chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPH, FLUX, RVX, DTAPIPV, FLUX, RVX
Symptoms: Food allergy, Frequent bowel movements, Hypersensitivity, Mucous stools
Clinical narrative: Case number PHHY2015US099654, is an initial spontaneous report from a consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS, reference number: 578836) website on 11 AUG 2015. This report refers to a 5 months old female patient. Concurrent condition included dairy and soy fed through breast milk. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown), rotavirus vaccine (manufacturer and batch number unknown) and TETRAMUNE (batch number unknown, other manufacturer) on 06 FEB 2015. On the same day after vaccination the patient developed four large bumps on legs, bright butt rash and had a mucus stools. The patient's bowel movement increased from one bowel movement a day to six. Further the patient had allergic reactions to multiple foods of her mother's diet through breast milk. It was reported that two bumps disappeared after two months. Final outcome of the events was not recovered. The case was assessed as non-serious. Causality of the events were not reported.
Age: 0.5
Sex: F
Vaccine: DTAPH, FLUX, RVX, DTAPIPV, FLUX, RVX
Symptoms: Food allergy, Frequent bowel movements, Injection site rash, Mucous stools, Rash
Clinical narrative: Case number PHHY2015US099654, is an initial spontaneous report from a consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS, reference number: 578836) website on 11 AUG 2015. This report refers to a 5 months old female patient. Concurrent condition included dairy and soy fed through breast milk. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown), rotavirus vaccine (manufacturer and batch number unknown) and TETRAMUNE (batch number unknown, other manufacturer) on 06 FEB 2015. On the same day after vaccination the patient developed four large bumps on legs, bright butt rash and had a mucus stools. The patient's bowel movement increased from one bowel movement a day to six. Further the patient had allergic reactions to multiple foods of her mother's diet through breast milk. It was reported that two bumps disappeared after two months. Final outcome of the events was not recovered. The case was assessed as non-serious. Causality of the events were not reported.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Case number PHHY2015US099119, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 579147) website on 11 Aug 2015. This report refers to a 48 year old male patient. No medical history was reported. Concomitant medication was not reported. On 19 Sep 2014, he was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into left arm. On 19 Nov 2014, the patient experienced pain in arms, wrists, neck, shoulder, back and right side of jaw. He also experienced sparks of electrical current down arms and tingling of fingertips, lightheadedness, shortness of breath and chest tightness. Lab tests included stress test, MRI of neck, x-rays, blood work, EKG and nerve conduction. The results of lab tests were not reported. He went to the emergency room. Outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported as non-serious. No further information was provided.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Electrocardiogram, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Case number PHHY2015US099119, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 579147) website on 11 Aug 2015. This report refers to a 48 year old male patient. No medical history was reported. Concomitant medication was not reported. On 19 Sep 2014, he was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into left arm. On 19 Nov 2014, the patient experienced pain in arms, wrists, neck, shoulder, back and right side of jaw. He also experienced sparks of electrical current down arms and tingling of fingertips, lightheadedness, shortness of breath and chest tightness. Lab tests included stress test, MRI of neck, x-rays, blood work, EKG and nerve conduction. The results of lab tests were not reported. He went to the emergency room. Outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported as non-serious. No further information was provided.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: Case number PHHY2015US099119, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 579147) website on 11 Aug 2015. This report refers to a 48 year old male patient. No medical history was reported. Concomitant medication was not reported. On 19 Sep 2014, he was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into left arm. On 19 Nov 2014, the patient experienced pain in arms, wrists, neck, shoulder, back and right side of jaw. He also experienced sparks of electrical current down arms and tingling of fingertips, lightheadedness, shortness of breath and chest tightness. Lab tests included stress test, MRI of neck, x-rays, blood work, EKG and nerve conduction. The results of lab tests were not reported. He went to the emergency room. Outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported as non-serious. No further information was provided.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Back pain, Blood test, Cardiac stress test, Chest discomfort
