chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 30 October 2013 and the case was received on 21 March 2014. A 8-year-old patient (gender was not provided) had received a dose of FLUZONE on an unspecified date. It was reported that the FLUZONE was projected out of the site immediately on administration to a child. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 29 Oct 2013. It was reported that pediatric patient had received second dose of FLUZONE at 20 days instead of 30 on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 22 October 2013. The cases were received on 21 Mar 2014. A 67-year-old female patient received FLUZONE (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Initial report received from a healthcare professional on 01 November 2013. A 59-year-old female patient who had diabetes at the time of vaccination and no known allergies, had received an intradermal first dose of FLUZONE ID (lot number: UT4721BA) on 19 September 2013. On 19 September 2013, the patient reported palm sized area of redness was at injection site day of vaccination, now has 1cm slightly tender nodule at site. Laboratory investigations and corrective medications were not reported. At the time of this report the patient did not recover from the event. Documents held by sender: None. Follow-up information was received from the healthcare professional on 07 August 2014. No new information was reported. Documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 October 2013. The case was received on 21 March 2014. 3 years and 5 months old patient had received FLUZONE 0.25 ml instead of 0.5 ml. 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 misuse report received from a healthcare professional (nurse) on 25 October 2013 and the case was received on 21 March 2014 at GPV. 2 patient (date of birth and gender was not provided) had received dose of expired FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 1.4
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 16 Oct 2013 and on 21 March 2013. A 1.5 year old patient had received a 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 18 October 2013 and the case was received on 21 March 2014. A 04-month-old patient (gender was not reported) had received a dose of FLUZONE (batch number, route and site of administration was not reported) on 17 October 2013. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. This case is link with case: 2014SA044587 with same product and same reporter. A 04 years old patient, received 0.25 ml dose of FLUZONE (no other 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 misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. It was reported FLUZONE was administered 0.25 ml to 5 year old instead of 0.5 ml dose. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from health care professional on 25 Oct 2013. It was reported that under age of 3 years patient had received 0.5 ml dose of FLUZONE instead of 0.25 as a first dose on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 October 2013. The cases were received on 21 March 2014. It was reported that 2 year-old patient had received 0.5 ml dose of FLUZONE. No adverse event was reported. List of documents held by sender: none.
Age: 0.7
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 22 October 2013. The cases were received on 21 March 2014. A 08-month-old patient received 0.5 ml dose of FLUZONE (no other 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 misuse report received from healthcare professional on 25 October 2013. The cases were received on 21 March 2014. An expired dose of FLUZONE was administered (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 October 2013 and on 21 March 2014. A patient of less than 06-months-old of unknown gender had received FLUZONE intradermal. The patient received FLUZONE at an incorrect age. No adverse event was reported. The list of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 16 OCT 2013. Cases were received on 21 March 2014. A patient whose demographic details, medical history and concomitant medication were not reported receivd a 0.25 ml dose of FLUZONE on unspecified date. (Route, site, dose and Batch number not reported). It was reported that on an unspecified date patient received an incorrect dose of vaccine. Laboratory investigation were not reported. 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 misuse report received from a healthcare professional on 22 October 2013. The cases were received on 21 March 2014. A patient had received FLUZONE. It was reported that the patient received expired vaccine which was expired last year (no other information was provided regarding the patient). 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 case was received from a healthcare professional on 31 OCT 2013. Cases were received on 21 March 2014. A 3-year-old patient whose demographic details, medical history and concomitant medication were not reported received a 0.25 ml dose of FLUZONE on unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an incorrect dose of vaccine. Laboratory investigation were not reported. 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 from a healthcare professional on 18 October 2013. The cases were received on 21 March 2014. A baby patient received 0.5ml dose of FLUZONE (no other information was provided regarding the patient). 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 case was received from a healthcare professional on 29 OCT 2013. Cases were received on 21 March 2014. A child patient whose demographic details, medical history and concomitant medication were not reported received a 0.5 ml dose of FLUZONE on unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received incorrect dose 0.5 ml instead of 0.25 ml. Laboratory investigation were not reported. 