 October 2010. An unidentified female patient with no reported past medical history, had received FLUZONE HIGH-DOSE (lot number, date, route and site of administration not reported) and an unspecified amount of time later, experienced "trouble breathing". The patient was evaluated in the emergency room (ER). No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 27 October 2010. The patient received FLUZONE HIGH-DOSE, lot number U3601AA. The patient experienced breathing problems 2 hours after receiving the flu immunization. She was rushed to the ER and the physician on staff informed her that the complications were directly linked to the flu immunization. The outcome was not reported. Follow-up information was received from a health care professional on 15 November 2010. The patient was identified as a 74 year-old female (73 years-old at time of vaccination) who had been stung by a bee or a wasp two days prior to vaccination. She had received her FLUZONE vaccine in the left deltoid. She was vaccinated on 29 September 2010 at approximately 2:00 pm and onset of the adverse event was approximately 4:00 pm on 29 September 2010. No further information was provided at the time of the report. The patient's outcome was reported as recovered (date not provided). The reporter for this case is the same as for 2010-06069. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Drug administered to patient of inappropriate age, Dyspnoea, Hypersensitivity, Respiratory rate increased
Clinical narrative: Initial report was received 19 October 2010 from a health care professional, which also involved a case of misuse (inappropriate age at vaccine administration). A 64-year-old female patient had received an injection of FLUZONE HIGH-DOSE, lot number U3613AA at 12:35 hours (date not reported) and at 15:00 hours (also reported as 3-4 hours after injection), the patient developed shortness of breath (SOB), increase respirations, chest tight, tightness in throat and a sensation of throat swelling (with no physical swelling). The patient presented to the emergency room with an allergic reaction and the course/duration of symptoms was noted to be improving. The patient had no rash, no redness, no itching, not burning, no pain and no streaking redness. It was also noted the patient had no dyspnea, wheezing or swelling and she denied difficulty swallowing, denied chest pain and denied nausea and vomiting. The degree of event onset was moderate, and the degree at the time of evaluation was minimal. Potential allergens were reported as unknown. Risk factors consisted of food allergies. The patient had no history of previous anaphylaxis, asthma or seasonal allergies. "Therapy today" was reported as none. The event duration was not reported; however, the patient's outcome was recovered (date not reported). Follow-up information received on 26 October 2010 from a health care professional. Additional contact information provided only. No further information available at the time of the report. The patient's outcome remained recovered (date not reported). The reporter for this case is the same as for case number 2010-06036. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Initial report was received 19 October 2010 from a health care professional, which also involved a case of misuse (inappropriate age at vaccine administration). A 64-year-old female patient had received an injection of FLUZONE HIGH-DOSE, lot number U3613AA at 12:35 hours (date not reported) and at 15:00 hours (also reported as 3-4 hours after injection), the patient developed shortness of breath (SOB), increase respirations, chest tight, tightness in throat and a sensation of throat swelling (with no physical swelling). The patient presented to the emergency room with an allergic reaction and the course/duration of symptoms was noted to be improving. The patient had no rash, no redness, no itching, not burning, no pain and no streaking redness. It was also noted the patient had no dyspnea, wheezing or swelling and she denied difficulty swallowing, denied chest pain and denied nausea and vomiting. The degree of event onset was moderate, and the degree at the time of evaluation was minimal. Potential allergens were reported as unknown. Risk factors consisted of food allergies. The patient had no history of previous anaphylaxis, asthma or seasonal allergies. "Therapy today" was reported as none. The event duration was not reported; however, the patient's outcome was recovered (date not reported). Follow-up information received on 26 October 2010 from a health care professional. Additional contact information provided only. No further information available at the time of the report. The patient's outcome remained recovered (date not reported). The reporter for this case is the same as for case number 2010-06036. Documents held by sender: None.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity, Pharyngeal oedema, Respiratory rate increased
