chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.88
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Abscess drainage, Bacterial test negative, C-reactive protein decreased, Injection site abscess, Injection site oedema
Clinical narrative: Information has been received from an investigator concerning an 11 month old male patient (AN#81318) with no concurrent conditions or medical history who entered a study. On 22-OCT-2012, consent was obtained. On 25-OCT-2012, the patient was randomized and was vaccinated with the first dose of MK-V419 STUDY dose 1, intramuscularly 2, 4, and 11 to 12 months of age. Other suspect therapies included first dose of rotavirus vaccine, oral and first dose of PREVENAR 13, intramuscularly on 25-OCT-2013 to complete the childhood immunization series. On 11-Dec-2012 the subject was vaccinated intramuscularly with the second dose (0.5ml) of MK-V419 STUDY. The subject was also vaccinated with the second dose (2.0ml) of rotavirus vaccine, oral and the second dose intramuscularly (0.5 ml) of PREVENAR 13 to complete the childhood immunization series. On 10-JAN-2013, the patient was vaccinated orally with the third dose of rotavirus vaccine to complete the childhood immunization series. On 15-JUL-2013, the patient was vaccinated intramuscularly with the third dose of MK-V419 STUDY. The patient was also vaccinated orally with the third dose intramuscularly with PREVENAR 13 to complete the childhood immunization series. There was no concomitant therapy, no secondary suspect therapy and no previous therapy history. On 13-AUG-2013, the patient experienced abscess on left thigh of severe intensity and was hospitalized on 24-SEP-2013. An ultrasound was done on the day of admission. Results showed liquid bubble of 12 mm of diameter, resembling pus, surrounded by edematous tissue sized 15x12x19mm. Other tests done on that date were: p-CRP-O, which was below 5mg/L; and normal, negative bacterial staining, culture and NhO (to be clarified). The abscess was drained under general anesthesia. A single dose of pre-operative intravenous cefuroxime (dose unknown) was administered. On 25-SEP-2013, the patient recovered from abscess on left thigh and was discharged from the hospital. The action taken with study therapy was none. The reporting investigator considered that abscess on left thigh was related to the third injection of blinded therapy, since the abscess was located on the injection site. The investigator is of the opinion that the event could have been induced either by the vaccine or the procedure. The investigator considered abscess on left thigh to be not related to PREVENAR 13 and rotavirus vaccine, oral. Additional information is expected. Follow-up information was received on 08-Oct-2013 from the investigator. Causality assessment was changed and rationale was provided. Injection cycles were provided complete. Weight, age at onset of event, intensity of event, diagnostic tests and treatment of event were also added. SAE stop date was confirmed. The record for this patient was unblinded on 11-Oct-2013.
Age: 0.88
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Ultrasound scan abnormal
Clinical narrative: Information has been received from an investigator concerning an 11 month old male patient (AN#81318) with no concurrent conditions or medical history who entered a study. On 22-OCT-2012, consent was obtained. On 25-OCT-2012, the patient was randomized and was vaccinated with the first dose of MK-V419 STUDY dose 1, intramuscularly 2, 4, and 11 to 12 months of age. Other suspect therapies included first dose of rotavirus vaccine, oral and first dose of PREVENAR 13, intramuscularly on 25-OCT-2013 to complete the childhood immunization series. On 11-Dec-2012 the subject was vaccinated intramuscularly with the second dose (0.5ml) of MK-V419 STUDY. The subject was also vaccinated with the second dose (2.0ml) of rotavirus vaccine, oral and the second dose intramuscularly (0.5 ml) of PREVENAR 13 to complete the childhood immunization series. On 10-JAN-2013, the patient was vaccinated orally with the third dose of rotavirus vaccine to complete the childhood immunization series. On 15-JUL-2013, the patient was vaccinated intramuscularly with the third dose of MK-V419 STUDY. The patient was also vaccinated orally with the third dose intramuscularly with PREVENAR 13 to complete the childhood immunization series. There was no concomitant therapy, no secondary suspect therapy and no previous therapy history. On 13-AUG-2013, the patient experienced abscess on left thigh of severe intensity and was hospitalized on 24-SEP-2013. An ultrasound was done on the day of admission. Results showed liquid bubble of 12 mm of diameter, resembling pus, surrounded by edematous tissue sized 15x12x19mm. Other tests done on that date were: p-CRP-O, which was below 5mg/L; and normal, negative