chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Oral herpes
Clinical narrative: Initial information received from a healthcare professional on 02 January 2014. A female patient, whose demographics, medical history and concomitant medications were unknown, had received a dose of influenza vaccine (Manufacturer unknown, batch number, dose number, route and anatomical site of administration unknown) on an unspecified date. On an unspecified date, the patient experienced a bad reaction and developed a cold sore. Laboratory data and corrective medications were unknown. Further details were not available at the time of this report. The patient outcome was unknown. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received from a consumer on 02-Dec-2013. a 67-year-old male patient whose medical history was not reported received and she had intradermally a dose of influenza vaccine (batch number and site of administration not reported). On an unspecified date, after vaccination the patient experienced allergy to vaccine. Lab investigations and treatment medications were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: This case is associate with 2013SA102511. Initial report received from consumer or other non HCP on 26 November 2013. A unknown-year-old female patient whose medical history and concomitant medications were not reported received FLU VACCINE (lot number unknown and expiration date unknown) (route, site and dose number not reported) on 05 October 2013. On an unknown date, the patient felt bad. Laboratory investigation and corrective treatment were not reported. As of this report, the event outcome was unknown. Documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Initial report reported by consumer on 18 November 2013. A 20 year old female, medical history and concomitant unknown, received dose of Flu vaccine (Lot#, vaccination site was unknown). Patient think vaccination was given intramuscular but she was not sure. It was reported that she experienced injection site pain and the pain travelled through her shoulder blade. Patient was recovered from the event on next day. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nasopharyngitis
Clinical narrative: Initial report received from healthcare professional on 26 November 2013. A 48-year-old female patient whose medical history and concomitant medications were not reported, received influenza vaccine (lot number and expiration date unknown) on 07 November 2013. The patient reported that she received influenza vaccine while in the hospital for her multiple sclerosis. On 08 November 2013, she has cold symptoms the next day but those are the same symptoms she has with her multiple sclerosis (MS) and stated did not think symptoms were related to flu vaccine. She stated that her resolved and she was fine now. The patient also reported that after she got home from hospitalization she had taken DAYQUIL and experienced dizziness after taking the DAYQUIL which had never happened before when she took DAYQUIL and stated that she had also been taking new information for her multiple sclerosis which probably didn't go with taking the DAYQUIL. As of this report, the patient was recovered from the event. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Periarthritis, X-ray
Clinical narrative: Initial report received from a health care professional on 21 November 2013. A male patient whose age, medical history and concomitant medications were not reported, received a dose of influenza vaccine (lot number: unknown, administration site and route was not reported) on 23 October 2013. Within 2 hours, patient complained of severe pain in the arm and shoulder of the injection site. Patient's primary care doctor who did an MRI and x-rays to r/o spine, nerve problems. He has since been seeing an orthopedic doctor and now doing physical therapy 3x week for a frozen shoulder. He has been receiving the flu shot yearly for 10 years with no problems. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Initial report received from a health care professional on 10 November 2013. A 69-years old female patient had received a dose of High-Dose vaccine (Influenza vaccine) (lot number unknown and route and site of vaccination was not reported) on an unspecified date in October 2013. The medical history of the patient and concomitant medication was not reported. It was reported that after vaccination in October 2013 the patient arm ws hurt for three days and her arm was warm to touch. The corrective treatment was not reported. At the time of this report, the patient was fully recovered. Documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Malaise
Clinical narrative: Initial case was received from a consumer on 14 November 2013. This female patent of unknown age whose medical history and concomitant medication was not reported had received an influenza vaccine (flu shot , batch number, dose, route and anatomical site of administration not reported) on 30 September 2013. On 08 November 2013 and on next day she "did not feel well" and went to emergency room. She ws experiencing "stomach issue". ON 11 November 2013, she was to start with teriflunomide (Aubagio) but, had not started because of warning about Aubagio that waiting period is about six months if they received certain vaccine before starting the teriflunomide. No corrective treatment or laboratory investigations were mentioned. The outcome of the event was unknown. The list of documents held by sender: none
Age: 20.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Initial information received from a consumer on 18 November 2013. A 20-year-old female patient whose medical history was not reported had received a flu shot (manufacturer unknown) (batch number, route and site of administration not reported) on 15 November 2013. On an unspecified date, the patient had lot of pain at the injection site but also traveled through her shoulder blade. The patient was ok very next day. Lab investigations and treatment medications were not reported. List of documents held by sender: none  Follow-up information received from a health care professional on 17 January 2014: No additional information was available.