Clinical narrative: Initial report was received 19 October 2010 from a health care professional. A 46-year-old male dialysis patient had received an injection of FLUZONE HIGH-DOSE, lot number U3566FA (lot number invalid for FLUZONE HIGH-DOSE, but consistent for FLUZONE) at 12:35 hours (date not reported) and at 15:00 hours (also reported as 3-4 hours after injection), the patient developed an allergic reaction with symptoms of shortness of breath (SOB), increase respirations, chest tight, tightness in throat and a sensation of throat swelling (with no physical swelling). The event did not require a doctor's visit or an emergency room visit. The event duration was not reported; however, the patient's outcome was recovered (date not reported). Follow-up information received on 26 October 2010 from a health care professional. Additional contact information provided only. No further information available at the time of the report. The patient's outcome remained recovered (date not reported). The reporter for this case is the same as for case number 2010-06035. Documents held by sender: None.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Initial report was received 19 October 2010 from a health care professional. A 46-year-old male dialysis patient had received an injection of FLUZONE HIGH-DOSE, lot number U3566FA (lot number invalid for FLUZONE HIGH-DOSE, but consistent for FLUZONE) at 12:35 hours (date not reported) and at 15:00 hours (also reported as 3-4 hours after injection), the patient developed an allergic reaction with symptoms of shortness of breath (SOB), increase respirations, chest tight, tightness in throat and a sensation of throat swelling (with no physical swelling). The event did not require a doctor's visit or an emergency room visit. The event duration was not reported; however, the patient's outcome was recovered (date not reported). Follow-up information received on 26 October 2010 from a health care professional. Additional contact information provided only. No further information available at the time of the report. The patient's outcome remained recovered (date not reported). The reporter for this case is the same as for case number 2010-06035. Documents held by sender: None.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lyme disease
Clinical narrative: Initial report was received from a health care professional on 17 September 2010. An unidentified patient had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced redness, swelling and pain at the injection site. No further information was available at the time of this report. The patient's outcome was not reported. Follow-up information was received 01 October 2010 from a health care professional. The patient was a 77-year-old male who had no concurrent illness and he had not been taking any concomitant medications. He had not received any other vaccines within four weeks of FLUZONE HIGH-DOSE and he had not experienced any adverse events following prior vaccinations. NO additional information was provided at the time of the report. Follow-up information was received 21 October 2010 from a health care professional who replied, "Error - pt had Lyme Disease". Based upon new information received, it was determined this case now meets seriousness criteria and this case has been upgraded from non serious to serious. No additional information was provided at the time of the report. Documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Initial case was received on 18 November 2010 from a healthcare professional. A 72 year old male patient received on 18 November 2010, an injection of FLUZONE HIGH-DOSE (lot number U3632AA). Six or seven hours later, he experienced an "allergic swelling of tongue." The healthcare professional was not notified until a couple of days later. No further information was provided. The patient's recovery status was not reported. Follow-up information was received 28 December 2010 from a health care professional. FLUZONE HIGH-DOSE had been administered as an intramuscular left deltoid injection on 25 October 2010 (previously reported as 18 November 2010). The event onset was also amended by the reporter to 25 October 2010 (previously reported as 18 November 2010) which changed the patient's age at the time of the event from 72 to 71 years of age. According to the reporter, the patient had no history of problems with previous influenza vaccinations or allergies and he had been discharged in good condition. Several days later, the reporter received a call from the patient's wife, who was also a nurse, stating that the patient had been experiencing swelling of the tongue several hours after vaccination. While on their way to the hospital the swelling began to subside and they chose not to go to the hospital, but chose to go to the doctor's office. Treatment was not required. The patient was advised to see his physician for his next influenza vaccination at which time the physician would administer antihistamines before administering the influenza vaccine. The patient's wife asked for the vaccine lot number and stated she would also file a VAERS report. According to the reporter, the patient recovered. Follow-up information received from a health care professional on 24 January 2011. The patient's tongue swelling began 3-4 hours post-vaccination (previously reported as 6-7 hours) and persisted 4-5 hours. The patient's spouse gave him BENADRYL prior to traveling to the emergency department. The patient was not seen by his physician, but spoke with his physician on the day of vaccination (previously reported as having gone to the physician's office). Etiology for the event was undetermined. The patient recovered and no further treatment was required. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: This patient is one of a cluster of 2 patient's with the same reporter and same vaccine administered; however lot number was not reported. Initial report received from a patient on 19 October 2010. A 61-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number not reported) at 9:30 am on 18 October 2010, and within 15-20 minutes later, she complained of a sore throat, SOB (shortness of breath) and coughing. The patient subsequently developed severe headache, dizziness, nausea, diarrhea, and complained of numbness and tingling in her hands and feet. It was also reported the patient had pain (not described) and that 90 minutes after vaccination the patient was sick. The patient has no known allergies and denied any pre-existing medical conditions or concurrent illnesses at the time of vaccination; however the patient was taking concomitant medications of PREMPRO and "MDV". She had not experienced any other adverse events with prior vaccinations in the past. The patient does receive the flu vaccine annually. At the time of this report, the patient was feeling better but still complained of a headache although not as severe. Follow-up information received from a physician on 17 November 2010. The lot number for the FLUZONE HIGH-DOSE was U3604BA. The patient had received the vaccination intramuscularly in the left deltoid. Recovery status was not mentioned by the reporter. Documents held by sender: None. The reporter for this case is the same as for non-serious case 2010-06028.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Malaise, Nausea, Oropharyngeal pain, Pain
Clinical narrative: This patient is one of a cluster of 2 patient's with the same reporter and same vaccine administered; however lot number was not reported. Initial report received from a patient on 19 October 2010. A 61-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number not reported) at 9:30 am on 18 October 2010, and within 15-20 minutes later, she complained of a sore throat, SOB (shortness of breath) and coughing. The patient subsequently developed severe headache, dizziness, nausea, diarrhea, and complained of numbness and tingling in her hands and feet. It was also reported the patient had pain (not described) and that 90 minutes after vaccination the patient was sick. The patient has no known allergies and denied any pre-existing medical conditions or concurrent illnesses at the time of vaccination; however the patient was taking concomitant medications of PREMPRO and "MDV". She had not experienced any other adverse events with prior vaccinations in the past. The patient does receive the flu vaccine annually. At the time of this report, the patient was feeling better but still complained of a headache although not as severe. Follow-up information received from a physician on 17 November 2010. The lot number for the FLUZONE HIGH-DOSE was U3604BA. The patient had received the vaccination intramuscularly in the left deltoid. Recovery status was not mentioned by the reporter. Documents held by sender: None. The reporter for this case is the same as for non-serious case 2010-06028.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: This patient is one of a cluster of 2 patient's with the same reporter and same vaccine administered; however lot number was not reported. Initial report received from a patient on 19 October 2010. A 61-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number not reported) at 9:30 am on 18 October 2010, and within 15-20 minutes later, she complained of a sore throat, SOB (shortness of breath) and coughing. The patient subsequently developed severe headache, dizziness, nausea, diarrhea, and complained of numbness and tingling in her hands and feet. It was also reported the patient had pain (not described) and that 90 minutes after vaccination the patient was sick. The patient has no known allergies and denied any pre-existing medical conditions or concurrent illnesses at the time of vaccination; however the patient was taking concomitant medications of PREMPRO and "MDV". She had not experienced any other adverse events with prior vaccinations in the past. The patient does receive the flu vaccine annually. At the time of this report, the patient was feeling better but still complained of a headache although not as severe. Follow-up information received from a physician on 17 November 2010. The lot number for the FLUZONE HIGH-DOSE was U3604BA. The patient had received the vaccination intramuscularly in the left deltoid. Recovery status was not mentioned by the reporter. Documents held by sender: None. The reporter for this case is the same as for non-serious case 2010-06028.