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 healthcare professional on 21 October 2013. The cases were received on 21 March 2014. The patient received intramuscular dose of FLUZONE but most amount of vaccine ran down (no further information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 16 OCT 2013. Cases were received on 21 March 2014. A 3-year-old patient whose demographic details, medical history and concomitant medication were not reported received a FLUZONE vaccine on 08 Oct 2013 (route, site, dose and batch number not reported). It was reported that on 08 Oct 2013 patient received an extra dose (two flus) of vaccine. No adverse event was reported. List of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from health care professional on 29 Oct 2013 and on 21 March 2013. It was reported that female patient (age not reported) had received a dose of FLUZONE on 15 October 2013 and stated that large amounts of fluid flowed down her arm. 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 misuse report received from a healthcare professional on 17 October 2013. The cases were received on 21 March 2014. A patient had received FLUZONE on unspecified date. It was reported that patient received expired dose of vaccine (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a non-healthcare professional (consumer) on 24 October 2013 and the case was received on 21 March 2014. A female patient (date of birth was not reported) had received second dose of FLUZONE (batch number, route and site of administration was not reported) on 18 October 2013. The patient had received first dose of FLUZONE on 01 October 2013. It was reported that the 2 doses should be administered one month apart. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Decreased appetite, Headache, Nausea
Clinical narrative: Initial report received from a nurse on 01 November 2013. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (Lot number UH894AA, route and site of vaccination were not reported), on 30 October 2013. On 30 October 2013, after receiving vaccine the patient experienced headache, no appetite, nausea, and stomach cramping. At the time of this report the outcome of adverse events were not recovered. Documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 23 October 2013 and the case was received on 21 March 2014. A 26-month-old patient (gender was not provided) had received first dose of 0.5 ml of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 06 December 2013. A 07-year-old female patient had received an intramuscular dose FLUZONE QIV (batch number and dose in series was not reported) in the left thigh on 05 December 2013. The patient had no illness at time of vaccination and had a medical history of seasonal allergies. Concomitant medications were not reported. On 06 December 2013, the patient developed a red area on the left thigh (area is 5cm in diameter and elevated 2 inches). No laboratory tests were done and corrective treatments were not reported. At the time of this report the patient did not recover. List of documents held by sender: None. Follow up information was received on 24 February 2014: It was updated that the patient was recovered from the event of red area on the left thigh; area is 5cm in diameter and elevated 2 inches. The vaccine was administered at private doctor's office/hospital. This adverse event was reported to the manufacturer.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Initial report received from healthcare professional on 03 October 2013. A 68-year-old male patient, had received second dose of FLUZONE (batch number UH888AA, route not reported in the deltoid) on 10 September 2013. The patient had diabetes mellitus, closed head injury and migraine as medical history and had received Ca channel blocker, aminoglycosides and migraine agents. On 02 October 2013 the patient was feeling dizzy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome of the adverse event was not reported. Documents held by sender: none. Addendum: 14 January 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. Follow-up information received on 04 November 2013 (not entered previously) was added. The patient was treated with meclizine for dizziness. "The physician assessed it as unrelated". Follow-up information received from a healthcare professional on 24 February 2014: It was reported that the patient and doctor had spoken and it was determined to be unrelated. The patient used meclizine for 3-4 doses.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Malaise
Clinical narrative: Initial report received from a healthcare professional on 03 September 2014. A female patient (age reported as 46 or 47 years), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number-U4669EA, dose number, route and site of administration not reported) on an unknown date in 2013. On an unknown date in 2013 after vaccination, the patient experienced large, swollen, red area of upper arm with hard lump at injection site and felt "sick". It was reported that patient was recently diagnosed with gluten allergy; and patient stated that when she felt "sick" after vaccination, it was the same kind of "sick" she feels if eats food with gluten ingredient. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient outcome was recovered on an unspecified date. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Initial report received from healthcare professional (pharmacist) on 17 February 2014. A 40-year-old male patient had received a dose of FLUZONE, (batch number UH908AA, dose number not reported) intramuscularly in left deltoid on 28 January 2014. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not provided. On 11 February 2014, the patient presented injection site pain for about 5 hours after injection, and left deltoid area hurt whenever he moved his arm. The patient had stopped, but reoccurred 2 weeks later. No laboratory investigations were performed and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Malaise, Pyrexia, Vomiting
