chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 03 April 2013. A female patient, who had no concomitant medications, had received an intradermal dose of FLUZONE ID (lot number: UT4473AA and dose number: not reported) in right deltoid and an intramuscular dose of ADACEL vaccine (lot number: U4421AA and dose number: not reported) in left deltoid on 19 November 2012. The patient had no known drug allergies. The patient had medical history of allergy hay fever, arthritis and elevated blood pressure. As per the reporter, the patient had no illness at time of vaccination. On an unspecified date, the patient had developed raised, hard lump at FLUZONE injection site on right deltoid. It was reported that the patient had not any other adverse events following vaccinations. Corrective treatment and laboratory investigations were not reported. As of 03 April 2013, the patient was not recovered from the adverse event. Documents held by sender: none. Follow up information received from a healthcare professional on 17 May 2013. The patient was 61 year-old, had received concomitant medications includes SINGULAIR, CLARINEX, LIPITOR, PATANASE and aspirin.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 06 September 2013. A 31-year-old female patient had received an intramuscular first dose of ADACEL (lot number: C4432AB) in the right deltoid on 04 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 03 February 2013 and the estimated date of delivery was reported as 10 November 2013. The patient's health during pregnancy, risk factors (e.g. : alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. Laboratory investigations were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 March 2013. A patient had received ADACEL vaccine in December 2012 and then received another dose on 22 March 2013. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 05 September 2013: A 28-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL, lot number: C4432AB and expiry date: 18 October 2015 (anatomical site of administration not reported) on 05 September 2013. The patient's health during pregnancy, specific risk factors (e.g. : alcohol, tobacco or recreational drugs) was not reported. The patient was pregnant at the time of vaccination. The patient's date of last menstrual period was reported as 01 January 2013 and the expected date of delivery is 08 October 2013. At the time of the report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 05 September 2013. A 30-year-old female patient had received an intramuscular first dose of ADACEL (Lot number C4432AB, anatomical site of vaccination was not reported) on 05 September 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 28 December 2012 and the expected date of delivery is 11 October 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. Treatment for infertility was not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 March 2013. A new born patient was administered a dose of ADACEL. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 07 OCTOBER 2013. A 28-year old female patient had received intramuscularly first dose of TDap (lot number: C4426AA, expiry date 10 SEPTEMBER 2015 and site of administration was not reported) on 07 OCTOBER 2013. The patient's last menstrual period date was 18 JANUARY 2013 and the expected date of delivery was 25 OCTOBER 2013. The patient health problem during pregnancy, specific risk factors and concomitant medications were not reported. At the time of this report, the patient  did not experience any adverse event. List of documents held by the sender: None
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial misuse report received on 11-Oct-2013 from a health care professional. A female patient, age, medical history and concomitant medications were not reported, received a dose of ADACEL through IM (lot number C4181AA and site of vaccination was not reported) on 11-Oct-2013. It was reported that a patient exposed to ADACEL during pregnancy. As of 11-Oct-2013, Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 March 2013. A new born patient was administered ADACEL. No adverse event was performed. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial report received from reporter on 07-Oct-2013: 37 year old female patient had received TDAP vaccine (lot number E4426AA and expiration date 10-Sep-2015), on 07-Oct-2013. The patient was pregnant during vaccination. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report receive from a healthcare professional on 18 March 2013. A patient was administered ADACEL through subcutaneous route. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Initial report received from a healthcare professional on 09 April 2013. A 41-year-old female patient had received first intramuscular dose of ADACEL, (batch number: U4567AA) on right deltoid on 04 April 2013. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient concomitant medication was not reported. On 06 April 2013, i.e. 2 days after vaccination, the patient developed asymptomatic erythematous macular rash (not C-W hives) on her upper body and was most notable after the shower. Lab investigations and corrective treatments were not reported. On an unspecified date, the patient had recovered from the event. