chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown gender, in the age between 11-17, who was a participant in a pharmaceutical study. The patient's medical history, drug reactions and allergies and concomitant medications were not reported. On an unknown date, estimated as September 2014 (it was reported as "last week"), the patient was vaccinated with one shot of GARDASIL, therapy route was not specified (described as "injection") in the shoulder, lot# and exp. date were not provided, the therapy reason for use was reported as investigational. On the same day, the patient was also vaccinated with MENACTRA (dose, frequency, lot#, exp. date and therapy route were not provided) in the shoulder and ADACEL (dose, frequency, lot#, exp. date and therapy route were not provided) in the shoulder. The patient had an injection site reaction (exact date unspecified, estimated as September 2014) on the shoulder that was injected with GARDASIL and ADACEL, it was reported that MENACTRA was administered on the opposite shoulder. Three days after receiving GARDASIL (estimated date September 2014), the patient experienced cellulitis, redness, swelling and hive-like symptoms of the GARDASIL-injection shoulder. The patient sought medical attention. The patient was given BENADRYL and ibuprofen and symptoms resolved within a day and a half (not specified date in September 2014). The relatedness between vaccination with GARDASIL and the events was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. The patient's pertinent medical history and drug reactions or allergies were not provided. On an approximately 24-SEP-2014 (reported as "about 1 week ago"), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). It was unspecified if the patient took any concomitant medications. The patient stated that, on an unspecified date in approximately 2014, she experienced swelling around the ZOSTAVAX injection site. The outcome of swelling around the injection site was unknown. The relatedness between the event and the ZOSTAVAX was unknown. Additional information is not expected because the reporter did not provide any contact details and no follow up is available.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose decreased, Confusional state, Fatigue, Pyrexia
Clinical narrative: Two hours post injection pt. started feeling fatigue and confusion. Symptoms persisted and worsened. Pt. went to hospital on 9/29/14 to seek treatment. Pt. BG was 11 at time of admission. Pt. received glucose tabs. Pt was discharged on 9/30/14. Pt. developed a fever of 102 degrees F on 9/27/14 - fever resolved on 10/1/14.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: On 9/18/14 at 16:00, 59 year old arrived our clinic for immigration immunizations. Patient was inadvertently given Tdap instead of Td. Pt had Tdap vaccine on 4-30-14 so just needed Td at this time.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Full blood count normal, Hypoaesthesia, Laboratory test normal, Lumbar puncture normal
Clinical narrative: 9/15/14 Routine checkup. Dr office. Flu vaccine given. 9/20/14 ER numbness hands and feet - nml vitals. NEURONTIN Rx'd. 9/23 - Saw PMD with (?) Bell's - acyclovir, prednisone Rx'd. 9/29 - ER with ongoing limb numb, (B) facial paralysis, poor ADL.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Red blood cell sedimentation rate normal, VIIth nerve paralysis
Clinical narrative: 9/15/14 Routine checkup. Dr office. Flu vaccine given. 9/20/14 ER numbness hands and feet - nml vitals. NEURONTIN Rx'd. 9/23 - Saw PMD with (?) Bell's - acyclovir, prednisone Rx'd. 9/29 - ER with ongoing limb numb, (B) facial paralysis, poor ADL.
