chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 24 October 2013. A patient aged 65 years or older had received a dose of FLUZONE ID on an unspecified date No adverse event was reported. List of documents held by sender: none
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Mass
Clinical narrative: Initial information received from a health care professional on 03 April 2014. A 33-year-old female patient whose medical history and concomitant medication were reported as unknown, had received an intradermal dose of ADACEL (lot number UT4722BA, dose number was unknown and anatomical site of administration were reported as "left:) on 18 October 2013. On 18 October 2013, same day after vaccination, the patient experienced injection site small lump under. The patient also experienced another small lump medial to the intradermal injection site appeared a few days ago under the skin. Laboratory investigation and corrective treatments were not reported. Documents held by sender: none
Age: 17.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 16 October 2013 and at GPV on 21 March 2014. A 17-year-old 06 months old patient of unknown gender had received FLUZONE ID. 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: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 16 October 2013.  The cases were received at GPV on 21 March 2014. It was reported FLUZONE was given to 10 patients over 65 years of age. No adverse event was reported. List of documents held by sender: none
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional (nurse) on 23 October 2013 and the case was received on 21 March 2014 at GPV. A 67-year-old patient (gender was not provided) had received a dose of FLUZONE ID on an unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 23 October 2013. A 66-year-old male patient received a dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 22 Oct 2013. A 69 year old patient had received a dose of FLUZONE ID on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 14.0
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 30 October 2013 and at agency on 21 March 2014. A 14-year-old patient 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: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 October 2013 and on 21 March 2014 at agency. A patient over 65 years of age of unknown gender had received FLUZONE ID on an unknown date. The patient received FLUZONE ID at incorrect age. No adverse event was reported. The list of documents held by sender: None.
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 at agency. Initial misuse report received from a healthcare professional on 18 September 2013. A patient whose age was over 64-year had received FLUZONE ID. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 13.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 18 October 2013. This case is linked to case 2014SA045541 (same reporter after FLUZONE ID). The cases were received on 21 March 2014 at agency. A 13-year-old patient received a dose of FLUZONE ID (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 12.0
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. A '12-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL inadvertently administered with no adverse event. I.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from healthcare professional on 18 November 2013. The case is linked with the case number 2014SA045502. The case was received on 21 March 2014 at GPV. A '14-year-old' patients whose gender, medical history, and concomitant medication were not reported had received dose of FLUZONE ID (Lot number, expiration date, dose number, route and site of vaccination was not reported) on an unspecified date, whose age falls outside the product indication i.e. inappropriate age at vaccination administration. No adverse event was reported.
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 25 November 2013 and at agency on 21 March 2014. A patient over 65 years old of unknown gender had received FLUZONE ID. The patient received FLUZONE ID at an incorrect age. No adverse event was reported. The list of documents held by sender: None.
Age: 12.0
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 (nurse) on 20 November 2013 and the case was received on 21 March 2014 at GPV. A 12-year-old patient (gender was not provided) had received a dose of FLUZONE intradermal on an unspecified date. It was reported that FLUZONE Intradermal vaccine had not been administered in patients less than 18 years or more than 65 years age. No adverse event was reported. 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 misuse report received from healthcare professional on 20 December 2013. The cases were received on 21 March 2014 at agency. FLUZONE ID was given to a patient over 64 years of age (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 68.0
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 (nurse) on 30 December 2013 and the case was received on 21 March 2014 at GPV. A 68-year-old patient (gender was not reported) had received a dose of FLUZONE ID vaccine (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.
Age: 65.0
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 30 December 2013. A '65-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL 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: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 18 DEC 2013. Cases were received on 21 MARCH 2014 at GPV.  A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE on unspecified date, (Route, dose and batch number not reported).  It was reported that on an unspecified date patient had administered vaccine in forearm as incorrect site. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Age: 15.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Erythema
Clinical narrative: Initial misuse report received from a healthcare professional on 16 January 2014. The cases were received at agency on 21 March 2014. It was reported that 15-year-old patient had received FLUZONE ID inadvertently. The patient experienced 3-4cm of erythema. List of documents held by sender: none.
Age: 11.0
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 January 2014. The cases were received on 21 March 2014 at GPV. An '11-year-old' patient (No information was provided regarding the patient) had received intradermal dose of FLUZONE INTRADERMAL on an unspecified date i.e. inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 74.0
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 16 January 2014. The cases were received at agency on 21 March 2014. It was reported that 74-year-old patient had received; FLUZONE ID vaccine inadvertently. No adverse event was reported. List of documents held by sender: none.