Age: 1.6
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number (VAERS ID 406018). A female patient who had no illness at the time of vaccination and a reported age of 1.6 (months or years were not reported), had received a first dose left leg injection of FLUZONE, lot number UT3570EA on 23 October 2010 and an unspecified amount of time later the same day, developed a fever (reported as "98 degrees AX") and then experienced a febrile seizure. The patient was evaluated in the emergency room and was reported to have been hospitalized. Treatments were not reported. No further information was provided at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Feeling cold, Movement disorder
Clinical narrative: Initial report received from a consumer on 05 November 2010. A 65-year-old patient received on 22 October 2010 a left deltoid intramuscular (IM) injection of FLUZONE HIGH-DOSE, lot number unknown. The patient had a history of diabetes, thyroid disorder, nerve pain in the feet and allergy to penicillin. Her concomitant medications included metformin, LEVOTHROID and gabapentin. She had no illness at the time of vaccination. The patient has had seasonal flu in the past 28 years but did not have either H1N1 or flu last year. One hour after vaccine the patient was dizzy with chills and then shaking. She then had repeated vomiting, extreme cold feeling and severe weakness. She could not get up to move to get the phone. The patient was found the next day "out of it on the couch covered with vomit". She could not turn her head to prevent herself from choking on the vomit due to her neck stiffness. The patient stated in one week she was "back to normal". The outcome was reported as recovered. Follow-up information received from a health care professional on 06 December 2010 reported that no additional information available at this time. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Tremor, Vomiting
Clinical narrative: Initial report received from a consumer on 05 November 2010. A 65-year-old patient received on 22 October 2010 a left deltoid intramuscular (IM) injection of FLUZONE HIGH-DOSE, lot number unknown. The patient had a history of diabetes, thyroid disorder, nerve pain in the feet and allergy to penicillin. Her concomitant medications included metformin, LEVOTHROID and gabapentin. She had no illness at the time of vaccination. The patient has had seasonal flu in the past 28 years but did not have either H1N1 or flu last year. One hour after vaccine the patient was dizzy with chills and then shaking. She then had repeated vomiting, extreme cold feeling and severe weakness. She could not get up to move to get the phone. The patient was found the next day "out of it on the couch covered with vomit". She could not turn her head to prevent herself from choking on the vomit due to her neck stiffness. The patient stated in one week she was "back to normal". The outcome was reported as recovered. Follow-up information received from a health care professional on 06 December 2010 reported that no additional information available at this time. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abnormal behaviour, Blood electrolytes normal, Computerised tomogram head, Computerised tomogram normal, Ear infection
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 406598. A 1-year-old male patient received a first left leg injection of FLUZONE (lot number UT3570DA) and a fourth intramuscular right leg injection of PREVNAR 13 (Pfizer/Wyeth, lot number E8008Z) on 01 October 2010. One day post-vaccination, at 2:13am, the patient began shaking, was "out of it", and subsequently vomited. He presented to the emergency department, where his fever was noted to be 102.3 degrees. Testing, including a head CT and electrolytes, were within normal limits. He was diagnosed with otitis and febrile seizure, and was treated with AMOXIL for 10 days. The patient was not ill at the time of vaccination, and had no medical history. He recovered on an unspecified date. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Febrile convulsion, Pyrexia, Tremor, Vomiting
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 406598. A 1-year-old male patient received a first left leg injection of FLUZONE (lot number UT3570DA) and a fourth intramuscular right leg injection of PREVNAR 13 (Pfizer/Wyeth, lot number E8008Z) on 01 October 2010. One day post-vaccination, at 2:13am, the patient began shaking, was "out of it", and subsequently vomited. He presented to the emergency department, where his fever was noted to be 102.3 degrees. Testing, including a head CT and electrolytes, were within normal limits. He was diagnosed with otitis and febrile seizure, and was treated with AMOXIL for 10 days. The patient was not ill at the time of vaccination, and had no medical history. He recovered on an unspecified date. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dehydration, Diarrhoea, Electrolyte imbalance, Pain
