chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30 December 2013. The cases were received on 21 March 2014. It was reported that 45-year-old patient had received FLUZONE HD vaccine inadvertently. No adverse event was reported. List of documents held by sender: none.
Age: 7.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 17 December 2013 and the case was received on 21 March 2014. A 7-year-old patient (gender was not reported) had received a dose of FLUZONE HD vaccine (batch number, route and site of administration was not reported) on an unspecified date. The patient had received FLUZONE HD vaccine by mistake. No adverse event was reported. List of documents held by sender: none.
Age: 35.0
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 17 January 2014 and at GPV on 21 March 2014. A 35-year-old patient of unknown gender had received FLUZONE HD. The patient received FLUZONE HD at an incorrect age. No adverse event was reported. The list of documents held by sender: none
Age: 13.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a health care professional on 17 January 2014. The cases were received at GPV on 21 March 2014. It was reported that 13-year-old patient had received FLUZONE HD inadvertently. No adverse event was reported. List of documents held by sender: none
Age: 64.0
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 25 Sept 2013. A dose of FLUZONE HD was administered to a 64 year 11 month old patient on an unspecified date. 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 at GPV. Initial misuse report received from a health care professional on 24 September 2013. A patient under 65 year of age had received FLUZONE HD. No adverse event ws reported. List of documents held by sender: none
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 23 September 2013. A male patient believes that he received two doses of FLUCONE High Dose within the last few weeks of reporting. (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: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 20 September 2013 and on 21 March 2014 at GPV. A patient of unknown age and gender had received FLUZONE and receiver another FLUZONE High Dose on an unknown date. No adverse event was reported. The list of documents held by sender: none
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The case was received on 21 March 2014 at GPV. Initial misuse report received from a Consumer on 18 September 2013. A male patient had received 0.5 ml dose of FLUZONE HD instead of FLUZONE on an unspecified date. The patient has a history of seasonal allergies, food allergies, nuts and peanuts. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: The case was received on 21 March 2014 at GPV. Initial misuse report received from a heath care professional on 18 September 2013. A patient had received an expired dose of FLUZONE HD on an unspecified date. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse case was received from a health care professional on 18 October 2013. Cases were received on 21 March 2014 at GPV. Two patients whose demographics details, medical history and concomitant medication were not reported received a dose of FLUZONE High Dose and a dose of ADACEL on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received unstable vaccine. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3, FLU3, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a health care professional  on 24 October 2013. This case is invalid as no patient information available. FLUZONE HD, ADACEL, and FLUZONE ID were stored at 52 Fahrenheit for 3 weeks. 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 case was received from a health care professional on 23 Oct 2013. Cases were received on 21 March 2014 at GPV. A patients whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE High Dose on an unspecified date (route, site, does and batch number not reported). It was reported that on an unspecified date patient who received a vaccine was incorrect. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
Age: 63.0
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 29 October 2013 and on 21 March 2014. This case concerns second patient of the two patients with 63 years of age. A 63 year old patient who had received FLUZONE HD on an unknown date. The patient received FLUZONE HD at the incorrect age. No adverse event was reported. The list of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 October 2013. The cases were received on 21 March 2014. A 64 years old patient had received unknown dose of FLUZONE HD (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 28 October 2013. The cases were received on 21 March 2014. A patient (younger than 65 years) had received unknown dose of FLUZONE HD (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 17 October 2013. 4 pregnant female patients had inadvertently received FLUZONE High-Dose. It was a wrong vaccine administered. No adverse event was reported. List of documents held by sender: none.
Age: 58.0
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 28 October 2013. The case were received on 21 March 2014 at GPV. A 58 year old patient (gender not provided) had received unknown dose of FLUZONE HD (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: The cases were received on 21 March 2014 at the agency. Initial misuse report received from a healthcre professional on 30 October 2013. A FLUZONE HD was administered intravenous. It's an inappropriate route of vaccination. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 October 2013 and on 21 March 2014. A patient of unknown age and gender had received unstable FLUZONE HD vaccine on unknown date. It was reported that FLUZONE HD order was shipped on 18 October 2013 and arrived on 21 October 2013 which was outside of time frame for shipping. The office was closed on weekend. Three doses were given. No adverse event was reported. The list of documents held by sender: None.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 October 2013. The cases were received on 21 March 2014. A 65 year old patient had received unknown dose of FLUZONE HD (No other information was provided regarding the patient). No adverse event was reproted. List of documents held by sender: none.
