chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Cerebral infarction, Laboratory test normal
Clinical narrative: Left frontal lobe infarct.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Fatigue, Loss of consciousness, Paraesthesia
Clinical narrative: Receive preservative free Flu shot, felt dizzy, on and off for 10 minutes. Walked off and was talking with someone for 20 or 25 minutes. Felt very tired. 15 minutes later, my mouth got really dry and my throat felt "weird". I disregarded it. 15 minutes later I felt dizzy again, very strong this time. Went to see the nurse, I was sitting on a chair and I said to her, I don't feel well and I passed out. Not completely, I felt exhausted and I could hear them talking but I was too exhausted to respond or move. Then I got up, and then passed out again. The ambulance came and I felt 2 more episodes in the ambulance. At the ER, one episode of syncope, then I felt diggling feeling in my torso, then it traveled to my legs. I felt, exhausted and winded for the next 5 days, on and off. I still do not feel right since then. The last 3 years I felt sick after the Flu shot, then I thought maybe it was the perservatives but I received preservative free shot and that was worse. I still get dizzy spells every now and then. Seeing a doctor today for it.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Throat irritation
Clinical narrative: Receive preservative free Flu shot, felt dizzy, on and off for 10 minutes. Walked off and was talking with someone for 20 or 25 minutes. Felt very tired. 15 minutes later, my mouth got really dry and my throat felt "weird". I disregarded it. 15 minutes later I felt dizzy again, very strong this time. Went to see the nurse, I was sitting on a chair and I said to her, I don't feel well and I passed out. Not completely, I felt exhausted and I could hear them talking but I was too exhausted to respond or move. Then I got up, and then passed out again. The ambulance came and I felt 2 more episodes in the ambulance. At the ER, one episode of syncope, then I felt diggling feeling in my torso, then it traveled to my legs. I felt, exhausted and winded for the next 5 days, on and off. I still do not feel right since then. The last 3 years I felt sick after the Flu shot, then I thought maybe it was the perservatives but I received preservative free shot and that was worse. I still get dizzy spells every now and then. Seeing a doctor today for it.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diet refusal, Intussusception, Vomiting
Clinical narrative: Throwing up, not eating, leading to bowel intussusception and needing surgery.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash pruritic, Urticaria
Clinical narrative: Per pt report on 12/9, within 24-48 hours of vaccination on 11/21, widespread hives/welts developed over pt's body that resolved after 7-10 days. As of 12/8, it started coming back up again and is spreading. Rash is very itchy & uncomfortable. Pt is intending to visit her physician to have it evaluated.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic shock, Dysstasia, Eye pain, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: Initial unsolicited report received on 02 December 2014 from a consumer (the patient). A female patient with a medical history of multiple sclerosis, experienced anaphylactic shock after she received a dose of influenza vaccine (manufacturer, lot number, date, route and site of administration not reported). Time to onset was not reported. The patient reported that she was very sensitive to things. About 5 years later, at the age of 54-year-old, the patient reported that after the 2nd day on AUBAGIO she started to have pain, "everywhere," her right side including her lip and tongue were numb, eye socket was painful, could not stand or lift right arm, and has been in bed for a month. She had to stop physical therapy. She is now starting to feel better. She went to the ER and was given a shot of DILAUDID and had an MRI. She was not admitted. She is on her second pack of oral steroids. She started COPAXONE. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Movement disorder, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Initial unsolicited report received on 02 December 2014 from a consumer (the patient). A female patient with a medical history of multiple sclerosis, experienced anaphylactic shock after she received a dose of influenza vaccine (manufacturer, lot number, date, route and site of administration not reported). Time to onset was not reported. The patient reported that she was very sensitive to things. About 5 years later, at the age of 54-year-old, the patient reported that after the 2nd day on AUBAGIO she started to have pain, "everywhere," her right side including her lip and tongue were numb, eye socket was painful, could not stand or lift right arm, and has been in bed for a month. She had to stop physical therapy. She is now starting to feel better. She went to the ER and was given a shot of DILAUDID and had an MRI. She was not admitted. She is on her second pack of oral steroids. She started COPAXONE. Documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Bronchitis, Influenza, Injection site nodule, Pleural effusion
Clinical narrative: Full flu for 2 weeks = 1 syx; knot in arm at site of injection. Acute bronchitis - 2nd syx. Fluid in lungs - 3rd syx. Pleurisy continues at time of report.  Projectile vomiting (lost 10 lbs).
