chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Initial report received from a health care professional on 01-Oct-2013. A male and female adult patients, whose age, medical history and concomitant medications were not reported, had FLUZONE HD vaccine (Lot number UT4719AA, Intradermal on deltoid site), on September 2013. On an unspecified date (at the time of vaccination), after receiving vaccine the patients experienced stinging more than last year reported. Patients also experienced red and warm to the touch at injection site. At the time of reporting, outcome of the events were unknown. No further relevant information was reported. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 02 October 2013. A 35 years old pregnant female patient received FLUZONE ID (Lot # UT472013A, expiration date unknown) intradermal at left deltoid on 01-Oct-2013. It was reported that the pregnant patient was administered with FLUZONE ID. The estimated date of delivery was 03-Feb-2014. As of 02-Oct-2013, the patient did not have any adverse events. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: Below narrative includes initial report received from a consumer on 02 October 2013 plus subsequent follow up: A 56-year-old female patient who had PCN and egg allergy and no illness at the time of vaccination, had received an intradermal dose of FLUZONE ID (lot number: not reported) in the left shoulder on 01 October 2013 at 12:30 hours. On 01-Oct-2013 at 13:00 hours, the patient felt nausea then vomited. The patient was tingling and her body was "going numb". Corrective treatment included Laboratory investigations were not reported and patient had a "shot" for the nausea and fluids. Patient was discharged and sent home after a few hours. 01-Oct-2013 the patient had recovered from the event. Documents held by sender: None. Additional report received from a consumer on 07 November 2013: Administered by name added. Country and state where vaccine administered were added. Contact #  of patient was added. Any other medication received within 4 weeks was reported none. Corrective treatments were added.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Initial report received on 19 September 2013 from a non-health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on September 2013. Patient had swelling, large raised bump, and redness. One patient had an area approx. 1.5 inches x .5 inches in other direction. Several complain of pain and itching. One person stated that they had trouble raising their arm. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial report received on 09 October 2013 from a health care professional. A 57-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number UT47119AA, expiration date unknown) by intradermal route and site of vaccination was deltoid 07-Oct-2013. It was reported that a patient over 57-year-old have received the FLUZONE ID. As of 08-Oct-2013, patient had 5.5 inch area of induration surrounding injection site with redness and warmth. No treatment prescribed. No physician evaluation. No self-treatment. Patient reported over time site has improved. List of documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Initial spontaneous report received on 04-OCT-2013 from a nurse. A 33 years old female patients whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot # UT4719AA, route is intradermal and site of vaccination was not reported) last injection on 10-Mar-2013. Nurse stated that patient was 9 weeks IUP. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial summary report received from a healthcare professional on 03 October 2013. A female patient (age unknown) whose medical history and concomitant medications were not reported received first dose of FLUZONE ID batch no 3, on left deltoid (route, dose, from, frequency not reported) on 03 October 2013. The female patient received vaccine during pregnancy. Mother did not experience any adverse event. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Initial report received from healthcare professional on 11 October 2013. A patient with unknown demographics whose medical history and concomitant medications were not reported received dose of FLUZONE INTRADERMAL (route, dose, from, frequency and batch number not reported) on an unspecified date. The patient received vaccine and developed rashes that covered body. Laboratory investigation and corrective treatment were not reported. At the time of report, the patient was not recovered from the event. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Headache
Clinical narrative: Initial report received from a healthcare professional on 03 October 2013. A 45-year-old male patient had received first dose of FLUZONE ID (batch number: UT4719AA, expiry date 01 Apr 2014 and route of administration was not reported) in the left deltoid on 02 October 2013. The patient had no illness at time of vaccination, the patient developed headache and some swelling under his eyes. Laboratory tests were not reported and the patient had received ADVIL as corrective treatments. At the time of this report the patient did not recover. List of documents held by sender: None
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial case was received from a health care professional on 15 October 2013. A female patient (age unknown) had no medical history reported, received a dose FLUZONE HD vaccine intradermally on an unspecified date in 2013 (site, batch number not reported). Patient had not reported concomitant medication. It was reported that on an unspecified date on 2013 patient experience 3.5 cm red and swollen at injection site. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial information received from nurse on 15-Oct-2013: Patient received FLUZONE ID (Lot unknown) on 09-Oct-2013. Patient reported that her left shoulder became red, swollen and tender to touch, shortly after vaccination. 7 days after vaccination, area is still sore and tender. No further relevant information reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial summary report received from a non-healthcare professional on 14 October 2013. 