chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3, MNQ, PPV, TDAP
Symptoms: Dyspnoea, Erythema, Local swelling, Skin warm
Clinical narrative: C/o on 10/21/14 had difficulty breathing and her arm was red, warm and had some swelling. Hx of HTN and asthma. Currently no difficulty breathing but c/o swelling under arm. Advised f/u w/ medical provider.
Age: 16.0
Sex: M
Vaccine: FLU3, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None - pt was given PROQUAD, thinking it has MMR II and varicella, along with influenza. Called shot line was told to fill out VAERS report.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient receive FLUVIRIN PF 2014/15 0.5 mL IM in left arm on 10/16/14. She came to pharmacy and reported to pharmacy that her left arm at injection site has been sore since 10/16/14 and she is unable to raise arm up.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Gave PNUE 23 to pt lt arm pt said it bothered her every. Went to clinic in town with pain and swelling of arm. Clinic sent her to the ER.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Baseball sized reaction of redness, swelling, itching and heat.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Called provider at home. Went to ER for shortness of breath, hives and throat felt tight. After treatment signs and symptoms cleared.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: MCV4 and flu vaccines administered on 10-21-14 and patient started with redness, swelling and pain to injection site within 24 hrs.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: Received flu shot and PPSV approx 6:30PM. 10:30PM - Severe chills, body aches, headache, rapid heart beat followed by nausea. 1:00AM - vomiting 6:00AM aches - fatigue fully recover.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Vomiting
Clinical narrative: Received flu shot and PPSV approx 6:30PM. 10:30PM - Severe chills, body aches, headache, rapid heart beat followed by nausea. 1:00AM - vomiting 6:00AM aches - fatigue fully recover.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient felt lightheaded and passed out.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Pt fainted and a few minutes after given the FLUVIRIN 14-15 vaccine. He was our for not even a minutes. Got up on his own, sat for 15 minutes. Then left with his mom.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Hot flush, Pruritus
Clinical narrative: Vaccinated 10/14 11 AM symptoms started at 8 or 9 pm. C/O constant itching on head (top of head), arms and back of neck, c/o hot flashes lasting 3-4 hrs subsided on its own.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Anger, Arthralgia, Bone pain, Fatigue
Clinical narrative: 48 hours after flu shot patient experienced arthritis-like joint pains - "doubled", fatigue, "bones aching" requiring laying down. Patient instructed to try TYLENOL. On Wednesday patient with urging admitted the symptoms were subsiding. She was angry and irate.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Redness swelling itching heat at the site size of a baseball.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal X-ray, Constipation, Cough, Full blood count normal, Nausea
Clinical narrative: Pt was given FLUMIST and has asthma. Was given on 10/2/14 and has had continuous cough and congestion along with fever since injection. Seen in our office on 10/16/14 given azithromycin tablets 250mg. Given albuterol and ROBITUSSIN AC on 10/17/14 given ZOFRAN for nausea on 10/20/14 along with prednisone 20 mg tablets.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Respiratory tract congestion, X-ray abnormal
Clinical narrative: Pt was given FLUMIST and has asthma. Was given on 10/2/14 and has had continuous cough and congestion along with fever since injection. Seen in our office on 10/16/14 given azithromycin tablets 250mg. Given albuterol and ROBITUSSIN AC on 10/17/14 given ZOFRAN for nausea on 10/20/14 along with prednisone 20 mg tablets.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Dysstasia, Injection site pruritus, Pain in extremity
Clinical narrative: Beginning about 1 hour after injection pt reported that arm became progressively more sore until she could not stand to touch it. Reported localised itching in the injection area that did not spread. Lump developed under her arm the next day. Advised pt to take BENADRYL, NSAIDS and use an ice pack on the area. Contact MD if symptoms worsened or spread. Pt reports symptoms resolving after 4 days.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Balance disorder, Blood magnesium decreased, CSF protein increased, Dyspnoea
