chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 27 September 2013. The case was received on 21 March 2014. A patient wanted FLUZONE HD but received regular FLUZONE. 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 (nurse) on 17 October 2013 and the case was received on 21 March 2014. A patient (gender and date of birth was not reported) had received a dose of FLUZONE vaccine (batch number, route and site of administration was not reported) on an unspecified date. The patient was given regular dose instead of HD. No adverse event was reported. List of documents held by sender: none.
Age: 0.4
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 19 March 2014. A 05-month-old patient received 0.25 ml dose of FLUZONE inadvertently thinking that the patient was at 6-month of age. (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: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from health care professional on 21 Oct 2013 and at agency on 21 March 2014. It was reported that patient (age and gender not reported) received a dose of FLUZONE on an unspecified date and it was noticed that blood in the syringe. No adverse event was reported. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from health care professional on 17 March 2014. It was reported that patient had received first 0.5 ml dose of FLUZONE HD to a 12 month old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 MARCH 2014. A patient had received 0.5 ml dose of FLUZONE on an unspecified date. It was reported that 0.5 ml dose was given to a child under 3. 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 healthcare professional on 21 October 2013. The cases were received on 21 March 2014 at agency. A patient (no other information was provided regarding the patient), received FLUZONE. It was reported that the patient received 2 doses 2 weeks apart thus the patient administered extra dose. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3, IPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 18 March 2014. The cas was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. The patient had received unstable FLUZONE and IPOL. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 16 October 2013. The cases were received on 21 March 2014. A patient (no other information was provided regarding the patient) had received FLUZONE on unspecified date. It was reported that patient received 2 doses 10 days apart. No date on administration 2 doses to adults in the same season. No adverse event was reported. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram normal, Hypoaesthesia, Neuralgia, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Initial report received from a non-health care professional (consumer) on 30 April 2014. A 42-years-old female patient, had received a first dose of FLUZONE vaccine (lot number: UH941AF) intramuscularly in the right arm on 13 December 2013. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not applicable. On 17 December 2013, 3 days after the vaccine right arm started to hurt and is still sore. At times she feels numbness and tingling in fingers. The arm is sore in the morning and when she sits up. Any movement or pressure hurts her right arm. It is getting worse every month. The patient went to the doctor a few times and they are now ordering an EMG. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome of the event was not recovered from the adverse event. Documents held by sender: None. Follow-up information received from a non-health care professional (consumer) on 16 July 2014: EMG was normal; therefore there was no nerve damage from shot. MRI was ordered and showed tear of rotator cuff tendon. The patient was referred to orthopedic surgeon. Gabapentin was started for nerve pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Rotator cuff syndrome, Tenderness
Clinical narrative: Initial report received from a non-health care professional (consumer) on 30 April 2014. A 42-years-old female patient, had received a first dose of FLUZONE vaccine (lot number: UH941AF) intramuscularly in the right arm on 13 December 2013. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not applicable. On 17 December 2013, 3 days after the vaccine right arm started to hurt and is still sore. At times she feels numbness and tingling in fingers. The arm is sore in the morning and when she sits up. Any movement or pressure hurts her right arm. It is getting worse every month. The patient went to the doctor a few times and they are now ordering an EMG. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome of the event was not recovered from the adverse event. Documents held by sender: None. Follow-up information received from a non-health care professional (consumer) on 16 July 2014: EMG was normal; therefore there was no nerve damage from shot. MRI was ordered and showed tear of rotator cuff tendon. The patient was referred to orthopedic surgeon. Gabapentin was started for nerve pain.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 23 October 2013. The cases were received on 21 March 2014. It was reported that patient had received FLUZONE vaccine instead of FLUZONE HD leading to wrong vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 29 April 2014. A 06-months-old patient (gender was  not reported) had administered a dose of 0.5ml of FLUZONE vaccine instead of 0.25 ml. No adverse event was 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 healthcare professional on 24 October 2013 and at GPV on 21 March 2014. A male patient of unknown age received FLUZONE and then realized that the patient was vaccinated a week ago. The patient received an extra dose. No adverse event was reported. The list of documents held by sender: None.
