chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Hyperhidrosis, Oropharyngeal pain, Productive cough, Pyrexia, Troponin increased
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, MNQ
Symptoms: Cough, Dry throat, Throat tightness
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (CMA) referring to a 17 year old male patient with coeliac disease and allergic rhinitis due to pollen. The patient had no known drug reactions or allergies. On 05-MAY-2016 the patient was vaccinated with the first dose of GARDASIL 9 (lot # M004116, exp date 12-OCT-2017), intramuscularly and the second dose of MENACTRA. Concomitant therapies included COLACE, PRILOSEC and MIRALAX. It reported that "within 5 minutes" after administration of both vaccines, while still in the physician's office, patient reported that his throat felt "dry and like it was closing up" and he developed a "repetitive dry cough". No treatment was given for the events. No lab diagnostic studies were performed. All symptoms resolved within 15 minutes on 05-MAY-2016. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest discomfort, Differential white blood cell count normal, Echocardiogram, Electrocardiogram normal
Clinical narrative: Substernal chest tightness that worsened with exertion and gradually improved over the week prior to presenting. On evaluation, Troponins were marginally elevated (0.06; laboratory threshold-0.012) but ECG, CXR and CBC were unremarkable. Repeat Troponin the same day trended down.  The patient was discharged home from the urgent care center. The patient was started on Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). Echocardiogram is pending.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Full blood count normal, Haematocrit normal, Haemoglobin normal, Troponin increased, White blood cell count normal
Clinical narrative: Substernal chest tightness that worsened with exertion and gradually improved over the week prior to presenting. On evaluation, Troponins were marginally elevated (0.06; laboratory threshold-0.012) but ECG, CXR and CBC were unremarkable. Repeat Troponin the same day trended down.  The patient was discharged home from the urgent care center. The patient was started on Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). Echocardiogram is pending.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest discomfort, Differential white blood cell count normal, Electrocardiogram abnormal, Full blood count normal
Clinical narrative: Substernal chest tightness that worsened with exertion and gradually improved over the week prior to presenting. On evaluation, Troponins were marginally elevated (0.06; laboratory threshold-0.012) but ECG, CXR and CBC were unremarkable. Repeat Troponin the same day trended down.  The patient was discharged home from the urgent care center. The patient was started on Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). Echocardiogram is pending.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Haematology test normal, Haemoglobin normal, Troponin I increased, White blood cell count normal
Clinical narrative: Substernal chest tightness that worsened with exertion and gradually improved over the week prior to presenting. On evaluation, Troponins were marginally elevated (0.06; laboratory threshold-0.012) but ECG, CXR and CBC were unremarkable. Repeat Troponin the same day trended down.  The patient was discharged home from the urgent care center. The patient was started on Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). Echocardiogram is pending.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Mobility decreased, Paraesthesia
Clinical narrative: Didn't feel right in the car on the way home - body tingling, felt like she couldn't keep her head straight, headache, stomach upset, couldn't move arm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Posture abnormal
Clinical narrative: Didn't feel right in the car on the way home - body tingling, felt like she couldn't keep her head straight, headache, stomach upset, couldn't move arm.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Activities of daily living impaired, Body temperature increased, Crying, Decreased appetite
