chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Initial report received from a healthcare professional on 23 October 2012. A 62-year old female patient, whose concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (Batch number: UT4463BA) in left deltoid on 27 August 2012. The patient had no illness at the time of vaccination and had allergy to PCN. The patient had medical history of GERD, diabetes and high cholesterol. On 27 August 2012, on the same day after receiving FLUZONE ID, the patient experienced lump at injection site about half inch in diameter. At the time of this report, the patient had not seen the physician. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None. Follow up information received on 01 February 2013: The patient's concomitant medications included, Metformin 500 milligram, NEXIUM 40 milligram, Glipizide XL 5 milligram, Simvastatin 40 milligram, Chlorthalidone 25 milligram and NASONEX.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via direct contact, Eye irritation
Clinical narrative: Initial report received from a healthcare professional on 17 September 2012. A female patient of unspecified age, whose concomitant medications and medical history was not reported, had received dose of FLUZONE HD vaccine (Lot number, Route, anatomical site of vaccination were not reported) on unspecified date. It was reported that the patient was standing 6 feet way when the dose was adminsitered and the safety shield was activated. After 5 hours of administering the vaccine i.e. on 10 September 2012, the patient had burning sensation in her eyes and thought that the vaccine must have gone into her eyes. The reporter advised the patient to flush her eye and the burning sensation in eyes had resolved on unspecified date. Corrective treatment was not reported. List of documents held by the sender none.
Sex: M
Vaccine: FLU3
Symptoms: Scar
Clinical narrative: Initial report received from non-healthcare professional (Attorney) on 21 May 2013. The male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE intradermal (batch number and dose number were not reported) intradermally in upper left arm on 26 January 2013. It was reported that on an unspecified date, after receiving Influenza vaccine, the patient experienced scar.  The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fall, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Initial report received from a healthcare professional on 03 October 2012. A 43-year-old female patient, whose medical history is none and concomitant medication was not reported, received an intradermal dose 1 of FLUZONE ID (Lot number UT4472AA anatomical site of vaccine was not reported) on 01 October 2012. It was reported at the time of vaccination the patient had stiff neck and general malaise. On 02 October 2012, 1 day after vaccination patient experienced swelling and redness at the injection site that extended up to the right shoulder and neck area. At the time of this report patient reported the neck pain was stabbing and was referred to physician. No laboratory investigations were performed. Corrective medications were not reported. The patient's outcome was reported at as unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 19 December 2012: It was reported that after discussing reaction with employee it was discovered that she had hiked in the woods and fell. Her symptoms were not related to her vaccination. There were other personal reason she stated these symptoms were from the vaccine not the fall.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Initial report received from a healthcare professional on 03 October 2012. A 43-year-old female patient, whose medical history is none and concomitant medication was not reported, received an intradermal dose 1 of FLUZONE ID (Lot number UT4472AA anatomical site of vaccine was not reported) on 01 October 2012. It was reported at the time of vaccination the patient had stiff neck and general malaise. On 02 October 2012, 1 day after vaccination patient experienced swelling and redness at the injection site that extended up to the right shoulder and neck area. At the time of this report patient reported the neck pain was stabbing and was referred to physician. No laboratory investigations were performed. Corrective medications were not reported. The patient's outcome was reported at as unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 19 December 2012: It was reported that after discussing reaction with employee it was discovered that she had hiked in the woods and fell. Her symptoms were not related to her vaccination. There were other personal reason she stated these symptoms were from the vaccine not the fall.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Swelling
Clinical narrative: Initial report received from a healthcare professional on 22 October 2012. A 9-year-10-month-old male patient, who had no known allergies or illness at the time of vaccination and whose concomitant medications were not report, had received an intradermal dose 1 of FLUZONE ID (lot number: UT4470AA) in the left arm on 18 October 2012. It was reported that FLUZONE ID was given to a patient of 9 year 10 months of age, thus vaccine was administered at an inappropriate age. On 19 October 2012, 1 day after the vaccination, the patient developed swelling. Corrective treatment and laboratory investigations were not reported. At the time of this report, the swelling was decreasing and the patient had not recovered. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Initial report received from a healthcare professional on 23 October 2012. A 23-year-old female patient, who has medical history of allergy to food (Bananas and Avocados) and whose concomitant medications were not reported, received a dose of FLUZONE ID vaccine (lot number: UT4464AA) intradermally in the left deltoid on 20 October 2012. On 22 October 2012, 2 days after vaccination, the patient experienced swelling on her collar bone (left side same as injection site). There was no redness or pain. Corrective medications and laboratory investigations were not reported. As of 23 October 2012, the patient had not recovered from the event. List of documents held by sender: none.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Flushing, Hyperhidrosis, Paraesthesia oral
