chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: Patient stated that she had arm pain and had difficulty lifting her arm above shoulder level.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: C-reactive protein increased, Full blood count normal, Laboratory test normal, Polymyalgia rheumatica, Red blood cell sedimentation rate normal
Clinical narrative: PMR Sx - Hospitalization.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient said she has pain in arm since then she received the flu shot for almost 18 days.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Chest X-ray, Pneumonia, Pyrexia
Clinical narrative: Pt was given FLUMIST on 10-17-14. He developed fever on 10-22-14 but had nml exam. Seen again 10-27-14 w/persistent fever and now w/RLL pneumonia clinically. Fever persisted so CXR on 10-29-14.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Pneumonia, Pyrexia, Respiratory rate increased
Clinical narrative: Pt had fever and cough on 10-30-14, seen in urgent care 10-31-14. No improvement so seen in my office 11-4-14 w/persistent fever and found to have clinical pneumonia. Pt had increased RR and 02 sat 94% RA.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical assistant reported that, on an unknown date, multiple unspecified patients received a doses of ROTATEQ oral route of administration (dose, lot number and expiration were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Blister, Rash
Clinical narrative: Rash and blisters developed on top of nose.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Convulsion, Fatigue, Headache, Injection site pain
Clinical narrative: Began with soreness at injection site, progressed to joint soreness, fever and convulsions (from around 6 pm to 1 AM 9 Dec 2014). Continue to have headache, joint stiffness, fatigue and fever. Had I been able to drive at that point I would have gone to an emergency room.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Joint stiffness, Pyrexia
Clinical narrative: Began with soreness at injection site, progressed to joint soreness, fever and convulsions (from around 6 pm to 1 AM 9 Dec 2014). Continue to have headache, joint stiffness, fatigue and fever. Had I been able to drive at that point I would have gone to an emergency room.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Cheilitis, Lip blister
Clinical narrative: Developed rash and blisters above over lip.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt's mother called to report that patient's left leg at injection became progressively red, itchy, painful, and warm to touch shortly after injection of Kinrix and Proquad. Also the size of redness continued to increase in size. Pt's mother took pt to hospital where pt was diagnosed with suspected injection site reaction on left leg and suspicion for early cellulitis. At the hospital, patient was prescribed Benadryl and Keflex.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to the patients of unknown age and gender. The reporter stated that there was a supported excursion affecting ROTATEQ (lot # K006458, expiry date: 24-FEB-2016) which was also affected by prior supported excursions, starting 19-NOV-2014. Subsequently incorrectly stored ROTATEQ was administered to the patients (the onset date if therapy: 19-NOV-2014; dose and route of administration were not reported). There were no adverse events observed in patients post-vaccination and the patients did not seek a medical attention. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Myalgia, Pain
Clinical narrative: Vaccine administered on 12-4. Myalgia of all muscles on 12-5 - Weakness - Was able to work, but constant pain: treated with ADVIL. On Dec 9, sx started to subside.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Balance disorder, Fall, Irritability
Clinical narrative: Mom reports patient intermittently fussy, irritable, no fevers, eating well and slept overnight.  On 12/9/14, mom has noticed that patient seemed unsteady on his feet at times.  She noticed he would be standing and lose balance quicker than usual, take a few steps back and fall over.  Gait seems to be largely normal, although his age makes it difficult to assess.  Started walking at 10.5 months, walking well at 11 months although did have a slight regression 2 weeks ago when he learned to crawl but has been walking well again for about 1.5 weeks prior to appointment on 12/9.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Local swelling, redness, itching.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Musculoskeletal pain, Neuritis, Pain in extremity
Clinical narrative: PAIN IN SHOULDER AND DOWN THE ARM THAT INCREASED AS DAYS WENT BY WITH NUMBNESS IN FINGER TIPS--STILL CONTINUES ON DEC 10 BUT HAS LESSENED A BIT RECENTLY--PROBABLY ADMINISTERED TOO LOW IN ARM RESULTING IN NERVE INFLAMMATION.  IT STILL PERSISTS.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Computerised tomogram normal, Dizziness, Fall, Fatigue, Headache