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pleurisy, Vomiting projectile, X-ray
Clinical narrative: Full flu for 2 weeks = 1 syx; knot in arm at site of injection. Acute bronchitis - 2nd syx. Fluid in lungs - 3rd syx. Pleurisy continues at time of report.  Projectile vomiting (lost 10 lbs).
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Eye discharge, Eye swelling, Hypotension, Laboratory test normal
Clinical narrative: Symptoms happened 4 hours after shot, throat closing, eye secretion, swollen eyes and bloodshot. Low blood pressure in hospital.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Throat tightness
Clinical narrative: Symptoms happened 4 hours after shot, throat closing, eye secretion, swollen eyes and bloodshot. Low blood pressure in hospital.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Audiogram abnormal, Deafness unilateral, Dizziness, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Vertigo, lost hearing temporarily in left ear. Tinnitus with dizziness occurred later that afternoon around 1:00 PM. Following day around 10:00 AM patient reports of tinnitus and dizziness.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus, Vertigo
Clinical narrative: Vertigo, lost hearing temporarily in left ear. Tinnitus with dizziness occurred later that afternoon around 1:00 PM. Following day around 10:00 AM patient reports of tinnitus and dizziness.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Screaming
Clinical narrative: High pitched screaming, persistent for over 6 hours.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Anxiety, Bronchospasm, Cardiac pacemaker insertion, Dyspnoea
Clinical narrative: Lips and face numb, rash on injection site, anxious, difficulty breathing. Angioedema and bronchospasm seemed likely. EMS was contacted. Gave 50mg of diphenhydramine PO, and 0.5mg epinephrine IM at same site as influenza injection. Patient reported drinking 2 ounces of vodka after vaccine administration and symptom onset. Patient has a cardiac pacemaker and EMS transported patient to ER soon after arrival to pharmacy. In hospital, the patient received IV solumedrol and was observed for 5 hours before being released. Patient was given 60mg prednisone po daily for 2 days.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site rash
Clinical narrative: Lips and face numb, rash on injection site, anxious, difficulty breathing. Angioedema and bronchospasm seemed likely. EMS was contacted. Gave 50mg of diphenhydramine PO, and 0.5mg epinephrine IM at same site as influenza injection. Patient reported drinking 2 ounces of vodka after vaccine administration and symptom onset. Patient has a cardiac pacemaker and EMS transported patient to ER soon after arrival to pharmacy. In hospital, the patient received IV solumedrol and was observed for 5 hours before being released. Patient was given 60mg prednisone po daily for 2 days.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Fibromyalgia, Local swelling, Malaise, Neuralgia, Pain
Clinical narrative: Pt states she had fibromyalgia and neuromyalgia, malaise local pain and swelling, no rash, no fever no Gi s/sx.  Symptoms lasted for a couple of days.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, No therapeutic response, Pain, Pruritus, Skin warm
Clinical narrative: Patient received vaccine in right arm.  Discharged from hospital where she developed pruritus, increased swelling, pain and warmth develop over the week.  Returned to the emergency department on 12/07 where she was prescribed clindamycin oral for suspected cellulitis.  Patient presents again on 12/09 with "failure" of antibiotic therapy.  Patient received vancomycin, was switched to clindamcyin and is set for discharge.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient received vaccine in right arm.  Discharged from hospital where she developed pruritus, increased swelling, pain and warmth develop over the week.  Returned to the emergency department on 12/07 where she was prescribed clindamycin oral for suspected cellulitis.  Patient presents again on 12/09 with "failure" of antibiotic therapy.  Patient received vancomycin, was switched to clindamcyin and is set for discharge.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: Had a fever (highest temperature was 101.0).
