chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Shaking chills, fever 101 degrees, muscle aches, headache, weakness.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Convulsion, Nausea, Pyrexia, Vomiting
Clinical narrative: STARTED RUNNING 103.9 FEVER; HAD CONVULSIONS; EXTREME VOMITING AND NAUSEA; TOOK TYLENOL TO BRING FEVER DOWN; DR. GAVE PRESCRIPTION FOR PROMETHAZINE.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Muscle spasms, Nausea, Vomiting
Clinical narrative: About an hour after I received vaccination, I began feeling very nauseous. I then vomited three times. The nausea improved, but my equilibrium felt off for the rest of the night. Since the day of vaccination I have had involuntary muscle spasms that started the day after I received the vaccine and have not yet subsided.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: REDNESS AND EDEMA AT INJECTION SITE. COMPLAINED OF FEVER.
Age: 1.66
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse outcomes.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm. Can't lift arm above head. Described as a nagging toothache.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Heart rate increased, Mobility decreased
Clinical narrative: Airways blocked, unable to breathe, rapid and very loud heartbeat, diarrhea weakness and unable to call or get help. Lasted from 9:30 to after 4:30 AM, at which time I either passed out or fell asleep, woke up at 7:00 AM, surprised I had lived through it.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Obstructive airways disorder, Palpitations, Respiratory tract congestion
Clinical narrative: Airways blocked, unable to breathe, rapid and very loud heartbeat, diarrhea weakness and unable to call or get help. Lasted from 9:30 to after 4:30 AM, at which time I either passed out or fell asleep, woke up at 7:00 AM, surprised I had lived through it.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Eye swelling, Headache, Heart rate increased, Insomnia
Clinical narrative: Swollen eyes, increase heart rate, joint and head aches, frequent urination, insomnia, sore throat. Pt. did not take anything and symptoms subsided within a few hours,
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pollakiuria
Clinical narrative: Swollen eyes, increase heart rate, joint and head aches, frequent urination, insomnia, sore throat. Pt. did not take anything and symptoms subsided within a few hours,
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Feeling hot, Lacrimation increased, Pruritus
Clinical narrative: Facial/eye swelling, itching, redness, heat, watery eyes.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Facial/eye swelling, itching, redness, heat, watery eyes.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Skin discolouration
Clinical narrative: Large red swelling at injection site.  Was hot and sore to the touch.  Swelling and discoloration lasted approximately 14 days.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: RED AND WARM AREA UNDER UPPER ARM APPROXIMATELY 8 INCHES FROM INJECTION SITE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Pyrexia, Urticaria
Clinical narrative: Patient developed hives/fever/decreased appetite one hour after administration and patient mother stated it lasted 4 days.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Severe abdominal cramping and liquid diarrhea.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Seizure x 1, assumed to be febrile.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Dry cough and sore throat.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Patient with left upper arm swelling, redness and warmth from shoulder to her elbow. Blanchable. Treated with Keflex 500 mg/ every 12 hours for 10 days, Benadryl 25 mg at bedtime and Alavert 10 mg for 5 days.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site reaction, Urticaria
Clinical narrative: Injection site reaction--mild bleeding and then a 1-inch diameter raised/bruised welt.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fluid retention, Injected limb mobility decreased, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: PT reported swelling/fluid retention at site/soreness and tightness in upper arm and back of neck in addition to fever. PT WAS ALSO ADMINISTERED PNEUMOVAX in the same arm (RIGHT).
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle tightness, Pyrexia
Clinical narrative: PT reported swelling/fluid retention at site/soreness and tightness in upper arm and back of neck in addition to fever. PT WAS ALSO ADMINISTERED PNEUMOVAX in the same arm (RIGHT).
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal discomfort, Skin warm
Clinical narrative: Hot to touch; discomfort in shoulder area when moving arm laterally.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Headache, redness and swelling of right upper arm where vaccine administered; developed fever to 100.4 degrees F on 09/21/2014. Treated with aspirin, Tylenol, Advil and fluids.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives without other symptoms.  Treated with Benadryl and then Zyrtec.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Nausea, Pain, Paraesthesia oral
Clinical narrative: Nausea, tongue feels tingly (no SOB, feels sore, HA. Advised to take Benadryl and monitor for any worsening of symptoms.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Autism, Exanthema subitum, Pyrexia
Clinical narrative: Roseola infantum high fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Eye swelling
Clinical narrative: Mother states noticed left eye swollen for 24 hours.