Clinical narrative: After giving Gardasil vaccine, had unwitnessed syncopal event.  Found on the floor next to exam table, within a few seconds of hearing a fall, eyes open, extremities shaking, shaking stopped after a few seconds, immediately returned to normal level of consciousness. No loss of bowel or bladder function.  Placed supine, with pillow under head.  Once awake, describes that he started to feel dizzy, leaned head back against wall, then doesnt remember further events. Complains of right sided posterior head pain, and also left shoulder pain. Initially tachycardic to palpation.  HR quickly returned to normal and then vital signs stable throughout.  Almost immediately returned to alertness, oriented X 3.  Noted < 1 cm hard lump on right posterior occiput, no step offs.  Initially pale, but color returned within a few minutes. Initially normal neuro exam, except c/o blurry vision, given water and snack, tolerated well, confirmed vision change on eye chart.  Soon after walked around office without assistance. Greater than 15 minutes after the event, reported b/l hand tingling, at tips of finger tips, with sensation and strength intact.  Resolved, but then reoccurred and spread up right arm.  While awaiting stat MRI, developed left sided facial droop, lasted < 2 minutes, resolved while walking to ER as did tingling in arms/fingers, otherwise symmetrical facial movements and continued to have otherwise normal neuro exam.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site pain, Nausea, Neurological examination abnormal, Pallor, Paraesthesia
Clinical narrative: After giving Gardasil vaccine, had unwitnessed syncopal event.  Found on the floor next to exam table, within a few seconds of hearing a fall, eyes open, extremities shaking, shaking stopped after a few seconds, immediately returned to normal level of consciousness. No loss of bowel or bladder function.  Placed supine, with pillow under head.  Once awake, describes that he started to feel dizzy, leaned head back against wall, then doesnt remember further events. Complains of right sided posterior head pain, and also left shoulder pain. Initially tachycardic to palpation.  HR quickly returned to normal and then vital signs stable throughout.  Almost immediately returned to alertness, oriented X 3.  Noted < 1 cm hard lump on right posterior occiput, no step offs.  Initially pale, but color returned within a few minutes. Initially normal neuro exam, except c/o blurry vision, given water and snack, tolerated well, confirmed vision change on eye chart.  Soon after walked around office without assistance. Greater than 15 minutes after the event, reported b/l hand tingling, at tips of finger tips, with sensation and strength intact.  Resolved, but then reoccurred and spread up right arm.  While awaiting stat MRI, developed left sided facial droop, lasted < 2 minutes, resolved while walking to ER as did tingling in arms/fingers, otherwise symmetrical facial movements and continued to have otherwise normal neuro exam.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Swelling, Syncope, Tachycardia, Tremor, VIIth nerve paralysis
Clinical narrative: After giving Gardasil vaccine, had unwitnessed syncopal event.  Found on the floor next to exam table, within a few seconds of hearing a fall, eyes open, extremities shaking, shaking stopped after a few seconds, immediately returned to normal level of consciousness. No loss of bowel or bladder function.  Placed supine, with pillow under head.  Once awake, describes that he started to feel dizzy, leaned head back against wall, then doesnt remember further events. Complains of right sided posterior head pain, and also left shoulder pain. Initially tachycardic to palpation.  HR quickly returned to normal and then vital signs stable throughout.  Almost immediately returned to alertness, oriented X 3.  Noted < 1 cm hard lump on right posterior occiput, no step offs.  Initially pale, but color returned within a few minutes. Initially normal neuro exam, except c/o blurry vision, given water and snack, tolerated well, confirmed vision change on eye chart.  Soon after walked around office without assistance. Greater than 15 minutes after the event, reported b/l hand tingling, at tips of finger tips, with sensation and strength intact.  Resolved, but then reoccurred and spread up right arm.  While awaiting stat MRI, developed left sided facial droop, lasted < 2 minutes, resolved while walking to ER as did tingling in arms/fingers, otherwise symmetrical facial movements and continued to have otherwise normal neuro exam.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Vision blurred, Vomiting
Clinical narrative: After giving Gardasil vaccine, had unwitnessed syncopal event.  Found on the floor next to exam table, within a few seconds of hearing a fall, eyes open, extremities shaking, shaking stopped after a few seconds, immediately returned to normal level of consciousness. No loss of bowel or bladder function.  Placed supine, with pillow under head.  Once awake, describes that he started to feel dizzy, leaned head back against wall, then doesnt remember further events. Complains of right sided posterior head pain, and also left shoulder pain. Initially tachycardic to palpation.  HR quickly returned to normal and then vital signs stable throughout.  Almost immediately returned to alertness, oriented X 3.  Noted < 1 cm hard lump on right posterior occiput, no step offs.  Initially pale, but color returned within a few minutes. Initially normal neuro exam, except c/o blurry vision, given water and snack, tolerated well, confirmed vision change on eye chart.  Soon after walked around office without assistance. Greater than 15 minutes after the event, reported b/l hand tingling, at tips of finger tips, with sensation and strength intact.  Resolved, but then reoccurred and spread up right arm.  While awaiting stat MRI, developed left sided facial droop, lasted < 2 minutes, resolved while walking to ER as did tingling in arms/fingers, otherwise symmetrical facial movements and continued to have otherwise normal neuro exam.
