chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-NOV-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) 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 09-OCT-2015 the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster also known as shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) and prednisone for management of his persistent and painful symptoms. 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 has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-NOV-2014, the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) 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 27-NOV-2016 the patient was treated for the onset of a severe 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: Arthralgia, Headache, Injection site pain
Clinical narrative: This spontaneous report was received from a 71 year old female patient reporting on herself with sciatica. The patient's concomitant therapies included vitamins. The patient's has no drug Reactions or allergies. No information was provided regarding the patient's medical history. On 26-OCT-2017, the patient was vaccinated with ZOSTAVAX in the left arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 28-OCT-2017, the patient developed pain starting near her left shoulder radiating down her left side to her left hip an intermittent headache. The consumer states she was evaluated at a local urgent care facility, by an unspecified physician assistant, and was prescribed tramadol hydrochloride (TRAMADOL), methocarbamol (ROBAXIN), and ice compresses. The reporter also stated that the symptoms improved after taking the medication, but eventually returned. The pain was improved with movement. The outcome of the events pain starting near her left shoulder radiating down her left side to her left hip an intermittent headache was reported as resolving. Additionally, the reporter did not provide causality assessment between he events and vaccination with ZOSTAVAX.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist, concerning an approximately 67 year old female patient. The patient's medical history included cancer but she was completely in remission at the time of this report. The patient did not have concomitant medications, drug reactions or allergies were unknown by the reporter. On 07-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # N022704 and expiration date on 27-FEB-2019 (strength was not reported), one injection shot was administered once for prevention of pneumococcal disease; but her arm swelled up overnight. The reporter stated that the swelling resembled Cellulitis, but was not Cellulitis". The patient was told to see her doctor it was unknown if she has made contact with her physician. No treatment was given for the event and no laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. At the time of this report, the patient had not recovered from the swollen arm. The causal relationship between the swollen arm and PNEUMOVAX 23 was not provided.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a other health physician assistant, regarding a 12 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-NOV-2017, the patient was vaccinated with GARDASIL 9 intramuscularly, lot # N017832 with expiration date on 16-NOV-2019 (strength, dose and frequency were not reported) for prophylaxis. On the same date just 5 seconds after vaccination, the patient had a syncopal episode, and as reported he was "out for 10 seconds". His blood pressure and oximetry were checked and by the time of this report the patient was doing fine. The causal relationship between vaccination with GARDASIL 9 and the syncopal episode was not mentioned by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blindness, Cataract nuclear, Emotional distress, Eye pain
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2015, the patient was inoculated at a Medical Center 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 series of devastating complications, resulting in catastrophic total loss of her vision. On or about 11-FEB-2016, she sought treatment at center for visual interferences, described as "cob webs" and floaters in her vision, primarily on her right side. She was diagnosed with uveitis and elevated intraocular pressure (IOP) and prescribed prednisone. On 11-FEB-2016, she was also treated for iritis and panuveitus. On or about 16-FEB-2016, she sought treatment for worsening blurring and redness of her eyes and was prescribed prednisolone, TIMOPTIC and atrophine BID right eye for management of her painful eye complications. On or about 09-MAR-2016, she was treated for worsening vision in both eyes which was diagnosed as acute retinal necrosis, a condition cause secondary to herpes zoster keratitis, known as shingles infection of the eye. She was prescribed VALTREX in attempt to treat optic condition and was increased steadily in attempt of curb her necrosis. In April 2016, it was observed there was optic atrophy, nuclear sclerotis, obliteration of the retinal arterioles, and retinal detachment. Required surgery. On or about 06-JUN-2016, she was designated to be "legally and permanently blind" due to her zoster-related injuries and secondary necrosis. As a direct result of the vaccine, she suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition and irreversible blindness. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, uveitis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were determined a significant medical events. Uveitis, vaccination failure, nuclear sclerosis, iritis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injury, Intraocular pressure increased, Iritis, Necrotising retinitis, Ocular hyperaemia
