chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Barium swallow abnormal, Dysarthria, Dysphagia, Dysphonia, Muscular weakness
Clinical narrative: Diffusely weak on his legs.  Progressed to the point that he had complete loss of strength in the legs. Speech became dysarthic and hoarse, unable to swallow well. (Patient surgery right total hip arthroplasty. On Post op day 2 & 3 he started noticing he was having difficulty getting out of bed but still able to ambulate.  On POD 4 received the vaccines. Neurologist consulting thinks incident not due to vaccines but other issues related to admission diagnosis and condition).
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: Severe headache, lethargy, elevated temperature, nausea, loss of appetite, Fever>103.  Symptoms progressed over 72 hours and dissipated over 7 days.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Intense pain, swelling, redness, and warmth at injection site.
Age: 0.19
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: 2 month old child was given Kinrix instead of Pediarix.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: Upper arm tender to touch, "knot" at injection site, swollen, painful.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Pain, Weight bearing difficulty
Clinical narrative: Soreness after shot. Pain worsened and am now unable to raise my arm or bear weight using it. Constant pain, especially at night. Appointment with an orthopedic doctor tomorrow.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Soreness after shot. Pain worsened and am now unable to raise my arm or bear weight using it. Constant pain, especially at night. Appointment with an orthopedic doctor tomorrow.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itching at injection site.  Rash extending to the elbow, 1 week after date of injection.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Neck pain, Pallor, Vomiting
Clinical narrative: PT RECEIVED VACCINE AND WAITED IN THE CLINIC WAITING ROOM FOR 15 MINUTES. AFTER LEAVING THE CLINIC THE PARENT OF THE CHILD RETURNED STATING HE THINKS HIS CHILD IS HAVING AN ALLERGIC REACTION DUE TO THE CHILD COMPLAING OF HIS NECK HURTING AND HE COULDNT PUT ON HIS SEALBELT. THE FATHER ALSO STATED HE EXPERIENCED SOME VOMITING IN THE CAR AND HE WAS VERY PALE.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Local swelling, Myalgia, Pain in extremity
Clinical narrative: Increasing pain at injection site that spread to shoulder, neck, head. Within 8 hrs, generalized muscle aches. Arm pain lasted 72 hrs. Arm swelling and redness lasting 4 to 5 days. Pain slowly faded to tenderness within 7 days. I thought this was just a bad reaction until provider suggested it may be an allergic reaction as this was just the second time I have recieved a flu shot. Have had the flu only once in my life. Don't believe in the flu shot for myself, felt forced by my employer to have a flu shot.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Increasing pain at injection site that spread to shoulder, neck, head. Within 8 hrs, generalized muscle aches. Arm pain lasted 72 hrs. Arm swelling and redness lasting 4 to 5 days. Pain slowly faded to tenderness within 7 days. I thought this was just a bad reaction until provider suggested it may be an allergic reaction as this was just the second time I have recieved a flu shot. Have had the flu only once in my life. Don't believe in the flu shot for myself, felt forced by my employer to have a flu shot.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema
Clinical narrative: Mom called to say that the baby was crying inconsolably and his leg was red from the injection. OTC pain reliever recommended.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: LEFT LEG RED AND ERYTHEMETOUS AT CLINIC; PT PLAYFUL; AFEBRILE; TREATED WITH TYLENOL Q 4-6 HOURS PRN; ICE; MASSAGE; RTC IN 2 DAYS OR GO TO ER IF S/S WORSEN OR DO NOT IMPROVE; A PEN WAS USED TO DRAW AROUND THE SITE OF ERYTHEMA AND PARENTS INSTRUCTED THAT WITH TIME AND MEDS, SHOULD GET BETTER. IF RASH GET WORSE AND ERYTHEMA INCREASES TO GO TO ER.
