chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness postural, Erythema, Local swelling, Pain
Clinical narrative: First it was just heat and soreness.   Then my arm began to swell to twice it's size and red.   Started itching.   Took Benadryl which helped with the itching.  A few hours later very hot and swollen.   Ran a fever of 101 most of the night along with chills.   Dizzy when standing up.   Called Dr. next day.   Told to keep up the antihistamine.   Swelling now dropping below elbow to mid lower arm.   The 3rd day, still have swelling even with icing and some pain, but definitely swollen and sore.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: First it was just heat and soreness.   Then my arm began to swell to twice it's size and red.   Started itching.   Took Benadryl which helped with the itching.  A few hours later very hot and swollen.   Ran a fever of 101 most of the night along with chills.   Dizzy when standing up.   Called Dr. next day.   Told to keep up the antihistamine.   Swelling now dropping below elbow to mid lower arm.   The 3rd day, still have swelling even with icing and some pain, but definitely swollen and sore.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Abnormal behaviour, Antisocial behaviour, Aphasia, Autism, Cognitive disorder
Clinical narrative: Severe unprovicated crying; lack of sleep; Sensory processing issues; regression of speech (complete loss); anti-social behavior; limited to no eye-contact; aversion to certain food textures; repetitive behaviors and delayed cognitive skills.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Crying, Decreased eye contact, Dyspraxia, Food aversion, Hypotonia
Clinical narrative: Severe unprovicated crying; lack of sleep; Sensory processing issues; regression of speech (complete loss); anti-social behavior; limited to no eye-contact; aversion to certain food textures; repetitive behaviors and delayed cognitive skills.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Insomnia, Sensory disturbance, Speech disorder developmental
Clinical narrative: Severe unprovicated crying; lack of sleep; Sensory processing issues; regression of speech (complete loss); anti-social behavior; limited to no eye-contact; aversion to certain food textures; repetitive behaviors and delayed cognitive skills.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Acute respiratory failure, Bacterial test negative, Demyelination, Enterovirus test negative, Herpes simplex serology negative
Clinical narrative: Demyelinating disease including bulbar and extremity weakness as well as acute respiratory failure.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Demyelinating disease including bulbar and extremity weakness as well as acute respiratory failure.
Age: 60.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Injection site urticaria, Tachycardia, Throat tightness, Urticaria
Clinical narrative: Hives developed at injection site on left upper extremity and at left upper back area, throat tightness, tachycardia.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Face injury, Fall, Heart rate decreased, Loss of consciousness
Clinical narrative: Patient was sitting in chair when she passed out and fell on her face. She was convulsing (head and upper part of body) which ceased after approx. 10 seconds. At that time the patient became conscious. An ambulance arrived to assess patient. She was transported to the hospital for an extremely low heart rate.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 13-APR-2013, the patient was vaccinated with GARDASIL dose 1 (route and lot number were not reported). On 11-JUL-2013, the patient was vaccinated with GARDASIL dose 2 (route and lot number were not reported). On 11-SEP-2013, the patient was vaccinated with GARDASIL dose 3 (route and lot number were not reported). The nurse reported that the patient was in the office to receive dose 3 of GARDASIL which would be late. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other register nurse reporting an unknown number of patients of an unkonwn age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that an unknown date, an unknown number of patients were administered VARIVAX (Merck) that had been improperly stored. No adverse effects reported. This is one of three reports from the same source (MARRS 1408USA017042, 1409USA006413). Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test, Erythema, Feeling hot, Pain