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 25 September 2013. A39-year old female patient had received an intramuscular dose of ADACEL vaccine (batch number: C4426AA and anatomical site of administration was not reported) on 25 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 11 February 2013. The estimated date of delivery was 18 November 2013. At the time of the report, the patient had not experienced any adverse events. Patients health during pregnancy, risk factors, concomitant medication and treatment for infertility were not reported. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Initial misuse report received from a healthcare professional on 02 January 2014. Pregnant women had received a dose of ADACEL on 02 January 2014 and then found out it was previously given on 12 November 2014. No adverse event was reported. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 11 September 2013. A 32-year-old female patient had received an intramuscular dose of ADACEL vaccine (lot number U4655AA) in left deltoid on 11 September 2013. The patient was pregnant at the time of vaccination. Patient's last menstrual period date was 04 July 2013 and the estimated date of delivery was reported as "10 May 2004". Laboratory tests were not reported. The patient was healthy. Medical history and concomitant medications were not reported. The patient did not receive any treatment for infertility. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow-up received on 22-Oct-2013: estimated date of delivery was updated.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from healthcare professional on 21 January 2014. A 18-year-old female patient, who has no medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL, batch number: C4332BA (anatomical site of administration was not reported) on 20 January 2014. The patient's last menstrual period was not reported and the expected date of delivery is 25 March 2014. The patient did not experience any adverse event. List of documents held by the sender: none.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 09 SEPTEMBER 2013. A 27-year-old female patient had received an intramuscular first dose of ADACEL (lot number: U4612AA, anatomical site of vaccination was not reported) on 09 SEPTEMBER 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 04 FEBRUARY 2013 and the expected date of delivery was reported as 06 NOVEMBER 2013. The patient's health during pregnancy and risk factors (e.g. alcohol, tobacco or recreational drugs) were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: None
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial pregnancy report received from healthcare professional on 30 January 2014.  A female patient, whose date of birth, age, medical history and concomitant medications were not reported, had received dose of ADACEL (batch number, dose number, route and anatomical site of administration were not reported) on 30 January 2014. The patient's last menstrual period and the expected date of delivery were not reported. List of documents held by the sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information for this case was received from healthcare professional on 06 FEBRUARY 2014. A 30-year-old female patient whose past medical history and concomitant medication was not reported became pregnant on an unknown date and had received first dose of an intramuscular ADACEL, batch number C4426AA, dose and site of administration not reported) on 27 DECEMBER 2013 and second dose of an intramuscular ADACEL (batch number: C4426AA, dose and anatomical site of administration not reported) on 10 JANUARY 2014, during pregnancy. The last date of menstrual period was unknown. The estimated date of delivery was 24 MARCH 2014. The patient did not experience any adverse or serious adverse event during pregnancy. She was healthy at the time of this report.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information was received from a healthcare professional on 02 January 2014. This case concerns pregnant women of unknown age whose medical history and concomitant medication was not reported received two ADACEL vaccines 24 weeks apart (dose, route, form, frequency, batch number and anatomical site of administration not reported). Last menstrual period, gestational period and expected date of delivery not reported.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Petechiae
Clinical narrative: Initial report received from a healthcare professional on 19 MARCH 2013.  A 24-year-old female patient whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number: U4567AA) in left deltoid on 18 MARCH 2013. The patient had received an intradermal dose of APLISOL (Manufacturer: JHP Pharmaceuticals, batch number: 293238) in left forearm on 12 MARCH 2013. The reporter denied providing information about patient's pre-existing physician diagnosed allergies, birth defects, and illness at time of vaccination. On 19 MARCH 2013, the patient developed what appeared to be petechiae on the left forearm. The petechiae were localized to the left forearm area and had not spread to other areas of the body at time of report. Laboratory investigations and corrective treatment were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: None.  Follow-up information received from a healthcare professional on 24 MAY 2013. On an unspecified date, the patient had recovered.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from healthcare professional on 13 JANUARY 2014. A 28-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscularly first dose of ADACEL, batch number: U467BBA (anatomical site of administration was not reported) on 13 JANUARY 2014. The patient's last menstrual period and the expected date of delivery were not reported. The patient did not experience any adverse event. The reporter did not have any information regarding patient's pregnancy except was 28 weeks Intra Uterine Pregnancy now. List of documents held by the sender: None