Age: 0.3
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 January 2014. A '04-month-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE) on an unspecified date, and no adverse event was reported. i,e, inappropriate age at vaccine administration. List of documents held by sender: none. This case is linked with case number: 2014SA046378.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 January 2014. The case was received on 21 March 2014 at agency. A 33 months old patient received FLUZONE 0.5 ml instead of 0.25 ml. 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: Initial misuse report received from a healthcare professional on 25 April 2014. The patient had received FLUZONE intradermal expired on 19 April 2014. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 January 2014 and at the agency on 21 March 2014. A patient over 14 years of age of unknown gender had received FLUZONE 0.25 ml instead of 0.5 ml. The patient received incorrect dose of FLUZONE. No adverse event was reported. The list of documents held by sender: None.
Sex: U
Vaccine: FLU3, IPV, MNQ, TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 April 2014. This is an invalid case as individual patient identifiers are not reported. The patient had received expired dose of FLUZONE, IPOL, MENACTRA and TENIVAC. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: This case is linked with the case number 2014USA046378 with same product and reporter. Initial misuse report received from a healthcare professional on 24 January 2014. The cases were received on 21 March 2014 at GPV. A '09-month-old' patient (No information was provided regarding the patient) had received dose of FLUZONE 0.5 ml, on an unspecified date i.e. overdose. No adverse event was reported. List of documents held by sender: none.
Age: 0.7
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 21 January 2014 and the case was received on 21 March 2014 at the agency. A 08-month-old patient (gender was not provided) had received a dose of 0.5 ml of FLUZONE (batch number, dose in series and site of administration was not reported0 on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site scar
Clinical narrative: Initial report received from a non-healthcare professional (patient's parent) on 05 June 2014. A male patient of unspecified age and gender had received a dose of FLUZONE, (batch number, dose number and route of vaccination not reported) in left arm on an unspecified date in October 2013. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bruise and a reoccurring scar that falls off and comes back at the injection site. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: The cases were received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 21 January 2014. A patient whose age was less than 35 months (No information was provided regarding the patient) had received dose of FLUZONE 0.5 ml on an unspecified date i.e. overdose. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, FLU3, MNQ, TD, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 07 May 2014. A patient (date of birth and gender was not reported) had received a doses of ADACEL, MENACTRA, IPOL, PENTACEL, TUBERSOL, FLUZONE, ACTHIB and TENIVAC on an unspecified date. It was reported from 1 August 2014 temperature for all vaccines was 65 F for 16 hours, which led to incorrect product storage. No adverse event was reported. List of documents held by sender: None.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 28 January 2014. The cases were received on 21 March 2014 at agency. This case is link to case no: 2014SA046378 with same reporter. A 4-year-old patient had received 0.25 ml of FLUZONE as the second dose in the priming series. It was a vaccine underdose. No adverse event was reported. List of documents held by sender: none.
Age: 1.4
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 21 January 2014. The cases were received at agency on 21 March 2014. It was reported that 17-month-old patient had received 0.5ml dose of FLUZONE vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 24 January 2014. The cases were received on 21 March 2014 at GPV. A 06-month-old patient had received 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report receive from a healthcare professional (nurse) on 24 January 2014 and the case was received on 21 March 2014 at the agency. This case is linked to case 2014SA046378 (same reporter and same product). A 2-year-old patient (gender was not reported) had received first dose of 0.5 ml of FLUZONE (batch number, route and site of administration was not reported) on an unspecified date. It was reported that he adult dose was administered to a child. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial miuse report received from a healthcare professional on 20 January 2014. 2014 and the case was received on 21 March 2014 at GPV. A '04-year-old' patient (No information was provided regarding the patient) had received second dose of FLUZONE 0.25 ml, and first dose of FLUZONE 0.5 ml on an unspecified date i.e. Underdose. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3, IPV, MNQ, TD
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 13 May 2014. IPOL, TENIVAC, FLUZONE and MENACTRA were stored at inappropriate temperature as the fridge temperature had dropped at 32 Fahrenheit. No adverse event was reported. List of documents held by sender: none.
