chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Skin warm, Vision blurred
Clinical narrative: On 1/22/2015 My vision was extremely blurred. I had pain, swelling, and fever in my arm at the injection sight just above left elbow which radiated to armpit. By 5:00 PM my vision was somewhat better. I went to bed on 1/22/2015 around 10:30 PM. I awoke just after midnight with severe throbbing pain in my arm both at injection site and radiating up my Left arm. By morning on 1/23/2015 around 8:00 AM I awoke to severe pain and fever in my arm and a marble sized lymph node that was swollen and tender in my armpit. The pain and swelling had my left arm pretty much immobilized. On both occasions, I contacted the pharmacy where immunization for shingles was given. I was instructed by pharmacist to keep a close watch on it and call back if it became worse. The pharmacist also called me back at random times to see if I was having further reaction. No plan for treatment was discussed at this time and was assumed to be a normal reaction.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Injection site reaction, Pain
Clinical narrative: Chicken pox vaccine, first dose, given to me on 1/7/2015 (I have not had chicken pox before, and titer done/proved that so vaccine preventative). My body aches starting afternoon of 1/20, continued for 2 days. Rash and soreness appeared 1/21/2015 at the site where the vaccine shot was given. Went back to doctor 1/23 and she confirmed shingles outbreak at site of where shot was given.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Dyskinesia, Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Flu shot administered 1-13-15. A.M. of 1-14-15 C/O numbness/tingling in hands but quickly resolved. Participated in swim practice 1-14-15 and (L) arm "flapping" occurred. States would not stop unless she squeezed a stress ball. Did not occur during sleep. 1-15-15 Lifted weights and participated in swim practice. 1-16-15 ER. Told it was "stress" related.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Stress, Urine analysis
Clinical narrative: Flu shot administered 1-13-15. A.M. of 1-14-15 C/O numbness/tingling in hands but quickly resolved. Participated in swim practice 1-14-15 and (L) arm "flapping" occurred. States would not stop unless she squeezed a stress ball. Did not occur during sleep. 1-15-15 Lifted weights and participated in swim practice. 1-16-15 ER. Told it was "stress" related.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asterixis, Blood test, Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Flu shot administered 1-13-15. A.M. of 1-14-15 C/O numbness/tingling in hands but quickly resolved. Participated in swim practice 1-14-15 and (L) arm "flapping" occurred. States would not stop unless she squeezed a stress ball. Did not occur during sleep. 1-15-15 Lifted weights and participated in swim practice. 1-16-15 ER. Told it was "stress" related.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tremor
Clinical narrative: Developed tremor 24 hr after receiving vaccine. Pt seen 1/15/15 and reports tremor improving.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itchiness and some small red bumps around the area of injection. Treated with BENADRYL 25 mg as needed for 2-3 days.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Peripheral swelling, Pruritus generalised, Skin warm, Urticaria
Clinical narrative: Lt arm lg welp, hot and swollen. Also c/o itching all over , sore throat.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Area of injection became red, warm to touch, tender, size is 3 x 3 in. Pt. c/o itching and burning sensation. KEFLEX ordered on 1-14-15-improved by 1-15-15.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain radiated down arm. Patient came into pharmacy 1/1/15 to complain about not being able to move arm.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Alopecia, Biopsy skin, Laboratory test normal
Clinical narrative: 2-3 month history of gradual hair loss. Currently being evaluated by Dermatology.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Autopsy, Death, Influenza, Influenza A virus test positive, Pulmonary congestion
Clinical narrative: A report from a physician concerns a 13 year old female patient. Relevant history, concurrent diseases and concomitant drugs were not reported. The patient received FLUMIST QUADRIVALENT (intranasal) in Oct-2014 at a local pharmacy. Apparently patient had received FLUMIST QUADRIVALENT at an outside pharmacy, so the doctor doesn't have information on lot number. Patient passed away on 16-Dec-2014. Patient was positive for influenza A. The parents requested an autopsy, and the preliminary report states following Diagnosis: 1. Congestive hemorrhagic lungs. 2. Influenza A. 3. Staphylococcus aureaus (+) from the lungs. Physician said that once they receive the final autopsy report they will notify our office. The patient died from the congestive hemorrhagic lungs on 16-Dec-2014. The outcome of the staphylococcus aureus (+) from lungs and influenza A was unknown. The cause of death was congestive hemorrhagic lungs. An autopsy was performed. The reporter considered the congestive hemorrhagic lungs to be serious by the criterion of death and other events to be serious by the life threatening criterion.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Pulmonary haemorrhage, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: A report from a physician concerns a 13 year old female patient. Relevant history, concurrent diseases and concomitant drugs were not reported. The patient received FLUMIST QUADRIVALENT (intranasal) in Oct-2014 at a local pharmacy. Apparently patient had received FLUMIST QUADRIVALENT at an outside pharmacy, so the doctor doesn't have information on lot number. Patient passed away on 16-Dec-2014. Patient was positive for influenza A. The parents requested an autopsy, and the preliminary report states following Diagnosis: 1. Congestive hemorrhagic lungs. 2. Influenza A. 3. Staphylococcus aureaus (+) from the lungs. Physician said that once they receive the final autopsy report they will notify our office. The patient died from the congestive hemorrhagic lungs on 16-Dec-2014. The outcome of the staphylococcus aureus (+) from lungs and influenza A was unknown. The cause of death was congestive hemorrhagic lungs. An autopsy was performed. The reporter considered the congestive hemorrhagic lungs to be serious by the criterion of death and other events to be serious by the life threatening criterion.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Enema administration, Haematochezia, Intussusception