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Incorrect route of drug administration, Pruritus, Swelling
Clinical narrative: Initial report received from a healthcare professional on 21 March 2013. The female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL vaccine (lot number "C43668A", dose number and anatomical site of administration were not reported) subcutaneously on an unspecified date. On an unspecified date, the patient received ADACEL vaccine with one inch needle subcutaneously. Thus vaccine was administered by wrong route and experienced swelling, redness and itching. The corrective treatment and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from healthcare professional on 06 January 2014. A 25-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL, batch number: C4424AA (anatomical site of administration was not reported) on 06 January 2014. The patient's last menstrual period was not reported and the expected date of delivery is 21 February 2014. The patient did not experience any adverse event. List of documents held by the sender: none.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: Initial report received from a healthcare professional on 26 March 2013. A 66-year-old female patient, who had codeine allergy and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (Lot number : U4585AA0 in left deltoid on 19 March 2013. Illness at the time of vaccination "denies" by reporter. On 20 March 2013 i.e. 24 hours after vaccination, the patient developed a lump at injection site, no bruising or bleeding. No pain at injection site lump until 25 March 2013. Laboratory investigations were not reported. As per reporter the patient did not self treat for pain. The patient's outcome was unknown. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 24 October 2013 from a health care professional: A 31-year-old female patient whose medical history and concomitant medication were not reported, received in intramuscular ADACEL (lot number C4385AA, Expiry date unknown) on 18 October 2013. It was reported that the patient was exposed during 12 weeks of pregnancy. Administration site reaction was not reported.  List of documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial report received from healthcare professional on 20 December 2013. A female patient (age unknown) whose medical history and concomitant medications were not reported received ADACEL (lot number U4046AB and expiration date unknown) intramuscularly (site and dose number not reported) on 19 December 2013. At time of vaccination (on 19 December 2013), the patient was pregnant. Date of delivery was unknown. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial report received from a healthcare professional on 31 October 2013. A pregnant female patient whose age, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number: C4426AA) on right deltoid via intramuscular route on 29 October 2013. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from nurse on 25-Nov-2013. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of ADACEL intramuscularly (lot number and site of vaccination were not reported), on 25 November 2013. On an unspecified date, after receiving vaccine the patient experienced no adverse event occurred but ADACEL given was expired and administered during pregnancy. Corrective treatment was not reported. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial spontaneous report received on 07 November 2013 from a pharmacist. A female patients whose age, medical history and concomitant medications were not reported, received a dose of ADACEL (route was intramuscular, lot # C4247AA and site of vaccination was not reported) on 07-Nov-2013. Patient is pregnant and drug exposed during pregnancy. List of documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, MMR, SMALL
Symptoms: Electrocardiogram, Encephalitis, Nuclear magnetic resonance imaging brain
Clinical narrative: Case number PHHY2013US117327 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS, reference number: 482089) website on 15 Oct 2013. This reported SAE occurred in a study and the MAH for the flu vaccine is unknown. This report refers to a 22-year-old male patient with past medical history of headaches. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 01 Oct 2012. On the same date, he was also vaccinated with ACAM2000 (other manufacturer, batch number: not reported), anthrax vaccine (manufacturer and batch number unknown) and MMR vaccine (manufacturer and batch number unknown). On 17 Oct 2012, 17 days after vaccination, he was found to have unspecified cause of encephalitis. An ECG (electrocardiogram) and MRI (magnetic resonance imaging) of the brain were not available. Troponin I result, Echocardiogram, Lumbar puncture and MRI of the spinal cord and heart were not performed. The patient had a visit to emergency room. Treatments were not reported. The patient's outcome was not reported. No further information was provided.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Blood test, Chills, Ear congestion, Fatigue