Age: 0.8
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 24 January 2014. A '9-month-old' patient (no information was provided regarding the patient) had received first dose of FLUZONE 0.5 ml on an unspecified date. I.E. overdose. No adverse event was reported. List of documents held by sender: none. This case is linked with case number 2014SA046384.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 September 2013 and on 21 March 2014 at agency. A pregnant woman of unknown age had received FLUZONE 1 ml. No adverse event was reported. The list of documents held by sender: None. Addendum: 24 April 2014 upon second internal review a significant correction was made in the case to add the no adverse event detail in the as reported event.
Age: 0.8
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 18 December 2013. A 9-month-old patient had received 0.5 ml of FLUZONE. It was an overdose. 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 health care professional on 22 May 2014. A patient (gender not reported) had received 0.25 ml dose of FLUZONE on 14 January 2014 and 0.5 ml dose of FLUZONE on 12 January 2014, which led to extra dose of vaccination. No adverse event was reported. List of documents held by sender: None.
Age: 0.8
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 22 May 2014. A patient had received 0.5 ml second dose of FLUZONE on an unspecified date. It was reported that the patient was administered 0.5 ml for the second dose in flu vaccine series instead of age appropriate dose of 0.25 ml. No adverse event was reported. List of documents held by sender: none.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Malaise, Pruritus, Rash
Clinical narrative: Initial report received from a healthcare professional on 19 September 2013. A 94-year-old female patient who had no illness at the time of vaccination and was allergic to aspirin, chocolate, weeds and tomatoes, had received an intramuscular dose of FLUZONE HD (dose number, lot number and anatomical site of administration were not reported) on 16 September 2013. On 16 September 2013 same day after vaccination, the patient felt ill and developed a severe rash on scalp and eyebrows and eyelids was swelled. The patient was feeling itchy on these areas. No Laboratory investigations were done and corrective medications were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Rash generalised
Clinical narrative: Initial report received from a consumer on 20 September 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD vaccine (Batch number, Route, dose and anatomical site of administration were not reported) on an unspecified date (date reported as : "Friday September"). On an unspecified date, the patient had marble size white raised bumps on her body. One was a domino size, round in shape. Patient also had pain in shoulder and hip. Patient consulted the physician and prescribed her unspecified antibiotics and allergy medicine which patient did not consume. On an unspecified date, some bumps had resolved while some were persisting. It was reported that it might be an infection or an allergy. Patient was not sure whether she had the events before or after vaccination with FLUZINE HD. Laboratory investigations and corrective medications were not reported. As of 20 September 2013, the patient had not recovered from the events. List of documents held by the reporter none.
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Initial report received from a healthcare professional on 10 September 2013. A male patient (demographic details were not provided), whose medical history and concomitant medications were not reported, received FLUZONE HD (Lot number, route and site of vaccine administration were not reported) on 10 September 2013. It was reported, that the patient had experience muscle cramping on an unspecified date. Laboratory investigations and corrective treatments were not reported. The patient's outcome was unknown. List of documents held by sender: None
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature, Fatigue
Clinical narrative: Initial report received from a healthcare professional on 19 September 2013. A 66-year-old female patient had received an intramuscular dose of FLUZONE HD vaccine (lot number U4760AA) in left deltoid on 13 September 2013. The patient's illness at the time of vaccination includes urinary tract infection and acute cystitis and concomitant medications include CIPRO, PYRIDIUM and Acyclovir. The patient's physician diagnosed allergies, birth defects and medical conditions include asthma. On 14 September 2013, the patient felt fatigued, had aching joints and a "temperature". Laboratory data was not reported and no treatment was provided by the physician. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Injection site reaction, Myalgia
