chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4, FLU3, HEPA, HPV4, MNQ
Symptoms: Electrocardiogram normal, Palpitations, Tachycardia
Clinical narrative: Information has been received from a physician and a nurse referring to a 17 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. The physician and the nurse reported that on 12-OCT-2015 the patient was vaccinated with a dose (dose number unspecified) of GARDASIL (dose not reported, lot # K016966 with expiration date in May 2017, intramuscular). There were no concomitant medications. The nurse noted that on an unspecified date after receipt of the GARDASIL (in October 2015), the patient began to experience intermittent heart palpitations and tachycardia. The nurse noted that the patient's father recorded the patient's beats per minute (while at home) to be 177 (in October 2015). The patient came to the office on 27-OCT-2015 to be assessed, and it was noted that the patient's blood pressure and heart rate were within normal limits. The patient was sent home and on 28-OCT-2015, the patient again came to the office complaining of heart palpitations and tachycardia. The nurse stated that the patient's assessment was again within normal limits and an electrocardiogram (EKG) was conducted and no results were available at the time of the call. Unspecified laboratory work would be conducted. The nurse stated that the patient would have an echocardiogram conducted "tomorrow" (29-OCT-2015) at the Hospital and had an appointment "next week" with a cardiologist. No product quality complaint (PQC) was involved. No treatment was given for the events. Outcome of the events was reported as not recovered. The reporter considered the events to be disabling due to the patient not going to school. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, FLU3, HEPA, HPV4, MNQ
Symptoms: Cardiac function test, Electrocardiogram, Palpitations
Clinical narrative: Information has been received from a physician and a nurse referring to a 17 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. The physician and the nurse reported that on 12-OCT-2015 the patient was vaccinated with a dose (dose number unspecified) of GARDASIL (dose not reported, lot # K016966 with expiration date in May 2017, intramuscular). There were no concomitant medications. The nurse noted that on an unspecified date after receipt of the GARDASIL (in October 2015), the patient began to experience intermittent heart palpitations and tachycardia. The nurse noted that the patient's father recorded the patient's beats per minute (while at home) to be 177 (in October 2015). The patient came to the office on 27-OCT-2015 to be assessed, and it was noted that the patient's blood pressure and heart rate were within normal limits. The patient was sent home and on 28-OCT-2015, the patient again came to the office complaining of heart palpitations and tachycardia. The nurse stated that the patient's assessment was again within normal limits and an electrocardiogram (EKG) was conducted and no results were available at the time of the call. Unspecified laboratory work would be conducted. The nurse stated that the patient would have an echocardiogram conducted "tomorrow" (29-OCT-2015) at the Hospital and had an appointment "next week" with a cardiologist. No product quality complaint (PQC) was involved. No treatment was given for the events. Outcome of the events was reported as not recovered. The reporter considered the events to be disabling due to the patient not going to school. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Infection, Lymphadenopathy, Pain, Pruritus, Swelling
Clinical narrative: Swelling, itching, pain, swollen glands, infection. Doctor started antibiotic.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Localised infection
Clinical narrative: Swelling, itching, pain, swollen glands, infection. Doctor started antibiotic.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Erythema, Headache, Herpes virus infection, Infection, Lymphadenopathy
Clinical narrative: Swelling, itching, pain, swollen glands, infection. Doctor started antibiotic.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling, itching, pain, swollen glands, infection. Doctor started antibiotic.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Infection, Lymphadenopathy, Pain, Pruritus, Swelling
Clinical narrative: Pain, swelling, redness, itchy, headache, achy all over. Infection, swollen glands, herpes outbreak. Dr started me on antibiotics and antiviral med. Filed report earlier E report 97818.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Localised infection
Clinical narrative: Pain, swelling, redness, itchy, headache, achy all over. Infection, swollen glands, herpes outbreak. Dr started me on antibiotics and antiviral med. Filed report earlier E report 97818.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Erythema, Headache, Herpes virus infection, Infection, Lymphadenopathy
Clinical narrative: Pain, swelling, redness, itchy, headache, achy all over. Infection, swollen glands, herpes outbreak. Dr started me on antibiotics and antiviral med. Filed report earlier E report 97818.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, VARZOS
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Pain, swelling, redness, itchy, headache, achy all over. Infection, swollen glands, herpes outbreak. Dr started me on antibiotics and antiviral med. Filed report earlier E report 97818.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complained of severe redness and swelling and itching at the injection area for over 10 days.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Swollen axillary lymph nodes on arm where injection given.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: S/P flu shot on 10/27 site Lt arm warm red.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Tremor, Vomiting
