chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram PR shortened, Electrocardiogram abnormal, Pain, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 30 January 2014. A female subject (date of birth not reported) had received the following vaccines on 23 January 2014: ACAM2000 (lot number, route and site of administration not reported), ANTHRAX (manufacturer, lot number, route and site of administration not reported) and TYPHOID (manufacturer, lot number, route and site of administration not reported) and five days later, experienced a 20 minute episode of chest pain during exercise which resolved spontaneously without any treatment. Rapid Troponin was negative and on 30 January 2014 a preliminary ECG was slightly abnormal with minimally shortened PR interval. The subject was referred appropriately. No further information was available at the time of the report. The subject's outcome was recovered on 28 January 2014. According to the investigator, the event of chest pain was considered mild, an "other important event" and possibly related to vaccination. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Antineutrophil cytoplasmic antibody negative, Aspergillus test negative, Atelectasis, Blood immunoglobulin E increased, Chest X-ray abnormal
Clinical narrative: Initial report was received from scientific literature on 25 January 2014. The following is verbatim from the article: A 74 year old non-smoker male with history of asthma and allergic rhinitis presented with a 3-week history of malaise, low grade fever, nonproductive cough and shortness of breath. He denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco, or starting new medications. he had received his yearly influenza vaccine a week before the onset of his symptoms. On exam, the patient was in no distress. Pulse oximetry measured 95% on room air. Auscultation revealed fine crepitation in lung bases bilaterally. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. Chest radiography showed slight atelectasis and effusion at the right lung base, and high-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. Further testing showed increased IgE (918 IU/mL) but testing for Aspergillus-specific IgE was negative, as were p-ANCA, and c-ANCA. Sputum culture was negative. The patient was started on treatment with oral prednisone, with remarkable improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done 2 weeks after the initiation of steroids, was normal. A 74-year-old male patient (date of birth not reported) had received Influenza vaccine, (batch number unknown, route and anatomical site of administration not reported) on an unspecified date. The patient presented with symptoms of malaise, low grade fever, nonproductive cough and shortness of breath. One week after the vaccination, the patient was diagnosed with eosinophilic pneumonia. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. High-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. The patient had increased IgE (918 IU/mL) but negative Aspergillus-specific IgE. The patient was treated with Oral Prednisone. The patient was recovered from the event along with associated symptoms. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Computerised tomogram thorax abnormal, Cough, Culture negative, Dyspnoea, Eosinophil percentage increased
Clinical narrative: Initial report was received from scientific literature on 25 January 2014. The following is verbatim from the article: A 74 year old non-smoker male with history of asthma and allergic rhinitis presented with a 3-week history of malaise, low grade fever, nonproductive cough and shortness of breath. He denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco, or starting new medications. he had received his yearly influenza vaccine a week before the onset of his symptoms. On exam, the patient was in no distress. Pulse oximetry measured 95% on room air. Auscultation revealed fine crepitation in lung bases bilaterally. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. Chest radiography showed slight atelectasis and effusion at the right lung base, and high-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. Further testing showed increased IgE (918 IU/mL) but testing for Aspergillus-specific IgE was negative, as were p-ANCA, and c-ANCA. Sputum culture was negative. The patient was started on treatment with oral prednisone, with remarkable improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done 2 weeks after the initiation of steroids, was normal. A 74-year-old male patient (date of birth not reported) had received Influenza vaccine, (batch number unknown, route and anatomical site of administration not reported) on an unspecified date. The patient presented with symptoms of malaise, low grade fever, nonproductive cough and shortness of breath. One week after the vaccination, the patient was diagnosed with eosinophilic pneumonia. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. High-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. The patient had increased IgE (918 IU/mL) but negative Aspergillus-specific IgE. The patient was treated with Oral Prednisone. The patient was recovered from the event along with associated symptoms. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Eosinophilic pneumonia, Leukocytosis, Lung disorder, Malaise, Pleural effusion