Clinical narrative: Initial report received from a non-healthcare professional on 22 September 2013. A 79-year-old female patient had received an intramuscular 0.5 ml dose of FLUZONE HD (Lot Number: U4761AA, Exp. Date: 03 May 2014) in the left deltoid on 21 September 2013 at 10:30 hours. The patient had history of stable hypertension, stable glaucoma and has a pacemaker since 12 Nov 2012 for left bundle branch block. the patient had received influenza vaccine every year and previously had the high-dose vaccine. The patient had not a similar event after any previous influenza vaccine. The patient was taking Amlodipine/Benazepril 2.5 mg - 10 mg. 1 Capsule qd hs; Metoprolol ER 25 Mg 1 po qd; Triam/HCTZ 37.5 / 25 mg 1 po qd; KLOR-CON M 20, 20 Meq - 1 tab every other day and 2 tabs on opposite days; Latanoprost 0.005%, 1 drop each eye daily; Multi-vitamin, Calcium/Vitamin D Chocolate Chews as concomitant medications. On 21 Set 2013 At approximately 13:00 hour (approximately 2 1/2 hrs after receiving vaccine), the patient had sudden onset of nausea and felt hot/sweaty like was going to be sick. Feeling lasted about 5-10 minutes. No other complaints or symptoms. Home blood pressure taken at that time and was found to be normal at 120/60 with a pulse of 60. The patient had drunk some grape juice and as stated within 5-10 minutes felt back to "normal". As of 22 Sep 2013, the patient had normal baseline, no other complaints with the exception of slight soreness of the muscle at injection site left arm as expected with the shot. Documents held by sender: none
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Initial report received from a non-healthcare professional on 22 September 2013. A 79-year-old female patient had received an intramuscular 0.5 ml dose of FLUZONE HD (Lot Number: U4761AA, Exp. Date: 03 May 2014) in the left deltoid on 21 September 2013 at 10:30 hours. The patient had history of stable hypertension, stable glaucoma and has a pacemaker since 12 Nov 2012 for left bundle branch block. the patient had received influenza vaccine every year and previously had the high-dose vaccine. The patient had not a similar event after any previous influenza vaccine. The patient was taking Amlodipine/Benazepril 2.5 mg - 10 mg. 1 Capsule qd hs; Metoprolol ER 25 Mg 1 po qd; Triam/HCTZ 37.5 / 25 mg 1 po qd; KLOR-CON M 20, 20 Meq - 1 tab every other day and 2 tabs on opposite days; Latanoprost 0.005%, 1 drop each eye daily; Multi-vitamin, Calcium/Vitamin D Chocolate Chews as concomitant medications. On 21 Set 2013 At approximately 13:00 hour (approximately 2 1/2 hrs after receiving vaccine), the patient had sudden onset of nausea and felt hot/sweaty like was going to be sick. Feeling lasted about 5-10 minutes. No other complaints or symptoms. Home blood pressure taken at that time and was found to be normal at 120/60 with a pulse of 60. The patient had drunk some grape juice and as stated within 5-10 minutes felt back to "normal". As of 22 Sep 2013, the patient had normal baseline, no other complaints with the exception of slight soreness of the muscle at injection site left arm as expected with the shot. Documents held by sender: none
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pallor
Clinical narrative: Initial report received on 25 September 2013 from a pharmacist. A 65 year old female patient appeared pale and had bloodshot eyes after receiving FLUZONE HIGH DOSE. On 20-Sep-2013, the patient had received FLUZONE HD (lot # U4718AA and expiration date 14-Apr-2014) on left deltoid. Four hours after receiving the vaccine the patient appeared pale and had bloodshot eyes. She went to the emergency room for evaluation. She did and they told her that they thought it was an adverse reaction to the vaccine and sent her home. The patient was discharged from the emergency room (ER). The pharmacist reported that she was doing well now. The outcome of the event was recovered. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Lethargy, Nausea, Pain
Clinical narrative: Initial misuse report received from a pharmacist on 24-Sep-2013. A 80 year old female patient had received intramuscular (IM) FLUZNE HD (lot # U4713AA and expiration date unknown) on left deltoid on 10-Sep-2013., On 18-Sep-2013, she has experienced nausea, body aches, chills, tender injection site and lethargy for unknown length of tie. On 21-Sep-2013, she felt better but not completely. Documents held by sender: none
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Initial report received from healthcare professional on 29 September 2013. A 59-year-old female patient whose concomitant medications were not reported, had received intramuscular dose of FLUZONE HD, batch number: U4764AA (dose number was unknown) in right deltoid on 29 September 2013. The patient has no known allergies and illness at the time of vaccination was unknown. It was reported that on 29 September, the patient was given HD by mistake. Thus there was vaccine overdose and experienced 1 inch red swollen area, hot to touch with rash around injection site on right deltoid, chest tightness and dizzy feeling. The patient's corrective treatment and laboratory investigations were not reported.  At the time of this report, the outcome was not recovered. Documents held by sender:  none