Clinical narrative: 10/1/2014 8:15 am vaccine given, patient immediately felt severe burn, sting from vaccine. 8:00 pm legs very weak, felt like jelly. 8:30 pm legs gave way and stumbled. 10/2/2014 6:00 am Next morn unable to walk without hyper-extending knees. 2:00 pm Doctor visit with prognosis of Guillain Barre, referred to Neurologist. 10/3/2014 12:45 pm Neurology appt. 3:00 pm neurologist admitted to Medical Center for prognosis of Guillain Barre. 10/4/14 Lumbar puncture showed high protein in spinal fluid. Diagnosed with Guillain Barre and critically low magnesium level. MRI of head and neck: showed bulging disc in neck only, affecting left side of body only, dismissed. 10/5/14 IVIG started for 5 days of treatment. Released on 10/9/14. Returned to hospital ER on 10/11/14 and admitted with returning symptoms of weakness in legs, loss of sensation on right side of body, and labored breathing. 10/13/14 MRI of spine: no findings. Diagnosis: Flare up, observation only, no treatment. 10/14/14 discharged from hospital. 10/15/14 referral to physical therapy due to weakness and short endurance. Visits will be two times per week until stronger and then three times per week until goals met. Residual twitches in upper body, extreme weakness in lower extremities, unable to balance, residual numbness in right side from hips upward, then both sides residual numbness from hips down, headaches.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: 10/1/2014 8:15 am vaccine given, patient immediately felt severe burn, sting from vaccine. 8:00 pm legs very weak, felt like jelly. 8:30 pm legs gave way and stumbled. 10/2/2014 6:00 am Next morn unable to walk without hyper-extending knees. 2:00 pm Doctor visit with prognosis of Guillain Barre, referred to Neurologist. 10/3/2014 12:45 pm Neurology appt. 3:00 pm neurologist admitted to Medical Center for prognosis of Guillain Barre. 10/4/14 Lumbar puncture showed high protein in spinal fluid. Diagnosed with Guillain Barre and critically low magnesium level. MRI of head and neck: showed bulging disc in neck only, affecting left side of body only, dismissed. 10/5/14 IVIG started for 5 days of treatment. Released on 10/9/14. Returned to hospital ER on 10/11/14 and admitted with returning symptoms of weakness in legs, loss of sensation on right side of body, and labored breathing. 10/13/14 MRI of spine: no findings. Diagnosis: Flare up, observation only, no treatment. 10/14/14 discharged from hospital. 10/15/14 referral to physical therapy due to weakness and short endurance. Visits will be two times per week until stronger and then three times per week until goals met. Residual twitches in upper body, extreme weakness in lower extremities, unable to balance, residual numbness in right side from hips upward, then both sides residual numbness from hips down, headaches.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Injection site pain, Intervertebral disc protrusion, Lumbar puncture, Muscle twitching
Clinical narrative: 10/1/2014 8:15 am vaccine given, patient immediately felt severe burn, sting from vaccine. 8:00 pm legs very weak, felt like jelly. 8:30 pm legs gave way and stumbled. 10/2/2014 6:00 am Next morn unable to walk without hyper-extending knees. 2:00 pm Doctor visit with prognosis of Guillain Barre, referred to Neurologist. 10/3/2014 12:45 pm Neurology appt. 3:00 pm neurologist admitted to Medical Center for prognosis of Guillain Barre. 10/4/14 Lumbar puncture showed high protein in spinal fluid. Diagnosed with Guillain Barre and critically low magnesium level. MRI of head and neck: showed bulging disc in neck only, affecting left side of body only, dismissed. 10/5/14 IVIG started for 5 days of treatment. Released on 10/9/14. Returned to hospital ER on 10/11/14 and admitted with returning symptoms of weakness in legs, loss of sensation on right side of body, and labored breathing. 10/13/14 MRI of spine: no findings. Diagnosis: Flare up, observation only, no treatment. 10/14/14 discharged from hospital. 10/15/14 referral to physical therapy due to weakness and short endurance. Visits will be two times per week until stronger and then three times per week until goals met. Residual twitches in upper body, extreme weakness in lower extremities, unable to balance, residual numbness in right side from hips upward, then both sides residual numbness from hips down, headaches.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Sensory loss