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, Culture urine, Febrile convulsion, Generalised tonic-clonic seizure, Haemoglobin normal
Clinical narrative: Well at time of vaccination.  Developed fever to 101.5 and brief tonic clonic seizure on night of vaccination.  Infant was taken to ED by EMS and had normal exam with exception of fever to 101.5.  Blood samples and urine samples were obtained and infant was given dose of rocephin due to leukocytosis.  Seizure was felt to be due to fever.  He did not require hospitalization and fully recovered prior to discharge from ED.  Follow-up exam the following day was entirely normal.  Seizure not likely true adverse event.  More likely due to fever.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Leukocytosis, Platelet count increased, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Well at time of vaccination.  Developed fever to 101.5 and brief tonic clonic seizure on night of vaccination.  Infant was taken to ED by EMS and had normal exam with exception of fever to 101.5.  Blood samples and urine samples were obtained and infant was given dose of rocephin due to leukocytosis.  Seizure was felt to be due to fever.  He did not require hospitalization and fully recovered prior to discharge from ED.  Follow-up exam the following day was entirely normal.  Seizure not likely true adverse event.  More likely due to fever.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry throat, Dysphagia, Dyspnoea, Sensation of foreign body
Clinical narrative: Short of breath, dizziness, dry throat, felt lump in throat and problems swallowing.  Given Kenalog 80 mg IM and Benadryl 50 mg IM. O2 started and transported to the ER per EMS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash
Clinical narrative: Rash, redness, pain.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Hypotonia, Lethargy, Unresponsive to stimuli
Clinical narrative: Client became lethargic, unresponsive and unable to open eyes. Client was limp. This occurred during last bit of vaccine.
Age: 29.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Abasia, Abdominal pain, Headache, Hypoaesthesia, Laboratory test normal
Clinical narrative: Started with headache, on 11/20/2014 afternoon, legs numb and tingly, on night of 20th, progressed to severe abdominal pain, unable to walk on morning of 11/21/2014 to ER 7 AM on 11/21/2014, transfered 11/21/2014 night, until 12/3/2014 when transfered again, remains hospitalized.
Age: 29.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Myelitis transverse, Paraesthesia
Clinical narrative: Started with headache, on 11/20/2014 afternoon, legs numb and tingly, on night of 20th, progressed to severe abdominal pain, unable to walk on morning of 11/21/2014 to ER 7 AM on 11/21/2014, transfered 11/21/2014 night, until 12/3/2014 when transfered again, remains hospitalized.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Cold sweat, Eye swelling, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: Hives onset shortly after admin of Hep A vaccine. Eye swelling, blurry vision, clammy feeling, afebrile, tired, sore throat, feels a bit ill, slept well.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria, Vision blurred
Clinical narrative: Hives onset shortly after admin of Hep A vaccine. Eye swelling, blurry vision, clammy feeling, afebrile, tired, sore throat, feels a bit ill, slept well.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Flu shot given 10/30/14. Since then he is having clear nasal drainage if he moves from laying down or reclining position to a more upright position.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Shaking chills that lasted for 45 minutes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash erythematous, Vaccination site pain, Vaccination site swelling
Clinical narrative: Sore, red, and swollen arm at vaccine site (Saturday night). Arm symptoms increased the following day (Sunday). Monday - red rash on face which went away on Wednesday after taking antihistamines for 3 days.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Drug administered at inappropriate site, Injection site reaction, Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: First, I would like to state that prior to vaccination, I did not have any left shoulder pain or injuries. I was given the flu shot into my left shoulder by the pharmacist. It was given too high on the shoulder. It was administered approximately 2cm below the acromion. I began to have pain and stiffness within one hour of the injection. When the symptoms continued to get worse, I went to the urgent care two days after vaccination, and despite requesting a steroid, I was given Meloxicam and sent home. When the pain continued to persist and get worse, I went to see my primary physician on November 13, 2013. She prescribed prednisone. It worked while I was taking it, but once I discontinued it, the symptoms returned soon after. I saw a pain management physician on December 9th, who ordered an MRI. The MRI was performed on December 11, 2013. This showed bursitis and tendonitis of the left shoulder. He ordered physical therapy, which I did in January 2014. I