Clinical narrative: He received flu shot around 4:30 pm and felt fine. Around 11:30 pm that night he came down with chills and the shakes. He said he was "freezing" and wound up throwing up. The next day he gradually felt better.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Pt woke up with welt measuring 1/2-1 inch in diameter on buttocks raised area on buttocks also on top of feet welt measuring 1/20-1 inch in diameter. It has been itching. Also quarter size. Pinkish in color slightly raised at injection site. Pt has been taking BENADRYL oral tablets as well as applying cortisone cream. Pt reports welts morning of the 10/29/15.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Nasal congestion, Sensory disturbance
Clinical narrative: He received an Afluria vaccination in the right deltoid during the AD Flu-fair, and reports that as soon as he left the building he began to have a dry cough, and by the time he arrived back to his duty area, about 1 mile away, had fullness of the right side of his nose and reports that he was not able to breathe through the right nostril, but the cough had resolved.  Additionally, he began to notice some change in sensation in the right side of his jaw which progressed to include the right side of the face up to the line b/w his ear and eye, and included area around the right ear, and right side of his tongue.  This sensation was fully developed at 2 hours post vaccination and lasted until he went to bed around midnight, but was gone when he awoke around 0530.  He did have a slight headache when he awoke the next morning, but denies any further sensory changes.  The HA dissipated toward the end of the day.  The congestion in his right nostril followed the same time course as the numbness.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Aphonia, Cough, Throat tightness
Clinical narrative: " Throat started to close off", coughing, loss of voice.  NO swelling of lips or tongue, NO rash or cold like symptoms, denied shortness of breath. Treated in Emergency Department with 1liter Normal saline for hydration; Benadryl 25mg IV push; Epinepherine 0.3mg IM; Pepcid 20mh IV push; Solu Medrol 125mg IV push.  Sent home, instructed to take Benadryl 25mg as needed for itching or rash.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Extreme pain where shot was given in upper arm. 6 weeks of pain so far.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Bartonella test negative, Blood creatine phosphokinase, Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Fatigue
Clinical narrative: Pt presented to the office on 10/26/15 and reports that she started having body aches and generally not feeling well on the evening of 10/20/15.  Symptoms progressed and patient states she developed arm pain the night of 10/21/15.  The arm pain and not feeling well continued.  On 10/25/15, pt noted that she had enlarged lymph nodes in her left axilla and left arm to her left elbow.  Pt was examined on 11/26/15 and was noted to have normal CBC and to be without fever.  Symptoms persisted and continued to worsen over 10/27/15 and 10/28/15.  Pt was re-examined on 10/28/15 and was found to have more enlarged lymph nodes in the left axilla and left arm. Lymph nodes were tender and visibly swollen.  Pt has also developed tenderness around the ribs and lower back.  CBC on 10/28/15 was also normal.  Viral titers of Bartonella virus, CMV, EBV were drawn.  CK, Sedrate and mono spot were also drawn this day.  Pt was scheduled for an ultrasound of the left axilla and left breast.  10/29/15 pt called the office c/o worsening symptoms, increased pain and increased swelling of the left arm and left axilla. Pt went for u/s which showed enlarged lymph nodes and no other findings.  10/30/15 pt was re-examined in the physician office.  Lymph nodes were noted to have increased in size and swelling was noted in the left axilla and left arm.  Pt continues to c/o pain and generalized fatigue and malaise and body aches.  All viral titers that were drawn on 10/28/15 were normal. Pt was prescribed Dexamethasone 1mg to help with pain and swelling.  Pt also continues to take Ibuprofen/Tylenol as she has been doing through out the illness. Pt did receive her Flu Vaccine on 10/16 in her left deltoid. It was advised on 10/30/15 that pt is experiencing an adverse reaction to her flu vaccine.  All other causes have been ruled.  Advised to report adverse reaction.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count normal, Lymph node pain, Lymphadenopathy, Malaise, Mononucleosis heterophile test
Clinical narrative: Pt presented to the office on 10/26/15 and reports that she started having body aches and generally not feeling well on the evening of 10/20/15.  Symptoms progressed and patient states she developed arm pain the night of 10/21/15.  The arm pain and not feeling well continued.  On 10/25/15, pt noted that she had enlarged lymph nodes in her left axilla and left arm to her left elbow.  Pt was examined on 11/26/15 and was noted to have normal CBC and to be without fever.  Symptoms persisted and continued to worsen over 10/27/15 and 10/28/15.  Pt was re-examined on 10/28/15 and was found to have more enlarged lymph nodes in the left axilla and left arm. Lymph nodes were tender and visibly swollen.  Pt has also developed tenderness around the ribs and lower back.  CBC on 10/28/15 was also normal.  Viral titers of Bartonella virus, CMV, EBV were drawn.  CK, Sedrate and mono spot were also drawn this day.  Pt was scheduled for an ultrasound of the left axilla and left breast.  10/29/15 pt called the office c/o worsening symptoms, increased pain and increased swelling of the left arm and left axilla. Pt went for u/s which showed enlarged lymph nodes and no other findings.  10/30/15 pt was re-examined in the physician office.  Lymph nodes were noted to have increased in size and swelling was noted in the left axilla and left arm.  Pt continues to c/o pain and generalized fatigue and malaise and body aches.  All viral titers that were drawn on 10/28/15 were normal. Pt was prescribed Dexamethasone 1mg to help with pain and swelling.  Pt also continues to take Ibuprofen/Tylenol as she has been doing through out the illness. Pt did receive her Flu Vaccine on 10/16 in her left deltoid. It was advised on 10/30/15 that pt is experiencing an adverse reaction to her flu vaccine.  All other causes have been ruled.  Advised to report adverse reaction.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate, Tenderness
