chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Initial information received from a non-healthcare professional on 04 November 2013. A female patient (whose demographics and medical history was not reported) had received a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date, the patient developed one swollen lymph node. Lab investigation and treatment medications were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a health care professional on 28 October 2013. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number UH898AD), via intramuscular (IM), (site of vaccination were not reported), on 28 October 2013. On 28 October 2013, patient received vaccine during her pregnancy. Patient did not experience adverse event. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Hypoaesthesia, Injection site pain, Nuclear magnetic resonance imaging spinal abnormal, Pain
Clinical narrative: Initial report received from a healthcare professional on 29 October 2013. A 32-year-old female patient who had no illness at the time of vaccination, no medical history and concomitant medication were not reported, had received an intramuscular dose of FLUZONE, lot number, dose number were reported) in the left deltoid on 15 October 2013. On 17 October 2013, the patient had experienced soreness at injection site, 2 days later sudden onset of pain in the left shoulder, clavicular area but a little more medial. The symptoms were progressed and patient had burning pain and numbness in the nerve distribution of the left arm. It was reported that the brachial plexus is affected and symptoms were continue to worsen. Corrective medications were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: None. Additional information received on 29-Oct-2013: Subsequent Magnetic resonance imaging (MRI) shows herniated nucleus pulposus (HNP) C5-6. Follow up information was received on 18 December 2013. At the time of report outcome of the event was recovered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Muscular weakness, Rash, Rash pruritic, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 01 November 2013. A 38-year-old female patient had intramuscularly received a dose of FLUZONE (batch number: UH895AA, dose in series was not reported) in the left deltoid on 30 October 2013. The patient had no illness at time of vaccination and had a medical history of hypertension and migraines. Concomitant medication were not reported. On 31 October 2013, few hours after vaccination the patient developed rash that developed into hives and was very itchy. No laboratory tests were done and the patient had received Medrol dose pack as corrective treatment. At the time of this report, the patient was not recovered. It was reported the patient was not recovered. It was reported the patient required ER/doctor visit. List of documents held by sender: None. Follow information received on 06 January 2014. The patient rash was resolving and had developed headache and weakness in arm on an unspecified date. The FLUZONE vaccine expiry date was 30 June 2014. The patient had a history of chills/rigors, vertigo, nausea and headache. The patient had taken flu shot before. The patient was currently married and had 2 sons. The patient smokes every day. The patient had a surgery of dilation and curettage. The patient did not have any severe life threatening allergy to eggs, had no Guillain-Barre Syndrome (within 6 weeks of previous flu vaccine), the patient never had a severe reaction to the flu vaccine and the patient was not ill with a fever greater than 100 degree. The patient's father had a medical history of Alzheimer's disease and cerebrovascular accident CVA (stroke). The patient' mother had a medical history of Diabetes and CAD Coronary artery disease. On an unspecified date the patient's physical examination was done that included: The patient constitutional was normal (well developed), ear: normal, respiratory was normal (inspection, efforts and auscultation was normal), cardiovascular was normal (regular rate and rhythm, no murmurs, gallops or rubs), vascular was normal (pulses, Dorsalis pedis was normal), Abdomen was normal (inspection, auscultation was normal and no abdominal tenderness), skin was red diffuse, patch slightly raised across abd and extremity was normal (no edema). Vital signs included: The patient was 89.811 kg, blood pressure was 128/86 mm/hg and pulse was 60beats/min. The patient received orally Prednisone (0.5mg/kg) 20mg, every day for 4 days, metoprolol tartrate (orally 100mg tablet 1 times every day with meal), Hydrochlorothiazide (orally 25 mg tablet every day), Lisinopril (orally 40 mg 2 tablet every day), Triamcinolone Aceonide (thin film of 0.1% was applied to the affected skin areas 1 to 2 times every day), ZYRTEC (orally 10 mg tablet every morning), FIORICET (50mg-325mg-40mg, one tablet by oral route every 4 hours as needed not to exceed 6 tablets per 24 hours) and BENADRYL. Follow up information received on 07 February 2014. The event of rash was resolved on 06 November 2013 and the reporter had no record of weakness in arm.