Clinical narrative: Case number PHHY2015US099119, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 579147) website on 11 Aug 2015. This report refers to a 48 year old male patient. No medical history was reported. Concomitant medication was not reported. On 19 Sep 2014, he was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into left arm. On 19 Nov 2014, the patient experienced pain in arms, wrists, neck, shoulder, back and right side of jaw. He also experienced sparks of electrical current down arms and tingling of fingertips, lightheadedness, shortness of breath and chest tightness. Lab tests included stress test, MRI of neck, x-rays, blood work, EKG and nerve conduction. The results of lab tests were not reported. He went to the emergency room. Outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported as non-serious. No further information was provided.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Musculoskeletal pain, Neck pain
Clinical narrative: Case number PHHY2015US099119, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 579147) website on 11 Aug 2015. This report refers to a 48 year old male patient. No medical history was reported. Concomitant medication was not reported. On 19 Sep 2014, he was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into left arm. On 19 Nov 2014, the patient experienced pain in arms, wrists, neck, shoulder, back and right side of jaw. He also experienced sparks of electrical current down arms and tingling of fingertips, lightheadedness, shortness of breath and chest tightness. Lab tests included stress test, MRI of neck, x-rays, blood work, EKG and nerve conduction. The results of lab tests were not reported. He went to the emergency room. Outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported as non-serious. No further information was provided.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Case number PHHY2015US099119, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 579147) website on 11 Aug 2015. This report refers to a 48 year old male patient. No medical history was reported. Concomitant medication was not reported. On 19 Sep 2014, he was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into left arm. On 19 Nov 2014, the patient experienced pain in arms, wrists, neck, shoulder, back and right side of jaw. He also experienced sparks of electrical current down arms and tingling of fingertips, lightheadedness, shortness of breath and chest tightness. Lab tests included stress test, MRI of neck, x-rays, blood work, EKG and nerve conduction. The results of lab tests were not reported. He went to the emergency room. Outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported as non-serious. No further information was provided.
Age: 59.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: Case number PHHY2015US100280 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 580060) on 11 Aug 2015. This report refers to a 59 year old female patient. She had no medical history or illness at the time of vaccination. No concomitant medications were reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 17 Oct 2014. On the same day after vaccination, her upper left arm between the elbow and shoulder ached at vaccination site for a couple of days. She noticed over the next few months that certain backward motion of the arm caused some discomfort. She stopped using the arm other than for forward motion. The upper left arm and shoulder area became painful when used. After months of discomfort, she went to doctor who prescribed Naproxen and physical therapy. The Naproxen upset her stomach and hence she just continued physical therapy. The arm and shoulder were still painful and she was working on regaining some mobility in the arm. It was difficult to get dressed -to put on or take off a garment as her left arm would not co-operate in an extended up and backward motion. The physician's assistant conducted a physical examination, but no other diagnostic or laboratory tests were done. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 59.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Limb discomfort, Mobility decreased, Vaccination site pain
Clinical narrative: Case number PHHY2015US100280 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 580060) on 11 Aug 2015. This report refers to a 59 year old female patient. She had no medical history or illness at the time of vaccination. No concomitant medications were reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 17 Oct 2014. On the same day after vaccination, her upper left arm between the elbow and shoulder ached at vaccination site for a couple of days. She noticed over the next few months that certain backward motion of the arm caused some discomfort. She stopped using the arm other than for forward motion. The upper left arm and shoulder area became painful when used. After months of discomfort, she went to doctor who prescribed Naproxen and physical therapy. The Naproxen upset her stomach and hence she just continued physical therapy. The arm and shoulder were still painful and she was working on regaining some mobility in the arm. It was difficult to get dressed -to put on or take off a garment as her left arm would not co-operate in an extended up and backward motion. The physician's assistant conducted a physical examination, but no other diagnostic or laboratory tests were done. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2015US098451 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 581438) website on 11 Aug 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date, a few years ago. On an unknown date after vaccination the patient experienced anaphylaxis. It was reported that the patient was not sensitive to latex. Outcome of the event was unknown. Case was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of anaphylaxis was upgraded based on the NVS-IMS list.