Clinical narrative: Initial report was received from scientific literature on 25 January 2014. The following is verbatim from the article: A 74 year old non-smoker male with history of asthma and allergic rhinitis presented with a 3-week history of malaise, low grade fever, nonproductive cough and shortness of breath. He denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco, or starting new medications. he had received his yearly influenza vaccine a week before the onset of his symptoms. On exam, the patient was in no distress. Pulse oximetry measured 95% on room air. Auscultation revealed fine crepitation in lung bases bilaterally. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. Chest radiography showed slight atelectasis and effusion at the right lung base, and high-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. Further testing showed increased IgE (918 IU/mL) but testing for Aspergillus-specific IgE was negative, as were p-ANCA, and c-ANCA. Sputum culture was negative. The patient was started on treatment with oral prednisone, with remarkable improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done 2 weeks after the initiation of steroids, was normal. A 74-year-old male patient (date of birth not reported) had received Influenza vaccine, (batch number unknown, route and anatomical site of administration not reported) on an unspecified date. The patient presented with symptoms of malaise, low grade fever, nonproductive cough and shortness of breath. One week after the vaccination, the patient was diagnosed with eosinophilic pneumonia. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. High-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. The patient had increased IgE (918 IU/mL) but negative Aspergillus-specific IgE. The patient was treated with Oral Prednisone. The patient was recovered from the event along with associated symptoms. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Pulmonary function test normal, Pyrexia, Rales, Spirometry normal, Sputum culture
Clinical narrative: Initial report was received from scientific literature on 25 January 2014. The following is verbatim from the article: A 74 year old non-smoker male with history of asthma and allergic rhinitis presented with a 3-week history of malaise, low grade fever, nonproductive cough and shortness of breath. He denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco, or starting new medications. he had received his yearly influenza vaccine a week before the onset of his symptoms. On exam, the patient was in no distress. Pulse oximetry measured 95% on room air. Auscultation revealed fine crepitation in lung bases bilaterally. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. Chest radiography showed slight atelectasis and effusion at the right lung base, and high-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. Further testing showed increased IgE (918 IU/mL) but testing for Aspergillus-specific IgE was negative, as were p-ANCA, and c-ANCA. Sputum culture was negative. The patient was started on treatment with oral prednisone, with remarkable improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done 2 weeks after the initiation of steroids, was normal. A 74-year-old male patient (date of birth not reported) had received Influenza vaccine, (batch number unknown, route and anatomical site of administration not reported) on an unspecified date. The patient presented with symptoms of malaise, low grade fever, nonproductive cough and shortness of breath. One week after the vaccination, the patient was diagnosed with eosinophilic pneumonia. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. High-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. The patient had increased IgE (918 IU/mL) but negative Aspergillus-specific IgE. The patient was treated with Oral Prednisone. The patient was recovered from the event along with associated symptoms. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: Initial report was received from scientific literature on 25 January 2014. The following is verbatim from the article: A 74 year old non-smoker male with history of asthma and allergic rhinitis presented with a 3-week history of malaise, low grade fever, nonproductive cough and shortness of breath. He denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco, or starting new medications. he had received his yearly influenza vaccine a week before the onset of his symptoms. On exam, the patient was in no distress. Pulse oximetry measured 95% on room air. Auscultation revealed fine crepitation in lung bases bilaterally. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. Chest radiography showed slight atelectasis and effusion at the right lung base, and high-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. Further testing showed increased IgE (918 IU/mL) but testing for Aspergillus-specific IgE was negative, as were p-ANCA, and c-ANCA. Sputum culture was negative. The patient was started on treatment with oral prednisone, with remarkable improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done 2 weeks after the initiation of steroids, was normal. A 74-year-old male patient (date of birth not reported) had received Influenza vaccine, (batch number unknown, route and anatomical site of administration not reported) on an unspecified date. The patient presented with symptoms of malaise, low grade fever, nonproductive cough and shortness of breath. One week after the vaccination, the patient was diagnosed with eosinophilic pneumonia. Laboratory exam was remarkable for leukocytosis (30.6 k/uL) with 71% eosinophil. High-resolution chest computed tomography demonstrated bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilia pneumonia. The patient had increased IgE (918 IU/mL) but negative Aspergillus-specific IgE. The patient was treated with Oral Prednisone. The patient was recovered from the event along with associated symptoms. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Drug ineffective, Influenza, Influenza virus test positive, Polymerase chain reaction
