chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Activities of daily living impaired, Convulsion
Clinical narrative: August 14, 2007 - lot # 0384U - afternoon shot injection site itchy, sore. Flu like symptoms. Sore joints and muscles in the months to follow. Exhaustion. Dr.'s office said the symptoms were normal. November 14, 2007 - lot # 0927U - afternoon shot. Injection site more itchy, sore, red, swelling. Flu like symptoms for days. Sore joints and muscles, headaches, hair loss, exhaustion. Dr. office was not worried about symptoms. February 14, 2008 - lot # 12APR10 - vomiting, shaking, feverish, itchy/sore injection site, redness, swelling entire arm. Sore joints, muscles, fatigue, hair loss (more) migraine, home from school 1 1/2 wks flu like symptoms. Many, many, many Dr. visits, hospitalization ER visits until October 2009 when she became paralyzed on right side, loss of vision, hearing loss. Stay for couple weeks, home recovery. Learned to walk again. Repeat of above January 2011. Week stay. Hospitalization for seizures (4 days). Medical diagnoses: Perfectly healthy until GARDASIL now suffers daily from: Leaky Gut Syndrome, pins/needles in extremities, dizziness, dental issues, brain fog, sensitivities to chemicals, chest pains, constipation/diarrhea, enlarged liver, sound sensitivity, anxiety, extreme pain tailbone, fainting, fevers and blisters, back pain, hot/cold intolerance, sleep problems, itching, joint pain, knee pain, light sensitivity, blindness (right side), depression, personality changes, panic attacks, loss of bladder control, bladder issues, muscle aches, spasms, muscle tension tumor in left tibia, paleness, chronic fatigue syndrome paralysis, pneumonia, severe nerve pain, shortness of breath, slurred speech, smell sensitivity, sore throat stomach pain, swelling/edema, tremors, random twitching of extremities, bloating, uterine spasms, blood clotting, numerous UTI's, kidney problems, vision loss, stomach aches, nausea, rashes, appetite loss, vomiting, dyslexia, hallucinations, large weight loss, seizures, autistic behaviors. Tumor removed December 2010.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old female patient. The patient's concurrent diseases included Allergic rhinitis. No medical history and concomitant medications were reported. On 16-Oct-2012, the patient received nasal FLUMIST. Dosing and frequency were not reported. It was reported that 5 children got FLUMIST and then came back in and tested positive for Flu A. This patient was tested positive for Influenza A on 23-Dec-2012. The patient treatment medication included TAMIFLU. The patient recovered from the event of tested positive for Influenza A on an unspecified date. The report was considered to be non-serious by the reporter. Summary of follow-up information received 24-Jan-2013 from medical representative. Event outcome was updated from unknown to recovered. Reporters details updated. Concomitant disease was added. County of administrator was added. Corrected report: 28-Jan-2013: Action taken was changed corrected from unknown to not applicable.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a health professional. The report concerns a 5 year old patient of unknown gender. The patient's concurrent diseases included allergies and asthma. Concomitant medications included Allergy Medications, Salbutamol Sulfate, Fluticasone Propionate and Mometasone Furoate. On 29-Aug-2012, patient received nasal FLUMIST. The patient tested positive for influenza A on 07-Jan-2013. The patient recovered from the event of tested positive for Influenza a on an unspecified date. The reporter was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 24-Jan-2013 from health professional: Outcome of event was updated from unknown to recovered. Concomitant drug and concomitant diseases were added. Corrected report 29-Jan-2013: Manufacturer of suspected drug added. Reporter's type med rep was added. Corrected report on 01-Mar-2013: event coding changed, narrative updated.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Gaze palsy, Hyperhidrosis, Palpitations, Posture abnormal
Clinical narrative: After Menactra administered in R deltoid Pt head dropped to the R and his eyes looked crossed - pt was sweating profusely (911 was called) immediately. Pt tapped on shoulder and asked if OK and he "come to" and said Yes I' OK. Pt was breathing fine. Heart racing and still sweating. Pt walked out with EMS.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase normal, Blood test, C-reactive protein normal, Computerised tomogram, Full blood count normal
Clinical narrative: Headache; Muscle spasms in calf and finger; Deep bilateral muscle pain/discomfort/stiffness in lower back and thighs; Peroneal nerve and tendon damage; Paresthesia; Hypoesthesia.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Muscle spasms, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: Headache; Muscle spasms in calf and finger; Deep bilateral muscle pain/discomfort/stiffness in lower back and thighs; Peroneal nerve and tendon damage; Paresthesia; Hypoesthesia.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Paraesthesia, Peroneal nerve injury, Red blood cell sedimentation rate normal, Tendon injury
Clinical narrative: Headache; Muscle spasms in calf and finger; Deep bilateral muscle pain/discomfort/stiffness in lower back and thighs; Peroneal nerve and tendon damage; Paresthesia; Hypoesthesia.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site extravasation, Needle issue
Clinical narrative: Patient had leakage of flu shot from arm. Claimed needle was bent and leaked.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised, Varicella post vaccine
Clinical narrative: Whole body rash. Chicken pox outbreak. Fever.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Wheezing
Clinical narrative: Tightness in chest, wheezing, difficulty breathing.
