chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Excessive granulation tissue, Glycosylated haemoglobin increased, Hyperhidrosis, Hypoalbuminaemia, Muscle spasticity
Clinical narrative: Initial unsolicited report received from a Physician via partner company (Novartis) (under reference number- PHHY2015US173497) on 14 January 2016. This case involves 54-year-old male patient who was vaccinated with a dose of Fluzone (batch number, route and site of administration not reported) on 21 September 2015. The patient's medical history includes pump implanted on 09 March 2005 and 05 December 2011, dialysis, inguinal lobectomy in 2009 and neck surgery in 2014, quitted tobacco in 2009, spinal cord injury, anemia necrotizing enterocolitis, benign hypertension, chronic kidney disease stage three, diabetes type II NIDDM (non-insulin dependent diabetes mellitus), diabetes type II uncontrolled, quality insulin dependent, esophageal reflux, hypertension, kidney disease ben without chronic kidney disease, bronchogenic, obstructive sleep apnea, other constipation neurogenic bowel, panic disorder (episodic paroxysmal anxiety) without agoraphobia, paraplegia, complete with spasticity of muscles, paraplegia complete with spasm, pressure ulcer, pressure ulcer of unspecified site stage 1 on scrotum, pressure ulcer stage intravenous left ischial tuberosity, renal failure on dialysis, renal osteodystrophy, type 2 diabetes mellitus with other specified complication unspecified kidney failure on dialysis, panic disorder episodic paroxysmal anxiety without agoraphobia, paraplegia, complete thoracic 4, rarely drank alcohol, never used illegal drugs and had drug allergy to Septra and Metformin, hernia, lymph node excision, cervical spinal stenosis, femur fracture, spinal cord injury and vaccination with Fluvirin injection on 12 December 2013 and lung cancer in 2009. The patient's concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced anxiety (2 weeks prior) daily, the length of episode was 05 minutes, deep breathing, and avoidance behavior, dizziness with position change, dyspnea, lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia. The patient denied diaphoresis, feeling of dread and palpitations. The patient was hospitalized for 11 months. Laboratory data and corrective treatment were not reported. The patient was not recovered from event anxiety and event of deep breathing, and avoidance behavior, dizziness with position change, dyspnea, and lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia were not reported. List of documents held by sender: none. Sender's Comments: Anxiety, excessive granulation tissue, skin lesion, Social avoidant behavior, hypoalbuminemia, Are unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but dizziness postural is listed. However Concomitant medication, Concurrent condition and family history are needed to complete this case.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Scrotal ulcer, Skin lesion, Social avoidant behaviour
Clinical narrative: Initial unsolicited report received from a Physician via partner company (Novartis) (under reference number- PHHY2015US173497) on 14 January 2016. This case involves 54-year-old male patient who was vaccinated with a dose of Fluzone (batch number, route and site of administration not reported) on 21 September 2015. The patient's medical history includes pump implanted on 09 March 2005 and 05 December 2011, dialysis, inguinal lobectomy in 2009 and neck surgery in 2014, quitted tobacco in 2009, spinal cord injury, anemia necrotizing enterocolitis, benign hypertension, chronic kidney disease stage three, diabetes type II NIDDM (non-insulin dependent diabetes mellitus), diabetes type II uncontrolled, quality insulin dependent, esophageal reflux, hypertension, kidney disease ben without chronic kidney disease, bronchogenic, obstructive sleep apnea, other constipation neurogenic bowel, panic disorder (episodic paroxysmal anxiety) without agoraphobia, paraplegia, complete with spasticity of muscles, paraplegia complete with spasm, pressure ulcer, pressure ulcer of unspecified site stage 1 on scrotum, pressure ulcer stage intravenous left ischial tuberosity, renal failure on dialysis, renal osteodystrophy, type 2 diabetes mellitus with other specified complication unspecified kidney failure on dialysis, panic disorder episodic paroxysmal anxiety without agoraphobia, paraplegia, complete thoracic 4, rarely drank alcohol, never used illegal drugs and had drug allergy to Septra and Metformin, hernia, lymph node excision, cervical spinal stenosis, femur fracture, spinal cord injury and vaccination with Fluvirin injection on 12 December 2013 and lung