Clinical narrative: 5/10/2016: 1:00PM  Inconsolable crying, thrashing on floor for 1 hour, complaints of right arm pain (injection site in deltoid) from shoulder to fingertips. Administered Ibuprofen and Thuja occidentalis (homeopathic remedy). Napped from 3-5pm. Poor appetite at dinner. 7:00PM  Inconsolable crying, thashing, kicking, biting until 8pm. Administered Tylenol, chamomilla (homeopathic remedy). 8pm-7am -Restless all night, crying out every 1-2 hours, inconsolable crying for 30 minutes at 1am. Administered Ibuprofen, chamomile at 1am. 5/11/2016: 8am- Temperature 100F, complaints of right arm pain, favoring arm, not using it but holding it close to the body. Administered Tylenol, Arnica Montana/thuja occidentalis/chamomilla (homeopathic remedies). Lethargic and restless all day. Napping frequently, refusing to play, wanting to rest on couch. Appetite poor, refusing to eat. 4-6pm- playing, spirits better. Ate small amount of dinner 7pm- crying, thrashing on floor, inconsolable. Administered Tylenol, Arnica Montana/thuja occidentalis/chamomilla (homeopathic remedies). 8pm- Bedtime, no issues. 5/12/2016: Woke in normal spirits, Administered Tylenol. Normal day.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Diet refusal, Injection site movement impairment, Injection site pain, Lethargy, Pain in extremity
Clinical narrative: 5/10/2016: 1:00PM  Inconsolable crying, thrashing on floor for 1 hour, complaints of right arm pain (injection site in deltoid) from shoulder to fingertips. Administered Ibuprofen and Thuja occidentalis (homeopathic remedy). Napped from 3-5pm. Poor appetite at dinner. 7:00PM  Inconsolable crying, thashing, kicking, biting until 8pm. Administered Tylenol, chamomilla (homeopathic remedy). 8pm-7am -Restless all night, crying out every 1-2 hours, inconsolable crying for 30 minutes at 1am. Administered Ibuprofen, chamomile at 1am. 5/11/2016: 8am- Temperature 100F, complaints of right arm pain, favoring arm, not using it but holding it close to the body. Administered Tylenol, Arnica Montana/thuja occidentalis/chamomilla (homeopathic remedies). Lethargic and restless all day. Napping frequently, refusing to play, wanting to rest on couch. Appetite poor, refusing to eat. 4-6pm- playing, spirits better. Ate small amount of dinner 7pm- crying, thrashing on floor, inconsolable. Administered Tylenol, Arnica Montana/thuja occidentalis/chamomilla (homeopathic remedies). 8pm- Bedtime, no issues. 5/12/2016: Woke in normal spirits, Administered Tylenol. Normal day.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Restlessness, Somnolence
Clinical narrative: 5/10/2016: 1:00PM  Inconsolable crying, thrashing on floor for 1 hour, complaints of right arm pain (injection site in deltoid) from shoulder to fingertips. Administered Ibuprofen and Thuja occidentalis (homeopathic remedy). Napped from 3-5pm. Poor appetite at dinner. 7:00PM  Inconsolable crying, thashing, kicking, biting until 8pm. Administered Tylenol, chamomilla (homeopathic remedy). 8pm-7am -Restless all night, crying out every 1-2 hours, inconsolable crying for 30 minutes at 1am. Administered Ibuprofen, chamomile at 1am. 5/11/2016: 8am- Temperature 100F, complaints of right arm pain, favoring arm, not using it but holding it close to the body. Administered Tylenol, Arnica Montana/thuja occidentalis/chamomilla (homeopathic remedies). Lethargic and restless all day. Napping frequently, refusing to play, wanting to rest on couch. Appetite poor, refusing to eat. 4-6pm- playing, spirits better. Ate small amount of dinner 7pm- crying, thrashing on floor, inconsolable. Administered Tylenol, Arnica Montana/thuja occidentalis/chamomilla (homeopathic remedies). 8pm- Bedtime, no issues. 5/12/2016: Woke in normal spirits, Administered Tylenol. Normal day.
Age: 1.03
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: Vomiting and nausea, fever (101 degrees F), lethargy - ongoing after 48 hours - treatment 3.75 mL infant TYLENOL every 4 hours, cool compresses, water/Pedialyte/frozen desserts.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Edema, redness, warmth and itching to right upper arm.  BENADRYL cream and ice to site.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Itching at injection site (back of upper arm).  Welt formed about 2" x 1".  Increased to 3"x 1" within 2 hours.  By 10 PM entire upper arm red, swollen, hot, itching.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Itching at injection site (back of upper arm).  Welt formed about 2" x 1".  Increased to 3"x 1" within 2 hours.  By 10 PM entire upper arm red, swollen, hot, itching.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Breast pain, Peripheral swelling, Swelling face, Tenderness
Clinical narrative: Right arm was very tender to the touch, swollen, and the pain radiated to the right breast.  Face was swollen under the eyes.