Age: 63.0
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 29 October 2013 and on 21 March 2014. This case concerns first patient of the two patients with 63 year of age. A 63 year old patient who had received FLUZONE HD on an unknown date. The patient received FLUZONE HD at the incorrect age. No adverse event was reported. The list of documents held by sender: None.
Age: 84.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 18 October 2013. The cases were received on 21 March 2014. An 84-year-old patient received FLUZONE HD on 30 September 2013 and again on 07 October 2013 (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 21 February 2014. The case was received on 21 March 2014 at agency. FLUZONE HD was inadvertently administered to patient under age 65 years. No adverse event was reported. List of documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 21 February 2014. A 65-year-old patient had inadvertently administered FLUZONE HIGH DOSE. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 February 2014. The cases were received on 21 March 2014 at agency. A 61-year-old patient had inadvertently administered FLUZONE HIGH-DOSE. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Initial report received from a healthcare professional on 08 April 2014: A female patient (date of birth and age at the time of event was not reported) whose medical history and concomitant medications were unknown had received a dose of FLUZONE HD vaccine (lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient developed rash on arms and trunk. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. The patient required ER/doctor visit. Documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. A patient under 65-years of age had received a dose of FLUZONE HD on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Initial report received from healthcare professional on 17 April 2014. A patient, whose gender, date of birth, age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, route and anatomical site of administration were not reported) on an unspecified date of 2011. It was reported that on an unspecified date, after receiving FLUZONE HD, the patient experienced rash on both arms and trunk. The corrective treatments and laboratory investigations were not reported. The patient was recovered within one week on an unspecified date. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Rash
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Albumin globulin ratio, Anion gap normal, Arthralgia
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthropod bite, Aspartate aminotransferase normal, Autoimmune disorder, Basophil count decreased, Blood albumin normal
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium increased, Blood chloride normal, Blood creatinine normal
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Blood osmolarity normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood urea normal, Body temperature decreased, Body tinea, Bone pain, Carbon dioxide normal
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Conjunctivitis, Eosinophil count normal, Eosinophil percentage, Fatigue, Flushing
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Globulins increased, Glomerular filtration rate, Haematocrit normal, Haemoglobin normal, International normalised ratio normal
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Joint swelling, Lumbar puncture normal, Lymphocyte count normal, Lymphocyte percentage
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Meningeal disorder, Mobility decreased
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Monocyte percentage increased, Musculoskeletal stiffness, Myalgia, Neck pain, Neutrophil count
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neutrophil count normal, Neutrophil percentage, Pain, Petechiae, Platelet count normal
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Protein total normal, Prothrombin time shortened, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate increased, Red blood cells urine negative, Red cell distribution width, Tenderness
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urobilinogen urine, Vaccination complication, Vasculitis, White blood cell count normal, White blood cells urine negative
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: pH urine normal
Clinical narrative: Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Rash
Clinical narrative: Initial case was received from a non-healthcare professional on 27 May 2014. A female patient of unknown age whose medical history and concomitant medication was not reproted had received FLUZONE High-dose, (batch number N-49281LUV/N-49281Lu4, dose, route and anatomical site of administration not reported) on 21 October 2013. On an unknown date, the patient experienced reaction within two days of vaccination. The patient could not turn her neck and it followed on down to her other extremities. She also developed a rash on both of her lower legs. It was reported that later she was mostly able to function properly except she could not turn her neck all the way. The patient went to hospital and underwent test. The cause was not known and it was recommended not to have FLUZONE HD shot again. No corrective treatment was reported. The outcome of the event was not resolved. The list