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Axillary pain, Dry mouth, Musculoskeletal chest pain, Neck pain
Clinical narrative: Initial case was received from a healthcare professional on 30 October 2013. This cluster case of two female patients of unknown age whose medical history and concomitant medications were not reported had received FLUZONE (batch number UH907AB, dose and site of administration not reported) on an unspecified date. On an unknown date, the one of the patients reported that they couldn't leave their home without difficulty" and experienced pain that was not at the injection site rather more concentrated under the arm. They claimed the patient felt feverish (temps not taken), the pain moved up into the neck and even went into the side of the body long the rib cage. They also complained of severe dry mouth. No laboratory details were reported. The event outcome was not reported. The list of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial case was received from a healthcare professional on 30 October 2013. This cluster case of two female patients of unknown age whose medical history and concomitant medications were not reported had received FLUZONE (batch number UH907AB, dose and site of administration not reported) on an unspecified date. On an unknown date, the one of the patients reported that they couldn't leave their home without difficulty" and experienced pain that was not at the injection site rather more concentrated under the arm. They claimed the patient felt feverish (temps not taken), the pain moved up into the neck and even went into the side of the body long the rib cage. They also complained of severe dry mouth. No laboratory details were reported. The event outcome was not reported. The list of documents held by sender: None.
Age: 0.9
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 02-Oct-2013: The 11-months-old patient received FLUZONE 0.5 ml. No adverse event was reported. Lists of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 October 2013. A 6 months old patient had received FLUZONE. The patient received 0.5 ml dose instead of 0.25 ml. No adverse event was reported. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Initial medication error report received on 04 October 2013 from a nurse. A 3 years old unknown patients whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unspecified date. Nurse reported that she gave 7 children over the age of 3 0.25ml instead of 0.5ml. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 10 OCT 2013, 9 patients were treated with expired FLUZONE ID . No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: None.
Age: 5.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial report received from a healthcare professional on 08 OCTOBER 2013.  A 5 year old patient had received 0.25 ml FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: None.
Age: 55.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a nurse on 02-OCT-2103. The 55-years-old patient had received FLUZONE 0.25 ml. No adverse events was reported. List of documents held by sender: None.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial report received from a healthcare professional  on 17 OCTOBER 2013.  A 9-year-old female patient had received a dose of FLUZONE (batch number: UA780AA, dose number was not reported) intramuscularly in deltoid on 24 OCTOBER 2013. The patient had no illness at time of vaccination. The patient had medical history of asthma, rhinitis and allergy to Singulair and concomitant medications was not report4ed. On 15 OCTOBER 2013, one day of vaccination, the patient developed redness and itching at injection site. Laboratory tests and corrective treatments were not reported. At the time of this report the outcome was unknown. List of documents held by sender: None.   Follow-up information received from a healthcare professional on 20 JANUARY 2014. On an unspecified date, the patient had recovered from the event. The physicians address was updated. The patient had not received any other vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 14 OCTOBER 2013. The patient had received FLUZONE. Nurse gave an expired dose from last season. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: None.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial report received from a consumer (the patient's parent) on 18 OCTOBER 2013. A 07-years-old female patient (date of birth 23 August 2006), whose medical history and concomitant medications were not reported, had received intramuscular dose of FLUZONE (batch number unknown, anatomical site of administration was not reported) on "Oct 2013" or "Oct 2012". On 13 October 2012, it was reported that the patient developed into full blown hives. The patient treated with oral Benadryl as a corrective treatment. Physician stated this will probably flare up for the next 2-3 weeks. Lab details were not reported. The outcome was unknown. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 OCTOBER 2013. The patient had received FLUZONE. Patient's age was less than 3 years. The patient received 0.5 ml dose instead of 0.25 ml. No adverse event was reported. List of documents held by sender. None.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial report received from a non-healthcare professional on 08 October 2013. Two patients had received a dose of FLUZONE, (batch numbers- UH898AD and UH899AA, site of administration not reported) intramuscularly on an unspecified date of September 2013. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patiens complained of soreness when it was being injected and for 2 days after. Laboratory details and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from the healthcare professional on 28 January 2014. The case was medically confirmed in follow up. The patient recovered on an unspecified date. The patient was vaccinated at private doctor office/hospital. Any other vaccination prior within 4 weeks prior to an unspecified date in September 2013 was reported as "NA".