then began seeing an orthopedic surgeon on February 21, 2014. He ordered more physical therapy. When that wasn't helping, he gave me a steroid shot into the left shoulder. We proceeded with more physical therapy. When that still was not helping, we opted for surgery. I had a subacromial decompression and biceps tendonesis on June 10, 2014. I began more physical therapy after surgery. The pain continued to persist. He gave me another steroid injection into the left shoulder on October 3, 2014. The symptoms have continued through all of this treatment. The orthopedic surgeon recommended in November 2014 that I get a second opinion. I am currently doing this and have a new orthopedic surgeon who has ordered an arthrogram MRI of my left shoulder because he believes there may be more damage in the shoulder.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Rotator cuff repair, Surgery, Tendonitis, Tenodesis
Clinical narrative: First, I would like to state that prior to vaccination, I did not have any left shoulder pain or injuries. I was given the flu shot into my left shoulder by the pharmacist. It was given too high on the shoulder. It was administered approximately 2cm below the acromion. I began to have pain and stiffness within one hour of the injection. When the symptoms continued to get worse, I went to the urgent care two days after vaccination, and despite requesting a steroid, I was given Meloxicam and sent home. When the pain continued to persist and get worse, I went to see my primary physician on November 13, 2013. She prescribed prednisone. It worked while I was taking it, but once I discontinued it, the symptoms returned soon after. I saw a pain management physician on December 9th, who ordered an MRI. The MRI was performed on December 11, 2013. This showed bursitis and tendonitis of the left shoulder. He ordered physical therapy, which I did in January 2014. I then began seeing an orthopedic surgeon on February 21, 2014. He ordered more physical therapy. When that wasn't helping, he gave me a steroid shot into the left shoulder. We proceeded with more physical therapy. When that still was not helping, we opted for surgery. I had a subacromial decompression and biceps tendonesis on June 10, 2014. I began more physical therapy after surgery. The pain continued to persist. He gave me another steroid injection into the left shoulder on October 3, 2014. The symptoms have continued through all of this treatment. The orthopedic surgeon recommended in November 2014 that I get a second opinion. I am currently doing this and have a new orthopedic surgeon who has ordered an arthrogram MRI of my left shoulder because he believes there may be more damage in the shoulder.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Speech disorder, Tongue biting
Clinical narrative: PATIENT REPORTED ITCHING BEHIND KNEE ABOUT 20 MINUTES POST INJECTION, AND NOT 5 MINUTES LATER SAID HE WAS CHEWING HIS TONGUE AND HAVING DIFFICULTY SPEAKING. I GAVE 0.3MG EPIPEN AT THAT TIME 6:50PM. 1 MINUTE LATER EMS ARRIVED AND EVALUATED. THEY TOOK PATIENT TO THE HOSPITAL AT 7.02 PM.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Symptoms: pain, redness and swelling. Treatment: Ibuprofen and warm compress.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac arrest, Death, Influenza, Malaise, Pulmonary oedema
Clinical narrative: Case number PHEH2014US024100 is a combined initial and follow up spontaneous report from a nurse received on 02 Dec 2014 and from quality assurance department (QA reference number: 340811) received on 03 Dec 2014. This report refers to a 66-year-old female patient. Her current conditions included type 2 diabetes and elevated cholesterol with values at normal limits and were being managed. She went for cardiac work up, 1-2 weeks prior to vaccination and everything was normal. She did not have any blockages, no complaints of chest pains, but had fever. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 04 Nov 2014. On the same date, since vaccination she was feeling ill and had flu. On an unknown date, she had fever. On 13 Nov 2014, she was burning up with fever, had taken off her night gown (Not typical behaviour), drank water, went to sofa, threw up en route and had cardiac arrest. Her husband performed CPR (cardiopulmonary resuscitation) and called the ambulance. In the emergency room, she was being resuscitated, but she died on the same day. No autopsy was performed. It was reported that something caused pulmonary edema. She had no congestive heart failure and not on any diuretics. The outcome of the events fever, feeling ill, flu and threw up was not reported. The outcome of the events pulmonary edema and cardiac arrest reported as death. The seriousness of the events fever, feeling ill, flu and threw up was not reported. The causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Resuscitation, Vomiting