Age: 67.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site vesicles, Vaccination site erythema
Clinical narrative: Patient noticed erythema at vaccine site, worsened on morning of 10/2/2014 and prompted visit to PCP office.  Noted erythema and vesicle at administration site.  NO systemic reaction.  Tx with local ice and oral NASIDS for inflammation.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Flu shot administered at her work site. Approximately 1 hour after the injection was given the patient reported generalized itching in her arm, neck and back. The nurse noted redness in these areas.The patient did not exhibit any signs/symptoms of respiratory distress. B/P 122/86, pulse 88, respiration 16. The patient denied any known allergies. The patient told the nurse that she was took 2 25mg Benadryl. The nurse instructed the patient to call her physician. The patient did so and went directly to his office. I followed up with the patient on 10/1/14. She was at work and stated the physician gave her a steroid injection and oral steroid and that she was not having any further problems.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Injection site pain, Muscle twitching
Clinical narrative: Severe pain under injected arm, shivering and muscle twitching, nausea & faintness when getting out of bed to use bathroom, loose stools.  Took acetaminophen which seemed to help.  Could finally get out of bed at 10:30 am.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Severe pain under injected arm, shivering and muscle twitching, nausea & faintness when getting out of bed to use bathroom, loose stools.  Took acetaminophen which seemed to help.  Could finally get out of bed at 10:30 am.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity, Paraesthesia
Clinical narrative: TINGLING IN ARM, DIFFICULTY BREATHING. PT HAD TAKEN BENADRYL BEFORE IN RESPONSE TO A GRASS ALLERGY. ADMINISTERED EPIPEN TO PATIENT ONCE SHE WAS HAVING BREATHING DIFFICULTIES.  THIS WAS NOT THE PT FIRST TIME HAVING ALLERGIC REACTION OR USING EPIPEN. AFTER EPIPEN ADMINISTRATION BLOOD PRESSURE AND PULSE WERE TAKEN AND WERE WITHIN NORMAL RANGE. EMS WAS CONTACTED AND ON SITE WITHIN 25 MINUTES. PT WAS NOT ADMITTED TO HOSPITAL BUT WAS SEEN BY A PHYSICIAN.  ACCORDING TO PT, DR ADMINISTERED DIPHENYRAMINE AND A STEROID.  PT WAS CONTACTED ON 10/2 AND SHE WAS AT HOME.
Age: 42.0
Sex: M
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Dizziness, Dyskinesia, Eye movement disorder, Foaming at mouth, Loss of consciousness
Clinical narrative: Client stated "I feel dizzy", and client became pale, loss consciousness, used amonia inhalant, client eyes rolled back and he became rigid. Lower client to floor, called 911. Client had uncontrolled body movement of arms and legs. Client foamed at the mouth. The episode lasted approx 1-2 minutes. Vss 140/90 respiration 20. client alert and oriented. assisted on seated up. EMS arrived, client stable. Client refused to go with EMS. Vital stable when EMS arrived. Client declined to leave with EMS. Wife arrived, this nurse insisted that client follow up with neuroligist. Wife verbalized an understanding. Client walked out of client stable with wife by his side.
Age: 42.0
Sex: M
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Muscle rigidity, Pallor
Clinical narrative: Client stated "I feel dizzy", and client became pale, loss consciousness, used amonia inhalant, client eyes rolled back and he became rigid. Lower client to floor, called 911. Client had uncontrolled body movement of arms and legs. Client foamed at the mouth. The episode lasted approx 1-2 minutes. Vss 140/90 respiration 20. client alert and oriented. assisted on seated up. EMS arrived, client stable. Client refused to go with EMS. Vital stable when EMS arrived. Client declined to leave with EMS. Wife arrived, this nurse insisted that client follow up with neuroligist. Wife verbalized an understanding. Client walked out of client stable with wife by his side.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Borrelia test negative, Fatigue, Hypoaesthesia, Joint stiffness
Clinical narrative: First, shock-like pains in leg for almost a month, then in same side developed numbness, tingling, other parasthesias, muscle pain, muscle fatigue, muscle shaking, general fatigue, sleepiness. After a couple of months I gradually developed a severe frozen shoulder, same side and other joint stiffness worsened as well. Almost a year later I continue to suffer and left side is also developing some symptoms now. Have had loads of tests done including MRIs, xrays, blood work, and they have not found any disease they (neurologist, rheumatologist, primary care) can diagnose, but I still suffer. This is not a complete list of symptoms -too long to remember them all.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle fatigue, Myalgia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity
Clinical narrative: First, shock-like pains in leg for almost a month, then in same side developed numbness, tingling, other parasthesias, muscle pain, muscle fatigue, muscle shaking, general fatigue, sleepiness. After a couple of months I gradually developed a severe frozen shoulder, same side and other joint stiffness worsened as well. Almost a year later I continue to suffer and left side is also developing some symptoms now. Have had loads of tests done including MRIs, xrays, blood work, and they have not found any disease they (neurologist, rheumatologist, primary care) can diagnose, but I still suffer. This is not a complete list of symptoms -too long to remember them all.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Periarthritis, Somnolence, Thyroid function test normal, Tremor
Clinical narrative: First, shock-like pains in leg for almost a month, then in same side developed numbness, tingling, other parasthesias, muscle pain, muscle fatigue, muscle shaking, general fatigue, sleepiness. After a couple of months I gradually developed a severe frozen shoulder, same side and other joint stiffness worsened as well. Almost a year later I continue to suffer and left side is also developing some symptoms now. Have had loads of tests done including MRIs, xrays, blood work, and they have not found any disease they (neurologist, rheumatologist, primary care) can diagnose, but I still suffer. This is not a complete list of symptoms -too long to remember them all.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Vitamin D decreased, X-ray normal
Clinical narrative: First, shock-like pains in leg for almost a month, then in same side developed numbness, tingling, other parasthesias, muscle pain, muscle fatigue, muscle shaking, general fatigue, sleepiness. After a couple of months I gradually developed a severe frozen shoulder, same side and other joint stiffness worsened as well. Almost a year later I continue to suffer and left side is also developing some symptoms now. Have had loads of tests done including MRIs, xrays, blood work, and they have not found any disease they (neurologist, rheumatologist, primary care) can diagnose, but I still suffer. This is not a complete list of symptoms -too long to remember them all.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic, Swelling face
Clinical narrative: Patient states that friends and acquaintances told her that her face appeared swollen, patient states it was. By evening hours 10/01/2014 patient states she noted itchy rash to neck, and chest which has spread to body.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Hyperhidrosis, Joint swelling, Myalgia
Clinical narrative: Started out as general ache, progressed to fire like pain in the muscles, generalized swelling, joint pain/swelling, low grade temperature, headache, diaphoretic.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Started out as general ache, progressed to fire like pain in the muscles, generalized swelling, joint pain/swelling, low grade temperature, headache, diaphoretic.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: RED AREA, WARM TO TOUCH.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Gingival pain, Glossodynia, Headache
Clinical narrative: I developed a dry cough about 7:30 PM, my tongue and gums felt painful. I went to bed at 10 PM and awoke at 1:30 am with headache, severely swollen tounge, severe facial swelling, eyes were completely blood shot. I was very concerned with possible anaphylaxis and contemplated going to the emergency room. I went back to bed at 4:30 am as my airway was patent and my wife frequently checked on me. I awoke at 8:30 am with headache, facial swelling and numbness but tongue was less swollen and not as painful. Eyes were not as bloodshot but I was very fatigued.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Ocular hyperaemia, Swelling face, Swollen tongue
Clinical narrative: I developed a dry cough about 7:30 PM, my tongue and gums felt painful. I went to bed at 10 PM and awoke at 1:30 am with headache, severely swollen tounge, severe facial swelling, eyes were completely blood shot. I was very concerned with possible anaphylaxis and contemplated going to the emergency room. I went back to bed at 4:30 am as my airway was patent and my wife frequently checked on me. I awoke at 8:30 am with headache, facial swelling and numbness but tongue was less swollen and not as painful. Eyes were not as bloodshot but I was very fatigued.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Localized erythema, swelling, itching and soreness.  Directly applied ice to reduce swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Contusion, Erythema, Headache, Pain
Clinical narrative: 3"X1" DARK RED PATCH, VERY HOT AND SORE, HEADACHE, ITCHY, ARMPIT SORE TO TOUCH, ON 6TH DAY BRUISE DEVELOPED, SEVERE LOWER BACK ACHE, 3RD WEEK DEVELOPED ITCHY SPOTS ON LEFT BACK, 5TH WEEK DEVELOPED RASH ON LEFT BACK AND AROUND LEFT KNEE.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm, Tenderness
Clinical narrative: 3"X1" DARK RED PATCH, VERY HOT AND SORE, HEADACHE, ITCHY, ARMPIT SORE TO TOUCH, ON 6TH DAY BRUISE DEVELOPED, SEVERE LOWER BACK ACHE, 3RD WEEK DEVELOPED ITCHY SPOTS ON LEFT BACK, 5TH WEEK DEVELOPED RASH ON LEFT BACK AND AROUND LEFT KNEE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Father noted little redness at site of injection on 9/30/14 after taking off bandaide. 10/1/14 noted more redness around the injection site and was speading by 10/2/14. Took child to ED in the am on 10/2/14 and follow up here this afternoon at the clinic. ED gave a prescription of Keflex and provider advised to give Benadryl as needed.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Initial insomnia, Injected limb mobility decreased, Injection site erythema, Injection site pruritus