of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Initial report received from a consumer (a healthcare professional) on 28 May 2014. A female patient whose age is above 65 units not reported, had received a dose of FLUZONE HD (lot number, dose number, route and site of vaccination was not reported), on an unspecified date. It was reported that after vaccination, the patient developed fever, aches and pains and feeling dizzy for 4 hours. Laboratory details and corrective treatment was not reported. On an unspecified date the patient was recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from healthcare professional on 09 June 2014. This case is invalid as no patient identifiers available. Numerous patients, whose gender, date of birth, age at the time of event, medical history and concomitant medications were not reported, had received ad ose of FLUZONE HD (batch number, route and anatomical site of administration were unknown and dose number was not reported) on an unspecified date (last 2 Flu seasons). It was reported that on an unspecified date (last 2 Flu seasons), after receiving FLUZONE HD vaccine, the patient experienced redness, swelling and warmth at the injection site. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site pain, Nausea, Vomiting
Clinical narrative: Initial report received from non-healthcare professional on 12 June 2014. A patient, whose gender, age, medical history and concomitant medications not reported had received a 0.5 ml dose of FLUZONE HD (dose, dose number, lot number, route, site of vaccination not reported) on 20 December 2013. It was reported that on an unspecified date patient developed joint pain, vomiting, nausea and site pain. Lab investigation and corrective treatment details not reported. The outcome of events was not reported. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional on 18 August 2014. A 66-year-old male patient, had received second dose of FLUZONE HD, (batch number U5015AA, route not reported in the left deltoid) on 15 August 2014. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unaware. Concomitant medications were not reported. On 15 August 2014, same day after vaccination, the patient developed a lump at injection site with tenderness. The arm was very sore and swollen with a lump and it had a large amount of bruising around site. Patient applied ice to site over weekend. To rule out possibility of allergy, patient was also advised to take BENADRYL and MOTRIN by pharmacist. Patient denied use of blood thinners. Complementary investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial report received from a health care professional on 20 August 2014. A 78-year-old male patient, had received an intramuscular dose of ADACEL vaccine (lot number: U4617AA, dose number was not reported) in right deltoid on unspecified date and had received an intramuscular dose of FLUZONE HD (lot number, dose number was not reported) in left deltoid on an unspecified date. The patient illness at the time of vaccination was not reported and the patient had no known allergies. It was reported that three day after vaccination on an unspecified date patient had experienced redness and itching around injection site of right arm and was becoming larger. Laboratory details and corrective treatments were not reported. At the time of this report, outcome of the event was not recovered. Documents held by sender: None. Follow-up information received from the healthcare professional on 20 Oct 2014. Received no additional information.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Initial report received from a healthcare professional on 25 August 2014. A female patient (age not reported) had received an intramuscular dose of FLUZONE HD, (batch number, dose in series and site of administration not reported) on an unspecified date. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. On an unspecified date, the patient developed 4x2 red patch at the site of injection and had pain and swelling. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial report received from non-healthcare professional on 25 August 2014. A male patient, whose date of birth, age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD, batch number: U5015AA (dose number, route and anatomical site of administration were not reported) having expiry date 25 March 2015 on an unspecified date. It was reported that on an unspecified date, after receiving FLUZONE HD vaccine, the patient experienced an unspecified adverse reaction. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Incorrect product storage
