chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC13
Symptoms: Malnutrition, Metal poisoning, Motor developmental delay, Obsessive-compulsive disorder, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: Extreme emotional meltdowns, self harm, suicidal thoughts. Later (May 2013) diagnosed as PANDAS, ADD (diagnosed May 2013) with some autistic features, Anxiety, OCD. Mercury toxicity (blood test; permeable gut resulting in multiple nutritional deficiencies. New teeth coming in had no enamel after perfect teeth up to this point. Documented, objective regression in fine motor and math.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC13
Symptoms: Suicidal ideation
Clinical narrative: Extreme emotional meltdowns, self harm, suicidal thoughts. Later (May 2013) diagnosed as PANDAS, ADD (diagnosed May 2013) with some autistic features, Anxiety, OCD. Mercury toxicity (blood test; permeable gut resulting in multiple nutritional deficiencies. New teeth coming in had no enamel after perfect teeth up to this point. Documented, objective regression in fine motor and math.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Hypoaesthesia, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging brain
Clinical narrative: Pt. developed Transverse Myelitis two months after getting the Shingles vaccine.  Pt. has severe right arm numbness/disability with numbness down the right side of her body.  Disease is not controlled at present.  Prognosis uncertain. Presently being treated with high dose steroids.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal, Ophthalmological examination, Scan with contrast
Clinical narrative: Pt. developed Transverse Myelitis two months after getting the Shingles vaccine.  Pt. has severe right arm numbness/disability with numbness down the right side of her body.  Disease is not controlled at present.  Prognosis uncertain. Presently being treated with high dose steroids.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Blood test normal, Constipation, Hypoaesthesia, Intervertebral disc protrusion
Clinical narrative: Pt. developed Transverse Myelitis two months after getting the Shingles vaccine.  Pt. has severe right arm numbness/disability with numbness down the right side of her body.  Disease is not controlled at present.  Prognosis uncertain. Presently being treated with high dose steroids.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture normal, Musculoskeletal disorder, Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Pt. developed Transverse Myelitis two months after getting the Shingles vaccine.  Pt. has severe right arm numbness/disability with numbness down the right side of her body.  Disease is not controlled at present.  Prognosis uncertain. Presently being treated with high dose steroids.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Spinal cord oedema
Clinical narrative: Pt. developed Transverse Myelitis two months after getting the Shingles vaccine.  Pt. has severe right arm numbness/disability with numbness down the right side of her body.  Disease is not controlled at present.  Prognosis uncertain. Presently being treated with high dose steroids.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Lethargy, Pyrexia, Rash
Clinical narrative: Lethargy, change in demeanor, (out of it) for 10 days, fever 104, rash on torso.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure, Blood test, Cough, Decreased appetite
Clinical narrative: 72 hours of loss of appetite, weak, headache, stuffy nose and sinuses, nocturnal coughing and sneezing. Insomnia, low grade fever.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Insomnia, Laboratory test, Nasal congestion, Pyrexia
Clinical narrative: 72 hours of loss of appetite, weak, headache, stuffy nose and sinuses, nocturnal coughing and sneezing. Insomnia, low grade fever.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Sinus congestion, Sneezing, Urine analysis, X-ray
Clinical narrative: 72 hours of loss of appetite, weak, headache, stuffy nose and sinuses, nocturnal coughing and sneezing. Insomnia, low grade fever.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Irritability, Nasopharyngitis, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Jan 17, patient started with runny nose, thought he caught a cold. Jan. 22, started with fever about 101.2, fever continued with administration of 5 mL. acetaminophen. Fever was about 102 on Fri, brought patient to Dr. to check if ear infection was gone or if it had gotten worse. Dr's office told me patient still had ear infection, but it was mild, they said his fever was more than likely from the MMR vaccination he had received on the 15th. Fever spiked to 103.8 around 1:30 a.m. on Jan. 24. By Saturday afternoon, fever was gone. Jan. 26, around 6:00 a.m. when baby woke for the day, noticed rash on face, and entire body. The worst of it is on the trunk of the body. Patient has been very fussy and irritable from Jan. 22 to present time. Contacted Dr's office again around 8:30 a.m. Jan. 26, they said to continue giving Motrin or Acetaminophen for aches and pains, and creams would not help the all over body rash; would just have to wait for it to go away. Was told that this would not be contagious to other children.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria, Local swelling, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Mom phoned to report had hives at injection site, itching, fever, swelling to upper left arm, neck and face. Went to ER after 5:00pm on 1-23-15 for evaulation/treatment.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face
Clinical narrative: Mom phoned to report had hives at injection site, itching, fever, swelling to upper left arm, neck and face. Went to ER after 5:00pm on 1-23-15 for evaulation/treatment.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash papular
Clinical narrative: Subjective fever. Papular rash throughout body.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Impaired work ability, Influenza, Vomiting
Clinical narrative: Employee called in to work and said he feels like he has the flu. Vomiting.