Clinical narrative: Patient noticed itching to area of vaccine that day 9/26/14, area sore and red. On 9/27/14 area swollen and not able to raise her right arm above her shoulder, not able to fall asleep so took a Aleve help her. On 9/28/14 she noticed that she was short of breath, went away. Her mother told her to come in here to report what happened and she did today 10/2/14.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient noticed itching to area of vaccine that day 9/26/14, area sore and red. On 9/27/14 area swollen and not able to raise her right arm above her shoulder, not able to fall asleep so took a Aleve help her. On 9/28/14 she noticed that she was short of breath, went away. Her mother told her to come in here to report what happened and she did today 10/2/14.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Excruciating pain in arm receiving vaccination from fingers up arm to collar bone and shoulder blade.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Lacrimation increased, Pain
Clinical narrative: Chills, Headache, Watery Eyes, Achy Body.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Pain, Sleep disorder
Clinical narrative: Sudden chills aching all over my body.  Did not sleep much thru the night.  Aching and chills subsided about 08:00 on 10/01/2014.  Felt weak and exhausted, napped through out the day.  Feel all right today, 10/2/2014.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: CSF glucose normal, CSF protein increased, CSF white blood cell count increased, Cough, Lymphocyte percentage increased
Clinical narrative: Patient was admitted to hospital on 9/25/14 with acute onset of bilateral upper extremity weakness, which progressed to involved lower extremities as well as weak cough. He had cough and congestion about 2 weeks prior to these symptoms. CSF at the time of admission showed 129 white blood cells (82% lymphocytes) with normal glucose and protein of 123 mg/dL. MRI showed abnormal T2 hyperintensity along the spinal cord. He was treated with IV steroids and plasmapheresis with some improvement. I am the pediatric infectious diseases fellow who was consulted on this patient at admission. At the time of the report the patient is still admitted.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Plasmapheresis, Respiratory tract congestion
Clinical narrative: Patient was admitted to hospital on 9/25/14 with acute onset of bilateral upper extremity weakness, which progressed to involved lower extremities as well as weak cough. He had cough and congestion about 2 weeks prior to these symptoms. CSF at the time of admission showed 129 white blood cells (82% lymphocytes) with normal glucose and protein of 123 mg/dL. MRI showed abnormal T2 hyperintensity along the spinal cord. He was treated with IV steroids and plasmapheresis with some improvement. I am the pediatric infectious diseases fellow who was consulted on this patient at admission. At the time of the report the patient is still admitted.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, bruising, and warm to the touch at site of injection and surrounding area. Possible low-grade fever- reported being warm to the touch.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Woke up with 1 swollen finger on left side in the morning. It looks red and felt somewhat painful, but patient doesn't think it's due to a bug bite or cut, she thinks it's due to the vaccine.  She does not report any itching, facial swelling, difficulty breathing, or any other symptoms.  Just a red swollen finger. I advised her to take a Benadryl to see if that helps, but also call her doctor to see if they want her to come in and have it looked at.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Thyroid function test normal, Urticaria
Clinical narrative: I began seeing hives on my abdomen, by 09/20/14 I was almost covered in hives from my breast to hips and in the same location on my sides and back. I saw my doctor on 09/22/14 and was given prednisone. The hives faded through the week, however my last prednisone pill was 09/28/14.  The very next day 09/29/14 they began to appear again and have progressively gotten worse. I am seeing my doctor again tomorrow.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Chest pain, Influenza like illness, Rash, Rash vesicular
Clinical narrative: First, patient had flu like symptoms and then he got a bad rash all over his chest and back, look like chicken pox. Now he is having chest pains.
Age: 70.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Chills, Erythema, Headache, Induration, Malaise
Clinical narrative: Fever, chills, malaise, body aches, headache, and erythematous, warm, tender indurated lesion on right deltoid.
Age: 70.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Pain, Pyrexia, Skin lesion, Skin warm, Tenderness
Clinical narrative: Fever, chills, malaise, body aches, headache, and erythematous, warm, tender indurated lesion on right deltoid.