Clinical narrative: Initial report was received from the scientific literature on 30 January 2014. The following is verbatim from the abstract: Background. Each year, the Influenza Vaccine Effectiveness Network examines the effectiveness of influenza vaccines in preventing medically attended acute respiratory illnesses cause by influenza. Methods. Patients with acute respiratory illnesses of 7 days duration were enrolled at ambulatory care facilities in 5 communities. Specimens were collected and tested for influenza by real-time reverse-transcriptase polymerase chain reaction. Receipt of influenza vaccine was defined based on documented evidence of vaccination in medical records or immunization registries. Vaccine effectiveness was estimated in adjusted logistic regression models by comparing the vaccination coverage in those who tested positive for influenza with those who tested negative. Results. The 2011-2012 season was mild and peaked late, with circulation of both type A viruses and both lineages of type B. Overall adjusted vaccine effectiveness was 47% (95% confidence interval [CI], 36-56) in preventing medically attended influenza; vaccine effectiveness was 65% (95% CI, 44-79) against type A (H1N1) pdm09 but only 39% (95% CI, 23-52) against type A (H3N2). Estimates of vaccine effectiveness against both type B lineages were similar (overall, 58%; 95% CI, 35-73). An apparent negative effect of prior year vaccination on current year effectiveness estimates was noted, particularly for A (H3N2) outcomes. Conclusions. Vaccine effectiveness in the 2011-2012 season was modest overall, with lower effectiveness against the predominant A (H3N2) virus. This may be related to antigenic drift, but past history of vaccination might also play a role. The following is verbatim from the full article: A cluster of 213 patient of all ages (initials, gender and date of birth was not reported) had received a dose of Influenza vaccine (manufacturer unknown, batch number, dose in series, route and site of administration was not reported) on an unspecified date. The patients had medically attended acute respiratory illnesses that were confirmed by RTPCR as influenza; Total 681 influenza positive cases was identified out of this total 213 patients were vaccinated with influenza vaccine. 178 patients were Influenza A positive (155 Influenza A H3N1 and 23 patient influenza A H1N1) and 35 patients with Influenza B positive. The event was lack of efficacy. The RT-PCR (Reverse transcription polymerase chain reaction) was done. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Ear infection, Influenza virus test positive
Clinical narrative: This case was considered as serious, i.e. an important medical event. Unsolicited case received on 25-JAN-2014 from a consumer through internet. A female patient (age and age group unknown) with an unknown medical history and no reported concomitant medication had received a flu shot (manufacturer, batch number, route and administration site were not reported) on an unspecified date. On 22-JAN-2014, the patient had a positive flu culture and an ear infection. No information was reported on any corrective treatment given. At the time of the report, the patient recovered (recovery date not reported).
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Arthropathy, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in upper arm, over a three month time period. The pain is now also in the shoulder and is affecting mobility. I also hear popping when I move my shoulder.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling
Clinical narrative: Mother reports child's right arm became red and swollen approx 3" diameter area on the day after injection - 2/8/14. Today (R) arm is nontender and no redness or swelling noted.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Miliaria, Pruritus, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Client began w/red, prickly "heat" rash on her neck 2/9/14 9:00 AM. No whelps, blisters, etc. Rash described as confluent. Covered her body from her ears to her toes. Intense itching. Mild fever PM of 2/9/14. Parent began BENADRYL x 2 every 4 hours until 9:00 AM on 2/10/14. Itching has started to resolve. Rash is not as dark as it was 24 hours ago. Also tried CALADRYL LOTION and oatmeal baths to help w/itching. No hives. No SOB.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Patient became dizzy and nauseated an hour and a half after administration. Pt states she was sick the previous week but felt well at time of administration. Pt rested after being evaluated. Pt did not have a high pulse or blood pressure at time of event. Pt advised to rest and drink plenty of fluids if not feeling nauseated.
Age: 1.34
Sex: F
Vaccine: FLU3, HIBV, MMR
Symptoms: Irritability, Pallor, Rash
Clinical narrative: Blanching rash, w/ fussiness 1 week after vaccines.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 16 year old patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL in the buttocks. Dose, route and lot number were not reported. No adverse effects were reported. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Screaming