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2015, the patient was inoculated at a Medical Center 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 series of devastating complications, resulting in catastrophic total loss of her vision. On or about 11-FEB-2016, she sought treatment at center for visual interferences, described as "cob webs" and floaters in her vision, primarily on her right side. She was diagnosed with uveitis and elevated intraocular pressure (IOP) and prescribed prednisone. On 11-FEB-2016, she was also treated for iritis and panuveitus. On or about 16-FEB-2016, she sought treatment for worsening blurring and redness of her eyes and was prescribed prednisolone, TIMOPTIC and atrophine BID right eye for management of her painful eye complications. On or about 09-MAR-2016, she was treated for worsening vision in both eyes which was diagnosed as acute retinal necrosis, a condition cause secondary to herpes zoster keratitis, known as shingles infection of the eye. She was prescribed VALTREX in attempt to treat optic condition and was increased steadily in attempt of curb her necrosis. In April 2016, it was observed there was optic atrophy, nuclear sclerotis, obliteration of the retinal arterioles, and retinal detachment. Required surgery. On or about 06-JUN-2016, she was designated to be "legally and permanently blind" due to her zoster-related injuries and secondary necrosis. As a direct result of the vaccine, she suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition and irreversible blindness. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, uveitis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were determined a significant medical events. Uveitis, vaccination failure, nuclear sclerosis, iritis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Optic atrophy, Physical disability, Quality of life decreased, Retinal detachment
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2015, the patient was inoculated at a Medical Center 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 series of devastating complications, resulting in catastrophic total loss of her vision. On or about 11-FEB-2016, she sought treatment at center for visual interferences, described as "cob webs" and floaters in her vision, primarily on her right side. She was diagnosed with uveitis and elevated intraocular pressure (IOP) and prescribed prednisone. On 11-FEB-2016, she was also treated for iritis and panuveitus. On or about 16-FEB-2016, she sought treatment for worsening blurring and redness of her eyes and was prescribed prednisolone, TIMOPTIC and atrophine BID right eye for management of her painful eye complications. On or about 09-MAR-2016, she was treated for worsening vision in both eyes which was diagnosed as acute retinal necrosis, a condition cause secondary to herpes zoster keratitis, known as shingles infection of the eye. She was prescribed VALTREX in attempt to treat optic condition and was increased steadily in attempt of curb her necrosis. In April 2016, it was observed there was optic atrophy, nuclear sclerotis, obliteration of the retinal arterioles, and retinal detachment. Required surgery. On or about 06-JUN-2016, she was designated to be "legally and permanently blind" due to her zoster-related injuries and secondary necrosis. As a direct result of the vaccine, she suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition and irreversible blindness. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, uveitis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were determined a significant medical events. Uveitis, vaccination failure, nuclear sclerosis, iritis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Retinopexy, Uveitis, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2015, the patient was inoculated at a Medical Center 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 series of devastating complications, resulting in catastrophic total loss of her vision. On or about 11-FEB-2016, she sought treatment at center for visual interferences, described as "cob webs" and floaters in her vision, primarily on her right side. She was diagnosed with uveitis and elevated intraocular pressure (IOP) and prescribed prednisone. On 11-FEB-2016, she was also treated for iritis and panuveitus. On or about 16-FEB-2016, she sought treatment for worsening blurring and redness of her eyes and was prescribed prednisolone, TIMOPTIC and atrophine BID right eye for management of her painful eye complications. On or about 09-MAR-2016, she was treated for worsening vision in both eyes which was diagnosed as acute retinal necrosis, a condition cause secondary to herpes zoster keratitis, known as shingles infection of the eye. She was prescribed VALTREX in attempt to treat optic condition and was increased steadily in attempt of curb her necrosis. In April 2016, it was observed there was optic atrophy, nuclear sclerotis, obliteration of the retinal arterioles, and retinal detachment. Required surgery. On or about 06-JUN-2016, she was designated to be "legally and permanently blind" due to her zoster-related injuries and secondary necrosis. As a direct result of the vaccine, she suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition and irreversible blindness. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, uveitis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were determined a significant medical events. Uveitis, vaccination failure, nuclear sclerosis, iritis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were considered disabling. Additional information has been requested.