Clinical narrative: Initial report received from a pharmacist on 24 July 2013. A 60 years old five adult patients, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (Lot number UH889AA, route and site of vaccination were not reported). On an unspecified date between August 2013 and October 2013. On an unspecified date, after receiving vaccines the patient experienced malaise, chills, fever and vomiting. Complementary investigation was reported as 'NA' and corrective treatment was not reported. At the time of this report the outcome of adverse event was recovered. 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 14 October 2013. The four month old patient had received FLUZONE 0.25 ml dose. This would be an invalid dose per Centers for Disease Control and Prevention (CDC) and if the child requires the dose flu series then it may be initiated when the child turns six months old. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain, Skin burning sensation, Tremor
Clinical narrative: Initial report was reported by healthcare professional on 03-Dec-2013: A 18 year old female, medical history and concomitant medication were unknown, received dose of FLUZONE at unknown anatomical site intramuscular in 2012. Patient developed general malaise and progressed to hurting all over, shakes and burning sensation of her skin. Events were for lasted for one - two hour and resolved at the time of report. Documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 23 January 2014: A male patient in late 50s had received an intramuscular dose of FLUZONE, (lot number: UH752AB, expiration date: 30 June 2013, dose number and site of vaccination not reported) on an unspecified date of 2012. The patient has had flu vaccines in previous years. The patient's illness at the time of vaccination, pre-existing medical conditions were unknown and concomitant medications were unknown. On an unspecified date of 2012, the patient presented hives all over. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 07 April 2014: A 52-year-old patient had received 0.5 ml intramuscular dose of FLUZONE on 06 November 2012 in left deltoid. On an unspecified date, within 24 hours of flu shot, the patient developed rash. He went to emergency room on 06 November 2012 and was given steroid shot and oral prednisone. The patient followed up with his doctor who tapered prednisone dosage. The patient was suggested allergy patch testing at allergist or top get a shot at allergist to verify if it continues to be a problem. No laboratory test were done. Patient's medications include pravastatin 10 mg daily and multivitamin one daily.
Age: 0.6
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 May 2014. A 03-month-old patient received 0.25 ml dose of FLUZONE. (No other information ws provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 18 September 2013. Three patients received less than 0.5 ml dose of FLUZONE due to leakage from luer lock hub with Ter sumo safeguard 25 GA 1" needle. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial report received on 20 September 2013 from a consumer. this case is one of two cases reported by the same reporter, who each experienced adverse events following administration of FLUZONE HD Lot # UT761AA. The reporter in this case was also the reporter for case # 2013-09720. A 69 year old female was vaccinated on 12 September 2013 intramuscularly into the left deltoid with FLUZONE HD, lot # reported as UT761AA and to be confirmed. The reporter denied that the patient had any illness at the time of vaccination or any pre-existing allergies or medical conditions. On 12 September 2013, time not specified, the patient experienced redness and pain at the injection site. The patient was evaluated by a physician, date not reported and was prescribed BACTRIM DS, dose and route not reported. The reporter stated that the patient's condition has improved. Laboratory tests were not reported. The patient outcome was reported as unknown. Documents held by sender: None
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial report received on 20 September 2013 from a consumer. This case is one of two cases reported by the same reporter, who each experienced adverse events following administration of FLUZONE HD Lot # UT761AA. The reporter in this case was also the reporter for case # 2013-09719. A 76 year old female was vaccinated on 16 September 2013 with FLUZONE HD, lot # reported as UT761AA (to be confirmed) intramuscularly into the left deltoid. The patient's medical history was reported as allergies to sulfa drugs, hypothyroid and hyperlipidemia. The reporter denied that the patient had any illness at the time of vaccination. On 16 September 2013, time not specified, the patient experienced redness and pain at the injection site. The patient was evaluated by a physician, date not reported and was prescribed CIPRO, dose and route not reported. The reporter stated that the patient's condition has improved. Laboratory tests were not reported. No further details were available at the time of this report. The patient outcome was reported as unknown. Documents held by sender: None
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling hot, Headache, Heart rate increased
Clinical narrative: Initial report received from a consumer on 25 September 2013. A male patient (date of birth 02 December 1946, age at the time of vaccination was not reported), whose medical history and concomitant medications were not reported, had received intramuscular dose of FLUZONE HD (batch number: unknown, anatomical site of administration was not reported) on 24 September 2013 at 2 PM. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) where unknown. On 24 September 2013 at 10 PM, the patient experience shaking chills with teeth chattering for 1 hour, headache and myalgia in legs and abdomen. He felt hot with increased pulse of 100 and felt weak, muscle aches, mild chills. Complementary investigations and laboratory data were not reported. As of 25 September 2013, the outcome  was  not reported. As of 25 September 2013, the outcome was not recovered. Documents held by sender: none
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Myalgia, Tremor