Clinical narrative: Information has been received from a registered nurse concerning a male patient of unknown age with no drug allergies, new born torticollis, Ventricular septal defect (VSD) and plagiocephalies who on 19-NOV-2013, was vaccinated with a first dose of ROTATEQ, 2 ml, oral (lot # not provided) and on 27-JAN-2014 was vaccinated with a second dose of ROTATEQ, 2 ml, oral (Lot # J010139, exp date 19-MAR-2015). Concomitant therapies included vitamin D (unspecified). The registered nurse stated that patient developed an unspecified rash on his face immediately after receiving his second dose of ROTATEQ on 27-JAN-2014. The nurse also stated that patient was "screaming" while his second dose of ROTATEQ was being administered. The nurse described that patient was given BENADRYL in the physician office on 27-JAN-2014 for the unspecified rash on his face after and sent home; the outcome of unspecified rash on his face was unknown. The patient was seen by an allergist "recently" on an unspecified date. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Dyspnoea, Nausea
Clinical narrative: Client started to complain of stomach pain, shakes, nausea, diarrhea, difficulty breathing few hours after the vaccine administration. She went to the Local Hospital Emergency room on the same night. Client felt weakness for 2 days after the vaccine administration.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Client started to complain of stomach pain, shakes, nausea, diarrhea, difficulty breathing few hours after the vaccine administration. She went to the Local Hospital Emergency room on the same night. Client felt weakness for 2 days after the vaccine administration.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Axillary mass, Chills, Cyst, Fatigue, Headache
Clinical narrative: Headache; chills; fatigue; extreme tenderness at site of injection; slight cough. Sunday 4:00 PM new symptoms: tender lump (maybe a cyst) in left under arm; cyst on chin; itching hands and feet.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Pruritus, Tenderness
Clinical narrative: Headache; chills; fatigue; extreme tenderness at site of injection; slight cough. Sunday 4:00 PM new symptoms: tender lump (maybe a cyst) in left under arm; cyst on chin; itching hands and feet.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Apathy, Fatigue, Fibromyalgia, Impaired work ability, Insomnia
Clinical narrative: Widespread pain, stiffness, sleeplessness due to pain, unrelieved by nsaids, asa, apap, Benadryl.  Severe fatigue and discouragement as these reactions were so severe it was difficult to work as my usual level and I had to turn down work. These symptoms continued without reprieve and on 12-4-13 I visited a rheumatologist where I received a new diagnosis of fibromyalgia. It has been 4 months and I am only now STARTING to feel better, however, I have not recovered to the same level I was when this all started.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Widespread pain, stiffness, sleeplessness due to pain, unrelieved by nsaids, asa, apap, Benadryl.  Severe fatigue and discouragement as these reactions were so severe it was difficult to work as my usual level and I had to turn down work. These symptoms continued without reprieve and on 12-4-13 I visited a rheumatologist where I received a new diagnosis of fibromyalgia. It has been 4 months and I am only now STARTING to feel better, however, I have not recovered to the same level I was when this all started.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Abdominal discomfort, Activities of daily living impaired, Fatigue, Pyrexia, Sluggishness
Clinical narrative: Sluggish while playing basketball - very tired. Slept Sunday evening/night Monday, 2-3-14, began running low grade fever 99-100 degrees/mom.  States he has normal appetite when awake, but sleeping so soundly he slept through meal times.  Left school Tues early-came home to nap - couldn't wake him up. "had an upset stomach Wednesday - no N/V. When she got home from work"  remained sluggish this weekend as well. Doesn't think it's serious enough to see the Dr., but very abnormal for him.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Somnolence
Clinical narrative: Sluggish while playing basketball - very tired. Slept Sunday evening/night Monday, 2-3-14, began running low grade fever 99-100 degrees/mom.  States he has normal appetite when awake, but sleeping so soundly he slept through meal times.  Left school Tues early-came home to nap - couldn't wake him up. "had an upset stomach Wednesday - no N/V. When she got home from work"  remained sluggish this weekend as well. Doesn't think it's serious enough to see the Dr., but very abnormal for him.
Age: 0.34
Sex: F
Vaccine: DTAPH
Symptoms: Emotional distress, Screaming
Clinical narrative: Nonstop, high pitch screaming for 5 plus hours... unconsolable... screamed for 3 plus hours after 2 month vaccines.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Redness, severe itching, small bumps along the back and chest of the body.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm that vaccine was injected in, with little relief from Ibuprofen and aspirin. Worse at night when laying down, no relief from ice pack.  Some relief from prescription muscle relaxant I had available on hand.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Big red swelling spot where injection was given.  Continued to swell until about 5 inches in diameter.  Very painful.