cancer in 2009. The patient's concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced anxiety (2 weeks prior) daily, the length of episode was 05 minutes, deep breathing, and avoidance behavior, dizziness with position change, dyspnea, lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia. The patient denied diaphoresis, feeling of dread and palpitations. The patient was hospitalized for 11 months. Laboratory data and corrective treatment were not reported. The patient was not recovered from event anxiety and event of deep breathing, and avoidance behavior, dizziness with position change, dyspnea, and lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia were not reported. List of documents held by sender: none. Sender's Comments: Anxiety, excessive granulation tissue, skin lesion, Social avoidant behavior, hypoalbuminemia, Are unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but dizziness postural is listed. However Concomitant medication, Concurrent condition and family history are needed to complete this case.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Dizziness, Dizziness postural, Dyspnoea, Excessive granulation tissue
Clinical narrative: Initial unsolicited report received from a Physician via partner company (Novartis) (under reference number- PHHY2015US173497) on 14 January 2016. This case involves 54-year-old male patient who was vaccinated with a dose of Fluzone (batch number, route and site of administration not reported) on 21 September 2015. The patient's medical history includes pump implanted on 09 March 2005 and 05 December 2011, dialysis, inguinal lobectomy in 2009 and neck surgery in 2014, quitted tobacco in 2009, spinal cord injury, anemia necrotizing enterocolitis, benign hypertension, chronic kidney disease stage three, diabetes type II NIDDM (non-insulin dependent diabetes mellitus), diabetes type II uncontrolled, quality insulin dependent, esophageal reflux, hypertension, kidney disease ben without chronic kidney disease, bronchogenic, obstructive sleep apnea, other constipation neurogenic bowel, panic disorder (episodic paroxysmal anxiety) without agoraphobia, paraplegia, complete with spasticity of muscles, paraplegia complete with spasm, pressure ulcer, pressure ulcer of unspecified site stage 1 on scrotum, pressure ulcer stage intravenous left ischial tuberosity, renal failure on dialysis, renal osteodystrophy, type 2 diabetes mellitus with other specified complication unspecified kidney failure on dialysis, panic disorder episodic paroxysmal anxiety without agoraphobia, paraplegia, complete thoracic 4, rarely drank alcohol, never used illegal drugs and had drug allergy to Septra and Metformin, hernia, lymph node excision, cervical spinal stenosis, femur fracture, spinal cord injury and vaccination with Fluvirin injection on 12 December 2013 and lung cancer in 2009. The patient's concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced anxiety (2 weeks prior) daily, the length of episode was 05 minutes, deep breathing, and avoidance behavior, dizziness with position change, dyspnea, lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia. The patient denied diaphoresis, feeling of dread and palpitations. The patient was hospitalized for 11 months. Laboratory data and corrective treatment were not reported. The patient was not recovered from event anxiety and event of deep breathing, and avoidance behavior, dizziness with position change, dyspnea, and lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia were not reported. List of documents held by sender: none. Sender's Comments: Anxiety, excessive granulation tissue, skin lesion, Social avoidant behavior, hypoalbuminemia, Are unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but dizziness postural is listed. However Concomitant medication, Concurrent condition and family history are needed to complete this case.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Hyperventilation, Hypoalbuminaemia, Skin lesion, Social avoidant behaviour