Clinical narrative: Pt presented to the office on 10/26/15 and reports that she started having body aches and generally not feeling well on the evening of 10/20/15.  Symptoms progressed and patient states she developed arm pain the night of 10/21/15.  The arm pain and not feeling well continued.  On 10/25/15, pt noted that she had enlarged lymph nodes in her left axilla and left arm to her left elbow.  Pt was examined on 11/26/15 and was noted to have normal CBC and to be without fever.  Symptoms persisted and continued to worsen over 10/27/15 and 10/28/15.  Pt was re-examined on 10/28/15 and was found to have more enlarged lymph nodes in the left axilla and left arm. Lymph nodes were tender and visibly swollen.  Pt has also developed tenderness around the ribs and lower back.  CBC on 10/28/15 was also normal.  Viral titers of Bartonella virus, CMV, EBV were drawn.  CK, Sedrate and mono spot were also drawn this day.  Pt was scheduled for an ultrasound of the left axilla and left breast.  10/29/15 pt called the office c/o worsening symptoms, increased pain and increased swelling of the left arm and left axilla. Pt went for u/s which showed enlarged lymph nodes and no other findings.  10/30/15 pt was re-examined in the physician office.  Lymph nodes were noted to have increased in size and swelling was noted in the left axilla and left arm.  Pt continues to c/o pain and generalized fatigue and malaise and body aches.  All viral titers that were drawn on 10/28/15 were normal. Pt was prescribed Dexamethasone 1mg to help with pain and swelling.  Pt also continues to take Ibuprofen/Tylenol as she has been doing through out the illness. Pt did receive her Flu Vaccine on 10/16 in her left deltoid. It was advised on 10/30/15 that pt is experiencing an adverse reaction to her flu vaccine.  All other causes have been ruled.  Advised to report adverse reaction.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan abnormal, Vaccination complication
Clinical narrative: Pt presented to the office on 10/26/15 and reports that she started having body aches and generally not feeling well on the evening of 10/20/15.  Symptoms progressed and patient states she developed arm pain the night of 10/21/15.  The arm pain and not feeling well continued.  On 10/25/15, pt noted that she had enlarged lymph nodes in her left axilla and left arm to her left elbow.  Pt was examined on 11/26/15 and was noted to have normal CBC and to be without fever.  Symptoms persisted and continued to worsen over 10/27/15 and 10/28/15.  Pt was re-examined on 10/28/15 and was found to have more enlarged lymph nodes in the left axilla and left arm. Lymph nodes were tender and visibly swollen.  Pt has also developed tenderness around the ribs and lower back.  CBC on 10/28/15 was also normal.  Viral titers of Bartonella virus, CMV, EBV were drawn.  CK, Sedrate and mono spot were also drawn this day.  Pt was scheduled for an ultrasound of the left axilla and left breast.  10/29/15 pt called the office c/o worsening symptoms, increased pain and increased swelling of the left arm and left axilla. Pt went for u/s which showed enlarged lymph nodes and no other findings.  10/30/15 pt was re-examined in the physician office.  Lymph nodes were noted to have increased in size and swelling was noted in the left axilla and left arm.  Pt continues to c/o pain and generalized fatigue and malaise and body aches.  All viral titers that were drawn on 10/28/15 were normal. Pt was prescribed Dexamethasone 1mg to help with pain and swelling.  Pt also continues to take Ibuprofen/Tylenol as she has been doing through out the illness. Pt did receive her Flu Vaccine on 10/16 in her left deltoid. It was advised on 10/30/15 that pt is experiencing an adverse reaction to her flu vaccine.  All other causes have been ruled.  Advised to report adverse reaction.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Rash: 1-3 mm red maculopapular rash on trunk and exptremities that spread to the face and hand and feet.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Extreme soreness in the upper arm that didn't go away after the first few days after the vaccine.  Pain has continued in the upper arm and there has been a loss of motion in the shoulder.  Will also be following up with my Dr. to ensure this isn't a side effect or issue in how the vaccine was administered.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Chills, Heart rate increased, Injection site erythema, Injection site swelling
Clinical narrative: Fever, (100.7), chills, rapid heart beat, (125 beats per minute)elevated blood pressure (193/114) muscle aches, swollen and red at site of injection.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, (100.7), chills, rapid heart beat, (125 beats per minute)elevated blood pressure (193/114) muscle aches, swollen and red at site of injection.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness and nausea.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Orthopaedic examination abnormal
Clinical narrative: Patient mentioned belief the vaccination was given too high  in the shoulder, not the deltoid muscle. Patient voiced,  "It hurt pretty bad the first two days. I could tell the puncture hole was more near the shoulder instead of the muscle... And, now I can barely move the [left arm] at the shoulder joint I made an appointment with my primary care for tomorrow." She states when not moving the shoulder joint the discomfort level is a "2-3" on a scale of 1 to 10, 10 being the most painful. However, with shoulder movement, the pain elevates to a "7 or something especially when I abduct my arm."