bacterial staining, culture and NhO (to be clarified). The abscess was drained under general anesthesia. A single dose of pre-operative intravenous cefuroxime (dose unknown) was administered. On 25-SEP-2013, the patient recovered from abscess on left thigh and was discharged from the hospital. The action taken with study therapy was none. The reporting investigator considered that abscess on left thigh was related to the third injection of blinded therapy, since the abscess was located on the injection site. The investigator is of the opinion that the event could have been induced either by the vaccine or the procedure. The investigator considered abscess on left thigh to be not related to PREVENAR 13 and rotavirus vaccine, oral. Additional information is expected. Follow-up information was received on 08-Oct-2013 from the investigator. Causality assessment was changed and rationale was provided. Injection cycles were provided complete. Weight, age at onset of event, intensity of event, diagnostic tests and treatment of event were also added. SAE stop date was confirmed. The record for this patient was unblinded on 11-Oct-2013.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Nasal oedema, Swelling face
Clinical narrative: Face swelling around eyes and nose.  Swollen nasal turbinates.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Haematochezia
Clinical narrative: Blood in stool.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Difficulty breathing, chest pain, followed with fatigue, chills and then fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Patient has redness and swelling at injection site. She is also experiencing blisters and itching at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash under left breast and left thoracic back around T4-T5 dermatome.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Swelling in arm.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: RED 3 INCH LONG CIRCLE ON DELTOID AREA. WARM TO TOUCH.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: I started having a headache on the day of the vaccination. I thought it would just go away, but I had it for 7 days. I took Advil initially. Then the 2nd day, I took an Imitrex. The headache still did not go away. I took Advil over the next couple of days. I went to Employee Health on 10/7/13, because the headache would not go away. I was given Phenergan which I took on the 7th at bedtime. The headache ws dulled but still there. It went away on 10/9/13.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac enzymes normal, Computerised tomogram head, Computerised tomogram normal, Dry mouth, Echocardiogram normal
Clinical narrative: Tingling/numbness in left wrist, sharp pain in neck (as if getting a stiff neck) followed by facial numbness on left side (same side as shot was administered), followed by dry mouth. Tingling/numbness in wrist resolved within 10 minutes, pain in neck resolved within 20 minutes, facial numbness and excessive thirst began subsiding in about 7 hours.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Neck pain, Paraesthesia, Thirst, Ultrasound Doppler
Clinical narrative: Tingling/numbness in left wrist, sharp pain in neck (as if getting a stiff neck) followed by facial numbness on left side (same side as shot was administered), followed by dry mouth. Tingling/numbness in wrist resolved within 10 minutes, pain in neck resolved within 20 minutes, facial numbness and excessive thirst began subsiding in about 7 hours.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan normal
Clinical narrative: Tingling/numbness in left wrist, sharp pain in neck (as if getting a stiff neck) followed by facial numbness on left side (same side as shot was administered), followed by dry mouth. Tingling/numbness in wrist resolved within 10 minutes, pain in neck resolved within 20 minutes, facial numbness and excessive thirst began subsiding in about 7 hours.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Loss of consciousness, Pallor
Clinical narrative: 1 MINUTE AFTER RECEIVING HIS FLU SHOT AND HPV VACCINE HE APPEARED TO SEIZURE, HIS ARMS STARTING FLAILING AND HIS HANDS STARTED CLENCHING AND RELEASING. HE TURNED VERY PALE AND WENT UNCONSCIOUS. JUST BEFORE HE LOST CONSCIOUSNESS HIS EYES ROLLED IN HIS HEAD.
Age: 11.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Fall, Haemorrhage, Head injury, Loss of consciousness, Syncope
Clinical narrative: At 10:30 AM patient received two shots and stated he felt fine.  He and his mother went to the waiting room and at 10:38, patient fainted and fell, striking forehead on counter.  He had a approx. 5 cm open wound on his forehead, that was bleeding.  911 was called, pressure gauze was applied to wound, legs were elevated, and vitals were assessed. Patient was conscious within seconds. Patient was assessed by a Nurse Practioner until EMS arrived.