Clinical narrative: Case number PHEH2014US024100 is a combined initial and follow up spontaneous report from a nurse received on 02 Dec 2014 and from quality assurance department (QA reference number: 340811) received on 03 Dec 2014. This report refers to a 66-year-old female patient. Her current conditions included type 2 diabetes and elevated cholesterol with values at normal limits and were being managed. She went for cardiac work up, 1-2 weeks prior to vaccination and everything was normal. She did not have any blockages, no complaints of chest pains, but had fever. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 04 Nov 2014. On the same date, since vaccination she was feeling ill and had flu. On an unknown date, she had fever. On 13 Nov 2014, she was burning up with fever, had taken off her night gown (Not typical behaviour), drank water, went to sofa, threw up en route and had cardiac arrest. Her husband performed CPR (cardiopulmonary resuscitation) and called the ambulance. In the emergency room, she was being resuscitated, but she died on the same day. No autopsy was performed. It was reported that something caused pulmonary edema. She had no congestive heart failure and not on any diuretics. The outcome of the events fever, feeling ill, flu and threw up was not reported. The outcome of the events pulmonary edema and cardiac arrest reported as death. The seriousness of the events fever, feeling ill, flu and threw up was not reported. The causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Bradyphrenia, Immediate post-injection reaction, Injection site pain, Pain in extremity, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer. A 62-year-old female patient started to receive PREVNAR 13 (lot # and expiration date unknown, NCD: 00005 1971 02) via an unspecified route of administration at 1 DF, single on 27Oct2014. Medical history included asthma and diabetes mellitus from. Caller only mentioned asthma and diabetes as other medical conditions and declined to mention others, she says they are the only life threatening ones. She stated the asthma and diabetes keep her in the hospital a lot. The patient's concomitant medications were not reported: caller declined to provide other medications, they were too many. The patient experienced sleepy on 27Oct2014, burned a little going in on 27Oct2014, sore right arm on 28Nov2014, it made her mind slow down on an unspecified date in 2014. The patient recovered from Sleepy and Burned a little going in on 27Oct2014, and from sore right arm in 2014. Therapeutic measures were taken as a result of sore right arm. Course of events: Caller mentioned that when she received PREVNAR 13 vaccine on 27Oct2014 that it burned a little going in, she got a little sleepy for about 15 minutes after receiving the vaccine and the next day her right arm where she received the vaccine was sore for a day and a half. Caller also mentioned that it made her mind slow down which she liked. She also stated that the symptoms wore off before she left the office. She told the nurse she was back to normal. She said her arm was a little sore. She took some ibuprofen when she got home. The next morning it was still a little sore, not horrible. Caller said she is no longer experiencing any of those symptoms anymore, the symptoms are normal and her experience was not bad at all. Caller gave permission for Pfizer to contact her physician for further questions if needed.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Burning sensation, Dizziness, Insomnia, Loss of consciousness
Clinical narrative: The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 21Nov2014, this case now contains all required information to be considered valid. This is a spontaneous report from a non-clinical study program. A contactable 84-year-old female consumer reported that she received PREVNAR 13 single dose, on 15Oct2014. The patient had a soy allergy. The patient experienced on 18Oct2014 pain in stomach, burning in lungs, lightheadedness, could not sleep in her bed, extreme cold, passed out trying to get up. The patient recovered from all adverse events on 15Nov2014. The consumer stated she was extremely allergic to soy and that was not told to her that it was a component.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Lung disorder, Nasopharyngitis
Clinical narrative: The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 21Nov2014, this case now contains all required information to be considered valid. This is a spontaneous report from a non-clinical study program. A contactable 84-year-old female consumer reported that she received PREVNAR 13 single dose, on 15Oct2014. The patient had a soy allergy. The patient experienced on 18Oct2014 pain in stomach, burning in lungs, lightheadedness, could not sleep in her bed, extreme cold, passed out trying to get up. The patient recovered from all adverse events on 15Nov2014. The consumer stated she was extremely allergic to soy and that was not told to her that it was a component.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Dizziness, Eye pruritus, Fatigue, Headache
Clinical narrative: C/o dizziness on 9/22/14, fatigue, headache, congestion, itchy eye. Tool 9/23/14 off b/c dizzienss and myalgia.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Respiratory tract congestion
Clinical narrative: C/o dizziness on 9/22/14, fatigue, headache, congestion, itchy eye. Tool 9/23/14 off b/c dizzienss and myalgia.