Clinical narrative: Sx began 01/19/2015, pt refused to nurse, bloody stool, inconsolable crying. resolved by intussusception reduction using air enema at hospital.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Joint injury, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Received Flu shot at pharmacy 11/11 and arm was sore for 2 days then felt fine. 11/18 site was very painful and remained so getting worse each day.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Bursitis, Inflammation, Injection site infection, Injection site pain, Injection site warmth
Clinical narrative: Received Flu shot at pharmacy 11/11 and arm was sore for 2 days then felt fine. 11/18 site was very painful and remained so getting worse each day.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pyrexia, Surgery, Tendonitis
Clinical narrative: Received Flu shot at pharmacy 11/11 and arm was sore for 2 days then felt fine. 11/18 site was very painful and remained so getting worse each day.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Received Flu shot at pharmacy 11/11 and arm was sore for 2 days then felt fine. 11/18 site was very painful and remained so getting worse each day.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Injection site pain, Joint injury, Nuclear magnetic resonance imaging abnormal, Vaccination complication
Clinical narrative: Received Flu shot at pharmacy 11/11 and arm was sore for 2 days then felt fine. 11/18 site was very painful and remained so getting worse each day.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea
Clinical narrative: About 2 hours after injection pt got chills and nausea...could not get warm & felt very nauseated.  Lasted for about 12 hours.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chest discomfort, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Heart palpitations, tightness of chest, shortness of breath, fatigue.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram ambulatory, Fatigue, Palpitations, Pulmonary function test
Clinical narrative: Heart palpitations, tightness of chest, shortness of breath, fatigue.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, C-reactive protein increased, Condition aggravated, Full blood count normal, Gait disturbance
Clinical narrative: 1/18/15: Presented to Urgent Care Center with complaints of left leg limp and pain (same limb as vaccination). Parent states the symptoms began 1/17/15.  Pneumovax had been given in left thigh at PCP office on 1/16/15.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain, Red blood cell sedimentation rate normal, Reticulocyte count normal, Sickle cell anaemia with crisis
Clinical narrative: 1/18/15: Presented to Urgent Care Center with complaints of left leg limp and pain (same limb as vaccination). Parent states the symptoms began 1/17/15.  Pneumovax had been given in left thigh at PCP office on 1/16/15.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: 1/18/15: Presented to Urgent Care Center with complaints of left leg limp and pain (same limb as vaccination). Parent states the symptoms began 1/17/15.  Pneumovax had been given in left thigh at PCP office on 1/16/15.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Decreased appetite, Pain, Pyrexia
Clinical narrative: Shivering, violent trembling, fever, chills - lasting nearly 4 days; also complete loss of appetite, achiness, lack of energy, loss of bladder control - lasting about 7 days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Urinary incontinence
Clinical narrative: Shivering, violent trembling, fever, chills - lasting nearly 4 days; also complete loss of appetite, achiness, lack of energy, loss of bladder control - lasting about 7 days.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash
Clinical narrative: RASHES ON THE UPPER BACK AND FACE.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: Patients are swelled up to the size of a baseball.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, swelling, warmth, pain.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: The patient said he felt bad the evening after recieving the vaccine. The patient woke up on 1/18/15 at about 3am and felt bad. later in the morning patient reported headache, stiff neck, and felt exhausted, felt tired and reported he just felt like he was getting sick. Patient said he felt better the evening of 1/18/15.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: This office was informed today that patient was taken to emergency room last night for fever of 102 degrees.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Pt reported having a painful blistering rash on the right side of her neck.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Red and swollen area around injection site and arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Nausea
Clinical narrative: Severe pain at site of injection, chills, malaise, tiredness, nausea.