Clinical narrative: Redness/sore and hot. Had BENADRYL 25mg tab.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt complained of pain at injection site going down into fingertips.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: After receiving a FLUZONE HD, the site of injection progressively became red, sore and warm to touch. The symptoms got worse over time and was referred to see the Dr. Patient took a BENADRYL and MOTRIN.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness in back of arm (PNEUMOVAX). Packed it and TYLENOL.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Nausea, Ocular hyperaemia, Oropharyngeal pain, Pain of skin
Clinical narrative: Patient said symptoms occurred right after shot. Fever, nausea, red eyes, very sore throat, skin sensitive to touch.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient said symptoms occurred right after shot. Fever, nausea, red eyes, very sore throat, skin sensitive to touch.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient vaccinated Thursday approx. 2 PM. That evening he experienced severe chills. His arm was very sore, red, and very hot. Friday he went to facility, received a shot and prescription for cephalexin.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Administered FLUZONE HD to 64 1/2 y/o patient at a senior flu clinic. Mistakenly believed he was 65 y/o. No adverse side effects reported or observed.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: The day after receiving immunizations, half dollar size area of hard, warm induration on side of leg (at site of MMRV), lasted 2-3 days. No fever, didn't affect child's daily activities, no further treatment sought. Mother reported reaction to health department.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swollen and red (hot to the touch), very sore to touch - pt has previously had flu shots with no reaction - advised pt to ice, take BENADRYL and ibuprofen and to follow-up with MD.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt has 4-5 inch diameter oval shaped red rash around injection site. Pt reports pain at the area "like a bruise". Pt says started night of vaccination.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Gingival pain, Injection site bruising, Injection site haemorrhage
Clinical narrative: Started with bleeding/bruising at injection site. Five hours after injection, she started getting cold feet. Went to bed and woke up with extreme shaking, teeth chattering, muscle soreness, gum soreness. She took ADVIL and helped some, but continued over next 8 hours. Went back to bed for 7 hours and woke up with scalp pain and back/spine pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain of skin, Peripheral coldness, Spinal pain, Tremor
Clinical narrative: Started with bleeding/bruising at injection site. Five hours after injection, she started getting cold feet. Went to bed and woke up with extreme shaking, teeth chattering, muscle soreness, gum soreness. She took ADVIL and helped some, but continued over next 8 hours. Went back to bed for 7 hours and woke up with scalp pain and back/spine pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a program manager (also reported as Health Care worker) refers to multiple patients of unknown demographics. The patients medical history and historical conditions are not reported. It was reported that on an unknown date the patients were vaccinated with ROTATEQ (unknown strength, dose and frequency) that was stored improperly. No product quality complaint was reported. The outcome of the event is unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a program manager (also reported as health care worker) refers to multiple patient of unknown demographics. The patients medical history and historical conditions are not reported. It was reported that on an unknown date the patients were vaccinated with LIQUID PEDVAX (unknown strength, dose and frequency) that was stored improperly. No product quality complaint was reported. The outcome of the event is unknown. This is one of the several reports received from the same reporter (1409USA005116, 1409USA006384). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a program manager (also reported as Health care worker) refers to multiple patients of unknown demographics. The patients medical history and historical conditions are not reported. It was reported that on an unknown date the patients were vaccinated with GARDASIL (unknown strength, dose and frequency) that was stored improperly. No product quality complaint was reported. The outcome of the event is unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported that unspecified patients received improperly stored GARDASIL exposed to 49F for 35 minutes on an unknown date. No adverse effects were reported. This is one (1) of four (4) reports from the same source (MARRS 1408USA016198, 1409USA006389, 1409USA00638 and 1409USA006390). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of VAQTA, dose number, lot number, expiration date and route were not reported. Co-suspect and concomitant therapies were not reported. The medical assistant reported that unspecified patients received VAQTA exposed to 49F for 35 minutes, on an unknown date. No adverse effects were reported. This is one (1) of four (4) reports from the same source (MARRS 1408USA016198, 1409USA006389, 1409USA00638 and 1409USA006390. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported. The medical assistant reported that on an unknown date, that unspecified patients received improperly stored GARDASIL, exposed to -1C for 24 hours on 19-AUG-2014. No adverse effects were reported. This is one (1) of four (4) reports from the same source (MARRS 1409USA002639, 1409USA006394, 1409USA006395 and 1409USA006396). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a consumer refers to her cousin of unkonwn age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, strength, frequency, route and lot number were not reported). Secondary and concomitant therapies were not reported. The patient's cousin stated "that her cousin was diagnosed with autism, after receiving M-M-R II (dose, strength, frequency, route and lot number were not reported). Secondary and concomitant therapies were not reported. The patient's cousin stated "that her cousin was diagnosed with autism, after receiving M-M-R II. The outcome autism was not reported. Additional information is not expected because no reporter details were provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 year old female patient with high blood pressure, diabetes, allergy to Donnagel and allergy to penicillin G.  On 28-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (0.5 ml, intramuscular, in the arm, once, dose no. unknown; lot # K004016 exp 08-MAR-2015) as part of wellness visit. Concomitant therapies included GLUCOPHAGE, JANUVIA, LANTUS, clonopril and  metoprolol. On 29-AUG-2014, the patient started to "have pain in her left arm, area was hot to touch, reddened and tracking to shoulder". Nurse stated the patient was treated with BACTRIM DS twice daily for 10 days. The patient sought medical attention (office visit). No lab diagnostic studies were performed. The patient returned to office on 31-AUG-2014 stated there has been "big improvement. The redness is less, the swelling is reduced, and pain improved and no reported fevers. Nurse states "there may have been something in the way the shot was given as it was given lower down more inner upper arm versus deltoid". Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other register nurse reporting an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that an unknown date, an unknown number of patients were administered ZOSTAVAX that had been improperly stored. No adverse effects reported. This is one (1) of three (3) reports from the same source (MARRS 1408USA017042, 1409USA006413 and 1409USA006413). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (strength and lot number were not reported). Secondary therapy were not reported. The pharmacist reported that a patient received a does of ZOSTAVAX on 08-SEP-2014, that had been stored at 34 degrees for 1 hour. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed  nurse reported that since 17-JUL-2014, improperly stored (Oka/Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported.  On 06-SEP-2014, the patient was vaccinated with PNEUMOVAX23 lot # J006242, expiration date 30-AUG-2014 (also reported as 03-AUG-2014, 0.5 ml, intramuscular). Secondary and concomitant therapies were not reported. Pharmacist reported that a patient received a dose of PNEUMOVAX23 that had expired. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other register nurse reporting an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (oka-merck) PROQUAD (dose, dose number, lot number, expiration date and route were not reported. Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unknown number of patients were administered (oka-merck) PROQUAD that had been  improperly stored. No adverse effects were reported. This is one (1) of three (3) reports from the same source (MARRS 1408USA017042, 1409USA006413 and 1409USA006413). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of VAQTA (dose, dose number, lot number, expiration date and route were not reported). The medical assistant reported that on an unknown date, that unspecified patients received improperly stored VAQTA, exposed to -1C for 24  hours on 19-AUG-2014. No adverse effects were reported. This is (1) of four (4) reports from the same source (MARRS 1409USA002639, 1409USA006394, 1409USA006395 and 1409USA006396). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported.  