Age: 11.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Wound
Clinical narrative: At 10:30 AM patient received two shots and stated he felt fine.  He and his mother went to the waiting room and at 10:38, patient fainted and fell, striking forehead on counter.  He had a approx. 5 cm open wound on his forehead, that was bleeding.  911 was called, pressure gauze was applied to wound, legs were elevated, and vitals were assessed. Patient was conscious within seconds. Patient was assessed by a Nurse Practioner until EMS arrived.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Dysphagia, Dyspnoea, Pain
Clinical narrative: Cough, couldn't swallow, labored breathing, chills, fever, vomiting, body aches.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Cough, couldn't swallow, labored breathing, chills, fever, vomiting, body aches.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis, X-ray
Clinical narrative: As reaching for binoculars, experienced extreme pain in right shoulder area.  After having X-rays and MRI, was diagnosed with "frozen shoulder".  Received 3 cortisone injections, multiple physical therapy visits, and pain medication.  After receiving no relief, I changed orthopedic surgeons.  I am now scheduled for "manipulation under anesthesia" with arthroscopic release from Dr. on 11/5/13.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient passed out and felt light-headed after shots.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye inflammation, Eye pruritus, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Left eye red, itchy and weeping.  By 1:00pm on 10/10/2013, both eyes were red and bloodshot and very light sensitive.  Also, I believe that eye draining into nose and throat, responsible for sore throat.  As of 10/11/2013 1:15 PM PDT, while symptoms were better, eyes were still inflamed.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Photophobia
Clinical narrative: Left eye red, itchy and weeping.  By 1:00pm on 10/10/2013, both eyes were red and bloodshot and very light sensitive.  Also, I believe that eye draining into nose and throat, responsible for sore throat.  As of 10/11/2013 1:15 PM PDT, while symptoms were better, eyes were still inflamed.
Age: 13.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Feeling hot, Headache, Pallor, Vomiting
Clinical narrative: 5 minutes after shots patient complained felt light headed, dizzy, headache, complained of feeling hot, room was warm in temperature, pallor noted, no anaphylaxis noted, no shortness of breath. Blood pressure monitored 92/54, 86/51 by EMS personnel/co-located with EMS. Patient did vomit small amount, had not eaten prior to vaccines since 7:30 PM night before. Patient rested 45 minutes and then felt better, mom took her home.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dry eye, Eye discharge, Eye pruritus, Hypoaesthesia oral
Clinical narrative: Tightness in chest, throat irritation, developed productive cough. Eyes dry, itchy, eatery, feel mattery. Lower lip numb and tinglingly, feels like novacaine shot.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Paraesthesia oral, Productive cough, Throat irritation
Clinical narrative: Tightness in chest, throat irritation, developed productive cough. Eyes dry, itchy, eatery, feel mattery. Lower lip numb and tinglingly, feels like novacaine shot.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Swelling face
Clinical narrative: Received phone call from patient who reports shortly after receiving vaccine she noticed swelling in her jaw and into her neck on her L side, the side where she received the injection.  She took some Benadryl and the swelling has gone down.  She is going to take Benadryl again tonight.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia
Clinical narrative: Have lost sense of taste since receiving the flu vaccine.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Herpes zoster, Hyperaesthesia, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph node (right under arm), sore right arm, hypersensitive skin on right side of body and scalp, blister sores under right arm. Within five days blister sores on right side of Che's, down right arm and on right side of back. Diagnosed with shingles on 10/09/2013.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Deafness, Dizziness, Headache, Pain in extremity
Clinical narrative: States at 1501 she received her Influenza vaccine and then went up to work.  States she was cleaning up in an OR room about 1510.  States her hearing was foggy, then she couldn't hear anything, co-workers said she looked white and then sat her down and brought her down to Employee Health.  Arrived in EHS about 1525 and states she has a headache and her arm hurts from the flu shot.  States she feels better but a little dizzy, states she can hear and see. Instructed to rest and lay down.  Employee took her blood sugar and it was 100.  BP was 98/60 in EHS.  By 4:00 PM states her arm hurts, denies headache or dizziness or vertigo. P Drda RN
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: States at 1501 she received her Influenza vaccine and then went up to work.  States she was cleaning up in an OR room about 1510.  States her hearing was foggy, then she couldn't hear anything, co-workers said she looked white and then sat her down and brought her down to Employee Health.  Arrived in EHS about 1525 and states she has a headache and her arm hurts from the flu shot.  States she feels better but a little dizzy, states she can hear and see. Instructed to rest and lay down.  Employee took her blood sugar and it was 100.  BP was 98/60 in EHS.  By 4:00 PM states her arm hurts, denies headache or dizziness or vertigo. P Drda RN
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling, Pruritus
Clinical narrative: Arm is red, swollen. around 9:30 that night the arm began to itch. Fri Oct 11 arm is still red and swollen at injection site.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Site was itching x 1 week. No raised area. Received vaccine in left deltoid. Scratches on arm.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Crying, Headache, Influenza virus test negative, Pain