148 patients (details not provided) received FLUZONE ID batch no UT4721BA (route, dose, frequency and exact site of information not reported) on an unspecified date in 2013. The patients had moderate redness, swelling, pain at the injection site. This was described second hand from the distributor who got the information from one of their customers. No further information was provided. List of documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Initial report receive from a healthcare professional on 09 October 2013. A 56-year-old male patient, whose medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID, batch number - UT4721BA dose number was not reported in left deltoid on 07 October 2013. On 08 October 2013, one days after vaccination the patient experience redness, mild swelling and discomfort at injection site. Patient received ice compresses, hydrocortisone cream and bacitracin ointment to the injection site as corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 09 October 2013. A 61-year-old female patient, whose medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID, batch number - UT4721BA dose number was not reported in left deltoid on 07 October 2013. On 08 October 2013, one days after vaccination the patient experienced mild swelling, 6cm redness and a fine raised rash around the injection site. Patient also experienced in left deltoid area that went to her left armpit. Patient received cold compresses, topical application of hydrocortisone and bacitracin ointment as corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 09 October 2013. A 52-year-old female patient had received a dose of FLUZONE ID, (batch number- UT4721BA) intradermally in left deltoid on 07 October 2013. The patient denied any illness at the time of vaccination and had no pre-existing physician diagnosed allergies, birth defects, medical conditions. On 08 October 2013, 1 day after vaccination, the patient presented with 6 cm redness, 10 cm swelling and left deltoid pain. The patient stated that she felt feverish and was afebrile at evaluation. Laboratory details were not reported. The patient was treated with injection site cleansing, cold compresses, topical application of hydrocortisone and bacitracin ointment. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 09 October 2013. A 61-year-old male patient had received a dose of FLUZONE ID, (batch number- UT4721BA) intradermally in left deltoid on 07 October 2013. The patient denied any illness at the time of vaccination and had no pre-existing physician diagnosed allergies, birth defects, medical conditions. On 07 October 2013, same day after vaccination, the patient presented with redness (6cm), swelling and pain at injection site. Laboratory details were not reported. The patient was treated with ice compresses, hydrocortisone cream and bacitracin ointment to the injection site. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 07 October 2013. A female patient of unspecified age, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID, (batch number-UT4721BA, route and site of administration not reported) on an unspecified date. On 07 October 2013, same day after vaccination, the patient experienced pain from the injection site down to fingers. The patient stated that she had to sleep with a hot compress to make it feel better. Laboratory details were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information from a health care professional on 31 January 2014. The patient recovered on an unspecified date.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 07 October 2013. This is invalid case as the individual patient identifiers missing. It was reported that on an unspecified date a intradermal dose of FLUZONE INTRADERMAL was administered. It was noticed that, a large amount of liquid running down the patient's arm as they remove the needle. It's a vaccine underdose. No information was provided regarding the patient. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Feeling hot, Swelling
Clinical narrative: Initial report received from a healthcare professional on 17 October 2013. 20 patient, whose medical history was unknown and concomitant medications was not reported, had received an intradermal dose of FLUZONE ID, batch number, anatomical site of administration and dose number were not reported on 07 October 2013. On 07 October 2013, same day after vaccination, the patient experienced redness, swelling, hotness and burning sensation. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: This case is linked to case numbers 2013SA105996, 2013SA106345 and 2013SA106341. Initial report received from a healthcare professional on 18 October 2013. 55 patients (demographics unknown) had received a dose of FLUZONE ID, (batch number- UT4720AA, site of administration not reported) subcutaneously on 01 October 2013 and on. The patient's illness at time of vaccination and pre-existing diagnosed allergies, birth defects, medical conditions were unknown. On an unspecified date, patients had site reactions such as wheal and urticaria at sites with warmth at the site. Laboratory details and corrective treatments were not reported. At the time of this report, the patients had not recovered from the events. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Initial report received from a healthcare professional on 18 October 2013. A 32-year-old female patient had received a dose of FLUZONE ID, (batch number - UT4721BA) intradermally in left deltoid on 16 October 2013. The patient's illness at the time of vaccination was none as per reporter and had no known allergies. On 16 October 2013, 2 days after vaccination, the patient had a swollen, axillary lymph node. Laboratory details and corrective treatments were not reported. At the time of this report, the patients had not recovered from the event. Documents held by sender: none. Follow-up information received on 28 January 2014: The patient had no illness at the time of vaccination and no noted allergies and no lab tests were performed. The patient recovered within 2-3 days (unspecified date).