Clinical narrative: Case number PHHY2013US116488 is an initial report received via vaccine adverse event reporting system (VAERS reference number: 480090) on 15 Oct 2013. This report refers to an 52-year-old female patient. Her medical history included fibromyalgia and allergy to penicillin, BIAXIN, cats, grass, dust, pollen, ragweed, mold and cigarette smoke. Her concomitant medications were topiramate, PERCOCET, SYNTHROID, fexofenadine and clonazepam. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Dec 2012. Next day she experienced fever spikes, chills, extreme fatigue, headache, running nose, nausea and sinus and ear congestion. She had her blood work done. Symptoms persisted after 5 weeks making her bedridden. The outcome was reported was reported as condition unchanged.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pyrexia, Rhinorrhoea, Sinus congestion
Clinical narrative: Case number PHHY2013US116488 is an initial report received via vaccine adverse event reporting system (VAERS reference number: 480090) on 15 Oct 2013. This report refers to an 52-year-old female patient. Her medical history included fibromyalgia and allergy to penicillin, BIAXIN, cats, grass, dust, pollen, ragweed, mold and cigarette smoke. Her concomitant medications were topiramate, PERCOCET, SYNTHROID, fexofenadine and clonazepam. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Dec 2012. Next day she experienced fever spikes, chills, extreme fatigue, headache, running nose, nausea and sinus and ear congestion. She had her blood work done. Symptoms persisted after 5 weeks making her bedridden. The outcome was reported was reported as condition unchanged.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Fatigue, Pain, Pyrexia
Clinical narrative: Case number PHHY2013US116498 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480156) website on 15 Oct 2013. This report refers to a 46-year-old female patient. Her medical history was not reported. Her concomitant medication included pravastatin for cholesterol. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into right arm on 20 December 2012. On 22 Dec 2012, she developed fever, aches, fatigue, hoarseness, chest congestion and cough. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Case number PHHY2013US116498 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480156) website on 15 Oct 2013. This report refers to a 46-year-old female patient. Her medical history was not reported. Her concomitant medication included pravastatin for cholesterol. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into right arm on 20 December 2012. On 22 Dec 2012, she developed fever, aches, fatigue, hoarseness, chest congestion and cough. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Injection site pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Case number PHHY2013US116499 is an iniital spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480210) on 15 Oct 2013. This report refers to a 30-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly in to the right arm on 06 Nov 2012. On the same day after vaccination, she had a mild amount of discomfort. The next day, she had quite a bit of aching and soreness at the injection site which seemed similar to previous flu shots that she had received. This pain did not go away since the injection date and got worse. She visited emergency room following these events. Magnetic resonance imaging (MRI) done on 31 Dec 2012, showed no abnormalities. Outcome was reported as condition unchanged as on 04 Jan 2013. No further information about seriousness and causality was reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation, Eyelid margin crusting, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Case number PHHY2013US116503 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480235) on 15 Oct 2013: This report refers to a 61-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on 31 December 2013. On the same day after vaccination her eyes were red, irritated, watering and stuck shut in the morning. Outcome was reported as condition unchanged as on 04 Jan 2013. No further  information about seriousness and causality was reported.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Pain
Clinical narrative: Case number PHHY2013US116507 is an initial spontaneous report receive from Vaccine Adverse Event Reporting System (reference number: 480236) on 15 Oct 2013: This report refers to a 57-year-old male patient. His medical history included sinus congestion and concomitant medication was not reported. He was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on 31 Dec 2012. On 01 Jan 2013, he had lower body aches and burning leg nerves. Final outcome of the event was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Insomnia