Clinical narrative: Initial report received from the patient's daughter who is a Healthcare professional on 28 October 2010. A 72-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number unknown) three weeks prior to this report. At an unspecified amount of time after vaccination, the patient developed diarrhea, vomiting, body aches, fever and chills. One week later she went to the hospital for dehydration, electrolyte imbalance, and palpitations. Treatments received and diagnostic tests performed were not reported. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received from the patient's daughter on 03 January 2011. The patient was hospitalized for 3 days, and subsequently recovered. No additional information was reported. The reporter for this case is the same as for cases 2010-06223 - 06225. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Pyrexia, Vomiting
Clinical narrative: Initial report received from the patient's daughter who is a Healthcare professional on 28 October 2010. A 72-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number unknown) three weeks prior to this report. At an unspecified amount of time after vaccination, the patient developed diarrhea, vomiting, body aches, fever and chills. One week later she went to the hospital for dehydration, electrolyte imbalance, and palpitations. Treatments received and diagnostic tests performed were not reported. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received from the patient's daughter on 03 January 2011. The patient was hospitalized for 3 days, and subsequently recovered. No additional information was reported. The reporter for this case is the same as for cases 2010-06223 - 06225. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye pruritus, Pruritus
Clinical narrative: Initial report was received 03 November 2010 from a health care professional. A 66-year-old female patient who had a history of penicillin allergy, had received a first dose left deltoid intramuscular injection of FLUZONE HIGH-DOSE, lot number U3609A on 17 October 2010 and two days later, she developed shortness of breath, itchy eyes and itchy ears. Laboratory and diagnostic testing had not been performed and the event did not require a doctor's visit. Corrective treatments were not reported. The reporter further noted that a 1 inch 25 gauge needle had been used for vaccine administration and the patient had no concurrent illness at the time of vaccination. According to the reporter, medical notes on 01 November 2010 did not indicate if shortness of breath or itching was present at that time. At the time of the report, the patient's outcome was unknown. Follow-up information was received on 23 November 2010 from a health care professional. The patient's outcome was reported as recovered (date not provided). Follow-up information received from a health care professional on 07 January 2011. The date the patient had received the FLUZONE HIGH-DOSE vaccine was on 19 October 2010 not 17 October 2010 as previously reported. This makes the events occurring the same day as vaccination. Time of vaccination and time of onset of events were not reported. The patient was treated with unspecified antibiotics and recovered on 30 October 2010, 11 days after onset of events. Etiology for the events were not determined. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 407901. A 1-year-old female patient received the following vaccines on 09 November 2010: an intramuscular first injection of FLUZONE (lot number UT3575DA), a first intramuscular injection of VAQTA (Merck, lot number 0988Z), a fourth intramuscular injection of PREVNAR 13 (Pfizer/Wyeth, lot number 914274), a first subcutaneous injection of MMR II (Merck, lot number 0494Z), and a first subcutaneous injection of VARIVAX (Merck, lot number 0714Z). The day of vaccination, the patient's mother reported that she experienced a febrile seizure and was taken to the emergency department via ambulance. She was "cleared by ER" and subsequently recovered. The patient had no medical history and was not ill at the time of vaccination. Documents held by sender: None.
Sex: M
Vaccine: FLU3, HEP, HEPA, MMR, VARCEL
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Electroencephalogram normal, Endotracheal intubation
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 409414. A male child (age reported as 1.0) with no current illness and no past history, had received a first dose of intramuscular left leg injection of FLUZONE, lot number UT3645BA, and a second dose intramuscular left leg injection of RECOMBIVAX HB (manufacturer MERCK, lot number 1493Y), and an intramuscular right leg injection of HAVRIX (manufacturer GlaxoSmithKline, lot number AHAVB441AA, dose 0), and a subcutaneous right leg injection of MMR II (manufacturer MERCK, lot number 0406Z, dose 0), and a subcutaneous left leg injection of VARIVAX (manufacturer MERCK, lot number 0605Z, dose 0) on 01 November 2010 and 10 days later, the patient developed a prolonged atypical febrile seizure requiring intubation and hospitalization. Laboratory and diagnostic test results included normal EEG and MRI; and blood, urine and CSF cultures were all negative (dates not reported). The patient's outcome was recovered. Documents held by sender: None.