Age: 15.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Gave patient a MPSV4 without parents consent.  Resulted in him passing out.
Age: 0.02
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 9 day old baby came in for first visit. Was going to grab the Hepatitis B vaccine and mistakenly grabbed the FLUARIX 0.5 ml vaccine. I did not realize it at that time but about 20-30 minutes later I called CDC info and state Health Department. Called father with what had happened and information given to us.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Contusion, Pain in extremity, Wheelchair user
Clinical narrative: This spontaneous report as received from the patient's mother refers to her 18 year old female daughter. Medical history and concurrent conditions were not reported. On an unknown date in 2007, the patient was vaccinated with an unspecified dose of GARDASIL (administration route, dose, lot number and expiration date were not reported). No concomitant medication was reported. On an unknown date the patient experienced stomach and leg pains. The patient also developed a bruise on her leg (in 2008 or 2009, specific date was not known) and later became "wheelchair bound" (date unspecified). The reporter stated that her daughter the patient spoke with the physician. The outcome of events was reported as not recovered. Upon internal review, "wheelchair bound" was considered disabling. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental overdose
Clinical narrative: This case was reported by a nurse and described the occurrence of accidental overdose in a 12-year-old male patient who received FLULAVAL (batch number 9A3ZM, expiry date 30th June 2015). Co-suspect products included FLUMIST (batch number CJ2129, expiry date 5th January 2015). In 2014, the patient received FLULAVAL (unknown) and FLUMIST (unknown) at an unknown dose and frequency. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information received on 17 November 2014: The patient was inadvertently administered 2 Flu vaccines in the same visit.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Asthma, Drug hypersensitivity, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received Flu Seasonal TIV Dresden (flu vaccine).  Concomitant products included TAMIFLU, Relenza and fluticasone propionate, ADVAIR.  On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced allergic reaction and asthma. On an unknown date, the outcome of the allergic reaction and asthma were unknown.  Additional information received stated that patient is allergic to the flu vaccine, both the dead and live virus and TAMIFLU. She also stated she had such a bad reaction to it that she now has asthma. The patient is also taking ADVAIR.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Patient had redness from shoulder to elbow.
Age: 11.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Systemic lupus erythematosus
Clinical narrative: After patient received these vaccines, she was admitted in ER and was diagnosed of Lupus and currently receive treatment at hosp.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site vesicles
Clinical narrative: Cellulitis. Allergic Rx (L) thigh with yellow blister like lesion at site of vaccine like bug bite with erythema to inner thigh 3d after vaccine.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a prospective pregnancy case. This 40-year-old female subject was enrolled in a study. The subject received flu seasonal QIV .5 ml on 23rd September 2014. On an unknown date, an unknown time after receiving flu seasonal QIV the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 23 September 2014: The due date was unknown. No other adverse events were reported. This is one of the 3 cases reported by the same reporter for the same vaccine. Follow-up information received on 19 January 2015: The last menstrual period and the number of previous foetuses were also unknown.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pruritus, Hypersensitivity, Ocular hyperaemia, Paraesthesia oral
Clinical narrative: Initial report received on 25 November 2013 from a health care professional. A 65-year-old female patient medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, intramuscular and deltoid left). It was stated by the reporter that the patient reported to her that her eyes became red and itchy 2 hrs post vaccination and throat was scratchy lips tingling and nonproductive cough. Physician stated to patient that she probably had an allergic reaction to something. Reporter advised her to take BENADRYL 25mg orally per product directions. No further relevant information reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Initial report received on 25 November 2013 from a health care professional. A 65-year-old female patient medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, intramuscular and deltoid left). It was stated by the reporter that the patient reported to her that her eyes became red and itchy 2 hrs post vaccination and throat was scratchy lips tingling and nonproductive cough. Physician stated to patient that she probably had an allergic reaction to something. Reporter advised her to take BENADRYL 25mg orally per product directions. No further relevant information reported.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site bruising
