chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Antinuclear antibody positive, Anxiety, Arthralgia, Back pain
Clinical narrative: Information has been received from a nurse concerning her daughter who is 18 years old. The patient's historical medications included unspecified Hepatitis A vaccination received 2 weeks prior to GARDASIL and MENACTRA received at unspecified time prior to GARDASIL. The patient was allergic to Penicillin since unspecified time in early childhood. On an unknown date in August 2015, she was vaccinated with first dose of GARDASIL (dosing details were not reported) (lot # K010215, expiration date unknown). Concomitant therapies included ATIVAN. The first day after GARDASIL administration, patient had an episode of heart racing with heart rate to 180 beats and she became incoherent, had a severe decrease in blood pressure, and passed out in the ambulance on the way to the emergency room. The reporter stated that the same events happened again on the second and third days after GARDASIL, and on the third day patient experienced tonic-clonic jerking motions and was then admitted to an unnamed hospital. The patient's Magnetic resonance imaging (MRI) and electroencephalogram (EEG) results were "normal" according to reporter. Two weeks after the GARDASIL vaccination, patient had an episode where she could not breathe. At unspecified times after that, patient began to experience severe constipation, and sometimes she did not move her bowels for as long as 6 days, she had joint pain and episodes of rapid heartbeat. She was monitored at home with a portable Bolter-type cardiac monitor, which showed ventricular tachycardia to 203 beats during sleep, on the monitor. She was started on metoprolol at an unknown dose after the episodes of tachycardia began. Approximately in September 2015, she began to experience a persistent tic in her left arm beginning. On an unknown date in November 2015, she had episodes of low blood pressure and had a positive tilt table test. On an unknown date, she experienced episodes of rib and back pain, severe menstrual pain, she was passing large clots during menses and had frequent episodes of anxiety. She had a total of 12 ER visits, and missed her first year of college due to her frequent symptoms. At the time of the report if she gets "any type of virus", she gets leg weakness and pain in her joints. The outcome of the events were unknown. The reporter did not provide the relatedness of the events with GARDASIL. There was no product quality complaint reported. Upon internal review the events "Loss of consciousness, Tonic clonic movements and ventricular tachycardia" were determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Cardiac monitoring abnormal, Constipation, Dysmenorrhoea, Dyspnoea
Clinical narrative: Information has been received from a nurse concerning her daughter who is 18 years old. The patient's historical medications included unspecified Hepatitis A vaccination received 2 weeks prior to GARDASIL and MENACTRA received at unspecified time prior to GARDASIL. The patient was allergic to Penicillin since unspecified time in early childhood. On an unknown date in August 2015, she was vaccinated with first dose of GARDASIL (dosing details were not reported) (lot # K010215, expiration date unknown). Concomitant therapies included ATIVAN. The first day after GARDASIL administration, patient had an episode of heart racing with heart rate to 180 beats and she became incoherent, had a severe decrease in blood pressure, and passed out in the ambulance on the way to the emergency room. The reporter stated that the same events happened again on the second and third days after GARDASIL, and on the third day patient experienced tonic-clonic jerking motions and was then admitted to an unnamed hospital. The patient's Magnetic resonance imaging (MRI) and electroencephalogram (EEG) results were "normal" according to reporter. Two weeks after the GARDASIL vaccination, patient had an episode where she could not breathe. At unspecified times after that, patient began to experience severe constipation, and sometimes she did not move her bowels for as long as 6 days, she had joint pain and episodes of rapid heartbeat. She was monitored at home with a portable Bolter-type cardiac monitor, which showed ventricular tachycardia to 203 beats during sleep, on the monitor. She was started on metoprolol at an unknown dose after the episodes of tachycardia began. Approximately in September 2015, she began to experience a persistent tic in her left arm beginning. On an unknown date in November 2015, she had episodes of low blood pressure and had a positive tilt table test. On an unknown date, she experienced episodes of rib and back pain, severe menstrual pain, she was passing large clots during menses and had frequent episodes of anxiety. She had a total of 12 ER visits, and missed her first year of college due to her frequent symptoms. At the time of the report if she gets "any type of virus", she gets leg weakness and pain in her joints. The outcome of the events were unknown. The reporter did not provide the relatedness of the events with GARDASIL. There was no product quality complaint reported. Upon internal review the events "Loss of consciousness, Tonic clonic movements and ventricular tachycardia" were determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram normal, Heart rate increased, Incoherent, Loss of consciousness, Menstrual disorder