Clinical narrative: 8:15 started complaining of severe headache, body aches.  by 8:30 she was crying nonstop about how bad her body hurt, increasing headache, chills started.  By 9:00pm she was starting to run a fever around 100.7.  Gave her 325mg Tylenol.  Continues to cry throughout evening and symptoms worsened into the night.  By 1:30am 10/11/13 she was 103 degrees and more Tylenol was given.  By 4 she was 104.8 continues to cry how bad she hurts, head, stomach, anywhere to touch.  Gave her 200mg Motrin (which she doesn't usually tolerate well on her stomach).  She continued to run high fever into the morning.  More Tylenol given at 7 and called pediatrician at 8:15 to report symptoms.  Took her to drs office where she was examined.  Strep test was run and was negative.  Influenza nasal swab was checked and was negative.  Dr. thought possible virus.  Unsure of direct link between flu vaccine and illness.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Streptococcus test negative, Tenderness
Clinical narrative: 8:15 started complaining of severe headache, body aches.  by 8:30 she was crying nonstop about how bad her body hurt, increasing headache, chills started.  By 9:00pm she was starting to run a fever around 100.7.  Gave her 325mg Tylenol.  Continues to cry throughout evening and symptoms worsened into the night.  By 1:30am 10/11/13 she was 103 degrees and more Tylenol was given.  By 4 she was 104.8 continues to cry how bad she hurts, head, stomach, anywhere to touch.  Gave her 200mg Motrin (which she doesn't usually tolerate well on her stomach).  She continued to run high fever into the morning.  More Tylenol given at 7 and called pediatrician at 8:15 to report symptoms.  Took her to drs office where she was examined.  Strep test was run and was negative.  Influenza nasal swab was checked and was negative.  Dr. thought possible virus.  Unsure of direct link between flu vaccine and illness.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site persisted through night of injection, redness. Given Prednisone 40mg for three days then Prednisone 20mg for three days. Also given: Benadryl 25mg IM in office,  Prescription for Bactrim one tablet twice daily for 10 days and hydrocodone 5/325 one tablet every 6 hours as needed for pain.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Back pain
Clinical narrative: Pain in joints and lower back, can't walk, in lots of pain.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Migraine, Pain in extremity
Clinical narrative: Approximately 2 hours after receiving the shot the patient's arm that she had the injection in and that same hip hurt.  She also had migraines.  This lasted for 24-48 hours post vaccination.  She had no pain or swelling at injection site.  She self treated with aspirin and reported the event on 10/11/13.  She has had no other problems and is fine at this point.
Age: 61.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Fatigue, Injection site pain, Red blood cells urine positive
Clinical narrative: Patient developed very sore arm on L side where injection given, also complained of fatigue.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Eye irritation, Eye pruritus, Fatigue
Clinical narrative: Patient developed red itchy eyes about 3-4 hours after vaccine was given. She said they felt very scratchy. Took Benadryl for the itchy eyes. Upon follow-up at 6:30PM patient stated she was feeling more flu like symptom. Chills, weakness, stuffy nose, and tiredness. Unknown if she had a fever.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Nasal congestion, Ocular hyperaemia
Clinical narrative: Patient developed red itchy eyes about 3-4 hours after vaccine was given. She said they felt very scratchy. Took Benadryl for the itchy eyes. Upon follow-up at 6:30PM patient stated she was feeling more flu like symptom. Chills, weakness, stuffy nose, and tiredness. Unknown if she had a fever.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Eye pruritus, Malaise, Ocular hyperaemia
Clinical narrative: Patient developed red itchy eyes about 3-4 hours after vaccine was given and did not feel well. She left work to go to the emergency room about 3-4 hours later.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: I rec'd my Flu vaccine on 10/1/13 at the drive thru employee health clinic.  I suffered from left arm stiffness a few hours after the injection.  The left arm pain, tenderness and difficulty with range of motion remains 10 days post injection without relief to heat/Motrin/Tylenol.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever of 101, body aches, headache, congestion.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever of 100 degrees with soarness at the site and redness from the injection site down the arm reaching the elbow. Site was getting better each day. Instructed to continue Tylenol and cold compresses.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruising on underside of arm opposite deltoid where influenza vaccine was given.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Redness and bruising appearance at injection site reported by patient, gradually improving over 10 days. Patient reported 10-11-2013.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: The patient reported worsening skin reaction to Sanofi Pasteur intradermal vaccine beginning on her drive home from the store.  She states there was a burning sensation at the site of the injection and she developed a few localized hives.  She did not have problems breathing or hives beyond the injection site.  The site reaction worsened and she contacted her physician the following morning. The physician prescribed a course of prednisone to reduce the swelling and injection site reaction.  The patient reports a four inch diameter area of raised, reddish/purple skin which itches and burns.