On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were not reported). The medical assistant reported that on an unknown date, that unspecified patients received improperly stored RECOMBIVAX HB, exposed to  -1C for 24 hours on 19-AUG-2014. No adverse effects were reported. This is (1) of four (4) reports from the same source (MARRS 1409USA002639, 1409USA006394, 1409USA006395 and 1409USA006396). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported), oral route. The medical assistant reported that on an unknown date, that unspecified patients received improperly ROTATEQ, exposed to -1C for 24 hours on 19-AUG-2014. No adverse effects were reported.  This is one (1) of four (4) reports from the same source (MARRS 1409USA002639, 1409USA006394, 1409USA006395, 1409USA006396. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route. Co-suspect and concomitant therapies were not reported. The medical assistant reported that unspecified patients received improperly stored ROTATEQ exposed to 49F for 35 minutes, on an unknown date. No adverse effects were reported. This is one (1) of four (4) reports from the same source (MARRS 1408USA016198. 1409USA006389, 1409USA00638 and 1409USA006390).  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX (does, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported that unspecified patients received improperly stored RECOMBIVAX HB exposed to 49F for 35 minutes, on an unknown date. No adverse effects were reported.  This is one (1) of four (4) reports from the same source (MARRS1408USA016198, 1409USA006389, 1409USA00638 and 1409USA006390). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-AUG-2014 (reported as "a week ago"), the patient was vaccinated with second dose of GARDASIL (dose, strength frequency, route and lot number were not reported). On 04-SEP-2014 (reported as yesterday), the patient was vaccinated with third dose of GARDASIL (dose, strength frequency, route and lot number were not reported). Physician reported that an unspecified patient was administered the 2nd dose of GARDASIL "about a week ago" (on 04-SEP-2014) and was administered the 3rd dose of GARDASIL on 04-SEP-2014 (reported as yesterday). No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Paraesthesia, Tenderness
Clinical narrative: Patient got shingles, pain, tingling, was treated with antiviral.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia
Clinical narrative: Patient got shingles, pain, tingling, was treated with antiviral.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Moderate++ pain in L arm at and below injection site, pain prevents raising L arm more than 25% of normal rom.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Eye discharge, Eye pruritus, Injection site pain
Clinical narrative: 7:00 started coughing like my lungs were thick bronchial dry cough like I needed an inhaler, 7:30 my eyes got itchy, very red and major yellow discharge (like pink eye), my throat sore and felt like a nodule or something in my throat, very weak and shaky, injected site sore.  I spoke to two different hospitals and neither had heard of an eye reaction and one said they would likely put me on an IV and give me Benadryl so I went to the store and got Benadryl and spoke to the pharmacist at about 9:30 p.m. that night and he saw my eyes and symptons and again said he had never heard of such a reaction to the flu shot.  I got home and took the Benadryl, went to bed elevated - woke up at 4 am and took another dose.  By about 3:00 on 9/13/2014 I was felling back to normal.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Sensation of foreign body, Tremor
Clinical narrative: 7:00 started coughing like my lungs were thick bronchial dry cough like I needed an inhaler, 7:30 my eyes got itchy, very red and major yellow discharge (like pink eye), my throat sore and felt like a nodule or something in my throat, very weak and shaky, injected site sore.  I spoke to two different hospitals and neither had heard of an eye reaction and one said they would likely put me on an IV and give me Benadryl so I went to the store and got Benadryl and spoke to the pharmacist at about 9:30 p.m. that night and he saw my eyes and symptons and again said he had never heard of such a reaction to the flu shot.  I got home and took the Benadryl, went to bed elevated - woke up at 4 am and took another dose.  By about 3:00 on 9/13/2014 I was felling back to normal.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Musculoskeletal pain
Clinical narrative: SEVERE SHOULDER PAIN, SEVERE CHILLS.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Feeling abnormal, Feeling cold, Local swelling