Age: 58.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Dyspnoea, Influenza, Mycobacterium tuberculosis complex test positive, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US099069 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 581583) on 11 Aug 2015. This report refers to a 58 year old male patient. He had no reported medical history and current conditions. His concomitant medications included metformin, GLYBURIDE, amlodipine, lisinopril and atenolol. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2014. On 20 Feb 2015, he experienced tingling in his hands and soreness at vaccination site and the soreness spread to lower arm and shoulder. Within 2 weeks, he had full blown flu symptoms followed by difficulty in breathing. He went to emergency room. He was also tested positive for tuberculosis (TB) and was dealing with the county health department. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 58.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2015US099069 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 581583) on 11 Aug 2015. This report refers to a 58 year old male patient. He had no reported medical history and current conditions. His concomitant medications included metformin, GLYBURIDE, amlodipine, lisinopril and atenolol. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2014. On 20 Feb 2015, he experienced tingling in his hands and soreness at vaccination site and the soreness spread to lower arm and shoulder. Within 2 weeks, he had full blown flu symptoms followed by difficulty in breathing. He went to emergency room. He was also tested positive for tuberculosis (TB) and was dealing with the county health department. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Blood culture, Culture urine, Dyskinesia, Echocardiogram normal, Electroencephalogram normal
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Full blood count, Hyperventilation, Induration, Malaria antibody test, Metabolic function test
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging normal, Polymerase chain reaction, Urine analysis
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Blood culture negative, Borrelia test negative, Culture urine negative, Echocardiogram normal, Electroencephalogram normal
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Full blood count normal, Generalised tonic-clonic seizure, Laboratory test normal, Metabolic function test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Polymerase chain reaction, Smear site unspecified normal, Urine analysis normal
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Autonomic nervous system imbalance, Blood test, Dyspnoea, Electrocardiogram ambulatory abnormal, Hypotension
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Psychogenic seizure, Tachycardia, Tilt table test, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to an 18 year old female patient. The patient pertinent medical history included functional heart murmur, elevated thyroid antibodies. The patient had urticarial and swelling of hands and feet from penicillin. On 19-AUG-2015, the patient was vaccinated with GARDASIL injection of strength 120 Y (lot # K010215 and expiry date: 05-MAY-2017) (dose, route and site of administration not reported). No concomitant medications were reported. On 20-AUG-2015, the patient experienced tonic-clonic seizure and admitted to a hospital on 22-AUG-2015. On an unknown date in August 2015, laboratory tests included magnetic resonance imaging (MRI), Electroencephalogram (EEG), blood cultures, Lyme test, Polymerase chain reaction (PCR), comprehensive metabolic panel (CMP), complete blood count (CBC), Smear formulation, urine analysis (UA), urine culture, 2D echo were performed and showed negative results. The patient sought for the medical attention and visited the physician. The patient was discharged from the hospital on 24-AUG-2015. The outcome of tonic-clonic seizure was reported as not recovered/not resolved. The causality of tonic-clonic seizure was not reported. No additional information was reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Arm where vaccine was injected swelled to about the size of a golf ball starting at 0400AM and continued to worsen throught the day. Sore muscles and body aches occured throughout the body. Pain in the arm where vaccine was injected began to worsen throughout the day. Lymph node in the shoulder blade swelled on the side the vaccine was injected. All symptoms began to improve at around 11:00PM. By 9/6/2015 aches were minimal and pain improved. By 9/8/2015 swelling went down to normal. By 9/11/2015 lymph node returned back to normal.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Fatigue, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Swelling and redness at injection sight the size off the vaccine fluid injection. Over the next 12 hours swelling continued to increase at injection site (IS) to the size of 2inches also starting to get low grade heat radiating at (IS). Slight muscle aches all over body. Over the next 12 hours muscle pain increases especially in whole back. (IS) starting to be painful to the touch and difficult to use arm without moderate pain. Over the next 12 hours swelling at (IS) increased to 3inches heat radiating and extreme pain with limited to no movement. Body pain increased to extreme muscle and joint pain all over whole body. Extreme fatigue, nausea, headache and slight blurred vision. These symptoms continued for 12 hours. Over the next 12 hours swelling at (IS) increased in size to 4inches in diameter with heat radiating and limited movement ability.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Nausea
Clinical narrative: Swelling and redness at injection sight the size off the vaccine fluid injection. Over the next 12 hours swelling continued to increase at injection site (IS) to the size of 2inches also starting to get low grade heat radiating at (IS). Slight muscle aches all over body. Over the next 12 hours muscle pain increases especially in whole back. (IS) starting to be painful to the touch and difficult to use arm without moderate pain. Over the next 12 hours swelling at (IS) increased to 3inches heat radiating and extreme pain with limited to no movement. Body pain increased to extreme muscle and joint pain all over whole body. Extreme fatigue, nausea, headache and slight blurred vision. These symptoms continued for 12 hours. Over the next 12 hours swelling at (IS) increased in size to 4inches in diameter with heat radiating and limited movement ability.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: Swelling and redness at injection sight the size off the vaccine fluid injection. Over the next 12 hours swelling continued to increase at injection site (IS) to the size of 2inches also starting to get low grade heat radiating at (IS). Slight muscle aches all over body. Over the next 12 hours muscle pain increases especially in whole back. (IS) starting to be painful to the touch and difficult to use arm without moderate pain. Over the next 12 hours swelling at (IS) increased to 3inches heat radiating and extreme pain with limited to no movement. Body pain increased to extreme muscle and joint pain all over whole body. Extreme fatigue, nausea, headache and slight blurred vision. These symptoms continued for 12 hours. Over the next 12 hours swelling at (IS) increased in size to 4inches in diameter with heat radiating and limited movement ability.