Sex: M
Vaccine: FLU3, HEP, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 409414. A male child (age reported as 1.0) with no current illness and no past history, had received a first dose of intramuscular left leg injection of FLUZONE, lot number UT3645BA, and a second dose intramuscular left leg injection of RECOMBIVAX HB (manufacturer MERCK, lot number 1493Y), and an intramuscular right leg injection of HAVRIX (manufacturer GlaxoSmithKline, lot number AHAVB441AA, dose 0), and a subcutaneous right leg injection of MMR II (manufacturer MERCK, lot number 0406Z, dose 0), and a subcutaneous left leg injection of VARIVAX (manufacturer MERCK, lot number 0605Z, dose 0) on 01 November 2010 and 10 days later, the patient developed a prolonged atypical febrile seizure requiring intubation and hospitalization. Laboratory and diagnostic test results included normal EEG and MRI; and blood, urine and CSF cultures were all negative (dates not reported). The patient's outcome was recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 409820. A female child (age reported as 1.0) had received a first dose intramuscular left leg injection of FLUZONE, lot number UT3581AA, and a subcutaneous right leg injection of MMR II (manufacturer MERCK, lot number 0577z, dose 0), and a third dose intramuscular right leg injection of PREVNAR (manufacturer PFIZER/WYETH, lot number 914275) and a subcutaneous left leg injection of VARIVAX (manufacturer MERCK, lot number 0783z, dose 0) on 16 November 2010 and the following day (also reported as less than 24 hours after vaccine administration), she experienced a febrile seizure which lasted two minutes. The event required an emergency visit and the patient recovered. The patient had a current illness of AOM. Other medications consisted of Amoxicillin. No additional information was provided. Documents held by sender: None.
Sex: F
Vaccine: FLU3, HEPA, PNC13
Symptoms: Blood glucose normal, Body temperature increased, Febrile convulsion, Full blood count normal, Urine analysis normal
Clinical narrative: Initial report received from an extraction from VAERS database (VAERS identification number 409884) using a third party query tool on 27 January 2011. A female child, age reported as 2.0 (no birth date provided), received on 18 November 2010 an intramuscular right leg injection (dose 2) of FLUZONE, sanofi pasteur lot number UH224AB, an intramuscular left leg injection (dose 1) of HAVRIX, GlaxoSmithKline lot number B461AA and an intramuscular left leg injection (dose 1) of PREVNAR 13, Pfizer/Wyeth lot number E87534. The patient had a current illness of possible upper respiratory infection (URI) and was taking ibuprofen. The patient had no medical history. The patient had a current illness or possible upper respiratory infection (URI) and was taking ibuprofen. The patient had no medical history. On 19 November 2010, the patient had a febrile seizure approximately 12 hours after the vaccines. Her temperature was 104 (units not provided). The seizure lasted 15 minutes. The patient was seen in the Emergency Room (ER) where her laboratory findings which included a urinalysis, glucose and complete blood count (CBC) were all normal. The patient was seen on 23 November 2010 and a normal exam was reported. The outcome was reported as recovered. Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deep vein thrombosis, Electromyogram abnormal, Erythema, Fall, Herpes virus infection
Clinical narrative: Initial report and a copy of the patient's immunization record was received 03 January 2011 from a health care professional, who is also the patient's spouse. A 75-year-old male patient had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U3609AA on 14 October 2010 and six days later on 20 October 2010, he developed weakness in his right leg. On 21 October 2010, the patient experienced a fall at home and he had developed bright red lesions on his right leg. He was seen by his physician on 25 October 2010 and was prescribed "VALTRAX" for Herpes and physical therapy. On 03 November 2010, the patient had intense bilateral leg pain. An EMG was performed and the patient was diagnosed with bilateral polyneuropathy. He also had a swollen leg, 3+ edema of the right leg, and his foot was discolored. On 29 November 2010 the patient was hospitalized. He was diagnosed with bilateral multiple DVT and received corrective treatment with LOVENOX and was prescribed PT (physical therapy) and rehabilitation for mobility. On 22 December 2010 (hospital duration was also reported as 21 days duration), the patient was discharged home on coumadin. Bilateral leg weakness, decreased mobility and decreased leg reflexes continued. Outcome was not recovered. The patient was scheduled to see their physician on 04 January 2011. Documents held by sender: Immunization record.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyporeflexia, Mobility decreased, Muscular weakness, Oedema peripheral, Pain in extremity