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient mentioned belief the vaccination was given too high  in the shoulder, not the deltoid muscle. Patient voiced,  "It hurt pretty bad the first two days. I could tell the puncture hole was more near the shoulder instead of the muscle... And, now I can barely move the [left arm] at the shoulder joint I made an appointment with my primary care for tomorrow." She states when not moving the shoulder joint the discomfort level is a "2-3" on a scale of 1 to 10, 10 being the most painful. However, with shoulder movement, the pain elevates to a "7 or something especially when I abduct my arm."
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Acute respiratory distress syndrome, Chills, Coma, Dizziness
Clinical narrative: Severe headache, dizziness, extreme high blood pressure, vomited 5 times, stomach pain, and unstoppable shivering. Went to Hospital. I went in to coma. I was put on ventilator and then to a Rotating Bed. Was in a coma for ~2 weeks.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hypertension, Laboratory test, Mechanical ventilation, Vomiting
Clinical narrative: Severe headache, dizziness, extreme high blood pressure, vomited 5 times, stomach pain, and unstoppable shivering. Went to Hospital. I went in to coma. I was put on ventilator and then to a Rotating Bed. Was in a coma for ~2 weeks.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Induration, Pain, Skin warm
Clinical narrative: Mother text me a picture of daughters arm around 7 pm on 10/29/15. Are is hard and has an area of redness the size was 3 inches by 4 inches. Daughter complained of area hurting and was very hot. This am (10/30/2015) mother sent picture and redness is lighter but is larger and arm has a darker center like a bruise. Daughter says arm does not hurt like last night.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Heart rate increased, Injection site movement impairment, Mobility decreased
Clinical narrative: Mom called: Reported that child started with onset of temp of 104, increase heart rate and limited use of legs. Recommended that Pt go to ED for evaluation.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme pain in left arm from elbow to wrist; inability to easily move arm.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at injection Site immediately.  Pain continues intermittently  to present time. Pain is at shoulder and also more often Between should and elbow of left arm.  Shot administered to left arm.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity, X-ray limb abnormal
Clinical narrative: Onset about three hours after injection.  Patient states injection site seemed too high on shoulder.  Developed local pain.  Pain in shoulder joint.  Spread down arm.  Unable to lift arm.  Ongoing pain for many months.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Child's arm was red and hot to the touch in the shoulder area.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Respiratory disorder
Clinical narrative: Mild rash with signs of airway compromise. Went to ER prescribe inhaler and prednisone.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Swollen tongue
Clinical narrative: Severe arm, neck, and shoulder pain reported as 12 in a scale of 1-10. First year for HD, bad enough she will refuse in the future. Slight tongue swelling.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain
Clinical narrative: Extreme pain in right shoulder joint, bursa and clavicle area.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Ear pain, Headache, Oesophageal discomfort
Clinical narrative: 2 hours after vaccination noticed 2 hives on LLE, 4 hours after vaccination symptoms exacerbated to severe headache, ear pain, swollen facial features, periorbital edema, jaw pain, esophageal tightening, sternal tightening, SOB, PVC's, tachycardia; symptoms lasting for 1 1/2 hours. Symptoms subsided for 30 minutes, next round of same symptoms as above recurred for another 30 minutes. Took 325mg aspirin after 2nd round of symptoms. Notified Dr. 9/10/2015 at approximately 0800. Pt did not seek medical treatment.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in jaw, Periorbital oedema, Swelling face, Tachycardia, Urticaria
Clinical narrative: 2 hours after vaccination noticed 2 hives on LLE, 4 hours after vaccination symptoms exacerbated to severe headache, ear pain, swollen facial features, periorbital edema, jaw pain, esophageal tightening, sternal tightening, SOB, PVC's, tachycardia; symptoms lasting for 1 1/2 hours. Symptoms subsided for 30 minutes, next round of same symptoms as above recurred for another 30 minutes. Took 325mg aspirin after 2nd round of symptoms. Notified Dr. 9/10/2015 at approximately 0800. Pt did not seek medical treatment.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Ventricular extrasystoles
Clinical narrative: 2 hours after vaccination noticed 2 hives on LLE, 4 hours after vaccination symptoms exacerbated to severe headache, ear pain, swollen facial features, periorbital edema, jaw pain, esophageal tightening, sternal tightening, SOB, PVC's, tachycardia; symptoms lasting for 1 1/2 hours. Symptoms subsided for 30 minutes, next round of same symptoms as above recurred for another 30 minutes. Took 325mg aspirin after 2nd round of symptoms. Notified Dr. 9/10/2015 at approximately 0800. Pt did not seek medical treatment.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Tremor/shakiness- strong tremor