Age: 31.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Fatigue, Injection site erythema, Injection site mass, Pyrexia, Urticaria
Clinical narrative: Fever of 101.1. Baseball sized red lump at injection site, extreme fatigue, hives.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: My son had a low fever the day after his flu vaccine, but that evening it rose as high as 103.8 degrees.  He had chills and complained of a sore throat.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Aphasia, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 74 year old male patient with no pertinent medical history or drug reactions/allergies. On 04-OCT-2013 the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX23 (lot# J005067, expiration date 17-JAN-2015), intramuscularly. The reporter stated that the patient developed swelling of the left arm where the PNEUMOVAX23 was administered and the patient was unable to walk or talk on 05-OCT-2013. She stated that the patient went to a hospital on 05-OCT-2013 and was diagnosed with cellulitis of the left upper arm. He was sent home from the hospital on the same day and prescribed an unspecified amount of KEFLEX. The reporter stated that the patient was currently in the physician's office as a follow-up. She stated that his arm was still red but the patient was able to walk and talk as well as he was able to drive himself to the physician's office. The outcome of cellulitis of the left upper arm was reported as recovering/resolving. The outcome of patient was unable to walk or talk was reported as recovered/resolved. It was unspecified whether laboratory diagnostic studies were performed. The patient sought medical attention for the events. Causality was not reported. Upon internal review the event 'unable to talk' has been considered as medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Bradycardia, Cardiac arrest, Chromaturia, Cough, Nasopharyngitis
Clinical narrative: 10/8/13 - cold/cough symptoms. Urine - orangish color. Albuterol neb. 10/9/13 - brachycardia -> full arrest.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Intussusception, Ultrasound scan abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 4.5 months old male patient. The patient had no pertinent medical history nor drug reactions or allergies. Approximately on 25-JUL-2013 at the patient's "2 months old appointment the patient received his first 0.5 ml dose of ROTATEQ" with no adverse effects. On 22-AUG-2013 the patient was vaccinated with ROTATEQ (dose 2, 0.5 ml, oral; lot number not reported). No concomitant medication was reported. She reports that after the second dose of ROTATEQ, approximately at 3 months of age the patient was admitted to the hospital and was diagnosed with intussusception after an ultrasound (onset date reported as 09-SEP-2013). The intussusception was reduced by air enema (approximately in September 2013). The patient sought medical attention. The patient was reported as recovered in 2013. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Apnoea neonatal, Cardiac arrest, Convulsion, Epistaxis, Hypotonia
Clinical narrative: Sitting propped up on couch, father napping next to him. After a few minutes found slumped forward, lifeless, with blood around nose and mouth. Pt asystolic and apneic by paramedics. Transported to PICU. Pt with minimal cortical activity.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intensive care, Laboratory test abnormal, Mouth haemorrhage
Clinical narrative: Sitting propped up on couch, father napping next to him. After a few minutes found slumped forward, lifeless, with blood around nose and mouth. Pt asystolic and apneic by paramedics. Transported to PICU. Pt with minimal cortical activity.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Flushing, Gait disturbance, Muscular weakness
Clinical narrative: (L) leg and arm weakness x 4H, difficulty ambulating x 4H, facial flush x 4H, (L) facial edema x 4H.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt describes pain in/around injection site worse in AM, gets slightly better w/ time and ADVIL. Has persisted since shortly after injection.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: About 40 min after flu shot: tingling on (R) side of face and (R) arm.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Vertigo
Clinical narrative: Rec'd vaccine 10/7/13 on the morning of 10/8 awoke spinning and dizziness - no other symptoms. Urgent care MD checked thoroughly for other causes of vertigo - none found.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt called saying she has a rash today (10/6) and was given a flu shot for the first time on 10/5. Pt asked if she had come into contact with plants/food/animals to cause allergy, she did not think so. Pt says not allergic to eggs. Pt told to take BENADRYL right away and if rash progresses or any rxn worsens to call Dr or go to ER.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm is more sore than usual with flu shot. Her arm is still sore even though she got the shot one month ago. It was very sore at first, but it is now only sore to the touch so she is improving.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Flushing, Urticaria