Clinical narrative: Information has been received from a nurse concerning her daughter who is 18 years old. The patient's historical medications included unspecified Hepatitis A vaccination received 2 weeks prior to GARDASIL and MENACTRA received at unspecified time prior to GARDASIL. The patient was allergic to Penicillin since unspecified time in early childhood. On an unknown date in August 2015, she was vaccinated with first dose of GARDASIL (dosing details were not reported) (lot # K010215, expiration date unknown). Concomitant therapies included ATIVAN. The first day after GARDASIL administration, patient had an episode of heart racing with heart rate to 180 beats and she became incoherent, had a severe decrease in blood pressure, and passed out in the ambulance on the way to the emergency room. The reporter stated that the same events happened again on the second and third days after GARDASIL, and on the third day patient experienced tonic-clonic jerking motions and was then admitted to an unnamed hospital. The patient's Magnetic resonance imaging (MRI) and electroencephalogram (EEG) results were "normal" according to reporter. Two weeks after the GARDASIL vaccination, patient had an episode where she could not breathe. At unspecified times after that, patient began to experience severe constipation, and sometimes she did not move her bowels for as long as 6 days, she had joint pain and episodes of rapid heartbeat. She was monitored at home with a portable Bolter-type cardiac monitor, which showed ventricular tachycardia to 203 beats during sleep, on the monitor. She was started on metoprolol at an unknown dose after the episodes of tachycardia began. Approximately in September 2015, she began to experience a persistent tic in her left arm beginning. On an unknown date in November 2015, she had episodes of low blood pressure and had a positive tilt table test. On an unknown date, she experienced episodes of rib and back pain, severe menstrual pain, she was passing large clots during menses and had frequent episodes of anxiety. She had a total of 12 ER visits, and missed her first year of college due to her frequent symptoms. At the time of the report if she gets "any type of virus", she gets leg weakness and pain in her joints. The outcome of the events were unknown. The reporter did not provide the relatedness of the events with GARDASIL. There was no product quality complaint reported. Upon internal review the events "Loss of consciousness, Tonic clonic movements and ventricular tachycardia" were determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Musculoskeletal chest pain, Nuclear magnetic resonance imaging normal, Palpitations, Tic
Clinical narrative: Information has been received from a nurse concerning her daughter who is 18 years old. The patient's historical medications included unspecified Hepatitis A vaccination received 2 weeks prior to GARDASIL and MENACTRA received at unspecified time prior to GARDASIL. The patient was allergic to Penicillin since unspecified time in early childhood. On an unknown date in August 2015, she was vaccinated with first dose of GARDASIL (dosing details were not reported) (lot # K010215, expiration date unknown). Concomitant therapies included ATIVAN. The first day after GARDASIL administration, patient had an episode of heart racing with heart rate to 180 beats and she became incoherent, had a severe decrease in blood pressure, and passed out in the ambulance on the way to the emergency room. The reporter stated that the same events happened again on the second and third days after GARDASIL, and on the third day patient experienced tonic-clonic jerking motions and was then admitted to an unnamed hospital. The patient's Magnetic resonance imaging (MRI) and electroencephalogram (EEG) results were "normal" according to reporter. Two weeks after the GARDASIL vaccination, patient had an episode where she could not breathe. At unspecified times after that, patient began to experience severe constipation, and sometimes she did not move her bowels for as long as 6 days, she had joint pain and episodes of rapid heartbeat. She was monitored at home with a portable Bolter-type cardiac monitor, which showed ventricular tachycardia to 203 beats during sleep, on the monitor. She was started on metoprolol at an unknown dose after the episodes of tachycardia began. Approximately in September 2015, she began to experience a persistent tic in her left arm beginning. On an unknown date in November 2015, she had episodes of low blood pressure and had a positive tilt table test. On an unknown date, she experienced episodes of rib and back pain, severe menstrual pain, she was passing large clots during menses and had frequent episodes of anxiety. She had a total of 12 ER visits, and missed her first year of college due to her frequent symptoms. At the time of the report if she gets "any type of virus", she gets leg weakness and pain in her joints. The outcome of the events were unknown. The reporter did not provide the relatedness of the events with GARDASIL. There was no product quality complaint reported. Upon internal review the events "Loss of consciousness, Tonic clonic movements and ventricular tachycardia" were determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Tilt table test positive, Tonic clonic movements, Ventricular tachycardia, Viral infection