Age: 70.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Dizziness, Local swelling, Malaise, Night sweats, Pyrexia
Clinical narrative: Fever, chills, malaise, body aches, headache, and erythematous, warm, tender indurated lesion on right deltoid.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Appendicectomy, Attention deficit/hyperactivity disorder, Bladder scan, Cognitive disorder
Clinical narrative: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Cystitis interstitial, Emotional disorder, Food intolerance, Gastrointestinal disorder
Clinical narrative: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrooesophageal reflux disease, Headache, Hyperacusis, Hypotension, Laboratory test
Clinical narrative: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Mental impairment, Migraine, Nuclear magnetic resonance imaging, Ovarian cyst
Clinical narrative: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Parosmia, Photophobia, Sleep disorder, Ultrasound scan
Clinical narrative: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Pruritus
Clinical narrative: Itchy palms 6 hours after the injection; an hour later: severe head ache, chills, vomiting, diarrhea achy joints.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Itchy palms 6 hours after the injection; an hour later: severe head ache, chills, vomiting, diarrhea achy joints.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Erythema, Rash, Sinusitis
Clinical narrative: Unknown if related, but had injection in right arm, burning rash/redness in left armpit.  Probably unrelated but then 4 days later, go sinus infection.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Abnormal behaviour, Decreased eye contact, Speech disorder, Unresponsive to stimuli
Clinical narrative: Starting 1-2 days later my son became more quiet, stopped responding to his name, decreased eye contact and stopped talking (he said 3-4 words prior to) he is now 18 months and still non verbal, won't say mama or dada and has been evaluated and approved for early intervention speech therapy.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Back pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Severe headache, severe SI joint pain, and lower back pain. Temp 100.1 stiff neck. Took Motrin 800 mg with very little relief then Tylenol ES. Injection site hot red swollen. All the above still present.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Severe headache, severe SI joint pain, and lower back pain. Temp 100.1 stiff neck. Took Motrin 800 mg with very little relief then Tylenol ES. Injection site hot red swollen. All the above still present.
Age: 8.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Dizziness, Ear infection, Erythema, Local swelling
Clinical narrative: High fever, dizziness, red swollen (3 days later still spreading down the arm) hurting unable to move arm, vomiting, diarrhea,  ear infections.
Age: 8.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: High fever, dizziness, red swollen (3 days later still spreading down the arm) hurting unable to move arm, vomiting, diarrhea,  ear infections.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itchy, started on arms, spread to legs. Rec. Benadryl, Zantac, oatmeal bath to relieve itch.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Disorientation, Dizziness, Dysarthria, Gait disturbance
Clinical narrative: Reaction happened ½ hour of flu shot on 9/25/2014. Shot was administered in the AM. Vital signs were taken when I felt symptoms, they were normal. Symptoms included disorientation, confusion, dizziness to the point of syncope, slurred speech, staggering, malaise and elevated pulse.  I entered the ER and was admitted near 11AM.  Meclizine was administered, I was admitted to the hospital later that night.  I am a transplant recipient as of 2/19/2014.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Malaise, Metabolic function test, Syncope
Clinical narrative: Reaction happened ½ hour of flu shot on 9/25/2014. Shot was administered in the AM. Vital signs were taken when I felt symptoms, they were normal. Symptoms included disorientation, confusion, dizziness to the point of syncope, slurred speech, staggering, malaise and elevated pulse.  I entered the ER and was admitted near 11AM.  Meclizine was administered, I was admitted to the hospital later that night.  I am a transplant recipient as of 2/19/2014.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Electromyogram, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Pain at injection site initially and than overtime inability to abduct arm with continued severe pain in deltoid area.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site haemorrhage, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: PT SAID SHE HAD FEVER ON 9-29-2014 THEN IT INCREASED TO 100-102 DEGREES. INJECTION SITE HOT /HARD/BLOOD (SHE STATED BLOOD MAY HAVE BEEN THERE PREVIOUSLY) PT STATED CAN'T USE ARM.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash, not responding to antihistamines. Required oral prednisone.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash on right half of back.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash on right half of back.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Guest L. deltoid is extremely swollen and red from shoulder to elbow since receiveing both Fluzone hd and Pneumovax on same arm. Guest is concerned. Seems feels fine, but concerned since he has never reacted like this before.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient fainted, fell and hit her head. Was taken to ER for evaluation.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Abasia, Disorientation, Dysstasia, Fatigue, Hypoaesthesia
Clinical narrative: He was asleep when parents heard a bump in his room, found disoriented and complaining that his legs were numb, was not able to walk or stand.  Episode lasted about 20 minutes then resolved. He was noted to be febrile at that time, T max 102 over the next 24 hours, fatigue and sleepiness for following day.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Somnolence
Clinical narrative: He was asleep when parents heard a bump in his room, found disoriented and complaining that his legs were numb, was not able to walk or stand.  Episode lasted about 20 minutes then resolved. He was noted to be febrile at that time, T max 102 over the next 24 hours, fatigue and sleepiness for following day.