Age: 29.0
Sex: M
Vaccine: FLUN4, HEPAB
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Patient c/o felling dizzy, extremely warm-sweaty after receiving FluMist. Patient stay in the office for half and hour. Vitals (WNL) taken when symptoms started and before leaving.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness of right upper arm.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: DIZZINESS, LIGHTHEADEDNESS, HEADACHE, FATIGUE.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Head injury, Hyperhidrosis, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Pt recieved 2 vaccinations.  About 5 minutes later pt. felt sweaty and queasy.  Walked across room to desk and passed out.  Struck L side of head above L ear. Pt observed until 11:35 AM when pt. vomited and passed out again.  Pt. sent to Hospital for further evaluation.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Depression, Diarrhoea, Headache, Nasal congestion
Clinical narrative: Initial stomach ache, headache for 5 days, mild stuffiness, intermittent diarrhea, depressive thoughts.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Eye movement disorder, Feeling abnormal, Injection site pain, Respiratory arrest
Clinical narrative: Pt was nervous about vaccine and reported that she sometimes feels faint when getting any shots. Pt laid down for vaccine. After nurse gave vaccine, pt c/o burning at injection site and started to panic. Pt was assisted by 2 staff to chair and stated she felt bad. Pt's eyes rolled back, lost all color in face and appeared to stop breathing. Pt eased to floor by 2 staff and NP checked for pulse. No pulse found and code called. NP gave chest compressions x 5 and coworker gave sternal rub. Pt responded, started breathing, became alert to her name, DOB and location. Vitals: BP 118/78, HR 90, RR 18 and NSR. Given 02 and EKG. EMS arrived and transported pt to ED for evaluation. Ed assessed pt and monitored with no new findings.  Pt discharged to home.
Age: 1.07
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: LEG WHERE SHOT GIVEN BECAME RED HOT TO TOUCH SWOLLEN AND HARD SPOT IN MIDDLE.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation
Clinical narrative: Client called at 10:25 am to say the arm that received the flu vaccine felt like "extreme burning, hot coals" inside her arm. No redness, swelling, or itching at the site. Encouraged client to come back to the clinic for further evaluation. She declined. Given Immunization Coordinator's contact information.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Tenderness
Clinical narrative: Patient experienced soreness and tenderness in the armpit on the same arm the vaccine was administered in the next morning.  The swelling improved every day and is now gone.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Blood test abnormal, Condition aggravated, Cough, Dysphagia, Endoscopy
Clinical narrative: Fever of 103 F, sore throat, unable to eat, drink or swallow saliva, vomiting, cough, and nasal congestion, diagnosed in hospital with esophageal herpes simplex 1 infection- atypical infection, for a healthy child such as patient, he is not immune compromised and has no significant medical history, he was in the hospital for 8 days, was seen by neurologist and infectious disease Dr.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Herpes simplex oesophagitis, Immunology test, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever of 103 F, sore throat, unable to eat, drink or swallow saliva, vomiting, cough, and nasal congestion, diagnosed in hospital with esophageal herpes simplex 1 infection- atypical infection, for a healthy child such as patient, he is not immune compromised and has no significant medical history, he was in the hospital for 8 days, was seen by neurologist and infectious disease Dr.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Fever of 103 F, sore throat, unable to eat, drink or swallow saliva, vomiting, cough, and nasal congestion, diagnosed in hospital with esophageal herpes simplex 1 infection- atypical infection, for a healthy child such as patient, he is not immune compromised and has no significant medical history, he was in the hospital for 8 days, was seen by neurologist and infectious disease Dr.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Patient states he felt tightness in his chest and redness/swelling that began around the injection site and continued to the hand.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: SYNCOPE.  PATIENT BLACKED OUT WHILE DRIVING HOME.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Shot was given in left arm.  Injection site seemed fine.  Underarm seemed tender. This tenderness increased until I started to feel around under my arm.  Discovered an enlarged, moveable lump right in the underarm area.  As per my research this is called an axillary lymph node.  Googled to see if this was considered a normal reaction.  Saw some information indicating that some other people had complained of this.  Was warned to.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt fainted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: 1.25 inch diameter red, raised, not painful rash at injection site appeared 6 days post adminstration. No reaction prior to now except a little itching on day of administration.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain in extremity
Clinical narrative: Left leg pain.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchospasm, Flushing, Pruritus, Urticaria