Clinical narrative: 10/1/2014 8:15 am vaccine given, patient immediately felt severe burn, sting from vaccine. 8:00 pm legs very weak, felt like jelly. 8:30 pm legs gave way and stumbled. 10/2/2014 6:00 am Next morn unable to walk without hyper-extending knees. 2:00 pm Doctor visit with prognosis of Guillain Barre, referred to Neurologist. 10/3/2014 12:45 pm Neurology appt. 3:00 pm neurologist admitted to Medical Center for prognosis of Guillain Barre. 10/4/14 Lumbar puncture showed high protein in spinal fluid. Diagnosed with Guillain Barre and critically low magnesium level. MRI of head and neck: showed bulging disc in neck only, affecting left side of body only, dismissed. 10/5/14 IVIG started for 5 days of treatment. Released on 10/9/14. Returned to hospital ER on 10/11/14 and admitted with returning symptoms of weakness in legs, loss of sensation on right side of body, and labored breathing. 10/13/14 MRI of spine: no findings. Diagnosis: Flare up, observation only, no treatment. 10/14/14 discharged from hospital. 10/15/14 referral to physical therapy due to weakness and short endurance. Visits will be two times per week until stronger and then three times per week until goals met. Residual twitches in upper body, extreme weakness in lower extremities, unable to balance, residual numbness in right side from hips upward, then both sides residual numbness from hips down, headaches.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Upper arm ached around 4-5 pm. Shot administered approximately 12:00pm. Body ached with a fever of 99.1 degrees later in day. Weakness lasted 2 1/2-3 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Red in area - getting larger. Warm to touch.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None noted.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Reports after receiving flu shot at approx 1520 began to have hives on her arms, chest and ear. Reported itching on her back. Symptoms began at approx 1600pm. She states she took a CLARITIN at approx 1645 and by the time she reported to ER symptoms were nearly resolved according to providers notes.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, MMR, VARCEL
Symptoms: Blood test, Headache, Pyrexia
Clinical narrative: Severe headache/fever. Headache lasted 6 hrs. Low-grade fever for 4 days.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Had one episode of vomiting (3 times  consecutively) with no other symptoms. All symptoms resolved after episode. Patient stated she ate leftovers one hour before reaction. Feels normal today.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Expired drug administered
Clinical narrative: Administered PNEUMOVAX 23 with an expiration date of 8-10-14. Contacted Merck and was told that vaccine is supported and we do not need to revaccinate.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered PNEUMOVAX 23 with an expiration date of 8-10-14. Contacted Merck and was told that vaccine is supported and we do not need to revaccinate.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dyskinesia, Nausea, Pain, Tremor, Vomiting
Clinical narrative: Started shaking, hands shivering sideways not normal, got nauseous, vomited then got body aches that go along with the flu took TYLENOIL. By next day issues resolved. Today pt is fine.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Testicular pain
Clinical narrative: Extreme joint pain all over body - specifically arm and legs, also including testes. Sought treatment - follow up study scheduled for possible auto immune disorder.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fear, Malaise, Migraine, Pain in extremity
Clinical narrative: A few hours later a migraine headache, not well feverish. Next morning jaw pain and unusual sensations on left side of face and body, arm and fingers is too. Very scared went to Dr Mon. gave antibiotics. Sat. Oct 4, ER tongue swelled couldn't breathe, took allergy pills and gave me more steroids. Saw physician Mon. Don't know why I am having reactions. 3 weeks later still having problems. Pain in arm and swelling of tongue. Tingling in face.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw, Paraesthesia, Pyrexia, Sensory disturbance, Swollen tongue