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain, Pain, Rhinorrhoea
Clinical narrative: pt complained of bruising and site of injection and pain going down arm. Also had body aches and runny nose for 1 week. pt instructed to ask doctor and apply ice for bruising
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: RED RASH AROUND INJECTION SITE.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Apnoea, Decreased appetite, Diarrhoea, Head titubation, Pyrexia
Clinical narrative: Fever 104.7, body rash, apnea, head violently shaking while sleeping (seizures?), inconsolable screaming for days, loss of appetite, vomiting, diarrhea.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Rash generalised, Screaming, Vomiting
Clinical narrative: Fever 104.7, body rash, apnea, head violently shaking while sleeping (seizures?), inconsolable screaming for days, loss of appetite, vomiting, diarrhea.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Arm was sore immediately following shot.  In the evening on 10-28, upper arm became red, hot, inflamed, swollen, itchy, and painful from shoulder to elbow.  Treated with recommended Benadryl and Motrin every 6 hours and iced frequently.  Morning of 10-29 swelling and redness had decreased.  By the evening of 10-29 swelling, redness, hotness, and itch came back worse than the morning.  Went to Urgent care and was prescribed steroids and antibiotic for allergic reaction and possible infection.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Arm was sore immediately following shot.  In the evening on 10-28, upper arm became red, hot, inflamed, swollen, itchy, and painful from shoulder to elbow.  Treated with recommended Benadryl and Motrin every 6 hours and iced frequently.  Morning of 10-29 swelling and redness had decreased.  By the evening of 10-29 swelling, redness, hotness, and itch came back worse than the morning.  Went to Urgent care and was prescribed steroids and antibiotic for allergic reaction and possible infection.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Arm was sore immediately following shot.  In the evening on 10-28, upper arm became red, hot, inflamed, swollen, itchy, and painful from shoulder to elbow.  Treated with recommended Benadryl and Motrin every 6 hours and iced frequently.  Morning of 10-29 swelling and redness had decreased.  By the evening of 10-29 swelling, redness, hotness, and itch came back worse than the morning.  Went to Urgent care and was prescribed steroids and antibiotic for allergic reaction and possible infection.
Age: 31.0
Sex: M
Vaccine: FLUC3
Symptoms: Pain in extremity
Clinical narrative: Patient presented for an appointment with the provider 10/28/15 c/o right arm pain since receiving a flu shot 09/15/15.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Acute kidney injury, Back pain, Chills, Computerised tomogram, Dehydration
Clinical narrative: Started getting a golf ball sized knot in my left neck area several hours after I received the flu shot and the pneumonia and Tdap that I was recommended by the pharmacy workers because I had small kids at home.  Felt very bad that night cold chills shivers, low grade fever and a stiff neck. Went to work on 26th, had same symptoms all day. Coworkers stated I looked terrible. Went home took a hot shower n went to bed before dark. Went to work on the 27th and had diarrhea and felt nauseous. I went out patrolling as I am a Sheriffs Deputy. Around 9 am I started feeling much worse and was trying to drive back to my office to tell my boss I needed to go to the Emergency Room. Prior to making it to the office I was driving and my vision started fading out and it suddenly went bright white and the next thing I know was waking up to a large bump from hitting a curb.  During the time I blacked out I crossed two lanes of on coming traffic hit a curb and almost took out several feet of fence with my patrol truck. After a few minutes my vision came back enough to drive 2 miles to my office where I met my Sgt. He advised me to take my shirt off and cool down.  I was sweating really bad.  I called my wife and she came and took me to the Emergency room. I had BP of 80/50 during admission, acute renal failure and dehydration.  I was admitted into the hospital for 3 1/2 days. I now have pain in my lower back, legs, feet and hand.  I have been referred to a spine specialists and a neurologist.  It's been 35 days and my symptoms are worsening.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Diarrhoea, Feeling abnormal, Hyperhidrosis, Laboratory test, Loss of consciousness