Age: 67.0
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 23 January 2014. A '67-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL on an unspecified date, and no adverse event was reported i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Age: 11.0
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 21 January 2013. The cases were received on 21 March 2014 at agency. A 11-years old child patient received; FLUZONE INTRADERMAL (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: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 05 June 2014. 10 patients, whose gender, date of birth, age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that on an unspecified date, after receiving FLUZONE ID, the patient experienced redness, soreness at the injection site and an achy arm. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovered. Documents held by sender: none.
Age: 80.0
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 16 October 2013. The cases were received on 21 March 2014 at GPV. This case is link with case: 2014SA045133 with same product and same reporter. A 80 years old patient, received FLUZONE HD (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 81.0
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 16 October 2013. The cases were received on 21 March 2014 at agency. This case is link with case: 2014SA045132 with same product and same reporter. A 81 years old patient, received FLUZONE INTRADERMAL vaccine (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 71.0
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 27 November 2013 and at agency on 21 March 2014. A '71-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL on an unspecified date, and no adverse event was reported. I.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional via other company (GSK) on 08 January 2014. A 52-year-old male patient whose medical history, concomitant medication were reported as unknown had received a 0.5 ml dose of Influenza vaccine (lot number, dose number, route of administration were not reported) in the left arm on 16 October 2013 at around 15:00 hours. On 16 October 2013, same day after vaccination, the patient experienced sore arm. Laboratory investigation and corrective treatments were not reported. At the time of this report, the patient had not recovered. Causality as per reporter: Probable. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 15 January 2014. This case is a part of 2 cases (same reporter and vaccine FLUZONE QIV) and is linked to case number 2013SA106863. This case belongs to a female patient. A female patient (date of birth and age at the time of event was not reported) whose medical history and concomitant medication were not reported, had received an intramuscular dose of FLUZONE QIV vaccine (lot number: U4766AA, expiry date: 30 June 2014, dose number and anatomical site of administration were not reported) on 13 September of an unspecified year. On an unspecified date of last week, the patients experienced hurting arm for over a week with some bruising at the injection site. Laboratory investigation and corrective treatments were not reported. At the time of this report, the patients had not recovered from events. Documents held by sender: none.
Age: 0.9
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 02 January 2014. A 11-month-old patient had received a first dose of 0.25 ml of FLUZONE QIV on 19 October 2013. It's an inappropriate dose of vaccine administered. No adverse event was reported. List of documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscle fatigue, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional and follow-up information on 20 February 2014. A 8-year-old female patient, who had no known allergies and illness at the time of vaccination was unknown, had received an intramuscular dose of FLUZONE QIV (lot number: U4767AA, dose number was not reported) in the left deltoid on 18 October 2013. It was reported that the patient had received flu vaccines previously on an unspecified dates. On 18 October 2013 after vaccination, the patient had local pain with left arm weakness. The patient had daily pain in the arm for 4 months. The patient was complaining pain (once localized to the injection site), which involves the entire arm. The patient had difficulty carrying items in her left arm secondary to apparent muscle fatigue in the affected extremity. Physical examination was unrevealing: no redness or swelling involving the extremity, no motor or sensory deficit, ROM intact, no muscle wasting. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none. Addendum: 06 March 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. The event coding of the verbatim difficulty "carrying items in her left arm secondary to apparent muscle fatigue in the affected extremity" was corrected from left arm weakness to Muscle fatigue. The labelling in the assessment screen was corrected from unlabelled to labelled.