Age: 16.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMRV, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event took place.  I am reporting this because I inadvertently gave this child MMRV and varicella vaccines.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling cold, Feeling hot, Immediate post-injection reaction, Malaise
Clinical narrative: I was given a vaccination and there was an issue with administration of it. Unsure whether the retractable syringe retracted before the vaccine was given. I was poked a second time and received the full dose. My arm was immediately sore after be poked twice. Around 3:30 pm I started feeling fatigued and kind of achy and cold. Almost flu like symptoms. I have had numerous shots in the past and have never had a reaction. I'm not sure if it has to do with the administration error and was given a higher dose than I should have or what. Currently I just feel warm, tired and like I'm sick.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: I was given a vaccination and there was an issue with administration of it. Unsure whether the retractable syringe retracted before the vaccine was given. I was poked a second time and received the full dose. My arm was immediately sore after be poked twice. Around 3:30 pm I started feeling fatigued and kind of achy and cold. Almost flu like symptoms. I have had numerous shots in the past and have never had a reaction. I'm not sure if it has to do with the administration error and was given a higher dose than I should have or what. Currently I just feel warm, tired and like I'm sick.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Cognitive disorder, Guillain-Barre syndrome, Headache, Pain, Photosensitivity reaction
Clinical narrative: Mild Guillain Barre Syndrome: Right extremities had loss of sensation and no control.  Speech impairment, not able to speak clearly or fluently.  Unable to understand what was being said by others.  Mild headache in someone who does not usually get headaches.  Photo-sensitivity to bright light.  First signs of symptoms occurred when standing and talking.  Meningococcal Conjugate Vaccine was administered earlier in the day at a routine visit to the doctor's office for Tb booster and TDaP, which were both administered at the same time.  After two hours of symptoms, I slept it off for 4-6 hours.  When I woke up everything was back to normal with slight soreness that went away after a few hours.  I was informed that my parents had called the hospital as my doctor was not available.  Hospital informed them that if the symptoms got worse that I was to come to the ER.  Symptoms did not progress from onset, but did stay the same as mentioned above for the entire two hours.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Sensory loss, Speech disorder
Clinical narrative: Mild Guillain Barre Syndrome: Right extremities had loss of sensation and no control.  Speech impairment, not able to speak clearly or fluently.  Unable to understand what was being said by others.  Mild headache in someone who does not usually get headaches.  Photo-sensitivity to bright light.  First signs of symptoms occurred when standing and talking.  Meningococcal Conjugate Vaccine was administered earlier in the day at a routine visit to the doctor's office for Tb booster and TDaP, which were both administered at the same time.  After two hours of symptoms, I slept it off for 4-6 hours.  When I woke up everything was back to normal with slight soreness that went away after a few hours.  I was informed that my parents had called the hospital as my doctor was not available.  Hospital informed them that if the symptoms got worse that I was to come to the ER.  Symptoms did not progress from onset, but did stay the same as mentioned above for the entire two hours.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warm skin around injection site approximately 2in. in diameter.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Drooling, Dyskinesia, Dysstasia
Clinical narrative: Child was staggering, falling and drooling. Could not walk straight or stand.  Was seen at the ED at 10:30 AM-exam, labs-blod and urine, CAT scan performed.  Concluded possible flu shot reaction.  Followed up with Neurology Dept on 10/22/13.  Diagnosis Code 781.0 Involutary Movements; advise MRI.  Also advised to report to VAERS.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Gait disturbance, Urine analysis
Clinical narrative: Child was staggering, falling and drooling. Could not walk straight or stand.  Was seen at the ED at 10:30 AM-exam, labs-blod and urine, CAT scan performed.  Concluded possible flu shot reaction.  Followed up with Neurology Dept on 10/22/13.  Diagnosis Code 781.0 Involutary Movements; advise MRI.  Also advised to report to VAERS.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Pt stated that her heart rate increased rapidly and she experienced shortness of breath.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Middle insomnia, Pain, Tenderness
Clinical narrative: 16 days later still have significant pain with any range of motion. Wakes me at night. Limits my activities of daily living. Also have point tenderness.
Age: 100.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Dizziness
Clinical narrative: Dizzy - couldn't walk - stood up and had to sit back down - called a nurse and spoke w/ her, ruled out low/high blood sugar and low/high blood pressure. Went to bed and woke up and was still dizzy so stayed in bed all following day and around 10PM 9/5/13 went away.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Flushing, Paraesthesia
Clinical narrative: Pt given Pneumovax and Fluzone Quad vaccines in separate arms. Within 5 min pt began to c/o SOB, flushing, face tingling. Pt given epinephrine, IV fluid, IV solumedrol, and oxygen. Sx completely resolved and pt was discharged home with wife by PA-C.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Local swelling, Sensation of heaviness
Clinical narrative: Leg swelling/heavy. Feels like "has flu".
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Body temperature increased, Decreased appetite, Irritability
Clinical narrative: High temp 102.7 degrees F, irritability, decreased appetite.
