chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 23 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored VARIVAX, lot # N021719, expiration date 10-AUG-2019, by subcutaneous route in the right arm, (dose, dose number, and frequency were not reported), for prophylaxis. Concomitant therapies included sterile diluent (MERCK, lot number N020144 Expiration date 01-NOV-2019). No adverse reactions were observed. The temperature excursion occurred possibly from 22-DEC-2017 to 02-JAN-2018, when no temperature was recorded and also possibly due to the "power was turned off and the freezer door was open". No previous temperature excursion. The digital data logger was not involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1802USA006871.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 58 year old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The reporter stated that on 29-JAN-2018, the patient was vaccinated with PROQUAD for prophylaxis (strength, dosage, frequency, lot# and expiration date were not provided) reconstituted with sterile diluent (MERCK instead of MMR II.) No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter a 16 year old non-pregnant female patient with seasonal allergy and drug allergy to sulfa as concurrent conditions. The patient's medical history was not reported. There was no concomitant medication reported. On an unspecified date in September 2017, the patient was vaccinated with the first dose of GARDASIL 9. Later, on an unspecified date, the patient received the second dose of GARDASIL 9 both doses intramuscular for prevention of HPV. The reporter stated that after each dose of GARDASIL 9, the patient developed on unspecified dates, injection site pain and swelling, headache, fever, and nausea. The reporter mentioned that the patient "felt worse" after one of the doses, but could not specified which dose. Although, the patient talked with her physician, no treatment was given for the adverse events. The outcome of the events was reported as recovered (unspecified dates).
Sex: M
Vaccine: HPV4
Symptoms: Borrelia test, Chest pain, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. The patient's medical history included dizziness and syncope. The patient's concomitant therapies included VYVANSE. No information was provided regarding the patient's concurrent conditions. On an unspecified date in 2013, the patient was vaccinated with all three doses of GARDASIL. On an unspecified date in 2014, the patient complained of dizziness, tachycardia, shortness of breath and chest pains. The patient went to two different Hospitals, nevertheless, the reporter did not know when the patient went to these hospitals and did not know if the patient was admitted to either hospital or not. The physician sent the patient to a pulmonologist, a cardiologist and a gastroenterologist for medical attention. On an unknown date, the following laboratory tests were performed : X-ray, Holter monitor, echocardiogram, "tested for Lyme disease" nevertheless, no results were provided. At the time of the report, the outcome of dizziness, chest pain, dyspnoea and tachycardia was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL.
Sex: M
Vaccine: HPV4
Symptoms: Electrocardiogram ambulatory, Tachycardia, X-ray
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. The patient's medical history included dizziness and syncope. The patient's concomitant therapies included VYVANSE. No information was provided regarding the patient's concurrent conditions. On an unspecified date in 2013, the patient was vaccinated with all three doses of GARDASIL. On an unspecified date in 2014, the patient complained of dizziness, tachycardia, shortness of breath and chest pains. The patient went to two different Hospitals, nevertheless, the reporter did not know when the patient went to these hospitals and did not know if the patient was admitted to either hospital or not. The physician sent the patient to a pulmonologist, a cardiologist and a gastroenterologist for medical attention. On an unknown date, the following laboratory tests were performed : X-ray, Holter monitor, echocardiogram, "tested for Lyme disease" nevertheless, no results were provided. At the time of the report, the outcome of dizziness, chest pain, dyspnoea and tachycardia was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates, the patient was vaccinated with an improperly stored dose of vaccinated with PROQUAD (route, dose, frequency, and anatomical location were unknown) with lot# N021727 and expiration date 06-FEB-2019 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of -9 C to 8 C (5C) degree Celsius for 1 hour and 4 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a currently 76 year old male patient with hypertension. The patient did not have drug reactions or allergies and concomitant medications included losartan (AUROBINDO). On unknown dates, the patient may have received two doses of PNEUMOVAX 23 for prophylaxis, within a week from each other. The pharmacist reported lot # N025656 and expiration date on 19-APR-2019, but was not able to clarify if lot number and expiration date were the same for both doses of the vaccine (dose, route of administration and anatomical location were not reported). The pharmacist stated that the second vaccination should have been BOOSTRIX. On an unknown date, the patient reported that his arm was hurting. There was no treatment given for the adverse event, no lab diagnostics or studies were performed and the patient did not sought medical attention. The outcome of pain in the arm was unknown. The pharmacist did not provide a causality assessment between this event and the vaccination with PNEUMOVAX 23.