Age: 0.5
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The case was received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 18 September 2013. A 06-month-old patient had received 0.5 ml dose of FLUZONE QIV instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received on 07 October 2013 from a health care professional. A child, whose medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (lot number, expiry date and site of vaccination was not reported). It was reported that the child received 0.25ml of FLUZONE QIV on 10/3 and another 0.25ml on 10/7. No reaction was reported. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Initial information reported healthcare office to nurse on 08-Nov-2013: A pregnant female patient received FLUZONE QIV (Lot U4789AA and expiration date unknown) on 17-Oct-2013 and 07-Jul-2013. Reporter stated patient inadvertently received 2 of the FLUZONE QIV vaccinations. The estimated date of delivery is 08-Dec-2013. No further relevant information reported.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Initial report received on 07-Nov-2013 from a health care professional. A 4-year-old female child whose medical history and concomitant medications were not reported, received a intramuscular dose of FLUZONE QIV (lot number U4772AA; expiry date unknown) on left deltoid on 04-Nov-2013. It was reported that the patient experienced redness at the injection site with erythema and induration on 07-Nov-2013. The events were ongoing at the time of the report. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 06 November 2013. The 5-years-old patient had received FLUZONE QIV intradermal (dose, site not provided). Reporter stated that 5-years-old patient received 2 doses of FLUZONE QIV, one on 03-Oct-2013 and one on 06-Nov-2013. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.8
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a consumer on 06 November 2013. The 8-months-old patient had received 0.5 ml dose of FLUZONE QIV instead of 0.25 ml dose. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 08 November 2013. The pregnant patient had received two doses of FLUZONE QIV. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial medication error report received on 08 November 2013 from unspecified reported. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (route, lot number and site of vaccination was not reported) on an unspecified date. Reported stated that 6 month old and 1 year old got FLUZONE QIV 0.5 ml dose. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Movement disorder
Clinical narrative: Initial report received from a patient's mother on 24 November 2013. A 11 year old male patient, had received a dose of FLUZONE QIV (Lot number U4771AA, on left deltoid, route unknown) on 17 October 2013. On 18 October 2013, after receiving vaccine the patient experienced shaking his head back and forth all the time. Medical history includes flu shots. At the time of this report the outcome of adverse event was not recovered. Documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Initial report received from healthcare professional on 02 December 2013. A 08-year-old male patient who received FLUZONE QIV (lot number U4790AA and expiration date unknown) intramuscularly in right deltoid (dose number not reported) on 30 November 2013. Patient's medical history includes NKDA, small skull congenital defect, multiple cranial plasty and parietal foramina. Concomitant medication not reported. On an unknown date, the patient developed 6 cm red raised painful, hot to touch, no fever and cold compresses. Laboratory investigation and corrective treatment were not reported. As of this report, event outcome was recovered. Documents held by sender: none.
Age: 2.9
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 03 December 2013. A 37 months old patient had received 0.25 ml FLUZONE QIV instead of 0.5 ml. No adverse event was reported. List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Skin hyperpigmentation
Clinical narrative: Initial report received from a non-health care professional (consumer) on 31 December 2013. A 6-year-old female patient had received FLUZONE QIV intramuscularly (batch number- U4766AA, expiry date 30 June 2014) dose, dose number and anatomical site of administration were not reported on 27 November 2013. Patient had medical history of hyperpigmentation between Jan and May 2013, which cleared up with the use of aloe. Concomitant medications were not reported and had no illness at the time of vaccination. On 29 November 2013, two day after vaccination the patient developed hyperpigmentation. It began on the back of the neck, spread to the upper chest, behind the ears, a little on the face, top of forearms from the elbow to the wrists, ankles, bottom of the feet, between the toes, knees, and below the knees. Patient's mother pointed out a common ingredient in the azithromycin and FLUZONE QIV which is sodium phosphate. Patient's mother applies aloe and oatmeal baths. Laboratory investigations were not reported. At the time of this report, the patient was not recovered from the event. Documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 07 January 2013. A 03-year-old female patient who had received first dose of FLUZONE QIV batch number U4790AA, dose, route and anatomical site of administration were not reported intramuscularly on unspecified date. Patient's medical history and illness at the time of vaccination and Concomitant medications was unknown. Patient had allergy of egg. On unspecified date, after vaccination the patient developed reaction, does not know what the reaction was. Corrective treatment and laboratory investigations was not reported. Outcome of the event was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Ultrasound scan, X-ray limb
Clinical narrative: Initial report received from a healthcare professional on 04-November-2013. A female patient whose age, medical history was not reported, received a dose of FLUZONE QUADRIVALENT (lot number: U4788AA, expiry date: 30 Jun 2014) (site of administration and route ws unknown). Patient had pain and decreased range of motion which began about three hours after injection intensifying for about 24 hours. Pain has since been constant and increases with movement of upper arm and shoulder. Corrective treatment included ultrasound of arm, shoulder x ray, pain meds, and physical therapy three times a week and has nerve conduction study scheduled for end of November. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Tremor