Age: 20.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Initial information received from a consumer on 18 November 2013. A 20-year-old female patient whose medical history was not reported had received a flu shot (manufacturer unknown) (batch number, route and site of administration not reported) on 15 November 2013. On an unspecified date, the patient had lot of pain at the injection site but also traveled through her shoulder blade. The patient was ok very next day. Lab investigations and treatment medications were not reported. List of documents held by sender: none  Follow-up information received from a health care professional on 17 January 2014: No additional information was available.
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from consumer's sister on 05 November 2013 and on 07 November 2013. A 50-year-old female patient whose medical history and concomitant medications were not reported, received ADACEL (lot number U4689AA, expiration date unknown) intramuscularly and administration site was deltoid on an unknown date. Also patient received influenza (flu vaccine) (lot #, expiration date, route and administration site were unknown). On an unknown date, the patient's injection site was red, swollen, itchy and hard. Reporter stated that the patients symptoms were resolving without any medical intervention. Laboratory investigation and corrective treatment were not reported.  Documents held by sender: none
Age: 31.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Mobility decreased, Nausea, Pyrexia, Tremor
Clinical narrative: A 31-year-old female patient, whose had egg yolk allergy, hazelnut , PCN, bell peppers, received dose of INFLUENZA vaccine (batch number, route, dose and exact site of administration not reported) on an unspecified date in 2012 fall.  On the same day of vaccination, within an  hour the patient had shakes, fever, and nausea lasted for a week. The patient also had vomiting which lasted a week. Count not get out of bed. Missed work. Works in health care and was required to have the vaccine. Lab investigation and corrective treatment were not reported. At the time of this report, the patient was recovered. Documents held by sender: none
Age: 31.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: A 31-year-old female patient, whose had egg yolk allergy, hazelnut , PCN, bell peppers, received dose of INFLUENZA vaccine (batch number, route, dose and exact site of administration not reported) on an unspecified date in 2012 fall.  On the same day of vaccination, within an  hour the patient had shakes, fever, and nausea lasted for a week. The patient also had vomiting which lasted a week. Count not get out of bed. Missed work. Works in health care and was required to have the vaccine. Lab investigation and corrective treatment were not reported. At the time of this report, the patient was recovered. Documents held by sender: none
Age: 31.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: A 31-year-old female patient, whose had egg yolk allergy, hazelnut , PCN, bell peppers, received dose of INFLUENZA vaccine (batch number, route, dose and exact site of administration not reported) on an unspecified date in 2012 fall.  On the same day of vaccination, within an  hour the patient had shakes, fever, and nausea lasted for a week. The patient also had vomiting which lasted a week. Count not get out of bed. Missed work. Works in health care and was required to have the vaccine. Lab investigation and corrective treatment were not reported. At the time of this report, the patient was recovered. Documents held by sender: none
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Initial report received from a consumer or other health care professional on 22 October 2013. A female patient whose illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, but received an Flu vaccine (lt number not reported, site and route of administration were not reported) on an unspecified date. The next night after receiving the flu vaccine, she developed headache, sore throat, congestion but got better in a couple of days. Laboratory investigations were not reported. Corrective treatment was not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: None  Follow-up received on 13 November 2013: No new information can be obtained.