Clinical narrative: A few hours later a migraine headache, not well feverish. Next morning jaw pain and unusual sensations on left side of face and body, arm and fingers is too. Very scared went to Dr Mon. gave antibiotics. Sat. Oct 4, ER tongue swelled couldn't breathe, took allergy pills and gave me more steroids. Saw physician Mon. Don't know why I am having reactions. 3 weeks later still having problems. Pain in arm and swelling of tongue. Tingling in face.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm, Tenderness
Clinical narrative: Admin shot on 10/16 into deltoid via 1 inch needle. 10 mins after admin, pt has slight red rash size of quarter about 3in from admin site. Upon visit of pharmacy 10/17/14, rash was 3 in in diameter, warm, tender to touch.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Patient had severe pain in right arm such that she could not move her arm, weakness in arm. With left arm, patient can move her right.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site haematoma, Injection site haemorrhage, Joint swelling
Clinical narrative: Site bleed, stopped, blood pooled under skin. Instructed to massage arm, take BENADRYL if necessary. Returned 10/15/14 wrist on arm was swollen and had radiating pain. Pt. went to emergency room was prescribed IBU 600 mg TQ6-8H prn swelling and pain.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After receiving flu vaccine, developed raised red area at injection site (L deltoid) and warm to touch.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cough, Pain, Respiratory tract congestion
Clinical narrative: Patient woke the following day complaining of cough, body aches, and congestion that lasted for 2 weeks.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Skin warm, Vaccination site erythema, Vaccination site induration
Clinical narrative: Patient received flu shot on the morning of 10/13/14 and called our office on the evening of 10/14/14 after noting an area of erythema and induration on vaccine site. No fever or streaking but arm felt warm at time of discovery and affected arm was painful earlier in the day. She presented in the office the morning of 10/15 and her mother noted the area of erythema had gotten larger. Measured during the visit to be 9cm by 9cm and 6cm at narrowest portion. Warm to touch with no motor deficits or edema of LUE.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Gait disturbance
Clinical narrative: Pt. describes about 7 hrs after receiving vaccine developed chills, couldn't get warm, total body aches, fatigue felt as though she couldn't walk - lasted into next day, (Sat.) but did improve. States has never felt so terrible and has received many other vaccines including flu in the past.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pt. describes about 7 hrs after receiving vaccine developed chills, couldn't get warm, total body aches, fatigue felt as though she couldn't walk - lasted into next day, (Sat.) but did improve. States has never felt so terrible and has received many other vaccines including flu in the past.
Age: 65.0
Sex: U
Vaccine: FLUX
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Right arm pain hard to pick up heavy objects. Right leg lower calf.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Dyspnoea, Injection site reaction, Myalgia
Clinical narrative: Fever of 99 degrees, shortness of breath, aching of joints and muscles, full body weakness, throbbing of arm from shoulder to elbow where shot was given. Had vaccine approximately at noon- symptoms started about 5pm/much worse by 7 pm. Saw physician following day-no treatment.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 99 degrees, shortness of breath, aching of joints and muscles, full body weakness, throbbing of arm from shoulder to elbow where shot was given. Had vaccine approximately at noon- symptoms started about 5pm/much worse by 7 pm. Saw physician following day-no treatment.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Walking aid user
Clinical narrative: Knees (R.L) pain -sore difficulty walking used a cane to walk. Saw my doctor, prescribed P.T. going to 11 sessions. Improving after 5 but will continue P. therapy.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Inflammation, Pain in extremity
Clinical narrative: Pain, inflammation, cellulitis of (R) arm.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Pain, inflammation, cellulitis of (R) arm.