Clinical narrative: Initial report and a copy of the patient's immunization record was received 03 January 2011 from a health care professional, who is also the patient's spouse. A 75-year-old male patient had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U3609AA on 14 October 2010 and six days later on 20 October 2010, he developed weakness in his right leg. On 21 October 2010, the patient experienced a fall at home and he had developed bright red lesions on his right leg. He was seen by his physician on 25 October 2010 and was prescribed "VALTRAX" for Herpes and physical therapy. On 03 November 2010, the patient had intense bilateral leg pain. An EMG was performed and the patient was diagnosed with bilateral polyneuropathy. He also had a swollen leg, 3+ edema of the right leg, and his foot was discolored. On 29 November 2010 the patient was hospitalized. He was diagnosed with bilateral multiple DVT and received corrective treatment with LOVENOX and was prescribed PT (physical therapy) and rehabilitation for mobility. On 22 December 2010 (hospital duration was also reported as 21 days duration), the patient was discharged home on coumadin. Bilateral leg weakness, decreased mobility and decreased leg reflexes continued. Outcome was not recovered. The patient was scheduled to see their physician on 04 January 2011. Documents held by sender: Immunization record.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Polyneuropathy, Skin discolouration, Skin lesion
Clinical narrative: Initial report and a copy of the patient's immunization record was received 03 January 2011 from a health care professional, who is also the patient's spouse. A 75-year-old male patient had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U3609AA on 14 October 2010 and six days later on 20 October 2010, he developed weakness in his right leg. On 21 October 2010, the patient experienced a fall at home and he had developed bright red lesions on his right leg. He was seen by his physician on 25 October 2010 and was prescribed "VALTRAX" for Herpes and physical therapy. On 03 November 2010, the patient had intense bilateral leg pain. An EMG was performed and the patient was diagnosed with bilateral polyneuropathy. He also had a swollen leg, 3+ edema of the right leg, and his foot was discolored. On 29 November 2010 the patient was hospitalized. He was diagnosed with bilateral multiple DVT and received corrective treatment with LOVENOX and was prescribed PT (physical therapy) and rehabilitation for mobility. On 22 December 2010 (hospital duration was also reported as 21 days duration), the patient was discharged home on coumadin. Bilateral leg weakness, decreased mobility and decreased leg reflexes continued. Outcome was not recovered. The patient was scheduled to see their physician on 04 January 2011. Documents held by sender: Immunization record.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deep vein thrombosis, Electromyogram abnormal, Erythema, Fall, Hyporeflexia
Clinical narrative: Initial report and a copy of the patient's immunization record was received 03 January 2011 from a health care professional, who is also the patient's spouse. A 75-year-old male patient had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U3609AA on 14 October 2010 and six days later on 20 October 2010, he developed weakness in his right leg. On 21 October 2010, the patient experienced a fall at home and he had developed bright red lesions on his right leg. He was seen by his physician on 25 October 2010 and was prescribed "VALTRAX" for Herpes and physical therapy. On 03 November 2010, the patient had intense bilateral leg pain. An EMG was performed and the patient was diagnosed with bilateral polyneuropathy. He also had a swollen leg, 3+ edema of the right leg, and his foot was discolored. On 29 November 2010 the patient was hospitalized. He was diagnosed with bilateral multiple DVT and received corrective treatment with LOVENOX and was prescribed PT (physical therapy) and rehabilitation for mobility. On 22 December 2010 (hospital duration was also reported as 21 days duration), the patient was discharged home on coumadin. Bilateral leg weakness, decreased mobility and decreased leg reflexes continued. Outcome was not recovered. The patient was scheduled to see their physician on 04 January 2011. Documents held by sender: Immunization record.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Muscular weakness, Oedema peripheral, Pain in extremity, Polyneuropathy