Clinical narrative: Initial report received from a consumer on 25 September 2013. A male patient (date of birth 02 December 1946, age at the time of vaccination was not reported), whose medical history and concomitant medications were not reported, had received intramuscular dose of FLUZONE HD (batch number: unknown, anatomical site of administration was not reported) on 24 September 2013 at 2 PM. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) where unknown. On 24 September 2013 at 10 PM, the patient experience shaking chills with teeth chattering for 1 hour, headache and myalgia in legs and abdomen. He felt hot with increased pulse of 100 and felt weak, muscle aches, mild chills. Complementary investigations and laboratory data were not reported. As of 25 September 2013, the outcome  was  not reported. As of 25 September 2013, the outcome was not recovered. Documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case is a part of 2 cluster cases and is linked with 2013SA097330 (same reporter, same product lot number). Initial report received from a healthcare professional on 18 September 2013. Five adult patiens (gender not reported)  had received 0.5 ml subcutaneous dose of FLUZONE in the deltoid region on 06 September 2013 (lot number: UH905AB). The patients did not have any medical history and details of concomitant medications were not reported. IT was reported that adults received FLUZONE SC instead of IM and from an hour after vaccination to 48 hours after, the patients had pain, redness and swelling at site. The patients were treated with Tylenol. One of the six patients also reported to have dizziness. The laboratory details were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain
Clinical narrative: Initial report received from a healthcare professional on 04 October 2013. A 71 year old female patient received FLUZONE HD (lot # unknown, expiration date unknown) on 03-Oct-2013. After vaccination on 03-Oct-2013, the patient experienced wide spread body aches and chills. The patient did not recover from the events. 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 23 December 2013. The cases were received at GPV on 21 March 2014. A "15-month-old" patient (no information was provided regarding the patient) had received first dose of second dose series of FLUZONE 0.5 ml, on an unspecified date i.e. overdose. No adverse event was reported. List of documents held  by sender: none
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Initial report received from healthcare professional on 23 October 2013. A 64-year-old female patient whose medical history and concomitant medications were not reported received FLUZONE (lot number UH908AA and expiration date unknown) intramuscularly in left deltoid (dose number not reported on 29 September 2013). On 29 September 2013, the patient developed fever in her right shoulder with pain that radiates down the arm that persists as of today when she cane in to show the pharmacist her right arm. Record shows vaccines was given in the left arm. The patient's past medical condition includes morphine and VICODIN.  Laboratory investigation and corrective treatment were not reported. As of this report, the patient was recovered for event localized feeling of warmth and had not recovered from the event pain in arm. 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 healthcare professional on 23 December 2013. The cases were received at GPV on 21 March 2014. It was reported that patient (no information was provided regarding the patient) had received intravenous does of FLUZONE. No adverse event was reported. List of documenst held by sender: none
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30 December 2013 and at GPV on 21 March 2014. A 06 month old patient of unknown gender had received two doses of FLUZONE 08 days apart. The patient received an extra dose of FLUZONE. No adverse event was reported. The list of documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash
Clinical narrative: Initial report received from a consumer on 23 October 2013. A 52-year-old female patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE (batch number U4709AA, expire date 6/30/14) route anatomical site of administration and number in series was not reported on 16 October 2013 at 10 am by a Healthcare Professional. On 16 October 2013, -4 hours after receiving the patient developed rash inside of my arms. Within -24 hours the rash had spread throughout the patient's body. Patient was currently under the care of primary physician for the treatment of the allergic reaction. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient was recovering from the event. 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 16 December 2013. The cases were received on 21 March 2014. It was reported that patient received a second dose of FLUZONE for the season (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Cough, Dyspepsia, Dyspnoea, Pain, Pyrexia
Clinical narrative: Initial case was received from the healthcare professional on 29 October 2013. This cluster case of 50 patients (demographic details not reported) whose medical history and concomitant medication was not reported had received an intramuscular FLUZONE vaccine, (batch number UH889AA, dose and anatomical site of administration not reported) on an unknown date. On an unspecified date, the patients notified the reporter the symptoms of body ache, fever, indigestion and upper respiratory symptoms such as cough, wheezing and difficulty in breathing. These symptoms were short lived lasting from 12-24 hours. No laboratory details were reported. No corrective treatment was reported. The outcome of the event was recovered. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Upper respiratory tract infection, Wheezing