Age: 52.0
Sex: M
Vaccine: FLUC3
Symptoms: Headache, Swelling face, Urticaria
Clinical narrative: Per patient: major hives, facial swelling, headache.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Cellulitis, Erythema, Induration, Skin mass, Skin plaque
Clinical narrative: Knot underneath the skin that changed to an erythematous, indurated plaque on the skin, painful to touch.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Tenderness
Clinical narrative: Knot underneath the skin that changed to an erythematous, indurated plaque on the skin, painful to touch.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 2 hives to the left knee responded to 50mg diphenhydramine, observed with no further adverse reaction.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Nuclear magnetic resonance imaging brain normal, Paraesthesia, VIIth nerve paralysis, Vertigo
Clinical narrative: Patient with an episode of Bells palsy presenting with vertigo, unilateral neck pain and facial paresthesia and drooping s/p an upper respiratory infection one week prior.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Soreness on upper right arm, most painful on/near injection site. Feels like extremely stiff muscle with slight stiffness down and around injection site muscle.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse drug reaction, Arthralgia, Back pain, Injection site pain, Insomnia
Clinical narrative: 2-4 HOURS AFTER THE SHOT, PT DEVELOPED FEVER TO 102, NECK PAIN STARTED TO HURT SEVERELY, MIGRAINE CAME BACK, ARM STARTED TO HURT SEVERELY; SYMPTOMS LASTED FOR 2 DAYS.  PATIENT'S PRIMARY DOCTOR CALLED IN TAMIFLU WHICH SHE STARTED ON 1/25/14, AND PT TOOK 3 DOSES BUT STOPPED B/C BROKE OUT IN A RASH (RED DOTS) ON ARMS, LEGS, TORSO, AND ANKLES, SLIGHTLY ITCHY WHICH LASTED ABOUT 5 DAYS AND SLOWLY STARTED TO GO AWAY.  ARM CONTINUED TO BE SORE, BUT 3 DAYS LATER THE PAIN ALL OF A SUDDEN GOT EXCRUCIATINGLY WORSE; MUSCLE STARTED CRAMPING AND RADIATING TOWARD ELBOW.  THIS PAIN CAME ON OVER A PERIOD OF 2-3 HOURS.  PT COULD NOT SLEEP SECONDARY TO THE PAIN.  NECK PAIN WAS WORSE.  BY THE NEXT MORNING, ALL THE JOINTS WERE PAINFUL: ELBOWS, WRISTS, SHOULDER WHERE SHE GOT SHOT, NECK, KNEES, ANKLES (NOT HIPS).  UPPER BACK PAINFUL.  WAS SLIGHTLY BETTER THEN NEXT DAY, BUT IN THE MIDDLE OF THE NIGHT, THE PAIN WAS MUCH WORSE.  WENT TO FACILITY ON 1/29/14 AND 2/1/14.  WAS PRESCRIBED PREDNISONE (WHICH THE PATIENT DID NOT TAKE) AND PAIN MEDICATION.  WENT TO E.R. ON 2/2/14 AND GOT A SHOT OF STEROIDS AND WAS PLACED ON ORAL STEROIDS; XRAY WAS DONE.  WAS BETTER WITH STEROIDS AND SHOT, BUT WHEN OFF STEROIDS THE PAIN CAME BACK; YESTERDAY PAIN GOT WORSE WITH ACTIVITY.  TODAY HER DOCTOR CALLED IN MORE STEROIDS BUT DID NOT SEE HER.  HAS APPT TOMORROW.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Muscle spasms, Neck pain, Pain in extremity, Pruritus
Clinical narrative: 2-4 HOURS AFTER THE SHOT, PT DEVELOPED FEVER TO 102, NECK PAIN STARTED TO HURT SEVERELY, MIGRAINE CAME BACK, ARM STARTED TO HURT SEVERELY; SYMPTOMS LASTED FOR 2 DAYS.  PATIENT'S PRIMARY DOCTOR CALLED IN TAMIFLU WHICH SHE STARTED ON 1/25/14, AND PT TOOK 3 DOSES BUT STOPPED B/C BROKE OUT IN A RASH (RED DOTS) ON ARMS, LEGS, TORSO, AND ANKLES, SLIGHTLY ITCHY WHICH LASTED ABOUT 5 DAYS AND SLOWLY STARTED TO GO AWAY.  ARM CONTINUED TO BE SORE, BUT 3 DAYS LATER THE PAIN ALL OF A SUDDEN GOT EXCRUCIATINGLY WORSE; MUSCLE STARTED CRAMPING AND RADIATING TOWARD ELBOW.  THIS PAIN CAME ON OVER A PERIOD OF 2-3 HOURS.  PT COULD NOT SLEEP SECONDARY TO THE PAIN.  NECK PAIN WAS WORSE.  BY THE NEXT MORNING, ALL THE JOINTS WERE PAINFUL: ELBOWS, WRISTS, SHOULDER WHERE SHE GOT SHOT, NECK, KNEES, ANKLES (NOT HIPS).  