chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 31-AUG-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# reported as M056221, expiration date: 15-OCT-2017; lot# reported as M032358, expiration date: 05-JUL-2018; lot# M027347, expiration date: 01-JUN-2018 and lot# M023384, expiration date: 11-MAY-2018). No adverse effects were reported. Temperature excursion details: Temperature: >-10*C but <8*C Time frame: 190.5 hours Previous temperature excursion? No Digital data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007291:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 10-JAN-2017, the patient was inadvertently vaccinated with an expired dose of PROQUAD injection, subcutaneously, lot # L024122 with expiry date 30-DEC-2016 (exact dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# L046508, expiration date: 17-MAY-2017; lot# M033209, expiration date: 09-JAN-2018 and lot# M031941, expiration date: 27-DEC-2017). No adverse effects were reported. Temperature excursion details: Temperature: >-10 degree C but <8 degree C Time frame: 190.5 hours Previous temperature excursion? No Digital data logger was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002359.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself. A 67-year-old female patient received PREVNAR 13 (Lot # R12280) via an unspecified route of administration at 0.5ml, single on 29Dec2016 for pneumonia. Medical history included ongoing blood pressure abnormal, ongoing blood cholesterol abnormal. Concomitant medication included lisinopril (20 mg, 2x/day for blood pressure, fenofibrate 145 mg, 1x/day for Cholesterol, both ongoing. On 29Dec2016 the area that patient got shot in started to bruise about two inches around and then further out, it became blazing hot and it was at least 6 inches around that came to be really hot and swollen. It lasted a week and finally went to the doctor. On 29Dec2016 the patient also experienced little patch, where it has swollen and turned red, the colour was not returned to normal. When she was in so much pain, she could not sleep I took couple of TYLENOL. The doctor prescribed a cream, Triamcinolone for the itching when the swelling had come down and the pain had started to go away. The patient stated she recovered completely, the only thing that showing on arm write was a red patch where it has swollen and turn red and the colour has not returned to the normal.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself. A 67-year-old female patient received PREVNAR 13 (Lot # R12280) via an unspecified route of administration at 0.5ml, single on 29Dec2016 for pneumonia. Medical history included ongoing blood pressure abnormal, ongoing blood cholesterol abnormal. Concomitant medication included lisinopril (20 mg, 2x/day for blood pressure, fenofibrate 145 mg, 1x/day for Cholesterol, both ongoing. On 29Dec2016 the area that patient got shot in started to bruise about two inches around and then further out, it became blazing hot and it was at least 6 inches around that came to be really hot and swollen. It lasted a week and finally went to the doctor. On 29Dec2016 the patient also experienced little patch, where it has swollen and turned red, the colour was not returned to normal. When she was in so much pain, she could not sleep I took couple of TYLENOL. The doctor prescribed a cream, Triamcinolone for the itching when the swelling had come down and the pain had started to go away. The patient stated she recovered completely, the only thing that showing on arm write was a red patch where it has swollen and turn red and the colour has not returned to the normal.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A female patient of an unspecified age received first dose of PREVNAR 13 on Nov2016 in arm, at 0.5 ml single for immunisation and first dose of  PNEUMOVAX on Jan2017 in arm at 1 DF, single for immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced pretty severe reactions in the same arm when received the second injection: her arm was extremely swollen and so painful that she cannot lift it. She has been all day in bed. Final outcome of the events was unknown. Causality not be probed. No follow-up attempts are possible. No further information expected.
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: "She said on 12/30/16-she started having pain, in right arm, then she started having swelling, redness, and burning pain, after that, and swelling, pain, and redness got worse."
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Injection site cellulitis, Injection site infection, Pain, Pain in extremity
Clinical narrative: "She said on 12/30/16-she started having pain, in right arm, then she started having swelling, redness, and burning pain, after that, and swelling, pain, and redness got worse."
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Swelling
Clinical narrative: "She said on 12/30/16-she started having pain, in right arm, then she started having swelling, redness, and burning pain, after that, and swelling, pain, and redness got worse."