Sex: U
Vaccine: FLU3
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional 18 October 2013. This case is cluster case of 58 patients and linked to case numbers 2013SA106326, 2013SA105996 and 2013SA106345. 58 patient had received an intradermal dose of FLUZONE ID vaccine (dose number and anatomical site of administration were not reported) on an unspecified date. The vaccination was given 13 October 2013 and on. On an unspecified date, the patients had developed site reactions such as wheal and urticaria at sites with warmth at the site. Laboratory investigation was and corrective treatments were not reported. At the time of this report, the patients had not recovered from events. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: This case is linked to 2013SA106326, 2013SA105996 and 2013SA106341 (same reporter and same product). Initial report received from a healthcare professional on 18 October 2013. A patient (whose demographics and medical history was not reported) had received a dose of FLUZONE ID (batch number: UT4720AA, intradermally, site of administration not reported) on 01 October 2013. On an unspecified date, the patient went to urgent care due to body rash. lab investigation and treatment medications were not reported. At the time of this report, the outcome was not recovered. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Initial report received pharmacist on 18 October 2013. A 31 year old female patients whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (route intradermal, lot # UT4721AA and site of vaccination was right deltoid) on 17 October 2013. Reporter stated that on 17 October 2013 patient received FLUZONE ID in right deltoid and within few minutes experienced numbness in left side of face and neck. Patient also reported that numbness continued into the evening. On 10/18/2013, patient stated all numbness resolved and no other symptoms experienced. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial report received from a healthcare professional on 18 October 2013. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: unknown, expiry date: unknown) on left deltoid via intradermal route on 16 October 2013. Patients experienced site reaction of redness and itchiness 1-7cm on 16 October 2013. The events were resolved. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Inflammation
Clinical narrative: Initial report received from a healthcare professional on 18 October 2013. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: unknown, expiry date: unknown) on left deltoid via intradermal route on 16 October 2013. Patients experienced site reaction of redness and itchiness 1-7cm on 16 October 2013. The events were resolved. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Initial misuse report received from healthcare professional on 18 Aug 2014. A patient (age and sex not reported) had received a dose of FLUZONE HD (dose, lot number, dose number and site of vaccination not reported) on an unspecified date. It was reported that while administration of dose, the needle was not tight and a lot of vaccine leaked out. At the time of this report, the patient did not experience any adverse events. Documents held by sender: None.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, Full blood count, Pyrexia, Urine analysis
Clinical narrative: Initial report received from a physician on 05 September 2014. An 87-year-old female patient, with a history of idiopathic jaundice (resolved), received a left deltoid injection of FLUZONE HD (lot number U4997AA) on 27 August 2014. One day post-vaccination, on 28 August 2014, the patient experienced a fever up to 101.6 degrees Fahrenheit, still ongoing at the time of the report. The patient had been seen by her physician, and laboratory testing including CBC, urinalysis, and blood cultures, had been obtained (results not reported). No additional information was reported. Documents held by sender: None.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Initial report received from a healthcare professional on 05 September 2014. A 85-year-old female patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE HD (batch number-U4997AA) dose, dose in series was not reported intramuscularly in left deltoid on 04 September 2014. On 05 September 2014, one day after vaccination, the patient developed 3 and 1/2 inch red rash area about 1 inch below injection site. Laboratory investigations and corrective treatment was not reported. At the time of this report the patient was not recovered from the event. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Coordination abnormal
Clinical narrative: Initial report received from a healthcare professional on 08 September 2014. A male patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE HD (batch number, dose, dose in series, route of administration and site of administration was not reported) on 06 September 2014 at 12 p.m. On 06 September 2014 at 7 p.m., seven hours after vaccination, the patient presented coordination. Reporter stated the intent of her call was to find out FLUZONE HD could affect a person's coordination. Reporter was calling on behalf of a patient who contacted her regarding to obtain this information. Laboratory investigations and corrective treatment was not reported. At the time of this report the patient outcome was unknown. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Grip strength decreased, Pain, Pyrexia