Age: 1.53
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP
Symptoms: Full blood count, Injection site reaction, Local reaction, Lymphadenopathy
Clinical narrative: Large local reaction to left thigh with swelling of lymph node to right inguinal area.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, pain, and redness.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Mother states sudden onset of red spots on back of neck.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site nodule
Clinical narrative: States redness, and knot at site. C/O fatigue for several months after vaccine.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Pain
Clinical narrative: 3-4 INCHES OF REDNESS, LOCALIZED PAIN, FEELING SICK (GENERAL) FOR AT MINIMUM 3 DAYS FOLLOWING INJECTION; NO ANAPHYLACTIC SIGNS; NO TREATMENT REQUIRED.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: Developed mild herpes labialis 4 days after flu shot.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fluid retention, Injection site irritation, Injection site reaction, Injection site swelling
Clinical narrative: Pt reports swelling/irritation/fluid at site... fever/chills temporary body aches.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Pt reports swelling/irritation/fluid at site... fever/chills temporary body aches.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthenia, Disorientation, Dyskinesia, Immediate post-injection reaction, Lethargy
Clinical narrative: After shots were given - immediately Pt laid head in moms lap and began to make an odd noise - I jumped up and hugged patient around trunk and she jerked her head back and started to move uncontrollably. Moved all equipment away and eased patient to the floor and placed her feet up above her head.  Mom helped to secure patients head and called for help of RN Administrator and she came and called for ambulance. Pt had incontinent episode and urinated in the floor while arms and legs and body violently moving and jerking in the floor. This went on for about 2 minutes and then patient sat straight up and was very lethargic and disoriented.  Started to come around and was asked by RN CDNS if she had had anything to eat this a.m. and patient stated "pretzels". Pt started getting very nauseated and started dry heaves with no production.  Ambulance arrived at approximately 9:08 AM patient was able to stand with assistance but was very weak and ambulance driver lifted the patient to the gurney and patient was placed on gurney and was taken to Medical Center for further evaluation.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Nausea, Retching, Urinary incontinence
Clinical narrative: After shots were given - immediately Pt laid head in moms lap and began to make an odd noise - I jumped up and hugged patient around trunk and she jerked her head back and started to move uncontrollably. Moved all equipment away and eased patient to the floor and placed her feet up above her head.  Mom helped to secure patients head and called for help of RN Administrator and she came and called for ambulance. Pt had incontinent episode and urinated in the floor while arms and legs and body violently moving and jerking in the floor. This went on for about 2 minutes and then patient sat straight up and was very lethargic and disoriented.  Started to come around and was asked by RN CDNS if she had had anything to eat this a.m. and patient stated "pretzels". Pt started getting very nauseated and started dry heaves with no production.  Ambulance arrived at approximately 9:08 AM patient was able to stand with assistance but was very weak and ambulance driver lifted the patient to the gurney and patient was placed on gurney and was taken to Medical Center for further evaluation.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes virus infection, Skin lesion
Clinical narrative: Patient had severe herpes outbreak. Had multiple lesions arise on lip, inside nose, on buttox and groin area.  Pt began taking Benadryl 25mg for 2 days, and then increased to 50mg on 9/21.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Pain, Respiratory tract congestion
Clinical narrative: Body aches, headache, fatigue with chest congestion for 3 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site mass, Injection site pain, Myalgia
Clinical narrative: Muscle aches in the back and legs, chills, and pain and lump at site of injection.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Lymph node pain, Lymphadenopathy, Metabolic function test normal, Ultrasound scan normal
Clinical narrative: Neck is supple with left supraclavicular tender lymphadenopathy soft without fluctuance.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient felt fine but had a large bruise about 3 inches in diameter on his arm where he recieved the injection.  He did not complain of any pain. Patient did not recieve any treatment here. Told patient that if the bruise got larger or spread that he should contact his physician.  The bruise lasted for about 2 weeks but then cleared up.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysgeusia, Erythema, Flushing, Palpitations