Clinical narrative: Woke up arm aching red swollen.  Lungs burning.  Continued to feel bad freezing with every blanket. I was shaking forhours then I got a fever. Had bloody infection in lungs later that night. Sick for about a week felt bad for about 6 weeks lost 11 lbs.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Lung infection, Malaise, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Woke up arm aching red swollen.  Lungs burning.  Continued to feel bad freezing with every blanket. I was shaking forhours then I got a fever. Had bloody infection in lungs later that night. Sick for about a week felt bad for about 6 weeks lost 11 lbs.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Weight decreased
Clinical narrative: Woke up arm aching red swollen.  Lungs burning.  Continued to feel bad freezing with every blanket. I was shaking forhours then I got a fever. Had bloody infection in lungs later that night. Sick for about a week felt bad for about 6 weeks lost 11 lbs.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, pain throughout body, swollen arm in area of injection.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Heart rate increased, Seizure like phenomena, Tremor
Clinical narrative: Rapid heartbeat, difficulty breathing, extreme chills, body shaking uncontrollably (seizure like).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Convulsion
Clinical narrative: SEIZURES
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness, Headache, Pallor, Syncope, X-ray
Clinical narrative: THE PATIENT WAS PALE, DIZZY AND EVENTUALLY FAINTED.  AFTERWARD SHE COMPLAINED OF A HEADACHE.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Anxiety disorder, Asthenia, Dizziness, Palpitations
Clinical narrative: TREMORS, DIZZINES, PALPITATIONS, ANXIETY AND GENERAL WEAKNESS.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: TREMORS, DIZZINES, PALPITATIONS, ANXIETY AND GENERAL WEAKNESS.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Pallor, Peripheral coldness, Syncope
Clinical narrative: THE PATIENT SKIN WAS PALE AND COLD, SHE WAS ALSO DIZZY AND EVENTUALLY FAINTED.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema, Paraesthesia, Skin warm
Clinical narrative: THE RIGHT ARM OF THE PATIENT WAS REDDISH AND WARM TO THE TOUCH, AN EDEMA.  HE ALSO SAID HE FELT TICKLING ALL OVER THE RIGHT ARM.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Nausea, Urticaria
Clinical narrative: Nausea. Hives on right side of face. Reported difficulty breathing.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Nausea, Retching, Urticaria, Vitreous floaters
Clinical narrative: Nausea. Hives on right side of face. Reported difficulty breathing.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT STATED THAT HER ARM HAS BEEN SORE EVER SINCE SHE RECEIVED VACCINATION. SHE COMPLAINED THAT SHE HAS TROUBLE LIFTING HER ARM TO PUT ON AND TAKE OFF HER BRA AS IF SOME NERVE PROBLEM EXISTS.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Complex partial seizures, Convulsion, Electroencephalogram abnormal, Eyeglasses therapy, Immunodeficiency
Clinical narrative: Patient developed strabismus. We gave him glasses for treatment.  On 03/22/14 he started having seizures, went into status elipticus, was hospitalized for two weeks. Released with medication without diagnosis. Still continues to have seizures and has been immune compromised since the vaccination.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Status epilepticus, Strabismus
Clinical narrative: Patient developed strabismus. We gave him glasses for treatment.  On 03/22/14 he started having seizures, went into status elipticus, was hospitalized for two weeks. Released with medication without diagnosis. Still continues to have seizures and has been immune compromised since the vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Ultrasound scan normal
Clinical narrative: Profound edema, heat, erythema R lateral thigh.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea, fatigue that lasted for 11 days.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Influenza A virus test negative
Clinical narrative: I had joint pain which started at approx 2pm which intensified by the hour followed by a low grade fever with chills starting at approx 5pm. My fever climbed quickly for a high of 102.6. I started treatment with Ibuprofen 600mg with plenty of water and later Tylenol 650mg. My fever broke at approx 1am as well as body aches and chills subsiding. I felt weak and tired for approx 12 hrs later. I was checked by an MD for a possible ear infection, UTI, pneumonia, strep throat and flu. All tests were negative. I had no congestion or sinus drainage nor cough.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza B virus test, Laboratory test normal, Pain, Pyrexia, Streptococcus test negative