Age: 65.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Reports 1 hr. after shot, of pain, redness, swelling, heat to (R) arm/shoulder. Pain, swelling moved down arm over 3 days to below elbow (inner aspect) to ER same day (9-17-13) Dx: cellulitis - gave her 2 antibiotics. S and S left after 3-4 days.
Age: 65.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Reports 1 hr. after shot, of pain, redness, swelling, heat to (R) arm/shoulder. Pain, swelling moved down arm over 3 days to below elbow (inner aspect) to ER same day (9-17-13) Dx: cellulitis - gave her 2 antibiotics. S and S left after 3-4 days.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Fatigue, Hyperhidrosis, Injection site bruising, Injection site erythema
Clinical narrative: Rcvd flu shot from pharmacy 10/17/2013 in rt. arm. During injection, I felt burn and pain and lasting a time after injection told pharmacist. My arm became more sore and red and painful thru day even when lifting arm thumb on rt hand locked up net morning extreme pain could not bend thumb w/o extreme pain. Pain and redness traveled down arm. Became tired and sweating. Since my husband also suffered from flu shot in his right arm with redness, pain and swelling, we both went to hospital emergency ctr for evaluation on Sat 10/19/13. Dr observed severe redness of upper right arm with swelling and pain plus extreme "bruise mark" at injection site. Released and told to follow-up with family physician. Followed up with dr.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Rcvd flu shot from pharmacy 10/17/2013 in rt. arm. During injection, I felt burn and pain and lasting a time after injection told pharmacist. My arm became more sore and red and painful thru day even when lifting arm thumb on rt hand locked up net morning extreme pain could not bend thumb w/o extreme pain. Pain and redness traveled down arm. Became tired and sweating. Since my husband also suffered from flu shot in his right arm with redness, pain and swelling, we both went to hospital emergency ctr for evaluation on Sat 10/19/13. Dr observed severe redness of upper right arm with swelling and pain plus extreme "bruise mark" at injection site. Released and told to follow-up with family physician. Followed up with dr.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Rash macular
Clinical narrative: Rcvd flu shot from pharmacy 10/17/2013 in rt. arm. During injection, I felt burn and pain and lasting a time after injection told pharmacist. My arm became more sore and red and painful thru day even when lifting arm thumb on rt hand locked up net morning extreme pain could not bend thumb w/o extreme pain. Pain and redness traveled down arm. Became tired and sweating. Since my husband also suffered from flu shot in his right arm with redness, pain and swelling, we both went to hospital emergency ctr for evaluation on Sat 10/19/13. Dr observed severe redness of upper right arm with swelling and pain plus extreme "bruise mark" at injection site. Released and told to follow-up with family physician. Followed up with dr.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Anaemia, Cardiac disorder, Chills, Local swelling, Pyrexia
Clinical narrative: Patient complained of chills, fever, swollen arm.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: I received flu shot from pharmacy 10/17/13 on Rt. arm and soon after injection, Rt arm became extremely red and sore. As day progressed my wife and I both with the same injection, we became more sore, redness, hot. We went to Med Ctr Sat. Oct 19, 2013. In hospital, no tests taken but ER physician noted extreme redness, heat, pain at site and black and blue mark at flu injection site.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: I received flu shot from pharmacy 10/17/13 on Rt. arm and soon after injection, Rt arm became extremely red and sore. As day progressed my wife and I both with the same injection, we became more sore, redness, hot. We went to Med Ctr Sat. Oct 19, 2013. In hospital, no tests taken but ER physician noted extreme redness, heat, pain at site and black and blue mark at flu injection site.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: I received flu shot from pharmacy 10/17/13 on Rt. arm and soon after injection, Rt arm became extremely red and sore. As day progressed my wife and I both with the same injection, we became more sore, redness, hot. We went to Med Ctr Sat. Oct 19, 2013. In hospital, no tests taken but ER physician noted extreme redness, heat, pain at site and black and blue mark at flu injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Inflammation, Skin induration, Skin warm
Clinical narrative: Local inflammatory skin reaction warm, pink, indurated, tender no fever (+) chills 11 cm x 8 cm left upper extremity no SOB no edema.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Local inflammatory skin reaction warm, pink, indurated, tender no fever (+) chills 11 cm x 8 cm left upper extremity no SOB no edema.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Body temperature increased, Dyspnoea
Clinical narrative: Elevated temperature, shortness of breath, memory loss.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: PATIENT REPORTS SWELLING FROM THE BACK OF HER ARM TO HER ELBOW AFTER RECEIVING THE ZOSTAVAX (SHINGLES) VACCINE.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme soreness and pain in shoulder, arm and upper chest muscles.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on an unspecified date was vaccinated with PNEUMOVAX (lot # J004242, expiration date 20Jul2014). On 01-OCT-2013, the patient experienced an adverse reaction (not further specified) to the PNEUMOVAX vaccine. Treatment and outcome of the adverse event was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Pruritus generalised, Urticaria, Wheezing