Clinical narrative: Began with a hive and itchy feeling in body. Then face became flush, noted hives on face. Then when taken to the hospital urgent care, airway constriction. Treatment: prednisone, diphenhyramine, ranitidine and at home when airway constriction reoccurred- ventolin.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pruritus
Clinical narrative: Patient says she experienced lots of itching and a headache.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Lymph node pain, Oropharyngeal pain, Pyrexia
Clinical narrative: High fever up to 104 degrees F. Intense headache. Sore throat and throat glands. Joint pain in fingers.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Body temperature fluctuation, Cardiac enzymes normal, Chest X-ray normal, Chills
Clinical narrative: Fever that peaks quickly over 102 degrees, major chills, cough, sever weakness and fatigue, sever dizziness, lack of appetite, unstable body temperature; goes from sweating to feeling of freezing.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Dizziness, Fatigue, Feeling cold
Clinical narrative: Fever that peaks quickly over 102 degrees, major chills, cough, sever weakness and fatigue, sever dizziness, lack of appetite, unstable body temperature; goes from sweating to feeling of freezing.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Full blood count normal, Hyperhidrosis, Influenza virus test negative, Laboratory test normal, Malaise
Clinical narrative: Fever that peaks quickly over 102 degrees, major chills, cough, sever weakness and fatigue, sever dizziness, lack of appetite, unstable body temperature; goes from sweating to feeling of freezing.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Fever that peaks quickly over 102 degrees, major chills, cough, sever weakness and fatigue, sever dizziness, lack of appetite, unstable body temperature; goes from sweating to feeling of freezing.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Dry mouth, Electrocardiogram normal, Feeling abnormal, Feeling hot
Clinical narrative: Patient states she was not feeling right; that her heart was racing; she also felt warm, and had dry mouth. We told her to sit down and rest while EMS arrives, gave her some water as well.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations
Clinical narrative: Patient states she was not feeling right; that her heart was racing; she also felt warm, and had dry mouth. We told her to sit down and rest while EMS arrives, gave her some water as well.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling below injection site and a huge red area around it also fever and rapid heartbeat.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Muscle rigidity, Muscle twitching, Syncope
Clinical narrative: LOC, dizziness, fainting, twiching & rigid arms for 20 seconds.
Age: 44.0
Sex: U
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt reported a very sore arm after the immunization. Difficult to move. She said it has improved but is still sore 9 days later.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 2 hours, injection site started swelling, looking red and became painful. Chest began to hurt and patient took nitrates. Diarrhea started, which she says was the worst she has ever experienced. Other symptoms have improved but is still experiencing some diarrhea.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching left scapular/clavicular area - injection given in left deltoid. Given steroid injection and Rx for PEPCID.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large red area around injection site, hard, warm, tender.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt returned on 10/03/2014 with right arm hot, red and swollen.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea
Clinical narrative: Patient returned minutes after complaining of SOB. Administered (1) dose of Epinephrine (EPIPEN) to (L) outer thigh area. Breathing improved.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 08-DEC-2014 the patient was vaccinated with one dose of ROTATEQ (dose, frequency, lot #, expiry date unspecified) that was exposed to an unsupported temperature excursion. No concomitant medications were reported. No adverse effect was reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with ROTATEQ. This is one of several reports received from the same source (MARRS # 1412USA005251). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: 5 hours later patient experienced pain, soreness and redness of injection site and around the arm. Felt warm to the touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: 5 hours later patient experienced pain, soreness and redness of injection site and around the arm. Felt warm to the touch.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Pyrexia
Clinical narrative: At 2 month and 4 month vaccines pt was crying uncontrollably began about 1 1/2 hrs after vaccines. After 4 month vaccines pt got a 102 fever.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to device use error, Injection site injury
Clinical narrative: Father was securing pt on lap during vaccine administration when pt freed arm and swatted at needle during shot. Injection was completed but as withdrawing needle pt hit hand near needle causing a scratch at injection site. Immediately made dad aware and show him what had happened and he was aware. Pt showed no adverse reaction during or after shot was given. Cleared to leave.