Age: 22.0
Sex: M
Vaccine: HPV9, TYP, YF
Symptoms: Skin papilloma
Clinical narrative: Patient stated that two warts developed. One on the top side of his right index finger on the middle/2nd knuckle and the other on top side of his left thumb between his knuckles. He said that the warts developed prior to his travel when he left on 12/28/2015.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Chest pain, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient received Rabies Vaccine. After receiving vaccine, Patient became pale, diaphoretic, and fainted. Approximately 3 seconds after fainting patient awakened. She c/o chest pain. 911 was called. EMT evaluated patient. Patent declined transport to ED.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness unilateral, Immunoglobulin therapy, Optic neuritis, Papilloedema, Pyrexia
Clinical narrative: After flu vaccine, patient developed a high fever for 48 hours, controlled with TYLENOL. Three weeks following the shot she complained of no vision in her right eye. Admitted to hospital. After being admitted to hospital on 1/29/16, patient stayed for 6 days on steroid treatment. She was discharged on oral steroids on a tapering dose of 25 mg. Patient was readmitted to hospital following a doctor's visit due to no significant changes in eyesight. She stayed in the hospital for 5 days for IVIG treatment. Patient to this day has 90% vision loss in her right eye due to the effects of the swollen optic nerve (optic neuritis).
Age: 31.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever/chills, body aches, H/A relieved with Motrin.  Symptoms returned when Motrin wore off.  Lasted 3 days.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, pain, swelling redness at injection site and down to elbow.  Received penicillin injection from Dr. Pain, redness, swelling continued to about 4 inches below elbow.  5/14/16 - symptoms started to improve through the day.  Continued improvement on 5/15.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Itching, pain, swelling redness at injection site and down to elbow.  Received penicillin injection from Dr. Pain, redness, swelling continued to about 4 inches below elbow.  5/14/16 - symptoms started to improve through the day.  Continued improvement on 5/15.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left arm. Left arm is where vaccine was given. Swelling is about the size of a tennis ball.
Age: 17.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Eye movement disorder, Feeling abnormal, Immediate post-injection reaction, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient got very pale and said "I don't feel good", immediately following vaccination with Meningococcal vaccine and Yellow Fever vaccine.  Her eyes then rolled back, and she got very stiff and made guttural throat noises, and postured with arms straight out, fisted hands.  She appeared to be having a seizure.  Her mom and I got her lowered from the chair to the floor, and observed her closely.  I assessed her, noting that she was breathing.  Seizure-like activity continued for about 20 seconds.  Then patient became conscious and was given oxygen administration by mask at 4L via oxygen tank, for a couple of minutes.  Then she sat up in chair, and drank some apple juice we gave her.  I called Clinic (where her PCP is) and spoke to Dr. He said that mom could take her to the urgent care in Clinic and see Dr., and they would get her added to his schedule.  We also advised mom that if patient had any further problems or similar behavior on the way there, to pull over and dial 911.  Mom agreed.  We observed the patient for several minutes before she left; she was alert, oriented, vital signs (breathing and pulse were normal, pink color), said she felt better.
Age: 17.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Posturing, Seizure like phenomena
Clinical narrative: Patient got very pale and said "I don't feel good", immediately following vaccination with Meningococcal vaccine and Yellow Fever vaccine.  Her eyes then rolled back, and she got very stiff and made guttural throat noises, and postured with arms straight out, fisted hands.  She appeared to be having a seizure.  Her mom and I got her lowered from the chair to the floor, and observed her closely.  I assessed her, noting that she was breathing.  Seizure-like activity continued for about 20 seconds.  Then patient became conscious and was given oxygen administration by mask at 4L via oxygen tank, for a couple of minutes.  Then she sat up in chair, and drank some apple juice we gave her.  I called Clinic (where her PCP is) and spoke to Dr. He said that mom could take her to the urgent care in Clinic and see Dr., and they would get her added to his schedule.  We also advised mom that if patient had any further problems or similar behavior on the way there, to pull over and dial 911.  Mom agreed.  We observed the patient for several minutes before she left; she was alert, oriented, vital signs (breathing and pulse were normal, pink color), said she felt better.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo, nausea.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: DEVELOPED RASH AROUND INJECTION SITE.