Clinical narrative: Itching all over with development of hives; wheezing; hoarseness of voice; coughing.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Left arm sore and swollen started on 10/11/13 pm. Using hot and cold pack, started taking TYLENOL extra strength pain medication. Left arm is still sore and swollen. Feeling much better since started taking pain medication 10/21/13.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator regarding a male patient, age unknown, who was vaccinated with ZOSTAVAX, lot # J004310 (expiration 12-JUL-2014) (date of vaccination, dosage and route of administration not provided). On 01-OCT-2013, the patient had an adverse reaction (not further specified) "to shingles vaccine" and ZOSTAVAX. "It is not known at this time which vaccine the customer had the reaction to." The outcome of the adverse reaction is unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and vomiting after 1st pill.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: 10/17: Redness and swelling at the injection. 10/17: Past 6 PM fever 100.5 degrees F, inflammation at the site of injection. (ADVIL 400mg). 10/18: No fever, myalgia, inflammation at the site. (Ice pac, ADVIL and rest).
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: Pt discovered rash when she removed band aid the next AM, rash is just around injection site and has not enlarged since midday on 10/21/13; some itching (recommended Benadryl and Cortisone cream). Zostavax inj site only.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Wheezing
Clinical narrative: Pt received flu shot 1114 am, reported itching to injection site and redness noted. Wheezing (R) upper anterior lobe EMS notified after epinephrine,  0.3 ml SQ given (R) arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Pt had flu shot at 1435, Hx: asthma, came to nurses room in ER c/o chest tightness, urticaria, itching gave epinephrine 0.3 ml SQ (L) arm 1636.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Papular rash, neither pruritic nor tender, progressing over approximately 1 week from bridge of nose to entire body spreading caudally. Rash faded in same rostral to caudal pattern.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site atrophy, Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site swelling
Clinical narrative: Allergic reactions at injection site - skin atrophy, itching, redness. (Swelling about half dollar size). Pt taking BENADRYL and HYDROCORTIZONE 1% CREAM.
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Macule, Scab
Clinical narrative: 2 x 0.5 in diameter 4 discrete erythematous macules with scabbing.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count normal, Grand mal convulsion, Laboratory test normal, Urine analysis normal
Clinical narrative: Tonic clonic seizure 48 hours after vaccines. Patient transported to local hospital.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysgeusia, Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediately developed "metallic" taste in mouth erythema and swelling at injection site involving area at site to "shoulder" 10/16 -> 10/22 metallic taste persisted 10/16 -> 10/22.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Musculoskeletal pain, Pain in extremity
Clinical narrative: C/O pain and burning sensation from shoulder area that radiated to mid arm. This pain and burning lasted for approximately 12 hrs.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MMR, MNQ
Symptoms: Immediate post-injection reaction, Rash erythematous, Rash macular, Skin tightness, Skin warm
Clinical narrative: Client broke out with a red, blotchy rash on his head, neck and core body that was noticed immediately following administration of all vaccines. Client's body was radiating heat. He c/o tightness in his right arm but no breathing difficulties of any kind. 0.3 ml of epinephrine was administered subcutaneously in client's left deltoid; within minutes, the redness was gone completely. Paramedics  were called, client was assessed, and client was sent home with Benadryl.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received a flu shot on 9/17/13 of FLUVIRN. Pt called pharmacy the 1st week of Oct complaining of arm pain from shot. Pain is constant and doesn't resolve with prescription pain meds.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, IPV, MMRV
Symptoms: Dermatitis allergic, Injection site reaction
Clinical narrative: Rash x 5x5cm on the left thigh - did not look infected, but allergic.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Juvenile idiopathic arthritis
Clinical narrative: Experienced a flare of her juvenile RA, which was in remission. Rheumatologist thinks GARDASIL injection given.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown age patient. Pertinent medical history, drug reactions or allergies were not reported. On 09-OCT-2013, the patient was vaccinated with an expired dose of ROTATEQ, 2 ml oral, lot # 0059AE, expiration date: 23-SEP-2013. Concomitant medication was not reported. No adverse event was reported. The outcome of the patient receiving an expired vaccine dose was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt seen in ER for zoster 2 days after Zostavax,
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Throat irritation
Clinical narrative: Coughing sensation of a mucus plug, voice change, constantly trying to clear throat. Voice dry residual day after.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient describes painful right forearm starting at elbow (pt claims shot was given in elbow?).