Clinical narrative: Initial unsolicited report received from a Physician via partner company (Novartis) (under reference number- PHHY2015US173497) on 14 January 2016. This case involves 54-year-old male patient who was vaccinated with a dose of Fluzone (batch number, route and site of administration not reported) on 21 September 2015. The patient's medical history includes pump implanted on 09 March 2005 and 05 December 2011, dialysis, inguinal lobectomy in 2009 and neck surgery in 2014, quitted tobacco in 2009, spinal cord injury, anemia necrotizing enterocolitis, benign hypertension, chronic kidney disease stage three, diabetes type II NIDDM (non-insulin dependent diabetes mellitus), diabetes type II uncontrolled, quality insulin dependent, esophageal reflux, hypertension, kidney disease ben without chronic kidney disease, bronchogenic, obstructive sleep apnea, other constipation neurogenic bowel, panic disorder (episodic paroxysmal anxiety) without agoraphobia, paraplegia, complete with spasticity of muscles, paraplegia complete with spasm, pressure ulcer, pressure ulcer of unspecified site stage 1 on scrotum, pressure ulcer stage intravenous left ischial tuberosity, renal failure on dialysis, renal osteodystrophy, type 2 diabetes mellitus with other specified complication unspecified kidney failure on dialysis, panic disorder episodic paroxysmal anxiety without agoraphobia, paraplegia, complete thoracic 4, rarely drank alcohol, never used illegal drugs and had drug allergy to Septra and Metformin, hernia, lymph node excision, cervical spinal stenosis, femur fracture, spinal cord injury and vaccination with Fluvirin injection on 12 December 2013 and lung cancer in 2009. The patient's concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced anxiety (2 weeks prior) daily, the length of episode was 05 minutes, deep breathing, and avoidance behavior, dizziness with position change, dyspnea, lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia. The patient denied diaphoresis, feeling of dread and palpitations. The patient was hospitalized for 11 months. Laboratory data and corrective treatment were not reported. The patient was not recovered from event anxiety and event of deep breathing, and avoidance behavior, dizziness with position change, dyspnea, and lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia were not reported. List of documents held by sender: none. Sender's Comments: Anxiety, excessive granulation tissue, skin lesion, Social avoidant behavior, hypoalbuminemia, Are unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but dizziness postural is listed. However Concomitant medication, Concurrent condition and family history are needed to complete this case.
Age: 1.17
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Urticarial reaction that had onset several hours after receiving the Hep A and pneumococcal vaccines.  Rash has been coming and going for last 3 days and is still present.  They did not seek medical care until today.  Zyrtec was prescribed today.  No wheezing, fever, angioedema, difficulty swallowing or other systemic symptoms.  Normal PO intake and activity level.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Chest X-ray, Fatigue, Headache, Malaise
Clinical narrative: FEVER, HEADACHE MALAISE, FATIGUE, VISUAL DISTURBANCE RIGHT>LEFT FROM OPTIC NERVE SWELLING, TACHYCARDIA, ORTHOSTATIC HYPOTENSION. Thought to be Aseptic meningitis but pt declined LP.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Meningitis aseptic, Nuclear magnetic resonance imaging brain, Ophthalmological examination, Orthostatic hypotension, Papilloedema
Clinical narrative: FEVER, HEADACHE MALAISE, FATIGUE, VISUAL DISTURBANCE RIGHT>LEFT FROM OPTIC NERVE SWELLING, TACHYCARDIA, ORTHOSTATIC HYPOTENSION. Thought to be Aseptic meningitis but pt declined LP.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tachycardia, Visual impairment
Clinical narrative: FEVER, HEADACHE MALAISE, FATIGUE, VISUAL DISTURBANCE RIGHT>LEFT FROM OPTIC NERVE SWELLING, TACHYCARDIA, ORTHOSTATIC HYPOTENSION. Thought to be Aseptic meningitis but pt declined LP.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Patient feels pain at site of injection with touch or rotation of the arm.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Pt c/o pain at site, swollen lymph nodes, fever and head ache.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Axillary pain, Body temperature increased, Chest pain, Chills
Clinical narrative: Pt c/o pain at site, swollen lymph nodes, fever and head ache.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Ear discomfort, Eye irritation, Fatigue, Feeling abnormal, Headache
Clinical narrative: Pt c/o pain at site, swollen lymph nodes, fever and head ache.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Heart rate increased, Lymphadenopathy, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Pt c/o pain at site, swollen lymph nodes, fever and head ache.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Respiratory rate increased
Clinical narrative: Pt c/o pain at site, swollen lymph nodes, fever and head ache.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash on face and trunk  No fever, felt fine, No treatment.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Somnolence
Clinical narrative: Drowsiness and shortness of breath.
