chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (L.V.N) refers to unspecified number of unspecified patients of unknown age and gender. The patients were administered an unspecified number of improperly stored doses of PROQUAD (Merck) (subcutaneous injection, dose, frequency, lot# and expiration date were not reported) on unspecified dates since 01-FEB-2015. No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female non-pregnant patient. The patient's concurrent conditions and medical history were not reported. On 28-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX, dose and route were not reported (lot # K015310, expiration date: 17-DEC-2015). On 10-MAR-2015, the patient experienced 2 inch red, swollen ring at the injection site. The patient did not seek medical attention. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 27 year old female patient. On 11-MAR-2015 the patient was vaccinate with a standard dose of ZOSTAVAX instead of VARIVAX (Merck). Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 43 year old male patient with no drug reactions/allergies and no medical history. On an unspecified date in February 2015, the patient was vaccinated with a first dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot# and expiration date were not provided) as a mandatory vaccination. No concomitant medication was reported. In the evening of the date of administration, he experienced three inches of swelling at injection site. The patient did not seek medical attention. No treatment was given for the event. The patient recovered in three to four days on an unspecified date in 2015. The relatedness between the event and VARIVAX (Merck) was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to unspecified number of unspecified patients of unknown age and gender. The patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) (subcutaneous injection, dose, frequency, lot# and expiration date were not reported) on unspecified dates since 01-FEB-2015. No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 09-DEC-2014, the patient was vaccinated with a dose of MMR II (route, dose, frequency and lot # not reported) which had undergone a temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 12-DEC-2014, the patient was vaccinated with a dose of MMR II (route, dose, frequency and lot # not reported which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. Information about patient's medical history was not provided. On 13-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, frequency, indication and lot # were not specified, subcutaneously) instead of VARIVAX (Merck). No adverse event was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date since 26-NOV-2014, the patients were vaccinated with an incorrect storage doses of RECOMBIVAX HB (lot #, expiration date, dose and route were not reported). No concomitant medication was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 04-DEC-2014, the patient was vaccinated with a dose of M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients were administered doses of improperly stored PROQUAD (Merck) (dose, route and lot# were not reported) on unspecified dates since 26-FEB-2015. No adverse effect reported. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency and therapy route were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gener. Patients medical history and current conditions were not provided. On an unknown date since 26-NOV-2014, the patients were vaccinated with an incorrect storage doses of GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medication was reported. No concomitant medication was reported. No adverse effect reported. This is one of several reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB (0.5 ml, intramuscular, expiration date 01-FEB-2015, lot# was not specified). Dose was supported. It was unspecified which dose number this was in the vaccination series. No adverse experience was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 04-DEC-2014, the patient was vaccinated with a dose of MMR II (route, dose, frequency and lot # not reporter) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency and therapy route were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experienced were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to 15 patients of unknown age and gender. No concurrent or historical conditions were reported. The nurse reported that the 15 patients received improperly stored M-M-R II (lot number, dose, frequency and route were not reported) on an unspecified day. Information regarding concomitant medication was not reported. No adverse effects were reported. It was unspecified if the patients sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored vaccinated with RECOMIVAX HB (dose, frequency, route and lot number not provided). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been quested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Vaccination site erythema, Vaccination site pain