Clinical narrative: Initial case was received from a healthcare professional on 04 November 2013. A 73 years old female had received a dose of FLUZONE HD vaccine, batch number UH787BA in the left deltoid on 29 October 2013 (dose number was not reported). Patient had no illness at the time of vaccination and had no known allergies. On 30 October 2013, the patient developed bruising on arm at the site of vaccination. Corrective treatments and laboratory investigations were not reported. As off this report, the outcome of the event was unknown. List of documents held by the sender none. Follow-up information received from healthcare professional on 14 January 2014. As of 14 January 2014, the outcome was recovered.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 22 November 2013. A 76-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE HD (lot number, expiration date and site of administration intramuscular) at right deltoid (dose number not reported) on 01 October 2013. On 01 October 2013, the patient received vaccine and since that day she had pain in the arm where she received the vaccine. Her pain started that day and she could not raise her arm. It is now 7 weeks later and the pain continues and she is still unable to raise her arm. Laboratory investigation and corrective treatment were unknown. As of this report, the patient had not recovered from the event. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Stomatitis
Clinical narrative: Initial report received from a health care professional on 12 November 2013. A male patient, whose date of birth, age, medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, lot number, route, site of administration, dose number were not reported) on an unspecified date. On an unspecified date, after vaccination the patient experienced mouth sores, flu like symptoms and achiness. Corrective treatments and laboratory investigations were not reported. At the time of this report the outcome of the event was unknown. Documents held by sender: none  Additional information received from a health care professional on 11-Dec-2013. The patient was in his 50's. The vaccine was administered in Oct/Nov 2013. The event occurred in Oct/Nov 2013.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a nurse on 22 November 2013. A 75 year old male patient received FLUZONE HD (lot # and expiration date unknown) intramuscular in right deltoid on 01-Oct-2013. The patient reported that since that day he has had pain in the arm where he received the vaccine. His pain started that day and increased day by day for 3 days. He stated that it was now 7 weeks later and the pain continues. He was unable to exercise or swim as he used to. The event was ongoing at the time of this report. Medical history includes hypertension. List of documents held by sender: none
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a health care professional on 07 November 2013. A 12-year-old patient received FLUZONE HD. (No 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: Initial misuse information was received from a health care professional on 19 Sep 2013. Cases were received on 21 March 2014 at GPV. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE HD on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received incorrect route of vaccination. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 23 September 2013. This case was received on 21 March 2014 at GPV. FLUZONE HD was administered to a patient less than 65 years of age. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Wound
Clinical narrative: Initial report received from a non-health care profession on 05 December 2013.  Two patients, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (lot number, route and size of vaccination were not reported) on 04 December 2013. On 03 December 2013, reporter stated that had 2 patients who had reaction following FLUZONE HD vaccination. A female patient had a 4 in open wound at injection site. At the time of this report the outcome of adverse event was unknown. 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 health care professional on 16 Sep 2013. A dose of FLUZONE HD was administered to a 61 year old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 56.0
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. A 56-year-old patient had received FLUZONE HD, (batch  number, dose and anatomical site of administration not reported) which is indicated for the use in patients with >65 years. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013. The case was received on 21 March 2014. The patient had received two doses of FLUZONE HD in 10 days. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 February 2014. A patient (no information was provided regarding the patient) had received a dose of FLUZONE HD vaccine exposure during pregnancy and no adverse event was reported. I.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial report received from non-healthcare professional (patient) on 07 January 2014. Almost 80-year-old female patient, whose 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. It was reported that on an unspecified date, 12 days after receiving FLUZONE HD vaccine, the patient experienced ongoing have and urticaria. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 25 September 2013 and on 21 March 2014. A 56-year-old patient of unknown gender had received FLUZONE HD on an unknown date. The patient received FLUZONE HD at incorrect age. No adverse event was reported. The list of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 September 2013. A pregnant female patient 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: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 January 2014. This is invalid case as the individual patient identifiers missing. The patient had received FLUZONE HD vaccine on unspecified date and then the patient stated they may have had it already in last two months. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 16 January 2014. A female (initials, date of birth and age at the time of event was not reported) were not reported had received an intramuscular dose of FLUZONE HD (lot  number: U4785AA, expiry date: 06 December 2014 and dose in series was not reported) in the left deltoid on 26 November 2013. The patient had no illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date, shortly after receiving the vaccination, the patient developed pain in the left arm that feels like bone pain. No laboratory investigations were done and corrective medication was not reported. At the time of this report, the outcome was unknown. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 January 2014. This is an invalid case as individual patient identifiers are missing. It was reported that the patient (no information was provided regarding the patients) inadvertently received 2 doses of FLUZONE HD 1 week apart. No adverse event was reported. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Injection site reaction, Myalgia, Urine output decreased