Clinical narrative: Dizziness, heart palpitations, different taste in throat, lump feeling in throat, face was red and flushed and I was seeing spots.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Sensation of foreign body, Visual impairment
Clinical narrative: Dizziness, heart palpitations, different taste in throat, lump feeling in throat, face was red and flushed and I was seeing spots.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Lip swelling, Ocular hyperaemia, Wheezing
Clinical narrative: Wheezing swollen lips red eyes.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis at injection site. (Soreness, redness and warmth to left deltoid). Ceftriaxone 1 gm once, sulfamethoxazole/trimethoprim 1 tab BID.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMRV
Symptoms: Eyelid oedema, Local swelling, Pruritus
Clinical narrative: Pt experienced itching, swelling of hands and eyelids. Pt was given BENADRYL per Dr.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 13 cm x 13 cm area of warmth and erythema around site of DTaP injection -> redness started evening of vaccine and it its worst today. Started treatment with BENADRYL PO q6 hours and cool compresses.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Puffy and swollen / elbow to shoulder burning, red in some spots.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered  nurse refers to a 4 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 26-AUG-2014 the patient who was intended to received (Oka/Merck) VARIVAX was inadvertently vaccinated with ZOSTAVAX (single dose), subcutaneous. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Small red rash around injection site. Slightly warm. No fever, no breathing issues.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with a dose of GARDASIL (lot number H017698 expiration date 02-JUL-2015, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Rec'd imm. at WCE on 9-16-14. Light red rash to (Rt) upper arm began 9-17-14 and increased in size -> office visit on 9-18-14. (S/S = warmth, erythema and induration to (Rt) deltoid approximately 8 x 7cm; no fever or c/o pain). Monitor area, return if s/s increase.
Sex: U
Vaccine: VARZOS
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 drug reactions or allergies were not specified. On 12-SEP-2014, the patient was administered an expired dose of ZOSTAVAX lot  number J004271, expiration date 12-JUL-2014, 0.65 ml, subcutaneously (dose number and anatomical location were not reported). No adverse events were reported. Concomitant medications were not specified. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: 5-yr. imm. rec'd on 9-16-14. (LA) with redness and edema no warmth began 9-17-14. (+) low-grade fever on 9-18-14. Seen 9-19-14 for s/s. (10 x 8 cm area erythema on (L) upper arm without induration or tenderness. Tx'd with ibuprofen, warm compresses and return if s/s increase.
Age: 10.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Local induration of injection site 6 cm x 8 cm with redness and warmth.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Oedema, Skin warm, Tenderness
Clinical narrative: Edema, redness 4 in, diameter, hot to touch, tender.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain limiting movement in arm day following injection, no medicines used, problem resolved by Monday 9/22/14. Patient just wants us to know.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Patient received influenza vaccination.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 17-SEP-2014 the patient was vaccinated with a dose of GARDASIL (lot#, dose, route were unknown, indication reported as routine). Concomitant medications were not provided. The physician reported that the patient fainted "immediately" after receiving a dose of GARDASIL. The physician reported that the patient was monitored in the office for an unspecified amount of time after fainting and then was sent home after feeling better. No treatment was given for the adverse event. No lab diagnostics studies were performed. Outcome of the event was reported as recovered on 17-SEP-2014. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on limbs within 24 hours of receiving ADACEL inj. Lasted 6 days before pt presented to office. Treated with tapering dose of Prednisone 20mg resolved within 2 days of starting medication.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Palpitations
Clinical narrative: Lightheadedness, dizzy, heart palpitations. It was a bit intense for a few hours.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Rash macular
Clinical narrative: Patient developed rash; (2) weeks after vaccine. -There is no fever bu patient is crancky. -Macular rash all over trunk.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with a dose of GARDASIL (Lot number J002641, expiration date 10-DEC-2015, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reports injection site redness and swelling. Tender to the touch. Seen at urgent care 9/21/14 was treated with BACTRIM and MEDROL dose pak. 9/22/14 follow up for symptoms. (Symptoms improved today).