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red bumps around injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe Shingle type Pain in exact area Shingles had erupted 7 months prior lasting 10 days. TX. Pain meds and patches.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint swelling, Paraesthesia, Peripheral swelling
Clinical narrative: Right hand swollen, numbness and tingling in hand, over night it continued to progress to elbow and shoulder. The next day she had bilateral knee swelling.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Pt c/o burning sensation at injection site. Slightly swollen, looks like pimples or blisters under skin. Monitor for now, Tylenol and ice for pain/discomfort.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vomiting
Clinical narrative: About 1/2 hour after vaccine, mom reported Noah vomiting on drive home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Mom describes red rash and swelling at injection site approx 4 in wide.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode s/p vaccination. Fluids given, monitored for ~15m, VSS at d/c.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient reported that her arm began hurting the evening of vaccine administration.  It was red and itchy and warm.  She put ice on it. Then she put heat on it.  The redness began to spread and get worse so she went to the ER. The ER told her it was an allergic reaction and gave her IV steroids, antihistamine and PEPCID.  She was prescribed a course of BENADRYL, prednisone, and PEPCID at discharge.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Very red and swollen at site spread out as days progressed. Still red and painful after 4 days. Headache ... triggered a migraine . Area feels like a bad burn.
Age: 0.36
Sex: F
Vaccine: DTAPH, IPV, RVX
Symptoms: Diarrhoea
Clinical narrative: Excessive Diarrhea.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Patient had rash and redness at injection site 1 day after administration. 2 days later had rash in chest area. Patient went to ER on 5/14/16 was told to take BENADRYL.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Somnolence
Clinical narrative: Client fainted, lost consciousness for approximately 20 seconds. Was pale and diaphoretic. He had not eaten and was very nervous about receiving this or any shot. We wiped his forehead with a wet cloth, gave chocolate, water, and a lollipop. He was talking and moving. Reported he still felt dizzy. No nausea, no vomiting. Colored returned to face but still dizzy and sleepy. Sent client home with mother and siblings. Advised feed him, let him rest and not to leave him unattended. Advised that fainting is  common side-effect.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: Client fainted, lost consciousness for approximately 20 seconds. Was pale and diaphoretic. He had not eaten and was very nervous about receiving this or any shot. We wiped his forehead with a wet cloth, gave chocolate, water, and a lollipop. He was talking and moving. Reported he still felt dizzy. No nausea, no vomiting. Colored returned to face but still dizzy and sleepy. Sent client home with mother and siblings. Advised feed him, let him rest and not to leave him unattended. Advised that fainting is  common side-effect.
Age: 16.0
Sex: M
Vaccine: HPV4, MEN, TD
Symptoms: Eye movement disorder, Loss of consciousness, Pallor, Peripheral coldness
Clinical narrative: Eyes rolled back in his gead, turned white, cold and past out...lifted legs to get nlood flow and had to spend additional 1 1/2 hour before he felt somewhat okay.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Balance disorder, Dizziness, Fall, Feeling abnormal
Clinical narrative: I received the GARDASIL vaccine and Passed out.  I passed out about 2 times after that. the dr. office called 911 and went to the ER and they found nothing wrong.  Said it was a Vasovagal reaction.  I went home.  Had a headache, felt nauseous and dizzy since.  Friday night I fell down the stairs because my balance is not right.  I went back to my dr on Saturday.  He said I was fine and that it was maybe because I hit my head but he said it was not a concussion.  My head still hurts and I am still not feeling right.  I am nauseous and dizzy.  I feel very weak and have a headache since receiving this vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Full blood count normal, Head injury, Headache, Loss of consciousness, Metabolic function test normal
Clinical narrative: I received the GARDASIL vaccine and Passed out.  I passed out about 2 times after that. the dr. office called 911 and went to the ER and they found nothing wrong.  Said it was a Vasovagal reaction.  I went home.  Had a headache, felt nauseous and dizzy since.  Friday night I fell down the stairs because my balance is not right.  I went back to my dr on Saturday.  He said I was fine and that it was maybe because I hit my head but he said it was not a concussion.  My head still hurts and I am still not feeling right.  I am nauseous and dizzy.  I feel very weak and have a headache since receiving this vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Presyncope, Thyroid function test normal