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient currently in her 80's years of age. The patient's medical history and concurrent condition were not reported. The patient was vaccinated with ZOSTAVAX (strength, dose, lot# and route unknown) when she was in her late 70's years of age (date unspecified). Concomitant therapy was unknown. After getting the ZOSTAVAX vaccine, the patient lost her ability to taste and her sense of taste on an unknown date. The patient sought medical attention by contacting the pharmacist. The outcome of the event was reported as not recovered. The reporter considered the event to be significant disability. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Pain in arm where vaccine was given.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Raised rash and swelling at injection site.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Choking, Coordination abnormal, Gait disturbance, Injection site pain, Pain in extremity
Clinical narrative: Pain traveling from upper arm down the arm on same side as shot. Going down to hand. Pain continuing over days to other arm and hands. Pain stays for months. Hands coordination poor--dropping things. Gait somewhat unstable. Choking easily on food. Starting late spring, pain starts subsiding in arms. As of Sept. 2015, pain is only in both thumbs. Pain is not easily localized. It is not constant but occurs when doing some motion and is not localized in joints, more like in nerves or muscles/tendons and may be anywhere in thumb. Choking is now rarer and unstable gate is once in a while.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen; warm to touch & red in color - Cellulitis- prescribed antibiotics Cephalexin Tabs 500 mg 1 tab orally BID for 10 days.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Rash
Clinical narrative: Patient reported Rash on abdomen and lower legs, self treated with left over shingles medications. 9/14/15 rash with streaks and swelling of lips. Patient reported she went to Private MD who administered injection (?) for possible allergy and gave Rx for prednisone and Zyrtec. Provided relief.
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Joint injury, Lung infection, Rosacea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of lung infection in a adult male patient who received FLUARIX QUADRIVALENT (batch number LZ4S2, expiry date unknown). Concurrent medical conditions included knee injury and acne rosacea. On 23rd September 2014, the patient received FLUARIX QUADRIVALENT. On 24th September 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced lung infection (serious criteria GSK medically significant), rosacea aggravated and knee injury. On an unknown date, the outcome of the lung infection and knee injury were recovered/resolved and the outcome of the rosacea aggravated was not recovered/not resolved. It was unknown if the reporter considered the lung infection and knee injury to be related to FLUARIX QUADRIVALENT. The reporter considered the rosacea aggravated to be probably related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter stated that he had a severe reaction to FLUARIX QIV. He received the flu shot on 23rd September 2014 and the day after getting the shot he developed a lung infection that lasted for 8 months. Also he stated that an old knee injury that had occurred many years ago flared up and lasted for 11 months and his Rosacea acne was aggravated as well and was not resolved. He felt that the flu shot caused his body to have an inflammatory immune response. All issues required no hospitalization but the health care professional did seek treatment with a physician.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from Pfizer Medical Information for a contactable consumer. This consumer reported that he/she received PREVNAR 13, single dose. On unknown date the patient experienced pneumonia. The outcome of the event was unknown. Follow-up (12Mar2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable health care professional, a medical assistant, through a Pfizer sales representative and follow-up from a contactable physician. A patient of unspecified age and gender received PREVNAR 13 on unspecified date, at 0.5 ml single, intramuscular. Medical history and concomitant medications were not provided. The patient experienced high fever on unknown date which required hospitalization. The facility had ordered around 60 doses of the product. The ordering physician was a part of a 4 site practice. Event outcome was unknown at the time of report. The physician could not confirm the occurrence of the event. Follow-up (18Dec2014): New information received from a contactable physician includes: the physician could not confirm the event. Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Severe headache, vertigo upon rising or moving my head in any manner.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis, Vertigo
Clinical narrative: Severe headache, vertigo upon rising or moving my head in any manner.