Age: 1.5
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: FLUMIST vaccine given 10-30-14. No symptoms from vaccine and no treatment needed.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Laboratory test normal, Local swelling, Loss of consciousness, Mobility decreased
Clinical narrative: Both vaccines given in same arm per pt request. Pt had immediate pain after PNEUMOVAX. She had to pull over on interstate. Pt arm was swollen and unable to move/raise arm. Pt blacked out on 12/05 and went to ER. Was tested for blood clot - test negative. Was given NSAID/muscle rel. and steroid. Pt said gained 7 lbs in fluid weight. Pt went to pain mgmt. MD and got a steroid shot on 12/06. Pt also had a fever on 12/2 or 12/3.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Weight increased
Clinical narrative: Both vaccines given in same arm per pt request. Pt had immediate pain after PNEUMOVAX. She had to pull over on interstate. Pt arm was swollen and unable to move/raise arm. Pt blacked out on 12/05 and went to ER. Was tested for blood clot - test negative. Was given NSAID/muscle rel. and steroid. Pt said gained 7 lbs in fluid weight. Pt went to pain mgmt. MD and got a steroid shot on 12/06. Pt also had a fever on 12/2 or 12/3.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Mobility decreased, Pain in extremity
Clinical narrative: Pt describes arm pain and was referred to urgent care center who recommended ibuprofen as area was inflamed. Area not getting better and pt saw orthopedist who recommended additional 2 wks of antiinflammatory. Pt states arm still not better and cannot lift it past 90 degrees. Orthopedist now recommending physical therapy.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV2, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site (L) arm. Cephalexin Rx 500 mg PO TID.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Hyperventilation, Muscle twitching, Vaccination complication
Clinical narrative: Approximately 2 hours after vaccines administered patient complained of being dizzy and light-headed. Over next 30 min. pt. was asleep and 'twitching', long deep breathing. Went to ER. Was told reaction from vaccine. Patient discharged around midnight.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling abnormal, Flushing, Heart rate increased, Nausea
Clinical narrative: Within 15min of vaccine, pt reports feeling dizzy, nauseous, tingling of mouth/arm and flushing of face as well as "not feeling right". Left for urgent care at 12:15 PM.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Within 15min of vaccine, pt reports feeling dizzy, nauseous, tingling of mouth/arm and flushing of face as well as "not feeling right". Left for urgent care at 12:15 PM.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Headache that started 12/3/14 about 10:30 pm. The next morning headache was worse. (R) shoulder and neck pain that radiated down right side of my back to about mid back. Headache, neck/back pain lasted 12/3/14, 12/4, 12/5, 12/6, 12/7 and missed work 12/9/14 due to the headache.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Dizziness
Clinical narrative: Dizziness right after shot was given. Had pt lay down for 20 minutes. Rechecked 02 sats. pulse and B/P which were all WNL.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of ROTATEQ (dose and lot # not reported) orally after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Viral test, Viral titre decreased
Clinical narrative: This spontaneous report as received from a 30 year old female pharmacist referring to herself. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, when she was younger, the pharmacist was vaccinated with (Oka/Merck) VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). The reporter stated that, at that time, her items showed she had immunity. No concomitant therapies were reported. On an unknown date, recently, the patient had a baby and experienced her titers drawn and it no longer showed immunity. The outcome of titers drawn and no longer showed immunity was unknown. The relatedness between titers drawn and no longer showed immunity and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a 30 year old female pharmacist referring to herself. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, when she was younger, the pharmacist was vaccinated with (Oka/Merck) VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). The reporter stated that, at that time, her items showed she had immunity. No concomitant therapies were reported. On an unknown date, recently, the patient had a baby and experienced her titers drawn and it no longer showed immunity. The outcome of titers drawn and no longer showed immunity was unknown. The relatedness between titers drawn and no longer showed immunity and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer's boyfriend refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 18-NOV-2014 the patient was vaccinated with GARDASIL (dose, dose number, schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date in 2014, shortly after receiving the GARDASIL vaccine, the patient became pregnant with last menstrual period (LMP) of an unknown date in 2014 (first trimester of exposure). The pregnancy outcome was pending. The outcome of the event was unknown. Additional information is not expected because no reporter details were provided.