Clinical narrative: I received the GARDASIL vaccine and Passed out.  I passed out about 2 times after that. the dr. office called 911 and went to the ER and they found nothing wrong.  Said it was a Vasovagal reaction.  I went home.  Had a headache, felt nauseous and dizzy since.  Friday night I fell down the stairs because my balance is not right.  I went back to my dr on Saturday.  He said I was fine and that it was maybe because I hit my head but he said it was not a concussion.  My head still hurts and I am still not feeling right.  I am nauseous and dizzy.  I feel very weak and have a headache since receiving this vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eyelid pain, Herpes zoster, Ocular hyperaemia, Pain
Clinical narrative: Redness and rash appeared on my forehead above the right temple 3 days after the (05/05/2016) shingles immunization; each day the rash developed slowly in size, slight bubbling, and very slight swelling; after 9 days, my right eye became very red, bloodshot, and a small bubble appeared on each of my eyelids; no itching was associated with the rash; on day 9, I also began infrequently to experience sharp pains shooting down the rash and into my eyelids; I treated the rash with bag balm for four days, but switched to Calamine lotion on day 10. It had a very effective drying impact on the skin and stopped the little weeping I was getting from slight pocks in my skin. Today I saw a physician and ophthalmologist who prescribed Prednisolone drops 2x/day for my right eye and Acyclovir 800 mg tablets 5x/day for shingles.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular, Secretion discharge, Swelling
Clinical narrative: Redness and rash appeared on my forehead above the right temple 3 days after the (05/05/2016) shingles immunization; each day the rash developed slowly in size, slight bubbling, and very slight swelling; after 9 days, my right eye became very red, bloodshot, and a small bubble appeared on each of my eyelids; no itching was associated with the rash; on day 9, I also began infrequently to experience sharp pains shooting down the rash and into my eyelids; I treated the rash with bag balm for four days, but switched to Calamine lotion on day 10. It had a very effective drying impact on the skin and stopped the little weeping I was getting from slight pocks in my skin. Today I saw a physician and ophthalmologist who prescribed Prednisolone drops 2x/day for my right eye and Acyclovir 800 mg tablets 5x/day for shingles.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Ophthalmic herpes zoster, Rash, Skin lesion
Clinical narrative: Redness and rash appeared on my forehead above the right temple 3 days after the (05/05/2016) shingles immunization; each day the rash developed slowly in size, slight bubbling, and very slight swelling; after 9 days, my right eye became very red, bloodshot, and a small bubble appeared on each of my eyelids; no itching was associated with the rash; on day 9, I also began infrequently to experience sharp pains shooting down the rash and into my eyelids; I treated the rash with bag balm for four days, but switched to Calamine lotion on day 10. It had a very effective drying impact on the skin and stopped the little weeping I was getting from slight pocks in my skin. Today I saw a physician and ophthalmologist who prescribed Prednisolone drops 2x/day for my right eye and Acyclovir 800 mg tablets 5x/day for shingles.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vitreous floaters
Clinical narrative: Redness and rash appeared on my forehead above the right temple 3 days after the (05/05/2016) shingles immunization; each day the rash developed slowly in size, slight bubbling, and very slight swelling; after 9 days, my right eye became very red, bloodshot, and a small bubble appeared on each of my eyelids; no itching was associated with the rash; on day 9, I also began infrequently to experience sharp pains shooting down the rash and into my eyelids; I treated the rash with bag balm for four days, but switched to Calamine lotion on day 10. It had a very effective drying impact on the skin and stopped the little weeping I was getting from slight pocks in my skin. Today I saw a physician and ophthalmologist who prescribed Prednisolone drops 2x/day for my right eye and Acyclovir 800 mg tablets 5x/day for shingles.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect product storage
Clinical narrative: Patient was not told to keep the medication in the refrigerator. Will need to revaccinate according to the manufacturer.
Age: 11.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect product storage
Clinical narrative: Patient was not told to keep the medication in the refrigerator. Will need to revaccinate according to the manufacturer.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site pain, Pain, Peripheral swelling
Clinical narrative: SWELLING ON ARM, SEVERE PAIN, AND DISCOMFORT.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray, Chest discomfort
Clinical narrative: Tightness if chest upon waking the next morning.