Age: 1.8
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial medication error report received on 01 OCTOBER 2013 from a health care professional (nurse). A 20 months old unknown patients whose gender, medical history and concomitant medications were not reported,, received a dose of FLUZONE (route, lot # and site of administration was not reported) on an unspecified dare. Nurse gave expired dose to 20 months old patient. Lost of documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial medication error report received on 04 OCTOBER 2013 from a nurse. A 5 month years old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unspecified date. Nurse was given to 5 month old patient. List of documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Heart rate increased, Scab
Clinical narrative: Initial report 5received from a non-health care professional (consumer) on 16 OCTOBER 2013. A 47-year-old male patient, with history of allergy to procaine and cortisone, had received a dose of FLUZONE, in left deltoid region on 14 OCTOBER 2013 (batch number and route of administration were not reported). It was reported that, on 05 OCTOBER 2013 the patient experienced 1/8" diameter redness, scab will not heal for 2 weeks. The patient got dizzy a couple of times, heart ped up 3-4 times the first week after the vaccine, now resolved. Correction treatment was not reported.   At the time of this report, the patient was not recovered from the event. Documents  held by sender: None.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Pruritus, Rash
Clinical narrative: Initial report received from a healthcare professional on 08 OCTOBER 2013.  A 05-year-old male patient had received a dose of FLUZONE (batch number, dose number and site of administration was not reported on 27 SEPTEMBER 2013.  The patient had sore throat at the time of vaccination and had medical history of Autism, allergy to PCN and Suprex and concomitant medication was not reported. On 2 October 2013, five day after vaccination, the patient developed itching and on an unspecified date after 8 days of vaccination the patient developed rash.  Laboratory tests were not reported and the patient had received Benadryl mg Q 4 hr as corrective treatments.  On an unspecified ate, the patient had recovered. List of documents held by sender: None. Follow up information received from the healthcare profession on 28 January 2014. The case was medically confirmed in follow up. The patient date of birth was 20 December 1996. The patient had no illness at time of vaccination. On an unspecified date, after 6 days of vaccination the patient had developed rash on neck (previously the event rash was reported). The patient had received an intramuscular dose of FLUZONE vaccine (batch number: UH904AA) in the left arm on 17 September 2013. The patient had received an intramuscular dose of Hepatitis A vaccine.  (manufacturer other, batch number: 5J5HT) in the left arm on an unspecified date. No laboratory investigations were done. The number of brothers and sisters was reported as 2. The patient was vaccination in private doctor office/hospital. The patient did not receive any other vaccination prior within 4 weeks prior to 27 September 2013.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 14 October 2013. A 03 year-old male patient, whose illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects were unknown, had received an intramuscular dose of FLUZONE (batch number: UH899AE) in the left deltoid on 12 October 2013.  (Expiry date: 14 JUNE 2014, dose number was not reported).  Patient had previously received many doses of influenza vaccine. On 13 October 2013, the patient developed swelling, heat and induration of 14 by 7 cm in diameter in the left arm. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Initial medication error report received on 11 October 2013 from a pharmacist. A 2 year old unknown patients whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot # and site of vaccination was not reported) on an unspecified date. Patient was administered 0.5ml instead of the 0.25ml. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Initial misuse report received on 04 October 2013 from a doctor. A patient whose gender, age, medical history and concomitant medications were not reported, received FLUZONE (route, lot number and site of vaccination not reported) on an unspecified date.  Patient received less than 0.5 ml of FLUZONE. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 07-Oct-2013.  A 9-month old patient (gender unknown) had received FLUZONE (batch number: unknown, dose number and site of administration not reported) on 25 SEP-2013. The patient's medical history was unknown. The patient had no illness at the time of vaccination and concomitant medications. Patient did not have minimum internal between doses. No laboratory tests were performed and corrective treatments were not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Needle issue, Underdose
Clinical narrative: Initial misuse report received from a health care professional on 03 OCT-2013. A patients who gender, age, medical history and concomitant medications were unknown, received a dose of FLUZONE (lot number, route and site of vaccination were unknown) on an unspecified date. The needle was leaked and patient did not get full dose. List of documents held by sender: none.