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Contusion, Injection site erythema
Clinical narrative: Reddened area around injection site no pain no itch. Stated that it feels like a bruise. No treatment.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 78 year old female patient with no pertinent medical history and no drug reactions or allergies. On 11-OCT-2013, the patient was vaccinated with a first 0.5 ml dose of PNEUMOVAX23 (Lot # J004747, expiration date 20-JUL-2014) intramuscularly in the right arm and a dose of FLUVIRIN administered in the left arm. Concomitant therapies included RESTASIS, fluorometholone, omeprazole (manufacturer unknown), atorvastatin and diazepam. The pharmacist reported that on 11-OCT-2013, the patient experienced warmness and soreness at the injection site. The pharmacist stated that she also vaccinated three or four other people with this vaccine, PNEUMOVAX23 on 11-OCT-2013 but nobody else developed any adverse experiences. The patient was treated with TYLENOL. The outcome of warmness and soreness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Flu shot administered 9/30/13. Patient still has complaint of sore arm, as of today 10/22/13.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to an over 65 years old female patient. On 01-OCT-2013 (a week ago) the patient was vaccinated with ZOSTAVAX (dose, route and indication unknown). Concomitant medication included warfarin. Pharmacist reported that after the patient was administered ZOSTAVAX, "a week ago" (01-OCT-2013), the patient developed a "half dollar sized red mark" at the injection site "the next day". The pharmacist stated "the red mark turned into a bruise 5 days later (06-OCT-2013)". The pharmacist stated the patient saw her unspecified primary care provider on an unspecified date in regards to this reaction. At time of reporting, the patient had not recovered from the events. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccine 10/01/2013. Complaint is arm is still sore, as of today 10/22/13.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Acute disseminated encephalomyelitis, Computerised tomogram, Laboratory test, Nuclear magnetic resonance imaging, Scan with contrast
Clinical narrative: 6 days after flu injection, woke up with blurred vision, projective vomiting,. TO ED, CT scan, lab work, MRI with and without contrast. Acute disseminated encephalomyelitis noted. Steroid infusion x 3 days.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Vision blurred, Vomiting projectile
Clinical narrative: 6 days after flu injection, woke up with blurred vision, projective vomiting,. TO ED, CT scan, lab work, MRI with and without contrast. Acute disseminated encephalomyelitis noted. Steroid infusion x 3 days.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Influenza like illness, Malaise, Myalgia
Clinical narrative: A few hours after flu vaccine, patient began to feel very weak, dizzy, fever and myalgias throughout the body. He call again the next morning with continued sickness, flu like symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: A few hours after flu vaccine, patient began to feel very weak, dizzy, fever and myalgias throughout the body. He call again the next morning with continued sickness, flu like symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Shoulder bursitis developed within 48 hours of flu vaccine suspect SIRVA.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Injection site erythema, Insomnia, Local swelling, Nausea
Clinical narrative: Went to bed at night at 11:00pm. Woke up at 1am covered in red blotchy rash in face, neck, arm took BENADRYL. Woke up a bit later and it had spread to knees and legs. Next day was hoarse, nausea, ears were itchy. Went to ER on 10/17/13 because felt like throat closing up. Was given BENADRYL IV, antihistamine blocker, nausea. Was in ER of 2 1/2 hours and released afterwards. Site of injection was red area the size of 1/2 dollar the day after the vaccination. The arm was swollen and sore; couldn't sleep because it was so swollen. Followed up with doctor on 10/21. Today feel OK, injection site is size of dime.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash erythematous, Rash macular, Throat tightness
Clinical narrative: Went to bed at night at 11:00pm. Woke up at 1am covered in red blotchy rash in face, neck, arm took BENADRYL. Woke up a bit later and it had spread to knees and legs. Next day was hoarse, nausea, ears were itchy. Went to ER on 10/17/13 because felt like throat closing up. Was given BENADRYL IV, antihistamine blocker, nausea. Was in ER of 2 1/2 hours and released afterwards. Site of injection was red area the size of 1/2 dollar the day after the vaccination. The arm was swollen and sore; couldn't sleep because it was so swollen. Followed up with doctor on 10/21. Today feel OK, injection site is size of dime.