Clinical narrative: Information has been received from a nurse concerning her daughter who is 18 years old. The patient's historical medications included unspecified Hepatitis A vaccination received 2 weeks prior to GARDASIL and MENACTRA received at unspecified time prior to GARDASIL. The patient was allergic to Penicillin since unspecified time in early childhood. On an unknown date in August 2015, she was vaccinated with first dose of GARDASIL (dosing details were not reported) (lot # K010215, expiration date unknown). Concomitant therapies included ATIVAN. The first day after GARDASIL administration, patient had an episode of heart racing with heart rate to 180 beats and she became incoherent, had a severe decrease in blood pressure, and passed out in the ambulance on the way to the emergency room. The reporter stated that the same events happened again on the second and third days after GARDASIL, and on the third day patient experienced tonic-clonic jerking motions and was then admitted to an unnamed hospital. The patient's Magnetic resonance imaging (MRI) and electroencephalogram (EEG) results were "normal" according to reporter. Two weeks after the GARDASIL vaccination, patient had an episode where she could not breathe. At unspecified times after that, patient began to experience severe constipation, and sometimes she did not move her bowels for as long as 6 days, she had joint pain and episodes of rapid heartbeat. She was monitored at home with a portable Bolter-type cardiac monitor, which showed ventricular tachycardia to 203 beats during sleep, on the monitor. She was started on metoprolol at an unknown dose after the episodes of tachycardia began. Approximately in September 2015, she began to experience a persistent tic in her left arm beginning. On an unknown date in November 2015, she had episodes of low blood pressure and had a positive tilt table test. On an unknown date, she experienced episodes of rib and back pain, severe menstrual pain, she was passing large clots during menses and had frequent episodes of anxiety. She had a total of 12 ER visits, and missed her first year of college due to her frequent symptoms. At the time of the report if she gets "any type of virus", she gets leg weakness and pain in her joints. The outcome of the events were unknown. The reporter did not provide the relatedness of the events with GARDASIL. There was no product quality complaint reported. Upon internal review the events "Loss of consciousness, Tonic clonic movements and ventricular tachycardia" were determined to be medically significant. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Acute kidney injury, Dizziness, Erythema, Hypotension, Injection site erythema
Clinical narrative: Received PPSV23 on 11/3.  The next day she had mild arm soreness.  On 11/5 her arm hurt quite a bit and the redness at the site was spreading.  On 11/7 she felt malaise, dizziness, floaters in supine position, could eat/drink very little. Her arm was red and hot from the shoulder nearly to the elbow and was hot.  Went to ED and admitted to ICU for hypotension, elevated WBC and Acute Renal Failure.  She was in ICU for 2 days, general unit for 1 day and discharged.  Cause of illness not known, but immunization is suspect.  Much better today (11/21), but not all the way back to normal.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Intensive care, Malaise, Pain in extremity, Vitreous floaters, White blood cell count increased
Clinical narrative: Received PPSV23 on 11/3.  The next day she had mild arm soreness.  On 11/5 her arm hurt quite a bit and the redness at the site was spreading.  On 11/7 she felt malaise, dizziness, floaters in supine position, could eat/drink very little. Her arm was red and hot from the shoulder nearly to the elbow and was hot.  Went to ED and admitted to ICU for hypotension, elevated WBC and Acute Renal Failure.  She was in ICU for 2 days, general unit for 1 day and discharged.  Cause of illness not known, but immunization is suspect.  Much better today (11/21), but not all the way back to normal.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Pain
Clinical narrative: Injection site of PNEUMOVAX across the entire arm is red, hard and itchy about the size of a baseball. Patient reports pain as well.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeding disorder, Headache, Nausea
Clinical narrative: Pt first experienced dizziness, where the whole room was spinning, nausea, extremely heavy headache, pt was very weak, vomiting, couldn't eat - pt is sitting up for the first time today (11/21) and the dizziness is improving.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Vomiting
Clinical narrative: Pt first experienced dizziness, where the whole room was spinning, nausea, extremely heavy headache, pt was very weak, vomiting, couldn't eat - pt is sitting up for the first time today (11/21) and the dizziness is improving.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, Fatigue, Pain, Red blood cell sedimentation rate
Clinical narrative: Fatigue, body aches. May have come on sooner but I do not have a doctors record.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle sore radiating to the left lower body. "It hurt periodically, not constant."