Clinical narrative: Started getting a golf ball sized knot in my left neck area several hours after I received the flu shot and the pneumonia and Tdap that I was recommended by the pharmacy workers because I had small kids at home.  Felt very bad that night cold chills shivers, low grade fever and a stiff neck. Went to work on 26th, had same symptoms all day. Coworkers stated I looked terrible. Went home took a hot shower n went to bed before dark. Went to work on the 27th and had diarrhea and felt nauseous. I went out patrolling as I am a Sheriffs Deputy. Around 9 am I started feeling much worse and was trying to drive back to my office to tell my boss I needed to go to the Emergency Room. Prior to making it to the office I was driving and my vision started fading out and it suddenly went bright white and the next thing I know was waking up to a large bump from hitting a curb.  During the time I blacked out I crossed two lanes of on coming traffic hit a curb and almost took out several feet of fence with my patrol truck. After a few minutes my vision came back enough to drive 2 miles to my office where I met my Sgt. He advised me to take my shirt off and cool down.  I was sweating really bad.  I called my wife and she came and took me to the Emergency room. I had BP of 80/50 during admission, acute renal failure and dehydration.  I was admitted into the hospital for 3 1/2 days. I now have pain in my lower back, legs, feet and hand.  I have been referred to a spine specialists and a neurologist.  It's been 35 days and my symptoms are worsening.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Nausea, Nodule, Nuclear magnetic resonance imaging
Clinical narrative: Started getting a golf ball sized knot in my left neck area several hours after I received the flu shot and the pneumonia and Tdap that I was recommended by the pharmacy workers because I had small kids at home.  Felt very bad that night cold chills shivers, low grade fever and a stiff neck. Went to work on 26th, had same symptoms all day. Coworkers stated I looked terrible. Went home took a hot shower n went to bed before dark. Went to work on the 27th and had diarrhea and felt nauseous. I went out patrolling as I am a Sheriffs Deputy. Around 9 am I started feeling much worse and was trying to drive back to my office to tell my boss I needed to go to the Emergency Room. Prior to making it to the office I was driving and my vision started fading out and it suddenly went bright white and the next thing I know was waking up to a large bump from hitting a curb.  During the time I blacked out I crossed two lanes of on coming traffic hit a curb and almost took out several feet of fence with my patrol truck. After a few minutes my vision came back enough to drive 2 miles to my office where I met my Sgt. He advised me to take my shirt off and cool down.  I was sweating really bad.  I called my wife and she came and took me to the Emergency room. I had BP of 80/50 during admission, acute renal failure and dehydration.  I was admitted into the hospital for 3 1/2 days. I now have pain in my lower back, legs, feet and hand.  I have been referred to a spine specialists and a neurologist.  It's been 35 days and my symptoms are worsening.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Ultrasound scan, Visual impairment
Clinical narrative: Started getting a golf ball sized knot in my left neck area several hours after I received the flu shot and the pneumonia and Tdap that I was recommended by the pharmacy workers because I had small kids at home.  Felt very bad that night cold chills shivers, low grade fever and a stiff neck. Went to work on 26th, had same symptoms all day. Coworkers stated I looked terrible. Went home took a hot shower n went to bed before dark. Went to work on the 27th and had diarrhea and felt nauseous. I went out patrolling as I am a Sheriffs Deputy. Around 9 am I started feeling much worse and was trying to drive back to my office to tell my boss I needed to go to the Emergency Room. Prior to making it to the office I was driving and my vision started fading out and it suddenly went bright white and the next thing I know was waking up to a large bump from hitting a curb.  During the time I blacked out I crossed two lanes of on coming traffic hit a curb and almost took out several feet of fence with my patrol truck. After a few minutes my vision came back enough to drive 2 miles to my office where I met my Sgt. He advised me to take my shirt off and cool down.  I was sweating really bad.  I called my wife and she came and took me to the Emergency room. I had BP of 80/50 during admission, acute renal failure and dehydration.  I was admitted into the hospital for 3 1/2 days. I now have pain in my lower back, legs, feet and hand.  I have been referred to a spine specialists and a neurologist.  It's been 35 days and my symptoms are worsening.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Computerised tomogram, Dysarthria, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Shot given at 2:30pm on 9/30/15. Within 1 hr. pt. experienced leg weakness, slurred speech, sedation. Diagnosed on 10/2/15 w/ stroke. Note: PREVNAR 13 given 2 weeks prior to Flu shot.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Sedation
Clinical narrative: Shot given at 2:30pm on 9/30/15. Within 1 hr. pt. experienced leg weakness, slurred speech, sedation. Diagnosed on 10/2/15 w/ stroke. Note: PREVNAR 13 given 2 weeks prior to Flu shot.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest pain, Differential white blood cell count normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: Chest pain, SOB, presyncope, headache, tachycardia.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count normal, Headache, Metabolic function test normal, Presyncope, Tachycardia
Clinical narrative: Chest pain, SOB, presyncope, headache, tachycardia.