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: 12/30 started having pain, in right arm, then she started having swelling, redness, and burning pain, after that, and swelling, pain, and redness got worse. 1.13.17 seen by surgeon Excerpt from note - patient comes to the office today because she developed an infection at the site of a tetanus toxoid injection in her right arm. She received injection in the December, and it is still troubling her quite a bit. She has been placed on doxycycline. She is using hot packs. In the right deltoid area, the patient has an area of cellulitis measuring about 3 cm x 1.5 cm. However, there is no evidence of fluctuation to suggest an abscess, at this time. Therefore, at this time, surgical intervention such as an I&D will not help. I have told her to continue with the doxycycline, and warm moist heat. [I have told her not to use hot packs].
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Injection site cellulitis, Injection site infection, Pain, Pain in extremity
Clinical narrative: 12/30 started having pain, in right arm, then she started having swelling, redness, and burning pain, after that, and swelling, pain, and redness got worse. 1.13.17 seen by surgeon Excerpt from note - patient comes to the office today because she developed an infection at the site of a tetanus toxoid injection in her right arm. She received injection in the December, and it is still troubling her quite a bit. She has been placed on doxycycline. She is using hot packs. In the right deltoid area, the patient has an area of cellulitis measuring about 3 cm x 1.5 cm. However, there is no evidence of fluctuation to suggest an abscess, at this time. Therefore, at this time, surgical intervention such as an I&D will not help. I have told her to continue with the doxycycline, and warm moist heat. [I have told her not to use hot packs].
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Swelling
Clinical narrative: 12/30 started having pain, in right arm, then she started having swelling, redness, and burning pain, after that, and swelling, pain, and redness got worse. 1.13.17 seen by surgeon Excerpt from note - patient comes to the office today because she developed an infection at the site of a tetanus toxoid injection in her right arm. She received injection in the December, and it is still troubling her quite a bit. She has been placed on doxycycline. She is using hot packs. In the right deltoid area, the patient has an area of cellulitis measuring about 3 cm x 1.5 cm. However, there is no evidence of fluctuation to suggest an abscess, at this time. Therefore, at this time, surgical intervention such as an I&D will not help. I have told her to continue with the doxycycline, and warm moist heat. [I have told her not to use hot packs].
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Bursitis, Immediate post-injection reaction, Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: Immediate site reaction large red bands, soreness progressed to pain on movement, touch, limited range of motion progressed to frozen shoulder, bursitis, adhesive capsulitis.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Osteoarthritis, Pain, Periarthritis, X-ray
Clinical narrative: Immediate site reaction large red bands, soreness progressed to pain on movement, touch, limited range of motion progressed to frozen shoulder, bursitis, adhesive capsulitis.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Lymphadenopathy, Mouth breathing, Snoring, Tonsillar hypertrophy
Clinical narrative: Noticed an enlarged, moveable(size of dime, 2cm?) lymph node on daughter's left side of neck with enlarged tonsils and possible adenoids.  Known side effect of mumps portion of MMR is enlarged lymph nodes (duration of this side effect is not listed). She is breathing heavy at night with mouth open breathing/snoring due to her enlarged tonsils.