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to a 71 year old male patient. On 19-FEB-2015 the patient was vaccinated with PNEUMOVAX 23, .5 ml, 1 injection (lot no. K016295, expiry unknown). On 19-FEB-2015, the patient developed vaccination site reaction immediately after receiving PNEUMOVAX 23. The patient had vaccination site pain and vaccination site erythema. The patient did not receive any treatment for the events. The outcome of vaccination site reaction, vaccination site pain and vaccination site erythema was reported as recovered on an unknown date. The causality of events was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date since 26-NOV-2014, the patients were vaccinated with an incorrect storage doses of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported). No concomitant medication was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about patient's medical history was not provided. On 17-MAR-2015, the patient was inadvertently administered PROQUAD (Merck) (dose, frequency, route of administration and lot # were not specified) and VARIVAX (Merck) (dose, frequency, route of administration and lot # were not specified) on the same day. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of accidental overdose was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 19-MAR-2015, the patient was inadvertently vaccinated with a single dose of ZOSTAVAX lot # J011882 (subcutaneously, dose and anatomical location were not reported) that expired in 04-JAN-2015. No concomitant therapy was reported. No adverse effects were reported. Additional information is not expected, the reporter does not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practice nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients were administered doses of improperly stored VARIVAX (Merck) (dose, route and lot# were not reported) on unspecified dates since 26-FEB-2015. No adverse effect reported. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 21-NOV-2014, the patient was vaccinated with a dose of M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 25-NOV-2014, the patient was vaccinated with a dose of M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with improperly stored doses of GARDASIL. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot number not provided). No adverse effect reported. It was unspecified if the patients sought any medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction - moderate to severe swelling, itching, redness x 5 days. Patient used hydrocortisone cream and BENADRYL. Patient reported symptoms resolved 3/6/15.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection area extremely red and warm to the touch. Over the rest of the day the red area continued to get bigger and red area of arm hurts to touch. As of 3/21/15 red area has swelled to 6" x 4". As a norm I take ZYRTEC daily. Began taking BENADRYL on 3/21/15 at 10:15 p.m.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient complained of sore arm for 1 week after receiving the shot. Site of injection was sore and tender.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Allergy test negative, Arthralgia, Blood test normal, Borrelia test negative, Chest pain
Clinical narrative: Started as headache / migraines and fatigue and eventually over time escalated to many other symptoms like tachycardia, joint pain, chest pain, redness around joints.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Computerised tomogram normal, Dental examination normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Erythema
Clinical narrative: Started as headache / migraines and fatigue and eventually over time escalated to many other symptoms like tachycardia, joint pain, chest pain, redness around joints.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fatigue, Headache, Migraine, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal
Clinical narrative: Started as headache / migraines and fatigue and eventually over time escalated to many other symptoms like tachycardia, joint pain, chest pain, redness around joints.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Tachycardia
Clinical narrative: Started as headache / migraines and fatigue and eventually over time escalated to many other symptoms like tachycardia, joint pain, chest pain, redness around joints.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swollen, redness and itching. Patient took Benadryl and put ice on.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia, Mobility decreased, Pain
Clinical narrative: Came on very slowly starting with soreness in area of shot, progressing to pain when doing Yoga moves to difficulty dressing and sleeping. By beginning of January, had to completely stop Yoga. Went to orthopedic doctor on January 13, 2015. X-rays showed "frozen shoulder" - no rotator cuff tears. Gave me a cortisone shot and some simple shoulder exercises. Immediately started improving. Was able to return to Yoga classes (with limitations) by beginning of February, 2015. As of now (3/22/2015) shoulder is much better, but not back to normal. Still some pain where shot was given. Still some moves that used to be easy that I can not do with that arm (e.g., eagle arms with left arm on top; triangle pose to the right - left arm will just not go up straight from that position; arm will go behind my back, but can not get hand up at all (used to be able to do reverse namaste. Unfortunately, improvement seems to have stopped in last couple weeks.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, X-ray limb abnormal
Clinical narrative: Came on very slowly starting with soreness in area of shot, progressing to pain when doing Yoga moves to difficulty dressing and sleeping. By beginning of January, had to completely stop Yoga. Went to orthopedic doctor on January 13, 2015. X-rays showed "frozen shoulder" - no rotator cuff tears. Gave me a cortisone shot and some simple shoulder exercises. Immediately started improving. Was able to return to Yoga classes (with limitations) by beginning of February, 2015. As of now (3/22/2015) shoulder is much better, but not back to normal. Still some pain where shot was given. Still some moves that used to be easy that I can not do with that arm (e.g., eagle arms with left arm on top; triangle pose to the right - left arm will just not go up straight from that position; arm will go behind my back, but can not get hand up at all (used to be able to do reverse namaste. Unfortunately, improvement seems to have stopped in last couple weeks.