Age: 0.37
Sex: M
Vaccine: HIBV, PPV
Symptoms: Crying, Diet refusal, Feeling abnormal, Neurological symptom
Clinical narrative: Inconsolable crying for 4-5 hours straight. Refusal to eat, followed by neurologic changes. Became "spacey". Otherwise, easily consolable, happy infant. Never cried. First time not consolable. No other medical problems such as otitis media present.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchitis, Cough, Dry mouth, Dysphonia, Laryngitis
Clinical narrative: Excessive hoarseness; dry mouth (woke me up x 2 nites); dry cough. 2nd day after getting vaccine! Throat "tightened". Ears had buzzing sound. 2 days after vaccine: paroxysmal cough, wheezing on expiration; per Dr: bronchitis and laryngitis x 1 wk.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Tinnitus, Wheezing
Clinical narrative: Excessive hoarseness; dry mouth (woke me up x 2 nites); dry cough. 2nd day after getting vaccine! Throat "tightened". Ears had buzzing sound. 2 days after vaccine: paroxysmal cough, wheezing on expiration; per Dr: bronchitis and laryngitis x 1 wk.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Sharp pain in the beginning at the injection site eventually it went down now occasional pain at site.
Age: 1.68
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Low grade fever that responds to TYLENOL. 5th dose of DTaP was given 2 months after 4th dose.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness-swelling-hot to touch painful and sore.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Patient had large bruise and still has pain and soreness 1 1/2 months later.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Chills, Computerised tomogram normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: I got flu shot at 1:15 PM, 2 hrs later I noticed itchy eyes, scratchy throat and tiredness. By 5 PM was wheezy, watery, mattered eyes. 6 PM got severe chills, then got hot-sweaty approx 8 PM had trouble breathing - tightness in throat, started passing out. Went to E.R. given nebulizer, X-rays, CT scan, blood work, EKG, etc.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Eye pruritus, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: I got flu shot at 1:15 PM, 2 hrs later I noticed itchy eyes, scratchy throat and tiredness. By 5 PM was wheezy, watery, mattered eyes. 6 PM got severe chills, then got hot-sweaty approx 8 PM had trouble breathing - tightness in throat, started passing out. Went to E.R. given nebulizer, X-rays, CT scan, blood work, EKG, etc.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, Loss of consciousness, Throat irritation, Throat tightness, Wheezing
Clinical narrative: I got flu shot at 1:15 PM, 2 hrs later I noticed itchy eyes, scratchy throat and tiredness. By 5 PM was wheezy, watery, mattered eyes. 6 PM got severe chills, then got hot-sweaty approx 8 PM had trouble breathing - tightness in throat, started passing out. Went to E.R. given nebulizer, X-rays, CT scan, blood work, EKG, etc.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: I got flu shot at 1:15 PM, 2 hrs later I noticed itchy eyes, scratchy throat and tiredness. By 5 PM was wheezy, watery, mattered eyes. 6 PM got severe chills, then got hot-sweaty approx 8 PM had trouble breathing - tightness in throat, started passing out. Went to E.R. given nebulizer, X-rays, CT scan, blood work, EKG, etc.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching neck and shoulders. Hives neck, chin and posterior shoulder area and erythema. TX ER BENADRYL and steroid Rx.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Piercing pain. Soreness. Red swollen area 8" long x 3" wide, left arm, beyond elbow! 1/2" tall. Still hurts today off and on, all day itching. Hurt to lift left arm. "However, it is first time in 10 years I have not had the flu."