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Apnoea, Appetite disorder, Bradycardia, Pallor
Clinical narrative: Appetite change, pale, apnea spells, bradycardia in the 50's.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: LITTLE BLEEDING ON BANDAID AFTER SHOT; NEXT FEW DAYS NOTICED BRUISING AROUND INJECTION SITE; PATIENT STATES NOT ON ANY BLOOD THINNERS; NO NUMBNESS OR TINGLING.
Age: 26.0
Sex: M
Vaccine: HEPAB, IPV, TDAP
Symptoms: Cognitive disorder, Craniocerebral injury, Gastrointestinal disorder, Multi-organ disorder, Renal function test abnormal
Clinical narrative: Renal Function Nonspecific Abnormal Findings (Rhabdomyolysis). Multi-organ chronic signs and symptoms. Traumatic brain injury with cognitive impairment. Gastrointestinal illness.
Age: 26.0
Sex: M
Vaccine: HEPAB, IPV, TDAP
Symptoms: Renal impairment, Rhabdomyolysis
Clinical narrative: Renal Function Nonspecific Abnormal Findings (Rhabdomyolysis). Multi-organ chronic signs and symptoms. Traumatic brain injury with cognitive impairment. Gastrointestinal illness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper arm swollen, itchy tender about 3 inches in all directions surrounding injection site 1 week ago. Other arm is fine. In left arm, he received flu vaccine and KINRIX.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Dysgeusia, Erythema
Clinical narrative: Chills, irritation of red eyes, ears, esophagus, sinus, urethra, expectoration of phlegm & froth, aching of injection site, body, ongoing aching in kidneys, joint pain, foul taste in mouth & throat. Some nausea & dizziness. took TYLENOL. Ongoing symptoms include kidney aching & joint pain & muscle weakness.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Foaming at mouth, Injection site pain, Muscular weakness, Nausea
Clinical narrative: Chills, irritation of red eyes, ears, esophagus, sinus, urethra, expectoration of phlegm & froth, aching of injection site, body, ongoing aching in kidneys, joint pain, foul taste in mouth & throat. Some nausea & dizziness. took TYLENOL. Ongoing symptoms include kidney aching & joint pain & muscle weakness.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Productive cough, Renal pain, Urethritis noninfective
Clinical narrative: Chills, irritation of red eyes, ears, esophagus, sinus, urethra, expectoration of phlegm & froth, aching of injection site, body, ongoing aching in kidneys, joint pain, foul taste in mouth & throat. Some nausea & dizziness. took TYLENOL. Ongoing symptoms include kidney aching & joint pain & muscle weakness.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid margin crusting, Lip swelling
Clinical narrative: Patient states she woke up the morning of November 17, 2016 with matted eyes and swelling of the lips. She was encouraged to seek prompt evaluation by her primary care provider or Urgent Care/ER for reported symptoms and/or at any time if she feels symptoms are worsening.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Drug administered at inappropriate site
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Unit (PFU), subcutaneously, "one time vaccination" (lot # and expiration date were not reported). It was stated that the vaccine was administered incorrectly at the wrong injection site. The patient sought medical attention by visiting doctor's office and was diagnosed with cellulitis; which was treated with unspecified antibiotics. There was not a product quality complaint (PQC) involved. At the time of reporting the outcome of cellulitis was reported as unknown. The causality assessment between cellulitis and ZOSTAVAX was not reported. Upon internal review cellulitis was determined to be a medically significant event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Antinuclear antibody positive, Anxiety, Arthralgia
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's concurrent condition include juvenile type 1 diabetes mellitus diagnosed at 5 years. The patient's historical drugs include varicella vaccine (manufacturer unknown) and developed chickenpox during childhood (reported in MARRS # 1611USA009929). Reporter stated that patient had no titers for rubella or hepatitis B despite being vaccinated for those during childhood (captured in MARRS # 1611USA009930 and 1611USA009931 respectively). On an unspecified date in August 2014, the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) dose 1. In two weeks, unspecified date of 2014, the patient experienced one throat infection after another, and her blood sugar was out of control with her A1C level reaching 10. Patient also experienced elevated ketones, vomiting 25 - 30 times per day, pain in her chest and pain around her liver, and such severe joint pain, especially in her feet and ankles, that she stopped all of her normal sports activities, including her competitive swimming. Patient also experienced anxiety and a 20 pound weight gain. Reporter stated that patient saw both a psychiatrist and an endocrinologist in December 2014 to evaluate the symptoms. Patient's thyroid tests and other testing came back with normal results, except for expected blood glucose tests, as patient had been a Type 1 diabetic since age 5 years. The patient seemed to improve and continued with school. In August 2015, patient received her second dose of GARDASIL (dose and route not reported) lot K010215, expiration date unknown. Reporter stated that all of her daughter's symptoms came back, just like before. Patient experienced joint pain, headaches, frequent vomiting, severe menstrual pain, and stomach aches. Reporter stated that patient described rib pain, back pain, anxiety, and a second 20 pound weight gain. Reporter stated that patient experienced frequent insomnia, and had multiple ER visits totaling 5 or 6 ER visits over two years, with one hospital admission for rapid heartbeat. Patient tested ANA antinuclear antibody positive. At the time of this report the patient's present status was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood glucose abnormal, Blood ketone body increased, Chest pain, Dysmenorrhoea