Age: 94.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received PNEUMOVAX on 10-14-13 and called us on 10-15-13 stating arm is red from elbow to shoulder and hot to touch. Patient was to use cool compresses and ibuprofen 200 mg 1 or 2 every 8 hours.
Age: 0.01
Sex: M
Vaccine: HEP, HEP
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizures.
Age: 16.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Blood creatinine increased, Face oedema, Feeling abnormal, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Case number PHHY2013US110851 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 497569) web site on 04 Oct 2013, with the follow-up received from Quality Assurance Department (reference number: 257028) on 18 Oct 2013. This report refers to a 16-years-old female patient. Her medical history included kidney transplantation at the age of 9 years and egg allergy. Concomitant medications were clindamycin 150 mg, cholecalciferol 1000 units, azathioprine 50 mg, sodium bicarbonate, prednisone 2.5 mg, tacrolimus 5 mg capsule, multivitamin and TUMS 500. Her vaccination history included anaphylaxis following administration of unspecified vaccine. She was told that she could receive vaccines that were not live and that did not contain egg due to allergy. She was vaccinated with MENVEO (batch number: M11051 and expiry date: Mar 2014) and IPOL (other manufacture, batch number: H13541); both vaccines administered intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: H016238) intramuscularly in the right arm on 23 Jul 2013. On 24 Jul 2013, she was presented to the emergency room as she was feeling weird. Her throat was hurting and it was felt swollen. She had facial edema. She was given BENADRYL 50 mg intravenously, PEPCID 20 mg, SOLUMEDROL 125 mg intravenously, DUONEB and two doses of EPI. Her blood samples were drawn for laboratory tests in emergency room and she was kept for observation overnight. It was reported that the creatinine laboratory tests needed to be repeated due to elevated creatinine (values were not reported) after vaccination. The outcome was reported as complete recovery. The reporter assessed the event as life threatening and causality of the events was not assessed. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11051) was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Follow up received Quality Assurance Department (reference number: 257028) on 18 Oct 2013: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Blood creatinine increased, Blood test, Face oedema, Feeling abnormal, Oropharyngeal pain
Clinical narrative: Case number PHHY2013US110851 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 497569) web site on 04 Oct 2013, with the follow-up received from Quality Assurance Department (reference number: 257028) on 18 Oct 2013. This report refers to a 16-years-old female patient. Her medical history included kidney transplantation at the age of 9 years and egg allergy. Concomitant medications were clindamycin 150 mg, cholecalciferol 1000 units, azathioprine 50 mg, sodium bicarbonate, prednisone 2.5 mg, tacrolimus 5 mg capsule, multivitamin and TUMS 500. Her vaccination history included anaphylaxis following administration of unspecified vaccine. She was told that she could receive vaccines that were not live and that did not contain egg due to allergy. She was vaccinated with MENVEO (batch number: M11051 and expiry date: Mar 2014) and IPOL (other manufacture, batch number: H13541); both vaccines administered intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: H016238) intramuscularly in the right arm on 23 Jul 2013. On 24 Jul 2013, she was presented to the emergency room as she was feeling weird. Her throat was hurting and it was felt swollen. She had facial edema. She was given BENADRYL 50 mg intravenously, PEPCID 20 mg, SOLUMEDROL 125 mg intravenously, DUONEB and two doses of EPI. Her blood samples were drawn for laboratory tests in emergency room and she was kept for observation overnight. It was reported that the creatinine laboratory tests needed to be repeated due to elevated creatinine (values were not reported) after vaccination. The outcome was reported as complete recovery. The reporter assessed the event as life threatening and causality of the events was not assessed. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11051) was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Follow up received Quality Assurance Department (reference number: 257028) on 18 Oct 2013: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Pharyngeal oedema
Clinical narrative: Case number PHHY2013US110851 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 497569) web site on 04 Oct 2013, with the follow-up received from Quality Assurance Department (reference number: 257028) on 18 Oct 2013. This report refers to a 16-years-old female patient. Her medical history included kidney transplantation at the age of 9 years and egg allergy. Concomitant medications were clindamycin 150 mg, cholecalciferol 1000 units, azathioprine 50 mg, sodium bicarbonate, prednisone 2.5 mg, tacrolimus 5 mg capsule, multivitamin and TUMS 500. Her vaccination history included anaphylaxis following administration of unspecified vaccine. She was told that she could receive vaccines that were not live and that did not contain egg due to allergy. She was vaccinated with MENVEO (batch number: M11051 and expiry date: Mar 2014) and IPOL (other manufacture, batch number: H13541); both vaccines administered intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: H016238) intramuscularly in the right arm on 23 Jul 2013. On 24 Jul 2013, she was presented to the emergency room as she was feeling weird. Her throat was hurting and it was felt swollen. She had facial edema. She was given BENADRYL 50 mg intravenously, PEPCID 20 mg, SOLUMEDROL 125 mg intravenously, DUONEB and two doses of EPI. Her blood samples were drawn for laboratory tests in emergency room and she was kept for observation overnight. It was reported that the creatinine laboratory tests needed to be repeated due to elevated creatinine (values were not reported) after vaccination. The outcome was reported as complete recovery. The reporter assessed the event as life threatening and causality of the events was not assessed. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11051) was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Follow up received Quality Assurance Department (reference number: 257028) on 18 Oct 2013: Updated batch review report.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Blood test, Crying, Dehydration, Infantile spitting up
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 08 October 2013, with additional information received from a health care professional on 17 October 2013. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of Sanofi Pasteur. A six month-old male patient had received on 03 July 2013 the following vaccines; ACTHIB, lot number UH785AA (route and site of administration not reported) PEDIARIX, lot number 5GS7L (route and site of administration not reported), ROTATEQ, lot number H017722 (route and site of administration not reported) and PREVNAR, lot number F99044 (route and site of administration not reported) and on 08 July 2013, was found to have a fever and irritability. According to the patient's parent, "he had a 104 temperature for seven days, his white blood count dropped and he stopped saying words. He started leaning his head to the left and couldn't hold it up. The neurologist said that "cerecellara ataxia" (cerebellar ataxia) caused the head to tilt to the side from the virus from the vaccination". No further information was available at the time of the event. The patient's outcome was not reported (unknown). Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Malaise, Posture abnormal, Pyrexia, Rash, Ultrasound abdomen
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 08 October 2013, with additional information received from a health care professional on 17 October 2013. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of Sanofi Pasteur. A six month-old male patient had received on 03 July 2013 the following vaccines; ACTHIB, lot number UH785AA (route and site of administration not reported) PEDIARIX, lot number 5GS7L (route and site of administration not reported), ROTATEQ, lot number H017722 (route and site of administration not reported) and PREVNAR, lot number F99044 (route and site of administration not reported) and on 08 July 2013, was found to have a fever and irritability. According to the patient's parent, "he had a 104 temperature for seven days, his white blood count dropped and he stopped saying words. He started leaning his head to the left and couldn't hold it up. The neurologist said that "cerecellara ataxia" (cerebellar ataxia) caused the head to tilt to the side from the virus from the vaccination". No further information was available at the time of the event. The patient's outcome was not reported (unknown). Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis, Viral infection, Vomiting, X-ray
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 08 October 2013, with additional information received from a health care professional on 17 October 2013. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of Sanofi Pasteur. A six month-old male patient had received on 03 July 2013 the following vaccines; ACTHIB, lot number UH785AA (route and site of administration not reported) PEDIARIX, lot number 5GS7L (route and site of administration not reported), ROTATEQ, lot number H017722 (route and site of administration not reported) and PREVNAR, lot number F99044 (route and site of administration not reported) and on 08 July 2013, was found to have a fever and irritability. According to the patient's parent, "he had a 104 temperature for seven days, his white blood count dropped and he stopped saying words. He started leaning his head to the left and couldn't hold it up. The neurologist said that "cerecellara ataxia" (cerebellar ataxia) caused the head to tilt to the side from the virus from the vaccination". No further information was available at the time of the event. The patient's outcome was not reported (unknown). Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Aphasia, Cerebellar ataxia, Irritability, Posture abnormal, Pyrexia
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 08 October 2013, with additional information received from a health care professional on 17 October 2013. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of Sanofi Pasteur. A six month-old male patient had received on 03 July 2013 the following vaccines; ACTHIB, lot number UH785AA (route and site of administration not reported) PEDIARIX, lot number 5GS7L (route and site of administration not reported), ROTATEQ, lot number H017722 (route and site of administration not reported) and PREVNAR, lot number F99044 (route and site of administration not reported) and on 08 July 2013, was found to have a fever and irritability. According to the patient's parent, "he had a 104 temperature for seven days, his white blood count dropped and he stopped saying words. He started leaning his head to the left and couldn't hold it up. The neurologist said that "cerecellara ataxia" (cerebellar ataxia) caused the head to tilt to the side from the virus from the vaccination". No further information was available at the time of the event. The patient's outcome was not reported (unknown). Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cell count decreased