Age: 0.34
Sex: F
Vaccine: RVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 month old female patient. Medical history and current conditions were not reported. On 16-JUL-2014, the patient was vaccinated with ROTATEQ, oral (lot number and expiration date were not reported). The patient received another dose of rotavirus vaccine on 16-SEP-2014 from another manufacturer. The patient had not received a third dose of ROTATEQ at the time of the report. No adverse effects were reported. Concomitant therapies were not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Lung infection, Oral herpes, Pain
Clinical narrative: Information was received from an approximately 69 year old female patient with vancomycin and penicillin allergies and heart disease. In  approximately 2008 (reported as "about 6 years ago"), the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided) for the prevention of shingles. Concomitant therapies included vitamins (unspecified), B12, B6 and folic acid. A few months ago, the patient developed shingles after being vaccinated with ZOSTAVAX. The patient reported that her experience was horrible. She had pains (unspecified locations), it "infected her breathing and lungs." The patient could not sleep because of the pain. She also mentioned having feelings of fever blisters around her lips and feeling very fatigued. She saw her doctor and was treated with acyclovir (manufacturer unknown). The outcome of the events was nit reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of MMR II (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patient were vaccinated with doses of PNEUMOVAX 23 (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VAQTA (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 08-DEC-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # J005011, expiry date: 04-DEC-2014) .5 ml, intramuscular. No concomitant medications were reported. No adverse effects were reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with PNEUMOVAX 23. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 51 year old male patient with no pertinent medical history and nor drug allergies/reactions. On 29-OCT-2014, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot # 670178/0468AA, expiration date 31-MAR-2013 (also reported as 30-OCT-2015) 0.5 ml, subcutaneous. The medical assistant was reporting that the patient was diagnosed with chickenpox on 17-NOV-2014, 20 days after onset of therapy. The patient was prescribed acyclovir for treatment. Laboratory diagnostics studies were not performed. The patient sought medical attention by an office visit. No further information provided. The outcome of chickenpox was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that on an unknown date 30 improperly stored GARDASIL (0.5 ml, intramuscular, unknown dose number) doses have been administered to unspecified number of patients (patient demographic information unspecified). No adverse effects reported. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from store, via claims examiner concerning a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX (manufacturer unknown), subcutaneous injection, 0.05ml, (strength and anatomical location were not reported) (lot number 1947AA). Other suspect therapies included ZOSTAVAX, (start date of therapy, strength, dose, route and lot number were not reported). On an unknown date the patient was diagnosed with cellulitis after receiving the pneumococcal vaccine (manufacturer unknown). The reported stated that the procedure and items used administering the shot were entirely sterile. Bacterial etiology was believe to be from the vaccine. The outcome of cellulitis was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Concussion, Dizziness, Head injury, Syncope
Clinical narrative: This is a patient who has never been vaccinated, this was his first vaccine. 15 mins post vaccine he was standing by counter and suddenly felt light headed and fainted and hit his head was transported for a concussion.