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's concurrent condition include juvenile type 1 diabetes mellitus diagnosed at 5 years. The patient's historical drugs include varicella vaccine (manufacturer unknown) and developed chickenpox during childhood (reported in MARRS # 1611USA009929). Reporter stated that patient had no titers for rubella or hepatitis B despite being vaccinated for those during childhood (captured in MARRS # 1611USA009930 and 1611USA009931 respectively). On an unspecified date in August 2014, the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) dose 1. In two weeks, unspecified date of 2014, the patient experienced one throat infection after another, and her blood sugar was out of control with her A1C level reaching 10. Patient also experienced elevated ketones, vomiting 25 - 30 times per day, pain in her chest and pain around her liver, and such severe joint pain, especially in her feet and ankles, that she stopped all of her normal sports activities, including her competitive swimming. Patient also experienced anxiety and a 20 pound weight gain. Reporter stated that patient saw both a psychiatrist and an endocrinologist in December 2014 to evaluate the symptoms. Patient's thyroid tests and other testing came back with normal results, except for expected blood glucose tests, as patient had been a Type 1 diabetic since age 5 years. The patient seemed to improve and continued with school. In August 2015, patient received her second dose of GARDASIL (dose and route not reported) lot K010215, expiration date unknown. Reporter stated that all of her daughter's symptoms came back, just like before. Patient experienced joint pain, headaches, frequent vomiting, severe menstrual pain, and stomach aches. Reporter stated that patient described rib pain, back pain, anxiety, and a second 20 pound weight gain. Reporter stated that patient experienced frequent insomnia, and had multiple ER visits totaling 5 or 6 ER visits over two years, with one hospital admission for rapid heartbeat. Patient tested ANA antinuclear antibody positive. At the time of this report the patient's present status was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Glycosylated haemoglobin increased, Headache, Heart rate increased, Hepatic pain, Insomnia
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's concurrent condition include juvenile type 1 diabetes mellitus diagnosed at 5 years. The patient's historical drugs include varicella vaccine (manufacturer unknown) and developed chickenpox during childhood (reported in MARRS # 1611USA009929). Reporter stated that patient had no titers for rubella or hepatitis B despite being vaccinated for those during childhood (captured in MARRS # 1611USA009930 and 1611USA009931 respectively). On an unspecified date in August 2014, the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) dose 1. In two weeks, unspecified date of 2014, the patient experienced one throat infection after another, and her blood sugar was out of control with her A1C level reaching 10. Patient also experienced elevated ketones, vomiting 25 - 30 times per day, pain in her chest and pain around her liver, and such severe joint pain, especially in her feet and ankles, that she stopped all of her normal sports activities, including her competitive swimming. Patient also experienced anxiety and a 20 pound weight gain. Reporter stated that patient saw both a psychiatrist and an endocrinologist in December 2014 to evaluate the symptoms. Patient's thyroid tests and other testing came back with normal results, except for expected blood glucose tests, as patient had been a Type 1 diabetic since age 5 years. The patient seemed to improve and continued with school. In August 2015, patient received her second dose of GARDASIL (dose and route not reported) lot K010215, expiration date unknown. Reporter stated that all of her daughter's symptoms came back, just like before. Patient experienced joint pain, headaches, frequent vomiting, severe menstrual pain, and stomach aches. Reporter stated that patient described rib pain, back pain, anxiety, and a second 20 pound weight gain. Reporter stated that patient experienced frequent insomnia, and had multiple ER visits totaling 5 or 6 ER visits over two years, with one hospital admission for rapid heartbeat. Patient tested ANA antinuclear antibody positive. At the time of this report the patient's present status was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Musculoskeletal chest pain, Pharyngitis, Thyroid function test normal, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's concurrent condition include juvenile type 1 diabetes mellitus diagnosed at 5 years. The patient's historical drugs include varicella vaccine (manufacturer unknown) and developed chickenpox during childhood (reported in MARRS # 1611USA009929). Reporter stated that patient had no titers for rubella or hepatitis B despite being vaccinated for those during childhood (captured in MARRS # 1611USA009930 and 1611USA009931 respectively). On an unspecified date in August 