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Inflammation, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # J009833, expiration date: 25-JAN-2015) intramuscular, 1 single shot, (exact date was not reported). On an unknown date, the patient experienced cellulitis at the injection site and went to emergency room but was not admitted. The patient sought medical attention. The outcome of cellulitis at the injection site was reported as recovered on an unknown date. The relatedness between the event and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # J009833, expiration date: 25-JAN-2015) intramuscular, 1 single shot, (exact date was not reported). On an unknown date, the patient experienced cellulitis at the injection site and went to emergency room but was not admitted. The patient sought medical attention. The outcome of cellulitis at the injection site was reported as recovered on an unknown date. The relatedness between the event and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope following flu vaccine. Patient sat down and recovered within 10 minutes.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Chest discomfort, Dyspnoea, Wheezing
Clinical narrative: After receiving flu shot and GARDASIL vaccine c/o SOB and wheezing with tightness of chest. MD notified and meds administered BENADRYL-25mg PO, Albuterol-Duo Nebulizer, Prednisolone-60mg PO, EPIPEN-injection, O2 6L-content. Transferred ER via ambulance.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: 10-12 hours after injection experienced redness, inflammation and warmth at injection site. Lasted about 2 days. Did not seek treatment but site remained itchy 3 days later. No issues in past.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None noted.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Mobility decreased, Pain, Tenderness
Clinical narrative: Sore for 2 days then better for remainder of week. Started again 10/20/14. Swollen, tender, difficult to lift arm.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Four to five hours after receiving influenza vaccine IM in left deltoid, developed scattered hives on left arm and left side of neck, had pruritis of scalp. She took a dose of BENADRYL and symptoms subsided.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and red around injection to around front of the arm, painful, heat/hot to touch pain lasted 3 days and heat/inflamation for 5-6 days. (left arm) - patient did not report til 10/16/14. No treatment occurred.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Sore arm that has become difficult to raise and move in certain positions. When I'm sleeping I wake up in pain if I have rolled on that side. Getting undressed is the hardest. Treatment - ibuprofen, TYLENOL, naproxen, ICY HOT cream.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness about 1-2 inches below injection site that began 2 days after vaccine. No pain associated or any other symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site. Inability to lift arm (right) over head.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Dermatitis contact, Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen at injection site (50 mm diameter). Started same day.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Syncope, Vomiting
Clinical narrative: 12 hours after shots patient lost control of his body. He collapsed to floor and could not get up. This lasted 14 hours. This was accompanied by chills and vomiting.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Phone call with report of signs and symptoms starting 8 hours after receiving IIV4 and PPSV23 to left arm. Fever 100.9 body aches, redness, swelling and hot to touch at injection site and approx. size of a large apple later swelling to arm to elbow. Area so itchy. Pt applied cold compress and took over the counter medication for fever and body aches. Also took BENADRYL. Did not seek medical care. 8-30 hrs. after was worst.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Phone call with report of signs and symptoms starting 8 hours after receiving IIV4 and PPSV23 to left arm. Fever 100.9 body aches, redness, swelling and hot to touch at injection site and approx. size of a large apple later swelling to arm to elbow. Area so itchy. Pt applied cold compress and took over the counter medication for fever and body aches. Also took BENADRYL. Did not seek medical care. 8-30 hrs. after was worst.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Bronchospasm
Clinical narrative: Bronchospasm. Anaphylaxis. Pneumococcal vaccine 1.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Vaccination failure
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decreased perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, minimal risk factors for HBV transmission, and transmission rates. Tests for HBsAG (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAG-positive as of January 2012 (Table 4). All these 25 patients had hepatitis B immune globulin (H-BIG) and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patients had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. A copy of the published article is attached as further documentation of the patient's experience. This is one of 25 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: to investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg(HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had H-BIG and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patient had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Vaccination failure
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observation study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012 (Table 4). All these 25 patients had H-BIG and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patient had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. A copy of the published article is attached as further documentation of the patient's experience. This is one of 25 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg(HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had H-BIG and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patient had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors to HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012 (Table 4). All these 25 patients had H-BIG and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patient had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. A copy of the published article is attached as further documentation of the patient's experience. This is one of 25 reports from the same source. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: Vaccine given 10/6/14, 12 days later patient started w/vesicular rash at site of immunization which became firm, red, mildly painful. After 3 days improving but small vesicles present.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vaccine given 10/6/14, 12 days later patient started w/vesicular rash at site of immunization which became firm, red, mildly painful. After 3 days improving but small vesicles present.