Age: 74.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported events with the same suspect vaccines for herself and her husband. This is the second of two reports (referred to the consumer husband). This 74 year-old male patient of an unspecified ethnicity received a single dose of PREVNAR 13 and FLU SHOT, both via an unspecified route of administration on 03Nov2014. Relevant medical history and concomitant medications were unknown. It was reported that on 07Nov2014 after vaccinations he experienced arm, shoulder and neck pain. At the time of the report the patient was getting better, with events outcome reported as improved. No follow up attempts possible. No further information expected.
Age: 14.0
Sex: F
Vaccine: MEN
Symptoms: Blindness, Deafness, Meningitis, Tremor, Weight decreased
Clinical narrative: Initial unsolicited report received from a consumer (parent) on 12 September 2015. This case involves a 14-year-old female patient, who was vaccinated with a dose Meningococcal vaccine [dose, dose in series, route and site of administration were not reported] on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had meningitis, hearing loss, vision loss, tremors on her left side and lost 20 pounds. The patient was hospitalized for two weeks (on an unknown date). The patient was completely healthy at the age of 19 year. Laboratory data was not reported. Corrective treatment included azithromycin. On an unknown date, the patient was recovered from all the events. List of documents held by sender: none.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable female consumer, the grandmother of the patient. A 1-year-old male patient possibly received a dose of PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medication were not reported. The patient developed pneumonia on an unspecified date. The outcome of the event was unknown. The reporter suspected that the event could be related to PREVNAR 13 but did not really know if the child had been vaccinated with PREVNAR 13 or not. Follow-up (21FEB2012) Follow-up attempts completed. No further information expected.
Age: 1.9
Sex: M
Vaccine: PNC13
Symptoms: Pneumococcal bacteraemia, Pneumococcal infection
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 23-month-old male patient received the fourth dose of PREVNAR 13 on an unknown date. Relevant medical history included Down Syndrome. The patient was hospitalized on an unknown date due to pneumococcal disease (type unknown). The physician suspected it could be bacteremia. Therapeutic measures taken as a result of the event were unknown. The patient was discharged on an unknown date. The outcome of the event was unknown.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site swelling, Injection site warmth, Throat tightness
Clinical narrative: Largely swollen right arm at injection site; fever at injection site, chest pains, closing of the throat.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Oropharyngeal pain
Clinical narrative: Sore throat in PM. Sore throat and warm temperature next AM (9/23/15).
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: 103 Fever on and off for 24 hours.  Severe aches.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Feeling abnormal, Heart rate increased, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient stated she felt weird and had tingling on her upper lip and neck area. Her blood pressure and pulse were elevated. Patient also had red blotches on her chest when EMS arrived.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Patient stated she felt weird and had tingling on her upper lip and neck area. Her blood pressure and pulse were elevated. Patient also had red blotches on her chest when EMS arrived.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Excessive redness and swelling at injection site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Eye swelling, Peripheral swelling, Rash
Clinical narrative: Swelling of face, hands, eyes, redness, rash on hands (B), (B) arms, chest area, light rash and burning on thighs and legs, BENADRYL, hydrocortisone cream, CLARITIN.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Swelling of face, hands, eyes, redness, rash on hands (B), (B) arms, chest area, light rash and burning on thighs and legs, BENADRYL, hydrocortisone cream, CLARITIN.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Resuscitation, Seizure
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported for a 2-month-old patient, unspecified ethnicity, who was vaccinated with PREVENAR 13, PEDIARIX, ACTHIB and rotavirus vaccine liquid; all vaccines on unspecified date, at an unknown dose, formulation and indication. The patient had experienced questionable seizure twice witnessed by patient's mother. The second event required mouth to mouth resuscitation by the mother. At that point, the patient was taken to a facility. The patient was admitted for full work up including CT head and EEG with results all negative. No further events witnessed. Unsure at this point if events are due to vaccines. The patient is responding normally at this point in time. Follow-up (10Oct2014): Follow-up attempts completed. No further information expected.