Age: 44.0
Sex: M
Vaccine: FLU3, TYP, YF
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: After taking the Vivotif (Typhoid vaccine) on Monday, September 16th and Wednesday, September 18th, I began to feel stomach cramps at approximately and then had a low grade fever after going to be that evening at approximately 11:30PM.
Age: 1.03
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash morbilliform, Rhinorrhoea
Clinical narrative: Fever 101.4; Runny nose; About 9 days later measles-like rash on back and front; High fever continued.
Age: 1.03
Sex: M
Vaccine: MMR, MMR
Symptoms: Measles, Pyrexia, Rash, Rhinorrhoea, Viral test
Clinical narrative: Fever 101.4; Runny nose; About 9 days later measles-like rash on back and front; High fever continued.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac function test normal, Computerised tomogram head normal, Dizziness, Headache, Laboratory test normal
Clinical narrative: Dizziness, headache, nausea.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Urine analysis normal
Clinical narrative: Dizziness, headache, nausea.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysarthria, Dysphagia, Paraesthesia oral, Swollen tongue
Clinical narrative: Dry, non productive cough with throat irritation, tongue feeling "fuzzy" progressed into swelling, slurred speech and difficulty swallowing.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Dry, non productive cough with throat irritation, tongue feeling "fuzzy" progressed into swelling, slurred speech and difficulty swallowing.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Pt reports redness that was several inches around, felt hot to touch.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm, Dyspnoea, Pharyngeal oedema
Clinical narrative: Tracheal spasms, throat swelling, difficulty breathing.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Confusional state, Fatigue, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Extreme fatigue, HA, sensitive to the light, red and warm and the site of the injection, confusion.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Photophobia
Clinical narrative: Extreme fatigue, HA, sensitive to the light, red and warm and the site of the injection, confusion.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity, Urticaria
Clinical narrative: Arm swelling, localized welts, arm pain.
Age: 1.2
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5cm area of erythema around the injection site with 2 cm area of induration beneath the injection site.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood prolactin normal, C-reactive protein increased, Erythema, Injection site cellulitis, Intensive care
Clinical narrative: Initial cellulitis around site and fever, ED visit, sent home with Keflex.  Came back in to ED wtih cellulitis at vaccine site in right upper arm and septic shock.  Admitted to ICU for treatment.   Recovered sent to floor.  Recovered.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local swelling, Pyrexia, Septic shock
Clinical narrative: Initial cellulitis around site and fever, ED visit, sent home with Keflex.  Came back in to ED wtih cellulitis at vaccine site in right upper arm and septic shock.  Admitted to ICU for treatment.   Recovered sent to floor.  Recovered.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Injection site cellulitis, Intensive care, Pyrexia, Sepsis
Clinical narrative: Initial cellulitis around site and fever, ED visit, sent home with Keflex.  Came back in to ED wtih cellulitis at vaccine site in right upper arm and septic shock.  Admitted to ICU for treatment.   Recovered sent to floor.  Recovered.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dyspnoea, Fatigue, Increased upper airway secretion, Oropharyngeal pain
Clinical narrative: On first day 9/11 I woke up with a sore throat and fever. The condition progressed over the next few days to uncotrollable, painful coughing with a screaming sound and other time a whooping sound that caused shortness of breath.  After the first five days the coughing lead to vomiting. Throughout the process there was head and chest congestion with large amounts of phlegm and mucus. Exhaustion. Trouble breathing.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Respiratory tract congestion, Screaming, Secretion discharge, Sinus congestion
Clinical narrative: On first day 9/11 I woke up with a sore throat and fever. The condition progressed over the next few days to uncotrollable, painful coughing with a screaming sound and other time a whooping sound that caused shortness of breath.  After the first five days the coughing lead to vomiting. Throughout the process there was head and chest congestion with large amounts of phlegm and mucus. Exhaustion. Trouble breathing.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: On first day 9/11 I woke up with a sore throat and fever. The condition progressed over the next few days to uncotrollable, painful coughing with a screaming sound and other time a whooping sound that caused shortness of breath.  After the first five days the coughing lead to vomiting. Throughout the process there was head and chest congestion with large amounts of phlegm and mucus. Exhaustion. Trouble breathing.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Local swelling
Clinical narrative: Large area of redness, swollen and painful. Denies fever, chills, and any other abnormal symptoms. 24 hours after injection: Wide area of warmth, erythema and tenderness extending from axilla to just below elbow medially on right arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin warm, Tenderness