Age: 88.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Multiple allergies
Clinical narrative: Initial report received from a non-health care professional (consumer) on 23 October 2013. A female patient (whose age and date of birth was not reported)  had received an unknown dose of flu vaccine (influenza vaccine) (lot number unknown and route and site of vaccination was not reported) on an unspecified date. The medical history of the patient and concomitant medication was not reported. It was reported that the patient had multiple allergies due to flu shot. The corrective treatment was not reported. At the time of this report, the outcome of adverse event was not reported. Documents held by sender: none
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: Initial case received from the consumer on 08 October 2013. This patient with unknown demographics (age and gender not reported) whose medical history was not reported and received HYALURONATE sodium injection to the knee, had received INFLUENZA vaccine (manufacturer, batch number, dose, route and anatomical site of administration unknown) on an unknown date. On an unknown date, she got a severe reaction when she got a flue shot. No laboratory details were reported. No corrective treatment was reported. The outcome of the event was not reported. List of documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Immediate post-injection reaction, Joint swelling, Nausea, Syncope
Clinical narrative: This case is linked to the case 2014SA009417. Initial report received from a health care professional on 17 January 2014. A female patient had received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported on an unspecified date in 2013. On 28 January 2013, the patient experienced vomiting for 3 times, syncope attack for 3 times, hot flush and nausea. It was reported that the patient had experienced softball size swelling of arm immediately after vaccination. Laboratory details and corrective treatment was not reported. The outcome of the adverse event was unknown. Documents held by sender: none  Follow-up received on 24 March 2014. No additional information to add. Documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case is linked to the case 2014SA009417. Initial report received from a health care professional on 17 January 2014. A female patient had received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported on an unspecified date in 2013. On 28 January 2013, the patient experienced vomiting for 3 times, syncope attack for 3 times, hot flush and nausea. It was reported that the patient had experienced softball size swelling of arm immediately after vaccination. Laboratory details and corrective treatment was not reported. The outcome of the adverse event was unknown. Documents held by sender: none  Follow-up received on 24 March 2014. No additional information to add. Documents held by sender: none
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Initial report received from a consumer on 21 January 2014. A 61-year-old female patient had received an intradermal dose of FLUZONE ID, batch number and dose number were not reported) in the left arm on 16 January 2014. Patient is allergic to mycins, penicillin and has arthritis in her hands. Patient had no illness at the time of vaccination. On 17 January 2014, at 08:00 PM the patient developed a 4 inch long, 3 inch wide, oval, red rash, hot to touch, and a little itchy area on her left arm at the vaccination site. It was reported that the area had become lighter in color and had reduced in size.   Corrective treatments were not reported. Laboratory investigations were not done. The patient had not recovered from the events. Documents held by sender: none
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 06 January 2014. This case is linked to case number 2044SSA009286 (vaccine and reporter are same). A 70-year-old patient received a dose of FLUZONE ID. No adverse event was reported. Documents held by sender: none
Age: 9.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial case was received from health care professional on 07 January 2013. This case concerns 9-yr-old child whose medical history and concomitant medication was not reported received FLUZONE ID. The safety and immunogenicity of FLUOZONE Intradermal vaccine have not been established in persons <15 or 65 and over years of age. If FLUZONE Intradermal vaccine has been administered inadvertently to an individual whose age falls outside the product indication, consider re-immunizing the person with influenza vaccine appropriate for the persons age/underlying condition(s).