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-NOV-2017, the patient was vaccinated with an expired VAQTA (dose and route of administration were not reported) lot # M047658 and expiration date: 28-OCT-2017. The vaccine did not have any temperature excursions prior to administration. No adverse symptoms were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 from lot N017697 expiry date 21-JAN-2020 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1711USA004679: US-009507513-1711USA004680: US-009507513-1710USA000490: US-009507513-1711USA004677.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 12 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 28-SEP-2017 the patient was vaccinated with improperly stored dose of GARDASIL 9 from lot N017697 expiry date 21-JAN-2020 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1711USA004679: US-009507513-1711USA004680: US-009507513-1711USA004678: US-009507513-1711USA004676: US-009507513-1711USA004805.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 28-SEP-2017 the patient was vaccinated with improperly stored doses of GARDASIL 9 from lot N017697 expiry date 21-JAN-2020 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1710USA000490: US-009507513-1711USA004679: US-009507513-1711USA004680: US-009507513-1711USA004676: US-009507513-1711USA004677.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 28-SEP-2017 the patient was vaccinated with improperly stored doses of GARDASIL 9 lot # N015087 expiry date 20-OCT-2019 by intramuscular route for prophylaxis.  No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1710USA000490: US-009507513-1711USA004680: US-009507513-1711USA004676: US-009507513-1711USA004677.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 from lot N015087 expiry date 20-OCT-2019 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1711USA004679: US-009507513-1710USA000490: US-009507513-1711USA004676: US-009507513-1711USA004677.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 29-SEP-2017 the patient was vaccinated with improperly stored dose of GARDASIL 9 from lot N017697 expiry date 21-JAN-2020 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1711USA004679: US-009507513-1711USA004680: US-009507513-1711USA004678: US-009507513-1711USA004676: US-009507513-1711USA004677.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse via consumer from other company Pfizer (under the reference number: 2017382866) on 30-Oct-2017. This case involves a female patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced anaphylaxis. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event: anaphylaxis. Documents held by sender: none. Sender's Comments: The patient experienced anaphylaxis post vaccination with Flu vaccine (MFR UNK). No information regarding the time to onset has been reported. No information regarding product lot or brand name has been reported. Additional information regarding latency, product lot or brand name must be obtained. Alternate etiologies along with patient's immunological and allergic history should be assessed. Based upon reported information the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Nausea, Vomiting, Vomiting in pregnancy
Clinical narrative: Initial solicited report received on 30 October 2017 from a health care professional. This is a prospective pregnancy registry case for Study. This case involves a female subject of unspecified age who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was reported as 27 May 2018. The mother and father's health status were not reported. The father's age was not reported. The current pregnancy history was reported as "no illness reported during this pregnancy". The subject's previous pregnancy was not reported. The subject's maternal drug exposure was not reported. The subject received a 0.5 ml intramuscular dose of FLUZONE QIV in the left deltoid on 30 October 2017 (frequency: one dosage, batch number not reported). The subject's pregnancy complication was not reported. It was not reported if the subject had any treatment for infertility. The subject's family history of congenital abnormality was not reported. On an unspecified date the subject experienced relevant non serious adverse event morning sickness with nausea and vomiting. The corrective treatment of the non-serious adverse event morning sickness with nausea and vomiting was not reported. Prenatal testing was not reported. Outcome of non-serious adverse event of morning sickness with nausea and vomiting was not reported. The pregnancy was ongoing at the time report. List of documents held by sender: none.; Sender's Comments: A pregnant female received a dose of study product. The subject had non-serious adverse event of morning sickness with nausea and vomiting. Based on the information available the sponsor assess the event as not related to the vaccine. "The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose".