Age: 1.01
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Amylase increased, Ascites, Asthenia, Computerised tomogram abdomen abnormal, Lipase increased
Clinical narrative: 1/10/2015 Weakness and vomiting, 1/11/2015 CT scan of her abdomen showed ascites and fluid around the pancreas. 1/11/2015 Lipase 1528 and Amylase 162. She was NPO and on IV fluids until Lipase decreased to 49 then she was on clears for 1 day (1/18) then breast milk and solids low fat on 1/14/15 and did fine to 1/15/15.
Age: 1.01
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Peripancreatic fluid collection, Vomiting
Clinical narrative: 1/10/2015 Weakness and vomiting, 1/11/2015 CT scan of her abdomen showed ascites and fluid around the pancreas. 1/11/2015 Lipase 1528 and Amylase 162. She was NPO and on IV fluids until Lipase decreased to 49 then she was on clears for 1 day (1/18) then breast milk and solids low fat on 1/14/15 and did fine to 1/15/15.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swollen eyes and lips that lasted 36 hours. Went to the doctor and was given an IV of steroids and prescribed steroids to take for the next couple days and allergy medication.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Flu-like symptoms lasting 3 days: low grade fever, malaise, body aches, fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Awakened by pain in left arm, arm bright red, hot to touch and painful. The Shingles vaccine (Zostavax) was administered to my left arm near my tricep on Thursday evening at approximately 5PM by a pharamacist.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site warmth, Pain in extremity
Clinical narrative: Awakened by pain in left arm, arm bright red, hot to touch and painful. The Shingles vaccine (Zostavax) was administered to my left arm near my tricep on Thursday evening at approximately 5PM by a pharamacist.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Crying, Musculoskeletal stiffness, Opisthotonus, Seizure
Clinical narrative: Mother reports patient stiffened for 5 seconds, arched her back and head turn right. Patient cried after, EMS called vitals were normal, no fever and not transported. Patient had a follow up visit with provider today to ensure neurological status intact. No further signs or symptoms occurred or reported after the one time event. Father reports they thought she had seizure at 11 mo old and had fever the day prior. None since.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy, Rash
Clinical narrative: Swelling, fever at injection site, enlarged lymph gland, rash on arms.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Erythema, Injection site rash, Pyrexia, Rash generalised
Clinical narrative: My son started getting one side of his cheek completely red and swollen and hot that happened on the 21st, then on the 22nd he started running a fever of 102, I administered Tylenol to him, call the doctor my son went to the doctors on Friday the 23rd, they stated he had a ear infection however my son started getting rashes and it started on his legs and face by the end of the day he had it from head to toe. He was given his medication later that night that was prescribed to him and his fever broke. But the severe head to toe rash remained and got worse. It looked like measles but not a full dose of measles.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform, Skin warm, Swelling face
Clinical narrative: My son started getting one side of his cheek completely red and swollen and hot that happened on the 21st, then on the 22nd he started running a fever of 102, I administered Tylenol to him, call the doctor my son went to the doctors on Friday the 23rd, they stated he had a ear infection however my son started getting rashes and it started on his legs and face by the end of the day he had it from head to toe. He was given his medication later that night that was prescribed to him and his fever broke. But the severe head to toe rash remained and got worse. It looked like measles but not a full dose of measles.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Swollen tongue
Clinical narrative: Red Eyes, swollen palete under tongue and cough. Treatment -IV and medication at home: diphenhydramine, famotidine, prednisone.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient's wife called asking what she should do. Her husband's arm was swelling, with some limited heat, but no redness in the area. She was instructed to have him take a Benadryl tablet, apply cold compresses to the area, and take him to either an urgent care or an emergency room. At around 10:15am when the patient checked-in with the immunizing pharmacist, there was no sign of reaction to the immunization. There were no reports from the patient or family members until 4:20pm.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Pruritus, Skin infection, Vaccination complication
Clinical narrative: Patient is a 75 yrs female who presents with a skin infection vs reaction to Prevnar (PCV-13). She got the vaccine on Thurs. 1-23-15.   She first noticed symptoms on 1-24-15. The infection is located on the medial to the anterior side of the R upper arm. (vaccine given on lateral side).  She has not had fever.   She has not had chills, rigors and/or sweats.  She has not noticed red streaks moving proximally from the main area of infection.  There is a history of trauma.  She had the vaccine in the lateral portion of the arm. Symptoms are burning and itching.  No previous reaction to any vaccines. Plan: Cephalexin (KEFLEX) 500 mg Oral Cap.