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Overdose
Clinical narrative: Initial report received from healthcare professional on 29 September 2013. A 59-year-old female patient whose concomitant medications were not reported, had received intramuscular dose of FLUZONE HD, batch number: U4764AA (dose number was unknown) in right deltoid on 29 September 2013. The patient has no known allergies and illness at the time of vaccination was unknown. It was reported that on 29 September, the patient was given HD by mistake. Thus there was vaccine overdose and experienced 1 inch red swollen area, hot to touch with rash around injection site on right deltoid, chest tightness and dizzy feeling. The patient's corrective treatment and laboratory investigations were not reported.  At the time of this report, the outcome was not recovered. Documents held by sender:  none
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: Initial report received from a healthcare professional on 01 October 2013. A 70-year-old female patient had received an intramuscular dose of FLUZONE HD (batch number: U4715AA, expiry date: 04 June 2014 and dose number was not reported) in the right arm on 16 September 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and had no illness at time of vaccination. Concomitant medications were not reported. On 16 September 2013, same day of vaccination, the patient developed black and blue bruising 2" below injection site and knot at injection site. Laboratory tests were not reported and the patient did not seek any medical care. On an unspecified date, knot at injection site was resolved and the outcome of th event black and blue bruising 2" below injection site was unknown. List of documents held by sender: none
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Initial report received from a healthcare professional on 01 October 2013. This case is linked to case number 2013SA098091 (this case was of patient's wife) both had same reporter, received same vaccine having same lot number. A male patient (date of birth and age at the time of event was not reported) had received an intramuscular dos e of FLUZONE HD (batch number: UA714AA, expiry date: 04 April 2014, dose number and site of administration not reported) on 08 September 2013. The patient's medical history and concomitant medications were not reported. On 10 September 2013, one day after vaccination, the patient developed muscular aches in his arm. No laboratory tests were performed and corrective treatments were not reported. At the time of this report, the patient was not recovered and the event did not become worse and not improved.   Follow up information received from a healthcare professional on 17 March 2014. The patient was 49 years old. The patient had no illness at the time of vaccination. The patient had history od L wrist cyst, inguinal hernias, DJD (degenerative joint disorder) R shoulder prostatitis, obesity, EX anal fissure, asthma, renal cyst, Type 2 Diabetes mellitus, BPH (benign prostatic hyperplasia) , CKD (Chronic Kidney disease) stage 3 ASCVD (arteriosclerotic cardio vascular disease) hyperlipidemia an essential hypertension. The patient had done Quad bypass, right shoulder replacement as surgery. The patient had allergy to IV dye, iodine containing contrast media: contraindication, penicillin, sardines (fish) and rash. The patient was taking Prinivil 10 mg one tablet daily , Ziac 5-6.25 mg one tablet daily, Fenofibrate micronized 200 mg 1 capsule by oral route e very day with food, Crestor 20 mg one tablet daily, Onglyza 2.5 mg one tablet once a day, Aspiz 81 mg, Nasonex 50 mcg/ ACT 2 sprays ea nostril daily, Mupirocin 2% apply cream to affected area every eight hours, Vitamin D 2000 unit QD, Vitamin B12 1000 mcg 1 QD, Acid reducer maximum strength 20 mg QD, Advair Diskus 250-50 mcg/dose take 1 puff(s) inhaled 2 times a day, Free style lite test strip as directed each morning. Free style lancets  strength miscellaneous as directed, Tamsulosin HCI 0.4 mg capsule extended release 24 hour 1 capsule 30 minutes after the same meal each day once a day stop date: 07 December 2013. The patient had routine checkup. The patient had vital signs of height: 67.25, weight: 225, BMI: 34.97, BP: 118/62 Pain scale: 0, BSA: 220. The patient had laboratory investigation on 16 July 2013.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Feeling cold