UPPER BACK PAINFUL.  WAS SLIGHTLY BETTER THEN NEXT DAY, BUT IN THE MIDDLE OF THE NIGHT, THE PAIN WAS MUCH WORSE.  WENT TO FACILITY ON 1/29/14 AND 2/1/14.  WAS PRESCRIBED PREDNISONE (WHICH THE PATIENT DID NOT TAKE) AND PAIN MEDICATION.  WENT TO E.R. ON 2/2/14 AND GOT A SHOT OF STEROIDS AND WAS PLACED ON ORAL STEROIDS; XRAY WAS DONE.  WAS BETTER WITH STEROIDS AND SHOT, BUT WHEN OFF STEROIDS THE PAIN CAME BACK; YESTERDAY PAIN GOT WORSE WITH ACTIVITY.  TODAY HER DOCTOR CALLED IN MORE STEROIDS BUT DID NOT SEE HER.  HAS APPT TOMORROW.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash erythematous, Rash generalised, X-ray normal
Clinical narrative: 2-4 HOURS AFTER THE SHOT, PT DEVELOPED FEVER TO 102, NECK PAIN STARTED TO HURT SEVERELY, MIGRAINE CAME BACK, ARM STARTED TO HURT SEVERELY; SYMPTOMS LASTED FOR 2 DAYS.  PATIENT'S PRIMARY DOCTOR CALLED IN TAMIFLU WHICH SHE STARTED ON 1/25/14, AND PT TOOK 3 DOSES BUT STOPPED B/C BROKE OUT IN A RASH (RED DOTS) ON ARMS, LEGS, TORSO, AND ANKLES, SLIGHTLY ITCHY WHICH LASTED ABOUT 5 DAYS AND SLOWLY STARTED TO GO AWAY.  ARM CONTINUED TO BE SORE, BUT 3 DAYS LATER THE PAIN ALL OF A SUDDEN GOT EXCRUCIATINGLY WORSE; MUSCLE STARTED CRAMPING AND RADIATING TOWARD ELBOW.  THIS PAIN CAME ON OVER A PERIOD OF 2-3 HOURS.  PT COULD NOT SLEEP SECONDARY TO THE PAIN.  NECK PAIN WAS WORSE.  BY THE NEXT MORNING, ALL THE JOINTS WERE PAINFUL: ELBOWS, WRISTS, SHOULDER WHERE SHE GOT SHOT, NECK, KNEES, ANKLES (NOT HIPS).  UPPER BACK PAINFUL.  WAS SLIGHTLY BETTER THEN NEXT DAY, BUT IN THE MIDDLE OF THE NIGHT, THE PAIN WAS MUCH WORSE.  WENT TO FACILITY ON 1/29/14 AND 2/1/14.  WAS PRESCRIBED PREDNISONE (WHICH THE PATIENT DID NOT TAKE) AND PAIN MEDICATION.  WENT TO E.R. ON 2/2/14 AND GOT A SHOT OF STEROIDS AND WAS PLACED ON ORAL STEROIDS; XRAY WAS DONE.  WAS BETTER WITH STEROIDS AND SHOT, BUT WHEN OFF STEROIDS THE PAIN CAME BACK; YESTERDAY PAIN GOT WORSE WITH ACTIVITY.  TODAY HER DOCTOR CALLED IN MORE STEROIDS BUT DID NOT SEE HER.  HAS APPT TOMORROW.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Vaccination complication
Clinical narrative: Rash x 3 days. Rash evaluated in office, consistent with a reactive rash to the MMR.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported developing 4-5 dime- sized welts on left arm and 2-3 dime-sized welts on upper right arm starting two days after vaccine administration. Welts were accompanied by itching. Patient reports that signs/symptoms started to subside on 2/8/14.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, FLUX, PPV
Symptoms: Crying, Dyskinesia, Muscle twitching, Poor quality sleep
Clinical narrative: Was given the Pentacel, Pneumococcal conjugate and seasonal flu vaccines at around 10:15am.  That evening, he had persistent crying, twitching, involuntary body movements, restless sleep, and awakenings every 30-40 minutes throughout the night. The following two days, inconsolable crying continued persistently with now know cause; unusual for a baby who is easily consolable.
Age: 43.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Cognitive disorder, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Hemiparesis
Clinical narrative: Seizures, left sided weakness, cognitive loss.
Age: 43.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Scan with contrast normal, Toxicologic test normal
Clinical narrative: Seizures, left sided weakness, cognitive loss.
Age: 1.13
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Rash erythematous, Skin warm, Urticaria
Clinical narrative: First noticed severe warm red rash with hives all over body @ 6:30 am on 2/8/2014 lasted until 11:30 AM 2/9/2014. Went to the ER and Benadryl was prescribed.