Clinical narrative: Initial report and a copy of the patient's immunization record was received 03 January 2011 from a health care professional, who is also the patient's spouse. A 75-year-old male patient had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U3609AA on 14 October 2010 and six days later on 20 October 2010, he developed weakness in his right leg. On 21 October 2010, the patient experienced a fall at home and he had developed bright red lesions on his right leg. He was seen by his physician on 25 October 2010 and was prescribed "VALTRAX" for Herpes and physical therapy. On 03 November 2010, the patient had intense bilateral leg pain. An EMG was performed and the patient was diagnosed with bilateral polyneuropathy. He also had a swollen leg, 3+ edema of the right leg, and his foot was discolored. On 29 November 2010 the patient was hospitalized. He was diagnosed with bilateral multiple DVT and received corrective treatment with LOVENOX and was prescribed PT (physical therapy) and rehabilitation for mobility. On 22 December 2010 (hospital duration was also reported as 21 days duration), the patient was discharged home on coumadin. Bilateral leg weakness, decreased mobility and decreased leg reflexes continued. Outcome was not recovered. The patient was scheduled to see their physician on 04 January 2011. Documents held by sender: Immunization record.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Skin discolouration, Skin lesion
Clinical narrative: Initial report and a copy of the patient's immunization record was received 03 January 2011 from a health care professional, who is also the patient's spouse. A 75-year-old male patient had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U3609AA on 14 October 2010 and six days later on 20 October 2010, he developed weakness in his right leg. On 21 October 2010, the patient experienced a fall at home and he had developed bright red lesions on his right leg. He was seen by his physician on 25 October 2010 and was prescribed "VALTRAX" for Herpes and physical therapy. On 03 November 2010, the patient had intense bilateral leg pain. An EMG was performed and the patient was diagnosed with bilateral polyneuropathy. He also had a swollen leg, 3+ edema of the right leg, and his foot was discolored. On 29 November 2010 the patient was hospitalized. He was diagnosed with bilateral multiple DVT and received corrective treatment with LOVENOX and was prescribed PT (physical therapy) and rehabilitation for mobility. On 22 December 2010 (hospital duration was also reported as 21 days duration), the patient was discharged home on coumadin. Bilateral leg weakness, decreased mobility and decreased leg reflexes continued. Outcome was not recovered. The patient was scheduled to see their physician on 04 January 2011. Documents held by sender: Immunization record.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension, Joint swelling, Pain
Clinical narrative: Initial case received from a healthcare professional on 16 December 2010. A 79-year-old male patient received FLUZONE HIGH-DOSE (lot number U3612AA) on 01 October 2010. On 11 October 2010, 10 days post-vaccination, the patient notified his physician that he was experiencing pain all over his body, swollen ankles, and high blood pressure. He was seen by his physician, who confirmed that the symptoms had not been present prior to vaccination. No additional information was reported. Follow-up information was received from the health care professional on 07 February 2011. The FLUZONE HIGH-DOSE was administered intramuscularly in the left deltoid. The patient was taking ZETIA, aspirin, and ZITHROMAX concomitantly, and had a cough at the time of vaccination. Symptoms resolved on an unspecified date, and the patient recovered. Follow-up information was received from 21 March 2011 from a health care professional who reported that the patient recovered (date of recovery not reported). Follow-up information was received 11 April 2011 from a health care professional. According to the reporter, they had no additional information to provide. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Discomfort, Erythema, Hypoaesthesia, Influenza like illness
Clinical narrative: Patient developed "flu" like symptoms shortly after receiving the vaccine. She experienced body discomfort, mild fever, chills, pain, redness, numbness and tingling that lasted 2-3 hours. She also developed a rash. She described it as little red bumps all over but later went away.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Pyrexia, Rash erythematous
Clinical narrative: Patient developed "flu" like symptoms shortly after receiving the vaccine. She experienced body discomfort, mild fever, chills, pain, redness, numbness and tingling that lasted 2-3 hours. She also developed a rash. She described it as little red bumps all over but later went away.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: (R) upper thigh became red & swollen, lower (R) leg became bright red & purplish. Baby cried inconsolably.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Pt has 2 inch x 2 inch bruise to area. Pt reports arm had bigger bruise a few days after receiving vaccine. No hardness, swelling, redness, or warmth to area.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Joint swelling, Pruritus
Clinical narrative: Pt was rubbing site-pt got redness at injection site- started itching got redness & swelling down the arm where sl itched- Wash/cortisone/BENADRYL. Pt 100% better.