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Headache, Injection site urticaria, Lymphadenopathy, Malaise, Oral mucosal exfoliation
Clinical narrative: Temp to 99.9, headache in the evening of injection day. Hives at injection site and contralateral deltoid, cervical lymphadenopathy, and soreness/desquamation of the patient's soft palate by the next morning. Resolved fever, headache by second day, but malaise continued for four days.
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Oral pain, Pyrexia
Clinical narrative: Temp to 99.9, headache in the evening of injection day. Hives at injection site and contralateral deltoid, cervical lymphadenopathy, and soreness/desquamation of the patient's soft palate by the next morning. Resolved fever, headache by second day, but malaise continued for four days.
Age: 11.0
Sex: F
Vaccine: FLUX, HPVX, MEN, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Fainting and possible seizure, paleness sweating. Visit to ER via ambulance.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Malaise, Pain, Rash vesicular
Clinical narrative: Malaise, sensitivity of L frontal scalp & cheek & eye. Progressed to have more pain & then vescicular rash consistent with shingles.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Seizure
Clinical narrative: This spontaneous report as received from a mother of the patient refers to a 15 month old female patient who was at present 5 year old. No medical history and concurrent conditions were reported. On an unknown date approximately in 2011 when the patient was 15 month old, the patient was vaccinated with M-M-R II, 1 single shot. No concomitant therapy was reported. On an unknown date approximately in 2011, she developed a fever of 102 degrees and 4 hour later she had a seizure (medically significant). She had another seizure (medically significant) 3 months later on an unspecified date approximately in 2011. The outcome of both seizures and fever was unknown. The causality assessment was not given. Patient sought medical attention and spoke with physician. Product quality complaint was not reported. Upon internal review the event of seizure was considered medically significant. Additional information is not expected as reporter did not wish to provide specific information.
Age: 23.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Bacterial test positive, Headache, Photophobia, Pyrexia
Clinical narrative: Pt. states she woke up Thursday (01/22/15) AM with headache and fever (approximately 104 degrees). She took Ibuprofen with no relief of headache, fever. On Friday night she decided to go to hospital. She was seen at Medical Center. She states spinal tap done and told had "bacteria". She was given morphine for headache with no relief of headache. She was discharged at 6 AM on Saturday (01/23/15) with rx. for TYLENOL. This nurse spoke with patient on 01/26/15 at approximately 10 am after friend called clinic concerned about patient. The above is what the patient stated over the phone. Patient states she continues to have headache and fever, feels very light sensitive. Does not want to take TYLENOL because she states that TYLENOL "makes my headache and fever worse". Pt. was counseled to return to hospital to be checked again. Pt. expressed that she did not want to go back to hospital. Encouraged patient to get follow up since her symptoms persist. Pt. states she will think about it.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head normal, Generalised tonic-clonic seizure
Clinical narrative: 2 hours after being administered ADACEL, pt had a grand mal seizure. Sent to Hospital ER via ambulance.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Skin discolouration
Clinical narrative: Area was discolored and painful. Patient reported to doctor and he recommended warm compress and ADVIL - ached for 3 days - then severe pain.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Injection site pain, Local swelling, Muscular weakness
Clinical narrative: Pt said that she got dizziness and swelling of face, neck, chills in November 2014 and she visited ER 1 month after inj. ER was unable to determine the cause of dizziness and recomm pt to go to primary MD. Primary MD unable to find cause. Pt also complain of pain at inj. site even after a month. Pt still has weakness in arm where she got injection. Pt also develop dizziness approximately 1 month after inj. in Nov and got worst in December 2014. Pt said got rash/itchiness after inj. but no known actual date (Kw/in the month).