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 08 October 2013, with additional information received from a health care professional on 17 October 2013. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of Sanofi Pasteur. A six month-old male patient had received on 03 July 2013 the following vaccines; ACTHIB, lot number UH785AA (route and site of administration not reported) PEDIARIX, lot number 5GS7L (route and site of administration not reported), ROTATEQ, lot number H017722 (route and site of administration not reported) and PREVNAR, lot number F99044 (route and site of administration not reported) and on 08 July 2013, was found to have a fever and irritability. According to the patient's parent, "he had a 104 temperature for seven days, his white blood count dropped and he stopped saying words. He started leaning his head to the left and couldn't hold it up. The neurologist said that "cerecellara ataxia" (cerebellar ataxia) caused the head to tilt to the side from the virus from the vaccination". No further information was available at the time of the event. The patient's outcome was not reported (unknown). Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Pyrexia, Sneezing
Clinical narrative: A report has been received from a Health Professional and consumer, concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 17-Aug-2013. The patient experienced Temperature of 101F, Sneezing and Mucus which started on 19-Aug-2013. The outcome of the event of Temperature of 101F, Sneezing and Mucus is unknown. The report was considered to be non-serious by the reporter.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Body temperature increased, Rhinorrhoea, Sneezing
Clinical narrative: A report has been received from a Health Professional and consumer, concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 17-Aug-2013. The patient experienced Temperature of 101F, Sneezing and Mucus which started on 19-Aug-2013. The outcome of the event of Temperature of 101F, Sneezing and Mucus is unknown. The report was considered to be non-serious by the reporter.
Age: 0.58
Sex: M
Vaccine: FLUN4, HEPA, MMR, VARCEL, FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 6 month old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 05-Sep-2013. It was reported that a seven months old patient inadvertently given FLUMIST on 05-Sep-2013. FLUMIST QUADRIVALENT (Intranasal) was discontinued on 05-Sep-2013. The outcome of the event of 7 month old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 88.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Between 4:00-5:00 PM I got very cold with chattering teeth and unable to get warm, called a neighbor and took my temperature which was 106 degrees she called an ambulance and was admitted to ER. At time of vaccine a prescription for Hydrocodone was filled, I took one before a light supper and along with chills started vomiting and went to ER. Pharmacist was notified and agreed they were wrong filling the prescription as it was on my records that I was allergic to codeine. However I suffered and I had a bill to hospital for $65 I can't recover.
Age: 88.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Chills, Feeling cold, Laboratory test, Vomiting
Clinical narrative: Between 4:00-5:00 PM I got very cold with chattering teeth and unable to get warm, called a neighbor and took my temperature which was 106 degrees she called an ambulance and was admitted to ER. At time of vaccine a prescription for Hydrocodone was filled, I took one before a light supper and along with chills started vomiting and went to ER. Pharmacist was notified and agreed they were wrong filling the prescription as it was on my records that I was allergic to codeine. However I suffered and I had a bill to hospital for $65 I can't recover.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: Acute onset of aching, chills, fever (101.1) fatigue, muscle pain. Lasted approximately 12-15 hrs.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Acute onset of aching, chills, fever (101.1) fatigue, muscle pain. Lasted approximately 12-15 hrs.
Age: 90.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Induration, Injection site discolouration, Injection site reaction, Local swelling
Clinical narrative: Initial report was received from a healthcare professional on 12 October 2013. A 90-year-old female patient with no known medical history and allergies had received an intramuscular dose of FLUZONE HD (Sanofi Pasteur, batch number U4717AA) in the left deltoid on 11 October 2013. On 12 October 2013 A.M, the patient presented with facial swelling and with "white ring" around needle injection site, and red, swollen, hot to touch, area around injection site with "hard area that can be felt beneath injection site". No information was reported on any corrective treatment given. At the time of the report, the patient had not recovered. Documents held by sender: None.