Clinical narrative: Initial report received on 01-Oct-2013 from pharmacist. A three patients of unknown age and unknown gender received FLUZONE HD (lot number, expiration date and route unknown). Patients had chills from, teeth chattering. Reporter stated that 3 people had chills, feeling cold and it began about 3 hours after vaccine administration and lasted about a day (24 hours). Outcome of the events was unknown at the time of this report. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Initial report received from a vaccine provider on 01-Oct-2013. A male and female patient, whose age, medical history and concomitant medications were not reported, had received a does of FLUZONE HD (lot number U4714AA, intramuscularly and site of vaccination were not reported, on 09-Sep-2013. On 10-Sep-2013, after receiving vaccine the female patient experienced muscular aches in her arm and back. The male patient also had muscular aches in his arm. At the time of reporting, outcome of the event was not recovered. No further relevant information was reported. Documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Body temperature increased, Fatigue, Feeling abnormal, Muscle spasms, Pain
Clinical narrative: Initial information received from a healthcare professional on 30 September 2013 plus subsequent follow up: A 85 year old female patient had received a second dose of FLUZONE HD intramuscularly in the left deltoid region (batch number: U4761A) on 27 September 2013. The patient had codeine allergy.  Illness at the time of vaccination was leg pain and knee. On 27 September 2013, the patient felt "yucky" and then had a low grade temp on 28 September with severe leg cramps and body aches until 29 September 2013 and now feels tired and work out. She stated that also felt this way last year after the flu vaccine. She has had leg cramps in the past unrelated to the vaccine. Laboratory investigations and treatment medications were not done. On an unspecified date the patient had recovered. List of documents held by sender: none  Additional report received from a consumer on 07 November 2013. Administered person by name added. County and state where vaccine administered were added. Contact details of patient and physician was added. Any other medication received within 4 weeks was reported none. Laboratory and corrective treatment was reported none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Initial report received on 27 September 2013 f4rom a health care professional. A 75-year-old male patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number U4781AA, expiration date 25-May-2014 and site of vaccination was not reported) intramuscularly on 24 Sep 2013. It was reported that a 75-year-old male patient have received the FLUZONE HD. On 25-Sep-2013, patient developed a red area at injection site which has been getting larger and is now up to 4 inches across. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial information received from a health care professional on 30 September 2013. This is an invalid case as individual patient identifiers are missing. The elderly patients had received FLUZONE High-Dose (batch number, route and site of administration not reported) on an unspecified date. Medical history and concomitant medications were not reported. It was reported that the patients who had received FLUZONE High-Dose developed more fever as compared to other patients. Laboratory investigations and treatment medications were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Initial report received from a health care professional on 26 September 2013. A female patient of unspecified age (birth date reported ad "06"), whose medical history, concomitant medications were not reported and had  no known allergies, had received an intramuscular dose of FLUZONE HD (lot number UH717AA, expiry date: 30 July 2013) in the left deltoid region on 24 September 2013. On 26 September 2013, the patient's arm was red, tender and painful 3 inches below the vaccination site. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. List of document held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Initial report received on 23 September 2013 from a pharmacist. A female patient of unknown age, whose medical history included diabetes mellitus and concomitant medications was not reported, received a dose of FLUZONE via intramuscular route for prophylactic vaccination from 19-Sep-2013. After vaccination, on 20-Sep-2013 the patient experienced a purplish area size of a dime at insertion site, hardness and some redness also present. Pharmacist reported that patient stated it was painful and itching. The events were ongoing at the time of this report. List of documents held by sender: none. Follow up information was received from health care professional on 23 September 2013. The cases were received on 21 March 2014 at GPV. It was reported that patient believed that the vaccine was given subcutaneously.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain, Injection site warmth