Clinical narrative: I had joint pain which started at approx 2pm which intensified by the hour followed by a low grade fever with chills starting at approx 5pm. My fever climbed quickly for a high of 102.6. I started treatment with Ibuprofen 600mg with plenty of water and later Tylenol 650mg. My fever broke at approx 1am as well as body aches and chills subsiding. I felt weak and tired for approx 12 hrs later. I was checked by an MD for a possible ear infection, UTI, pneumonia, strep throat and flu. All tests were negative. I had no congestion or sinus drainage nor cough.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis normal
Clinical narrative: I had joint pain which started at approx 2pm which intensified by the hour followed by a low grade fever with chills starting at approx 5pm. My fever climbed quickly for a high of 102.6. I started treatment with Ibuprofen 600mg with plenty of water and later Tylenol 650mg. My fever broke at approx 1am as well as body aches and chills subsiding. I felt weak and tired for approx 12 hrs later. I was checked by an MD for a possible ear infection, UTI, pneumonia, strep throat and flu. All tests were negative. I had no congestion or sinus drainage nor cough.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Back pain, Blister, Chest pain, Herpes zoster, Injection site pain
Clinical narrative: Sharp pain in right chest radiating to right shoulder and right upper back. On 09/12/14 noticed red blistering painful rash on right chest and right armpit. On 09/13/14 went to Medical Center for treatment and diagnosed with Shingles. Given prescription for severe pain and anti-viral medication.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Sharp pain in right chest radiating to right shoulder and right upper back. On 09/12/14 noticed red blistering painful rash on right chest and right armpit. On 09/13/14 went to Medical Center for treatment and diagnosed with Shingles. Given prescription for severe pain and anti-viral medication.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Axillary pain, Back pain, Blister, Chest pain, Herpes zoster
Clinical narrative: Sharp pain in right chest radiating to right shoulder and right upper back. On 09/12/14 noticed red blistering painful rash on right chest and right armpit. On 09/13/14 went to Medical Center for treatment and diagnosed with Shingles. Given prescription for severe pain and anti-viral medication.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Musculoskeletal pain, Pain, Rash erythematous, Rash vesicular
Clinical narrative: Sharp pain in right chest radiating to right shoulder and right upper back. On 09/12/14 noticed red blistering painful rash on right chest and right armpit. On 09/13/14 went to Medical Center for treatment and diagnosed with Shingles. Given prescription for severe pain and anti-viral medication.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Feeling hot
Clinical narrative: Patient experienced warmth over body and intense back pain and weakness. The sensation lasted about 10 minutes and subsided.  EMT was called and brought patient in for check-up.
Sex: M
Vaccine: PPV
Symptoms: International normalised ratio increased, Mobility decreased, Muscle swelling
Clinical narrative: This spontaneous report as received from a physician via Pfizer refers to a male patient who is currently 65 year old (age at onset of event not reported). Patient's allergic condition included myalgia and impotence with ZOCOR, severe myalgia with flu vaccine (manufacturer unknown), thrombocytopenia with heparin, gemfibrozil intolerance, ZETIA intolerance, muscle cramping with LIPITOR, muscle cramping with CRESTOR, myalgia with pravastatin, anaphylaxis with plasma, myalgia with lovastatin and myalgia with TRILIPIX. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. Concomitant medications included LYRICA, warfarin, PLAVIX, aspirin, AVAPRO, TOPROL XL, NORVASC, bumetanide, KLOR-CON M10, NIASPAN ER, fish oil, GLUCOPHAGE, nitroglycerine, acetaminophen, NORCO, cholecalciferol, magnesium oxide, COENZYME Q10, multivitamin and VIAGRA. On an unknown date the patient reported that his muscle were swelled up and he could not move (disability). On an unknown date INR was 2.0-3.0. The outcome of events were unknown. Causality of events were unknown. Upon internal review, event he could not move was considered serious due to disability as seriousness criteria. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Aneurysm, Death, Pneumococcal infection