Clinical narrative: Case number PHHY2013YS116811 is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS reference number 480311) on 15 Oct 2013. This report refers to a 37-year-old female patient. Her medical history included hypothyroidism and concomitant medications were CYTOMEL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 26 DEC 2012. On 28 DEC 2012, she had tingling and numbness at vaccination site which spread to other parts of body at different times. She also experienced chills, nervousness and difficulty in sleeping. She went to emergency room. The outcome was reported as complete recovery.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Nervousness, Paraesthesia
Clinical narrative: Case number PHHY2013YS116811 is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS reference number 480311) on 15 Oct 2013. This report refers to a 37-year-old female patient. Her medical history included hypothyroidism and concomitant medications were CYTOMEL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 26 DEC 2012. On 28 DEC 2012, she had tingling and numbness at vaccination site which spread to other parts of body at different times. She also experienced chills, nervousness and difficulty in sleeping. She went to emergency room. The outcome was reported as complete recovery.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Bed rest, Chills, Dizziness, Headache, Muscular weakness
Clinical narrative: Case number PHHY2013US116526 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480342) on 15 OCT 2013. This report refers to a 54-year-old male patient. Her preexisting conditions included medication allergies to Sulfa drugs, codeine, penn. Concomitant medications  included joint supplements, magnesium and Omega 3 (fish oil). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 04 JAN 2013. Next day she experienced fever, muscle pain, stuffy head, headache, nausea, dizziness, chills and weakness in extremities. She was advised to take Advil (ibuprofen) bed rest and if symptoms persist seek help. Outcome of the events was reported as not recovered as of 05 JAN 2013. Seriousness and causality was not reported for the events.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: Case number PHHY2013US116526 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480342) on 15 OCT 2013. This report refers to a 54-year-old male patient. Her preexisting conditions included medication allergies to Sulfa drugs, codeine, penn. Concomitant medications  included joint supplements, magnesium and Omega 3 (fish oil). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 04 JAN 2013. Next day she experienced fever, muscle pain, stuffy head, headache, nausea, dizziness, chills and weakness in extremities. She was advised to take Advil (ibuprofen) bed rest and if symptoms persist seek help. Outcome of the events was reported as not recovered as of 05 JAN 2013. Seriousness and causality was not reported for the events.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2013US116815 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480344) website on 15 Oct 2013. This case refers to 50-year-old male patient. Concomitant medication included BYSTOLIC. He was vaccinated with Influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on 08 Dec 2012. On 09 Dec 2012, after the vaccination, the patient developed pain in upper arm. Pain had increased and had affected range of motion, especially when getting dressed. The outcome of events was reported as condition unchanged as of 06 Jan 2013. The seriousness and causality of events was not reported.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Headache, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2013YS116818 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS) reference number: 480348) on 15 Oct 2013. This report refers to an 58-year-old female patient.Her medical history was not reported and concomitant medications were alendronate sodium, fish oil,  Baby aspirin, magnesium, Vitamin D3, calcium and daily vitamin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 17 DEC 2012. On 18 DEC 2012, she had extreme pain in left arm and across shoulders which was into neck and head after three weeks. She also had loss of mobility in vaccinated arm and had a lot of pain. She reported that the vaccine was given higher up to the arm almost to the shoulder which she ever had before. She could not raise her arm and could not reach across body or wash hair. She would see doctor soon. The outcome was reported as condition unchanged.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2013YS116818 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS) reference number: 480348) on 15 Oct 2013. This report refers to an 58-year-old female patient.Her medical history was not reported and concomitant medications were alendronate sodium, fish oil,  Baby aspirin, magnesium, Vitamin D3, calcium and daily vitamin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 17 DEC 2012. On 18 DEC 2012, she had extreme pain in left arm and across shoulders which was into neck and head after three weeks. She also had loss of mobility in vaccinated arm and had a lot of pain. She reported that the vaccine was given higher up to the arm almost to the shoulder which she ever had before. She could not raise her arm and could not reach across body or wash hair. She would see doctor soon. The outcome was reported as condition unchanged.