Clinical narrative: Initial report received on 27 September 2013 from a health care professional. A 65-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number U41714AA, Expiration date 04-Apr-2014 route was unknown and site of vaccination was left deltoid) on 25-Sep-2013. It was reported that a 65-year-old female patient have received the FLUZONE HD. On 26-Sep-2013, patient had 4-5 inch echymotic, tender, afebrile at the injection site. List of documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Insomnia, Vertigo
Clinical narrative: Initial report received from a consumer ion 02 OCTOBER 2013.  A 74-year-old male patient has received first dose of FLUZONE HD (batch number, route, and site of administration was not as "NA") on 25 SEPTEMBER 2013. The patient had received flu injections in the past. The patient had hypertension at time of vaccination. The patient had history of allergy of sulfa, NSAIDS and some beta blockers. The patient had egg allergy 40 years ago but he could eat egg. Six month prior, the patient had history of TIA (Transient Ischemic attack). The patient's concomitant medications included Lipitor, ASA and Alonopine and had received AZOR until one week.  On 25 September 2013, one day after vaccination the patient had oral surgery and developed dizziness and vertigo, on 27 September 2013, the patient was sent to Emergency room for dizziness and MIR of head was normal and on 30 September 2013, the patient developed sleeplessness.  Laboratory tests and corrective treatment were not reported. At the time of this report, the patient was not recovered. List of documents held by sender: None.  Follow-up information received from  non-healthcare professional on 28 February 2014. The patient received intramuscular dose of FLUZONE HD (batch number: U4717AA).
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Initial report received from a non-health care professional on 03 October 2013. A 91 years old male patient, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number, route and site of vaccination were not reported), on an unspecified date in 2013. On an unspecified date, after receiving vaccine the patient experienced severe chills and fever. At this time of this report the outcome of adverse event was unknown. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 4 October 2013. A 70 year old female received FLUZONE HD (Lot # U4781AA, expiration date unknown) intramuscularly at left deltoid on 02-Oct-2013. After vaccination, on 04-Oct-2013 (onset of reaction not reported) he experienced severe flu like symptoms and a nodule formed at the injection site and it was red and swollen. The patient did not recover from the events. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 03-Oct-2013. The patient at the nursing home was given two doses (injections) of the FLUZONE High Dose Vaccine. (No information was provided regarding the patient). No adverse event was reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial report received from a non-healthcare professional on 10-Oct-2013. A 67-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number and route was not reported) on 30-Sep-2013. On 09/30 at 1:30 pm patient received vaccine at a pharmacy, 3 hours after the injection, strange feeling in arm developed and excruciating pain in arm. Patient called pharmacist, at 5:30pm. Pharmacist told her to put some ice on it, take some ADVIL or bufferin. Two hours later the pain got worse, intolerable. She had worst pain. She went to physical therapist, three times a week. Saw the doctor 3 days after the vaccine. Started in the injection area, down to hand, up to shoulder and then up to the shoulder and neck. Patient was not capable of doing anything with right hand. Patient was unable to do things with her hand and arm. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Initial report received from a pharmacist on 03-Oct-2013. A 83-year-old female patient had received FLUZONE HD (batch number: U4759AA, dose number not reported and site of administration deltoid right) on 02-Oct-2013. The patient's medical history was none. Concomitant medication was unknown. On 03-Oct-2013, the patient developed 10 cm swollen, erythematous, tender area, and the size of a softball. There are no other symptoms and no fever. She was prescribed antihistamines, compresses. Laboratory tests and corrective treatments were unknown. Outcome of event ws unknown. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial report received on 09 October 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE High-Dose (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient have received the High-Dose Flu Vaccines. On an unknown date, reporter stated that a patient received two doses of the high-dose flu vaccine within 10 minutes. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Eye pruritus, Headache, Ocular hyperaemia