Clinical narrative: Large area of redness, swollen and painful. Denies fever, chills, and any other abnormal symptoms. 24 hours after injection: Wide area of warmth, erythema and tenderness extending from axilla to just below elbow medially on right arm.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4
Symptoms: Angioedema, Injection site erythema, Injection site swelling, Lip swelling, Local swelling
Clinical narrative: Severe swelling and redness in the upper left arm, radiating out from the injection site.  Three weeks later, he has developed angioedema with an episode of swelling in the left lip/face and and episode of severe swelling of the left hand.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4
Symptoms: Swelling face
Clinical narrative: Severe swelling and redness in the upper left arm, radiating out from the injection site.  Three weeks later, he has developed angioedema with an episode of swelling in the left lip/face and and episode of severe swelling of the left hand.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site pruritus, Local swelling, Pain in extremity
Clinical narrative: INJECTION SITE STARTED TO ITCH; ARM SWELLED AND HAS BECOME SWOLLEN AND PAINFUL. STILL SWOLLEN AND PAINFUL TODAY, BUT IMPROVING.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Eyelid oedema, Oral discomfort
Clinical narrative: I received a call from mom at 130 telling me she had just taken him to urgent care.  Patient's eye's were swollen shut he was complaining of his mouth feeling funny.  Mom took him to urgent care he was started on steroids and Benadryl.  Mom was given a 5 day coarse of steroids to give at home as well.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain lower, Chills, Myalgia, Pyrexia
Clinical narrative: Fever to 102.7 degrees, myalgia, rigors, severe left-lower quadrant abdominal pain.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Myalgia, Nervousness
Clinical narrative: Cold hands & feet, internal "nervousness", legs & arms muscle aches, painful walking. Next morning feeling hot, fatigued & mild fever 99.8 degrees. Hearing somewhat impared thru 2nd day.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Peripheral coldness, Pyrexia
Clinical narrative: Cold hands & feet, internal "nervousness", legs & arms muscle aches, painful walking. Next morning feeling hot, fatigued & mild fever 99.8 degrees. Hearing somewhat impared thru 2nd day.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial onset at 130 PM: Dr. reported to me that patient's mom had called reporting a reaction to the flu shot. Patient has hives all over their body. Dr. advised mom to treat with Benadryl and to take patient to PCP's office. Patient was not reported to have any signs of respiratory distress. I called mom who stated that he was seen by his pcp and that the Benadryl was effective. Mom states PCP has not advised any other treatment of reaction. Mom states patient gets flu shot every year and that this is the first time the patient has had a reaction. Mom understands to call back if she has any other questions or concerns. Continued symptoms reported at 330P: 2013/09/12 15:42: Called mom, she stated they were in the PCP office when he was given the Benadryl and the hives did get better. They have now returned and they are cover more of his body. Mom stated they are on the way to ER. Told mom that if she can she may want to call her PCP to make them aware. Mom verbalized understanding. Patient presented at ED at: 1612: Treatment there: Treatments Rendered: prednisolone oral soln: Orapred 35 mg po stat; ranitidine oral syrup: Zantac 35 mg po stat; hydroxyzine hcl: Atarax 9 mg po stat.  Prescriptions Written: prednisolone sodium phosphate 25 mg/5 mL (5 mg/mL) Oral Soln;Dispense: 35 milliliters; Refills: 0; Substitution: YesPrescription Type: Standard epinephrine 0.15 mg/0.15 mL (1:1,000) IM Pen Injector (Also Known As Adrenaclick); Dispense: 2 injectors; Refills: 0; Substitution: Yes Special Instructions: inject into lateral thigh if difficulty breathing, syncope/hypotension, altered mental status, profuse diarrhea/abdominal pain. Prescription Type: Standard diphenhydramine 12.5 mg/5 mL Elixir; Dispense: 240 milliliters; Refills: 0; Substitution: Yes Prescription Type: Standard hydroxyzine 10 mg/5 mL (5 mL) Syrup; Dispense: 75 milliliters; Refills: 0; Substitution: Yes. Prescription Type: Standard famotidine 40 mg/5 mL Oral Susp (Also Known As Pepcid); Dispense: 30 milliliters; Refills: 0; Substitution: Yes. Prescription Type: Standard. Please followup with the below contact(s):  Please followup with your primary care provider in: 1-2 days. Discharged at 17:56 on 9/12.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Anxiety, Dizziness, Flushing, Immediate post-injection reaction, Pruritus
Clinical narrative: Lightheadedness and dizziness immediately after injection. Flushing, anxiety, rash around neck and shoulders, itching approximately 1 hour after injection.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash
Clinical narrative: Lightheadedness and dizziness immediately after injection. Flushing, anxiety, rash around neck and shoulders, itching approximately 1 hour after injection.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Anxiety, Dizziness, Flushing, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: Lightheadedness and dizziness immediately after injection. Flushing, anxiety, rash around neck and shoulders, itching approximately 1 hour after injection.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus generalised, Rash
Clinical narrative: Lightheadedness and dizziness immediately after injection. Flushing, anxiety, rash around neck and shoulders, itching approximately 1 hour after injection.