Age: 0.83
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Speech disorder developmental
Clinical narrative: My child stopped making sounds or attempting to talk. She never made a sound except cry for the next year. Her speech is very delayed and unable to pronounce all words.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Syncope
Clinical narrative: Syncope. Died at ER.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Migraine, Myalgia, Nausea, Neck pain
Clinical narrative: 3/20/15 11 PM-Migraine headache, lightheadedness, nausea, vomiting. 3/21/15 AM-sore muscles, lightheadedness, nausea, diarrhea; PM-sore muscles, migraine, neck pain, nausea.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vomiting
Clinical narrative: 3/20/15 11 PM-Migraine headache, lightheadedness, nausea, vomiting. 3/21/15 AM-sore muscles, lightheadedness, nausea, diarrhea; PM-sore muscles, migraine, neck pain, nausea.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Diarrhoea, Dizziness, Migraine, Myalgia, Nausea
Clinical narrative: 3/20/15 11 PM-Migraine headache, lightheadedness, nausea, vomiting. 3/21/15 AM-sore muscles, lightheadedness, nausea, diarrhea; PM-sore muscles, migraine, neck pain, nausea.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Neck pain, Vomiting
Clinical narrative: 3/20/15 11 PM-Migraine headache, lightheadedness, nausea, vomiting. 3/21/15 AM-sore muscles, lightheadedness, nausea, diarrhea; PM-sore muscles, migraine, neck pain, nausea.
Age: 1.74
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: My daughter had a low grade fever (101.5' F) and a spotted rash that broke out first on her abdominal area, and later spread to her face and extremities - essentially, head to toe. The fever occurred first in the afternoon and as the day went on, more and more spots appeared. I took a picture and sent it to the Drs office at 9:30pm. By looking at the photo of the rash and asking me questions, he was able to pinpoint it's likely cause to her MMR vaccine administered 10 days prior.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dysarthria, Guillain-Barre syndrome
Clinical narrative: Weakness, Slurring of speech, later discovered to have Guillain Barre.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Diarrhoea, Fatigue, Lethargy, Nausea, Pyrexia
Clinical narrative: Began showing a rash starting at neck then by 3pm it was full body and temp of 101.9 was taken. I called Dr. and they said no problem it was a reaction I called back at 3 pm when temp reached 102 and my child was nauseous and lethargic at 8 pm I called and they said watch him closely through the night and bring him a 8 am to Dr. office unless breathing stopped or became labored before that point or fever reached 104 or higher. At this point he was sleeping hard with a 102 fever and very tired but responsive. At this appt we were tested for strep and Scarlett Fever which were both positive. we were given antibiotics for these illnesses. After 7 days on antibiotic March 17th 2015  my child began running a high temperature of 100.2 vomitting and began diarrhea which has continued on till 03/22/2015 with no relief we will be seeing Dr. tomorrow.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash generalised, Streptococcus test positive, Vomiting
Clinical narrative: Began showing a rash starting at neck then by 3pm it was full body and temp of 101.9 was taken. I called Dr. and they said no problem it was a reaction I called back at 3 pm when temp reached 102 and my child was nauseous and lethargic at 8 pm I called and they said watch him closely through the night and bring him a 8 am to Dr. office unless breathing stopped or became labored before that point or fever reached 104 or higher. At this point he was sleeping hard with a 102 fever and very tired but responsive. At this appt we were tested for strep and Scarlett Fever which were both positive. we were given antibiotics for these illnesses. After 7 days on antibiotic March 17th 2015  my child began running a high temperature of 100.2 vomitting and began diarrhea which has continued on till 03/22/2015 with no relief we will be seeing Dr. tomorrow.