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: Pt said that she got dizziness and swelling of face, neck, chills in November 2014 and she visited ER 1 month after inj. ER was unable to determine the cause of dizziness and recomm pt to go to primary MD. Primary MD unable to find cause. Pt also complain of pain at inj. site even after a month. Pt still has weakness in arm where she got injection. Pt also develop dizziness approximately 1 month after inj. in Nov and got worst in December 2014. Pt said got rash/itchiness after inj. but no known actual date (Kw/in the month).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was administered with an improperly stored dose of ROTATEQ oral solution (strength, dose, dose number, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was administered with an improperly stored dose of ROTATEQ oral solution, (strength, dose, dose number, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that ROTATEQ, 2 ml, oral (lot # not reported) was given to multiple unspecified subjects after the vaccine was exposed to temperature outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The registered nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of ROTATEQ 2.0 ml, oral, (lot # and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.56
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: Seen in office on 1.22.15 1:30 pm for generalized hives. No fever or other illness noted. BENADRYL 12.5mg/5ml, 2.5 ml every 6 hours given. Hives resolved 1.23.15 in evening.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 17.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014. A dose of FLUZONE ID was given to 17-year-old patient. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site nodule
Clinical narrative: Initial report received from a healthcare professional on 22 January 2014. A 64-year-old female patient had received a dose of FLUZONE ID (Batch number: UT4721AA, expiry date: 08 April 2014, dose number was not reported) on 05 November 2013. Patient had no illness at the time of vaccination. The patient is allergic to BISCODYL, EFFEXOR, LEXAPRO. On 06 November 2013, the patient developed knot at the vaccination site. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the event. Documents held by sender none.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Initial pregnancy report received from a healthcare professional on 21 January 2014. A 38-year-old female patient, had received an intradermal first dose of FLUZONE ID (batch number: UT4722AA, expiry date 10 April 2014, anatomical site of vaccination was not reported) on 20 January 2014. The patient had neither allergies nor any medical history. The patient received vaccine during pregnancy. The patients last menstrual period date was not reported and the estimated date of delivery is 01 April 2014. As of this report, the patient had not experienced any adverse events. Laboratory investigations were not reported. Follow-up pregnancy report received from a healthcare professional on 29 July 2014. It was reported that patient was vaccinated at private hospital and vaccine purchased with private fund. Mother's health status (relevant ongoing illness) was reported as healthy. No family history of congenital abnormality was reported. Pregnancy information: Estimated date of delivery was reported as 12 April 2014. No previous pregnancy was reported. Route of vaccination was reported as intradermal right deltoid (arm). Mother did not receive any drug during pregnancy. It was reported that mother did not experience any relevant non serious adverse events. Pregnancy outcome was reported as healthy baby girl without any pregnancy complications. Child outcome: (healthy baby girl born). Apgar score was reported as '4, 5 and 8' in 10 minutes, week of gestation was reported as 42. Height of the baby child was reported as 150 inches. Weight: 2.96 kg.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Injury associated with device, Needle issue
Clinical narrative: Initial misuse report received from a healthcare professional on 18 February 2014. The patient whose demographics were not reported. The patient's medical history and concomitant medication was not reported and previous medication was also reported as unknown. The patient had received a dose of FLUZONE ID (route and site  of vaccination was not reported) on 17 February 2014. It was reported that the needle cover did not deploy and the nurse was stuck with the needle. The patient was undergoing testing in to the hospital protocol. The reporter does not have any other information of the report. The detail of corrective treatment and laboratory investigations was not reported. The patient recovered from adverse event was unknown at the time of report. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Hypersomnia, Limb discomfort
Clinical narrative: Initial information was received from a health care professional on 24 FEB 2014. A 61-year-old female patient had medical history of seizure disorder and with an immune condition whose concomitant medication were not reported received, a dose of FLUZONE ID vaccine, intradermally on 31 JAN 2014 (dose, site not reported batch number: UT4725BA). It was reported that on 06 Feb 2014 patient had experienced feeling of heavy limbs, slept for 20 hours, tiredness and difficulty breathing. Laboratory investigations were not reported. Patient had received corrective treatment of Tamiflu (route, site, dose and batch number not reported). At the time of report, outcome of event was not recovered. List of documents held by sender: none.  Follow up information received from a health care professional on 10 June 2014. The patient received FLUZONE ID in the left deltoid. The patient had medical history of Epstein-Barr and autoimmune problem trigger neuromuscular response. The patient experienced reactions took about one week. The laboratory investigations were done.