Clinical narrative: Initial report was received from a healthcare professional on 18 October 2012. The reporter for this case is the same as for case number 2012-09899. An unknown patient (age, gender and birth date not reported) received an Intradermal injection of FLUZONE intradermal, Sanofi Pasteur Inc., lot number UT4470AA (site and side not reported) on 18 October 2012. On 18 October 2012, within a few minutes after the vaccination, the patient experienced chest tightness and diaphoresis and had to go to the emergency room due to anaphylactic reaction. The patient also experienced numbness and tingling on the roof of the mouth, severe vertigo, flushing and shortness of breath. The patient was observed in the emergency room for one half hour and then the patient was discharged when symptoms subsided. The patient's medical conditions and illness at time of vaccination was reported as unknown. The patient had a penicillin (PCN) allergy and had received Flu vaccines in the past. The patient's outcome was reported as unknown. Follow-up information was received from a healthcare professional on 19 October 2012. Based upon the new information provided, this case has been downgraded to non-serious. The patient was 39-years-old. As information was provided for both cases (cluster), the individual patient's history was not able to be determined. One of the two patients had a penicillin (PCN) allergy and the other patient had no allergies. Neither patient had a food allergy or history of anxiety disorder. Both patients had received intramuscular Influenza vaccines in the past without incident. Both patients had tightness of chest and diaphoresis. One of the two patients experienced flushing and "throat tingling". Both patients were observed in the emergency room (ER); no epinephrine or antihistamine was administered. The patient was discharged from the ER after one half hour observation when symptoms subsided. Based on follow-up information, the events of anaphylactic reaction, shortness of breath, vertigo CNS origin and numbness mouth were removed from MedDRA coding. The patient's outcome was reported as recovered. Documents held by sender: None. Follow-up information was received on 06 November 2012. This case is cluster with 2012-09899 and 2012-10407 same reporter and same lot number. The patient's gender male. The patient had received intramuscular Influenza vaccine in the past without adverse event and had no allergy. The previously reported event diaphoresis was no longer reported in the follow-up. On 18 October 2012, the patient had recovered. The patient did not receive any treatment in the emergency department.
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Initial report was received from a healthcare professional on 17 October 2012. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose intradermal FLUZONE Intradermal (batch number and site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient experienced redness from shoulder to elbow. The corrective treatments and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Initial report received from a healthcare professional on 09 October 2012. The patient (No information about number of patient), whose age, gender, medical history and concomitant medications were not reported, had received intradermal dose of FLUZONE intradermal vaccine (lot number: UT4467BA, site of vaccination was not reported) on an unspecified date. It was reported that, the patient experiences soreness, redness and swelling up to 1 week after injection, date was not reported. It was also reported the physicians' here in office no longer want to administer the intradermal due to the side effects and patient complaints. The patient corrective treatment and lab detail were not reported. The patient's outcome was not reported. List of documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling of body temperature change, Hot flush, Musculoskeletal stiffness, Neck pain
Clinical narrative: Initial reprot received from a healthcare professional on 11 October 2012. A 32-year-old female patient received FLUZONE intradermal (batch number: UT4473AA) in the left deltoid on 10 October 2012. Medical history reported as none. Concomitant medications not reported. On 10 October 2012, after receiving vaccine at 10 AM, by 12 noon the patient had really achy body. At 3 PM, she was having hot flashes and hot and cold hands and feet, racing heart, dizziness and was just able to crawl into bed. At 3 AM, she reported neck and spine pain and stiffness. She was advised to see doctor. The lab investigations and treatment medications were not reported. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Palpitations, Spinal pain