Age: 1.71
Sex: M
Vaccine: PNC13
Symptoms: Dry skin, Injection site induration, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: Red rash, rough texture with hard lumps at injection site and within 2-inches of site. hot to touch.
Age: 1.71
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Red rash, rough texture with hard lumps at injection site and within 2-inches of site. hot to touch.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Localised infection, Musculoskeletal pain, Pain in extremity, Skin swelling
Clinical narrative: Pain in shoulder and arm. Swelling and redness of skin. Redness and pain spread to other parts of the upper arm. Went to urgent care on 03/22 and prescribed antibiotic for infection in the arm.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Toes got tingly the evening of shot. Tingling next day progressed up the legs to the knees on day 2. Day 3 in the evening, symptoms started to regress. By the end of the week all but tingling in toes was gone. In 2015 I now only have tingling & numbness in one big toe.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician concerning an unspecified patient. On an unknown date the patient inadvertently received his/her (it was also reported as their) first dose of ROTATEQ (2 ml, once, orally, strength and lo# were not reported) at aged five months. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot number, dose and route were unknown). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction, Pain, Peripheral swelling
Clinical narrative: Local reaction more extensive than usual. Significant swelling at deltoid. Tissue firm and sore. Redness and swelling extended down anterior bicep area. Began eve. 3/20 (date of injection).
Sex: U
Vaccine: VARZOS
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. No concurrent or historical conditions were reported. On 16-MAR-2015, the patient received an expired dose of ZOSTAVAX lot # k003596, expiry date 12-MAR-2015, 0.65 ml, subcutaneous. There were no adverse effects reported. It was unspecified if the patient sought medical attention. Additional information is not expected as the reporter declined to provide any patient specific information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with doses of improperly stored GARDASIL (dose, frequency and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acupuncture, Erythema, Feeling hot, Injection site joint pain, Local reaction
Clinical narrative: Day of inoculation pain in (L) arm. 2nd day to 8th day 6" red diameter. Itching and soreness. 2nd week redness gone. Pain increased. Spread to tendons and joints in (L) elbow and shoulder.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Day of inoculation pain in (L) arm. 2nd day to 8th day 6" red diameter. Itching and soreness. 2nd week redness gone. Pain increased. Spread to tendons and joints in (L) elbow and shoulder.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: Day of inoculation pain in (L) arm. 2nd day to 8th day 6" red diameter. Itching and soreness. 2nd week redness gone. Pain increased. Spread to tendons and joints in (L) elbow and shoulder.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tendon pain
Clinical narrative: Day of inoculation pain in (L) arm. 2nd day to 8th day 6" red diameter. Itching and soreness. 2nd week redness gone. Pain increased. Spread to tendons and joints in (L) elbow and shoulder.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Day of inoculation pain in (L) arm. 2nd day to 8th day 6" red diameter. Itching and soreness. 2nd week redness gone. Pain increased. Spread to tendons and joints in (L) elbow and shoulder.