Clinical narrative: Hive on left cheek, flushed skin, anterior neck and chest and anterior upper shoulder. Slightly lightheaded - symptoms occurred 3 min after shots. Patient was given 25 mg of BENADRYL and appeared stable one hour later when she came to my clinic.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Pt reported a skin infection (redness and swelling) at site of injection, saw MD and was prescribed abx, KEFLEX 500mg 1 QID, this was on Sunday 10/6/13 temp 102-103 degrees F, Mon (10/7) temp decreased to 100 degrees F. Temp normal 10/7 16:00.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Approx. 5 hrs. after receiving shot had extreme chills which lasted several hours. Arm began to ache and I am unable to lift my arm without pain. When the shot was given it felt as though the serum was running inside my arm, like fluid running between a wall.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Feeling abnormal, Laboratory test normal, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Three days after injection pt developed severe aches/pains from his knees to his feet. Went to MD and tested for gout and test was negative. Back also now is in pain and pt complains of overall body stiffness. He said it's like his body feels poisoned and is being attacked from the inside out. Unsure if fever exists. Pt still having symptoms.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Bruising around injection site. Large, red, inflammation around site. Warm to touch.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Right arm swollen, red upper arm - down to the elbow. Pt received antibiotic for it on 9-27-13. Resolved in 3 days.
Age: 86.0
Sex: U
Vaccine: FLUX
Symptoms: Blood pressure increased, Dizziness, Gait disturbance
Clinical narrative: 9-28-2013 7:00 PM blood pressure shot up to 200/98, very dizzy, could not walk very good. Same condition for several days. In previous years (yearly) no bad effects.
Age: 6.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Insomnia, Joint range of motion decreased, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Severe arm pain, decreased ROM, could not sleep due to pain, vomited, fever.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: Patient developed rash one day after vaccines administered. Rash consistent with erythema multiforme.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Neuralgia
Clinical narrative: Sharp lower back pains began second day after shot. Nerve like pains where spine meets pelvis joint. After 3 days pain began to subside. Three weeks after shot lower back still sensitive at times. Much like healing from a back strain injury.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 86 year old male patient with penicillin allergy refers to himself. The patient's medical history included hives. Three years ago (exact date unspecified0 the patient was vaccinated with ZOSTAVAX for Shingles Vaccination. Concomitant therapies included levothyroxine sodium (dosage and manufacturer unspecified) and simvastatin (dosage and manufacturer unspecified). On 16 SEP-2013 the patient experienced shingles. The patient sought medical attention and Aciclovir (dosage and manufacturer unspecified) was given for treatment. None lab diagnostic was performed. The outcome of developed shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site induration, International normalised ratio increased
Clinical narrative: Patient presents at pharmacy on 9-17-13 to show us his arm which is bruised from shoulder to elbow. The injection site seems hard but no warmth or redness. Patient reports reaction came on the evening of vaccination but he has no pain or itching, so he did not report until now. Patient says INR's have been slightly elevated. Advised to see MD.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # and route not reported) that expired on 08-SEP-2013. No adverse effects reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Started with cough/wheezing that would not stop. Eyes became very red. Onset of fever (99.4). Patient tried to rest but started experiencing chills and pain. Was able to sleep through night but visited doctor in the morning.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Started with cough/wheezing that would not stop. Eyes became very red. Onset of fever (99.4). Patient tried to rest but started experiencing chills and pain. Was able to sleep through night but visited doctor in the morning.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age, gender unspecified. On 01-OCT-2013 the patient was vaccinated with a dose of VARIVAX (lot# H017880, expiration date 27-SEP-2014 and route not reported) that was exposed to 50 Fahrenheit (F) for 32 hours was not supported. No adverse effects reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: 14 well separated thin blistered lesions on deltoid area, no erythema - 5-10 mm.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Fever, pain, redness, warmth of arm occurred evening of IZ, redness and pain persist x 3 days. 7 x 16 cm on 10/4/13.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a friend of the patient via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial injections (Lot number, expiry date, route and dose were not reported). On an unknown date, approximately two weeks following administration of dose of ZOSTAVAX the patient developed non-painful rash on chest. The patient sought medical attention for the same (physician appointment). The rash cleared up within an unspecified period of time. On an unknown date, the event non-painful rash on chest was recovered/resolved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 12 hours after injection patient noted a red, swollen, hot area at site of injection, area grew to the size of her hand at 48 hours, reaction then started to subside. Now - 42 hours after injection, red area is the size of silver dollar. Patient never experienced systemic side effects. Took no treatments.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and drug allergies/reactions were not reported. In August 2012, the patient was vaccinated with GARDASIL dose 1. Concomitant medication was not reported. On 01-OCT-2013, the patient went to the office to receive her second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 1.57
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Pt. presented  at office for 18 mo WCC on 10-10-13. T: 99.2, pt asymptomatic for viral or bacterial illness. Pt. received vaccine at 4:00 PM and developed fever of 102 degrees during the night. Pt's mother did not note time during the night.