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bronchitis, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, bronchitis patient given antibiotics from ER. They said her body rejected the vaccine.
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: No redness or swelling. Weakness with extension and downward pressure of left arm tingling occasionally first three fingers let hand began 20th September 3 days after receiving flu shot. Initially pain radiating to elbow yesterday and today down to fingers.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Immediate post-injection reaction, Induration, Local swelling
Clinical narrative: Arm immediately hard/red swollen. No other issues. Went home. Took BENADRYL. Arm swelled shoulder to elbow. Went to ER. Given steroid tx. Pt ok, swelling down.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Fatigue, Headache, Influenza like illness, Skin warm
Clinical narrative: Pt. felt run down on Friday (day after shots). No appetite and felt like she had the flu. Got a severe HA on Sat but as of Monday seems to start going away. The shot was in deltoid and rash was going around arm below that and hot to the touch.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Right arm redness/rash.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Vomiting
Clinical narrative: Vomiting on 3 occasions and specks of blood in stool.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Friday night 9/19/14 swelling started. Get worse Saturday 9/20/14. Swelling, warm at injection site to elbow. Sunday 9/21/14 swelling improves per wife statement. No fever. Wife gave ice to affected area. Pt on blood thinner so RPH told to give TYLENOL for pain and follow up w/PCP on Monday 9/22/14. Follow-up call on 9/22/14 and pt said swelling went down and didn't want us to follow-up with doctor.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthma, Body temperature increased, Chest discomfort, Cough
Clinical narrative: Joint pain, temp of 100.5, dizziness and nausea, headache, asthma irritation/cough/tightness.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Joint pain, temp of 100.5, dizziness and nausea, headache, asthma irritation/cough/tightness.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5 cm x 7 cm sl. elevated and red area noted below injection site. Slight warmth to area.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Insomnia, Irritability
Clinical narrative: Fussy after vaccines, decrease in appetite, not sleeping through the night.
Age: 43.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Four doses of polio vaccine administered instead of one. No reactions noted.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Right upper arm/deltoid, redness, very painful swelling, area is hot to touch, approximately 8cm x 7cm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash, 2.4 inches diameter, itchy. Recommended ice, hydrocortisone cr. Anti histamine.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received PNEUMOVAX and FLUVIRIN. She developed redness and swelling at the site. By the second day, the swelling was down and no more pain or itching.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain
Clinical narrative: Leg cramps on and off on both legs, from knee to toes, happened after she got vaccine, from 10PM to 2PM, painful. She got vaccine at 1:14 PM on 9-15-2014.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain in left arm deltoid travels to neck w/ mild headache 2/10 pain - pain (sharp) in elbow to wrist. Numb in forearm - slight tingling of fingers. Reaction began at time of injection (8:00 AM) and continued to worsen with soreness beginning in deltoid, and traveling to neck, head, shoulder, and forearm. Muscle spasm left side of neck followed by (mild) dizziness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Neck pain, Paraesthesia
Clinical narrative: Pain in left arm deltoid travels to neck w/ mild headache 2/10 pain - pain (sharp) in elbow to wrist. Numb in forearm - slight tingling of fingers. Reaction began at time of injection (8:00 AM) and continued to worsen with soreness beginning in deltoid, and traveling to neck, head, shoulder, and forearm. Muscle spasm left side of neck followed by (mild) dizziness.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Blood urine present, Computerised tomogram, Dehydration, Urinary tract infection
Clinical narrative: Father of pt. called Health Dept. 9-18-14 reported his son was urinating blood and he was taking him to the ER. On 9-19-14 father reports son was seen in ER: was told he was dehydrated. He had an IV with IV antibiotics and was released. Per father txd for UTI is not taking any medications at home.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: Father of pt. called Health Dept. 9-18-14 reported his son was urinating blood and he was taking him to the ER. On 9-19-14 father reports son was seen in ER: was told he was dehydrated. He had an IV with IV antibiotics and was released. Per father txd for UTI is not taking any medications at home.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain
Clinical narrative: 1:45 PM - shot administered. 5 PM - throat sore. 6 PM - trouble breathing 1 BENADRYL taken. 7 PM - notified pharmacy additional BENADRYL and advised to go to ER.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac telemetry normal, Dizziness, Electrocardiogram normal, Fatigue, Feeling cold
Clinical narrative: Extreme fatigue, dizziness, headache, felt cold, nauseous. Lasted 3 full days. Better on 4th day, but not well. Went to ER 09.14.2014. Checked urine, EKG, Troponin I, Telemetry monitoring, Saline Lock IV - 1 time, CBC D, Metabolic Panel all normal.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Headache, Metabolic function test normal, Nausea, Troponin I normal
Clinical narrative: Extreme fatigue, dizziness, headache, felt cold, nauseous. Lasted 3 full days. Better on 4th day, but not well. Went to ER 09.14.2014. Checked urine, EKG, Troponin I, Telemetry monitoring, Saline Lock IV - 1 time, CBC D, Metabolic Panel all normal.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Extreme fatigue, dizziness, headache, felt cold, nauseous. Lasted 3 full days. Better on 4th day, but not well. Went to ER 09.14.2014. Checked urine, EKG, Troponin I, Telemetry monitoring, Saline Lock IV - 1 time, CBC D, Metabolic Panel all normal.
Age: 20.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Pain in extremity
Clinical narrative: Experienced (R) arm pain within an hour of injection, with increase of pain in arm. On day 3 experienced decreased sensitivity in (R) arm with decreased finger grip strength and arm numbness.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 44 year old female patient. On 19-SEP-2014 the patient was vaccinated an expired dose of PNEUMOVAX23 (lot # J009827, expiration date: 10-AUG-2014, dose, units, frequency, route of administration, anatomical location were not reported). No adverse experience had been observed or reported.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Aphasia, Attention deficit/hyperactivity disorder, Autism, Gastrointestinal disorder
Clinical narrative: This spontaneous report as received from patient's mother refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated   with RECOMBIVAX HB (dose and route unspecified). Concomitant medications were unknown. On an unknown date the patient developed gastrointestinal tract issues, attention deficit hyperactivity disorder and patient stopped talking. Patient was currently on physical therapy and was diagnosed with autism. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Autism
Clinical narrative: This spontaneous report as received from patient's mother refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dose and route unspecified). Concomitant medications were unknown. On an unknown date the patient developed autism. The outcome of autism was unknown. The causality of the event with RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site mass
Clinical narrative: Patient had a lump at the injection site after the vaccine that was the size of a quarter and then went down to the size of a dime after about 30 minutes.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Pt has huge black and blue at site of injection.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 29-AUG-2014 the patient who was intended to receive (Oka/Merck) VARIVAX was inadvertently vaccinated with ZOSTAVAX (single dose), subcutaneous. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a consumer, wife of the patient, refers to a 78 year old male patient with blood pressure issues, who was diabetic and had a triple bypass in 2012. The patient had no drug reactions or allergies. On an unknown date, reported as approximately two to three years ago, the patient was vaccinated with a single dose of ZOSTAVAX, 0.65 ml, subcutaneous  (lot number was not reported). Concomitant medications included an unspecified blood pressure medicine on an unspecified diabetic medicine. At the end of August 2014, the patient got a case of shingles: the patient's back started hurting and on 09-SEP-2014, reported as this past Tuesday, the patient got shingles rash from his back around to his belly button. The patient sought medical attention via contacting the primary physician. The patient was treated with Valacyclovir hydrochloride (28 pill, 1000 mg) and Acetaminophen (+) hydrocodone bitartrate (reported as HYDORCO-ACETA) pain killer. No laboratory diagnostics studies were performed. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: This spontaneous report has been received from a pharmacist via company representative refers to a 51 year old female patient. On 09-SEP-2014 the patient was vaccinated with ZOSTAVAX, subcutaneously (lot number K003599, expiry date 13-MAR-2015) for prevention of shingles. It was unknown if the patient received concomitant medications. On an unspecified date the patient experienced a large red area, 4x4 inches in size, at injection site receiving ZOSTAVAX. Patient sought medical attention. Patient was diagnosed with cellulitis by her health care provider (physician assistant), on an unknown date in September 2014. She was treated with unspecified antibiotics. No product quality complaint was involved. The outcome of cellulitis was unknown. The reporter's causality was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 27-AUG-2014 the patient who was intended to receive (Oka/Merck) VARIVAX was inadvertently vaccinated with ZOSTAVAX (single dose), subcutaneous. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route, lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that patient fainted shortly after receiving the GARDASIL vaccine on unspecified date. It was unknown which injection (in a series of three) the fainting was occurred. The patient was assisted back to an upright position and had no additional side effects. No treatment was given for the event. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Nausea