Clinical narrative: Initial reprot received from a healthcare professional on 11 October 2012. A 32-year-old female patient received FLUZONE intradermal (batch number: UT4473AA) in the left deltoid on 10 October 2012. Medical history reported as none. Concomitant medications not reported. On 10 October 2012, after receiving vaccine at 10 AM, by 12 noon the patient had really achy body. At 3 PM, she was having hot flashes and hot and cold hands and feet, racing heart, dizziness and was just able to crawl into bed. At 3 AM, she reported neck and spine pain and stiffness. She was advised to see doctor. The lab investigations and treatment medications were not reported. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Initial reporter received from a consumer who is also the patient on 10 October 2012. A 36-year-old female patient, whose concomitant medications and medical conditions were not reported, had received FLUZONE ID vaccine (Lot number unknown, route and anatomical site of vaccination were not reported) on 09 October 2012. The patient had no known allergies. On 10 October 2012, the patient had itching, redness, hard lump about size of golf ball around injection site. Corrective treatment and laboratory investigations were not reported. The patient's outcome was not recovered. Follow-up information received from a healthcare professional on 18 January 2013. The patient received FLUZONE HD (Lot number- UT4404AA, expiry date- 3/26/2013), in left deltoid. The patient had no illness at the time of vaccination. The patient  had spontaneously recovered from the events without any prescription or treatment on an unspecified date. List of documents held by the sender: None.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 10 October 2012. A 34-year-old female patient whose medical history and concomitant medications were not reported; had received first intradermal (ID) dose of FLUZONE ID (lot number UT4474AA) in right deltoid on 08 October 2012. On 08 October 2012 in the evening of vaccination, the patient developed area of approximately 4 inches of induration around injection site, red and swollen states area continues at present. Details of corrective treatments were not reported. Laboratory investigation was reported as none. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional who is also the patient on 10 October 2012. A female patient whose age, medical history and concomitant medications were not reported; had received a dose of FLUZONE intradermal vaccine (lot number, anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient reported that she had had large amount of swelling in upper arm following the administration. Lab investigations and corrective measures were not reported. The patient's outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional on 10 October 2012. A female patient whose age, medical history and concomitant medications were not reported; had received a dose of FLUZONE intradermal vaccine (lot number, anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient reported that she had very large swollen upper arm following the administration. Lab investigations and corrective measures were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Headache, Injection site pruritus
Clinical narrative: Initial report received from a healthcare professional on 09 October 2012. A 34-year-old female patient, whose illness at the time of vaccination was none and had allergy to sulfa drugs with no medical conditions, had received second dose of FLUZONE intradermal (Lot number: UT4473AA) in left deltoid on 02 October 2012. The patient had received one dose of FLUZONE ID in past. It was reported that on 02 October 2012 after receiving vaccine i.e. within 15 minutes, the patient experienced metallic taste in mouth, headache and itch at injection site. Laboratory details were none. Corrective measures were not reported. On 04 October 2012, 48 hours later, the patient recovered from the events. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: This is a cluster of 4 cases linked with AER 2012-09425, 2012-09427 and 2012-09434 developed adverse events following the FLUZONE ID administration (lot number UT4467AA). This case is also linked with 2012-09426, 2012-09424, 2012-09431. Initial and follow up report received from a healthcare professional on 05 October 2012. A 43-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE intradermal (lot number UT4467AA) in the left/right deltoid on 18 September 2012 or 19 September 2012 or 25 September 2012 or 28 September 2012. Within about 24 hours of vaccination, arm had 3 inch round welt and swelling and redness from side to side of shoulder and markedly raised and also have considerable itching. Lab investigations and corrective treatments were not reported. The patient's outcome was recovered on unspecified date. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: This is a cluster of 4 cases linked with AER 2012-09425, 2012-09427 and 2012-09435 developed adverse events following the FLUZONE HD administration (lot number UT4467AA). This case is also linked with 2012-09426, 2012-09424, 2012-09431. Initial report received from a healthcare professional on 08 October 2012. A 37-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE intradermal vaccine (lot number UT4467AA) in the left/right deltoid on 18 September 2012 or 19 September 2012 or 25 September 2012 or 28 September 2012. Within about 24 hours of vaccination, arm had 3 inch round welt and swelling and redness from side to side of shoulder and markedly raised. Lab investigations and corrective treatments were not reported. The patient's outcome was recovered on unspecified date. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Initial report received from a consumer on 05 October 2012. A 42-year-old female patient, who had no known allergies and whose concomitant medications included 'Loestran' and MVI, had received a dose of the FLUZONE vaccine (batch number: unknown) in the right arm intradermally on 3 October 2012. The patient has received many doses of FLUZONE ID in the past. On 3 October 2012, same day of vaccination, the patient experienced 3 inches redness around the injection site that was warm to touch. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 17 December 2012. The patient had received dose one of FLUZONE Intradermal on an unspecified date in 2011. The patient had received dose 2 of FLUZONE Intradermal (lot number: UT4474AA).