Clinical narrative: This spontaneous report was received from a Nurse professional via a company representative regarding her mother (age unknown). Pertinent medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23, injection due to a chronic respiratory issue (dose and route not reported). No other concomitant therapies reported. On an unknown date, the patient developed pneumococcal disease, a strain which PNEUMOVAX 23, was supposed to cover. On an unknown date in March 2014 (about 6 months ago) the patient died from an aneurysm which was after she developed the pneumococcal disease. The lab diagnostic tests were unspecified. It was unknown whether patient sought medical attention. The outcome of the event aneurysm was reported as fatal. The outcome of the event pneumococcal disease was unknown. The causality of the events was unspecified. No PQC involved. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patinet. On 31-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date: 10-AUG-2014) (dose, strength, route were unknown) which was expired. No adverse effect reported. No PQC reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site warmth, Oral herpes
Clinical narrative: 915AM 12SPT14 - red/hot/hard at injection site. Advised to call MD ("cold sores" corners of mouth). 12 noon 13SPT14 - saw MD. Prescribed prednisone 5PM 14SPT14 - patient reports generalized discomfort entire arm/shoulder radiating to back.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Pt complain of ache/pain, chills, "flu like symptoms" after vaccination.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site abscess, Injection site swelling
Clinical narrative: Redness, slight swelling began 9/13/14. Upon coming in on 9/14, she stated the swelling and redness had gone down some. All swelling and redness localized around injection site.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Asthenia, Blood pressure decreased, Blood test, Chest X-ray, Chills
Clinical narrative: Chills, high temp, dizziness, weakness, headache, nausea, loss of appetite, sore Rt nostril, Rt arm inflamed, hard/red and sore, lower B/P, coughing. TYLENOL, TORADOL, sodium chloride. Chest x-ray, urinalysis, blood work. ZOFRAN, VANCOCIN.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Cough, Decreased appetite, Dizziness, Erythema, Headache
Clinical narrative: Chills, high temp, dizziness, weakness, headache, nausea, loss of appetite, sore Rt nostril, Rt arm inflamed, hard/red and sore, lower B/P, coughing. TYLENOL, TORADOL, sodium chloride. Chest x-ray, urinalysis, blood work. ZOFRAN, VANCOCIN.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Induration, Inflammation, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Chills, high temp, dizziness, weakness, headache, nausea, loss of appetite, sore Rt nostril, Rt arm inflamed, hard/red and sore, lower B/P, coughing. TYLENOL, TORADOL, sodium chloride. Chest x-ray, urinalysis, blood work. ZOFRAN, VANCOCIN.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Rhinalgia, Urine analysis
Clinical narrative: Chills, high temp, dizziness, weakness, headache, nausea, loss of appetite, sore Rt nostril, Rt arm inflamed, hard/red and sore, lower B/P, coughing. TYLENOL, TORADOL, sodium chloride. Chest x-ray, urinalysis, blood work. ZOFRAN, VANCOCIN.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash after 24 hours with pain and subsiding rash after 48 hours all at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 9/13/14 Mom called, left arm has very large red, hot area, extremely itchy. 9/13/14 Pt seen. Lg. area (non-tender) erythema (L) deltoid local. AUGMENTIN Rx given.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Heart rate increased, Local swelling
Clinical narrative: Pt. stated he had fast beating heart. Chills and arm swollen. The onset of was approx. 2 hrs. later and last approx. 12-24 hrs.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Received vaccinations at 3:30 PM. Around 8 PM started experiencing shooting pain from shoulder to elbow. Also had trouble sleeping and immobility in right arm. Dr. prescribed LORTAB. Patients thinks it's PNEUMOVAX.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an approximately 44 year old female patient of unknown age. The patient's medical history included autoimmune condition. On 03-APR-2014 the patient was vaccinated with ZOSTAVAX, 0.65 Microlitre, subcutaneous. On an unknown date in approximately 2014 the patient experienced reoccurring minor breakout of a rash on their left shoulder. The patient sought medical attention for the event. Patient was treated with acyclovir (manufacturer unknown). There was no  intervention to prevent serious criteria. The caller could not confirm if the patient has rash at the time of report. Product quality complaint was not reported. The outcome of reoccurring minor breakout of a rash on their left shoulder was unknown. The causality of event with ZOSTAVAX was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: Received PNEUMOVAX and FLUVIRIN in the left arm over 1 in apart. Patient developed redness, warmth. She was informed to use BENADRYL and ice. It helped relieve symptoms.