Age: 7.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Blood test, Injection site erythema, Pyrexia, Ultrasound scan normal, Vaccination site swelling
Clinical narrative: Patient started with fever of 104.6, redness and swelling of left upper arm where vaccines were given. Patient given both TYLENOL and ibuprofen to help with fever. Patient went to the ER and received an ultrasound, which was normal. He followed up in clinic on 1/11/17 and his arm was continuing to swell and redness was spreading down his arm. He was then admitted to the hospital to rule out cellulitis.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to unknown number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On unknown dates, the patients were inadvertently administered ROTATEQ oral liquid (lot number M035452, expiration date 04-APR-2018, dose was not reported) that had been improperly stored. No adverse effects were reported. The vaccine experienced a temperature excursion of 47 Fahrenheit degrees (F) for 5 minutes, which was detected by a digital data logger. There was no previous temperature excursion. Lot number M035452 has been verified to be a valid lot number for ROTATEQ. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1701USA002059: US-009507513-1701USA002060: US-009507513-1701USA002061.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date in September 2014, the patient was vaccinated with a first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided). Then, on an unspecified date in September 2015, the patient received the second dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not provided). No adverse effect was reported. The outcome of the event and the causality assessment between the event and both the suspect vaccines were not reported. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 226-day-old (32 weeks and 2 days) patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the third dose of ROTATEQ (lot # M026491, expiration date: 28-FEB-2018) (dose was not reported), orally. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 08-SEP-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M015695 with expiration date 26-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 08-SEP-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M015695 with expiration date 26-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 07-SEP-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M015695 with expiration date 26-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 06-SEP-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M015695 with expiration date 26-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 02-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 9.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 02-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer concerning a 19 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, reported as at the age of 18 years old, the patient was vaccinated with the first dose of GARDASIL 9 as prophylaxis. One year later on an unknown date, at 19 years old, the patient received the second dose of GARDASIL 9 as prophylaxis. (Strength, dose, lot numbers, expiration dates and route of administration were not reported). No adverse effect was reported. Additional information is not expected because contact details were not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a technician and refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 29-JUL-2016, the patient was vaccinated with her first dose of GARDASIL 9, lot # M007764 with expiry date 30-JAN-2018 (dose and route of administration were not reported). Subsequently, the patient received the second dose of GARDASIL 9 on 06-JAN-2017, lot # M007764 with expiry date 30-JAN-2018 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to 2 patients of unknown age and gender. On 10-JAN-2017, the patients were vaccinated with expired doses of M-M-R II (lot # L000458, expiration date: 06-JAN-2017). There were no temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (concentration, dose, dose number, route, anatomical place of vaccination and frequency were not provided) which had a lot # M027879 and an expiration date of 24-JAN-2018, for prophylaxis. Which were exposed to a temperature range between 32F and 36F for a time frame of 2 hours, without a temperature excursion. The report did not involve a data logger and no adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not provide consent for further contact.
Age: 18.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Abdominal discomfort, Chest pain, Headache, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 18-year-old male patient received on 12Jan2017 TRUMENBA at 0.5 ml single dose and human papilloma vaccine (HPV) at 1 DF single, both for immunization. Medical history and concomitant medications were not reported. On 13Jan2017, the patient experienced fever, chest was hurting, headache, not feeling good at all and stomach did not feel good. Outcome was not recovered.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for her daughter. A female patient of unspecified age and ethnicity/race received 3rd dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced little red patch below the injection site; patch was bigger than the size of hand, it spread and was red warm and itchy all on an unspecified date with outcome of unknown. The reporter stated that below the injection site the patient had kind of size of a small orange like a little red patch but since then it spread and was really big itchy and bigger than hand. The reporter called the patient's pediatrician and dermatologist, the dermatologist put her on antibiotic. No follow-up attempts needed. No further information expected.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Headache, Hypoaesthesia, Migraine, Paraesthesia