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 09-FEB-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M004305, expiration date 25-JAN-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with a sterile diluent (MERCK) which was properly stored. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-FEB-2018, the patient was vaccinated with an expired dose of  GARDASIL 9 lot # M007764, expiration date 30-JAN-2018, for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-SEP-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-APR-2013, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-MAY-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-JAN-2014, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed valacyclovir for the management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-DEC-2014, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-JUL-2007, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-MAY-2016, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Immediate post-injection reaction, Rash vesicular
Clinical narrative: Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 15-FEB-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster immediately after being vaccinated. On or about 16-FEB-2016, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Immediate post-injection reaction, Rash vesicular
Clinical narrative: Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 15-JUN-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster immediately after being vaccinated. The patient was later treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # M044220, Expiry date: 31-JAN-2018) for prophylaxis (expired product administered). The reporting pharmacist stated that the ZOSTAVAX did not have any temperature excursions prior to administration. No adverse symptoms reported. No product quality compliant was involved.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a 21 year old non-pregnant female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with a series of GARDASIL (dose, frequency, route of administration, lot # and expiry date were not provided) for the prevention of human papillomavirus (HPV). On 20-JAN-2018, a biopsy was performed and patient was diagnosed positive for HPV-16 and on 12-MAR-2018, the patient was scheduled for a Loop Electrosurgical Excision Procedure (LEEP). The outcome of papilloma viral infection was reported as not recovered/not resolved. The causality assessment was not provided.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Blindness, Deafness, Hyperhidrosis, Hypoacusis, Nausea
Clinical narrative: About 5-7 mins after immunization, patient started to complain of not being able to hear and see. I gave him and ice pack and made him lay down to see if that would help for about 30-45 secs. Then complained of nausea. I listened to his lungs and was wheezing throughout, B/P: 60/ 40, HR was 74. He was diaphoretic and pale. After about 3-5 mins after giving epi, b/p was 90/60, clear lungs, hearing and vision changes resolved.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Pallor, Visual impairment, Wheezing
Clinical narrative: About 5-7 mins after immunization, patient started to complain of not being able to hear and see. I gave him and ice pack and made him lay down to see if that would help for about 30-45 secs. Then complained of nausea. I listened to his lungs and was wheezing throughout, B/P: 60/ 40, HR was 74. He was diaphoretic and pale. After about 3-5 mins after giving epi, b/p was 90/60, clear lungs, hearing and vision changes resolved.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: Patient's spouse reported swelling on the chest after injection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient was given HepA #1 and MMRV #1. Approx. 5 minutes later she developed a hive an her right thigh, closed to the MMRV injection site. She then developed a few more hives on her back. I called patient today to follow up-no rash after 8pm last night. No swelling or edema noted per parents-RN.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3x3 cm erythema, puffiness, pain at injection site beginning on 2/11. Rx'd AUGMENTIN 875/125 BID x 5 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Papule, Pruritus, Vaccination site rash
Clinical narrative: 2 inch rash initially developed around vaccination site but on presentation in office on 2/13 child had 8 red papules ranging in size from 1-3mm on face, arms and torso. They were pruritic but not vesicular and developing quickly during the course of the visit.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-OCT-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-APR-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-OCT-2011, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-OCT-2011, the patient was treated by a physician assistant for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed valacyclovir, prednisone, and gabapentin for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Chorioretinal disorder, Eye inflammation, Eye pain, Glaucoma