Clinical narrative: Initial report received from consumer on 12 Sep 2014. A 70-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (lot number, dose, dose number, route of vaccination not reported) in the left deltoid on 09 Sep 2014. The patient had previously received erythromycin. The patient had a medical history of percutaneous nephrostomy, arthritis, breast cancer. It was reported that, on an unspecified date, Tuesday at 19:00 hours, the patient developed chills and low grade fever and resolved. It was reported patient again chills, low grade fever, joint pain and had difficulty closing right hand and had aches. The patient required ER visit. Lab investigation details and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Initial report received from healthcare professional on 11 September 2014. A 66-year-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number: U5017AA, intramuscular in left deltoid) having expiry date: 3 April 2015 on 11 September 2014. It was noted that, the patient had no known allergies but has hypertension and glaucoma. As per reporter, the patient had no acute illness at the time of vaccination. It was reported that on 11 September 2014, on the same day after receiving FLUZONE HD vaccine, the patient experienced tingling in the face. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from the healthcare professional on 20 Oct 2014. Received no additional information.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site nodule, Injection site pain
Clinical narrative: Initial report received from a healthcare professional on 17 September 2013. This is an invalid case as no patient identifiers were reported. A cluster of patients (5 patients) had received an intradermal dose of FLUZONE intradermal (batch number-UT4720AA, dose number in series and anatomical site of administration were not reported) on an unspecified date in September 2013. It was not reported if the patients had any illness at the time of vaccination and also the patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications were not reported. On an unspecified date in September 2013, after vaccination, the patients developed redness, 3-4 inch knot and pain at the injection site. Pain was reported to last a few to 5 days ans one of the patient had bad tasted in the mouth after vaccination. No laboratory investigations were done and corrective treatments were not reported. On an unspecified date, the patient had recovered from the events. List of Documents held by sender: None
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site swelling
Clinical narrative: Initial report received from a healthcare professional on 18 September 2013. A 51-year-old male patient, who had no medical history and concomitant medications were not reported had received an intradermal dose of FLUZONE ID (Batch number: UT4721AA, anatomical site of vaccination was not reported) on 09 September 2013. On 09 September 2013, the patient had pain at vaccination site, redness, knot and swelling of two inch in diameter at the vaccination site. Patient had dull pain radiating downward to his elbow for about 2 days. Laboratory investigations and corrective treatments were not reported. As of 18 September 2013, the patient had not recovered from the events. List of documents held by sender: none. Follow up information received from a healthcare professional on 28 July 2014. Responsible physician details were updated. Follow-up information received from a healthcare professional on 15 September 2014: The patient was vaccinated with first dose of FLUZONE intradermal in left deltoid. The patient had no illness at the time of vaccination. No laboratory tests were performed. The events resolved approximately 2 weeks with no lasting effects.
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site mass, Injection site pain, Vaccination site induration, Vaccination site warmth
Clinical narrative: Initial report received from a healthcare professional on 18 September 2013. A female patient, whose age and date of birth were not reported, had received an intradermal first dose of FLUZONE ID (Batch number and anatomical side of vaccination was not reported) on 13 September 2013. The patient had no illness at the time of vaccination. The patient had previously received flu vaccine intramuscularly without side effects. Patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. On 13 September 2013, after vaccination, the patient felt the shot like thousand tiny needles, pain and very hard softball size lump at vaccination site hard and hot to touch. Patient had pain to armpit. it was reported that the lump was of dime size by 17 September 2013. The pain in armpit also extended to ribcage. Laboratory investigations and corrective treatments were not reported. As of 18 September 2013, the patient had not recovered from the events.