Age: 11.0
Sex: F
Vaccine: HPV4, IPV, MMR, VARCEL
Symptoms: Computerised tomogram head abnormal, Electroencephalogram abnormal, Generalised tonic-clonic seizure, Mental impairment, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from a consumer referring to her 16 years old daughter. The patient was not pregnant. The patient had no medical history and drug reactions or allergies. On an unknown date in 2011, the patient was vaccinated with her first dose of GARDASIL (0.5 ml, lot # and expiry date unknown, intramuscular). There was no concomitant therapy reported. In 2011, almost immediately following her first intramuscular injection, the patient experienced grand mal seizures. The patient's mother also noticed at that time that her daughter's mental acumen began declining (The patient was previously an honor student in school). On unknown dates, the patient was vaccinated with her second and third dose of GARDASIL (0.5 ml, lot # and expiry date unknown, intramuscular). On an unknown date, the patient's mother took the patient to a neurologist who ran a battery of tests including electroencephalogram (EEG), nuclear magnetic resonance imaging (MRI) and computerised tomogram (CAT scan). Subsequently, the test results determined the patient was "mentally challenged". In September 2014, the patient was hospitalized at a hospital for 2 days due to severe seizures (started in September 2014). The patient was also prescribed TEGRETOL (generic) by the neurologist to lessen seizures. The patient's mother also stated that the patient was still suffering from severe seizures. The outcome of grand mal seizures, mental acumen decline and "mentally challenged" was unknown. Causality was not provided. The events were considered to be disabling by the reporter. Upon internal review, the severe seizures and grand mal seizures were determined to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, IPV, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: Information has been received from a consumer referring to her 16 years old daughter. The patient was not pregnant. The patient had no medical history and drug reactions or allergies. On an unknown date in 2011, the patient was vaccinated with her first dose of GARDASIL (0.5 ml, lot # and expiry date unknown, intramuscular). There was no concomitant therapy reported. In 2011, almost immediately following her first intramuscular injection, the patient experienced grand mal seizures. The patient's mother also noticed at that time that her daughter's mental acumen began declining (The patient was previously an honor student in school). On unknown dates, the patient was vaccinated with her second and third dose of GARDASIL (0.5 ml, lot # and expiry date unknown, intramuscular). On an unknown date, the patient's mother took the patient to a neurologist who ran a battery of tests including electroencephalogram (EEG), nuclear magnetic resonance imaging (MRI) and computerised tomogram (CAT scan). Subsequently, the test results determined the patient was "mentally challenged". In September 2014, the patient was hospitalized at a hospital for 2 days due to severe seizures (started in September 2014). The patient was also prescribed TEGRETOL (generic) by the neurologist to lessen seizures. The patient's mother also stated that the patient was still suffering from severe seizures. The outcome of grand mal seizures, mental acumen decline and "mentally challenged" was unknown. Causality was not provided. The events were considered to be disabling by the reporter. Upon internal review, the severe seizures and grand mal seizures were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Myasthenia gravis, Premature menopause
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2008 (exact dates of each vaccination not reported), the patient received 3 doses of GARDASIL (route and site of administration, lot # and expiry date were not reported). On an unknown date, after receiving all 3 doses of GARDASIL, the patient experienced myasthenia gravis and premature ovarian failure. The outcome of the events was unknown. The relatedness between myasthenia gravis and premature ovarian failure and GARDASIL was not provided. Upon internal review, the event of myasthenia gravis was considered medically significant. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Lip swelling
Clinical narrative: Patient was given FLUZONE vaccine 3/2/16 at 9:30 am. She made a return office visit on 3/3/16 at 1 pm to report swelling of the upper lip. She was treated for angioedema as an outpatient with steroids and antihistamine.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Laboratory test, Respiratory arrest, Sudden infant death syndrome
Clinical narrative: Patient stopped breathing when napping - no foul play, no obstruction or suffication.  Autopsy diagnosed SIDS as cause of death.
Age: 64.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abasia, Hypoaesthesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: Pts husband reported that pt had numbness and tingling in arm and nausea/vomiting followed by inability to walk. Taken to ER work up under way for differential diagnosis including vaccine adverse event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pallor, Pruritus, Skin tightness
Clinical narrative: Left arm (posterior aspect) approx 2 inch by 2 inch raised red area. Patient describes area as itching and tight. Center of this area is blanched and has a red area in center.