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On 14-JUN-2016, the patient was inoculated ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles (lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 (reported as "shortly after receiving" ZOSTAVAX), he was diagnosed with shingles inside his left eye and on his head, which contributed to diminished eyesight in his left eye. The patient presented to an Ophthalmologist with these complaints and was diagnosed with glaucoma secondary to eye inflammation. Thereafter, he presented to an eye institute and was diagnosed with disseminated chorioretinal inflammation of the left eye and retinal edema.  Currently, the patient suffers from 50% loss of vision in his left eye, along with continued left eye pain and discomfort. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were not resolved. Causality assessment was related. Upon internal review, ophthalmic herpes zoster, glaucoma, and retinal edema were considered medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ocular discomfort, Ophthalmic herpes zoster, Retinal oedema, Visual impairment
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On 14-JUN-2016, the patient was inoculated ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles (lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 (reported as "shortly after receiving" ZOSTAVAX), he was diagnosed with shingles inside his left eye and on his head, which contributed to diminished eyesight in his left eye. The patient presented to an Ophthalmologist with these complaints and was diagnosed with glaucoma secondary to eye inflammation. Thereafter, he presented to an eye institute and was diagnosed with disseminated chorioretinal inflammation of the left eye and retinal edema.  Currently, the patient suffers from 50% loss of vision in his left eye, along with continued left eye pain and discomfort. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were not resolved. Causality assessment was related. Upon internal review, ophthalmic herpes zoster, glaucoma, and retinal edema were considered medically significant. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Malaise, Nausea
Clinical narrative: 08/07/2017 - Dr. visit - After dizziness, headache, nausea, sore neck-bumps, red swollen face. Red streaks on Left forearm, torso. Very sick for few weeks. Pain on back Left side of my neck for few week.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Rash, Swelling face
Clinical narrative: 08/07/2017 - Dr. visit - After dizziness, headache, nausea, sore neck-bumps, red swollen face. Red streaks on Left forearm, torso. Very sick for few weeks. Pain on back Left side of my neck for few week.
Age: 10.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: Patient came down with a 102° fever, aches, cough and the chills.
Age: 57.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Influenza like illness, Lethargy, Pain, Rash generalised, Rash pruritic
Clinical narrative: Starting the evening of getting vaccines had flu like symptoms. Body aches, excess lethargy and about 12 hours later a very itchy rash which started behind his knees and spread throughout his body. Caladryl lotion helped decrease the itching but did require BENADRYL in order to sleep.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Pt called pharmacy 3 days after receiving the vaccine complaining of swelling in the arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Skin warm
Clinical narrative: ARMS TURNED RED, HOT, AND COULD BARELY MOVE.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Allergy test negative, Crying, Pyrexia, Rash erythematous, Screaming
Clinical narrative: Fever of 102, screaming, crying, red dots all over his torso and back, interrupted sleep.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Sleep disorder
Clinical narrative: Fever of 102, screaming, crying, red dots all over his torso and back, interrupted sleep.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash macular, Vaccination site erythema, Vaccination site reaction
Clinical narrative: BILATERAL VACCINE SITES WITH DIFFUSED MACULAR ERYTHEMATOUS AREAS, OBSERVATION, PATIENT TO APPLY COMPESSES TO AFFECTED AREAS.
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Back pain, Coordination abnormal, Hypoaesthesia, Muscular weakness, Musculoskeletal pain
Clinical narrative: Had severe vertigo at 4:30 am on 01/31/2018., the next morning. Had trouble with coordination and leg weakness that day. Low back pain and arm pain and shoulder pain started the next day. I have had buzzing in head also. The shoulder pain and weakness has not subsided and the weakness in legs is ongoing. My toes have gotten more numb since the vaccine was administered.. I went to my family dr to report my symptoms from the flu vaccine. As of today two weeks and one day later I still have shoulder and arm pain. Shoulder pain is worse and leg weakness and aching in legs. My numbness in toes continues. And the buzzing in head continues. I drink lots of water and eat healthy hoping this will help but not as of yet.