Age: 7.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 07 January 2014. A 7-year-old patient had received FLUZONE ID vaccine. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 07 January 2014. A patient of unspecified demographics had received FLUZONE ID at inappropriate age. The patient did not experience any adverse event. Documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 8 January 2014. The patient whose age was under 18 year had received FLUZONE ID which was inappropriate age of vaccine administration. No adverse event was reported. List of documents held by sender: none
Age: 15.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 08 January 2014.  A 15-year-old patient had received FLUZONE HD. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Initial case was received from a health care professional on 17 January 2014. This 33-year-old-male patient whose medical history and concomitant medication was not reported had received FLUZONE ID, batch number UT4721BA, expiry date and dose not reported) on 15 January 2014 in the left deltoid. On 16 January 2014, the patient developed redness, swelling and pain at injection, size of a dollar coin. He also complained of itching, raised area. The patient had no fever and otherwise was fine. No corrective treatment was given. The outcome of the event was not recovered.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Initial report received from a health care professional on 15 January 2014. A 53-year-old male whose medical history any had received first dose of FLUZONE ID (lot number: UT4726AA and route of administration was not reported) in the left deltoid on 18 November 2013. The patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions. Concomitant medications were not reported. The patient had not received any previous dose of FLUZONE ID.  On an unspecified date, the patient developed a hard bump at the injection site; size is smaller than a dime . No redness, no fever, and no other symptoms were seen. The patient's laboratory investigations and corrective medications was not reported. At the time of this report, the patient felt fine but was not recovered. Documents held by sender: none.  Follow-up received on 10 March 2014. No new information received.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 29 October 2013. The cases were received on 21 March 2014 at GPV. An old patient (over 64 years) had received unknown dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse events was reported. List of documents held by sender: none
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 22 October 2013. The cases were received on 21 March 2014 at GPV. A 65 year old patient had received unknown dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 28 October 2013 and at GPV on 21 March 2014. A 12-year-old patient of unknown gender had received FLUZONE ID on an unknown date. No adverse event was reported. The patient received FLUZONE ID at incorrect age. The list of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 16 OCT 2013. Cases were received on 21 March 2014. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE ID on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received vaccine in inappropriate age. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 18 October 2013. The cases were received on 21 March 2014. 14-year-old patient received dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 23 September 2013. This case was linked to case # 2014SA041051 (same vaccine same reporter). A 70-year-old patient had received FLUZONE ID. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 23 September 2013. This case was linked to case # 2014SA041111 (same vaccine same reporter). A 68-year-old patient had received FLUZONE ID. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 25 September 2013. The cases were received on 21 March 2014. A 74-year-old patient received FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 September 2013. The cases were received on 21 March 2014. Three children 10 and under, received FLUZONE ID at flu clinic. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 23 September 2013. Three children of 10 years age and under than 10 had received FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 23 SEP 2013. Cases were received on 21 March 2014. Three child patients whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE ID on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received a vaccine of incorrect age. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 SEPTEMBER 2103. These cases were received on 21 MARCH 2014 at GPV. A child patient (10 and under) received FLUZONE (not other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 24 September 2013. The case was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. At the time of FLUZONE ID administration it was noted that the "vaccine ran down arm". (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none. Addendum: 07 April 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. The suspect product was taken as FLUZONE ID in the narrative previously taken as FLUZONE HD.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 September 2013 and on 21 March 2014. A 68-year-old patient of unknown gender had received FLUZONE ID on an unknown date. The patient received FLUZONE ID at incorrect age. No adverse event was reported. The list of documents held by sender: None.
Age: 9.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 27 September 2013. The cases were received on 21 March 2014. This case is linked to case 2014SA040010 (Same reporter after FLUZONE ID). FLUZONE ID was given to a 09-year-old patient. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a pharmacist on 06 November 2013. A female patient (age unknown), whose medical history and concomitant medication was not reported, received dose of FLUZONE ID route unknown, batch number: UT4726AA, expiry date 23 April 2014, (dose and exact site of administration not reported) on an unspecified date. On 06 November 2013, the patient had developed silver dollar size redness and swelling at the injection site. Patient experienced pain for 4 days at the injection site. Lab investigation and corrective treatment were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. This case is linked to 2013SA117345, 2014SA012989 and 2014SA012994.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial case was received from a healthcare professional on 06 November 2013. This case is cross linked with other cases 2013SA117345, 2014SA012989 and 2014SA012995 being a same reporter. A 60-yr-old female patient whose medical history and concomitant medication was not reported had received an intradermal FLUZONE (batch number: UT4726AA, dose and anatomical site of administration not reported) on an unspecified date. On an unknown date, the patient developed silver dollar size redness and swelling at the injection site. Corrective treatment of laboratory investigations were not reported. The outcome of the event was unknown. The list of documents held by sender: None. Follow-up information received from healthcare professional on 03 March 2014. It was reported that, the patient gender was male. At the time of this report, the outcome was recovered.