Clinical narrative: Initial report received from a non-healthcare professional on 7 October 2013. A 70 year old female patient received FLUZONE HD (Lot # U4781AA, expiration date unknown) intramuscularly on left deltoid on 10-Oct-2013. After vaccination, on 10-Oct-2013 the patient experienced headache, red eyes, soreness and itching of eyes, throat stuffiness, had body temperature as 100, chills and vomiting. The corrective treatment included BENADYL for throat stuffiness. The patient recovered from the events but still had body temperature as 100. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pharyngeal disorder, Vomiting
Clinical narrative: Initial report received from a non-healthcare professional on 7 October 2013. A 70 year old female patient received FLUZONE HD (Lot # U4781AA, expiration date unknown) intramuscularly on left deltoid on 10-Oct-2013. After vaccination, on 10-Oct-2013 the patient experienced headache, red eyes, soreness and itching of eyes, throat stuffiness, had body temperature as 100, chills and vomiting. The corrective treatment included BENADYL for throat stuffiness. The patient recovered from the events but still had body temperature as 100. Documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Initial report received from a non-healthcare professional on 10-Oct-2013. A 74-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number: U47117AA and route was not reported) on left deltoid on 16-Sep-2013. On 17-Sep-2013, patient had sore arm. Patient has not seen a physician. Patient experienced pain at the injection site, into the muscle. She had difficulty dressing herself. Patient was slowly getting better. The events were recovering. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Paraesthesia, Rash, Skin warm
Clinical narrative: Initial information received from nurse on 04-Oct-2013. Patient got FLUZONE HD broke out in a rash on the side of her arm. Red, raised, warm to touch, tingly and burning sensation. Getting bigger. Located distal to the injection site. Injection site is does not have a rash. No other symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Initial report received from healthcare professional on 07 October 2013. A 70-year-old female patient whose medical history and concomitant medications were not reported received FLUZONE HD (lot number U4761AA and expiration date unknown) intramuscularly in left deltoid (dose number not reported) on 05 October 2013. On 06 October 2013, the patient developed redness about palm size which was related and hot to the touch. Laboratory investigations and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Initial report received from a healthcare professional on 07-Oct-2013. On 03-Oct-2013, the patient had received FLUZONE HD vaccine (lot number U4767AA and expiration date unknown). Patient stated to reporter that she developed redness and bruising at the injection site over the weekend. Reporter does not know if it was Saturday 05-Oct-2013 or Sunday 06-Oct-2013. Patient did not indicate to reporter that she sought medical attention or self-treated. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local reaction, Rash erythematous, Vaccination complication
Clinical narrative: Initial report received from healthcare professional on 10 October 2013. A 77-year-old female patient, received first dose of FLUZONE HD (lot number U4765AA, expiration date unknown) (route and exact site of administration not reported) on 09 October 2013. On 09 October 2013, the patient had local reaction including redness, bruise. It went all the way down to the elbow. Red, dark coloring, rash, slightly raised. The physician thought it was a reaction to the vaccine. Laboratory investigation and corrective treatment not reported. The patient had not recovered from the events. Documents held by sender: none.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial case was received from a health care professional on 04 October 2013. A 70 year old patient (gender unknown) had medical history reported as negative R factor, received a dose of FLUZONE HD in left deltoid on 26 August 2013 (batch number U4714AA). Patient had not reported concomitant medication. It was reported that on 28 August 2013 patient experienced pain, redness and swelling at injected site. No corrective treatment was reported. At the time of report the outcome was unknown.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Initial case was received from a health care professional in on 11 October 2013. A 70 years old patient (Gender unknown) had no medical history reported, received a dose FLUZONE HD vaccine intramuscularly on left deltoid 08 October 2013 (batch number U4762BA). Patient had not reported concomitant medication. It was reported that on 08 October 2013 patients developed a red rash just below the injection site down the arm to the elbow. The area was hot to touch. No corrective treatment was reported. At the time of report the outcome of event was not recovered.