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity, Tinnitus, Vertigo
Clinical narrative: Had severe vertigo at 4:30 am on 01/31/2018., the next morning. Had trouble with coordination and leg weakness that day. Low back pain and arm pain and shoulder pain started the next day. I have had buzzing in head also. The shoulder pain and weakness has not subsided and the weakness in legs is ongoing. My toes have gotten more numb since the vaccine was administered.. I went to my family dr to report my symptoms from the flu vaccine. As of today two weeks and one day later I still have shoulder and arm pain. Shoulder pain is worse and leg weakness and aching in legs. My numbness in toes continues. And the buzzing in head continues. I drink lots of water and eat healthy hoping this will help but not as of yet.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Only the diluent part of PENTACEL was given to the patient so per employee at clinic, she states the patient only received IPV and Dtap and will need a separate HiB vaccine. Proper forms and documentation took place in our charting system.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient called to report continued pain (half dollar size) in the area she received the injection. She reports the pain is constant and started after receiving the shot and has continued (unchanged).
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Dizziness, Ear infection, Pyrexia, Somnolence
Clinical narrative: 103.8 plus fever for 72 hours. Dizziness. Excessive sleepiness. Loss of appetite. Ear infection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: The pharmacist gave PNEUMOVAX 23 to patient around 1 PM on Monday 2/12/18. Patient called the pharmacy around 8 PM on 2/12/18 complaining of redness, swelling, and arm warm touch. The pharmacist asked the patient to consult the doctor. Patient saw their primary care doctor on 2/13/18 in the morning and the doctor informed the patient to ice the site, gave her BENADRYL and ADVIL for her symptoms and asked the patient to call them back if the color of the site changed or the symptoms worsen.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, MMRV
Symptoms: Pruritus, Rash, Rash erythematous, Somnolence
Clinical narrative: Patient was scheduled at Clinic on 02/08/2018 for 5 year old vaccines. Child presented to clinic accompanied with his mom and mom's boyfriend. Immunization record received and reviewed.  Nurse determined child needs Dtap, MMR, Varicella, Flu and Hepatitis A#2. Nurse completed immunization assessment. Mom denied any serious complications from previous vaccines, NKA. Temp 98.4, WT=44lbs.  3:17pm Vaccines administered per protocol. Child asked to wait. 349Pm  CSR comes back to nurses and informs nurse child has a rash on abdomen. Client brought back to exam room. Noted child's ears are red, rash on abdomen and child is scratching his head NP and RN enter exam room with emergency kit. V/S taken B/P 84/62, pulse 120 Benadryl 0.5ml drawn up by NP, administered by RN in the right deltoid Epinephrine 0.2 ml drawn up by Np and administered by RN on right deltoid 350pm EMS is called by RN speaks to 911 operator. Operator gave instructions of no food or liquids, to lay child on side if vomits> nurse informed EMS on their way to the clinic. 355pm Ems arrives, escorted to exam room child's pulse 88 356- 400pm EMS with child and parents. Parents have declined to have EMS take child to Emergency room for monitoring 405pm EMS leaves 0406pm parents and child in lobby 412pm NP assessment sleepy but rousable, lungs clear, easy respiration, No rash on abdomen, truck or back, face 422pm pulse ox 97-98, no rash noted sleepy pulse 90 waiting in lobby 430pm pulse 90, lungs clear, no rash on abdomen, face or trunk, sleepy, discharged F/U on 02/09/2018 telephone call @355pm to patient, to cell number listed in profile. Spoke to step father. States child had a temperature in the morning , he was given Tylenol. Temperature resolved, sent to school. child is fine.