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial report received from a healthcare professional on 15 November 2012. A 64 year-old male patient had received an Intramuscular dose of FLUZONE vaccine (Lot number: UT4472BA) on Left arm on 11 October 2012. The patient's had allergy to latex and NSAIDs. The patients medical history, concomitant vaccines, family history was not reported. On 15 October 2012, the patient had left deltoid tenderness, induration, redness and swelling. Also the patient had pain down the arm and it hurts when moving the arm. Corrective treatment was not reported and laboratory investigations were reported as none. At the time of this report received the patient was not recovered. Document held by sender: None.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 15 November 2012. A 64 year-old male patient had received an Intramuscular dose of FLUZONE vaccine (Lot number: UT4472BA) on Left arm on 11 October 2012. The patient's had allergy to latex and NSAIDs. The patients medical history, concomitant vaccines, family history was not reported. On 15 October 2012, the patient had left deltoid tenderness, induration, redness and swelling. Also the patient had pain down the arm and it hurts when moving the arm. Corrective treatment was not reported and laboratory investigations were reported as none. At the time of this report received the patient was not recovered. Document 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 14 November 2012. A female patient (age not reported) had received a dose intradermal of FLUZONE ID vaccine (lot number and dose number were not reported) in right deltoid on 13 November 2012. The patient's had no illness at the time of vaccination and pre-existing physician-diagnosed allergies, birth defects and medical conditions were not available. The patient's concomitant medications were not reported. On 13 November 2012, after vaccination the patient's right shoulder and whole arm were sore all day after vaccine and now feel fine. Corrective medications and laboratory investigations were not reported. On an unspecified date, the patient's outcome was recovered. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case is a part of cluster of 5 cases and is linked with 2012-10398, 2012-10466, 2012-10467, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a healthcare professional on 06 November 2012. A male patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID vaccine (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case is a part of a cluster of 5 cases and is linked with 2012-10398, 2012-10466, 2012-10468, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a healthcare professional on 06 November 2012. A female patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case is a part of cluster of 5 cases and is linked with 2012-10398, 2012-10467, 2012-10468, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a healthcare professional on 06 November 2012. A female patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID vaccine (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain, Vomiting
Clinical narrative: Initially this case was reported with two unidentified patient in case ID 2012-09898. The reporter for this case is the same as for case number 2012-08999. Summary narrative: Initial report was received from a healthcare professional on 18 October 2012 and follow up information received on 19 October 2012 and 06 November 2012. A 57-year old male patient received an Intradermal injection of FLUZONE intradermal, sanofi pasteur Inc., lot number UT4470AA (site and side not reported) on 18 October 2012, one day after post vaccination the patient experienced a painful vomiting and he was away from work for three days, He did not seek medical care. The patient's medical conditions and illness at time of vaccination was reported as unknown. The patient's outcome was reported as recovered on unspecified date. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case is a part of a cluster of 5 cases and is linked with 2012-10466, 2012-10467, 2012-10468, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a consumer (healthcare professional) on 06 November 2012. A male patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Follow-up information received from a healthcare professional on 05 April 2013: The patient's age was updated as 42 years. The patient had no illness at the time of vaccination. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Mobility decreased, Swelling