Age: 1.1
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: VARIVAX was given in left thigh and MMR given in right thigh. Rash appeared immediately following injection at the site. Patient waited with nurse for 10 minutes. Left thigh cleared 100% and right thigh cleared 80%.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Middle insomnia, Mobility decreased
Clinical narrative: Interruption of sleep. Neck pain, mobility, headache, injection site soreness swelling.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: Interruption of sleep. Neck pain, mobility, headache, injection site soreness swelling.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis, Rotator cuff syndrome
Clinical narrative: Shoulder pain and immobility - Dx frozen shoulder and small tear in rotator cuff.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Shoulder pain and immobility - Dx frozen shoulder and small tear in rotator cuff.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left arm pain one month after injection. No swelling or redness.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, FLUN4, PNC13
Symptoms: Injection site urticaria
Clinical narrative: Parent reported small hives on area of arm at injection site. Possibly had a slight fever last evening.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hyperaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: I am having pain in my arm after getting the flu shot. Can't lift my arm or move it sideways w/o terrible pain. It is very sensitive where the injection was given high up on my right arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Received flu shot 11-5-14. Arm (left) was very sore and a week later experienced severe arm pain and even had trouble lifting arm. As of 11-26-14 arm still hurts to sleep on but can finally lift arm up above head.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: I experienced pain with the injection of the medication - the needle did not hurt, but there was terrible burning for 2-3 min following the injection, in the right arm (extreme upper right arm). I experienced pain at the injection site and my arm was very achy and weak for 2 1/2 weeks. Now, 3 weeks after the injection my arm is not nearly as sore, but I still feel pain at the injection site and with certain movements.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Red swollen upper arm -> started to resolve in 2 days but patient felt it might be moving lower on arm. MD diagnoses as cellulitis. Tx with doxycycline.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives 4-5 hrs. after receiving flu vaccine.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: 10 am pt. woke up on 12/03/14 with a rash from head to toe mom gave BENADRYL, CLARITIN, ZANTAC 6 pm this evening spoke with mom pt. is doing better.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Lymphadenopathy
Clinical narrative: Swollen throat/glands, runny nose, chills, weakness, cough, muscle aches, SOB with activity.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pharyngeal oedema, Rhinorrhoea
Clinical narrative: Swollen throat/glands, runny nose, chills, weakness, cough, muscle aches, SOB with activity.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site mass, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: TC on 11-17-14 reporting "red rashy itchy "area with a painful lump back at (L) lower arm with onset evening 11-13 approx. 5 hours after receiving vaccines. Taking ibuprofen q 6 hours and states "symptoms have been staying the same". Applying ice and cortisone cream as well which PHN advised to stop. Enc. warm wet compress and no topicals and con't ibuprofen. FU TC's 11-19-14, 11-26-14 and 12-2-14 with gradual resolution of symptoms.
Age: 84.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: On her left arm patient states she had blistering/itching at the site of injection. That started a couple days after vaccine given. When she came to me the sores were resolving.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Patient called on Monday November 17th 2014 to report that she had swelling of her axillary lymph nodes and was going to follow up with her PCP.
Age: 1.1
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red bumps over body, day following flu vaccine.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received Tdap vaccine to (R) deltoid on 10-7-14. Received call from patient on 12-4-14 reporting pain and decreased mobility to (R) arm since receiving injection. Has seen primary MD, advised to use ibuprofen. Reports no better, mobility is decreasing.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient developed dizziness when moving between sitting and standing on 11/12/14 after vaccination. Shortly thereafter patient developed intermittent bouts of nausea.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Fibrin D dimer normal, Full blood count normal, Joint range of motion decreased
Clinical narrative: Pain from shoulder to elbow and into neck following flu shot admin. Visible swelling and pain with palpation. Labs as below. Decreased ROM. Prednisone burst and taper. Patient slowly improving with symptoms after 2 months. Advised never to receive flu vaccine in future.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Red blood cell sedimentation rate increased, Swelling, Ultrasound Doppler normal
Clinical narrative: Pain from shoulder to elbow and into neck following flu shot admin. Visible swelling and pain with palpation. Labs as below. Decreased ROM. Prednisone burst and taper. Patient slowly improving with symptoms after 2 months. Advised never to receive flu vaccine in future.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Pain from shoulder to elbow and into neck following flu shot admin. Visible swelling and pain with palpation. Labs as below. Decreased ROM. Prednisone burst and taper. Patient slowly improving with symptoms after 2 months. Advised never to receive flu vaccine in future.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Day 1, 2, 3, extreme soreness in left shoulder - could not lay on left side. 4+ days - range of motion limited any movement, increased pain - pain w/ pressure. Pain continues when lifting arm.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus generalised, Rash generalised
Clinical narrative: Rash at injection site -> generalized rash with itch w/in 3 hrs.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Local swelling
Clinical narrative: Temp of 103 the night of administration arm swelling with fluid filled sac hanging from arm.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient's mother called pharmacy to report that patient had developed a rash on upper arm and shoulder. Both arms - no bruise or swelling at injection site. Patient leaving for school.
Age: 88.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: After 4 wks, raising my right arm is still hurting from shoulder to elbow. I am right handed, but had a fatty tumor on left arm. Went to drs. She said to put ince on it. Didn't work.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: About 3 hrs. after the flu shot, I started coughing and wheezing and experienced trouble breathing. I couldn't sit down because it was harder to breathe. The difficulty in breathing lasted about 6 hrs. I called the pharmacist and she suggested cough medicine and TYLENOL. I developed a headache about 7 hrs after the flu shot and also felt very tired and weak. The next day the breathing was better and the headache and tired and weak feeling persisted. It took about 4 days to feel better.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: About 3 hrs. after the flu shot, I started coughing and wheezing and experienced trouble breathing. I couldn't sit down because it was harder to breathe. The difficulty in breathing lasted about 6 hrs. I called the pharmacist and she suggested cough medicine and TYLENOL. I developed a headache about 7 hrs after the flu shot and also felt very tired and weak. The next day the breathing was better and the headache and tired and weak feeling persisted. It took about 4 days to feel better.