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Pruritus, Rash, Skin lesion, Varicella, Varicella virus test negative
Clinical narrative: Information has been received from a nurse practitioner and a certified medical assistant, and also received from a 55 year old female patient (also was a registered nurse) referring to herself with Guillain-Barre syndrome (GBS) and allergies to BACTRIM and IVP dye. On 15-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # was not reported). Concomitant therapies included lorazepam, AUGMENTIN, estrogen cream, progesterone cream and influenza virus vaccine. On 20-OCT-2014, the patient experienced vesicular rashes/shingles outbreak (first lesion) and resolved on an unspecified date. On 20-JAN-2015 the patient experienced vesicular rashes/shingles outbreak (second lesion) and resolved on an unspecified date in 2015. On 03-FEB-2015, the rash was cultured and tested and was diagnosed as herpes simplex virus (HSV). On 06-FEB-2015 vesicular rashes/shingles outbreak (third lesion) appeared and she was diagnosed with bronchitis as well, both resolved on an unspecified date in February 2015. On 27-FEB-2015 vesicular rashes/shingles outbreak (four lesion) appeared and she was also diagnosed with bronchitis again, and at this time she had not yet recovered from either illness. It was also reported that the patient was exposure to shingles recently. The patient was assessed by the nurse practitioner on unspecified dates and was treated with VALTREX and doxycycline on unspecified dates in February 2015. Causality between the events and ZOSTAVAX was not provided. The patient was in the nurse practitioner's office on 03-MAR-2015 and she was collected with another sample from skin vesicle/lesion. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Bronchitis, Herpes simplex, Herpes zoster, Rash vesicular, Simplex virus test positive
Clinical narrative: Information has been received from a nurse practitioner and a certified medical assistant, and also received from a 55 year old female patient (also was a registered nurse) referring to herself with Guillain-Barre syndrome (GBS) and allergies to BACTRIM and IVP dye. On 15-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # was not reported). Concomitant therapies included lorazepam, AUGMENTIN, estrogen cream, progesterone cream and influenza virus vaccine. On 20-OCT-2014, the patient experienced vesicular rashes/shingles outbreak (first lesion) and resolved on an unspecified date. On 20-JAN-2015 the patient experienced vesicular rashes/shingles outbreak (second lesion) and resolved on an unspecified date in 2015. On 03-FEB-2015, the rash was cultured and tested and was diagnosed as herpes simplex virus (HSV). On 06-FEB-2015 vesicular rashes/shingles outbreak (third lesion) appeared and she was diagnosed with bronchitis as well, both resolved on an unspecified date in February 2015. On 27-FEB-2015 vesicular rashes/shingles outbreak (four lesion) appeared and she was also diagnosed with bronchitis again, and at this time she had not yet recovered from either illness. It was also reported that the patient was exposure to shingles recently. The patient was assessed by the nurse practitioner on unspecified dates and was treated with VALTREX and doxycycline on unspecified dates in February 2015. Causality between the events and ZOSTAVAX was not provided. The patient was in the nurse practitioner's office on 03-MAR-2015 and she was collected with another sample from skin vesicle/lesion. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Bronchitis, Herpes simplex, Herpes zoster, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner and a certified medical assistant, and also received from a 55 year old female patient (also was a registered nurse) referring to herself with Guillain-Barre syndrome (GBS) and allergies to BACTRIM and IVP dye. On 15-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # was not reported). Concomitant therapies included lorazepam, AUGMENTIN, estrogen cream, progesterone cream and influenza virus vaccine. On 20-OCT-2014, the patient experienced vesicular rashes/shingles outbreak (first lesion) and resolved on an unspecified date. On 20-JAN-2015 the patient experienced vesicular rashes/shingles outbreak (second lesion) and resolved on an unspecified date in 2015. On 03-FEB-2015, the rash was cultured and tested and was diagnosed as herpes simplex virus (HSV). On 06-FEB-2015 vesicular rashes/shingles outbreak (third lesion) appeared and she was diagnosed with bronchitis as well, both resolved on an unspecified date in February 2015. On 27-FEB-2015 vesicular rashes/shingles outbreak (four lesion) appeared and she was also diagnosed with bronchitis again, and at this time she had not yet recovered from either illness. It was also reported that the patient was exposure to shingles recently. The patient was assessed by the nurse practitioner on unspecified dates and was treated with VALTREX and doxycycline on unspecified dates in February 2015. Causality between the events and ZOSTAVAX was not provided. The patient was in the nurse practitioner's office on 03-MAR-2015 and she was collected with another sample from skin vesicle/lesion. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a nurse practitioner and a certified medical assistant, and also received from a 55 year old female patient (also was a registered nurse) referring to herself with Guillain-Barre syndrome (GBS) and allergies to BACTRIM and IVP dye. On 15-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # was not reported). Concomitant therapies included lorazepam, AUGMENTIN, estrogen cream, progesterone cream and influenza virus vaccine. On 20-OCT-2014, the patient experienced vesicular rashes/shingles outbreak (first lesion) and resolved on an unspecified date. On 20-JAN-2015 the patient experienced vesicular rashes/shingles outbreak (second lesion) and resolved on an unspecified date in 2015. On 03-FEB-2015, the rash was cultured and tested and was diagnosed as herpes simplex virus (HSV). On 06-FEB-2015 vesicular rashes/shingles outbreak (third lesion) appeared and she was diagnosed with bronchitis as well, both resolved on an unspecified date in February 2015. On 27-FEB-2015 vesicular rashes/shingles outbreak (four lesion) appeared and she was also diagnosed with bronchitis again, and at this time she had not yet recovered from either illness. It was also reported that the patient was exposure to shingles recently. The patient was assessed by the nurse practitioner on unspecified dates and was treated with VALTREX and doxycycline on unspecified dates in February 2015. Causality between the events and ZOSTAVAX was not provided. The patient was in the nurse practitioner's office on 03-MAR-2015 and she was collected with another sample from skin vesicle/lesion. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Additional information has been requested.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Acute disseminated encephalomyelitis, Choreoathetosis, Decreased eye contact, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Posture abnormal, Somnolence, Visual impairment, White matter lesion
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Crying, Decreased activity, Decreased appetite, Depressed mood
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Dyskinesia, Gaze palsy, Hyperhidrosis, Irritability, Posture abnormal
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Somnolence
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Anti-NMDA antibody positive, Childhood disintegrative disorder, Encephalitis autoimmune, Hypophagia
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Irritability
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Anti-NMDA antibody positive, Dyskinesia, Encephalitis autoimmune, Encephalopathy
Clinical narrative: 7 month old female presents to hospital in on 2/3/2015 for depressed mood, rolling eyes, being agitated and unusual body movements, loss of activeness, diminished appetite and constant sweating from hands and feet x 4 days.  Pt received 2nd influenza vaccine 7 days ago (1/28/2015) and got extrememly sleepy aftewards.  Since then, she seems to be getting worse each day that she has not wanted to eat or drink much, does not want to sit in her walker, does not sit up and just wants to sleep.  She is acting fussy & crying in her sleep.  Mom is concerned that she is not active as before and that she is not holding her head up.  Child received 6 mo immunizations along with 1st influenza vaccine on 23 Dec 2014 and the 2nd flu vaccine was given 28 Jan 2015.  Mom denies fever, cough, or vomiting.  Pediatrician has concerns for encephalopathy and referred pt to pediatric neuro.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Feeding disorder, Mobility decreased, Nausea
Clinical narrative: Fatigue, by 9:00 PM had fever <100, shaking chills, body aches, exhaustion. Took Ibuprofen 600 mg and hot shower. 3-20-2015 Next day could not get out of bed until 10:30 AM, had to nap from 1:00 to 3:00 PM. Low grade temp, fatigue, shaking chills, body aches (treated with Ibuprofen 600mg), nausea - forced fluids, could not eat.    3-21-2015 Better, but fatigue all day.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Fatigue, by 9:00 PM had fever <100, shaking chills, body aches, exhaustion. Took Ibuprofen 600 mg and hot shower. 3-20-2015 Next day could not get out of bed until 10:30 AM, had to nap from 1:00 to 3:00 PM. Low grade temp, fatigue, shaking chills, body aches (treated with Ibuprofen 600mg), nausea - forced fluids, could not eat.    3-21-2015 Better, but fatigue all day.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Paitent recieved TDAP and a few minutes later complained that injection site area was itching. Area was red but was not swollen or hot to touch. Provider assessed site and ice applied and Benadryl given.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Patient complained of pain, redness and swelling at injection site a few hours after receiving the vaccine. States she had chills overnight. Patient came back into the office the next day to be evaluated. Use ice, elevation, Benadryl and naprosyn. Call if symptoms worsen.