Clinical narrative: Initial case was received from the healthcare professional on 29 October 2013. This cluster case of 50 patients (demographic details not reported) whose medical history and concomitant medication was not reported had received an intramuscular FLUZONE vaccine, (batch number UH889AA, dose and anatomical site of administration not reported) on an unknown date. On an unspecified date, the patients notified the reporter the symptoms of body ache, fever, indigestion and upper respiratory symptoms such as cough, wheezing and difficulty in breathing. These symptoms were short lived lasting from 12-24 hours. No laboratory details were reported. No corrective treatment was reported. The outcome of the event was recovered. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional (nurse)on 18 December 2013 and the case was received on 21 March 2014. A patient (gender and date of birth was not reported) had received a dose of 0.5 ml of FLUZONE (batch number, route and site of administration was not reported) on an unspecified date. The patient was given 0.5ml of FLUZONE vaccine instead of 0.25ml. 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 professional on 20 June 2014. A patient received two doses of FLUZONE (no other information was provided regarding the patient). Thus extra dose administered but no adverse events reported. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 November 2013. The cases were received on 21 March 2014. A female patient (No other information was provided regarding the patient), received FLUZONE on unspecified date. It was reported that the pregnant patient received 2012 dose of vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 November 2013 and on 21 March 2014. A '02-weeks-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE, PREVNAR, PEDIARIX on an unspecified date, and no adverse event was reported, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial report received from healthcare professional on 14-July-2014. A female patient (age not reported) whose medical history and concomitant medication were not reported, had received a dose of FLUZONE, (dose, batch number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, patient experienced urticarial reaction. The patient's laboratory investigations and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 November 2013. The cases were received on 21 March 2014. It was reported that pregnant female had received last year dose of FLUZONE vaccine. 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 misuse report received from a healthcare professional on 10 July 2014. A patient had received a dose of FLUZONE on 10 July 2014. It was reported that the patient was administered vaccine that had expired on 30 June 2014, thus, an expired vaccine was used. No adverse event was reported. List of documents held by sender: none.
Age: 1.3
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 22 October 2013. The cases were received on 21 March 2014. A 15-month old patient (no other information was provided regarding the patient), received FLUZONE. The patient had received two dose of FLUZONE vaccine last year on unspecified date. It was reported that some leaked out during the administration to a 15 month old when the needle was loose and some leaked out, thus the patient had received vaccine under dose. 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 misuse report received from a healthcare professional on 22 November 2013. The case were received at GPV on 21 March 2014. A patient (no other information was reported) received FLUZONE on unspecified date. It was reported that FLUZONE was stored at 34F on 18 November (year not specified) and then 33F and 22 November (year not specified) and administered. 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 misuse report received from a healthcare professional on 16 July 2014. A patient (gender and age not reported) had received an expiry dose of IPOL on an unspeicfied date. It was reported that patient was administered a dose that expired on 30 June 2014. No other information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Initial report received from a healthcare professional on 17 September 2013. A 58-year-old female patient had received an intramuscular dose of FLUZONE, (lot number UH894AA) in right deltoid on 10 September 2013. The patient had no illness at the time of vaccination and allergies were unknown. On 12 September 2013, the patient experienced "explosive diarrhea". Laboratory data and corrective medications were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 20 Aug 2014. A patient (age and sex not reported) had received an expired dose of FLUZONE (expiry date: 14 Apr 2014) (dose, lot number, dose number and site of vaccination not reported) on an unspecified date. At the time of this report, the patient did not experience any adverse events. 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 26 August 2014. A patient (gender and age not provided) received a fifth dose of FLUZONE. It was reported that expired vaccine used that expired on 06.30.14 was administered to 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 the health care professional on 29 August 2014. A patient (gender and age not reported) had received 0.25 ml dose of FLUZONE instead of 0.5 ml dose on an unspecified date, which led to vaccine under dose. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case is part of 2 cluster cases and is linked with 2013SA098949 (same reporter and same product lot number). Initial report received from a healthcare professional on 18 September 2013. An adult patient (gender not reported) had received 0.5 ml subcutaneous dose of FLUZONE vaccine in the deltoid region on 16 September 2013 (lot number: UH905AB). The patient did not have any medical history and details of concomitant medications were not reported. It was reported that the patient received FLUZONE SC instead of IM and from an hour after vaccination to 48 hours after, the patient had pain, redness and swelling at site. The patient was treated with TYLENOL. The patient also reported to have dizziness. The laboratory details were not reported. At the time of this report, the outcome was not 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 professional on 25 November 2013. A patient (no information was provided regarding the patient) had received an intramuscular dose of FLUZONE about a week ago, and FLUMIST on an unspecified date, and no adverse event was reported, i.e. extra dose administered. List of documents held by sender: none.