Sex: M
Vaccine: PPV
Symptoms: Splenectomy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, lot# and route of administration were not reported). On an unknown date the patient had his spleen removed after receiving PNEUMOVAX 23. The outcome of the event was unknown. Upon internal review the event of patient had his splenectomy was determined to be medically significant. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year old male patient, with no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 29-JAN-2014 at 3:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Patient was going to consult with physician. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 06-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. that may had been improperly stored since February2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be   confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported.  This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On 08-SEP-2014 unspecified number of patients were vaccinated with ROTATEQ, oral (dose, lot # not reported) that had been improperly stored. No adverse event symptoms were reported.  This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not give a consent for contact.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. The reporter referred to a 18-year-old female patient, who had no known drug allergies or illness at time of vaccination. The reporter informed that this patient was vaccinated with the second dose of GARDASIL (intramuscular injection batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 22-JAN-2014 at 4:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Patient was informed to revaccinate and parents were going to consult with physician. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: (R) thigh swelling, redness, tightness. Slight pain at site of injections. Mother gave 1 tsp BENADRYL and cool compress.
Age: 59.0
Sex: M
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: On 9/18/14 at 16:00, 59 year old arrived our clinic for immigration immunizations. Patient was inadvertently given Tdap instead of Td. Pt received Tdap vaccine on 04-30-14, so just needed Td at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling to left arm after MMRV.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Oedema
Clinical narrative: Joint pain. Weakness, tired. Fallin asleep. Edema (legs, arms, joints). Symptoms started 15 days after shot.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Pt was given vaccine around 2:44 pm without any problems. The pt awoke the following morning with his arm noted to be very red and swollen. Pt c/o pain when arm is moved. Area of redness about the size of a grapefruit.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash
Clinical narrative: Positive for rash on trunk of body following vaccines.
Age: 8.0
Sex: F
Vaccine: FLUN4, HEPA
Symptoms: Computerised tomogram, Grand mal convulsion
Clinical narrative: 30 second grand mal seizure and Hep A. No fever at 9/26/14. Flu mist 9/17/2014 - 9/26/14.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site rash, Pain, Pyrexia, Tinnitus
Clinical narrative: Patient come in day after receiving flu and pneumonia shot. Left arm covered with rash at injection sites. Pt. complained of dizziness, tinnitus, body aches. Pt. went to ER, had fever was given TYLENOL and felt better. Follow up next day pt. was doing ok.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Skin discolouration
Clinical narrative: 5 marks below shot (bl and blue ?). Took more than a week to heal. Hurt in the arm muscle.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: 9.5 x 10.5 cm local reaction to Tdap 2 days after administered to (L) deltoid. Rx BENADRYL, ice, Ibuprofen. Improved 10/2/14.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inflammation, Nausea, Nodule
Clinical narrative: Nausea and dizziness x 24 hours. Local inflammation x 72 hours. Local nodule x several days.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site scab
Clinical narrative: Patient reports itching at injection site which began 2 days prior to reporting. Patient reports no itching at time of administration or leading up to 9/30/14. Area appears red and slightly inflamed with small scab (pin sized) at injection site.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram, Grand mal convulsion
Clinical narrative: Pt had what sounded like an afebrile grand mal seizure at 9:30 AM lasting 30 sec. on the day after her 4 m shots.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient says right upper arm has been hurting for 2 weeks since getting the shot. It hurts especially at bedtime. She has been taking ibuprofen for the pain. Mobiliy has not been affected.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Patient states that she feels constant pressure in her head since receiving the vaccination. She does not have HBP. The symptom is still present.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema
Clinical narrative: Angioedema severe, BENADRYL/steroids/Epi at urgent care, no prior hx of reaction to vaccine.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Rash
Clinical narrative: Chills all nite, then rash on arm 1st nite. Shot area chills, whole day in bed next day. Muscle left red - surface redness, now gone.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Patient was complaining of pain in her arm and discomfort radiating to her breast and back.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling and warmth at injection site.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient had arm pain on date of vaccination then had arm numbness 2 days later.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on chest.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Rash, Urticaria