Clinical narrative: This case is a part of a cluster of 3 cases and is linked to 2012-10348 and 2012-10322 (reported by same reporter, after FLUZONE ID batch - number UT4472AA). Initial report received from a healthcare professional on 01 November 2012. A female patient, whose age, medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (batch number UT4472AA, site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination, the patient experienced warmth, swelling and trouble lifting arm. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome was not reported. Follow up information received from a healthcare professional on 25 March 2013. Patient's age at the time of event was reported as 52 years. The patient had no significant medical history or illness at the time of vaccination. The patient was vaccinated on 23 October 2012 in the right arm. The event start date was reported as 24 October 2012. The patient applied warm compresses and had taken MOTRIN as corrective treatment. The patient had recovered from the event after approximately 5 days. Document held by the sender: Consent for Influenza vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: This case is a part of a cluster of 3 cases and is linked to 2012-10349 and 2012-10322 (reported by same reporter, after FLUZONE ID batch number: UT4472AA). Initial report received from a healthcare professional on 01 November 2012. A female patient, whose medical history and concomitant medications were not reported, whose age, medical history and concomitant medication were not reported, had received an intradermal dose of FLUZONE ID (batch number UT4472AA, site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination, the patient developed redness on entire length of upper arm with warmth. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Follow-up information received from a healthcare professional on 25 March 2013: The patient's age was updated as 52 years. The patient had no illness at the time of vaccination and had no pre-existing physician diagnosed allergies birth defects or medical conditions. The patient had no history of adverse event post vaccination in the past. The vaccine was administered in the left deltoid on 24 October 2012. Redness of arm and warmth had started on 25 October 2012. The patient received warm compression and TYLENOL as corrective treatment approx. 04 days. The patient's outcome was recovered on an unspecified date.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 02 November 2012. A 43-year old male patient, whose medical history and concomitant medications were unknown, had received an intradermal dose of FLUZONE ID (batch number UT4474AA) in the right arm on 31 October 2012. On 01 November 2012, 1 day after vaccination, the patient developed a red raised area 4.5 inches surrounding the site. Corrective treatment and laboratory details were not reported. At the time of this report, the patient had not recovered. List of documents held by sender was none.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Limb discomfort, Musculoskeletal pain
Clinical narrative: Initial report received from a healthcare professional on 05 October 2012. A female patient whose medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID vaccine (lot number UT4464AA, site of administration were not reported) on an unspecified date. On an unspecified date, the patient complained of left shoulder pain, extremity heaviness, numbness, dizziness more than two weeks and severity of pain was reported as 7/10. Corrective treatment and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Tenderness
Clinical narrative: This case is a part of cluster of 3 cases and is linked to 2012-10349 and 2012-10348 (reported by same reporter, after FLUZONE ID batch number UT4472AA). Initial report received from a healthcare professional on 01 November 2012. A female patient whose age, medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (batch number UT4472AA, site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination, the patient developed redness down upper arm with extreme tenderness and the patient could not touch the arm. The patient had 6 to 8 inches redness. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome was not reported. List of documents held by sender was none. Follow-up information received from healthcare professional on 25 March 2013. The patient was 43-year-old. The patient has a history of immunocompromise due to unspecified medication for Rheumatoid arthritis. The patient had no illness at the time of vaccination with no adverse event following prior vaccination. The patient received Intradermal FLUZONE on 23 October 2012 in right arm and experienced adverse event on 24 October 2012. The patient applied warm compresses. At the time of this report, the patient's outcome was recovered on unspecified date (approx. 1 week).