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from a health care professional on 23 January 2014. A patient had received a dose of FLUZONE ID (batch number: UT4719AA, dose number and site of administration not reported) intradermally on an unspecified date of December 2013. The patient had no illness at the time of vaccination and had no known drug allergies. On an unspecified date, the patient's upper arm became swollen, inflamed and sore. Symptoms developed on the same day as vaccination was administered. No laboratory tests were performed and corrective treatments were not reported. The patient had recovered on an unspecified date. Documents held by sender: none
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial report received from a consumer on 18 October 2013. A female patient who medical history and concomitant medication were not reported, had received a dose of flu vaccine (lot number, dose number, route and anatomical site of administration were not reported) on 16 October 2013. On an unspecified date, on next day, the patient experienced little redness and then the second day it was still pretty red and looked inflamed. The affected area became maybe 7 centimeters in diameter and was more oval than round. It was not completely red all over, but had varying areas of redness. It seemed like a larger area reacting than usual. Laboratory investigations and corrective medications were not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Inflammation
Clinical narrative: Initial report received from a consumer on 18 October 2013. A female patient who medical history and concomitant medication were not reported, had received a dose of flu vaccine (lot number, dose number, route and anatomical site of administration were not reported) on 16 October 2013. On an unspecified date, on next day, the patient experienced little redness and then the second day it was still pretty red and looked inflamed. The affected area became maybe 7 centimeters in diameter and was more oval than round. It was not completely red all over, but had varying areas of redness. It seemed like a larger area reacting than usual. Laboratory investigations and corrective medications were not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial case was received from a health professional on 17 January 2014. This case concerns one male patient whose medical history and concomitant medication was not reported had received FLUZONE ID (batch number, dose and anatomical site of administration not reported) on an unspecified date during 2013 influenza season. No corrective treatment or laboratory investigations were reported. The outcome of the event was unknown.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: The case was linked with the case number 2014SA011893. Initial report received from non-healthcare professional (patient's husband) on 26 January 2013. A 25-year-old female patient had received intradermally 1st dose of FLUZONE (INTRADERMAL, lot number: UT4728BA, expiry date: 30 April 2014) in the left forearm on 24 January 2013. The patient had no illness at time of vaccination and allergy to dairy product. On 24 January 2013, same day of administration the patient developed a large area of redness and swelling with raised red bumps at the injection site. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by the sender: None. Follow up information was received from consumer on 27 January 2014. The cases were received on 21 March 2014 at GPV. It was confirmed that after hrs. 01.26.14 9:10 pm. Patient called regarding site reactions, the dose of vaccine was administered in the left forearm and not over the deltoid stated in the PI. Follow up information received from a health care professional on 05-May-2014: It was reported that the patient reviewed flair cleared up on it own after 5 days. The patient was recovered from adverse event on an unspecified date.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Initial case was received from a non-health care professional on 24 January 2014. A 61-year-old male patient whose medical history and concomitant medication was not reported has received an intradermal FLUZONE (batch number UT4723AA, dose) on 20 January 2014 in deltoid. On an unspecified date, the patient developed "welt" at the injection site on his forearm. The patient consulted dermatologist on 24 January 2014. No corrective treatment or laboratory investigations were reported. The event of "west" at the injection site on his forearm was not recovered. The list of documents held by sender: none