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Nausea, Vomiting, Vomiting in pregnancy
Clinical narrative: Initial solicited report received on 30 October 2017 from a Pharmacist. This is a prospective pregnancy registry case for Study. This case involves a 28 year-old-female subject who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was not reported. The mother and father's health status were not reported. The father's age was not reported. The current pregnancy history was reported as, the subject was 13 weeks pregnant and "did not have any health issues during the pregnancy". The maternal drug exposure was not reported. The subject's past obstetric information was not reported. The subject received 0.5 ml intramuscular dose of FLUZONE QIV on 30 October 2017 (batch no: UI849AC, site of administration was not reported). The pregnancy complication was not reported. It was not reported if the subject had any treatment for infertility. The subject's family history of congenital abnormality was not reported. The subject had relevant non serious adverse event of morning sickness with nausea and vomiting from an unspecified date. Corrective treatment for non-serious adverse event morning sickness with nausea and vomiting was not reported. Outcome of non-serious adverse event morning sickness with nausea and vomiting was not reported. Prenatal testing was not reported. The pregnancy was ongoing at the time report. List of documents held by sender: none. Sender's Comments: A 28-year-old female subject received a dose of study vaccine during pregancy. She had non serious event morning sickness with nausea and vomiting. The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Dermatitis, Rash
Clinical narrative: 2 Weeks after receiving the Hep A vaccine, patient began developing a rash on her left hip right above where the vaccine was administered. The rash continued to spread over the course of several days and did not respond to creams. A follow up visit with her pediatrician resulted in a diagnosis of dermatitis.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Radiculitis brachial
Clinical narrative: Acute Brachial neuritis.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Autopsy, Death, Decreased appetite, Dyspnoea, Irritability
Clinical narrative: Lethargy, substantial decreased eating - especially when trying to get her to eat, very pale in color. Eventually leading to breathing difficulties and death (one week from vaccinations). Starting the same afternoon of her vaccines, patient was very lethargic but fussy when awake. The next day and days to follow her eating substantially decreased and she was very pale in color. On February 2nd I noticed breathing changes, so I took her to the ER. She passed away at 68 days old on February 3rd. Now that I have done substantial research on adverse effects of vaccines, I know these vaccines had to do with her death.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Lethargy, Pallor
Clinical narrative: Lethargy, substantial decreased eating - especially when trying to get her to eat, very pale in color. Eventually leading to breathing difficulties and death (one week from vaccinations). Starting the same afternoon of her vaccines, patient was very lethargic but fussy when awake. The next day and days to follow her eating substantially decreased and she was very pale in color. On February 2nd I noticed breathing changes, so I took her to the ER. She passed away at 68 days old on February 3rd. Now that I have done substantial research on adverse effects of vaccines, I know these vaccines had to do with her death.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Pruritus, Swelling, Urticaria
Clinical narrative: Hives, shortness of breath, itching and swelling.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erosion, Peripheral swelling
Clinical narrative: She developed an impressive localized allergic reaction to the injection, with swelling from shoulder to forearm. She had no pain to indicate infection, and has excoriation at the injection site. Her sister had a similar reaction which resolved within 48 hours.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Severe edema and erythema extending to shoulder area posteriorly and to elbow. Approx. 25% in upper arm girth due to edema.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Patient states she began having severe muscle aches and cramps after receiving the vaccine. Was seen in clinic Nov 9th and stated she was beginning to feel better.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Normal arm discomfort the first week which progressed to shoulder/upper arm pain with movement, sharp when moving across the body, aching after use.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt given flu vaccine in right deltoid, 2 days later mom noticed site swollen, red, hot and painful to touch, gave a dose of BENADRYL with little improvement - seen in office on 11/9/17 and dx with cellulitis - given abx.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information on the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 14-OCT-2017, the patient was vaccinated with unknown dose of PNEUMOVAX 23 (route of administration, lot#, expiry date not reported) for prophylaxis.  On 15-OCT-2017, the patient came back to the pharmacy with a hot, swollen arm. Relevant lab data was unknown. The outcome of the events and causality assessment were not provided.