Age: 22.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 22-year-old female patient. No information regarding the patient's medical history and concurrent conditions was provided. On 26-JAN-2018, the patient was vaccinated with a dose of PROQUAD injection via subcutaneous route in the right arm, lot # N019251 with expiration date on 20-DEC-2018 instead of M-M-R II injection. Concomitantly, the patient received a dose of VARIVAX. Other concomitant therapies included SYNTHROID. On 26-JAN-2018, the patient experienced an unspecified localized injection site reaction. The patient recovered from the event on an unknown date in 2018. The relatedness between the event and PROQUAD was not reported.
Age: 22.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 22-year-old female patient. No information regarding the patient's medical history and concurrent conditions was provided. On 26-JAN-2018, the patient was vaccinated with a dose of PROQUAD injection via subcutaneous route in the right arm, lot # N019251 with expiration date on 20-DEC-2018 instead of M-M-R II injection. Concomitantly, the patient received a dose of VARIVAX. Other concomitant therapies included SYNTHROID. On 26-JAN-2018, the patient experienced an unspecified localized injection site reaction. The patient recovered from the event on an unknown date in 2018. The relatedness between the event and PROQUAD was not reported.
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report has been received from a nurse, and refers to a 22 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 25-JAN-2018, the patient received inadvertently a dose of VARIVAX lot # N020686, expiration date 27-JUL-2019 (dose, strength and route of administration were not reported) and a dose of PROQUAD lot # N019251, expiration date 20-DEC-2018 as reported to "entry college" (prophylaxis), the vaccines were reconstituted with sterile diluent. At the reporting time, no adverse effects were reported.
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse, and refers to a 22 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 25-JAN-2018, the patient received inadvertently a dose of VARIVAX lot # N020686, expiration date 27-JUL-2019 (dose, strength and route of administration were not reported) and a dose of PROQUAD lot # N019251, expiration date 20-DEC-2018 as reported to "entry college" (prophylaxis), the vaccines were reconstituted with sterile diluent. At the reporting time, no adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant referring to an infant patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 25-JAN-2018, the patient was inadvertently administered one dose of PNEUMOVAX 23 (route of administration, lot # and expiration date were not reported) instead of one dose of PREVNAR 13, for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Cataract nuclear, Chelation therapy, Corneal oedema, Corneal operation
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-AUG-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of zoster causing severe eye disorders. Beginning on 15-JAN-2015, the patient was treated for eye  disorders,  that were then identified as corneal band keratopathy. Throughout 2015, the patient was treated  over the course of twelve medical encounters for treatment of severe and worsening disorder, diagnosed as corneal band keratopathy, herpetic uveitis, scarring and opacity, corneal band nuclear sclerosis of both eyes, blisters on the eye, corneal edema, corneal ulcer, and Edta chelation, which doctors observed had flared up after her vaccination when she broke out with shingles in 2013 which has spread to her eyes, causing secondary complications from zoster infections in the eye. The patient underwent multiple surgeries to remove corneal epithelium and eventually sustained a corneal transplant in attempts to curb her condition and vision loss. The patient has continued to suffer, and was treated throughout seven encounters and procedures in 2016  for continued treatment of her condition. On or about 21-APR-2017, she began to suffer facial pain in addition to her eye disorders, which was then diagnosed as post-herpetic neuralgia of the face, a chronic  condition of nerve damage and residual and secondary to zoster  infections. The patient has sustained additional treatments on eight  additional medical encounters in 2017 for treatment of these extensive  zoster complications and vision. In addition to aggressive treatments and surgical interventions, she has been prescribed dorzolamide hydrochloride, timolol maleate (COSOPT), difuprednate (DUREZOL), acyclovir, prednisolone acetate, ofloaxin, prednisolone acetate (PRED FORTE), ofloxacin (OCUFLOX), brimonidine, moxifloxacin hydrochloride (VIGAMOX),  "sistane"  ointment, and artificial tears for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant  medical expenses, pain and suffering, and other damages. Upon internal