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's medical history, drug reactions and allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL, therapy route, dose, lot#, batch# and expiry date were not reported. On an unknown date, after the vaccination, the patient experienced abdominal pain and nausea. On an unspecified date, the patient had a gastrointestinal examination (reported as "gastrointestinal work up"), the results were not reported. The outcome of abdominal pain and nausea was unknown. The relatedness between vaccination with GARDASIL and the events was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route, lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that patient fainted shortly after receiving the GARDASIL vaccine on unspecified date. It was unknown which injection (in a series of three) the fainting was occurred. The patient was assisted back to an upright position and had no additional side effects. No treatment was given for the event. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-SEP-2014, the patient was administered with an expired dose of PROQUAD (expiration date: 12-SEP-2014) (dose, route of administration, lot # were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. On 17-SEP-2014, the patient was vaccinated with an expired dose of MMR II lot # H015824, expiration ate: 24-AUG-2014, albumin status verified as HSA, 0.5 ml dose, subcutaneous (dose number not reported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unkonwn demographics. No concurrent conditions or medical history were provided. In approximately 2013 (reported as "on an unspecified date last year"), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. The patient called pharmacy to report redness streaming down her arm further described as soreness going down the patient's arm from the site of ZOSTAVAX administration, developed on an unspecified date in 2013 (reported as "last year"). The outcome of the events was unkonwn. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a physician via a company representative and refers to a female patient of unknown age. In 2014 (exact date unspecified, reported as this summer) the patient was vaccinated with GARDASIL in the arm (dose, units, route of administration, lot number were not reported). In 2014 (exact date unspecified) the patient experienced numbness in an unspecified arm. There was treatment given for the adverse event ADVIL. The patient did not seek medical attention. The outcome of numbness in an unspecified arm was not reported. The relatedness between event and GARDASIL was not reported. Additional information has been requested.
Age: 0.43
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 25-AUG-2014 the patient was vaccinated with PEDVAXHIB (dose and route unspecified) (lot number: J016186 with expiry date of 24-OCT-2016) in the left leg. Concomitant medications were unknown. The nurse reported that refrigerator temperatures were out of range from 19-AUG-2014 to 26-AUG-2014 and the vaccines were viable. No adverse effects were reported. The outcome of the events was unkonwn. The causality of the events with PEDVAXHIB was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 26-AUG-2014 the patient was vaccinated with ROTATEQ (dose unspecified)(lot number: J015689 with expiry date of 20-NOV-2015), orally and PEDVAXHIB (dose and route unspecified) (lot number: J016186 with expiry date of 24-OCT-2016) in the right leg. Concomitant medications were unknown. The nurse stated that refrigerator temp were out of range from 19-AUG-2014 to 26-AUG-2014. All vaccines were viable. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ROTATEQ and PEDVAXHIB was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient developed an unspecified reaction to penicillin on an unspecified date. The patient did not have none pertinent medical history. On 10-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX at dose: 0.65 ml injected subcutaneously in the right arm (lot # K003599, expiry date: 13-MAR-2015); therapy reason for use reported as "age appropriate". Concomitant therapies included metformin, ZYRTEC and estradiol (manufacturer unspecified). The reporter stated that the patient called him on 12-SEP-2014 to sought medical attention: she stated over the phone that she had a reddish, warm area the size of an orange which was slightly swollen and itchy at the site of administration on her right arm (developed in September 2014, exact date unkonwn). No treatment was given for the experienced events and no laboratory test were performed. The outcome of the events was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports from the same source. 