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 17 Sep 2013. A dose of FLUZONE ID was administered to 68 years old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 22 March 2014 at GPV. Initial misuse report received from a health care professional on 18 September 2013.  A 66-year-old male patient had received FLUZONE ID. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
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 (nurse) on 26 September 2013 and the case was received on 21 March 2014 at GPV. Four patient (age and under 18 years) had received a dose of FLUZONE ID (batch number, route, dose in series and site of administration was not reported) on an unspecified date. The 4 patient (age was under 18 years) received FLUZONE ID vaccine  and it was reported that the vaccine should  not be administered to patient less than 18 years or 65 and over. No adverse event was reported. List of documents held by sender: none
Age: 7.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 10 March 2014.A 07-uear old patient had received a dose of FLUZONE ID on an unspecified date. It was reported that the vaccine was administered to a 07 year old patient. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 26 September 2013. The cases were received on 21 March 2014 at GPV. A dose of FLUZONE HD was given to a person over age of 65 years (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: Injection site scar
Clinical narrative: Initial report received from a health care professional on 25 February 2014. A patient whose demographics, medical history and concomitant medications were not reported, had received a dose of FLUZINE ID (batch number, dose number, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, the patient had a scar from the injection. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome unknown. Documents held by sender: none
Age: 9.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 21 March 2014 at GPV. Initial misuse report received from a health care professional on 16 September 2013. This case was linked to case # 2014SA040026 (same vaccine same reporter). A 9-year-old patient had received FLUZONE Intradermal. It's an inappropriate age at vaccine administration. 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 26 September 2013. The case was received on 21 March 2014 at GPV. This is an invalid case as individual patient identifiers are not report4ed. FLUZONE ID was given to a patient over 64. (No information was provided regarding the patients). No adverse event was reported. List of documents held by sender: none
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 21 March 2014 at GPV. Initial misuse report received from a health care professional on 16 September 2013. This case was linked to case # 2014SA040017 (same vaccine same reporter). A 12-year old patient had received FLUZONE ID. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Initial misuse report received from a health care professional on 25 September 2013. The cases were received on 22 March 2014 at GPV. FLUZONE Intradermal was ran down from vaccine administrator's arm because patient pulled away. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 60.0
Sex: F
Vaccine: FLU3, RAB
Symptoms: Erythema, Induration, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from non-health care professional (consumer) on 27 January 2013. This case is linked to case number 2014SA011913 (same patient). A 60-year-old female patient has received intradermally 1st dose of FLUZONE ID (lot number was unknown) in the left deltoid on 27 January 2013. The patient had no illness at time of vaccination. Te patient had allergy to many chemicals and drugs. On 27 January 2013, same day of administration the patient developed left arm sore, quarter size reddened area that was red and hot that was painful, low grade fever, malaise for a few week, pea size reddened and hard area which was raised. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient was not recovered. The patient required ER/doctor visit. List of documents held by sender: none  Follow up information received from non-health care professional (consumer) on 19 March 2014. The details include lot number: 4T47198A, and expiration date 04-02-2014. The patient has chemical insensitivity not specific; also have metal allergy, Inderal allergy, peanuts allergy, latex intolerance, latex sensitivity, amoxacillin intolerance. The patient has severe reaction to rabies vaccine many years ago. It was also reported that redness at site for two weeks and able to peel lump under skin.