Clinical narrative: Initial misuse report received from non-healthcare professional on 02 Sep 2014. A 67-year-old male patient, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, (route, site, dose in series and batch number was not reported) on 26-Aug-2014. On 26-Aug-2014, patient has been feeling weak, tired since vaccination and FLUZONE HD was administered to him, which had not been stored properly. Patient will need to come in for a repeat dose. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): NKA, diabetes, high cholesterol, takes metformin, lisinopril and ACTFOREN. The patient's laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the events was reported as not recovered. Documents held by sender: none.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 26 Aug 2014. A 64-year-old patient (sex not reported) had received a dose of FLUZONE HD on unspecified date leading to inappropriate age at vaccine administration. At the time of this report, the patient did not experience any adverse event. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Local swelling, Pain, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 10-Oct-2013. A 41-year-old female patient was given FLUZONE ID intradermal (on left) on 08-Oct-2013. Patient had injection site mosquito bite red, and stated was a painful day of vaccine. Also had golf ball sized next day, hot to the touch, red, slightly raised area. Event was improving by 10-Oct-2013. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: Initial report received from a consumer on 10-Oct-2013. An 11-year-old male patient whose concomitant medications was not reported, received a dose of FLUZONE ID (lot number, expiry date, route and site of administration was unknown). On 09 October 2013, patient noticed constant dull pain, difficulty lifting his arm when he started swimming. Patient saw doctor in the office and she called it a swollen lymph node. Patient had small red spot at injection site, not raised, not hot. Patient was 10 year old received FLUZONE ID. The events were not resolved. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 04 October 2013. A 40-year-old female patient had received intradermally first dose of FLUZONE ID (lot number: UT4719BA and site of administration was not reported) on 04 October 2013. The patient's last menstrual period date was unknown and the expected date of delivery was not reported. The patient had no health problem during pregnancy and had no specific risk factors. Concomitant medications were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None. Follow up information received from a healthcare professional on 20 June 2014. At this time of report the outcome was reported as unknown. No laboratory investigations were done. The vaccine was purchased with private funds. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Eye pruritus, Pruritus
Clinical narrative: Initial misuse report received from a healthcare professional on 11 October 2013. This case is a part of 1 cluster cases and is linked to case number 2013SA103882 (same reporter, events after FLUZONE ID, lot number: UT4725AA). The two patients of age between 18-49 years received FLUZONE ID (batch number: UT4725AA, expiry date: 19 April 2014) intradermal route on 11 October 2013. After received FLUZONE ID, immediately afterwards, patients reported itching at site spreading to face and neck, and eyes. Patient's received therapy with BENADRYL or ranitidine. The event was resolved. List of documents held by sender: none.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Eye pruritus, Immediate post-injection reaction, Injection site pruritus, Pruritus
Clinical narrative: Initial misuse report received from a healthcare professional on 11 October 2013. This case is a part of 1 cluster cases and is linked to case number 2013SA103895 (same reporter, events after FLUZONE ID, lot number: UT4725AA). A 66 year old received FLUZONE ID (batch number: UT4725AA, expiry date: 19 April 2014) on 11 October 2013. After received FLUZONE ID, immediately afterwards, patient reported itching at site spreading to face and neck, and eyes. Patient was outside of age indications for FLUZONE ID. Patients received therapy with BENADRYL or ranitidine. The event was resolved. List of documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 04 October 2013. A 43-year-old female patient had received an intramuscular dose of FLUZINE ID (Lot number UT4725AA, anatomical site of vaccination was not reported) on 04 October 2013. The patient was pregnant. The last menstrual period date and the expected date of delivery was not reported. The patient was healthy during pregnancy. At the time of this report, the patient did not experience any adverse event. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Initial report received from a non-healthcare professional on 10-Oct-2013. A 34-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: UT4721BA and route was not reported) on left deltoid on 07-Oct-2013. On 07-Oct-2013 and in evening she experienced redness, swelling, at injection site and pain at injection site of deltoid that extended down to wrist. She had 6 cm. size red, swollen areas around injection site that was very tender to touch and itchy also had a fine red, raised rash at injection site. Patient stated had felt feverish the night before but did no take a temperature. She did not have a elevated temperature when seen. She stated that patient treated with cool compress for redness and swelling and Hydrocortisone cream around injection site area but not on injection site. Patient stated today, 10-Oct-13 and redness is dissipating, swelling is subsiding. The events were not resolved. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test negative, Chlamydia test negative, Exposure during pregnancy, HIV test negative, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 26 September 2013. A 31-years-old female patient had received an intradermal first dose of FLUZONE ID (Lot number: UT4719AA) on left deltoid on 20 September 2013. The patient was pregnant at the time of vaccination. Date of last menstrual period was 19 Jun 2013 and the estimated date of delivery was reported as 26 March 2014. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, specific risk factors (e.g. : alcohol, tobacco or recreational drugs) was not reported. Treatment for infertility and concomitant medications were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 07 July 2014: The patient was 32-years-old at the time of pregnancy (initially reported as 31-year-old) with no relevant health issues. The patient had no family history of congenital anomaly and the patient did not receive any treatment for infertility. The patient had two previous pregnancies with no live birth with congenital abnormalities, no pre-term birth, elective abortion, spontaneous abortion prior to 20 weeks gestation and no fetal deaths. The patient did not experience any relevant non-serious adverse event. The patient's health during pregnancy and specific risk factors were not available. OB panel was done and everything from HIV to gonorrhea and chlamydia was negative. The patient had no complications during pregnancy. The patient delivered two babies with no complications of labor or delivery. The child's gender, APGAR score, delivery mode was not reported. Follow up received from healthcare professional on 28 Jul 2014: The patient received 0.5 ml dose of FLUZONE ID. The patient delivered two babies at 38 weeks of gestation with no congenital abnormality. One of the baby was male who weighed 5.5 and the female baby weighed 5.3 (units not reported).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Mobility decreased, Pain, Peripheral swelling, Skin warm
Clinical narrative: Initial report received from a non healthcare professional on 09-Oct-2013. A 42-year-old female patient was given FLUZONE Intradermal (batch number: UT4722AA, site of administration not provided) on an unknown date. On 09-Oct-2013 the patient experienced a burning sensation when the shot was administered. The day after initial visit patient had swelling from her upper deltoid region to the middle of her arm, uncharacteristic of what was to be expected based on the patient information and marketing diagram. The region felt very hot to touch, and patient was unable to move her arm without pain. On the pain scale, patient said it felt like it was at a 8/10. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a non-healthcare professional (patient) on 18 September 2013. A 32-year-old female patient, whose medical history and concomitant medications were not reported, had received intradermal first dose of FLUZONE ID vaccine (anatomical site of administration was not reported) on 18 September 2013. The patient's last menstrual period was not reported and the expected date of delivery is 02 April 2014. The patient did not experience any adverse event and stated that pregnancy will be normal to date. List of documents held by the sender: none. Follow-up received on 10 January 2014. It was reported that the patient did not receive the vaccine in reporter office. Hence, consider end of follow-up.
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Initial report received from non-healthcare professional on 03 October 2013. A female patient, whose initials, date of birth and age was not reported, had received a dose of FLUZONE intradermal vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. The patient also had received PNEUMOVAX (batch number, route and anatomical site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was reported that after vaccination the patient had enlarged lymph nodes in the arm pit of the injection site. Corrective treatment and laboratory details were not reported. At the time of this report the outcome of the adverse event was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: This case is linked to case number 2013SA097404, 2013SA116606 and 2013SA116605 (same reporter). Initial report received from healthcare professional on 18 September 2013. The three patient, whose gender, date of birth, age at the time of event and concomitant medications were not reported, had received intradermal dose of FLUZONE INTRADERMAL vaccine, batch number: UT4725AA (dose number and anatomical site of administration were not reported) on 09 September 2013. The patient's medical history and illness at the time of vaccination were reported was not applicable. It was reported that on 09 September 2013, after receiving FLUZONE ID vaccine, the patients experienced mild local reactions with no associated or radiating pain and only a small amount of redness or swelling. The corrective treatments and laboratory investigations were not reported. The event local reactions were resolved quickly over a day or two. (Recovery date was not reported). Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: This case is associated with case 2013SA103745. Initial report received from a reporter on 03-Oct-2013. An unknown year old male patient had received an intramuscular dose of FLUZONE intradermal (batch number: unknown, dose number and site of administration not reported) on 30-Sep-2013. The patient's medical history was unknown. Concomitant medication was unknown. On 01-Oct-2013, the patient experienced enlarged lymph nodes in the armpit of the injection site. Laboratory tests and corrective treatments were unknown. Outcome of event was unknown. List of documents held by sender: None.