Age: 1.58
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 19-month-old patient of unknown gender. No information regarding the patient's pertinent medical history,concomitant medications and drug reactions or allergies was provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA007325:
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Dry throat, Dysphagia, Dyspnoea
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a consumer on 30-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, route, site and dose in series not reported) on 10-Oct-2017. Patient had numerous allergies, specifically Sulfa and has a rare blood disease and throat issues. Concomitant medications was not reported. On an unspecified date, ever since following the vaccination, the patient had been sick not getting better and has a dry throat. On an unknown date, following vaccination patient had upper respiratory and draining, headache, chills, sore throat, wheezing, difficulty in breathing, hard to swallow, earache, and coughing which continues to today. It was reported that patient received the vaccine at her own doctor's office. Lab data and corrective treatment were not reported. The outcome of all the events was reported as not recovered except the event unwell which was not reported. Upon internal review the company decided to consider the case as serious due to Important Medical Events: upper respiratory and draining, difficulty breathing, swallowing difficult, headache, chills, sore throat, wheezing and coughing. List of documents held by sender: none. Sender's Comments: Patient developed upper respiratory tract infection and earache after vaccination. Exact time to onset is not known. More details regarding patient's medical history, event onset details, previous vaccination history, confirmatory diagnosis reports, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Headache, Malaise, Oropharyngeal pain, Respiratory disorder
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a consumer on 30-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, route, site and dose in series not reported) on 10-Oct-2017. Patient had numerous allergies, specifically Sulfa and has a rare blood disease and throat issues. Concomitant medications was not reported. On an unspecified date, ever since following the vaccination, the patient had been sick not getting better and has a dry throat. On an unknown date, following vaccination patient had upper respiratory and draining, headache, chills, sore throat, wheezing, difficulty in breathing, hard to swallow, earache, and coughing which continues to today. It was reported that patient received the vaccine at her own doctor's office. Lab data and corrective treatment were not reported. The outcome of all the events was reported as not recovered except the event unwell which was not reported. Upon internal review the company decided to consider the case as serious due to Important Medical Events: upper respiratory and draining, difficulty breathing, swallowing difficult, headache, chills, sore throat, wheezing and coughing. List of documents held by sender: none. Sender's Comments: Patient developed upper respiratory tract infection and earache after vaccination. Exact time to onset is not known. More details regarding patient's medical history, event onset details, previous vaccination history, confirmatory diagnosis reports, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a consumer on 30-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, route, site and dose in series not reported) on 10-Oct-2017. Patient had numerous allergies, specifically Sulfa and has a rare blood disease and throat issues. Concomitant medications was not reported. On an unspecified date, ever since following the vaccination, the patient had been sick not getting better and has a dry throat. On an unknown date, following vaccination patient had upper respiratory and draining, headache, chills, sore throat, wheezing, difficulty in breathing, hard to swallow, earache, and coughing which continues to today. It was reported that patient received the vaccine at her own doctor's office. Lab data and corrective treatment were not reported. The outcome of all the events was reported as not recovered except the event unwell which was not reported. Upon internal review the company decided to consider the case as serious due to Important Medical Events: upper respiratory and draining, difficulty breathing, swallowing difficult, headache, chills, sore throat, wheezing and coughing. List of documents held by sender: none. Sender's Comments: Patient developed upper respiratory tract infection and earache after vaccination. Exact time to onset is not known. More details regarding patient's medical history, event onset details, previous vaccination history, confirmatory diagnosis reports, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given a vaccine that expired 13 days ago, there has been no adverse event at this time.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Pt received flu vaccine on 11/9/17 in the morning, by the afternoon pt went to school nurse because she was in a lot of pain, said she felt like she was getting a Charlie horse in her arm, tried icing it and it didn't help, is swollen and hot below injection site, painful to touch. Seen in office and diagnosis with allergic rxn, the next day pt came back in office: direct swelling at shot site and this has decreased. But swelling now more diffuse and redness slightly increased as well. Less pain but still sore and pain w/ mvt. No fever. No angioedema. No wheeze/cough. No abd pain. No n/v/d. No rash. No hx of vaccine reactions in past.  - Pt given abx for cellulitis.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain, Pain in extremity