Sex: U
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning a child of unknown gender. No relevant history and concomitant medication was provided. The patient had been receiving nasal FLUENZ started on an unknown date.  After vaccination with FLUENZ, the patient experienced sniffles. The outcome of the event of sniffles is unknown. The report was considered to be non-serious by company physician.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Musculoskeletal stiffness
Clinical narrative: Vaccine went directly to my joints. Could hardly walk for about a day. Stiffness occurred and finally left on or about Sunday.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Myalgia, Pain, Tremor
Clinical narrative: Cough, hard to breathe, shaky, muscles hurt. Pt used expired albuterol inhaler-which helped with SOB, using TYLENOL for aches. Will call if sx's worsen or change. 9/16/13 Pt reported back sx's restored after 24 hrs.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: When pt noticed the reaction starting, she treated it by applying ice packs, then later moist heat (wash rags/warm water). She went to bed and the next morning the swelling/erythema had increased and spread down her arm - she called her PC clinic, who advised her to report to Emergency Department, where she was admitted for the above and pain, with suspicion of possible cellulitis. Vancomycin 1000 mg BID, diphenhydramine 12.5 mg TID, methylprednisolone 40 mg TID.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient reports by Friday evening (R) deltoid at injection site was hot, swollen, red, numb - "she put ice on it for 1 hr." Was painful to sleep on. She left as a message.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye discharge, Eye irritation, Eye pain, Oropharyngeal pain
Clinical narrative: States approx 1 hour after flu shot her throat started feeling tight and sore. Voice decreased, could only whisper. Eyes very irritated, painful to touch and a drainage noted from her eyes.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: States approx 1 hour after flu shot her throat started feeling tight and sore. Voice decreased, could only whisper. Eyes very irritated, painful to touch and a drainage noted from her eyes.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Admin at approximately 4pm. Reported diarrhea x3, vomiting, chills at 846pm. Husband called at 130am - fever 101.5 degrees F. APAP, fluids, prometh supp (at home).
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 27-Jan-2010, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Jan-2013. The Health professional reported that she had been accidentally administering expired FLUMIST to patient. The outcome of the event of ADMINISTERING EXPIRED FLUMIST/WE HAVE BEEN ACCIDENTALLY ADMINISTERING EXPIRED FLUMIST TO PATIENTS is unkonwn. The report was considered to be non-serious. Summary of follow-up information received by Astrazeneca / MedImmune 31-Jan-2013 from a consumer: Form completed date was updated. Reporters information updated.
Age: 19.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Break out in hives from collarbone down to mid-thighs areas affected - back, inner and outer thighs, chest, forearms.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Burning sensation, Melanocytic naevus, Neuralgia, Pain
Clinical narrative: Patient feels like back is on fire. Patient says the vaccine brought out black moles on her face, back, and under her breast. The pain started about 2 weeks after the injection and is on and off right up to present. Patient has been to the doctor twice and doctor told her it was a neuralgia due to the injection.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 30-Mar-2010, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 21-Jan-2013. The reporter stated that they had accidentally administered expired FLUMIST to patients. The outcome of the event of ADMINISTERING EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 31-Jan-2013 from consumer. The reporter's details updated. Corrected reported 08-Jan-2013. Patient was added as an additional reporter. Event onset date was removed.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving nasal FLUMIST. FLUMIST started on 21-Jan-2013. The reporter stated that patient was accidentally administered expired FLUMIST on 21-Jan-2013. The outcome of the event of ADMINISTERING EXPIRED FLUMIST is unknown. The report was  considered to be non-serious. Follow-up insignificant information received 31-Jan-2013: primary reporters title added.