Clinical narrative: Dizziness HA since Vacc #1 Migraine after Vacc #2 Now arms are tingling/numbness occasionally left arm numb.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Asthma, Condition aggravated, Pruritus, Rash, Rash pruritic
Clinical narrative: Slight swelling in the night 12/31/2016, itching and rash noted 1/1/17. 1/1/17 and 1/2/17 itchy, rash increasing on neck. No voice. Tuesday 1/3-went to pulmonologist increasing symptoms, asthma attack needing dose of epinephrine and IV BENADRYL.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: Slight swelling in the night 12/31/2016, itching and rash noted 1/1/17. 1/1/17 and 1/2/17 itchy, rash increasing on neck. No voice. Tuesday 1/3-went to pulmonologist increasing symptoms, asthma attack needing dose of epinephrine and IV BENADRYL.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Severe shoulder pain, have been to the doctor 4 times. Been prescribed to Prednisone, Tramadol, MOBIC, given a steroid shot and now ordering MRI.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Pain, Peripheral swelling, Rash
Clinical narrative: RASH, SWOLLEN ARM...UP TO TWICE THE NORMAL SIZE, 102.8 DEGREES TEMPERATURE, THUMPING PAIN.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Pain in extremity
Clinical narrative: Patient complained of her arm hurting, so we applied an ice pack on 1/13/17.  Swelling was significant, but not worrisome. On 1/14/17 at 6pm, we noticed a large raised red patch (rash like) around the injection site.  The patch was about as large as a square post-it note.  there were three small red patches to the left of the large patch  each the size of a quarter.  We drew circles around the patches to see if they grew larger. She didn't have a fever, so we iced the area and had her move her arm regularly.  Within 12 hours, all the red patches were gone and there was only a small lump at the injection site.  This was her 3rd dose of the HPV vaccine.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain in extremity, Swelling
Clinical narrative: Patient complained of her arm hurting, so we applied an ice pack on 1/13/17.  Swelling was significant, but not worrisome. On 1/14/17 at 6pm, we noticed a large raised red patch (rash like) around the injection site.  The patch was about as large as a square post-it note.  there were three small red patches to the left of the large patch  each the size of a quarter.  We drew circles around the patches to see if they grew larger. She didn't have a fever, so we iced the area and had her move her arm regularly.  Within 12 hours, all the red patches were gone and there was only a small lump at the injection site.  This was her 3rd dose of the HPV vaccine.
Age: 2.0
Sex: M
Vaccine: HPVX
Symptoms: Pain, Pyrexia
Clinical narrative: Pt woke up this AM with 101 temp and feeling "sore all over her body". No redness and no swelling noted to the site of injection. Mom gave some Acetaminophen and the fever came down by 9 AM.
Age: 19.0
Sex: F
Vaccine: MMRV
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient broke out in rash and had difficulty breathing.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: Patient had itchy rash on back but very little around vac. site. Patient is going to see md abotu treatment.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Redness and warmth over site of injection and pain.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom states child's left arm became red with swelling. The child complained of pain at injection site. 1/1/17 seen in the ER, was given liq prednisone. Swelling improved by AM of 1/2/17.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: 1/17/17 pt returned to our office complaining of sore left arm above elbow.  Left arm, mid area between elbow and shoulder,  with redness noted, a little warm to touch.pt states that arm had been unusually sore, but soreness did not start, nor did redness, until at least 2-3 days post injection.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV9, FLU3, HPV9
Symptoms: Erythema, Local reaction, Mass, Purulent discharge, Scab
Clinical narrative: Patient received the HPV vaccine in the right deltoid on 11/09/2016. Two days later she returned and had a lump and slight redness of the skin which was felt to be a local reaction and did not require treatment.  Patient returned on 01/09/2017 and reported the mass had drained pus over 1 week ago and now is scabbed over. Family did not seek medical attention at the time the mass was draining.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: Patient began having intermittent twitching of eyelids and shoulders, about 6 times on 1/16. Admitted to hospital for observation.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Arthralgia, Back pain, Chest X-ray, Chills, Drug screen
Clinical narrative: Extreme hypersensitivity to cold and hot temperatures. Difficulty breathing, shakiness, migraine headaches. Nausea, more frequent urination, extreme joint pain and back pain, chills and fever, and vasovagal syncope=extreme fainting.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Dyspnoea, Electrocardiogram, Full blood count, Migraine, Nausea