Sex: U
Vaccine: FLU3
Symptoms: Blister, Vaccination site reaction
Clinical narrative: Initial report received from a healthcare professional on 19 September 2013. This is a summary case to two patients. Two patients of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID batch number: UT4720AA (Expiry date: 04/03/2014, Route, dose number and anatomical site of administration were not reported) on 16 September 2013. On 19 September 2013, the patients had small blister around the vaccination site. The laboratory tests and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender were none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain, Pruritus, Swelling
Clinical narrative: This case is linked to case number 2013SA102257 (same reporter after FLUZONE ID). Initial report received from healthcare professional on 19 September 2013. The 9 patient's 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, route and anatomical site of administration were not reported) on an unspecified date of September 2013. It was reported that on an unspecified date, after receiving FLUZONE ID vaccine, the patient's experienced swelling, large raised bump, redness, pain and itching. The corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 24 September 2013. This case is for 59/60 employees who were given FLUZONE ID had various site reactions. Patients (demographics) details were not reported), whose medical history and concomitant medications were unknown, had received a dose of FLUZONE ID, (lot number: UT47719AA, Exp. date: 01 April 2014, site of administration was not reported) on an unspecified date. On unspecified date, it was reported that the patients had various site reactions. The reporter stated that it was her first time using this vaccine and she was not happy with it. She said out of all the vaccines she gave she had a 95% severe reaction and one employee (nurse) who had to go to the emergency room for pain. Complementary investigations and laboratory data were not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial case received from a non healthcare professional on 30 September 2013. A patient whose demographics were not reported had received a dose of FLUZONE Intradermal (batch number: UT4470AA, expiry date 03/20/13, dose number, route and site of administration was not reported) on an unspecified date. The patient's medical history was not reported. It was reported that after vaccination on an unspecified date the patient experienced unspecified adverse reaction. Details of laboratory investigations and treatment medications were not reported. At the time of this reporter, the outcome of the event was not reported. List of documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Muscular weakness, Pain in extremity
Clinical narrative: Initial report received on 24 November 2013 from a consumer. A 30-year-old female patient whose medical history and concomitant medications were not reported, received a Intradermal dose of FLUZONE ID (lot number UT4719AA, Expiry date 01-April-2014 and site of vaccination right arm). On 21 September 2013 she experienced cold extremities, extensive swelling of vaccinated limb, redness, feeling of warmth, weakness of arms and pain in arm. Corrective treatment included CLEOCIN, MEDROL Dosepak and NAPROSYN. Patient was recovered at the time of report. List of documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness
Clinical narrative: Initial report received on 24 November 2013 from a consumer. A 30-year-old female patient whose medical history and concomitant medications were not reported, received a Intradermal dose of FLUZONE ID (lot number UT4719AA, Expiry date 01-April-2014 and site of vaccination right arm). On 21 September 2013 she experienced cold extremities, extensive swelling of vaccinated limb, redness, feeling of warmth, weakness of arms and pain in arm. Corrective treatment included CLEOCIN, MEDROL Dosepak and NAPROSYN. Patient was recovered at the time of report. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 01 November 2013. A 63-year-old female patient had received first dose of FLUZONE intradermal (batch number and route of administration was not reported) on 30 October 2013. The patient had a history of sulfa allergy and concomitant medications were not reported. On 30 October 2013, same day after vaccination, the patient injection site was palm sized, red and raised, felt like a knot under site and was extremely itchy. The patient's laboratory tests and corrective treatments were not reported. At the time of this report, the patient was not recovered. Documents held by sender was none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case is part of 1 cluster case and is linked to case number 2013SA113810 (same reporter, events after FLUZONE ID intradermal), lot number: UT4726AA. The five female patients, ages 18 to 64, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number UT4726AA, intradermal and site of vaccination not reported), on 29 October 2013. On 29 October 2013, after receiving vaccine the patients experienced warmth, swelling, redness and tenderness at injection site. Corrective treatment was not reported. At the time of this report the outcome of adverse event was not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This case is part of 1 cluster case and is linked to case number 2013SA113810 (same reporter, events after FLUZONE ID intradermal), lot number: UT4726AA. The five female patients, ages 18 to 64, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number UT4726AA, intradermal and site of vaccination not reported), on 29 October 2013. On 29 October 2013, after receiving vaccine the patients experienced warmth, swelling, redness and tenderness at injection site. Corrective treatment was not reported. At the time of this report the outcome of adverse event was not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 31 October 2013. A six female staff members ages 18 to 64, whose, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number UT726AA) via intradermal route (site of vaccination not reported), on 29 October 2013. On 29 October 2013, after receiving vaccine all the patients experienced warmth, swelling, redness and tenderness at injection site. One reports pain radiating to the hand in the injection site arm. Corrective treatment was not reported. At the time of this report the outcome of adverse events were not resolved. Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 31 October 2013. A six female staff members ages 18 to 64, whose, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number UT726AA) via intradermal route (site of vaccination not reported), on 29 October 2013. On 29 October 2013, after receiving vaccine all the patients experienced warmth, swelling, redness and tenderness at injection site. One reports pain radiating to the hand in the injection site arm. Corrective treatment was not reported. At the time of this report the outcome of adverse events were not resolved. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Local swelling, Skin warm
Clinical narrative: Initial report received FLUZONE ID (Lot # UT4723BA and expiration date unknown) intradermal on deltoid in-between date and 31-Oct-2013. Within 24 to 48 hours of vaccination, the patients experienced increased swelling and heat on deltoid which were quarter sized to softball size. One allergic reactions and hives. At the time of the report the patients were recovering from the reported events. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to metals, Hypoaesthesia
Clinical narrative: Initial report received from a pharmacist on 30 October 2013. A 30-year-old female patient, whose age, concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number UT4721BA, intradermal at left deltoid on 30 October 2013). On 30 October 2013, 10 minutes after receiving vaccine the patient experienced numbness of fingers of left hand and then numbness extended to left hand and left arm. Patient was allergic to nickel. At the time of this report the outcome of adverse events was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 30 October 2013. Over 50 male and female adult patients, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (lot number UT4719BA) (route and site of vaccination not reported) on 2013. On an unspecified date, after receiving vaccine patients experienced redness and swelling, itching, and heat, grapefruit, burning during injection and hard knot at the injection, lasting over a week. Corrective treatment was not reported. At the time of this report the outcome of adverse events were resolved. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Initial report received from a health care professional on 30 October 2013. Over 50 male and female adult patients, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (lot number UT4719BA) (route and site of vaccination not reported) on 2013. On an unspecified date, after receiving vaccine patients experienced redness and swelling, itching, and heat, grapefruit, burning during injection and hard knot at the injection, lasting over a week. Corrective treatment was not reported. At the time of this report the outcome of adverse events were resolved. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from a consumer on 11-November-2013. The five patients whose medical history and concomitant medications were not reported., received a dose of FLUZONE HD (lot number: UT4721AA, expiry date and site of administration was unknown) via intradermal route. Doctor stated that he administered FLUZONE ID to 27 patients and 5 of those 27 patients experienced reactions at injection site ranging in size from 1-2 cm up to 5 cm area at injection site that was red, had induration, was warm to touch, and painful. Outcome of the events was unknown. List of documents held by sender: none
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Initial report received on 05 November 2013 from a health care professional. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZOEN HD (lot number UT4720AA, Expiration date and site of vaccination were unknown) administered intradermally on 2-Nov-2013. It was reported that a pregnant female patient have received the FLUZONE HD. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report received from a reporter on 21 October 2013. A couple hundred patients, whose age, medical history and concomitant medications were not reported, had received a dose FLUZONE HD (Lot number, route and site of vaccination were not reported), last year. The reporter stated that almost everyone had a run, including me. Corrective treatment was not reported. At the time of this report the outcome of adverse event was unknonw. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Initial report received on 22-October-2014 from a nurse. A female patient whose age, medical history and concomitant medications were not reported, received a doses of FLUZONE Intradermal (lot number UT4725AA) (site and route of vaccination was not reported). On an unspecified date, after receiving the patient experienced hard, red raised area 60 m diameter, blistered 15 mm center at injection site. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 22 October 2013. The two patients whose age, gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, expiry date, route and site of administration was unknown) on 21 October 2013. On 22 October 2013, the patient's complaints of a 3 inch red raised area at the injection site of FLUZONE ID. The outcome of the event was not resolved. List of documents held by sender: none
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Local reaction, Skin warm, Tenderness