review, zoster infections in the eye, corneal opacity, corneal ulcer, herpetic uvetis, Edta chelation, vision loss, multiple surgeries to remove epithelium, corneal transplant, were determined medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Corneal transplant, Eye disorder, Eye opacity, Facial pain, Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-AUG-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of zoster causing severe eye disorders. Beginning on 15-JAN-2015, the patient was treated for eye  disorders,  that were then identified as corneal band keratopathy. Throughout 2015, the patient was treated  over the course of twelve medical encounters for treatment of severe and worsening disorder, diagnosed as corneal band keratopathy, herpetic uveitis, scarring and opacity, corneal band nuclear sclerosis of both eyes, blisters on the eye, corneal edema, corneal ulcer, and Edta chelation, which doctors observed had flared up after her vaccination when she broke out with shingles in 2013 which has spread to her eyes, causing secondary complications from zoster infections in the eye. The patient underwent multiple surgeries to remove corneal epithelium and eventually sustained a corneal transplant in attempts to curb her condition and vision loss. The patient has continued to suffer, and was treated throughout seven encounters and procedures in 2016  for continued treatment of her condition. On or about 21-APR-2017, she began to suffer facial pain in addition to her eye disorders, which was then diagnosed as post-herpetic neuralgia of the face, a chronic  condition of nerve damage and residual and secondary to zoster  infections. The patient has sustained additional treatments on eight  additional medical encounters in 2017 for treatment of these extensive  zoster complications and vision. In addition to aggressive treatments and surgical interventions, she has been prescribed dorzolamide hydrochloride, timolol maleate (COSOPT), difuprednate (DUREZOL), acyclovir, prednisolone acetate, ofloaxin, prednisolone acetate (PRED FORTE), ofloxacin (OCUFLOX), brimonidine, moxifloxacin hydrochloride (VIGAMOX),  "sistane"  ointment, and artificial tears for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant  medical expenses, pain and suffering, and other damages. Upon internal review, zoster infections in the eye, corneal opacity, corneal ulcer, herpetic uvetis, Edta chelation, vision loss, multiple surgeries to remove epithelium, corneal transplant, were determined medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Keratopathy, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia, Retinal disorder
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-AUG-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of zoster causing severe eye disorders. Beginning on 15-JAN-2015, the patient was treated for eye  disorders,  that were then identified as corneal band keratopathy. Throughout 2015, the patient was treated  over the course of twelve medical encounters for treatment of severe and worsening disorder, diagnosed as corneal band keratopathy, herpetic uveitis, scarring and opacity, corneal band nuclear sclerosis of both eyes, blisters on the eye, corneal edema, corneal ulcer, and Edta chelation, which doctors observed had flared up after her vaccination when she broke out with shingles in 2013 which has spread to her eyes, causing secondary complications from zoster infections in the eye. The patient underwent multiple surgeries to remove corneal epithelium and eventually sustained a corneal transplant in attempts to curb her condition and vision loss. The patient has continued to suffer, and was treated throughout seven encounters and procedures in 2016  for continued treatment of her condition. On or about 21-APR-2017, she began to suffer facial pain in addition to her eye disorders, which was then diagnosed as post-herpetic neuralgia of the face, a chronic  condition of nerve damage and residual and secondary to zoster  infections. The patient has sustained additional treatments on eight  additional medical encounters in 2017 for treatment of these extensive  zoster complications and vision. In addition to aggressive treatments and surgical interventions, she has been prescribed dorzolamide hydrochloride, timolol maleate (COSOPT), difuprednate (DUREZOL), acyclovir, prednisolone acetate, ofloaxin, prednisolone acetate (PRED FORTE), ofloxacin (OCUFLOX), brimonidine, moxifloxacin hydrochloride (VIGAMOX),  "sistane"  ointment, and artificial tears for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant  medical expenses, pain and suffering, and other damages. Upon internal review, zoster infections in the eye, corneal opacity, corneal ulcer, herpetic uvetis, Edta chelation, vision loss, multiple surgeries to remove epithelium, corneal transplant, were determined medically significant. Additional information has been requested.