Age: 7.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 4 February 2014. A 7-year-old patient had received a dose of FLUZONE ID on unspecified date. It was an inappropriate age of vaccine administration. No adverse event was reported. List of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial case was received from a healthcare professional on 06 November 2013. A female patient (age unknown) whose medical history and concomitant medication was not reported had received an intradermal FLUZONE, batch number: UT4726AA, dose and anatomical site of administration not reported) on an unspecified date. On an unknown date, the patient developed silver dollar size redness and swelling at the injection site. One patient experienced pain for 4 days at the injection site. Corrective treatments of laboratory investigations were not reported. The outcome of the event was unknown. This case is cross linked with other cases 2013SA117345, 2014SA012994 and 2014SA012995 being a same reporter. The list of documents held by sender: None. Follow up information was received from a healthcare professional on 10 March 2014. It was reported that the vaccine was administered at unknown site. The lab result was unknown. The outcome of the event was recovered at the time of report.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 20 Sep 2013. A dose of FLUZONE ID was administered to greater than to 65 years old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 27 Sep 2013. A dose of FLUZONE ID was administered to a 12 year old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 17.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 September 2013 and on 21 March 2014 . A 17 old (gender unknown) was given FLUZONE ID on an unknown date. The patient received incorrect product. No adverse event was reported. The list of documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Initial information received from a healthcare professional on 23 March 2014. A 62-year-old female patient whose medical history and concomitant medications were not reported had received dose of FLUZONE ID (Lot number, expiration date was not reported) in the deltoid left on 31 January 2014. It was reported the patient had hard induration, size of a dime that was red at injection site since time of injection, and no pain was noted at site. The laboratory details and corrective treatment were not reported. At the time of this report the outcome of the adverse event was not resolved. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 07-Oct-2013: On 04-Oct-2013, the patient had received FLUZONE QIV vaccine. On 04-Oct-2013, 2 patients experienced high fever of 101 to 102F, and have flu like symptoms which include body aches. Patients are still having symptoms 72 hours after vaccination. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Foetal exposure during pregnancy, Heart rate increased
Clinical narrative: Initial report was received on 02 October 2013 from a consumer which is also the patient's parent. An unborn fetus at 30 weeks gestation had received transplacentally FLUZONE QUADRIVALENT (lot number not reported) on 01 October 2013 and an unspecified amount of time later was found to have an elevated heart rate. The patient's mother had been vaccinated and experienced difficulty breathing, throat feeling dry and coughing (captured in case 2013SA100435). The mother was treated with Prednisone, BENADRYL and Oxygen. No further information was available at the time of this report. Outcome was unknown. Documents held by sender: none. Follow up information received on 06 November 2013. Estimated date of delivery of mother was 07 December 2013. Mother had received treatment for infertility: sperm donor. Mother had previous 3 pregnancies with live birth. The lot number of FLUZONE was U4768AA. The mother had pregnancy complication of abdominal pain. Laboratory investigation included prenatal testing and USD was normal. Follow-up information received from a healthcare professional on 04-APR-2014 through the mother pregnancy report form. According to the form, the date of the last menstrual periods of the mother was on 16-MAR-2013. The mother past obstetric information mentioned 4 previous live births with no congenital abnormalities, no pre-term births, no elective abortions, no spontaneous abortions prior to 20 weeks gestation and no fetal deaths. The patient was born by cesarean delivery after 38 gestation weeks (there were not delivery complications). It was a single male of 53 cm height and 3.969 kg weight. He had no congenital anomalies. His APGAR score was 8 at 1 min and 9 at 5 min. To be noted that after internal review on 04-NOV-2013, it was clarified that the suspect product was not FLUZONE QUADRIVAL Thimerosal free vaccine (manufacturer Sanofi Pasteur SA) as previously coded but FLUZONE QUADRIVAL (manufacturer Sanofi Pasteur Inc.).