Clinical narrative: Extreme hypersensitivity to cold and hot temperatures. Difficulty breathing, shakiness, migraine headaches. Nausea, more frequent urination, extreme joint pain and back pain, chills and fever, and vasovagal syncope=extreme fainting.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Pollakiuria, Pyrexia, Syncope, Temperature intolerance, Tremor
Clinical narrative: Extreme hypersensitivity to cold and hot temperatures. Difficulty breathing, shakiness, migraine headaches. Nausea, more frequent urination, extreme joint pain and back pain, chills and fever, and vasovagal syncope=extreme fainting.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Urine analysis
Clinical narrative: Extreme hypersensitivity to cold and hot temperatures. Difficulty breathing, shakiness, migraine headaches. Nausea, more frequent urination, extreme joint pain and back pain, chills and fever, and vasovagal syncope=extreme fainting.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Pain left arm injection site numbness, tingle, burning in left arm can not lift arm above shoulder may need to seek more medical treatment.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Eye movement disorder, Loss of consciousness, Malaise, Musculoskeletal stiffness, Posture abnormal
Clinical narrative: Patient received flu inj. with no problems. Approximately 5 minutes after injection, she reported "I don't feel well". She slumped over - when I caught her and lifted her head, her eyes rolled back and she stiffened for approximately 30 seconds. Then she came to she reported she dreamed she was having a car accident while she was unconscious.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Angiogram, Arthralgia, Blood test, Borrelia test, Computerised tomogram head
Clinical narrative: Headache, intracranial pressure, nausea, joint pain, tingling in (arms, hand, legs), heavy arms, vertigo, light-headed.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Dizziness, Headache, Intracranial pressure increased, Limb discomfort, Nausea
Clinical narrative: Headache, intracranial pressure, nausea, joint pain, tingling in (arms, hand, legs), heavy arms, vertigo, light-headed.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Vertigo
Clinical narrative: Headache, intracranial pressure, nausea, joint pain, tingling in (arms, hand, legs), heavy arms, vertigo, light-headed.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Angiogram, Blood test, Computerised tomogram, Headache, Limb discomfort
Clinical narrative: Headache, intracranial pressure, nausea, joint pain, tingling in (arms, hand, legs), heavy arms, vertigo, light-headed.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Tension headache
Clinical narrative: Headache, intracranial pressure, nausea, joint pain, tingling in (arms, hand, legs), heavy arms, vertigo, light-headed.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt called clinic and reported red, warm, swollen area around injection site of varicella ((R) arm outer). Pt reports no other S/S.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Influenza virus test negative, Lymphadenopathy, Pyrexia
Clinical narrative: Left arm lymph node swollen in armpit, fever-low grade temp-99 degrees-100 degrees chills. Dr. put patient on LEVAQUIN 500mg every day for 10 days.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 101.8 with chills from 230p-10p. APAP 650mg orally given x1. Monitored x48hours at 3p.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 2-3 cm red, warm area around the injection site. Right thigh was also swollen and hard around injection site. Symptoms began the morning after he received the vaccine.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: 1 week after the vaccination, I found that my arm was still very painful and my mobility had decreased.  I contacted my Dr in November to ask about the pain that continued in my arm at the injection spot and then made a visit on 12/8/16.  X-rays were taken and Meloxicam and physical Therapy were prescribed.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Mass, Pain in extremity, Peripheral swelling
Clinical narrative: ARM RED, SWOLLEN, SORE, JOINT ACHES. HAD A LUMP. 1-14-17 LUMP DISAPPEARED. SORENESS, REDNESS AND SWELLING REMAINED UNTIL TODAY.
Age: 75.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and redness of entire upper arm, with pain scale 6/10. Spoke to client on day 8 with pain, redness and swelling unresolved.  Advised to seek care at PCP.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Injected limb mobility decreased, Injection site pain, Red blood cell sedimentation rate
Clinical narrative: Pain in left arm where injection was given.  Pain increased to the point where 4 weeks after injection mobility in left arm became decreased.  Pt reports follow up with provider on 1/11/17 with continued pain and decreased mobility to present when reported 01/17/17.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Pain at site worsened as day went on continues a little more sore and weak as time went on. 1/15/2017 increase soreness/ weakness in left shoulder and left upper arm decrease ROM, unable to put hand over head/ behind back/ lift out on side.
Age: 1.08
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLUX, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: I noticed a rash of small red dots on his neck and sides of face. I undressed him and rash was all over his torso, underarms, back, neck, tops of inner thighs.