Age: 48.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Dizziness, Eye irritation, Eye pruritus, Fatigue
Clinical narrative: 15-20 min after receiving vaccine, pt broke out in a sweat. Felt dizziness, light headed, and nausea. Right arm shook uncontrollably for a few minutes. Felt fatigue on 11/25/14 pt woke up nauseous and vomitied a few times. Continued to feel dizzy and fatigued. Eyes were itchy and burning. Joints were aching and was painful to walk.
Age: 48.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hyperhidrosis, Nausea, Pain, Tremor, Vomiting
Clinical narrative: 15-20 min after receiving vaccine, pt broke out in a sweat. Felt dizziness, light headed, and nausea. Right arm shook uncontrollably for a few minutes. Felt fatigue on 11/25/14 pt woke up nauseous and vomitied a few times. Continued to feel dizzy and fatigued. Eyes were itchy and burning. Joints were aching and was painful to walk.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Tingling nerve sensation from injection site to entire left side of face, body, trunk and legs. Tenderness at injection site. Lasted for about 1 hour severely then faded over 12 hours.
Age: 33.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: Patient states after being given Influenza and Hepatitis A vaccine 12/01/14 around 1 pm she had no symptoms but later that night developed hives on her arm.
Sex: U
Vaccine: FLU4
Symptoms: Wrong technique in drug usage process
Clinical narrative: Wrong injection technique.
Age: 13.0
Sex: M
Vaccine: FLUN4, HEP, HEPA, IPV, MMR, TD, VARCEL
Symptoms: Dizziness, Hypotension
Clinical narrative: Pt. became dizzy upon administering shots, (2:50pm), unrelieved by laying down with legs elevated. Gave juice and ice pack and pt continued to feel dizzy. Vitals WNL, but pt. not improving. Placed pt. on O2 and called EMS. Arrived around 3:09 and pt. became hypotensive: 148/107. EMS transferred to hospital.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood pressure decreased, Dyspnoea, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: at 3 PM blood press. dropped to 101/60 at store. At 3:30 PM at home had trouble breathing and my heart was beating fast. Then I go sharp pain at the top of my stomach. Then I knew I was having a allergic reaction to the Flu shot. I went back to the doctors office. (back of page). Have to ask my doctor.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: at 3 PM blood press. dropped to 101/60 at store. At 3:30 PM at home had trouble breathing and my heart was beating fast. Then I go sharp pain at the top of my stomach. Then I knew I was having a allergic reaction to the Flu shot. I went back to the doctors office. (back of page). Have to ask my doctor.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Psychomotor hyperactivity
Clinical narrative: Moderate to severe 'irritability" following immunizations at 2 and 9 month old visits. Described by mother as "hyperactivitiy".
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient is an RN who received flu vaccine on 11/10/14. On 12/8/14 reported to clinical educator that she had reduced ROM and pain at arm.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Joint range of motion decreased
Clinical narrative: Pain (L) shoulder 15 minutes post injection. No redness or swelling. Decreased range of motion. No fever. Site of injection high - under acromion.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Vision blurred
Clinical narrative: Chills, dizziness, blurred vision, bones ached, stomach pain, fatigue throughout the night.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Chest X-ray, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11-12-14 2.5 in. redness, swelling and warmth at site. 12-1-14 intermittent fever, wheezing, headache, green nasal discharge.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Pyrexia, Rhinorrhoea, Wheezing
Clinical narrative: 11-12-14 2.5 in. redness, swelling and warmth at site. 12-1-14 intermittent fever, wheezing, headache, green nasal discharge.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site swelling, Pyrexia
Clinical narrative: Patient states she had a fever of 103. Constant chills, swollen arm at the site of injection, along with a consistent headache.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Lip swelling
Clinical narrative: Rec'd FLUMIST approximately 530p, lips swelling 600pm. To ER. Rec'd BENADRYL elixir 30mg x1 and Ranitidine 150mg/10ml 90 mg once and sent home with Rx to be taken BID. Ice to lips.