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 38 year old male patient who was pharmacist family member. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, route, lot# were not reported). On an unknown date, the patient experienced rash all over his body and rash looked like mosquito bites. Patient was prescribed antibiotic, amoxicillin and AUGMENTIN by his physician. Patient sought medical attention by visiting physician. No Product Quality Complaint (PQC) was involved. The outcome of rash all over his body and rash looked like mosquito bites was unknown. Causality was not provided by the reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 71 year old female patient. The patient has reaction/allergy to latex. The patient was not immunosuppressed. On 01-OCT-2014 the patient was vaccinated with ZOSTAVAX (19400 plaque forming units, lot # K007986, expiry 03-SEP-2015, dose 0.65 ml) subcutaneously in the right deltoid. Concomitant therapies included prednisone. On an unknown date in October 2014 after the vaccination, the patient exhibited rash on her trunk region, including her breasts and her navel area. The patient also experienced pain bilaterally in her axilla region. The pharmacist did not provide a detailed description of the patient's rash, and he could not describe the quality of the patient's pain. He does not know when the symptoms began. He states that she has not consulted her physician and no treatment has been administered for the symptoms. No intervention was done to prevent serious criteria as the event was not serious. The outcome of the events was reported as not recovered. The causality of the events to suspect therapy was not specified by the reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site plaque, Injection site rash, Local reaction
Clinical narrative: Rash on (L) leg (quarter size erythemaous plaque, non tender, apparent local reaction) MMRV in that leg.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-OCT-2014, the patient was inadvertently vaccinated with expired PNEUMOVAX 23, lot # J010654, expiry date 17-OCT-2014, 0.5 ml (millimeter), intramuscularly, for an unknown indication. No concomitants were reported. No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Day after 4 m/o vaccines, child went to ER with fever increased 106 (reported per mother), 102 in ER, runny nose, no injection site redness/swelling fever x1 day, possible sore throat.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: I was discussing patient's medications/profile with her and she stated that she had a reaction to ZOSTAVAX. Itching and rash all over. She did not report reaction to her doctor or the pharmacy until today. Says she still itches and has rash.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a female healthcare student regarding herself as a patient of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date "as a child", the patient was vaccinated with M-M-R II series (lot, doses and route not reported). Concomitant medication was not reported. On an unknown date (reported as recently), the patient had titers draw for her school and the mumps titer was "too low". The outcome of mumps titer was "too low" was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: (L) thigh swelling and redness, oral shaped erythematic 3 cm induration with 5 cm erythema.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Under arm turned flaming red and very hot to touch and kept spreading to the pit to the elbow - I am taking ibuprofen 800 mg to ease the redness.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 20-OCT-2014, the patient was vaccinated with an expired dose of GARDASIL, injection administered intramuscularly at dose 0.5 ml (lot # 669313/0692AA (reported as: 0692AA) with expiry date: 13-AUG-2013; strength and indication unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as the healthcare worker did not grant permission to contact him or physician.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt states the left arm developed an egg at injection site. By morning painful to move the arm, redness increased, swollen, hot to touch. Pt had ice. Pt given antibiotic which she stared today with improvement. Pt states one thing, chart unclear whether reaction was to flu or pneumo.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: (L) arm, wheal approximately 10 cm in diameter; red and warm to touch. Treatment used at home - cold compress.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date approximately in September 2014, reported as "the past week and a half", the patients were vaccinated with improperly stored PEDVAXHIB (route, dose, lot number and expiration date not reported). No adverse effects were reported. Co-suspect and concomitant therapies were not reported. This is one of several reports from the same source. Additional information is not expected, since the reporter did not want to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous reprot as received from a nurse refers to a patient of unknown age and gender. On 20-OCT-2014, the patient was vaccinated with expired dose of M-M-R II lot # 1505AA (Batch # H018945), expiration date reported as 18-OCT-2014, albumin status; rHA, subcutaneous (dose was not reported). There was no known adverse effects. Aditional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Inflammation, itching, redness extending from just above injection site to elbow and about 5" wide. Advised cool compresses and BENADRYL 25mg Q6H.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: PREVNAR 13 given on 10/10/14 - Came to office on Oct 16 - Arm red and hot to touch - Redness measures 16 cm x 24 cm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 1 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 20-OCT-2014 the patient was vaccinated with VARIVAX (Merck), 0.5 ml (lot number unspecified), subcutaneously and PROQUAD (Merck), 0.5 ml (lot number unspecified), subcutaneously. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event overdose was unknown. The causality of the event with VARIVAX (Merck) and PROQUAD (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic HBV infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had hepatitis B immune globulin (H-BIG) and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patients had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a certified medical assistant refers to a patient of unknown age and gender. On 26-AUG-2014, the patient was vaccinated with a dose of  (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Vaccination failure
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic HBV infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had hepatitis B immune globulin (H-BIG) and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patients had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.