Age: 12.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea & vomiting for a week at a time. Stopped for several weeks then another full week of nausea & vomiting.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Electroencephalogram, Enema administration, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: Nausea & vomiting for several days then went away.  Came back about a month later then vomiting for a week. A week later it was back for a week. Gone for two weeks, back for a week.  January 6, 2016, it returned 24/7.  Vomiting 50-60 times/day.  Worst was 90.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting, X-ray with contrast, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Nausea & vomiting for several days then went away.  Came back about a month later then vomiting for a week. A week later it was back for a week. Gone for two weeks, back for a week.  January 6, 2016, it returned 24/7.  Vomiting 50-60 times/day.  Worst was 90.
Age: 17.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Patient developed fever on 5/13 after starting typ. pills, hep. A, yellow fever on 5/11. Fever over wknd 102.6 5/14. 5/15 100.6 and sore throat.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dizziness
Clinical narrative: Dizziness - chest pain.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Localized pain and redness (L) shoulder, fatigue. (L) bicep pain. TX: topical steroids, ice.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Erythema, Mobility decreased, Pain in extremity, Pruritus generalised
Clinical narrative: Localized pain and redness (L) shoulder, fatigue. (L) bicep pain. TX: topical steroids, ice.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash, Skin warm, Tenderness, Urticaria
Clinical narrative: Localized pain and redness (L) shoulder, fatigue. (L) bicep pain. TX: topical steroids, ice.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Immediate post-injection reaction, Injection site pain, Injection site swelling, White blood cell count
Clinical narrative: Patient reports she had pain at site immediately, but over the next 9 hours, the swelling and circumference grew to larger than the size of a quarter and height of 3 stacked quarters. She took APAP 325 mg and ice compression for relief. On 5-6, still some pain to the touch, but feels recovered.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Abasia, Activities of daily living impaired, Dysstasia, Feeding disorder, Loss of consciousness
Clinical narrative: Unable to walk, stand, eat by mouth, unable to use bathroom, seizures, passing out becoming unresponsive. My daughter has been in the hospital since Feb. 2015.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Seizure, Unresponsive to stimuli, X-ray
Clinical narrative: Unable to walk, stand, eat by mouth, unable to use bathroom, seizures, passing out becoming unresponsive. My daughter has been in the hospital since Feb. 2015.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Chills, Dizziness, Myalgia
Clinical narrative: Within 24 hours: I woke up with chills, extreme dizziness. One to two weeks: Muscle aches in arms and legs (Body felt as it were on fire).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Cough, Pain in extremity, Pyrexia
Clinical narrative: C/o of upset stomach, arms hurt, chills, cough, fever 100.8.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt has shots on Thursday; on Sun had pain and swelling of lt thigh; Monday came to office, noted to have mild swelling lt thigh, anteriorly. Advised MOTRIN, also went to urgent care.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX in her upper right arm on 5/12/16. On 5/13/16 she developed a rash, itchiness and swelling around injection site. She was evaluated in office on 5/16/16 and was told to use over-the-counter ZYRTEC. Symptoms were improving as of 5/16/16.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient came in stating that arm was severely hurting (couldn't lift or move). I explained to use warm compresses/TYLENOL/keep moving and that this was common with PREVNAR. Also called Doctor, which she went to see. They instructed her the same course of treatment according to patient. Still not satisfied with treatment, still hurts.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Had vaccine Wed. evening. Woke Thursday with headache and throbbing arm.  Went to hospital. Took BENADRYL and APAP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Friday (13th), patient asked my opinion on bumps (hive like) on ankles and legs. Sat, (14th) She came back in and the hives were more widespread and closer together. Advised her to seek medical treatment.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles at T4 distribution the next day.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Cough, Dyskinesia, Febrile convulsion, Pyrexia, Tremor
Clinical narrative: Given immun at WCC 5/5/16 at 1:15 pm. Called after hours at 10 pm on 5-5-16 reporting fever, advised to give TYLENOL 80 mg q 4-6 hours prn. Mom reported her waking up in night coughing. Head, arms and legs shaking, mouth clenched. To ER via ambulance dx with febrile seizure.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: "Swelling and soreness" 2 months after flu shot was given per pt. MD exam = No swelling (L) arm; Diffuse tenderness over radial nerve; similar tender opposite arm (left arm).