Age: 0.6
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event reported. 7 mo old was given KINRIX (DTAP/IPV) inadvertently. Advised by manufacturer to report to VAERS in the event child ever had reaction after this date.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever, pain - several hr after receiving vaccine. 2 days later increased pain at site of vaccine.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Very red swollen warm to touch - fever for 2 day low grade.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Very red, swollen arm from site of injection almost to elbow, starting about 2-3 hours after vaccine administered - went to own M.D. 48 hours later as rash and swelling kept getting worse - M.D. made diagnosis of cellulitis and put on clindamycin for 10 days.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased
Clinical narrative: Increased temp of 104 (R). Began 24 to 36 hrs after the shots.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Blister, Scab
Clinical narrative: 3 blisters- 2 on buttocks; 1 on back- 10 days after varicella vaccine administered. Scabbed over in 3 days- no treatment or doctor visit reported.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Fatigue, Sensation of heaviness, Vertigo
Clinical narrative: Next day woke up with severe dizziness. Entire room spinning violently, like body was on full tilt had to hold on to wall, furniture to walk. The rest of the day felt mildly dizzy but felt better by end of day. Every morning experiencing similar symptoms start really dizzy and gets better. Feel fatigue and heavy feeling like if weighed 100 more pounds. Pt is not allergic to thimerosal but prefers not to receive it. Doctor refused to give him thimerosal free vaccine saying it is reserved for children and pregnant women.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness
Clinical narrative: Next day woke up with severe dizziness. Entire room spinning violently, like body was on full tilt had to hold on to wall, furniture to walk. The rest of the day felt mildly dizzy but felt better by end of day. Every morning experiencing similar symptoms start really dizzy and gets better. Feel fatigue and heavy feeling like if weighed 100 more pounds. Pt is not allergic to thimerosal but prefers not to receive it. Doctor refused to give him thimerosal free vaccine saying it is reserved for children and pregnant women.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red 2-inch square at site of injection. Began spreading shoulder to elbow, hot to touch, hardness of skin.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Is swollen, red and warm to touch.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Eye swelling
Clinical narrative: Last year received the flu vaccines after a long time; had flu-like symptoms. This year a few minutes after vaccine got headache, felt lightheaded. By 9:30pm got severe chills, shaking body, severe body aches especially in joints, bad lower back pain. Took ADVIL felt too sick to go to ER. This morning chills gone but lower back pain remains. Took more ADVIL. Fatigue at same level as yesterday. Doesn't feel that bad today. Left eye swollen. About 1-2 hours ago took TYLENOL with codeine to take edge away from pain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Tremor
Clinical narrative: Last year received the flu vaccines after a long time; had flu-like symptoms. This year a few minutes after vaccine got headache, felt lightheaded. By 9:30pm got severe chills, shaking body, severe body aches especially in joints, bad lower back pain. Took ADVIL felt too sick to go to ER. This morning chills gone but lower back pain remains. Took more ADVIL. Fatigue at same level as yesterday. Doesn't feel that bad today. Left eye swollen. About 1-2 hours ago took TYLENOL with codeine to take edge away from pain.
Sex: U
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced NOSE BLEED. The outcome of the event of NOSE BLEED is unknown. The report was considered to be non-serious.
Age: 0.58
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, male patient. The relevant history and concomitant disease of the patient were not reported. It was reported that the patient was on no concomitant medications. The patient had been receiving nasal FLUMIST started on 23-Dec-2008. The reporter stated that after FLUMIST administration patient contracted Flu A which started on 24-Jan-2013 and which was tested positive on 24-Jan-2013. It was reported that the patient was treated with TAMIFLU and reporter said the patient had not been seen since then, she presumed the flu had resolved. The outcome of the event of Flu A was unknown. The reporter assessed the event of Flu A to be non serious. Summary of follow-up information received 26-Feb-2013 from health professional. Form completed date updated. Expiry date for drug added. Title added for primary reporter. Narrative updated with reporter's comment. Corrected report 08-Mar-2013: Lab value corrected.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza B virus test positive, Influenza virus test positive
Clinical narrative: A report has been received from a registered nurse concerning children of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST was administered on unknown dates. The patients later have been TESTED POSITIVE FOR INFLUENZA, mostly for Influenza B. The outcome of the event of TESTED POSITIVE FOR INFLUENZA is unknown. The report was considered to be non-serious by company physician.