Age: 41.0
Sex: F
Vaccine: ANTH
Symptoms: Influenza like illness, Injected limb mobility decreased, Lethargy, Musculoskeletal pain, Neck pain
Clinical narrative: BURNING PAIN DOWN LEFT ARM FOR APPROX 5 HRS, FEVER 101.2 NOTED APPROX 6.5 HRS POST VACCINE TOOK 400MG IBUPROFEN, 45 MIN LATER ANOTHER 200MG TO REDUCE PAIN. FLULIKE SYMPTOMS OF LETHARGY, FEVER AND PAIN DOWN ARM, ACROSS SHOULDER, (TO INCLUDE LEFT SHOULDER BLADE) AND UP NECK TO LOWER HEAD LASTING 3DAYS. LETHARGY APPROX 7 DAYS. PAIN PERSISTED FOR NEXT 3 WEEKS AT HIGH LEVEL. DOSED BETWEEN 400-600MG OF IBUPROFEN AT PRESCRIBED INTERVAL 3 WEEKS FOR PAIN.  STAYED WITH 400MG OF IBUPROFEN FOR NEXT 2 WEEKS AT PRESCRIBED INTERVALS. I CONTINUE TO HAVE CONSISTANT SHOULDER AND ARM PAIN WITH LIMITED MOBILITY IN MY LEFT ARM. CURRENTLY SEEING ORTHOPEDIC MD FOR PERSISTANT PROBLEM.
Age: 41.0
Sex: F
Vaccine: ANTH
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: BURNING PAIN DOWN LEFT ARM FOR APPROX 5 HRS, FEVER 101.2 NOTED APPROX 6.5 HRS POST VACCINE TOOK 400MG IBUPROFEN, 45 MIN LATER ANOTHER 200MG TO REDUCE PAIN. FLULIKE SYMPTOMS OF LETHARGY, FEVER AND PAIN DOWN ARM, ACROSS SHOULDER, (TO INCLUDE LEFT SHOULDER BLADE) AND UP NECK TO LOWER HEAD LASTING 3DAYS. LETHARGY APPROX 7 DAYS. PAIN PERSISTED FOR NEXT 3 WEEKS AT HIGH LEVEL. DOSED BETWEEN 400-600MG OF IBUPROFEN AT PRESCRIBED INTERVAL 3 WEEKS FOR PAIN.  STAYED WITH 400MG OF IBUPROFEN FOR NEXT 2 WEEKS AT PRESCRIBED INTERVALS. I CONTINUE TO HAVE CONSISTANT SHOULDER AND ARM PAIN WITH LIMITED MOBILITY IN MY LEFT ARM. CURRENTLY SEEING ORTHOPEDIC MD FOR PERSISTANT PROBLEM.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Pt was given Menveo, mother had expected pt to get mening B.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Body temperature increased, Decreased appetite, Diet refusal, Dyskinesia, Fatigue
Clinical narrative: Excessive tiredness, new mild uncontrolled jerking while sleeping, appetite decreased. Congestion, running nose and excessive fussiness started later that evening. 03/03/2016 at 3:00 PM a mild increase in temperature was noted (99.5), by 7:00 PM temperature had risen to 100.7, Tylenol given but baby threw that up within 10 minutes. Cool wash cloth applied to forehead and back of neck. At 3 am, baby woke up with a temperature of 101.3. Last temperature was 101.6 taken at 8:00 am on 03/04/2016. Still throwing up all Tylenol, refuses food and water but will nurse on and off.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Irritability, Respiratory tract congestion, Rhinorrhoea, Vomiting
Clinical narrative: Excessive tiredness, new mild uncontrolled jerking while sleeping, appetite decreased. Congestion, running nose and excessive fussiness started later that evening. 03/03/2016 at 3:00 PM a mild increase in temperature was noted (99.5), by 7:00 PM temperature had risen to 100.7, Tylenol given but baby threw that up within 10 minutes. Cool wash cloth applied to forehead and back of neck. At 3 am, baby woke up with a temperature of 101.3. Last temperature was 101.6 taken at 8:00 am on 03/04/2016. Still throwing up all Tylenol, refuses food and water but will nurse on and off.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Local reaction, Localised oedema, Myalgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 20 October 2015. This case linked with 2015SA169857, 2015SA169859, 2015SA169865 and 2015SA169870 (same batch number). This case involves a female patient (age not reported) who was vaccinated with a single dose of Fluzone QIV (batch number U5321BA, Expiry date 30 June 2016, dose, dose in series, route and site of administration was not reported) on 16 October 2015. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient developed rash and localized reaction. Lab data and corrective treatments were not reported. Outcome of events was not reported. List of documents held by sender: none. Followup information received from nurse on 12 January 2016. This case involves 57-year-old patient. It was reported that, the patient had not experienced any adverse event after flu vaccination previously. The patient had heart catheter with stent in October 2014, allergy to Simcor, penicillin and raw tomato, type 2 diabetes, weight loss, chemotherapy, peripheral neuropathy, hyperlipidemia, positive for myalgia. The patient's previous medications includes Lopressor, monopril, aspirin, Effient, Byetta, Zetia, Crestor, metformin. On 16 October 2015, same day following the vaccination, the patient had experienced edema and pink right deltoid, chest pain, severe arm pain and swelling. The right arm had pink area in deltoid region. Laboratory data includes blood pressure- 115/70 mm/hg, body temperature- 36 degree Celsius, body mass index- 24.50 kg/m2 oxygen saturation -94 percent. The patient had received ibuprofen and heat or cold topical treatment as corrective treatment. The patient was recovering from events chest pain, severe arm pain and swelling.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Rash, Skin discolouration
Clinical narrative: Initial unsolicited report received from a nurse on 20 October 2015. This case linked with 2015SA169857, 2015SA169859, 2015SA169865 and 2015SA169870 (same batch number). This case involves a female patient (age not reported) who was vaccinated with a single dose of Fluzone QIV (batch number U5321BA, Expiry date 30 June 2016, dose, dose in series, route and site of administration was not reported) on 16 October 2015. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient developed rash and localized reaction. Lab data and corrective treatments were not reported. Outcome of events was not reported. List of documents held by sender: none. Followup information received from nurse on 12 January 2016. This case involves 57-year-old patient. It was reported that, the patient had not experienced any adverse event after flu vaccination previously. The patient had heart catheter with stent in October 2014, allergy to Simcor, penicillin and raw tomato, type 2 diabetes, weight loss, chemotherapy, peripheral neuropathy, hyperlipidemia, positive for myalgia. The patient's previous medications includes Lopressor, monopril, aspirin, Effient, Byetta, Zetia, Crestor, metformin. On 16 October 2015, same day following the vaccination, the patient had experienced edema and pink right deltoid, chest pain, severe arm pain and swelling. The right arm had pink area in deltoid region. Laboratory data includes blood pressure- 115/70 mm/hg, body temperature- 36 degree Celsius, body mass index- 24.50 kg/m2 oxygen saturation -94 percent. The patient had received ibuprofen and heat or cold topical treatment as corrective treatment. The patient was recovering from events chest pain, severe arm pain and swelling.
Age: 13.0
Sex: M
Vaccine: FLUN4, HEP, HEPA, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient began feeling faint after vaccines were given.  Patient was sweaty and pale, told patient to sit and put legs up on another chair.  Checked patient's blood pressure and it was 88/62.  Gave the patient some water to drink and told patient to eat the peanut butter crackers he was given.  Asked the patient if he was dizzy or feeling better after five minutes.  Patient stated he was feeling better.  Rechecked blood pressure and it was 98 over 78.
Age: 21.0
Sex: F
Vaccine: FLU3, HPV9, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site warmth, Pain in extremity
Clinical narrative: Patient reports that left arm became painful the evening of 3/2/16.  Deltoid is reddened and hard and warm to touch.  Patient states today (3/4/16) it is difficult to move her left arm.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Localized erythema to MMR, VZV, and polio injections. Benadryl given at 12:00 PM and erythema was already decreasing, prior to Benadryl being given. No induration or difficulty breathing.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site papule
Clinical narrative: Multiple pink papules around site of Flu vaccine right deltoid area patient denied itching or pain in the arm. Patient was given 15 mgs of BENADRYL.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site discomfort, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with both arms with swelling around the deltoid, hot to touch, and a bit uncomfortable but he said he felt no pain. He was well and alert in office.