Age: 25.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from Licensed Practical Nurse concerning a 25 year old female patient with asthma and a medical history of sexual transmitted disease who on 26-JUN-2013 was vaccinated with a first dose of GARDASIL (dose, route and lot # not provided) an on 30-SEP-2013 at 14 weeks of pregnancy was vaccinated with a second dose of GARDASIL (dose, route and lot # not provided). Concomitant therapies included influenza virus vaccine (unspecified) (manufacturer by Sanofi) and prenatal vitamins (unspecified)). The patient became pregnant with LMP of 24-JUN-2013 and EDD of 31-MAR-2014. There was no treatment given for the event. No adverse effect was reported.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: This spontaneous report was received from an approximately 51 year old female pharmacist reporting on herself. The pharmacist (patient) mentioned that she received an unspecified pneumococcal vaccine (manufacturer unknown and PNEUMOVAX 23 could not be ruled out), (lot # not reported) and experienced redness at the injection site for 1 week and itching. The outcome of itching and redness at the injection site was unknown. This case is linked to MARRS 1310USA004330 from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender. On 08-OCT-2013, the patient was vaccinated with 0.5 milliliter (ml) of MMR II (lot number and expiry date unspecified), subcutaneously which was improperly stored in a syringe for 16 hours. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no drug reactions and allergies. On 28-SEP-2013 the patient was vaccinated with ZOSTAVAAX, lot # J003723, expiration date 28-JUN-2014, 1 dose 0.65 ml, subcutaneous for vaccination. No concomitant medication was reported. On 28-SEP-2013, the patient developed pain and "welt" at the ZOSTAVAX injection site. No lab diagnostics and studies were performed. The patient sought medical attention and saw the pharmacist. Ibuprofen and tramadol treatments were given for the events. Action taken with therapy was unknown. The patient was not recovered from the events at the time of reporting. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Symptoms started Wed - swelling, warm, redness in shape of "X" appeared and then redness spread out to top 2/3 of upper arm. Soreness and pink now. No fever.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of unspecified patients. On an unknown date, unspecified number of unspecified patient was vaccinated with ZOSTAVAX, (lot#, route, dose and indication were not reported). On an unknown date, the patients were experienced arm pain when ZOSTAVAX was administered. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, size (in diameter) about tennis ball and some swelling lasting about 1 week when reported.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Pruritus, Rash erythematous, Rash generalised, Rash papular, Scab
Clinical narrative: Numerous red bumps on back, abdomen, arms and legs. Some papular, some scabbed over. Itchy.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient with no pertinent medical history or drug reactions/allergies. On 04-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H021941, expiration date 11-JUL-2013, 0.5 ml, once, intramuscularly) for vaccination. In October 2013 the patient experienced pain from shoulder to wrist. There was ice treatment given for the event. No lab diagnostics studies performed. The patient sought medical attention via spoke to the pharmacist. The outcome of the event was unknown. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: UNK
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Pain and numbness from injection site - to hand and fingers. (L) arm. Visited ER - no treatment administered - medical staff did not believe patient's claims of severe discomfort.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Electrocardiogram, Hypersensitivity, Swollen tongue, Tachycardia, VIIth nerve paralysis
Clinical narrative: Patient started experiencing allergic reaction about 30 mins after immunization when she was at home. Reported swollen tongue, droopy face, tachycardia. Went to MD and received BENADRYL, EKG and was monitored for approximately 2 hours before sent home.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: This spontaneous report as received from a 60 year old female patient refers to herself. Three days ago (approximately on 23-SEP-2013) the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown, expiry date was reported as 14-JUL-2014). Two days later (approximately on 25-SEP-2013), the patient noticed a singular "welt" covering the injection site, which was accompanied by pain and redness. The patient also experienced a headache after receiving the injection, however the headache has since resolved and the patient "was not sure it was due to the vaccine." The outcome of headache was reported as recovered/resolved. The outcome of "welt, pain and redness" was unknown. The patient did not sought medical attention. No treatment was given for adverse event. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At injection site on (R) arm there was a 8x10 cm area of mild swelling and induration with warmth, mild erythema and mild tenderness. Skin was intact. No signs of cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Local swelling