Age: 2.6
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 October 2013. A 31 month old child patient had received FLUZONE adult dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 08 October 2013.  The patient had received FLUZONE 0.1 mg intradermal. No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: None.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 08 October 2013.  The female patient had received unstable FLUZONE and ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Initial misuse report received from a health care professional on 03-OCT-2013. A patients whose gender, age, medical history, and concomitant medications were unknown, received a doe of FLUZONE (lot number, route and site of administration were unknown) or an unspecified date. When the patient pulled away FLUZONE vaccine, it caused half of the dose to run down the arm. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Initial medication error report received on 09 October 2013 from a Nurse. A patient's whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unspecified date.  Nurse inadvertently administered 0.25 ml to adult patient instead of 0.5 ml dose. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial medication error report received on 08 October 2013 from a pharmacist. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (route was intravenous, lot number and site of vaccination was not reported) on an unspecified date.  The dose was given IV, Intravenous. Also reported that before and we are unaware of any associated adverse events. However, probably no immune effect will take place.  Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 08 October 2013. A child patient received 0.5 ml FLUZONE instead of 0.25 ml. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial medication error report received on 09-OCT-2013 from a pharmacist. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. Pharmacist reported that patient received the FLUZONE vaccine twice in the same flu season. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial report received from a reporter on 07-Oct-2013.  A unknown-year-old patient (gender unknown) had received FLUZONE (batch number: unknown, dose number and site of administration not reported) on an unknown date. The patient's medical history was unknown. The patient had no illness at the time of vaccination and concomitant medications. Expired FLUZONE vaccine was administered to patient and patient did not have any adverse event. No laboratory tests were performed and corrective treatments were not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: InInitial misuse report received from a nurse on 14 October 2013. The patient had received FLUZONE HD. The patient was given expired FLUZONE HD from MDV. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender. None.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Underdose
Clinical narrative: Initial report received from a healthcare professional on 10-OCT-2013. 4 employees received 0.25 ml dose instead of 0.5 ml dose of patients were treated with expired FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.3
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a pharmacist on 03-October-2013. The 3-month-year old patient had received FLUZONE. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a pharmacist on 14 October 2013.  The patient had received FLUZONE. Pharmacist claims dose was administered more subcutaneously than intramuscularly on a large patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.4
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 14-October-2013. The 4-months-old patient had received FLUZONE 0.25 ml. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare profession on 14 October 2013.  The child patient had received FLUZONE two doses series last year and inadvertently received an extra dose this year. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial medication error report received on 09-OCT-2013 from a nurse. A 8-year-old patients whose gender, medical history and concomitant medications were not reported, received dose of FLUZONE (lot number, route and site of vaccinations was not reported) on an unspecified date. Pharmacist reported that patient took FLUMIST instead of FLUZONE. List of documents held by sender: none.
Age: 0.7
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received from physician on 11-OCT-2103. 7 month old had one dose of FLUZONE and another 12 days later. No further relevant information reported.
Age: 0.3
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a pharmacist on 02-Oct-2013. The 03-months-old patient had received FLUZONE (dose unknown). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received on 02 October 2013 from a health care professional. An adult, whose medical history and concomitant medications were not reported, received a dose of FLUZONE. It was reported that adult patient received 1.0 ml of FLUZONE instead of 0.5 ml. No reaction was reported. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Initial misuse report received from a patient's mother to nurse on 02-Oct-2013. The 03-years-old patient had received FLUZONE (dose unknown) intramuscular (IM). No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: Medication error, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 14-October-2013. The 5-months-old patient had received FLUZONE. No adverse event was reported. List of documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Initial report received from a reporter on 07-Oct-2013. A unknown-year-old patient (gender unknown) had received FLUZONE (batch number: unknown, dose number and site of administration not reported) on an unknown date. The patient's medical history was unknown. The patient had no illness at the time of vaccination and concomitant medications. FLUZONE was administered to patient that was exposed to high temperatures for 90 hrs making it unacceptable for use. No laboratory tests were performed and corrective treatments were not reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Initial spontaneous report received on 08-OCT-2103 from a nurse. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. Nurse reported that patient administered 1.25 ml dose to adult instead of 0.5 ml dose. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 09 October 2013.  A 3 year old child patient had received FLUZONE a 0.25 ml dose instead of a 0.5 ml dose. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial misuse report received on 10 October 2013 from a nurse. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received FLUZONE ID.  As of unknown date, patient was adm to a 60 years old. No safety or immunogenicity under 65. Review PI for AER that occurred in the cl trials. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Initial report received on 01 November 2013 from a health care professional. A 57 year old female patient, medical history and concomitant medications were not reported, received a dose of FLUZINE (lot # UH900AD) intramuscular at left deltoid on 24-OCT-2103. It was reported that a patient had localized reaction shortly after (24-OCT-2013) vaccination with FLUZONE. Event was resolved. List of documents held by sender:  none.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 October 2013. The patient had received first dose of FLUZONE at one pharmacy and another dose at another pharmacy. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received on 17  October 2013 from a pharmacist. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient should receive high dose of FLUZONE. As of 17 October 2013. Patient did not have any adverse events. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 05 November 2013.  A 10 year old male child received dose of FLUZONE at left deltoid on 03 November 2013. On the same day, patient experienced nausea and fever, patient had sever does of FLUZONE previously. It ws reported that, evens lasted for 24 hours. List od documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 October 2013. The patient had received expired FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial report received from Nurse on 08-Oct-2013. The patient had received ADACEL (lot number, route and site of vaccination were not reported). (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Initial report received on 06 November 2013 from a health care professional. An unknown  age pf female patient, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot # unknown) intramuscular on an 17 October 2013. It was reported that a patient had local reaction unspecified systems with FLUZONE. Patient also had FLUZONE last year. Event outcome was unknown at the time of report. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial medication error report received from a physician on 05 November 2013. The 03 year old unknown gender patient received FLUZONE 0.25 ml (lot # was unknown) at unknown site on 04-Nov-2013. (No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Initial report received on 06-November-2013 from a health care professional. A 10-year-old male patient whose medical history included attention deficit hyperactivity disorder (ADHD) and concomitant medications were not reported, received a dose of FLUZONE (lot number U4789AA) via intramuscular route at left deltoid on  06-Nobember 2013. On 06-November-2013, 1 hour post vaccination the patient experienced headache. Corrective treatment included ibuprofen. At the time of this report the outcome of  headache was resolving. List of documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 08-November-2013. A 46-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number unknown) via intramuscular route (site of vaccination not reported) on 08-October-2013. On 08-October-2013, the patient experienced arm pain, which progressed to a numbness in the arm. The patient reported that she felt the vaccine was administered too low and may have gone into the tissue and not the muscle. Corrective treatment was not reported. At the time of this report the outcome of events was not resolved. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional on 06 November 2013. A 57-year-old female patient whose concomitant medications were not reported, received a dose of FLUZONE (lot number: UH908AA, expiry date: 30 June 2014) on right arm via subcutaneous route on an unspecified date in October 2013. Patient stated that FLUZONE administered subcutaneous instead of intramuscular. Patent stated that over 3-4 days after vaccination in the right arm developed a 2-3 inch in diameter red inflamed area, and warm to touch at site of injection. The events (vaccination site inflammation and vaccination site warmth) were resolved.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise
Clinical narrative: Initial report received from non-healthcare professional on 07 November 2013. A female patient (age unknown) whose medical history and concomitant medications were not reported received FLUZONE (lot number unknown and expiration date unknown)(route, site and dose number not reported) on an unknown date. On an unknown date, the patient experienced severe pain at injection site and she did not feel well for 2 days. Laboratory investigation and corrective treatment were not reported. As of this report, event outcome ws unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial information reported by consumer on 18-SEP-2013. An unknown age of female patient with unknown medical history and concomitant medication received unknown dose of FLUZONE (lot # and expiration date was unknown), intramuscular. Patient experienced pain with intramuscular flu shot. Event outcome was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 06 November 2013.  An unknown age and gender patient received dose of FLUZONE at unknown site and on an unknown date. Reporter mentioned that they had 3 year and 3 month old baby they gave it to but gave the baby the dose for 6/month to 35 month.   As of 06-NOV-2013, no adverse event reported. Documents held by sender: none.
Age: 0.6
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received on 14 October 2013 from a health care professional. A 6 months old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date.   It was reported that a patient who was 6 months old received 0.5 ml dose instead of age appropriate for 0.25 ml dose. As of 14 October 2013, the patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 02-OCT-2013. The patient had received last year's FLUZONE (dose unknown). No adverse event was reported. List of documents held by sender: none.