Clinical narrative: Patient broke out in hives/rash the day after receiving vaccine in areas of naval, arms, and buttocks. Rash/hives getting better. Although skin is still hypersensitive.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 29 -SEP-2014, patient was vaccinated expired dose of ZOSTAVAX (lot number: J006827 with expiry date of 14-SEP-2014 (dose unspecified), subcutaneously. Concomitant medications were not reported. No know adverse effects were reported. The outcome of the events was unknown. This causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from physician assistant refers to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant history was not reported. The reporter stated that improperly stored doses of PEDVAX HIB (lot number, dose and route unspecified) was administered to unspecified number of patients on unknown dates. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PEDVAX HIB was not reported. Product quality issue was not involved. 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 physician assistant refers to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that improperly stored doses of GARDASIL (dose and route unspecified) was administered to unspecified number of patients on unknown dates. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from physician assistant refers to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that improperly stored doses of RECOMBIVAX HB (lot number, dose and route unspecified) was administered to unspecified number of patients on unknown dates. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Product quality issue was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from physician assistant refers to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that improperly stored doses of MMR II (lot number, dose and route unspecified) was administered to unspecified number of patients of unknown dates. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II was not reported. Product quality issue was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-SEP-2014 (reported as "yesterday" of the reporting day) the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot# not reported, dose 0.5 ml, route reported as subcutaneous unspecified). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 36 year old female patient. Patient's concurrent conditions include hypothyroidism. Other relevant medical history was unknown. On 02-AUG-2014 the patient who was pregnant was vaccinated with MMR II (dose and route unspecified). Concomitant therapies included levothyroxine sodium (manufacturer unknown). Ultrasound carried on 22-AUG-2014, confirmed that the patient was pregnant with last menstrual period (LMP) calculated to be 21-JUN-2014 and estimated date of delivery (EDD) of 28-MAR-2015. Initial exposure to MMR II was at 6 week (s). The pregnancy outcome was outcome pending. No adverse events were reported. The patient sought medical attention at the facility of the physician. The outcome of the events was unknown. The causality of the events with MMR II was assessed to be not related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. The patient's medical history included lupus. On an unknown date the patient was vaccinated with ZOSTAVAX in the arm, route of administration reported as: injection (dose, units, lot number were not reported). On an unknown date, after receiving ZOSTAVAX the injection site was about 2 1/2 inches and it hurt for a week. The patient also reported that on an unknown date, after the injection, she noticed her shoulder was breaking out with a rash, like erythema, and also it appeared inside of arm at elbow. The patient visited her doctor and the physician told her it was not due to the ZOSTAVAX vaccine. The outcome of events was reported as not recovered. The patient's physician assessed that events were not related to the ZOSTAVAX vaccine. Additional information is not expected because there is not enough contact data to contact the patient or the physician.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Papilloma viral infection
Clinical narrative: This spontaneous report as received from a female nurse of unknown age refers to herself. Medical history and drug reactions or allergies were not specified. On an unknown date, reported as before her 26th birthday, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not specified. On an unknown date, after the vaccination, the patient had a biopsy of the cervix that was positive for human papilloma virus (HPV). The outcome of biopsy of the cervix that was positive for HPV was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected, because consent for contact was not obtained.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 61 year old female patient. On 19-SEP-2014 the patient was intramuscularly vaccinated with ZOSTAVAX (in the left arm, 0.65 ml, lot # K000727, expiration date: 30-JAN-2015) instead of subcutaneously. On 19-SEP-2014, reported as immediately afterward, another 0.65 ml dose of ZOSTAVAX (0.65 ml, lot # K000727, expiration date: 30-JAN-2015) was administered subcutaneously, in the same left arm, at a different site. No adverse effects reported at that time. 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 an unspecified number of patients of unknown age and gender. Unknown number of improperly stored GARDASIL (dose, route, lot # not reported) were administered to patients. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored ROTATEQ (dose, route, lot # not reported) were administered to patients. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.