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This case as linked with case#2013SA107205; both these cases are reported by same report for same product; FLUZONE QIV. Initial report received on 27 September 2013 from a health care professional. A 3-year-old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (lot number, expiration date route, and site of vaccination were unknown) on an unknown date. It was reported that 3-year-old child patient have received the FLUZONE QIV. On an unknown date, patient experienced local reactions at the injection site after receiving vaccine. The injection hurt dramatically either during or after administration. Also the patient was feeling miserable and cranky with a large baseball size area of redness, swelling at the injection site. Outcome not recovered. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Irritability, Local reaction
Clinical narrative: This case as linked with case#2013SA107205; both these cases are reported by same report for same product; FLUZONE QIV. Initial report received on 27 September 2013 from a health care professional. A 3-year-old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (lot number, expiration date route, and site of vaccination were unknown) on an unknown date. It was reported that 3-year-old child patient have received the FLUZONE QIV. On an unknown date, patient experienced local reactions at the injection site after receiving vaccine. The injection hurt dramatically either during or after administration. Also the patient was feeling miserable and cranky with a large baseball size area of redness, swelling at the injection site. Outcome not recovered. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial case was received from a non-health care professional on 27 September 2013. This 4-year-old female patient, whose medical history and concomitant medications were not reported, had received INFLUENZA QUADRIVAL A-B VACCINE 0.5 ml shot (route was not reported) during a family clinic in her upper arm on 25 September 2013. Her injection site was red, swollen, warm to touch, and tender. The area is approx 2.5" x 2.5". The patient said it hurt immediately following the shot and continued to say that hurts, until morning. The next morning, approx. 36 hours after injection, her arm was still red, swollen & warm. Not laboratory tests were reported. The corrective treatment was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial report received on 27-September-2013 from a reporter. A number of patients whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (route and site of vaccination was not reported). The reporter stated that after immunizing the staff, everyone was complaining of severe arm pain, radiating from the shoulder to the elbow. One employee stated that the pain was so severe it was keeping her from sleeping and she considered going to the emergency room. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a healthcare professional (Consumer) on 20 September 2013. A 23-year-old female patient, who had no medical history and concomitant medications was not reported, received intramuscular dose of FLUZONE QIV in left deltoid (lot number: U4756BA) on 20 September 2013. On 20 September 2013, within 15 minutes of vaccination, patient developed symptoms of swelling, burning, redness and rash at the left deltoid which was the site of vaccine injection and patient developed a low grade temp and her face and neck were blotchy. No laboratory investigations were done and the patient had received ZYRTEC and BENADRYL as a corrective treatment. The patient had not recovered from the events. List of documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: Initial report received from a healthcare professional (Consumer) on 20 September 2013. A 23-year-old female patient, who had no medical history and concomitant medications was not reported, received intramuscular dose of FLUZONE QIV in left deltoid (lot number: U4756BA) on 20 September 2013. On 20 September 2013, within 15 minutes of vaccination, patient developed symptoms of swelling, burning, redness and rash at the left deltoid which was the site of vaccine injection and patient developed a low grade temp and her face and neck were blotchy. No laboratory investigations were done and the patient had received ZYRTEC and BENADRYL as a corrective treatment. The patient had not recovered from the events. List of documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Peripheral swelling
Clinical narrative: Initial report received from healthcare professional on 31 July 2014. A female patient had received a dose of FLUZONE ID (batch number, dose in series, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the vaccine, the patient developed major swelling in arm and armpit after injection. The patient's corrective treatment 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 health care professional on 08 September 2014. A 49-year-old female patient had received a dose of FLUZONE ID on 30 September 2011 at 4.53 pm. Patient had received minocycline (100 mg daily) as a concomitant medication on an unknown date. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical condition was reported as none. It was reported that patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 01 October 2014 i.e. one day after vaccination patient had experienced major swelling in arm and armpit after injection. It was reported that swelling began within first 12 hours and continued for 24 hours then slowly improved for next 3 days. No laboratory investigations were done. On an unspecified date patient outcome was recovered.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 26 June 2014. A patient (gender and age not reported) had received an expired dose (expiry date: April 2014) of FLUZONE ID. No other information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Initial report received from a healthcare professional on 17 October 2013. A 05-year-old female patient had received an intramuscular dose of FLUZONE, batch number U4780AA, dose number was not reported in right deltoid on 14 October 2013. The patient has allergy of Penicillin, bananas, nuts and soy. And received DECADRON injection on 16 October 2013. On 17 October 2013, three day after vaccination, the patient experienced redness and rash around injection site. On 17 October 2013 the physician and prescribed ZYRTEC and prednisone. Laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 12 August 2014. No new information was reported. Documents held by sender:  None.