Sex: U
Vaccine: PNC13
Symptoms: Cardiac arrest, Dizziness, Loss of consciousness, Product packaging issue, Pulse absent
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVENAR 13 on unknown date, at single dose. Medical history and concomitant medications were not provided. On an unknown date the patient heart stopped, passed out, was unresponsive, stopped breathing with no respirations, he had no pulse, felt dizzy, got him on to the floor. The patient received few chest compressions. Furthermore there was not new package insert at all. Events outcome was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVENAR 13 on unknown date, at single dose. Medical history and concomitant medications were not provided. On an unknown date the patient heart stopped, passed out, was unresponsive, stopped breathing with no respirations, he had no pulse, felt dizzy, got him on to the floor. The patient received few chest compressions. Furthermore there was not new package insert at all. Events outcome was unknown.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 66-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. On unknown date, the patient experienced a cellulitis in the left arm 6 inch approximately. The patient was treated for the cellulitis with rx antibiotic. The outcome of the event was unknown.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Initial solicited case received on 20 October 2015 from the investigator in a trial. Seriousness criteria-other: important medical event. This case involves a 34-year-old male subject who developed non-specific myocarditis during the study participation. The subject had medical history of numbness or paralysis. The subject received a first dose of anthrax vaccine concomitantly on 27 August 2015 and Japanese encephalitis vaccine on 27 August 2015. On 29 September 2015, 11 days after receiving a dose of ACAM2000 on 18 September 2015 (batch number, route and site of administration not reported), the subject had non-specific myocarditis and on 30 September 2015, 12 days after receiving a dose of ACAM2000 on 18 September 2015, the subject had acute myocardial infarction, unspecified site. The subject's blood test done on 30 September 2015 recorded the highest value of Troponin I as 03.79 which was abnormal. The subject had an electrocardiogram (ECG) done on 29 September 2015 was normal and echocardiogram done on 30 September 2015 was normal. MRI (brain, spinal cord and heart) and lumbar puncture (spinal tap) was not performed. The subject's corrective treatment was not reported. Outcome of the event non-specific myocarditis and acute myocardial infarction, unspecified site was not reported. Relationship to investigational product according to Reporter: not reported. Relationship to investigational product according to company: associated. Whether the serious adverse event led to the termination of the subject from the study or not was not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Inflammation, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt. received PNEUMOVAX 23 and AFLURIA vaccine in the same arm (1 inch apart) the morning at 8:30 at (pt work location) as part of a flu clinic -> came in at 3:15 with severe sore and swollen arm. Arm warm to touch and stiff and sore arm with limited ability of movement. Pt also says she has a mucus sensation in her chest. Advised her that I will inform her Dr. and for her to take ibuprofen for the inflammation and pain.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt. received PNEUMOVAX 23 and AFLURIA vaccine in the same arm (1 inch apart) the morning at 8:30 at (pt work location) as part of a flu clinic -> came in at 3:15 with severe sore and swollen arm. Arm warm to touch and stiff and sore arm with limited ability of movement. Pt also says she has a mucus sensation in her chest. Advised her that I will inform her Dr. and for her to take ibuprofen for the inflammation and pain.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Nodule, Rash, Skin warm
Clinical narrative: Vaccine was administered on a Friday night. Patient came in on Sunday and said she had a rash in 2 places on upper arm, a small knot, and arm was feverish. Patient went to her doctor on Monday, who said she was fine. Followed up with patient on 10/16/15 and she said it was all gone and she is fine.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Hypophagia, Pyrexia
Clinical narrative: Fevers began night of vaccines to 101.5F continued for at least 3 days when seen by this MD. Taking TYLENOL, MOTRIN with some improvement. Poor oral intake. No vomiting, diarrhea, rash.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Condition aggravated, Feeling abnormal, Seizure
Clinical narrative: Approximately 24 hours after receiving hi dose flu shot, patient suffered for about 5 hours. She had a seizure and mostly aphasia. She felt like she was dying. She did not want to go to the hospital.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Reaction occurred on upper arm on bicep, not at injection site. Redness, hard to the touch, warm to the touch, approx. 1 or 1 1/2 inch diameter.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Reaction occurred on upper arm on bicep, not at injection site. Redness, hard to the touch, warm to the touch, approx. 2 inch diameter.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Metabolic function test, Pruritus, Swelling face
Clinical narrative: Onset 1 hr. post injection - facial itching - PO BENADRYL 25mg 2 hrs. after injection - left sided facial swelling - no airway obstruction - BENADRYL 50 mg IM with no relief. Taken to ER via ambulance discharged same day.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Myalgia, Pain
Clinical narrative: Muscle aches and pain and weakness. Pt rested to recover. Took TYLENOL 500 mg 1 dose only. Per pt did strenuous long walk for 2 miles then got sick.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: A rash developed at the injection site on the lateral side of the left arm approximately 4-5 inches in diameter. The rash improved with no treatment.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pain, Pyrexia
Clinical narrative: Pt received flu shot on 10/22/15 and then called pharmacy 10/23/15 approx. 12 PM and stated that he was achy, short of breath and fever. Recommended TYLENOL for fever and follow up w/ MD regarding breathing.