2014, the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) dose 1. In two weeks, unspecified date of 2014, the patient experienced one throat infection after another, and her blood sugar was out of control with her A1C level reaching 10. Patient also experienced elevated ketones, vomiting 25 - 30 times per day, pain in her chest and pain around her liver, and such severe joint pain, especially in her feet and ankles, that she stopped all of her normal sports activities, including her competitive swimming. Patient also experienced anxiety and a 20 pound weight gain. Reporter stated that patient saw both a psychiatrist and an endocrinologist in December 2014 to evaluate the symptoms. Patient's thyroid tests and other testing came back with normal results, except for expected blood glucose tests, as patient had been a Type 1 diabetic since age 5 years. The patient seemed to improve and continued with school. In August 2015, patient received her second dose of GARDASIL (dose and route not reported) lot K010215, expiration date unknown. Reporter stated that all of her daughter's symptoms came back, just like before. Patient experienced joint pain, headaches, frequent vomiting, severe menstrual pain, and stomach aches. Reporter stated that patient described rib pain, back pain, anxiety, and a second 20 pound weight gain. Reporter stated that patient experienced frequent insomnia, and had multiple ER visits totaling 5 or 6 ER visits over two years, with one hospital admission for rapid heartbeat. Patient tested ANA antinuclear antibody positive. At the time of this report the patient's present status was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's concurrent condition include juvenile type 1 diabetes mellitus diagnosed at 5 years. The patient's historical drugs include varicella vaccine (manufacturer unknown) and developed chickenpox during childhood (reported in MARRS # 1611USA009929). Reporter stated that patient had no titers for rubella or hepatitis B despite being vaccinated for those during childhood (captured in MARRS # 1611USA009930 and 1611USA009931 respectively). On an unspecified date in August 2014, the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) dose 1. In two weeks, unspecified date of 2014, the patient experienced one throat infection after another, and her blood sugar was out of control with her A1C level reaching 10. Patient also experienced elevated ketones, vomiting 25 - 30 times per day, pain in her chest and pain around her liver, and such severe joint pain, especially in her feet and ankles, that she stopped all of her normal sports activities, including her competitive swimming. Patient also experienced anxiety and a 20 pound weight gain. Reporter stated that patient saw both a psychiatrist and an endocrinologist in December 2014 to evaluate the symptoms. Patient's thyroid tests and other testing came back with normal results, except for expected blood glucose tests, as patient had been a Type 1 diabetic since age 5 years. The patient seemed to improve and continued with school. In August 2015, patient received her second dose of GARDASIL (dose and route not reported) lot K010215, expiration date unknown. Reporter stated that all of her daughter's symptoms came back, just like before. Patient experienced joint pain, headaches, frequent vomiting, severe menstrual pain, and stomach aches. Reporter stated that patient described rib pain, back pain, anxiety, and a second 20 pound weight gain. Reporter stated that patient experienced frequent insomnia, and had multiple ER visits totaling 5 or 6 ER visits over two years, with one hospital admission for rapid heartbeat. Patient tested ANA antinuclear antibody positive. At the time of this report the patient's present status was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Myalgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Initial onset was an extremely sore throat, low grade fever, muscle/body aches. The next few days the sore throat was accompanied by a dry cough. Then chest congestion with inability to sleep due to excessive coughing. Dr prescribed increase fluids, Tylenol and benzonatate 200mg 3xday.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Respiratory tract congestion, Sleep disorder, Streptococcus test negative
Clinical narrative: Initial onset was an extremely sore throat, low grade fever, muscle/body aches. The next few days the sore throat was accompanied by a dry cough. Then chest congestion with inability to sleep due to excessive coughing. Dr prescribed increase fluids, Tylenol and benzonatate 200mg 3xday.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Significant swelling and redness at the site. Mom reports that initially the biceps area where he received vaccine had redness the size of a softball- and following that the entire arm swelling, even down to his wrist/hand.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt came in to the pharmacy to inform us that she believes the vaccine was given to high in the arm. She said she went to her uncle who is a Dr. and he said it was given in the bursa and she may have bursitis. She said she has limited mobility of her arm now and will need therapy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: A small itchy bump appeared under his left breast on day 2. At the same time developed rash over legs and thighs.  Treated with eczema cream and saw a dermatologist.  Since then, rash has covered his torso, legs, thighs. Dermatologist thought it was due to Exforge. Primary Care Provider thinks it is due to the Zostavax.