Age: 0.8
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 November 2013 and the case was received on 21 March 2014. A 10-month-old patient (gender was not reported) had received a dose of 0.5 ml FLUZONE (batch number, route and site of administration was not reported) on an unspecified date. 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 from a healthcare professional on 19 November 2013. The cases were received on 21 March 2014. It was reported that infant patient had received 0.5 ml first dose of FLUZONE vaccine for 2 dose series. No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 November 2013. A '2-year-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE 0.5 ml dose instead of 0.25 ml dose with no adverse event, i.e. overdose. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 November 2013. A '2-month-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE 2 month old was given 0.25ml dose and given another dose 30 days later with no adverse event, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 November 2013 and on 21 March 2014. A '5-year-old' patient (No information was provided regarding the patient) had received a 0.25 ml dose of FLUZONE instead of 0.5 ml i.e. underdoes. No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 November 2013. A patient (no information was provided regarding the patient) had received a dose of FLUZONE given at 5 months, then came in at 6 months and received another with no adverse event, i.e. inappropriate age at vaccine administration. 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 21 November 2013 and on 21 March 2014. A patient of unknown age and gender who already had flu vaccine this season received FLUZONE on an unknown date. The patient received diluent. No adverse event was reported. The 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: The cases were received on 21 March 2014. Initial misuse report received from health care professional on 23 Nov 2013. It was reported that 5 month 3 week old patient (gender was not reported) had received a dose of FLUZONE vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 0.9
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 11 November 2013. The 11-months-old patient had received second dose of FLUZONE 0.5 ml dose instead of 0.25 ml. It was an overdose. No adverse event was reported. List of documents held by sender: none.
Age: 10.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from health care professional on 25 Oct 2013. A 10 year old patient had received a 0.25 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial report received from a healthcare professional on 23 September 2013. A 55-year-old female had received an intramuscular dose of FLUZONE vaccine (lot number: UH888A, dose number not reported) in the left deltoid on 22 September 2013. The patient had medical history of immune system problems, PCN allergy and no acute illness at the time of vaccination. On 22 September 2013 about 1 hour post vaccination, the patient had complained of metallic taste in her mouth. Laboratory investigations and corrective medications were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None. Additional information received on 02-Dec-2013: reported that physician didn't use FLUZONE.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 November 2013. The cases were received on 21 March 2014. A '2-week-old' patient's (no information was provided regarding the patient's) had received a dose of FLUZONE and no adverse event was reported, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Vaccination site inflammation
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 18 September 2013. 06 patient's (no information was provided regarding the patient's) had received subcutaneous 0.5 ml dose of FLUZONE instead of intramuscular dose on an unspecified date and had event of site redness and swelling, i.e. vaccination site inflammation. List of 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 26 September 2013. The case was received on 21 March 2014 at agency. A 0.5 ml dose of FLUZONE was given to a pediatric patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. A patient (no other information was provided regarding the patient), received FLUZONE. It was reported that upon intramuscular administration of vaccine, leaked around needle thus the patient received under dose of the vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 25 October 2013 and the case was received on 21 March 2014 at agency. A 24-month-old patient (gender was not reported) had received a dose of 0.5 ml of FLUZONE vaccine (batch number, route and site of administration was not reported) on an unspecified date. The patient was given 0.5ml of FLUZONE vaccine instead of 0.25 ml. 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 17 October 2013. The cases were received on 21 March 2014. A patient received half of the dose of FLUZONE by error (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.