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Listless, Muscle fatigue, Oropharyngeal pain, Pain
Clinical narrative: Case number PHHY2013US117332, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480495) website on 15 OCT 2013. This report refers to a 18-year-old female patient. Her medical history included  spondyloarthritis and seasonal allergies. Her concomitant drug included CLARINEX. Her previous vaccinations included Td Adsorbed and Hepatis A on an unknown dates and had flu like symptoms with both the vaccines. She was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 04 Jan 2013. On 05 Jan 2013, she felt achy, fatigue, sore throat, listless, muscle fatigue and congestion. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Case number PHHY2013US117332, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480495) website on 15 OCT 2013. This report refers to a 18-year-old female patient. Her medical history included  spondyloarthritis and seasonal allergies. Her concomitant drug included CLARINEX. Her previous vaccinations included Td Adsorbed and Hepatis A on an unknown dates and had flu like symptoms with both the vaccines. She was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 04 Jan 2013. On 05 Jan 2013, she felt achy, fatigue, sore throat, listless, muscle fatigue and congestion. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray, Heart rate increased
Clinical narrative: Case number PHHY2013US117344 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480513) website on 15 Oct 2013. This case refers to a 33-year-old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 18 Nov 2012, in left arm. On the same day, after the vaccination the patient had fast heart rate that was present for five days. The patient went to emergency room, had chest X-ray and was given IV fluid and anxiety medications. It was confirmed that the patient did not have anxiety. The outcome of event was reported as recovered. The seriousness and causality of event was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Case number PHHY2013US117347 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480519) website on 15 Oct 2013. This case refers to a 45-year-old female patient. Her medical history included hospitalization for low blood pressure and methicillin resistant staphylococcus aureus (MRSA) pneumonia. She had allergy to latex, sulfa drugs and meperidine. Her concomitant medications included ZOSYN, LEVAQUIN, KLONOPIN, TOPAMAX, WELLBUTRIN and Estrogen. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in her right arm and pneumococcal vaccine (other manufacturer) in her left arm on 12 Dec 2012. On the same day after vaccination she developed rash, her arms swelled and fever. She had severe pain in her arms and shoulder joints. Then she had a fever of 104.7 for four days. It was reported that she was still having joint pain in her shoulder and itching in her arms. She was treated with ibuprofen 800 mg and TYLENOL. Following the events she visited emergency room. The outcome of the events was reported as recovered. The seriousness and causality assessment of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Case number PHHY2013US117347 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480519) website on 15 Oct 2013. This case refers to a 45-year-old female patient. Her medical history included hospitalization for low blood pressure and methicillin resistant staphylococcus aureus (MRSA) pneumonia. She had allergy to latex, sulfa drugs and meperidine. Her concomitant medications included ZOSYN, LEVAQUIN, KLONOPIN, TOPAMAX, WELLBUTRIN and Estrogen. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in her right arm and pneumococcal vaccine (other manufacturer) in her left arm on 12 Dec 2012. On the same day after vaccination she developed rash, her arms swelled and fever. She had severe pain in her arms and shoulder joints. Then she had a fever of 104.7 for four days. It was reported that she was still having joint pain in her shoulder and itching in her arms. She was treated with ibuprofen 800 mg and TYLENOL. Following the events she visited emergency room. The outcome of the events was reported as recovered. The seriousness and causality assessment of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Case number PHHY2013US117353 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480618) website on 15 Oct 2013. This case refers to 53-year-old male patient. The patient's medical history included type 2 diabetes mellitus, chronic obstructive pulmonary disease and hypertension. Concomitant medications included ADVAIR, albuterol, metformin and lisinopril. He was vaccinated with flu vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on 01 Nov 2012. On 01 Jan 2013, rapid flu Ag/EIA test revealed that patient was positive for influenza A. The patient went to emergency room for the event. The outcome of event was reported as not yet recovered as of 08 Jan 2013. The seriousness and causality of event was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2013US116529 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480658) on 15 Oct 2013: This report refers to a 42-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 13 Dec 2012. Next day she experienced shoulder pain, weakness, numbness and limited range of motion. She visited emergency room following these events. Outcome of the events was reported as not recovered on 08 Jan 2013. Seriousness and causality was not reported for the events.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Case number PHHY2013US116533 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 480700) website on 15 Oct 2013. This report refers to a 59-year-old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 13 Oct 2013. On 26 Oct 2012, 13 days after vaccination, she developed shingles. Outcome of the event was reported as recovered. No seriousness and causality was reported for the event.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Feeling cold, Muscle spasms, Pyrexia
Clinical narrative: Case number PHHY2013US116537 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480785) on 15 Oct 2013: This report refers to a 69-year-old male patient. His concurrent condition included COPD. Concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 08 Jan 2013. On same day, he experienced diarrhea followed by shivering, muscle spasms, felt very cold and fever. He could not get warm. Outcome of the events was reported as recovered as of 09 Jan 2013. Seriousness and causality was not reported for the events.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Joint range of motion decreased, Muscular weakness, Musculoskeletal pain, Paraesthesia
Clinical narrative: Case number PHHY2013US117358 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480852) website on 15 Oct 2013. This case refers to 51-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as seasonal influenza vaccine INN) in her right arm intramuscularly on 03 Dec 2012. On 04 Dec 2012 after vaccination she had pain in right shoulder and mid clavicle area, weakness in right arm recently in the last week. She had numbness and tingling in all fingertips of right hand (except pinky finger) especially while sleeping. She had limited range of motion in right shoulder/arm. She was treated with ALEVE morning and night without pain relief. The outcome of the events was reported as condition unchanged as of 10 Jan 2013. The seriousness and causality assessment of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117509, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480860) website on 15 Oct 2013. This report refers to female patient of unspecified age. her medical history and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date after vaccination, she experienced Guillain-Barre syndrome. The event outcome, seriousness and causality were not reported. No additional information was available.