Age: 0.87
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Aphagia, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Nausea, fever, chills, aches, HA less than 24 hr after pneumococcal pneumonia vaccine unable to eat, dry heaves, no diarrhea. Swelling, redness Lt upper arm.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia, Retching
Clinical narrative: Nausea, fever, chills, aches, HA less than 24 hr after pneumococcal pneumonia vaccine unable to eat, dry heaves, no diarrhea. Swelling, redness Lt upper arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: On 2-6-14 shingles vaccine given. On 2-7-14 pt. at clinic left 9 PM. Showed redness, soreness, swelling and itching to area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Arm was hot to touch and swollen from shoulder to elbow. Patient received BENADRYL at local emergency room.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient was given Pneumovac here 10 October 2013 and called on 11 October 2013 with redness, hot to touch at injection site. Patient went to ER and was treated for cellulitis with 2 doses IV abx and PO abx for 1 week at home.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Vaccine approved for 18 years old. At the time of report, no adverse reaction yet, within 2 hrs of injection.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 62 year old female patient. The patient's medical history included left mastectomy. On 06-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot number J007211, expiration date; 20-SEP-2014) 0.65 ml, subcutaneous in the right arm for routine vaccination, she also received PNEUMOVAX 23 (Lot number J009827, expiration date: 10-AUG-2014) intramuscularly in the right arm in the same vaccination session in error. The patient was suppose to receive a dose of ADACEL (manufacturer unknown) along with the ZOSTAVAX but she was given PNEUMOVAX 23 in error. At the time of this report, the patient had no demonstrated or reported any adverse effects. Follow up information has been received from a nurse practitioner reported that the 62 year old female patient was vaccinated intramuscularly (IM)/deltoid with the second dose of ADACEL (manufacturer sanofi pasteur) (lot # C4496AA, exp. date not reported) on 09-DEC-2013 at 16:48. Additional information is not expected.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient received a dose of ZOSTAVAX (lot# and expiry date unknown), 0.65 ml, once, subcutaneously along with an influenza virus vaccine (manufacturer unknown) (lot # unknown) on the same unspecified day "about a month ago" (approximately in January 2014). The pharmacist reported that the patient developed a "rash" at the injection site on unspecified date in 2014. The patient contact her (unspecified) physician who stated the rash was shingles and prescribed unspecified antiviral medication for the patient. Action taken was not applicable. At the time of reporting, the outcome of event was unknown. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abasia, Bacterial infection, Chills, Decreased appetite, Fall
Clinical narrative: None stated.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Headache, Muscular weakness, Pyrexia, Viral infection
Clinical narrative: None stated.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Pt presented with 24hr of chest pain and SOB, found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at hospital after finding positive cardiac markers. Treated with Motrin and Colchicine with improvement after 4 days.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram ST segment elevation, Myocarditis, Pericarditis
Clinical narrative: Pt presented with 24hr of chest pain and SOB, found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at hospital after finding positive cardiac markers. Treated with Motrin and Colchicine with improvement after 4 days.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Pt presented with 24hr of chest pain and SOB, found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at hospital after finding positive cardiac markers. Treated with Motrin and Colchicine with improvement after 4 days.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Pt presented with 24hr of chest pain and SOB, found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at hospital after finding positive cardiac markers. Treated with Motrin and Colchicine with improvement after 4 days.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Patient complained of a throbbing headache. His body temperature was stable around 96 degrees Fahrenheit. Four hours after administration, his temperature rose to 99.8 degrees Fahrenheit. He also complained of increased sweating. Motrin 800 mg oral was provided to the patient per request. Temperature returned to normal around 12:30 AM of 11/13/13. The patient no longer had a headache. He was still slightly diaphoretic.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pulmonary embolism
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date, a couple of years ago the patient was vaccinated with GARDASIL (lot#, expiration date, dose, route, indication not reported). On an unknown date the patient experienced pulmonary embolism, and the patient had to be hospitalized at a hospital. The outcome of the event was unknown. Upon internal review, pulmonary embolism is considered as medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to her granddaughter, a 15 year old female patient. On 12-DEC-2013 the patient was vaccinated with her first dose of GARDASIL (dose, route and lot# not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (dose, route and lot# not reported) on 12-DEC-2013. It was reported that the patient received "4 shots" concomitantly at her psychiatrist's office while the only injections supposed to be given were GARDASIL, dose 1, and an unspecified influenza shot. The patient told the reporter she "thought" 3 of the shots were GARDASIL. The reporter was positive that 2 of the 4 shots given were: 1 injection of GARDASIL and 1 unspecified influenza virus vaccine (manufacturer unknown) shot. However, the other 2 vaccines were unidentified. Therefore, 2 extra doses of GARDASIL might have been given. No side effects reported. However, the reporter stated that while she had not been able to obtain the medical records, she spoke to an unspecified nurse at the location; this nurse said that it was "possible" that the 2 unspecified shots the patient received were an unspecified "hepatitis shot" and an unspecified meningitis shot. This GARDASIL lot, while unspecified, could possibly of the recalled GARDASIL lot. In addition, the reporter stated that the patient had a tendency to faint when getting shots. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Local swelling