Sex: U
Vaccine: FLU4
Symptoms: Underdose, Wrong technique in drug usage process
Clinical narrative: Initial report received from a healthcare professional on 14 October 2013. This case is a cluster of 2 patients. 2 patients whose gender, birthdate and age at the time of event, medical history and concomitant medication were not reported, had received a dose of FLUZONE QIV vaccine (lot number: U4767AA, dose number and route of administration were not reported) in the thigh on an unspecified date. It was reported that 0.25 ml prefilled syringe broke leaving needle piece in patient's thigh vaccine squirt out onto patients' leg leads to incorrect technique used for drug administration and vaccine under dose was administered. Laboratory investigations and corrective medications were not reported. Documents held by sender: None.
Age: 1.31
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Decreased interest, Fatigue, Pyrexia
Clinical narrative: Initial report received from a health care professional on 04 October 2013. A 15-month-old male patient, with no history of allergy and concomitant medications details were not reported, had received an intramuscular dose of FLUZONE QIV vaccine (lot number: U4779AA) on right thigh on 02 October 2013. It was reported that, after vaccination on the same day i.e. 02 October 2013, her son experienced fever of 102.2F and fatigue, no interest in playing, poor appetite. Patient received TYLENOL. Stated symptoms lasted 36 hours and then resolved. No other symptoms noted. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Initial report received from a non-healthcare professional on 10-Oct-2013. This case is part of 1 cluster cases and is linked to case number 2013SA103904 (same reporter, events after FLUZONE QIV, lot number: U4772AA). A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (Lot number: U4772AA, expiration date: 30-Jun-2014) intramuscular route (site of vaccination was not reported) on 08-Oct-2013. On 09-Oct-2013, patient had 10 patients complain of pain at the injection site lasting several days and more painful than what they recall from previous years influenza vaccine. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Initial report received from a non-healthcare professional on 10-Oct-2013. This case is part of 1 cluster cases and is linked to case number 2013SA103906 (same reporter, events after FLUZONE QIV, lot number: U4772AA). A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (Lot number: U4772AA, expiration date: 30-Jun-2014) intramuscular route (site of vaccination was not reported) on 08-Oct-2013. On 09-Oct-2013, two patients had shaking, chills and fever. One of these two patients had a temp of 103F. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 4 October 2013. Two patients received FLUZONE QUADRIVALENT (Lot # unknown, expiration date unknown). After vaccination, the patient experienced a red raised area at the injection site. Documents held by sender: none.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Lethargy
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history was unspecified. On an unknown date, the anonymous patient was concomitantly vaccinated with ZOSTAVAX (lot# J007209, expiration date: 20-SEP-2014, dose and route were unknown), PNEUMOVAX 23 (lot# J009067 is an invalid lot no, expiration date, dose and route were unknown) and unspecified flu vaccine (manufacturer unknown) (lot#, expiration date, dose and route were unknown). Concomitant medications were unspecified. On an unknown date the patient experienced extreme lethargy. The patient sought medical attention with the pharmacist and the treatment given was unspecified. The outcome of extreme lethargy was reported as recovered on an unknown date. The causality of the lethargy was not reported. No product complaint was reported for ZOSTAVAX, PNEUMOVAX 23 and unspecified flu vaccine (manufacturer unknown). This is one of three reports from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 76 year old female patient with anal cancer and no known drug reactions or allergies. On 12-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # J013555, expiration date 02-MAY-2015, 0.5 ml, subcutaneous in the patient's left upper arm. There was no information on concomitant medications. On 14-JAN-2015, the patient experienced peripheral swelling, erythema and pruritus described as swelling, redness and itchiness on her left upper arm after receiving PNEUMOVAX 23. The registered nurse was requesting a lot # check on PNEUMOVAX 23. The nurse reported that on 15-JAN-2015, the patient was seen by the physician and also was given an unspecified amount of BENADRYL. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.