Age: 15.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 October 2013. The 15 year old patient had received FLUZONE. Nurse reported that 0.25 ml vaccine was administered to patient instead of 0.5 ml. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a none-healthcare professional on 04 October 2013. The patient had received FLUZONE. The patient received FLUZONE in gluteal area.  (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 09 October 2013. A kid patient had received FLUZONE a 0.25 ml dose instead of a 0.5 ml dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a pharmacist on 03-October-2013. The 1-year-old patient had received a full dose of FLUZONE  0.5 ml. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial report received from office person medical assistant on 10-Oct-2013. 5 patients received unstable FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial medication error report received from a healthcare professional on 11 October 2013. Several patients had received FLUZONE which was expired on 03 April 2013. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional on 10 October 2013. A female patient whose, date of birth, age at the time of vaccination, medical history and concomitant medication were not reported, had received 0.5 ml of FLUZONE (batch number, dose number, anatomical site of administration were not reported on unspecified date. On unspecified date, the arm was more swollen than normal at location and lasted for a few days. Corrective treatments and laboratory investigations were not reported. At the time of this report the patient was recovered from the event. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: Initial report received from a consumer on 16-Oct-2013. A patient received FLUZONE (lot # and expiration date unknown). It was reported that the pharmacist injected high does flu shot intradermal rather than intramuscular. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 11 November 2013.  A 66-year-old female patient who medical history of Anemia, Hereditary peripheral neuropathy and muscles flinch and concomitant medication were not reported, but received an intramuscular dose of FLUZONE (lot number: UH920AC3, expiry date: 30 June 2014, dose number not reported) in the right deltoid and received a dose of Pneumococcal 23 Vaccine (manufacturer: MSD, lot number, dose number and route of administration were not reported) in the right arm, both on 16 October 2013. On 17 October 2013, the patient had sore arm and was sick after vaccination of flu shot. Laboratory investigations and corrective medications were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site mass, Injection site pain
Clinical narrative: Initial information reported on 08-Nov-2013. A 51  year old female patients whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number UH920AC, expiry date unknown) intradermal at left deltoid on 11-Jul-2013. Patient experienced large lump at injection site that was painful to touch and some fluid lead from injection site. List of documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from consumer on 11 November 2013. A female patient (age unknown) whose medical history and concomitant medications were not reported received fourth dose of intramuscular FLUZONE intramuscularly (batch number unknown) (frequency, dose and site of administration not reported). The patient received FLUZONE during pregnancy. The patient had no adverse event. Her estimated date of delivery 15 December 2013. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Age: 3.6
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: initial misuse report received from a healthcare professional on 01 November 2013. The 3.5 year old (41 months) patient had received incorrect does of FLUZONE (lot # and expiration date unknown) that was 0.25 ml in October. (No information was provided regarding the patient). N adverse event was reported. List of documents  held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from healthcare professional on 18 October 2013. A 03-year-7-month old patient received 0.25 ml dose of FLUZONE instead of 0.5 ml (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 06 November 2013. The 4-months-old patient had received FLUZONE 0.25 ml intradermal (site not provided). Reporter stated that 0.25ml dose administered to a 4 month old patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 11 November 2013. The 2 months old patient had received 0.25 ml FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 07 November 2013. The 2 and half-years-old patient had received FLUZONE 0.5 ml intradermal (site not provided). Reporter stated 2 1/2 year old was given 0.5ml dose of FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 08 November 2013. A 14-year-old patient received last year's FLUZONE 0.25 ml. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 1.3
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 07 November 2013. A 15-month-old patient received last year's FLUZONE 0.5 ml. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 07 November 2013. The 2-years-old patient had received FLUZONE 0.5 ml intradermal (site not provided). Reporter stated that 2 year old 9 month was given 0.5ml dose in early October. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 1.7
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 06 November 2013. The 21-months-old patient had received FLUZONE 0.5 ml intradermal (site not provided). Reporter stated that 21 months old received 0.5 ml dose instead of 0.25 ml age appropriate dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 2.3
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 November 2013. On unspecified date a 28-months-old male patient received second dose of FLUZONE earlier that what should have been scheduled date. Should have been administered one month after the first dose but was given 21 days after dose first dose. It's an inappropriate schedule of vaccine administered. No adverse event was reported. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from health care professional on 16 Oct 2013. This case is linked to case number 2014SA044360. A 3.5 year old patient had received 0.25 ml dose of FLUZONE instead of 0.5 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare profession on 11 November 2013. On unspecified date at 3 year patient received 0.25 ml of FLUZUNE instead of 0.5 ml. Incorrect dose was administered. No adverse event was reported. List of documents held by sender: none.