Clinical narrative: Patient got PNEUMOVAX shot Friday 10/4. She called the pharmacy Sunday 10/6 to report that her arm was swollen, red and uncomfortable. She was advised to take ibuprofen, BENADRYL and apply a cold pack.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting projectile
Clinical narrative: This spontaneous report was received from a physician refers to 5 patients of unknown demographics. On an unknown date the patients were vaccinated with a dose of ROTATEQ (lot#, expiration date and route not reported). The physician reported the patients experienced projectile vomiting immediately after administration of the first dose of ROTATEQ. The outcome of vomiting projectile was unknown. Causality was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20 years old female. The patient had no concomitant medication and drug reactions/allergies. No pertinent medical history. The reporter reported that the patient received the second dose of VARIVAX (Lot# 0418AA, expiry date: 16-MAR-2013 as reported), subcutaneous, dose and location unspecified for vaccination in January 2012. On 03-SEP-2013 the patient had varicella titers drawn for nursing school, and the results were negative. No treatment was given for the event. The patient did not seek medical attention. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous report as received from the patient's husband and as well as the 75 year old female patient regarding herself. Patient's medical history was none, drug reactions/allergies were none. On 16-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX Refrigerated VIAL 19400 PFU (Lot number, expiry date, route and dose were not reported). Concomitant therapies included Cymbalta, lisinopril (manufacturer unknown), metoprolol, hydrochlorothiazide (manufacturer unknown) and alendronate sodium (manufacturer unknown). Around 30-SEP-2013, the patient experienced wooziness, muscle ache, joint ache, nausea and headache. The patient sought medical attention and has called the doctor and the doctor has prescribed Methylprednisolone, 4 mg oral tablets, taken as a "dose pack" over the course of 5 days. The patient's husband was refusing to administer this medication to himself and his wife due to the adverse events that were reported in the PI (package insert) of this specific medication. Lab Diagnostics Studies Performed was none. No treatment was taken. The patient had recovered from most of the symptoms but the joint and muscle pain was still present, although it seemed to be getting better with time. Approximately on an unknown date in 2013, the events wooziness, headache and nausea were recovered/resolved. The outcome of joint ache and muscle ache was reported as recovering/resolving. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Muscle spasms, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from the patient's husband and as well as the 75 year old female patient regarding herself. Patient's medical history was none, drug reactions/allergies were none. On 16-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX Refrigerated VIAL 19400 PFU (Lot number, expiry date, route and dose were not reported). Concomitant therapies included Cymbalta, lisinopril (manufacturer unknown), metoprolol, hydrochlorothiazide (manufacturer unknown) and alendronate sodium (manufacturer unknown). Around 30-SEP-2013, the patient experienced wooziness, muscle ache, joint ache, nausea and headache. The patient sought medical attention and has called the doctor and the doctor has prescribed Methylprednisolone, 4 mg oral tablets, taken as a "dose pack" over the course of 5 days. The patient's husband was refusing to administer this medication to himself and his wife due to the adverse events that were reported in the PI (package insert) of this specific medication. Lab Diagnostics Studies Performed was none. No treatment was taken. The patient had recovered from most of the symptoms but the joint and muscle pain was still present, although it seemed to be getting better with time. Approximately on an unknown date in 2013, the events wooziness, headache and nausea were recovered/resolved. The outcome of joint ache and muscle ache was reported as recovering/resolving. Additional information has been requested.