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A consumer report has been received. The report concerns, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced congestion which started during 2011. The patient recovered from the event of CONGESTION on an unspecified date. The report was considered to be non-serious.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and vomiting for 28 hours - started 4 hours after receiving vaccine.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Hyperaesthesia, Joint range of motion decreased, Pain in extremity
Clinical narrative: A consumer report has been received. The report concerns a 3 year old, Male consumer, who had been receiving FLUMIST. The patient's medical history included HAND, FOOT AND MOUTH DISEASE and COLD. FLUMIST started during Nov-2012. The patient experienced HAD PAIN IN HIS ENTIRE RIGHT ARM/LOTS OF PAIN/PAIN IS NOW IN THE BICEP AND HE HAS A BUZZING PAIN which started on 02-Nov-2012, COULDN'T LIFT HIS SHOULDER/HE COULDN'T GIVE A HIGH FIVE OR RAISE HIS ARM and WHEN THEY LIGHTLY TOUCH HIS ARM IT HURTS. The patient recovered from the event of HAD PAIN IN HIS ENTIRE RIGHT ARM/LOTS OF PAIN/PAIN IS NOW IN THE BICEP AND HE HAS A BUZZING PAIN on an unspecified date and The outcome of the event of COULDN'T LIFT HIS SHOULDER/HE COULDN'T GIVE A HIGH FIVE OR RAISE HIS ARM and WHEN THEY LIGHTLY TOUCH HIS ARM IT HURTS and WHEN THEY LIGHTLY TOUCH HIS ARM IT HURTS is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered at inappropriate site
Clinical narrative: A report has been received from a Physician concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. INADVERTENT INOCULATION IN EYE is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered at inappropriate site
Clinical narrative: A report has been received from a Physician concerning a child of unknown gender, who had been receiving Intraocular FLUMIST. FLUMIST started on an unknown date. The patient received FLUMIST inadvertently in the eye. The outcome of the event of inadvertent inoculation in eye is unknown. The report was considered to be non-serious by the reporter.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Bronchitis, Ear congestion, Hypersensitivity, Otitis media, Pruritus
Clinical narrative: A consumer report had been received, concerning a 12 years old male patient. The patient's medical history included strep throat on 28-Mar-2008. Concomitant medications included antihistamines and ibuprofen for fever. The patient had been receiving nasal FLUMIST, started on 20-Mar-2013. Mother reported that her son exhibited the following symptoms after receiving FUMIST, which included sinus headache, congestion, runny nose and ears blocked. The nurse reported that, on follow-up, the patient was diagnosed with bronchitis, otitis media, and wheezing. He was treated with OMNICEF and albuterol. The nurse though that the patient recovered from the events after treatment. On 15-Jan-2013, the patient revisited the office for an allergic reaction. He had a rash all over, on his upper and lower extremities, waist and face. There was no indication in the patient's chart what the allergic reaction was from. He was treated with prednisone 10 mg and BENADRYL every 4-6 hours for itching. The outcome of the event was unknown. Company physician considered the event of otitis media, wheezing, itching, congestion, runny nose and rash all over to be non serious. The nurse added that she did not believe the patient's events (bronchitis, otitis media, rash all over and wheezing) were a reaction to FLUMIST. Summary of follow-up information received 22-Feb-2013 from Health Professional. New non serious events bronchitis, otitis media, wheezing, itching and rash all over added. Medical history and concomitant medication added. Healthcare professional added as primary reporter. Case medically confirmed. Dosing regimen updated. Reporters causality added.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash generalised, Respiratory tract congestion, Rhinorrhoea, Sinus headache, Wheezing
Clinical narrative: A consumer report had been received, concerning a 12 years old male patient. The patient's medical history included strep throat on 28-Mar-2008. Concomitant medications included antihistamines and ibuprofen for fever. The patient had been receiving nasal FLUMIST, started on 20-Mar-2013. Mother reported that her son exhibited the following symptoms after receiving FUMIST, which included sinus headache, congestion, runny nose and ears blocked. The nurse reported that, on follow-up, the patient was diagnosed with bronchitis, otitis media, and wheezing. He was treated with OMNICEF and albuterol. The nurse though that the patient recovered from the events after treatment. On 15-Jan-2013, the patient revisited the office for an allergic reaction. He had a rash all over, on his upper and lower extremities, waist and face. There was no indication in the patient's chart what the allergic reaction was from. He was treated with prednisone 10 mg and BENADRYL every 4-6 hours for itching. The outcome of the event was unknown. Company physician considered the event of otitis media, wheezing, itching, congestion, runny nose and rash all over to be non serious. The nurse added that she did not believe the patient's events (bronchitis, otitis media, rash all over and wheezing) were a reaction to FLUMIST. Summary of follow-up information received 22-Feb-2013 from Health Professional. New non serious events bronchitis, otitis media, wheezing, itching and rash all over added. Medical history and concomitant medication added. Healthcare professional added as primary reporter. Case medically confirmed. Dosing regimen updated. Reporters causality added.