Age: 1.08
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLUX, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: I noticed a rash of small red dots on his neck and sides of face. I undressed him and rash was all over his torso, underarms, back, neck, tops of inner thighs.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Back pain, Blood alcohol increased, Partner stress, Suicidal ideation
Clinical narrative: Information was received on 04JAN2017, 09JAN2017, 10JAN2017 and 13JAN2017 from GlaxoSmithKline (GSK) in the form of blinded CIOMS report. GSK physician indicated the study drug was unblinded and subject received ava (lot FAV634) only and did not receive raxibacumab. Suicidal Ideation. This female subject was enrolled in a blinded GSK study. The subject received ava vs ava+raxibacumab+diphenhydramine from an unknown date as a study participant. The subject's past medical history included impacted wisdom tooth, removal of wisdom teeth and lumbar spine compression fracture. Concurrent medical conditions included back pain. On 17th December 2016, an unknown time after the first dose of ava vs ava+raxibacumab+diphenhydramine, the subject developed moderate - grade 2 suicidal ideation. Serious criteria included hospitalization and GSK medically significant. The outcome of suicidal ideation was not recovered/not resolved. The GSK investigator considered that there was no reasonable possibility that the suicidal ideation may have been caused by ava vs ava+raxibacumab+diphenhydramine. Additional information: GSK study subject was upset over breaking up with her boyfriend and jumped out of 2-story window (about 15 feet from the ground). She was sent to the emergency room for evaluation. She had no physical injuries but was positive for ethanol. She reported back pain, but the subject has a current medical history of back pain and it is unclear at this time if this was a worsening of the back pain. The study subject was involuntarily committed to a mental health facility. She is expected to be released by the end of 2016 and will contact the GSK study site at that time so that they can update this information.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pustular
Clinical narrative: Single chicken Pox mark at site of LSO.
Age: 43.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: Pain and swelling on left deltoid where Tdap was injected; generalized itching.
Age: 29.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Influenza virus test, Injection site pain, Paraesthesia
Clinical narrative: It seem like fifteen minutes went by My left  shoulder started to throb uncontrollable, then I was in sever pain,following me making it home. I then rested, when  I awoke started to notice I had tingling and numbness in my feet that hasn't went away.
Age: 29.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Influenza virus test negative, Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: It seem like fifteen minutes went by My left  shoulder started to throb uncontrollable, then I was in sever pain,following me making it home. I then rested, when  I awoke started to notice I had tingling and numbness in my feet that hasn't went away.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash on neck and upper chest.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgic amyotrophy, Pain
Clinical narrative: I developed a very painful condition called Parsonage Turner syndrome, which I was diagnosed with on Monday, November 14th.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema, Swelling face
Clinical narrative: Mom reports left side facial swelling and erythema.
Age: 59.0
Sex: F
Vaccine: FLUR3
Symptoms: Parosmia, Throat irritation, Throat tightness
Clinical narrative: Patient reported a strange "chemical scent" in her nostrils shortly after FLUBLOK was administered, also reported a tickle/tightness in her throat after vaccine was administered. She used her rescue inhaler and took one 25mg diphenhydramine while still at the pharmacy.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Red, inflamed skin at the injection site, warm to the touch. Patient also states pain, itching at the injection site.