Age: 7.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 7 year old child patient. Current conditions and medical history was not reported. On 03-DEC-2014, the patient was vaccinated with GARDASIL injection, 0.5 milliliter, intramuscular. Concomitant medications were not reported. On 03-DEC-2014, 7 year old patient was vaccinated with GARDASIL injection. No adverse effects were reported. The outcome was unknown. Product quality complaint was not reported. No further information was provided. Additional information has been requested,
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On unknown dates, the patient was vaccinated with the first two doses of GARDASIL 0.5 ml, intramuscular, On 20-JUN-2014 and 14-OCT-2014, the patient was respectively vaccinated with the third and fourth dose of GARDASIL 0.5 ml, intramuscular. No adverse effect reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Ultrasound scan normal
Clinical narrative: This spontaneous report as received from a 72 year old male consumer refers to himself with high blood pressure and allergy to unspecified sulfa. In April 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported, one time vaccine, route reported as vaccine). Concomitant therapies included LYRICA, losartan potassium (manufacturer unknown) and omeprazole. On approximately 27-OCT-2014 (reported as "about 6 weeks ago") the patient started to experience "nerve pain on left side, middle of his stomach to around the back part of his back. The patient had sought medical attention. The patient had ultrasound done on an unknown date in 2014 which came back negative and was then prescribed LYRICA for pain. No other lab diagnostics studies were performed. Outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse regarding a female patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, dose number, frequency, product lot#, expiry date, route not reported). There was no information on concomitant medications. The nurse reported that on an unknown date, the patient developed shingles after receiving vaccination with ZOSTAVAX. There was no product quality complaint involved. The patient sought medical attention by visiting the office. There was no intervention done to prevent the serious criteria. The outcome and causality was unknown. Additional information is not expected as the reporter cannot be contacted for follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 08-DEC-2014 the patient was vaccinated with one dose of RECOMBIVAX HB (dose, frequency, lot #, expiry date unspecified) that was exposed to a supported temperature excursion. No concomitant medications were reported. No adverse effect was reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1412USA004863). Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 42 year old female patient with unspecified blood disorder and penicillin allergy. The patient became pregnant with last menstrual period (LMP) of 15-APR-2014 and estimated delivery date (EDD) of 20-JAN-2015. On 09-DEC-2014 the patient was vaccinated in error with GARDASIL dose 1 (dose, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies included LOVENOX. Initial exposure to GARDASIL was at 34 weeks (third trimester of pregnancy). The pregnancy outcome was pending. No adverse symptoms reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to the patients of unknown age and gender. The reporter stated that there was a supported excursion affecting GARDASIL (lot# K004204, expiry date: 12-JAN-2017; lot # K004205, expiry date: 12-JAN-2017), which was also affected by prior supported excursions, starting 19-NOV-2014. Subsequently incorrectly stored GARDASIL was administered to the patients. There were no adverse events observed in patients post-vaccination and the patients did not seek a medical attention. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to the patients of unknown age and gender. The reporter stated that there was a supported excursion affecting VAQTA (lot# K007791, expiry date: 22-AUG-2014), which was also affected by prior supported excursions, starting 19-NOV-2014. Subsequently VAQTA was administered to the patients (dose: 0.5ml intramuscularly, the onset date of therapy: 19-NOV-2014). There were no adverse events observed in patients post-vaccination and the patients did not seek a medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Redness and swelling of area.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site extravasation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 26-NOV-2014 the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not reported) 19400 plaque-forming unit (PFU), in the back of the arm by the triceps muscle. No concomitant medications were reported. The reporter stated that the patient did not receive a full dose of ZOSTAVAX when it was administered (on 26-NOV-2104). The reporter stated also the patient had thicker skin than usual and the needle did not go into the subcutaneous tissue during administration. The vaccine leaked out of the injection site during administration. The ZOSTAVAX was administered subcutaneously in the back of the arm by the triceps muscle and the patient had an area that looked like a mosquito bite at the injection site. The patient sought medical attention. There was no treatment given for adverse event. The outcome of the adverse events was reported as recovering. The relatedness between adverse events and ZOSAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-NOV-2104 the patient was vaccinated with a dose of expired ZOSTAVAX (lot number not provided) (strength, dose, frequency and route not provided). The dose of ZOSTAVAX expired on an unspecified date in July 2014. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On an unspecified date, 2 patients each received a dose of ZOSTAVAX (lot#, dose and route unknown). Then, on an unspecified date after this, these 2 patients both developed cellulitis. The present status of these patients was unspecified. All of the data listed here was reconfirmed with the reporter. Action taken was not provided. No PQC (Production Quality Control) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patient of an unknown age and gender. On an unspecified date, unspecified number of patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (Lot#, strength, dose route were not reported) for an unknown indication. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.