Sex: U
Vaccine: FLUN3
Symptoms: Asthma, Wheezing
Clinical narrative: A report has been received from a physician concerning an adult, patient of unknown gender. No medical history, concurrent disease or concomitant medication was provided. Approximately in 2010, the patient received nasal FLUMIST. The patient experienced wheezing and/or asthmatic episode. The outcome of the event of wheezing and or asthmatic episode was unknown. The report was considered to be non-serious by the reporter.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 30-Mar-2010, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 21-Jan-2013. The reporter stated that they had accidentally administered expired FLUMIST to patients. The outcome of the event of ADMINISTERING EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 31-Jan-2013 from consumer. The reporter's details updated. Corrected reported 08-Jan-2013. Patient was added as an additional reporter. Event onset date was updated.
Sex: U
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Health Professional  concerning, two patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patients experienced BLOODY NOSE. The patients recovered from the event of BLOODY NOSE on an unspecified date. The report was considered to be non-serious by the reporting health professionals.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Jan-2013. The patient ADMINISTERED EXPIRED FLUMIST. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear infection, Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, Male subject, who had been receiving nasal FLUMIST. FLUMIST started on 16-Sep-2012. The patient experienced TESTED POSITIVE FLU A which started on 12-Dec-2012 and EAR INFECTION. The patient recovered from the event of TESTED POSITIVE FLU A and EAR INFECTION on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received 26-Feb-2013 from Health professional. Non serious event of ear infection was added. Outcome for the events of tested positive Flu A and ear infection was updated as recovered. lot number and expiry date added for FLUMIST.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 15-Jan-2013. The reporter stated that expires FLUMIST was administered. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning, female subject, who had been receiving Nasal FLUMIST. FLUMIST started during Aug-2012. The patient was tested positive: flu A on 17-Dec-2012. The outcome of the event of TESTED POSITIVE: FLU A is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a health professional via medical representative concerning a 10 year-old female patient. The patient's medical history, concomitant medications and concurrent diseases were not reported. On 20-Aug-2012 the patient received nasal FLUMIST. On 19-Nov-2012 the patient was tested positive for Influenza B. At the time of reporting the outcome of the event was unknown. The report was considered to be non-serious by the reporter.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pneumonia, Sinusitis
Clinical narrative: A report has been received from a Pharmacist concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started during Oct-2012. The patient experienced pneumonia, cough and sinusitis which started during Oct-2012. The patient recovered from the event of pneumonia and cough on an unspecified date and the outcome of the event of sinusitis is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 19-Dec-2012. On 19-Dec-2012, the patient received FLUMIST, which expired on 03-Dec-2012. The patient experienced COUGH which started during Jan-2013. The outcome of the event of EXPIRED FLUMIST GIVEN and COUGH is unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 14-Feb-2013 from Health Professional: new event of COUGH added, narrative updated.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: VIIth nerve paralysis
Clinical narrative: A report has been received from a Physician concerning a 6 year old male patient. The patient's concurrent diseases included autism and speech and social delays. Patient had history of upper respiratory tract infection with fever 2 weeks previously, which was resolved. Concomitant medications included olopatadine hydrochloride, ibuprofen and paracetamol. On 26-Dec-2012 the patient received nasal FLUMIST. He experienced right sided facial drooping after receiving FLUMIST. He returned to the office, and the physician prescribed a short course of oral steroids. The patient returned to the clinic on 27-Dec-2012 and was diagnosed with Bell's palsy. Event was treated with steroids and Valacyclovir for 7 days. The patient recovered from the event of Bell's palsy on 31-Jan-2013. The company physician assessed the Bell's palsy to be serious with the criteria of important medical event. Summary of insignificant follow-up information received by AstraZeneca/MedImmune on 04-Mar-2013 from other type of reporter via spontaneous source: Updated patient initials. Reporter details updated. Corrected report 11-Mar-2013: Previously reported non-serious event of Bell's palsy as captured as serious event. Reporter details corrected. Summary of follow-up information received by AstraZeneca/MedImmune on 11-Mar-2013 from physician with spontaneous source: Added patient medical history and concomitant medication. Added indication, no. of previous doses, vaccinated at, vaccine purchased with for FLUMIST as well as updated dosing regimen for same. Added physician details. Added administered by details as well as responsible physician as reporter. Added stop date for event as well as updated event outcome to recovered. Updated patient demographics. Updated narrative.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza like illness, Secondary transmission