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: I am still having pain at injection site. It is usually a dull ache but sometimes sharp and shooting pain with use of arm.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pruritus
Clinical narrative: Very large area of erythema 4"x3" diameter with local pruritus.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Influenza, Malaise, Nausea
Clinical narrative: Case number# PHEH2016US027892, is a report initially received from a consumer (patient) through phone via a Patient Oriented Program on 26 Oct 2016. This report refers to a 77 years old female patient. Historical condition was not reported. Current condition included heart block. The patient was polymedicated. On 03 Sep 2016 the patient was hospitalized due to heart block and had a stent placement. The patient received ENTRESTO 24/26 mg for the treatment of an unknown indication in Sep 2016 at a dose of 50 mg, Q12H (oral) during the hospitalization. 08 Sep 2016, the patient was discharged. The patient reported that she was very happy with the ENTRESTO and does not feel that she had been experiencing any side effects. The patient received Influenza Virus Vacc Seasonal Inn on 16 Sep 2016, (route: injection NOS). Patient was advised by her doctor to get flu shot because he said that she may not survive if she catches the flu. On an unknown date, the patient developed flu symptoms off and on (influenza) and cough. Patient reported the same to her physician who prescribed her Azithromycin 250 mg, a cough syrup with codeine, and prednisone 10 mg. After about two days, getting the flu shot the patient began to feel nauseous. Patient reported that she does not feel well (malaise) and was having a hard time with her appetite (decreased appetite) and has not been eating much just drinking a lot of water and juice. Therapy with ENTRESTO was ongoing. The outcome of the events was unknown. The seriousness of the events was not reported. Seriousness assessment of the event, influenza (medically significant) was upgraded based on the information available in the source documents. The consumer assessed influenza as not suspected to treatment with ENTRESTO and was reported as suspected to Influenza Virus Vacc Seasonal Inn. Follow up report received from a consumer (patient) through phone via a Patient Oriented Program on 10 Jan 2017: Added co suspect drug (Influenza Virus Vacc Seasonal Inn), medications (azithromycin, prednisone, codeine and Vitamin A, D, E), events (cough, malaise and decreased appetite), history (heart block) and procedure (stent placement).
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Streptococcus test negative, Swelling, Urticaria
Clinical narrative: As per hx given by mom (+) erythema/hives and swelling in day 1 and 2 after vaccine administered BENADRYL given and resolved. No rash/swelling.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Exposure to communicable disease, Rash generalised
Clinical narrative: Exposed to chickenpox from daycare on 1-9-17. Patient came in 1-11-17 to office with bumps on arms, face, body x 2 days. Patient attends daycare.
Age: 44.0
Sex: F
Vaccine: TYP, YF
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site warmth, Mobility decreased
Clinical narrative: When she awoke at 6 a.m. on 10-17-16 she had a stiff neck and was unable to move from side to side without pain. Took ALEVE and it subsided, but again today her neck is stiff bilaterally and it is painful to move it side to side. Is able to move head up and down. Rpts that immediately after - Yellow Fever shot, the site was warm and red and itchy for 3 days. The redness, itching has subsided and now she has the stiffness since 10-17-16 at 6:00 a.m. Today she has pain when swallowing. Put heat on her neck, but it didn't help. Advise ice pack today.
Age: 44.0
Sex: F
Vaccine: TYP, YF
Symptoms: Musculoskeletal stiffness, Odynophagia, Pain
Clinical narrative: When she awoke at 6 a.m. on 10-17-16 she had a stiff neck and was unable to move from side to side without pain. Took ALEVE and it subsided, but again today her neck is stiff bilaterally and it is painful to move it side to side. Is able to move head up and down. Rpts that immediately after - Yellow Fever shot, the site was warm and red and itchy for 3 days. The redness, itching has subsided and now she has the stiffness since 10-17-16 at 6:00 a.m. Today she has pain when swallowing. Put heat on her neck, but it didn't help. Advise ice pack today.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left shoulder pain in injection site w/in hours of administration, continued pain and lost of ROM over next two weeks.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at site of imm. No streaking. No fever.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient had a reaction to the vaccine that developed approximately 3 days after receiving it. Redness and warmth developed on the outside and back of her right arm. This reaction did no occur at the injection site.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV, TDAP, FLUA3, PPV, TDAP
Symptoms: Induration, Injection site swelling, Pain, Skin warm
Clinical narrative: Pt had swollen arm from shoulder to elbow (right arm). Warm to touch, firm and painful, pt is warm to touch, not red.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV, TDAP, FLUA3, PPV, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt had swollen arm from shoulder to elbow (right arm). Warm to touch, firm and painful, pt is warm to touch, not red.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Shakes, blood pressure 210/110.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt described a localized cellulitis that she developed.