Age: 8.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Asthma, Dyspnoea, Erythema, Flushing, Oral pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse. This 8-year-old male patient of unknown ethnicity received PREVNAR 13 (lot number H65736, expiration date 31Jul2015) at 0.5 ml single dose intramuscular in right thigh for asthma on 29Sep2014. Concomitant medications included diphtheria and tetanus toxoids received on 29Sep2014, SINGULAIR, ZYRTEC, FLOVENT and albuterol, no dosage information or indications available for these medications. Medical history included Kawasaki's Disease diagnosed in Jan2014, food allergies (including peanut, egg, and tree nut allergies), and occasional episodes of angioedema. On 29Sep2014, within about 5 minutes of receiving the vaccines, the patient developed itching in his throat and mouth, hives on his neck and back, red flushing of his face and ears, then developed significant shortness of breath. He was transported to the emergency room where he was treated and observed for anaphylaxis. He was treated in the emergency room and was not admitted to the hospital. The patient recovery completely (date not reported). The allergy clinic was notified of the patient referral on 03Oct2014. The nurse would like to know if there is a presence of thimerosal, gelatin, or latex in PREVNAR 13. Follow-up (26Feb2015): Follow-up attempts completed. No further information expected.
Age: 8.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Throat irritation, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. This 8-year-old male patient of unknown ethnicity received PREVNAR 13 (lot number H65736, expiration date 31Jul2015) at 0.5 ml single dose intramuscular in right thigh for asthma on 29Sep2014. Concomitant medications included diphtheria and tetanus toxoids received on 29Sep2014, SINGULAIR, ZYRTEC, FLOVENT and albuterol, no dosage information or indications available for these medications. Medical history included Kawasaki's Disease diagnosed in Jan2014, food allergies (including peanut, egg, and tree nut allergies), and occasional episodes of angioedema. On 29Sep2014, within about 5 minutes of receiving the vaccines, the patient developed itching in his throat and mouth, hives on his neck and back, red flushing of his face and ears, then developed significant shortness of breath. He was transported to the emergency room where he was treated and observed for anaphylaxis. He was treated in the emergency room and was not admitted to the hospital. The patient recovery completely (date not reported). The allergy clinic was notified of the patient referral on 03Oct2014. The nurse would like to know if there is a presence of thimerosal, gelatin, or latex in PREVNAR 13. Follow-up (26Feb2015): Follow-up attempts completed. No further information expected.
Age: 98.0
Sex: F
Vaccine: PNC13
Symptoms: Bronchospasm
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A 98 years old female patient of unspecified ethnicity received PREVNAR 13 on unknown date at single dose. It was reported that on unknown date the patient experienced bronchospasm for which she got hospitalized. The physician thought that the PREVNAR 13 was not responsible for the bronchospasm and hospitalization. Follow-up (09Mar2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales Representative who reported on behalf of a patient. A male patient with HIV infection, received PREVNAR 13, single dose on unknown date. The next day he experienced pneumonia. No further information received.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Adverse reaction, Erythema, Feeling hot, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other HCP via Pfizer sales representative. An adult patient of unspecified age ethnicity and gender received PREVNAR 13 intramuscular at an unspecified dose, INFLUENZA VACCINE via an unspecified route of administration at UNK, both on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever 102 F, nausea, redness, warmth, had a reaction (influenza and PREVNAR 13), all on an unspecified date with outcome of unknown. The action taken in response to the events was not applicable. HCP stated that patient due to the medical condition had only one arm available for injection of PREVNAR 13 and Flu vaccine, both vaccines were administered in the same arm in separate syringes. The reporter queried whether influenza and PREVNAR 13 be given on the same arm when the alternate arm isn't an option and if not, what is spacing required when using the same arm. The reporter queried about information on administration of those two vaccines in the same arm. Follow-up (18Dec2014): Follow-up attempts completed. No further information expected.