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Induration, Local reaction, Musculoskeletal stiffness, Neck pain
Clinical narrative: Initial report received from a healthcare professional on 30 October 2012. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of intradermal FLUZONE vaccine (Lot number, dose number and site of administration not reported) on an unspecified date. On an unspecified date, the patient presented larger than normal localized reaction with golf ball sized induration last 7 days. The patient also experienced stiffness and pain running up to the base of her neck and brain stem as well as pain down to her wrist for 7 days in her immunized arm. Laboratory details and corrective treatment was not reported. The patient's outcome was not reported. List of documents held by the sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 30 October 2012. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of intradermal FLUZONE vaccine (Lot number, dose number and site of administration not reported) on an unspecified date. On an unspecified date, the patient presented larger than normal localized reaction with golf ball sized induration last 7 days. The patient also experienced stiffness and pain running up to the base of her neck and brain stem as well as pain down to her wrist for 7 days in her immunized arm. Laboratory details and corrective treatment was not reported. The patient's outcome was not reported. List of documents held by the sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional (Nurse) on 23 October 2012. A female patient, whose age, medical history and concomitant medication were not reported received an intradermal dose of FLUZONE vaccine; lot number UT4471AA (anatomical site of administration was not reported), on an unspecified date. On an unspecified date the patient's arm had swollen and she considered it as "severe" type of reaction. The corrective treatment and lab investigations were not reported. At the time of this report, outcome was not reported. Documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperhidrosis
Clinical narrative: Initial information received from a healthcare professional on 25 October 2012. A 48-year-old male patient with the history of type 2 diabetes and seasonal allergies and concomitant medication were reported as Janumet (Metformin and Sitagliptin), ASA (81mg) and vitamins; had received 2nd intradermal dose of FLUZONE intradermal (lot number UT4473AA) in the left deltoid on 24 October 2012 at 2:30 pm. The patient had no known drug allergy. On 24 October 2012, 6 hours after vaccination i.e. at 8:30 pm the patient developed achiness, headache, chills and sweats. The lab investigations were not reported. The patient self-medicated with ALEVE and had little relief. The patient's outcome was unknown. Documents held by sender: none.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 25 October 2012. A 53-year-old male patient had had no known allergies and no relevant medical conditions; had received 1st intradermal dose of FLUZONE ID (Lot number unknown) in left deltoid on 24 October 2012. The patient had received several doses of FLUZONE intramuscular on an unspecified date. The patient concomitant medication detail was not reported. As per reporter illness at the time of vaccination was none. On 24 October 2012, in the afternoon the patient experienced soreness at the injection site and swelling. Later that night the patient began to experience more swelling and redness at injection site which was 2-3 inches around injection site. The patient also experienced swollen glands of upper neck at left side of the neck. The forehead felt slightly warm and did know if the patient had fever. The lab investigations and treatment medications were not reported. At the time of this report, the outcome of the events was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 12 September 2013. This reported involved a cluster of three patients. This case is linked to case numbers 2012-10777, 2013-09581, 2013-09582, 2013-09583, 2013-09584 and 2013-09585. Three pregnant female patients (age ranges of 25-35 years) had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced injection site reactions. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This case is a part of 2 cluster cases and is linked to case number 2013-03417 (Same reporter, same vaccine: FLUZONE ID lot number UT4472AA). Initial report received from a healthcare professional on 25 February 2013. A male patient (age at the time of event and date of birth were not reported), had received a dose of FLUZONE ID (batch number: UT4472AA, expiry date 04-10-2013, dose number, route and anatomical site of administration were not reported) on an unspecified date in Flu season September 2012-January 2013. It was reported that, after receiving the vaccine on an unspecified date it was more painful. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was unknown. Follow up information received from a healthcare professional on 06 May 2013. The patient had recovered from the event on an unspecified date. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 07 March 2013. A 60-year-old male patient, had received first intradermal dose of FLUZONE ID (Lot number: UT4466BA, expiry date: 04/02/2013) on the right deltoid on 11 January 2013. The patient had no known allergies, previous medications or pre-medical history (PMH). The patient denied any illness at the time of vaccination and concomitant medications were not reported. On 12 January 2013, the patient had initially experienced swelling and bruising at the site however a hard pink nodule persisted at the injection site. Corrective treatments and relevant laboratory data were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional (receptionist) on 29 January 2013. A 25-year-old female patient received an intradermal first dose of FLUZONE ID (lot number unknown, anatomical site of administration was not reported) on 29 January 2013. The patient was 7 weeks pregnant at the time of vaccination. The reporter had no information regarding patient's pregnancy. The patient's last menstrual period date was unknown and estimated delivery date was not reported. The patient's concomitant medications were not reported. Laboratory data was not reported. As of 29 January 2013, the patient had not experienced any adverse event. Follow up information received from a healthcare professional on 01 July 2013: The patient had received FLUZONE intradermal (batch number: UT4466AA) in Left deltoid. The patient had experienced redness, swelling and warmth at the site of injectio on an unspecified date. Outcome of the injection site reaction was not reported. The patient had no previous pregnancies. The patient had no illness at time of vaccination and had not received any drug during pregnancy or prior to fertilization that could remain at the time of fertilization.  