Clinical narrative: Initial report received from non-health care professional on 10 January 2014. Reporter was also the patient in this case. It was reported that the 66 years old female patient received FLUZONE HD on 09 January 2014 by intramuscular route in deltoid left. Several hours later felt she was "sweating more than usual", had decreased urine output, and experienced muscle soreness at injection site. Stated continued to feel "as if sweating more than usual today, 10 January 2014. The subject's medical history was not reported. The lab details were not reported. The event sweating more than usual outcome is unknown at the time of reporting. No more information available. Documents held by the sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: Initial report received from a consumer (the patient) on 23 December 2013: A 72-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD, (batch number, dose number, route and site of administration not reported) on 25 September 2013. The patient experienced body wide itching two weeks later, on an unspecified date that comes and goes and rash was continuing. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow up information was received on 17 January 2014: The patient had received FLUZONE HD vaccine. The patient never had any reaction with flu vaccine. It was reported that the patient experienced itching. The patient received treatment with clotrimazole, betamethasone and dipropionate topical cream for her rash. The patient agreed to send the available information.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 February 2014. A 64-year-old female patient had received a dose of FLUZONE HD on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, X-ray normal
Clinical narrative: Initial case was received from a health care professional on 21 February 2014. A 71-year-old female patient whose medical history included allergic to latex and concomitant medications were not reported had received an intramuscular FLUZONE HD (batch number U4809AA, dose not reported) in the left arm on 28 December 2013. On 29 December 2013, in the morning the patient had trouble in moving her left arm. On 04 January 2014, she went to an urgent care and was told to put an ice on it and to take anti-inflammatory. On 17 January 2014, she saw her doctor who gave her a cortisone shot and took an X-ray. The event was still not recovered so Magnetic Resonance Imaging (MRI) was planned. No corrective treatment was reported. The list of documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 21 January 2014. A male patient whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, dose number, route and site of administration not reported) on an unspecified date. On an unspecified date, 3 days after vaccination, the patient developed severe pain in the left arm. Laboratory tests and corrective treatments were not reported. The patient visited the ER. At the time of this report, the outcome was unknown. List of documents held by sender: None. Follow-up information received from healthcare professional on 24 March 2014. It was reported that, on an unspecified date, the outcome was recovered.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erosion
Clinical narrative: Initial report received from a healthcare professional on 18 December 2013. A 71-year-old male patient who had no illness at the time of vaccination, no medical condition, allergies and concomitant medication was not reported, had received a dose 1 of FLUZONE HD vaccine (lot number: U4809AA, route of administration was not reported) in the left deltoid on 12 December 2013. On 13 December 2013, the patient experienced excoriation about 1/8 inches at the injection site. Laboratory investigations and corrective treatments were not reported. On an unspecified date, the patient had recovered from events. List of documents held by sender: none.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pain, Pyrexia, Somnolence
Clinical narrative: Initial case was received from a non-healthcare professional on 04 November 2013. An 89 years old female had received an intramuscular dose of FLUZONE HD vaccine, batch number U47982AA on 03 November 2013. Patient had no illness at the time of vaccination. Patient's physician diagnosed allergies, birth defects and medical conditions were unknown. On 03 November 2013 within a few hours of vaccination, the patient had vomiting, dizziness, fever/chills/shaking and aching. It was reported that the patient was recovering at the time of this report but was sleeping lot. Corrective treatments and laboratory investigations were not reported. As of this report, the patient had not recovered from the events. List of documents held by sender none.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Initial case was received from a non-healthcare professional on 04 November 2013. An 89 years old female had received an intramuscular dose of FLUZONE HD vaccine, batch number U47982AA on 03 November 2013. Patient had no illness at the time of vaccination. Patient's physician diagnosed allergies, birth defects and medical conditions were unknown. On 03 November 2013 within a few hours of vaccination, the patient had vomiting, dizziness, fever/chills/shaking and aching. It was reported that the patient was recovering at the time of this report but was sleeping lot. Corrective treatments and laboratory investigations were not reported. As of this report, the patient had not recovered from the events. List of documents held by sender none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Headache