Clinical narrative: Initial report received on 22-October-2013 from a health care professional. A 30-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number UT4722BA) at delt (route of vaccination was not reported) on 21-Oct-2013. On 21-Oct-2013, after receiving vaccine the patient experienced 2" in diameter, red, hot, tender to touch, localized reaction and temperature 99.5F. The events were ongoing at the time of this report. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Initial report received from a pharmacist on 23 October 2013. A 31 year old female patient whose medical history and concomitant medications were not reported, received dose one of FLUZONE INTRADERMAL (batch no: UT4722BA) (route, site of administration not reported) on an unspecified date. Patient saw redness from her wrists to her elbows 2-3 hours after vaccine administration. She was fine when the pharmacist followed up in the evening. Lab investigation and corrective treatment were not reported. At the time of this report, the event was recovered. Documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Initial report received from a health care professional on 28 October 2013. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: unknown, expiry date: unknown) on left deltoid intradermal route on 25 October 2013. Patients experienced mild itching at the site 3 days (28 October 2013) post vaccination. The outcome of the event was unknown. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Initial report received from health care professional on 24 October 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received  FLUZONE ID (lot number: UT4719AA and expiration date unknown) intradermal (site and dose number not reported) on 18 September 2013. On an unknown date, the patient experienced a BB size hard knot and red area at injection site which continues to today, 24 September 2013). Laboratory investigation and corrective treatment were not reported. As of 24 September 2013, outcome of events were not recovered. Documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Injection site scar
Clinical narrative: Initial report received on 25 October 2013 from a health care professional. A male patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number UT4471BA, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, after receiving vaccine the patient experienced scar at injection site, raised after one year. At the time of reporting, outcome of the event was unknown. List of documents held by sender: none
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from health care professional on 25 October 2013. A 52-year-old male patient received FLUZONE ID (lot number: UT4725AA and expiration date unknown) intradermal on left arm (dose number not reported) on 23 October 2013. The patient's medical history was not reported. The concomitant medication was not reported. On 24 October 2013, the patient had developed symptoms of an injection site reaction and patient's left deltoid area became red, swollen, and warm to touch.  Laboratory investigation and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Injection site pruritus, Injection site urticaria, Laboratory test normal
Clinical narrative: Initial report received from health care professional on 24 October 2013. A 24-year-old female patient received FLUZONE ID (lot number UT4722BA and expiration date unknown) intradermal in left deltoid (dose number not reported) on 19 October 2013 and BOOSTRIX on 19 October 2013. The patient's medical history was not reported. The concomitant medication was not reported. On 19 October 2013, the patient felt week and heart racing. The patient also experienced hives and itchy at the injection site. Patient felt like the heart racing and anxiety related. Laboratory investigation includes ran tests and nothing found. Corrective treatment were not reported. As of this report, the patient had recovered from the events. Documents held by sender: none
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Initial report received from health care professional on 24 October 2013. A 24-year-old female patient received FLUZONE ID (lot number UT4722BA and expiration date unknown) intradermal in left deltoid (dose number not reported) on 19 October 2013 and BOOSTRIX on 19 October 2013. The patient's medical history was not reported. The concomitant medication was not reported. On 19 October 2013, the patient felt week and heart racing. The patient also experienced hives and itchy at the injection site. Patient felt like the heart racing and anxiety related. Laboratory investigation includes ran tests and nothing found. Corrective treatment were not reported. As of this report, the patient had recovered from the events. Documents held by sender: none
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema
Clinical narrative: Initial report received from a health care professional on 28 October 2013. A 59-year-old male patient whose medical history and concomitant medication were not reported, received a dose of  FLUZONE ID (lot number: UT4720AA, expiry date: unknown) intradermal route on 27 September 2013. Patients had a red area at injection site after receiving vaccine on 27 October 2013. The event was not recovered. Patient received had several flu vaccines also last year. List of documents held by sender: none
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 28 October 2013. A 59-year-old male patient whose medical history and concomitant medication were not reported, received a dose of  FLUZONE ID (lot number: UT4720AA, expiry date: unknown) intradermal route on 27 September 2013. Patients had a red area at injection site after receiving vaccine on 27 October 2013. The event was not recovered. Patient received had several flu vaccines also last year. List of documents held by sender: none