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic shock
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient's concurrent conditions included egg yolk allergy and drug reaction included unspecified flu shot. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot number and route were unknown).  Concomitant medications were not reported. On an unknown date in January 2016, the patient experienced anaphylactic shock and was hospitalized for an unspecified amount of time. The patient sought the medical attention by communicating with her physician. The outcome of anaphylactic shock was unknown. Causality assessment was not provided. No product quality complaint was reported. The reporter considered the anaphylactic shock to serious due to hospitalization. Upon internal review, the event "anaphylactic shock" was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cough, Pneumonia
Clinical narrative: This spontaneous report was received from a consumer and refers to 2 patients in their 60's (gender was unspecified). No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). It was also reported that the reporter was not certain if it was PNEUMOVAX 23 or another pneumococcal vaccine. On unknown dates, both patients developed pneumonia and both had cough. It was unspecified if the patients received the treatment or had lab diagnostic studies performed. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information is not expected as no contact details were provided.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report was received from a consumer, as part of a marketing research study referring to a 18 month old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with MMR (manufacturer unknown) (lot number, dose, route and anatomical location unspecified) and the patient experienced autism (onset date reported as 21 years ago) following vaccination. At the time of the report, the patient had not recovered from autism. The causality between autism and MMR (manufacturer unknown) was unknown. The primary reporter considered autism to be an other important medical event and immediately Life threatening (reported as severe). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a female child of unknown age. The nurse practitioner had received a text message from a friend who informed about another friend's child. The patient's medical history, concurrent condition and concomitant medications were all unspecified. On unspecified date, the patient was vaccinated with GARDASIL (dose and lot number not reported) intramuscularly. The nurse practitioner stated the patient was otherwise healthy until she received the injection, but following vaccination with GARDASIL, the child began to experience multiple seizures (date unspecified), lasting up to 45 minutes. The patient sought medical attention - went to emergency room (date unspecified). The outcome of the event was unknown at the time of report. Causality assessment was not provided. No further information was provided. Upon internal review, the event seizure was determined to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 79 year old female patient. Patient's pertinent medical conditions were not provided. Patient's previous experienced diarrhea with use of amoxicillin and itchiness due to BIAXIN and DEMEROL. On 09-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 in her left arm, lot # M005287, expiration date 08-OCT-2017 (strength, dose, dose number and route was unknown). Concomitant therapies included diclofenac 50 twice daily, estradiol (manufacturer unknown) 1 mg, FLONASE and metoprolol 25 mg daily. On 11-MAY-2016, patient sought medical attention-she visited the office since she developed a red rash that was hot and swollen which was not just around the injection site but down around her elbow as well. Patient also experienced achiness and joint pain in her left arm. No fever was present. The patient was diagnosed with cellulitis (medically significant). Prior to returning to the physician's office on 11-MAY-2016, the patient self-administered BENADRYL (unspecified dose/ frequency) for treatment (hence onset date of cellulitis was approximately to May 2016). Patient was prescribed a MEDROL dose pack 4mg (unspecified frequency) and cephalexin 5mg three times daily for an unspecified number of days, as further treatment. The PNEUMOVAX 23 vaccine was administered by a new employee at the facility and "that may have played a role in the reason for the reactions". The outcome of the adverse event was unknown. Causality assessment was not provided. The reporter requested for a lot check for PNEUMOVAX 23 with lot # M005287, expiration date 08-OCT-2017. No product quality complaint (PQC) was reported. No further information was provided. Upon internal review, the event "cellulitis" was considered to be medically significant. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 79 year old female patient. Patient's pertinent medical conditions were not provided. Patient's previous experienced diarrhea with use of amoxicillin and itchiness due to BIAXIN and DEMEROL. On 09-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 in her left arm, lot # M005287, expiration date 08-OCT-2017 (strength, dose, dose number and route was unknown). Concomitant therapies included diclofenac 50 twice daily, estradiol (manufacturer unknown) 1 mg, FLONASE and metoprolol 25 mg daily. On 11-MAY-2016, patient sought medical attention-she visited the office since she developed a red rash that was hot and swollen which was not just around the injection site but down around her elbow as well. Patient also experienced achiness and joint pain in her left arm. No fever was present. The patient was diagnosed with cellulitis (medically significant). Prior to returning to the physician's office on 11-MAY-2016, the patient self-administered BENADRYL (unspecified dose/ frequency) for treatment (hence onset date of cellulitis was approximately to May 2016). Patient was prescribed a MEDROL dose pack 4mg (unspecified frequency) and cephalexin 5mg three times daily for an unspecified number of days, as further treatment. The PNEUMOVAX 23 vaccine was administered by a new employee at the facility and "that may have played a role in the reason for the reactions". The outcome of the adverse event was unknown. Causality assessment was not provided. The reporter requested for a lot check for PNEUMOVAX 23 with lot # M005287, expiration date 08-OCT-2017. No product quality complaint (PQC) was reported. No further information was provided. Upon internal review, the event "cellulitis" was considered to be medically significant. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: FLUX, MMR, TD
Symptoms: Condition aggravated, Pneumonia, Sickle cell anaemia
Clinical narrative: This spontaneous report as received from Nurse practitioner refers to currently 25 year old male patient. The patient experienced measles when he was at 6 years old, approximately in 1997, without any prior immunization. The patient's drug reactions and allergies were not reported. The patient was moved to another country at unspecified time. On November 2010 the patient was vaccinated with M-M-R II (strength, dose, route and lot number were not reported). It was reported that, the reporting nurse could not confirm if patient received PROQUAD (Merck) or MMR vaccine and the varicella vaccine (MMR plus VARIVAX) so the product listed was M-M-R II. The nurse reported that the patient received unspecified flu, tetanus, diphtheria vaccine concomitantly. On an unknown date in December 2010, the patient was hospitalized with relapse of sickle cell and pneumonia. The nurse stated that the patient received unspecified pneumonia vaccine while hospitalized. It was reported that no immunologic tests have been performed on patient but that might happen in the future. The reporter considered the events to be serious due to hospitalization. The nurse stated that, the patient is currently 25 years old "doing great" (recovering). The causality assessment was not provided. No product quality complaint was reported. Upon internal review the event "pneumonia" was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician via agency refers to unspecified number of male patients out of 30 patients, aged between 11 to 22 years old, who were enrolled the program. The patients had no relevant medical history. On unknown dates the patients were vaccinated with GARDASIL 9 (dose, route and lot # not reported). There was no concomitant medication. The patients complained of burning at injection site (onset dates unspecified). No tests were carried out for diagnosis. The administration of the second and third dose was not prevented. The outcome of the event was reported as recovering. The physician considered the event to be related to GARDASIL 9. This is one of the two reports from the same reporter. Additional information is not expected because the physician was not willing to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 09-MAY-2016 the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX23  (lot # K016294, expiration date: 28-APR-2016) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Migraine, Tachycardia
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old female patient who had allergic reaction to vaccine. Information about pertinent medical history and concomitant medication was unspecified. On 09-OCT-2014 and 09-DEC-2014 the patient was vaccinated with the first and second dose of GARDASIL (intramuscular, dose, dose# and lot# unknown) as recommended vaccine, respectively. On 12-DEC-2014 the patient was taken to the emergency room (ER) at hospital due to migraines and dizziness. The patient was experiencing tachycardia as well. Extensive workup was performed with no result provided. The vaccine was discontinued. The outcome of the events was not recovered. The vaccine was not reintroduced. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Migraine, Neuralgia, Tachycardia, Visual impairment
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old female patient who had allergic reaction to vaccine. Information about pertinent medical history and concomitant medication was unspecified. On 09-OCT-2014 and 09-DEC-2014 the patient was vaccinated with the first and second dose of GARDASIL (intramuscular, dose, dose# and lot# unknown) as recommended vaccine, respectively. On 12-DEC-2014 the patient was taken to the emergency room (ER) at hospital due to migraines and dizziness. The patient was experiencing tachycardia as well. Extensive workup was performed with no result provided. The vaccine was discontinued. The outcome of the events was not recovered. The vaccine was not reintroduced. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 19-FEB-2016, the patient received improperly stored VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported.  Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored RECOMBIVAX HB lot # L016959, expiration date 12-MAR-2018 and lot # L038499, expiration date 26-JUN-2017 dose and route were not provided. It was exposed to temperature of 47.7F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.