Clinical narrative: Initial report received from a healthcare professional on 05-Nov-2013. A 11 year old male received FLUZONE QIV (batch number U4790AA, expiry date and route were unknown) on 01 November 2013. The patient's medical history and concomitant medications were not reported. On 01 November 2013, after the vaccination the patient experienced shaking, chills and a temperature of 103.0F which was highest to 103.5. At the time of this report the outcome of the events were not resolved. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Back pain, Pyrexia, White blood cell count decreased
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 22 October 2013. A male patient (age and date of birth not reported) had received an injection of Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a 100F fever for five days, white blood cells decreased and lower back pain. The patient will have his labs, including blood count, checked on 23 October 2013. The patient is scheduled to have a right total knee replacement on 07 November 2013. Concomitant medication was AUBAGIO 7mg. The patient had a history of IVIG therapy for an unspecified reason, left knee replacement in 2010, a normal body temperature of 97.2F and a month history of numbness in his feet. Outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Feeling abnormal
Clinical narrative: Initial report received from the non health care professional on 20 October 2013. A 60s female patient whose demographics data (date of birth, age), medical history and concomitant medication details were not reported, had received a dose of influenza vaccine (manufacturer unknown, batch number, route and site of administration were not reported) on 18 October 2013. It was reported that after vaccination, patient experienced "bit under the weather" and thinks she was either coming down with something or having a "stronger than usual reaction to her flu shot yesterday." The patient's outcome was not reported. Documents held by sender: none. Addendum: 30 January 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant corrections were made for reporters e-mail in inbound, patient's age, patient's initials, pregnancy details, first dose of first reaction, event start date, duration in product screen, cycle/series, reporter's occupation, event coding.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Erythema, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Initial report received from a non-health care professional (consumer) on 21 October 2013. A female patient who had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, had received an Flu vaccine in left arm (lot number no reported) on an unspecified date in 1968. It was reported that on an unspecified date in 1968 the patient's arm was swollen, and red. kept swelling to a point where they thought they were going to have to operate. No treatment was taken. She could eat chicken and eggs but feels itchy of she is around chickens. laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: None. Follow-up information received on 21 January 2014. The patient date of birth was reported as 17 October 1931. The patient experienced adverse event immediately after vaccination. Patient address, responsible physician address was updated. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Erythema, Immediate post-injection reaction, Peripheral swelling, Pruritus
Clinical narrative: Initial report received from a non-health care professional (consumer) on 21 October 2013. A female patient who had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, had received an Flu vaccine in left arm (lot number no reported) on an unspecified date in 1968. It was reported that on an unspecified date in 1968 the patient's arm was swollen, and red. kept swelling to a point where they thought they were going to have to operate. No treatment was taken. She could eat chicken and eggs but feels itchy of she is around chickens. laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: None. Follow-up information received on 21 January 2014. The patient date of birth was reported as 17 October 1931. The patient experienced adverse event immediately after vaccination. Patient address, responsible physician address was updated. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Alopecia, Bladder catheterisation, Micturition urgency, Nausea, Urinary retention
Clinical narrative: A 60- year old female patient, had no medical history reported, received a Influenza vaccine on an unspecified date. (Route, site, dose and batch number were not reported). Patient had concomitant medication of dose of 14 mg AUBAGIO once a day (QD) (Route not reported, batch number 3AFESA) since before two month from date of report. On an unspecified date on 2013 patient had hair thinning and sick to stomach after flu shot since last month from date of report. It was reported that on an unspecified date patient had BOTOX in bladder. She feels she has to always urinate, bladder is always full. Patient said she did straight catheters herself. No corrective treatment was reported. At the time of reported the outcome of event was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Local swelling, Tremor
Clinical narrative: Initial report received from a consumer on 03 October 2013. A female patient of unspecified age, had received Flu vaccine from unknown manufacturer (batch number, dose number, route and anatomical site of vaccination were not reported) on an unspecified in 2009. Patient had received a Flu vaccine in 1979 and following vaccination had very red and swollen arm. Patient is allergic to Thimerosal. Patient's concomitant medications were not reported. On an unspecified date after receiving Flu vaccine with preservative, the patient had "the shakes", red arm with swelling of football size. Patient had received several flu vaccines since 2009, all of which did not contain thimerosal, and not had any reactions after any of those flu vaccines. Corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Document Held by Sender: None.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Peripheral swelling, Tremor