Age: 22.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, N/V.  Patient went ER symptoms lasted for 2 days.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, TYP
Symptoms: Condition aggravated, Eye pain, Fatigue, Headache, Migraine
Clinical narrative: Client's mom called to report client feels extremely tired and nauseous. Per mom, client complains of a headache and her eyes hurting and having a blind spot in one of her eyes. Mom reported client has frequent migraines.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, TYP
Symptoms: Nausea, Visual field defect
Clinical narrative: Client's mom called to report client feels extremely tired and nauseous. Per mom, client complains of a headache and her eyes hurting and having a blind spot in one of her eyes. Mom reported client has frequent migraines.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, FLUN4, HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Erythema, Induration
Clinical narrative: 12 hours post vaccines patient has temp of 104. 3 days later present with reddened induration over thighs with fever. Next day fever resolving as well as red area.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea, Pruritus
Clinical narrative: On 1/29/16 patient came to Employee Health. Reported that "day after injection c/o of episode of dizziness and nausea, and threw up." C/o itching. RUA, red and swollen. Ice applied to injection site. CLARITIN and TYLENOL give Xl. Hydrocortisone cream even applied to site. Instructed to follow up with her Primary Care Physician it needed.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: On 1/29/16 patient came to Employee Health. Reported that "day after injection c/o of episode of dizziness and nausea, and threw up." C/o itching. RUA, red and swollen. Ice applied to injection site. CLARITIN and TYLENOL give Xl. Hydrocortisone cream even applied to site. Instructed to follow up with her Primary Care Physician it needed.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Pt. received PNEUMOVAX 3/3/16. No reaction at time of injection. Pt. reports that night her arm got red and swollen. Presented to clinic 3/4/16 with Rt. arm swelling, redness, warm to touch, and decreased range of motion in Rt. arm. No fever. Treated with clindamycin and prednisone.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Malaise, Nausea, Pallor, Skin discolouration, Visual impairment
Clinical narrative: Pt. and parents confirmed eating breakfast before visit. Granola bar and bag of cookies and juice given to pt. prior to vaccine admin. Patient is waiting room for monitoring after immunizations. 920AM mom informed front desk that pt was not feeling well. In exam room pt stated felt nauseous, 'saw different colors' and per mom pt looked "green" and pale. Pt had stated felt better. Juice box was already given. Examined by MD no loss of consciousness cleared for discharge 925AM.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Blood glucose normal, Fall, Pallor
Clinical narrative: Patient received meningococcal vaccine at 9:30AM pt appeared fine, walked down hallway to check out, sat down in chair. Mom noticed child is pale and he then slid off chair. No LOC. P-76 B/P-114/70 - seen by MD. Blood sugar-104 - pt observed and discharged at 10:30AM.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Influenza, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer, reference number 2016049535) on 03 February 2016. This case involves a 50-year-old female patient who was vaccinated with a dose of FLU VACCINE (manufacturer unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date of October 2015. Medical history was not reported and patient other conditions were reported as COPD (chronic obstructive pulmonary), Hepatitis C, Thyroid removal, Bipolar disorder, Anxiety disorder, Bursitis, (GERD) Gastroesophageal Reflux Disease, Hysterectomy, Carpal tunnel syndrome and Shingles. Concomitant medications were Xanax (1mg tablet four times daily), Synthroid (50, tablet daily), Requip (4mg tablet three daily), Linzess (145mcg capsule once daily), topiramate (25mg tablet twice daily), hydroxyzine hcl (10mg tablet as needed every 6 hours), B12 injection (1cc injection once a month), Proair hfa (2 puffs every 6 hours), Symbicort (1 puff once daily), Spiriva (1 puff once daily) and albuterol (nebulizer once every 6 hours). On 25 January 2016, following the vaccination patient flu type A and B and also feels like she was about dead. Laboratory investigation and corrective treatment were not reported. The outcome of event was recovering. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Myalgia, Neck pain, Pyrexia, Skin warm
Clinical narrative: Fever on 2/29 afternoon, tactile hot, chills, and sore muscles, sore neck.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site induration, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: Allergic reaction w/severe localized reaction, edema, induration and warmth present right deltoid. Prednisone 10 mg dose pack Rx given.