Age: 65.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Chills, Dizziness, Erythema, Fatigue, Induration
Clinical narrative: Dizziness, fever, tinnitus, chills nauseas, fatigue, redness at injection site. 2 days later - arm red, swollen, warm, itchy and hard.
Age: 65.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Nausea, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Dizziness, fever, tinnitus, chills nauseas, fatigue, redness at injection site. 2 days later - arm red, swollen, warm, itchy and hard.
Age: 65.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Skin warm, Tinnitus
Clinical narrative: Dizziness, fever, tinnitus, chills nauseas, fatigue, redness at injection site. 2 days later - arm red, swollen, warm, itchy and hard.
Sex: M
Vaccine: PNC
Symptoms: Type 1 diabetes mellitus
Clinical narrative: This is a spontaneous report from a contactable consumer on behalf of son, from a Pfizer-sponsored program. A male child patient (son) of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unknown date at a single dose for immunization. Medical history included that he suffered from ear infections to the serious point of possibly needing his ears tubed. The patient's concomitant medications were not reported. On an unknown date, less than two weeks after pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) the patient developed type 1 diabetes. The consumer reported that the patient was currently a 22-year-old and was using an insulin pump so he did not have to use needles every day. The clinical outcome of the event, type 1 diabetes, was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Injection site swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 82-year-old female patient received PREVNAR 13, via an unspecified route of administration on 01Nov2016 at around 12:30 in arm right at single dose for immunization to prevent pneumonia.  No additional vaccines were administered at the same time. Medical history included spinal disorder from 2010 and ongoing treated with ibuprofen, and ongoing osteoarthritis diagnosed in 40s or 50s. Concomitant medication included influenza vaccine administered on 29Oct2016 in the left arm.  The patient had received flu shot every year, maybe since the 1980s. When she first started receiving the flu shot years ago, she felt a little bad at first but then would be fine. No reactions to the flu shot were reported in the last several years. The patient experienced a terrible reaction to it (Prevnar 13) on an unspecified date with outcome of not recovered, severe swelling on 01Nov2016 with outcome of not recovered, worsened severe pain on 10Nov2016 with outcome of recovering, can't move right arm on 12Nov2016 with outcome of recovering. The patient noticed a little bit of swelling right after she received the injection on 01Nov2016 but it got worse over the next couple days. Even the palm of her right hand was swollen and the muscle area on her arm, up around her shoulder joint was swollen. From her elbow up, on her right arm was swollen. Her pain got really bad. She took ibuprofen and this has helped with the pain in her arm.  She had also been using ice and heat alternating to try and help the swelling and pain. The patient underwent lab tests and procedures which included blood test  on 01Nov2016. No follow up attempts possible. No further information expected.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 82-year-old female patient received PREVNAR 13, via an unspecified route of administration on 01Nov2016 at around 12:30 in arm right at single dose for immunization to prevent pneumonia.  No additional vaccines were administered at the same time. Medical history included spinal disorder from 2010 and ongoing treated with ibuprofen, and ongoing osteoarthritis diagnosed in 40s or 50s. Concomitant medication included influenza vaccine administered on 29Oct2016 in the left arm.  The patient had received flu shot every year, maybe since the 1980s. When she first started receiving the flu shot years ago, she felt a little bad at first but then would be fine. No reactions to the flu shot were reported in the last several years. The patient experienced a terrible reaction to it (Prevnar 13) on an unspecified date with outcome of not recovered, severe swelling on 01Nov2016 with outcome of not recovered, worsened severe pain on 10Nov2016 with outcome of recovering, can't move right arm on 12Nov2016 with outcome of recovering. The patient noticed a little bit of swelling right after she received the injection on 01Nov2016 but it got worse over the next couple days. Even the palm of her right hand was swollen and the muscle area on her arm, up around her shoulder joint was swollen. From her elbow up, on her right arm was swollen. Her pain got really bad. She took ibuprofen and this has helped with the pain in her arm.  She had also been using ice and heat alternating to try and help the swelling and pain. The patient underwent lab tests and procedures which included blood test  on 01Nov2016. No follow up attempts possible. No further information expected.