Age: 60.0
Sex: F
Vaccine: FLU3, RAB
Symptoms: Skin warm, Swelling
Clinical narrative: Initial report received from non-health care professional (consumer) on 27 January 2013. This case is linked to case number 2014SA011913 (same patient). A 60-year-old female patient has received intradermally 1st dose of FLUZONE ID (lot number was unknown) in the left deltoid on 27 January 2013. The patient had no illness at time of vaccination. Te patient had allergy to many chemicals and drugs. On 27 January 2013, same day of administration the patient developed left arm sore, quarter size reddened area that was red and hot that was painful, low grade fever, malaise for a few week, pea size reddened and hard area which was raised. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient was not recovered. The patient required ER/doctor visit. List of documents held by sender: none  Follow up information received from non-health care professional (consumer) on 19 March 2014. The details include lot number: 4T47198A, and expiration date 04-02-2014. The patient has chemical insensitivity not specific; also have metal allergy, Inderal allergy, peanuts allergy, latex intolerance, latex sensitivity, amoxacillin intolerance. The patient has severe reaction to rabies vaccine many years ago. It was also reported that redness at site for two weeks and able to peel lump under skin.
Age: 60.0
Sex: F
Vaccine: FLU3, RAB
Symptoms: Feeling cold, Haematuria, Pyrexia
Clinical narrative: Initial report received from non-health care professional (consumer) on 27 January 2013. This case is linked to case number 2014SA011913 (same patient). A 60-year-old female patient has received intradermally 1st dose of FLUZONE ID (lot number was unknown) in the left deltoid on 27 January 2013. The patient had no illness at time of vaccination. Te patient had allergy to many chemicals and drugs. On 27 January 2013, same day of administration the patient developed left arm sore, quarter size reddened area that was red and hot that was painful, low grade fever, malaise for a few week, pea size reddened and hard area which was raised. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient was not recovered. The patient required ER/doctor visit. List of documents held by sender: none  Follow up information received from non-health care professional (consumer) on 19 March 2014. The details include lot number: 4T47198A, and expiration date 04-02-2014. The patient has chemical insensitivity not specific; also have metal allergy, Inderal allergy, peanuts allergy, latex intolerance, latex sensitivity, amoxacillin intolerance. The patient has severe reaction to rabies vaccine many years ago. It was also reported that redness at site for two weeks and able to peel lump under skin.
Age: 15.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse case was received from a health care professional on 25 October 2013. Cases were received on 21 March 2014 at GPV. A 15-year-old patient whose demographic details, medical history and concomitant medications were not reported received a dose of FLUZONE Intradermal on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an incorrect product. Laboratory investigation were not reported. No adverse event was reported. Lit 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 health care professional on 30  October 2013. A dose of FLUZONE ID administered on 30 patients over 65-years of age. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 18 October 2013. The cases were received on 21 March 2014 at GPV. A female patient, received FLUZONE ID. (No other information was provided regarding the patient). IT was reported that the patient used the forearm because the product is intradermal. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse case was received from a health care professional on 23 OCT 2013. Cases were received on 21 March 2014 at GPV. This case is linked to the case 2014SA41844 (cluster case). A patients whose demographic details, medical history and concomitant medications were not reported received a dose of FLUZONE ID on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received vaccine in inappropriate age. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The case was received from health care professional on 17-Oct-2013 and on 21 March 2014 at GPV.  Initial misuse report received from a health care professional on 17 October 2013. A 71-year-old patient had received a dose of FLUZONE intradermal on an unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 24 October 2013. The cases were received on 21 March 2014 at GPV. A 74-year-old patient received a dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report was received from a health care professional on 29 OCT 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 intradermal on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received a vaccine of incorrect age. Laboratory investigation were not reported No adverse event was reported. List od documents held by sender: none
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received on 22 March 2014 at GPV. Initial misuse report received from a health care professional on 16 October 2013. A 67-year-old patient had received FLUZONE Intradermal. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse case was received from a health care professional on 25 OCT 2013.  Cases were received on 21 March 2014 at GPV. A 24 year old patient whose demographic details, medical history and concomitant medication was not reported received a does of FLUZONE ID on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received vaccine in incorrect age. Laboratory investigation were not reporter. No adverse event was reported. List of documents held by sender were none.