The patient had no pregnancy complications or family history of congenital abnormality. The patient's last menstrual period date was 12 December 2012 and expected date of delivery was reported as 18 September 2013. Prenatal test data was not provided as it was not at the reporter's clinic. The father's age was reported as 26 years and he had no significant medical conditions. List of documents held by the sender: None.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event, Exposure during pregnancy
Clinical narrative: Initial report received from a healthcare professional on 04 March 2013. A female patient (age was not reported), had received an intradermal dose of FLUZONE ID vaccine (Lot number: UT4478AA, expiry date: 04/23/2013, number in series: unknown, site of administration was not reported) on 03 March 2013. The patient was pregnant. The patient's last menstrual period date and estimated date of delivery were not reported. The patient's health during pregnancy and risk factors was unknown. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced adverse event (no further details were reported). Corrective treatment and laboratory details were not reported. Documents held by sender: none. Follow up information received from a healthcare professional on 16 May 2013. The patient had no illness at the time of vaccination. No other information was reported. Follow up information received from a healthcare professional on 21 June 2013: The patient's pregnancy details were unknown.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Headache, Sinus congestion, Swelling face
Clinical narrative: Initial report received from healthcare professional on 22 January 2013. A 43-year-old female patient had medical history of FLAGYL allergy and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (batch number-UT4470AA) in left arm (deltoid) on 12 January 2013. The patient denied illness at the time of vaccination. On 13 January 2013 the patient experienced mild to moderate facial swelling 48 hour post vaccination and on unspecified date the patient experienced headache and sinus congestion 72-96 hours post vaccination. It was reported that, as per physician the patient had an allergy to the flu vaccine however it was not confirmed. The patient took self-treatment as BENADRYL, TYLENOL and Ibuprofen and symptoms were resolving within 1-2 hours. On 17 January 2013, the patient was evaluated by physician and no medical treatment was prescribed. Laboratory investigations/relevant diagnostic tests were not reported. At the time of this report, the outcome of events was unknown. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 23 January 2013. A female patient (age was not reported) had received an intradermal dose 1 of FLUZONE ID, lot number UT4471AA on 21 January 2013. The patient was pregnant. The patient's last menstrual period date was unknown. The estimated date of delivery was not reported. On an unspecified date, the patient had experienced redness and swelling at the injection site. The patient's health during pregnancy and risk factors were unknown. Concomitant medications and medical history were not reported. At the time of this report, the outcome of events was not reported. Documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Initial report received from a healthcare professional on 24 January 2013. A 39-year-old female patient, whose concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (batch number: UT4472A) in right deltoid on 23 January 2013. The patient had no illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were not enquired by reporter. On 23 January 2013 (same day of vaccine) the patient's jaw felt funny by her left ear and on 24 January 2013 patient reported facial numbness and left side of face appeared different than the right. Laboratory investigations/relevant diagnostic tests and corrective treatment were not reported. At the time of this report, the outcome of patient was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 05 April 2013. The patient's outcome was recovered on an unspecified date.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: Initial report received from healthcare professional on 16 January 2013. A 61-year-old female patient, who had medical history of sulfa allergies, GERD (Gastroesophageal reflux disease), osteopenia and dermatitis and concomitant medication included CENTRUM SILVER, Vitamin D3, Vitamin E and fish oil, had received an intradermal dose of FLUZONE ID (lot number: UT4473AA) in left deltoid on 22 October 2012. On 22 October 2012, the patient experienced redness and swelling at the injection site. On 16 January 2013, patient claimed of a flat lesion with a slight white scale at the injection site. The patient had not received any corrective treatment by physician and laboratory details were not reported. At the time of this report, the patient's outcome of the event was unknown. Follow up information received from a healthcare professional on 24 January 2013. The reporter's (physician) address was changed. Follow-up information received from a healthcare professional on 05 April 2013. The patient had developed permanent scar. Documents held by sender: Photo of the affected site. Follow-up information received on 05 June 2013 and 06 June 2013 from a healthcare professional. On an unspecified date, the patient had round erythematous area approximately of 1 cm in diameter consistent with post-inflammatory erythema. The patient also had a flat lesion with slight white scale at the vaccination site. It was reported that this post-inflammatory erythema will take some time to resolve. The physician advised the patient to refer to the dermatology for evaluation and management of lesion. The adverse event permanent scar was no longer reported, so this event was deleted from database. The patient was evaluated but didn't receive any treatment.