Clinical narrative: Initial report received from a consumer on 03 October 2013. A female patient of unspecified age, had received Flu vaccine from unknown manufacturer (batch number, dose number, route and anatomical site of vaccination were not reported) on an unspecified in 2009. Patient had received a Flu vaccine in 1979 and following vaccination had very red and swollen arm. Patient is allergic to Thimerosal. Patient's concomitant medications were not reported. On an unspecified date after receiving Flu vaccine with preservative, the patient had "the shakes", red arm with swelling of football size. Patient had received several flu vaccines since 2009, all of which did not contain thimerosal, and not had any reactions after any of those flu vaccines. Corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Document Held by Sender: None.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood thyroid stimulating hormone increased
Clinical narrative: Initial report received from a healthcare professional on 20 September 2013. A female patient, whose date of birth, age at the time of events, medical history, illness at the time of vaccination and concomitant medication were not reported, had received a dose of Influenza vaccine (lot number: not reported, dose number, route and anatomical site of administration were not reported) on an unspecified date of October 2012. On an unspecified date of October 2012 after vaccination, the patient had rising TSH levels. The patient was seen endocrinologist physician. Laboratory investigations and corrective medications were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: None.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dehydration, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 10 September 2013. A female patient whose medical history was not reported and had no concomitant medications, had received a dose of Flu vaccine (lot number, route, dose number and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient had had fever, dehydration. Laboratory investigations were not reported patient had received IV fluids and antibiotics as corrective medications. At the time of this report, the outcome was unknown. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urticaria
Clinical narrative: This case is linked to a serious case 2013-08799 (same patient, different adverse events). Initial report received from a patient who is a healthcare professional on 20 September 2013. A 38-year-old female patient, whose medical history and concomitant medications were not reported had received a dose of Influenza vaccine (manufacturer: unknown, lot number, dose in series, route and site of administration was not reported) on an unspecified date. On an unspecified date, post vaccination, the patient developed hives. Laboratory tests and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by the sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site reaction
Clinical narrative: Initial report received from a consumer on 18 September 2013. A male patient (age at the time of event was not reported), with a history of sulfa drug allergy, had received a dose of Flu vaccine (manufacturer unknown, batch number, dose in series, route and site of administration was unknown) on an unspecified date. On an unspecified date, after vaccination the patient had injection site reaction and tiredness for a few days. medical history included sulfa allergy, laboratory test and corrective treatments were not reported. At age 75-year-old patient received intramuscular dose of FLUZONE HD vaccine (batch number: U4713AA, expiry date: unknown and site of administration was left deltoid) on 11 September 2013. It was reported that on 11 Sep 2013, the patient had no reaction and was worried that he did not really received the vaccine. The events were recovered at the time of report. List of documents held by sender: None Follow up information received from consumer on 25 November 2013. Updates made to product details, suspect drug and event outcome changed. Follow-up information received from non-healthcare professional on 31 March 2014. The patient received FLUZONE HD in left deltoid and had no reaction (Previously captured as suspect). The patient did not experience any adverse event within 4 weeks prior to vaccination.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Blister, Erythema, Gait disturbance, Induration, Peripheral swelling
Clinical narrative: Initial information received on 03 October 2013 from a health care professional: Concomitant medications included cefdinir and BENADRYL started on 28 September 2013. A 11-year-old child female patient whose medical history was not reported, received in right vastus lateralis dose of MENACTRA (lot number U4583AA, expiry date unknown), ADACEL (C4385AA, expiry date unknown) in left vastus lateralis and FLUZONE (Lot # U47109AD and expiry date unknown) in right vastus lateralis on 25 September 2013. It was reported that the patient experienced right leg swollen, hard to touch, hurts to walk on 26 September 2013. On 27 September 2013, patient stated seen redness, swelling, clear blisters, mild tenderness and slightly warmer than rest of the skin. On 28 September 2013, redness bigger and swelling. Administration site reaction was not reported. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Initial information received on 03 October 2013 from a health care professional: Concomitant medications included cefdinir and BENADRYL started on 28 September 2013. A 11-year-old child female patient whose medical history was not reported, received in right vastus lateralis dose of MENACTRA (lot number U4583AA, expiry date unknown), ADACEL (C4385AA, expiry date unknown) in left vastus lateralis and FLUZONE (Lot # U47109AD and expiry date unknown) in right vastus lateralis on 25 September 2013. It was reported that the patient experienced right leg swollen, hard to touch, hurts to walk on 26 September 2013. On 27 September 2013, patient stated seen redness, swelling, clear blisters, mild tenderness and slightly warmer than rest of the skin. On 28 September 2013, redness bigger and swelling. Administration site reaction was not reported. List of documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Initial report received from healthcare professional on 25 August 2014. A 9-year-old male patient, whose medical history and concomitant medications were not reported, had received 0.5 ml dose of FLUZONE QUADRIVALENT, batch number: U4990DA (dose number, route and anatomical site of administration were not reported) on 16 August 2014. It was reported that on an unspecified date, after couple of hours of receiving FLUZONE QUADRIVALENT Vaccine, the patient experienced hives all over his body. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Erythema, Local reaction, Myalgia, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 03 September 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE QUADRIVALENT, (batch number UI192AA, dose in series, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patients experienced local reactions and fevers. The patient had high fevers and vomiting and local reactions such as large patch of redness, muscle pain and was not able to walk. Corrective treatment and laboratory details were not reported. At the time of this report the patient was recovering from the events. Patient was doing better today, and was walking today. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Initial report received from a healthcare professional on 03 September 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE QUADRIVALENT, (batch number UI192AA, dose in series, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patients experienced local reactions and fevers. The patient had high fevers and vomiting and local reactions such as large patch of redness, muscle pain and was not able to walk. Corrective treatment and laboratory details were not reported. At the time of this report the patient was recovering from the events. Patient was doing better today, and was walking today. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 09 September 2014. A 29-year-old female patient, had received an intramuscular fifth dose of FLUZONE QIV (batch number-UI171AB, expiry date-30 Jun 2015, site of administration was not reported) on 09 September 2014. The patient current pregnancy history was reported as healthy, some swelling and no risk factors. The last menstrual period was reported as 01 May 2014 and estimated date of delivery was reported as 10 October 2014. The patient did not receive any treatment for infertility. At the time of vaccination the patient was pregnant. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from health care professional on 17 September 2014. In this follow up no new information was reported.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30 January 2014. The cases were received at agency on 21 March 2014. It was reported that less than 3 years of age patient (no other information was reported) had received 0.5 ml dose of FLUZONE QIV on unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 January 2014 and at agency on 21 March 2014. This case was linked to other case linked to case 2014SA046378 being a same reporter. A patient unknown age and gender had received FLUZONE QIV subcutaneously. The patient received FLUZONE by incorrect route. No adverse event was reported. The list of documents held by sender: None.
Age: 0.3
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 April 2014. A 03-months-old patient of unknown gender had received FLUZONE QIV 0.25 ml (batch number not reported) on an unknown date. The patient did not experience any adverse event. The patient received FLUZONE QIV at an incorrect age. The list of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 17 DEC 2013. Cases were received on 21 March 2014 at the agency. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE QIV on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient had administered vaccine the gluteal as an incorrect site of administration. No adverse event was reported. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 30 October 2013. The cases were received on 21 March 2014 at agency. A 02-month-old patient received 0.25 ml dose of FLUZONE QIV (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: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse case was received from a healthcare professional on 29 OCT 2013. Cases were received on 21 March 2014 at agency. A 4 month old patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE QIV vaccine on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received a vaccine of incorrect product. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Alopecia, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received from a consumer on 08 January 2014. A female patient had received a dose of Flu Vaccine (therapy dates, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. The patient had family history of heart disease. The patient had received hypertensive medicine in October 2013. The patient had also received birth control pills to assist in regulating periods. The patient had received AUBAGIO 14 mg per oral daily from 04 January 2014 for the indication of multiple sclerosis. On an unspecified date after vaccination, the patient continuation in hair thinning, numbness in right leg and tingling sensation in left leg. Patient was fatigue too. Laboratory investigation and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information was received on 21 March 2014: No new information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Initial report received from a non-health care professional on 19 December 2013. The patients, whose age, medical history and concomitant medications were not reported, had received a dose of influenza vaccine (flu shot) (lot  number, route and site of vaccination were not reported), on an unspecified date in 2013. On an unspecified date, the all four patients were very sick with flu shot. At the time of this report, the outcome of adverse event was unknown. No further relevant information reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Local swelling
Clinical narrative: Initial information received from a consumer on 27 December 2013. A female patient of unspecified age, whose medical history and concomitant medications were not reported, had received a dose of Flu vaccine from unknown manufacturer (Route, dose number, lot number and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed a big red bump from flu shot. Laboratory investigations and corrective treatment was not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.