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a consumer refers to a 12 month old male patient with immunization. On 26-AUG-2014, the patient was vaccinated with (oka/merck) VARIVAX. The patient was vaccinated with (oka-merck) PROQUAD on the same day. On 26-AUG-2014, the patient's mother reported that injection sites on her son's thighs were still red and hardened underneath 10 day after vaccination. The patient sought medical attention and called the office. No treatment was given for the events. Product quality complaint was not involved. The outcome of the events was unknown. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from other health professional refers to a 22 year old patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot no. unknown). No concomitant medication was reported. On an unknown date the patient was mistakenly administered a dose of ZOSTAVAX instead of a dose of (Oka/Merck) VARIVAX. No adverse effects were reported. The outcome of events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare Worker refers to a female patient of unknown age. On 08-SEP-2014 the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # J003723, expiration date 28-JUN-2014), subcutaneous. No adverse effects noted by patient. The patient had not sought medical attention. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash macular, Rash vesicular, Scab, Vomiting
Clinical narrative: This spontaneous report as received from a consumer who was a company employee refers to her 13 month old daughter. On 30-JUL-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, strength and route unspecified). On 25-AUG-2014 the child developed a rash that was at first macular but quickly became vesicular. Some lesions were crusted on 25-AUG-2014. It was the fifth day a few new lesions have continued to appear on 29-AUG-2014. The patient had a low grade fever of 100.5 (unit unspecified) on the first day of illness (on 30-JUL-2014). Child also had some vomiting on unspecified date in August 2014, but otherwise appears well. The outcome of the vents was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. On unknown dates the patients was vaccinated with (Oka/Merck) VARIVAX (dose, frequency, lot # K003412 and expiration date were unknown 06-MAR-2014). On unknown date the patients experienced redness and swelling at the injection site. The outcome of redness and swelling at the injection site was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 10-Sep-2014, the patient was inadvertently vaccinated with the fourth dose of GARDASIL (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site streaking
Clinical narrative: Pt went to Dr about a blister and rash. Dr. diagnosed her with shingles.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Pt went to Dr about a blister and rash. Dr. diagnosed her with shingles.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head normal, Dizziness, Electrocardiogram normal, Fall, Full blood count
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with asthma and no Drug Reactions/Allergies. On 21-AUG-2014 the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route unspecified). No concomitant medication reported. On 21-AUG-2014, the patient experienced fainting for 30 seconds, hit his head as he fell, an abrasion and scalp hematoma, after receiving GARDASIL. The patient sought medication attention via office visit on an unspecified date. IV fluid (unspecified name, dose, frequency, and manufacturer) and ondansetron (unspecified dose, frequency and manufacturer) were given for treatment. The patient underwent Full Blood Count (CBC), metabolic panel, Comprehensive metabolic panel (CMP), Computerized tomogram (CT scan) and Electrocardiogram (EKG) without results provided. The events outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Headache, Loss of consciousness, Metabolic function test, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with asthma and no Drug Reactions/Allergies. On 21-AUG-2014 the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route unspecified). No concomitant medication reported. On 21-AUG-2014, the patient experienced fainting for 30 seconds, hit his head as he fell, an abrasion and scalp hematoma, after receiving GARDASIL. The patient sought medication attention via office visit on an unspecified date. IV fluid (unspecified name, dose, frequency, and manufacturer) and ondansetron (unspecified dose, frequency and manufacturer) were given for treatment. The patient underwent Full Blood Count (CBC), metabolic panel, Comprehensive metabolic panel (CMP), Computerized tomogram (CT scan) and Electrocardiogram (EKG) without results provided. The events outcome was unknown. Additional information has been requested.