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received PREVENAR 13; (Lot Number N16562, Expiration Date: Oct2017), intramuscular from 07Nov2016 at 0.5ml single dose for immunization. Medical history included rheumatoid arthritis. Concomitant medication included ongoing HUMIRA at 40 mg (every 2 weeks) via subcutaneous route for rheumatoid arthritis. The pharmacist mentioned that the patient was given pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and she was experiencing some itchiness around the injection site 2-3 days after injection was administered in (Nov2016). Therapeutic measure included CORTIZONE-10 applied around the injection site. There was no laboratory data provided. The clinical outcome of the event, itchiness around the injection site, was not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. An elderly female patient (over 65 years of age) of an unspecified race and ethnicity received a dose of PREVNAR 13 on an unspecified date at 0.5 ml single in the arm for protection against pneumococcal pneumonia. The patient medical history and concomitant medications were not reported.  The patient had soreness in the arm of the injection for a month after vaccination. The patient recovered on an unspecified date. Sender's Comments: Linked Report(s): US-PFIZER INC-2016537681 Same reporter/suspect product/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. An elderly patient (over 65 years of age) of an unspecified gender received a dose of PREVNAR 13, on an unspecified date at 0.5 ml single in arm for pneumonia pneumococcal.  The patient medical history was not reported.  There were no concomitant medications.  The patient had soreness in the arm of the injection for a month after vaccination. The final outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016537674 Same reporter/drug/event, different patient.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Rash macular, Tongue movement disturbance
Clinical narrative: Patient received 5 immunizations on 11/18/16 at HD administered by staff. Patient's mother called HD on 11/18/16 and stated her son was having issues after being vaccinated. The signs and symptoms of the Pt. were as follows: Temperature of 99.4* F, flicking of his tongue, blotchy rash on his face, chest and right leg. Child ate at 1:00 P.M. and would not eat at 4:00 P.M. No change in the Pt's. skin color. The Pt. did not have difficulties breathing. Mother administered TYLENOL and Ibuprofen to patient. Mother called the ambulance and took patient to the ER.  Mother stated that the ER did not give patient any medications nor was patient admitted into the hospital. Mother stated patient was back to his normal self after 2 days.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Redness and swelling at the injection site and redness and swelling further down the arm the following day.
Age: 60.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Abdominal discomfort, Rubber sensitivity, Skin reaction, Urticaria
Clinical narrative: Stomach felt sick. Developed skin reaction, small welps, went away after 2 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Bone pain
Clinical narrative: Patient came in at 11/21/16 at 11:30 AM with a question whether PREVNAR 13 vaccine she received could have caused "bone pain" in the hips since she saw on a TV ad. She stated the pain seems to be from bones rather than muscle, and though she always has this problem, but it seems to have slight increased pain since the shot.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Drug screen, Full blood count, Headache, Hypoaesthesia
Clinical narrative: Numbness and tingling in bilateral hands and legs/feet. Headache, muscle weakness, vomiting, lightheadedness.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test, Muscular weakness, Paraesthesia, Urine analysis, Vomiting
Clinical narrative: Numbness and tingling in bilateral hands and legs/feet. Headache, muscle weakness, vomiting, lightheadedness.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: Pain in right arm from elbow to shoulder. Weakness and feels almost like arm is asleep (numb) still ongoing.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient was given an extra HPV9. Patient was supposed to receive a Menactra but instead received an HPV9. He had already completed the HPV series. Pt had no s/s of adverse rxn.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm started swelling immediately and has been warm and painful to touch.  Neck ache.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: I started feeling a great deal of pain in my upper right shoulder where I receive the flu shot prior. My right shoulder was aching & it was lumpy and swollen with fluid. Saw my doctor on Nov. 14, 2016 & on Nov. 21, 2016 for the pain.
Age: 1.25
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Small red bump.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, X-ray limb
Clinical narrative: Severe pain in shoulder and weakness in arm. Got worse as the day went on and by 8:00 PM could not move my arm or hand at all.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: The patient developed a rash. Patient went to the doctor's office and was issued a prescription for MEDROL.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Reported large red area, hot to touch 4"x3" in size, with pain, but able to move.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Muscle spasms
Clinical narrative: MUSCLE CRAMPS.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: Felt tired over the next day. Sunday onset of pain  and swelling in the Lymph node of the L arm, injection was in the L arm.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: SWELLING, REDNESS, SORENESS, AND EXTREME ITCHING.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin reaction
Clinical narrative: Red, swollen and itching to site of varicella injection, delayed reaction.