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. In January 2013, the patient was vaccinated with a single dose of ZOSTAVAX (lot #, dose and route not provided) injection. In January 2014, the patient developed a circular red ring around the injection site and a "red bump" below the site. The patient did not seek medical attention. There was not given any treatment for the events. The outcome of circular red ring around the injection site and a "red bump" below the site was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown demographics. It was reported that improperly stored GARDASIL may have been administered (dates unknown) for vaccination. No adverse events reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, concerning an unspecified number of patients (patient's demographics not provided). Registered nurse first, requested temperature stability data for several vaccines. Then, stated that she believed that an unspecified number of patients may have received improperly stored M-M-R II (lot #, expiration date, route and dose were not reported). No symptoms reported. This is one of two reports from the same source (MARRS: 1401USA014578). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal tenderness, Back pain, Blister, Herpes zoster, Musculoskeletal chest pain
Clinical narrative: This spontaneous report as received from a 73 year old female patient with no pertinent medical history or drug allergies refers to herself. On an unknown date ("a few years ago") the patient was vaccinated with ZOSTAVAX (lot# unspecified). Concomitant therapies included famciclovir. The patient was now suffering with shingles. She felt a soreness on her lower back, the tenderness spread down her leg across her rib going to her abdominal area, 4 days later she got a rash, now she had full blown shingles and did has blister on her right side of the buttocks to her lower back. The event onset date was reported as 30-JAN-2014. Unspecified treatment was given. No lab tests were performed. The patient had sought unspecified medical attention. The outcome of the events was unknown. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: This spontaneous report as received from a 73 year old female patient with no pertinent medical history or drug allergies refers to herself. On an unknown date ("a few years ago") the patient was vaccinated with ZOSTAVAX (lot# unspecified). Concomitant therapies included famciclovir. The patient was now suffering with shingles. She felt a soreness on her lower back, the tenderness spread down her leg across her rib going to her abdominal area, 4 days later she got a rash, now she had full blown shingles and did has blister on her right side of the buttocks to her lower back. The event onset date was reported as 30-JAN-2014. Unspecified treatment was given. No lab tests were performed. The patient had sought unspecified medical attention. The outcome of the events was unknown. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Migraine, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with diabetes. On 12-DEC-2012, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number and expiry date not provided). The patient stated to the pharmacist that he experienced a severe headache described as a migraine and a rash mostly on one side of his upper body on an unspecified date shortly after being administered ZOSTAVAX. The patient sought medical attention at an unspecified physician's office on an unspecified date in January 2014 and was diagnosed with shingles. Treatment reported by pharmacist were prescriptions for VICODIN and Valacyclovir filled on 03-JAN-2014. The outcome of shingles, rash mostly on one side of his upper body and severe headache described as a migraine were reported as recovered/resolved on an unspecified date. The reporter did not assess the relationship between the events and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients from 5 patients of unknown age and gender. On an unknown date in 2013, the patient was vaccinated with ZOSTAVAX with lot # J006830 and expiry date 14-SEP-2014 (dose number, dose unit unknown) subcutaneously. On an unknown date in 2013 over the last six months, unspecified number of patients from 5 patients developed injection site reactions after receipt of the ZOSTAVAX. The injection site reactions were described as being swollen, itchy, painful and warm. On an unknown date, injection site reaction described as swollen, itchy, painful and warm was recovered. Pharmacist stated that lot numbers she has used in the last six months was J006830 (expiry date 14-SEP-2014) and J008528 (expiry date 19-OCT-2014). The outcome of injection site warm, injection site reaction, injection site swollen, injection site itchy and injection site painful was reported as recovered/resolved. This case # 1402USA002955 is linked to case # 1402USA004725 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients from 5 patients of unknown age and gender. On an unknown date in 2013 over the last six months, the patient was vaccinated with ZOSTAVAX vial with lot # J008528 and expiry date 19-OCT-2014 (dose number, dose unit unknown) subcutaneously for vaccination. On an unknown date of 2013 over the last six months, unspecified number of patients from 5 patients developed injection site reactions after receipt of the ZOSTAVAX. The injection site reactions were described as being swollen, itchy, painful and warm. On an unknown date, injection site reaction described as swollen, itchy, painful and warm was recovered. Pharmacist stated that lot numbers she has used in the last six months was J006830 (expiry date 14-SEP-2014) and J008528 (expiry date 19-OCT-2014). The outcome of injection site warm, injection site reaction, injection site swollen, injection site itchy and injection site painful was reported as recovered/resolved. This case # 1402USA004725 is linked to case # 1402USA002955 via same reporter link. Additional information has been requested.