Age: 46.0
Sex: M
Vaccine: FLUC3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on face, lateral trunk areas, itching.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Local reaction on left upper arm, mildly indurated, red and warm to touch. Measures 65 cm x 54 cm.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Electroencephalogram normal, Electromyogram normal, Headache, Laboratory test normal, Muscle spasms
Clinical narrative: Shock-like sensation starting in legs and migrating up body every 3-5 minutes to head. Results in muscle spasms and head pain lasting up to 45 minutes before complete resolution.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Nerve conduction studies normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Shock-like sensation starting in legs and migrating up body every 3-5 minutes to head. Results in muscle spasms and head pain lasting up to 45 minutes before complete resolution.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX LOT NUMBER 1740874 GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX LOT NUMBER 1740874 GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 6.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Affective disorder, Anxiety, Dizziness, Dysmenorrhoea, Food allergy
Clinical narrative: I developed a slew of digestive, hormonal, and mood disorders since the administration of the Gardasil vaccines. I had no health issues prior to the vaccines and within a year of receiving them, I developed multiple food allergies, PCOS, OCD, anxiety, dysmennorhea, random episodes of lightheadedness and feeling like I am going to faint, and now I am dealing with possible infertility, since I am on an extremely restricted nutrient rich diet and have not been able to conceive a child in almost a year. I was given this vaccine against my will as an almost 18 year old, I objected strongly to it after hearing of others' reactions, and now the quality of my life is severely diminished. I have wasted thousands of my own money trying to get well and having to deal with adverse health issues as they come up.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Hormone level abnormal, Irritable bowel syndrome, Obsessive-compulsive disorder, Polycystic ovaries
Clinical narrative: I developed a slew of digestive, hormonal, and mood disorders since the administration of the Gardasil vaccines. I had no health issues prior to the vaccines and within a year of receiving them, I developed multiple food allergies, PCOS, OCD, anxiety, dysmennorhea, random episodes of lightheadedness and feeling like I am going to faint, and now I am dealing with possible infertility, since I am on an extremely restricted nutrient rich diet and have not been able to conceive a child in almost a year. I was given this vaccine against my will as an almost 18 year old, I objected strongly to it after hearing of others' reactions, and now the quality of my life is severely diminished. I have wasted thousands of my own money trying to get well and having to deal with adverse health issues as they come up.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Quality of life decreased
Clinical narrative: I developed a slew of digestive, hormonal, and mood disorders since the administration of the Gardasil vaccines. I had no health issues prior to the vaccines and within a year of receiving them, I developed multiple food allergies, PCOS, OCD, anxiety, dysmennorhea, random episodes of lightheadedness and feeling like I am going to faint, and now I am dealing with possible infertility, since I am on an extremely restricted nutrient rich diet and have not been able to conceive a child in almost a year. I was given this vaccine against my will as an almost 18 year old, I objected strongly to it after hearing of others' reactions, and now the quality of my life is severely diminished. I have wasted thousands of my own money trying to get well and having to deal with adverse health issues as they come up.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: Nonproductive cough, fever, extreme fatigue, myalgia.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Formication, Monoplegia, Urticaria
Clinical narrative: Arm paralysis for 2 days that has gone away. She now has hives that are working down her shoulder. Only complaint currently is it feels like it's crawling. Recommended ice and to call Dr if symptoms didn't improve.
Age: 1.55
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: 15 month vaccines were repeated at 18 month check.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Not a true adverse event - given 3 months outside of age range.  Adacel was given and indicated for up to 64.  Patient just turned 65.
Age: 1.26
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever of 100-102 all day, then spiked to 103.9 around 6:00 PM.
Age: 55.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal cramping, diarrhea.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site rash, Injection site urticaria
Clinical narrative: Localized skin reaction 8x6 rash/wheal extending beyond the injection site with discomfort resulting in additional health care visit and prescribed topical Westcort cream, antihistamine and symptomatic home treatment.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever, redness/pain/warmth at injection site.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling, warm to touch, fever, fatigue, blistering to (L) deltoid area. TX: ROCEPHIN, OMNICEF.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, warm to touch, fever, fatigue, blistering to (L) deltoid area. TX: ROCEPHIN, OMNICEF.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 100 x 80 cm circular, raised, warm to touch, red swelling, on right thigh.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Follow up information was received on 12-FEB-2016, from health professional regarding a 4 year old male patient. On 09-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified date, the patient was vaccinated with one dose of improperly stored VARIVAX (Merck) injection (lot # L002217, expiration date: 21-JAN-2017) (dose and route of administration were not reported) following last temperature excursion of 7 degrees Fahrenheit for 48 hours. No adverse effects were reported. Details concerning previous temperature excursions were also provided: one at 18 degrees Fahrenheit for 15 hours and the other up to 14 degrees Fahrenheit for 323 hours and 7 minutes. This is one of two reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Follow up information was received on 12-FEB-2016, from health professional regarding a 5 year old male patient. On 04-DEC-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter, Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.