Age: 69.0
Sex: M
Vaccine: FLUC3
Symptoms: Abasia, Confusional state, Discomfort, Dizziness, Nausea
Clinical narrative: 10/15 shot given approx. 1:30 PM. About 3:30 extremely dizzy, unable to walk safely. Nausea and mental confusion. Extreme discomfort which continued throughout next day 10/16. Around sunset began to recover and finally did 10/17 morning. This Flu shot will be my last one, at 70 don't want to die next time from a second Flu shot.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pruritus
Clinical narrative: Patient has no hx of flu shot reactions. Received flu shot in AM. By the afternoon, he developed "itching and diarrhea". The following afternoon he went to ED for PO prednisone.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Headache, Influenza, Injection site pain, Pain
Clinical narrative: Fever, chills, achy, flu symptoms - headache - lasted approximately 24 hours and soreness at injection site on right arm (PREVNAR) only for about 4 days.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever, chills, achy, flu symptoms - headache - lasted approximately 24 hours and soreness at injection site on right arm (PREVNAR) only for about 4 days.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Eyelid function disorder, Hypoaesthesia oral, VIIth nerve paralysis, Visual impairment
Clinical narrative: Left sided mouth numbness, right sided facial drooping. Unable to blink right eye. Visual changes. Bell's palsy, right.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received Tdap (R) deltoid, IIV-3 Flu shot in (L) deltoid 10/16/15. Called provider on 10/19 to report reactions 2 days after shot, had redness and swelling, itching, and tenderness in upper (R) arm. Swelling was as large as a jumbo egg, painful to touch.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: (L) arm red, swollen, warm to touch, hard.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Quarter size swelling at site with pain, redness and itching which increased slightly over the course of a few hours and gradually receded. No medical treatment sought.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Erythema, Swelling
Clinical narrative: Pt given flu vaccine left deltoid. 48 hours later pt has quarter size ecchymotic area and large area of redness and sl. swelling.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: I woke in pain in my shoulder. The pain was similiar to the day of/after I received the shot.  It hasn't gone away since.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rash under arms and around waist.  Patient went to urgent care where patient was given a shot and prednisone.  She states that rash has resolved as of this morning (10/30/15).
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pain, Swelling, Tenderness
Clinical narrative: Pain, swelling, tenderness x 7 days; denies fever, nausea, vomiting, or any other symptom aside from lingering local injection site pain.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red, warm, rash around injection sites.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: My middle finger of the arm that was vaccinated began to hurt and stiffen up. I was unable to bend my finger at the top knuckle without pain. This lasted for 2 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Asthma, Condition aggravated
Clinical narrative: Diarrhea, vomiting, pain in all joints, extreme headache, dizzy, weak, had to be helped to bathroom. Numbness in right side of right thigh, confusion, asthma became severe enough to use a neblulizer, cannot swallow without sitting straight up, hoarseness earaches.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Decreased appetite, Diarrhoea, Dizziness, Dysphagia
Clinical narrative: Diarrhea, vomiting, pain in all joints, extreme headache, dizzy, weak, had to be helped to bathroom. Numbness in right side of right thigh, confusion, asthma became severe enough to use a neblulizer, cannot swallow without sitting straight up, hoarseness earaches.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Ear pain, Headache, Hypoaesthesia, Nausea
Clinical narrative: Diarrhea, vomiting, pain in all joints, extreme headache, dizzy, weak, had to be helped to bathroom. Numbness in right side of right thigh, confusion, asthma became severe enough to use a neblulizer, cannot swallow without sitting straight up, hoarseness earaches.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Diarrhea, vomiting, pain in all joints, extreme headache, dizzy, weak, had to be helped to bathroom. Numbness in right side of right thigh, confusion, asthma became severe enough to use a neblulizer, cannot swallow without sitting straight up, hoarseness earaches.
Age: 86.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Pt complaining left upper arm painful around injection site no redness, swelling or fever noted. Take OTC TYLENOL. Apply ice or heat.