Clinical narrative: Initial case was received from a healthcare professional on 29 October 2013. The 74-year-old female patient whose medical history and concomitant medication was not reported had received an intramuscular FLUZONE HD (batch number: U4781AA, dose unknown) on her left deltoid (LD) on 07 October 2013. The patient had previously received FLUZONE HD last year on an unknown date. The patient did not have any previous illness, allergies or other history at the time of vaccination. On 29 October 2013, the patient called up reporter and stated that she had been experiencing backache, headache and fatigue since the time of vaccination. The symptoms continued till 29 October 2013. No laboratory details were reported. No corrective treatment was reported. The outcome of the event was not recovered. List of documents held by sender: None. Follow-up information received from healthcare professional on 5 September 2014. No new information was updated.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Headache, Nausea
Clinical narrative: Initial report received from a non-healthcare professional on 29-Oct-2013. A male patient whose age and concomitant medications were not reported, received a dose of FLUZONE HD (lot number: U4781AA) on left deltoid via intramuscular route. Patient experienced backache, headache, fatigue and nausea since time of vaccination and symptoms continue to now on 29 October 2013. The events were not resolved. Patient had FLUZONE HD last year. Medical history included hypertension. Patient had penicillin, cephalosporins allergy. List of documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Initial report received from a vaccine provider on 24 October 2013. A 78 years old female patient, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number U4715AA, route and site of vaccination was left deltoid), on 11 September 2013. On 11 September 2013, after receiving vaccine, the patient experienced baseball sized diameter, rash around injection site that lasted for 3 days. Corrective treatment included ice compresses and BENADRYL. Last year, the patient had FLUVIRIN. Event was recovered at the time of this report. Documents held by sender: none.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site bruising, Urticaria
Clinical narrative: Initial report received from a pharmacist on 25 October 2013. A 82-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number U4785AA, on left deltoid, route was not reported) on 23-Oct-2013. On 24-Oct-2013, after receiving vaccine the patient bruise at injection, red hives below it, area got larger overnight. Corrective treatment included ice on the bruise and BENADRYL. At the time of reporting, outcome of the event was not recovered. No further relevant information was reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Pain, Tremor
Clinical narrative: Initial information regarding unsolicited case received from nurse on 25-Oct-2013: This case involves an elderly female patient. The patient's past medical histories and concomitant medications were unknown. In October 2013, the patient received FLUZONE HD (lot number, route, site of vaccination and expiration date were not reported). In October 2013, the patient experienced headache, shaking, generalized aches and pains, soreness at injection site. The patient self-medicated with TYLENOL and aspirin. Symptoms are resolving. No further information provided. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Rash
Clinical narrative: Initial information received from a healthcare professional on 18 October 2013. A 70-year-old female patient had received a dose of FLUZONE HD (batch number: U4784AA intramuscularly in the left deltoid region) on 16 October 2013. The patient's illness at the time of vaccination was unknown. The patient had allergy to penicillin and LEVAQUIN. On 16 October 2013, the patient's left deltoid injection site was red and sore. On 17 October 2013, there was rash around it. On 18 October 2013, the rash extended to her elbow. Lab investigations and treatment medications were not reported. At the time of this report, the outcome was not recovered. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Myalgia
Clinical narrative: Initial report received from a healthcare professional 18 October 2013. A 77-year-old male patient had received an intramuscular dose of FLUZONE HD vaccine (lot number, dose number and anatomical site of administration were not reported) on 10 October 2013. The patient had unknown illness at the time of vaccination and no known allergies. On 11 October 2013 one day after vaccination, the patient had malaise, diarrhea and muscle aches. Laboratory investigation was and corrective treatments were not reported. At the time of this report, the patients had not recovered from events. Documents held by sender: none. Follow up information received from the healthcare professional on 23 January 2014. The female patient had received an intramuscular dose of 0.5 ml of FLUZONE HD (batch number of vacine was U4764AA and expiry date: 27 May 2014) in the left arm.