Sex: M
Vaccine: FLUX
Symptoms: Pain, Rash
Clinical narrative: Case number PHHY2013US116619 is an initial spontaneous report from health case professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480880) website on 15 Oct 2013. This case refers to an elderly male patient. His medical history included chickenpox (at age of 10). Concomitant medication included prostaglandin. He was vaccinated with influenza vaccine (unknown manufacturer, batch number, not reported, so conservatively coded as Seasonal Influenza vaccine INN), on 13 Sep 2012. On 15 Sep 2012, after the start of vaccination, the patient developed a rash on his mid stomach and back and pain. Treatment included unspecified antiviral medication, prednisone and topical  medication. The outcome for the events was reported as recovering. The seriousness and causality of events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117361 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480883) website on 15 Oct 2013. This case refers to an adult female patient. The medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On 01 Nov 2011, the patient developed Guillain-Barre Syndrome. The outcome of event was reported as unknown. The seriousness and causality of event were not reported.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Case number PHHY2013US117520 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 480885) website on 15 Oct 2013. This report refers to a 75-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date (seven years ago). On an unknown date, after vaccination, he developed Guillain-Barre Syndrome (GBS) and was paralyzed from the waist down. He recovered from the events on an unspecified date. Seven years later he was again vaccinated with flu vaccine on an unspecified date and experienced GBS (see case PHHY2013US116616). No seriousness and causality was reported for the events.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Case number PHHY2013US116546 is an initial spontaneous report received from Vaccine Adverse Event Reporting system (reference number: 480901) on 15 Oct 2013. This report refers to a 47-year-old female patient. Her medical history included seasonal hay fever (spring allergies) and concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) in to the left arm on 04 Jan 2013. On 05 Jan 2013, she had sore throat, cough, and slight fever; followed the next morning (06 Jan 2013) by fever, body aches, headache, fatigue which persisted for 72 hours. By 10 Jan 2013, there was no fever, but congestion, cough, fatigue. Outcome was reported as condition unchanged as on 10 Jan 2013. No further information about seriousness and causality was reported.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Case number PHHY2013US116546 is an initial spontaneous report received from Vaccine Adverse Event Reporting system (reference number: 480901) on 15 Oct 2013. This report refers to a 47-year-old female patient. Her medical history included seasonal hay fever (spring allergies) and concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) in to the left arm on 04 Jan 2013. On 05 Jan 2013, she had sore throat, cough, and slight fever; followed the next morning (06 Jan 2013) by fever, body aches, headache, fatigue which persisted for 72 hours. By 10 Jan 2013, there was no fever, but congestion, cough, fatigue. Outcome was reported as condition unchanged as on 10 Jan 2013. No further information about seriousness and causality was reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Case number PHHY2013US116558 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 480914) website on 15 Oct 2013. This report refers to a 40-year-old female patient. Her concurrent condition included hypothyroidism. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 08 Jan 2013. On the same day, post vaccination she experienced extreme dizziness, vertigo and nausea. Outcome of the events was reported as not recovered as of 10 Jan 2013. Seriousness and causality was not reported for the events.