Age: 18.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Abasia, Asthenia, Blood test normal, Chest X-ray normal, Dizziness
Clinical narrative: Severe head and neck pain, stiff neck, 104 degrees and fever could not walk due to pain and weakness in entire body, dizzy. Received shot at 3 pm, next day symptoms started at 7 am. Required emergency room treatment (MD office advised to take to ER) about 4 pm till 10 pm (high blood pressure, meds for pain).
Age: 18.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Headache, Influenza virus test negative, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Severe head and neck pain, stiff neck, 104 degrees and fever could not walk due to pain and weakness in entire body, dizzy. Received shot at 3 pm, next day symptoms started at 7 am. Required emergency room treatment (MD office advised to take to ER) about 4 pm till 10 pm (high blood pressure, meds for pain).
Age: 18.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Severe head and neck pain, stiff neck, 104 degrees and fever could not walk due to pain and weakness in entire body, dizzy. Received shot at 3 pm, next day symptoms started at 7 am. Required emergency room treatment (MD office advised to take to ER) about 4 pm till 10 pm (high blood pressure, meds for pain).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Musculoskeletal stiffness, Pyrexia
Clinical narrative: After receiving high dose flu vaccine began to have chills around 6 pm. Awakened with 102 degree fever at 2 am and went to ER. Was sick 3 days and stiffness in neck and shoulder.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Dizziness, Urticaria
Clinical narrative: After vaccines were administered, pt. became dizzy and developed hives on face and neck. BENADRYL - 50 mg IM administered at 5:00 pm. BP 122/8, AP - 81, R-17. Pt. continued with dizziness while in supine/sitting positions. Hives subsided. Spoke with mother in am. Pt. slept most evening and night. Woke up at 3:00 AM c/o scratchy throat. Mom gave oral BENADRYL. Better this morning - went to school.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Erythema, Local swelling
Clinical narrative: 7 hours after flu shot and PNEUMOVAX in left upper arm pt got mild left medial arm swelling/redness and burning and 2 days later she is better.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Adenoma benign, Local swelling
Clinical narrative: I was sick after getting home and my left arm had swollen (lower side like med stayed there). Went to Dr. after 3 wks hadn't gone down and said it caused lymphadenoma.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: C/O pain (R) deltoif. No reddness or swelling noted. Tender to the touvh upon palpation. Unable to raise arm above shoulder height without assistance from (L) arm. Pain disturbs sleep. TYLENOL ineffective. Level of pain has plateaued.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient had painful swelling at ZOSTAVAX injection site which was tender to touch.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning 3 females infants patients who between 15-OCT-2014 and 27-OCT-2014 were vaccinated with improperly stored dose of ROTATEQ, oral (lot # K005397, expiration date 29-FEB-2016) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Received shot about 5 hours later arm started to swell up. Had redness and itchiness to injection site - continued to swell for 3 days - Redness has gone away about 4 days later - still some itchiness and swelling 4 days later but seems to be improving.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the unspecified number of unspecified patients were vaccinated with unspecified doses of improperly stored oral ROTATEQ injection (lot number not provided) (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of event was not reported. This is one of 4 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On 19-NOV-2014 the patient was vaccinated with a dose of ROTATEQ vial (dose number, lot# and expiration date unknown), administered orally that underwent a supported temperature excursion. No adverse experience reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine was expired (11/24/2014).
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Frank blood in stool x2 bowel movements.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist concerning a 70 year old male patient with no known allergies. On 04-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscular in the right arm (dose, lot # and expiration date not reported). Concomitant therapies included Influenza virus vaccine (unspecified administered in the left arm. On 05-NOV-2014, the patient developed redness, soreness and swelling from his right bicep to his right elbow. The right arm was not warm to touch. The patient sought medical attention called pharmacy. On unknown date in November 2014 the patient recovered from the adverse events. Additional information is not expected because the reporter cannot be contact.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date in August 2014 (also reported "5 months ago"), the patient was vaccinated with ZOSTAVAX, subcutaneous injection, (strength, dose, anatomical location, lot number and expiration date were not reported), on 20-NOV-2014 was inadvertently administered another ZOSTAVAX, subcutaneous injection, (strength, dose, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported that an unknown number of doses of GARDASIL (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information). GARDASIL was exposed to 30F then 48F for 72 hours,. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (strength, dose and route not provided). No adverse event was reported. The outcome of event was not reported. Additional information has been requested.