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 nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with a dose of GARDASIL (Lot number J015378, expiration date 09-APR-2016, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of 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 nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with GARDASIL (Lot number J008423, expiration date 21-JAN-2016, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Chills, Full blood count, Injection site erythema, Injection site pain
Clinical narrative: Immunized (R) deltoid with PNEUMOVAX 23 on Sept 9, 2014. Seen on 9/11/14 with tenderness over injection site, red streaking noted inner upper right arm, axillary lymphadenopathy, tenderness. Patient reported to office soreness of arm and nausea 9/10/14 - then on 9/11 reported about 2 am (9/11) chills/malaise.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenectomy, Malaise, Nausea, Pain in extremity, Tenderness
Clinical narrative: Immunized (R) deltoid with PNEUMOVAX 23 on Sept 9, 2014. Seen on 9/11/14 with tenderness over injection site, red streaking noted inner upper right arm, axillary lymphadenopathy, tenderness. Patient reported to office soreness of arm and nausea 9/10/14 - then on 9/11 reported about 2 am (9/11) chills/malaise.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound Doppler
Clinical narrative: Immunized (R) deltoid with PNEUMOVAX 23 on Sept 9, 2014. Seen on 9/11/14 with tenderness over injection site, red streaking noted inner upper right arm, axillary lymphadenopathy, tenderness. Patient reported to office soreness of arm and nausea 9/10/14 - then on 9/11 reported about 2 am (9/11) chills/malaise.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Patient had headache and dizziness immediately post GARASIL / Tdap / MENACTRA - did not eat breakfast - gave food felt better in 30 minutes. Vitals good throughout.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Ear congestion, Nasal congestion, Oropharyngeal pain, Urticaria
Clinical narrative: Hepatitis B vaccine received at 1030 AM 9/9/14. 9/9/14 evening at 930 pm noticed welts on back, nasal congestion, sore throat, ears congested.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, throbbing, burning and "prickly" sensation on (L) arm (upper) down to fingertips - after going to bed around 12 am on date of vaccination - same symptoms on date of second vaccine on (R) arm - symptoms did not go away completely - still experiencing numbness and tingling on forearm and fingers and hands off and on.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Eschar, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness, firmness and tenderness left deltoid erythema is 8x9cm tender, warm to the touch. Central induration 6x3cm. Patient had PNEUMOVAX and flu shot given in left deltoid 9/12/14. She noted feeling achy the following day. Then she noted redness, firmness and tenderness left deltoid. No fever or chills. Today the erythema is measuring 8 x 9 cm, the central induration 6 x 3 cm. Tender, warm. No fever. She maintains that she had never had the PNEUMOVAX in the past. A line is drawn at the border of erythema. She is to call if the erythema advances beyond the border, or if she develops fever/chills. She can apply ice to the area. Also noted is a plaque type lesion more proximally on the arm with erythematous serpiginous border, yet the mid to inferior portion of the lesion with healing ulcerations/eschar. She states that this lesion has been shrinking. Well refer her to derm.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pain, Skin plaque, Skin ulcer
Clinical narrative: Redness, firmness and tenderness left deltoid erythema is 8x9cm tender, warm to the touch. Central induration 6x3cm. Patient had PNEUMOVAX and flu shot given in left deltoid 9/12/14. She noted feeling achy the following day. Then she noted redness, firmness and tenderness left deltoid. No fever or chills. Today the erythema is measuring 8 x 9 cm, the central induration 6 x 3 cm. Tender, warm. No fever. She maintains that she had never had the PNEUMOVAX in the past. A line is drawn at the border of erythema. She is to call if the erythema advances beyond the border, or if she develops fever/chills. She can apply ice to the area. Also noted is a plaque type lesion more proximally on the arm with erythematous serpiginous border, yet the mid to inferior portion of the lesion with healing ulcerations/eschar. She states that this lesion has been shrinking. Well refer her to derm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 14-AUG-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 23-JUL-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot# J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one several reports from the same source. Additional information has been requested.