Clinical narrative: A consumer report has been received concerning a female patient. No medical history of the patient was reported. No concomitant medication of the patient was reported. The patient (mother) was exposed to her son, being in close proximity, who had been receiving nasal FLUMIST which was started on 16-Nov-2012. The patient's mother reported that she had a secondary transmission and developed flu like symptoms on 19-Nov-2012 and then had a flu. Action taken with suspect drug was unknown. At the time of reporting, the outcome of the event of secondary transmission and flu/flu like symptoms was unknown. The company physician assessed the events of secondary transmission and flu/flu like symptoms to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning an adult, female patient, who had been receiving Nasal FLUMIST. FLUMIST started on 25-Dec-2012. The patient experienced tested positive for Influenza A which started on 25-Dec-2012. The patient recovered from the event of tested positive for Influenza A on an unspecified date. The report was considered to be non-serious.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Encephalitis, Full blood count, Headache, Lethargy, Lumbar puncture
Clinical narrative: Fever, Lethargy, Body Aches, Headache.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Meningitis aseptic, Metabolic function test, Pain, Pyrexia, Viral test
Clinical narrative: Fever, Lethargy, Body Aches, Headache.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse symptoms noted. Another live vaccine given, just had Varicella, less than 28 days.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: 1 inc. diameter red ring rash around injection site, 3 in. lighter ring rash on outside.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Sensation of foreign body
Clinical narrative: Cough, red eyes, sensation of something caught in throat. Vital signs stable Peak flow 350. Treated w/ 4 mg chlorpheniramine and albuterol inhalation tx.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Tachycardia
Clinical narrative: Tachycardia- Heart rate 125-130 started 30 minutes after injection. No other symptoms, lasted 1-1.5 hours. No resolved. No shortness of breath or other symptoms. No heart palpitations.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Fever, chills, shaking uncontrollably.
Age: 18.0
Sex: M
Vaccine: TTOX
Symptoms: Arthralgia, Erythema, Local swelling
Clinical narrative: Donor stated having circular raised areas reddish in color fading and coming back, painful on both left and right wrists.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt's parents noticed rash starting to upper back and chest.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash, Urticaria
Clinical narrative: Started with rash/hives on trunk of body. Proceeded to develop the hives all over the body from neck down to feet. Gave cetirizine the first day. Gave Benadryl the second day.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Hypersomnia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Woke up with stiff neck and the feeling that my head was about to explode. Severe headache and was extremely tired. I slept for 14 hours on 01/10/2013, even after sleeping for 8 hrs that night. My arm that I received the shot in was stiff and hurt to raise it or lay on it. I felt like I got hit by a truck. On 01/11/2013 I was still tired, my neck was sore but better than the day before. The arm was still stiff and sore, a little better. On 01/12/13 symptoms were getting better, but still felt tired, a little ache in arm, headache now gone as well as stiff neck. On 01/13/13 felt like myself again, all symptoms gone. For treatment I took ibuprofen for 2 days until neck and headache were tolerable. And I slept alot. Thank goodness that I didn't have to work the day after the shot. I would have had to call in sick. I never felt like this before a vaccine. I will never get a Tdap again!
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Woke up with stiff neck and the feeling that my head was about to explode. Severe headache and was extremely tired. I slept for 14 hours on 01/10/2013, even after sleeping for 8 hrs that night. My arm that I received the shot in was stiff and hurt to raise it or lay on it. I felt like I got hit by a truck. On 01/11/2013 I was still tired, my neck was sore but better than the day before. The arm was still stiff and sore, a little better. On 01/12/13 symptoms were getting better, but still felt tired, a little ache in arm, headache now gone as well as stiff neck. On 01/13/13 felt like myself again, all symptoms gone. For treatment I took ibuprofen for 2 days until neck and headache were tolerable. And I slept alot. Thank goodness that I didn't have to work the day after the shot. I would have had to call in sick. I never felt like this before a vaccine. I will never get a Tdap again!
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Sore and red arm down to elbow of injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Limb discomfort, Local swelling
Clinical narrative: Swollen arm; Arm discomfort; OTC treatment (TYLENOL, BENADRYOL, etc.).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called pharmacy one day after receiving her flu shot (9/20/13) indicating the site of injection is swollen, red, and warm to the touch.