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from healthcare professional on 17 October 2013. Four pregnant female patients received FLUZONE HD inadvertently (no other information provided). The patients did not have any reported adverse reactions. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Initial report received pharmacist on 18 October 2013. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route intramuscular, lot # U4718AA and site of vaccination was right deltoid) on 16 October 2013. She reported that she had difficulty breathing the evening the vaccination was administered. Symptom resolved. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 21 October 2013. A 72 year old female patient whose concomitant medications were not reported, received a dose of FLUZONE HD (lot number: U4784AA, expiry date: unknown) on left deltoid via intramuscular route on 18 October 2013. Patient experienced soreness, redness, swelling at injection site with red ring that covered deltoid, biceps to the underarm area on 18 October 2013. Patient took ZYRTEC 10 mg for 3 days. Patient had allergy to CECLOR. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Nausea
Clinical narrative: Initial report received from a pharmacist on 23 October 2013. A 66 year old female patient had received FLUZONE HD (lot # U4785AA and expiration date unknown) intramuscular (IM) on lef6t deltoid on 16 Oct 2013. On 16 Oct 2013, the patient was having sweats, chills, nausea and a temperature of 99 Fahrenheit for approximately 24 hours after vaccination. Medical history includes allergy to Naproxen (Aleve). The patient was recovered at the time of this report. No further relevant information reported.
Age: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Rash pruritic, Scab
Clinical narrative: Initial report received from a healthcare professional on 17 October 2013. A 76-year-old patient, whose gender, medical history and concomitant medication was not reported had received a second dose FLUZONE HD (batch number: U4762BA, route of administration were not reported) in left deltoid on 08 October 2012.  On 06 October 2012, the patient complaint that, redness, firmness around site, star burst pattern, itchy bumps (blisters that broke open and scabbed), 3".  The patient corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient was recovered from the event.  Documents held by sender: none
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Initial report received from a non-health care professional on 17 October 2013. A male patient whose birth date and age at the time of event, medical history and concomitant medication were not reported, had received a dose of FLUZONE HD (lot number, dose number and anatomical site of administration were not reported) on 14 October 2013. The patient had no illness at the time of vaccination. On 14 October 2013 after vaccination, the patient experienced pain in the arm where vaccine was injected, and swelling of the lymph nodes under the arm in the axillary area. Symptoms had persisted for four days with no improvements but also not becoming worse. No laboratory investigations were done and corrective medications were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: none
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Initial information received from a consumer (the patient) on 17 October 2013. A 71-year-old female patient had received a dose of FLUZONE HD, (batch number: U4788AA, dose number not reported) intramuscularly in left deltoid on 15 October 2013. The patient was allergic to mercury preservatives and thimerosal and illness at the time of vaccination was not reported. On 16 October 2013, one day after vaccination, the patient developed 4 inch , red patch at injection site with hard lump at site. On 17 October 2013, the patient stated that the site was less red. Laboratory details and corrective treatments was not reported. At the time of this report, the outcome was unknown.   Follow-up information received from a health care professional on 10 March 2014. The patient was recovered on an unspecified date.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received on 07 October 2013 from a health care professional. A patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, expiry date and site of vaccination was not reported). It was reported that the patient received 2 doses of vaccine, 1.5 months apart. No reaction was reported. List of documents held by sender: none
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a doctor on 01 October 2013. The 4 years old female patient had received FLUZONE HD and patient pulled away and much of the does dripped down their arm. The patient received incorrect dose. No adverse event was reported. List of documents held by sender: none
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a health care professional on 14 October 2013.  A 63 year old patient had received FLUZONE HD. No 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 03 October 2013.  The patient had received FLUZONE HD on 03 October 2013 and then received another FLUZONE HD dose on 03 October 2013. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 03 October 2013.  The 69-year old patient had received FLUZONE HD that was expired. 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 pharmacist on 01 October 2013. The patient had received FLUZONE HD. Nurse gave a dose from last year which was expired. (No 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 10 October 2013.  The patient had received two doses of FLUZONE HD within 6 weeks. (No 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 nurse on 01 October 2013. The patient had received two doses of FLUZONE HD 10 minutes apart. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none