Clinical narrative: Pt received flu vaccine on 11/9/17 in the morning, by the afternoon pt went to school nurse because she was in a lot of pain, said she felt like she was getting a Charlie horse in her arm, tried icing it and it didn't help, is swollen and hot below injection site, painful to touch. Seen in office and diagnosis with allergic rxn, the next day pt came back in office: direct swelling at shot site and this has decreased. But swelling now more diffuse and redness slightly increased as well. Less pain but still sore and pain w/ mvt. No fever. No angioedema. No wheeze/cough. No abd pain. No n/v/d. No rash. No hx of vaccine reactions in past.  - Pt given abx for cellulitis.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Significant shoulder pain (NOT just at injection site) but entire left shoulder. Still in treatment.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Left shoulder pain since a couple days after the vaccine was given. I did expect some soreness but it has been 3 weeks and my left shoulder is still very sore. Have been using Advil sporadically but at advice of my doctor's nurse I will begin a course of Advil for several days to find out if this will remedy the situation. Have limited mobility with the arm and when I do use the arm I usually experience moderate pain. It is difficult to get comfortable in bed at night due to the shoulder pain. Thanks. PS:  Not sure that there is any other explaination for the shoulder pain but thought I should report it.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Malaise, Nasopharyngitis, Pulmonary congestion
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of lung congestion in a 63-year-old male patient who received Flu Seasonal QIV Dresden. Co-suspect products included LOVAZA capsule for cholesterol and ADVAIR inhalation powder for chronic obstructive pulmonary disease. On 30th October 2017, the patient received Influenza vaccine. On January 2001, the patient started LOVAZA 1 g at an unknown frequency and ADVAIR at an unknown dose and frequency. On an unknown date, less than a month after receiving Influenza vaccine and unknown after starting LOVAZA and ADVAIR, the patient experienced lung congestion (serious criteria GSK medically significant), cold, dry cough and feeling unwell. The action taken with LOVAZA was unknown (Dechallenge was unknown). Rechallenge with LOVAZA was unknown. The action taken with ADVAIR was unknown (Dechallenge was unknown). Rechallenge with ADVAIR was unknown. On an unknown date, the outcome of the lung congestion, cold, dry cough and feeling unwell were unknown. It was unknown if the reporter considered the lung congestion, cold, dry cough and feeling unwell to be related to Influenza vaccine, LOVAZA and ADVAIR. Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. On 1st January 2001, the patient started ADVAIR 250/50 at an unknown dose and frequency. The patient reported to get refills on his medications. On 30th October 2017, the patient received flu shot at the hospital (doctors office) and when he got home he started feeling ill. The reporter described the adverse event as being a cold, congestion on the chest and a dry hacking cough.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance
Clinical narrative: A nurse from Hospital called to say patient was just admitted with a symptom of barely being able to walk. She said the doctor wanted to know when the flu shot was given and the lot number/exp. date.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Bronchiolitis, Cyanosis, Ocular hyperaemia, Pulmonary function test
Clinical narrative: Within 24 hours of being vaccinated, the patient had a temperature of 105.5, beet red eyes, wheezing, turning blue and shaking. The ER gave her steroids and breathing treatments. The ER physician diagnosed her with vaccine induced acute bronchiolitis.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Tremor, Urine analysis, Vaccination complication, Wheezing
Clinical narrative: Within 24 hours of being vaccinated, the patient had a temperature of 105.5, beet red eyes, wheezing, turning blue and shaking. The ER gave her steroids and breathing treatments. The ER physician diagnosed her with vaccine induced acute bronchiolitis.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Decreased appetite, Dyskinesia, Headache, Heart rate increased
Clinical narrative: Around 6 pm began acting lethargic. She didn't want to eat dinner and asked to go to bed. I gave her a warm bath and put her pajamas on her. By 7 pm I had to carry her to bed. She was "whiny" and didn't want to read stories or do any of her bedtime routine. I took her temperature via forehead temperature was 99.9. I also took her pulse and oxygen with a finger pulse oximeter. Her heart rate was 147. I went downstairs to talk to my husband about how she was feeling. Approximately 10 minutes later we heard her screaming. I went in her room and she was screaming that her legs, arms, neck, head hurt. I picked her up and help her and she quickly went back to sleep. I took her temperature again 100.9/pulse still in the 140s. I stayed with her to monitor her. Between 12-1 am she woke up screaming and saying "I don't know where I am" I turned on lights. She was laying looking up. I yelled her name and after 3 times she looked at me. I picked her up and held her. She fell back asleep. Approx 10 minutes after she fell asleep I took her temperature again which was normal and heart rate which was still in the 140s. No fever and elevated heart rate continued through morning.  Also it should be noted that her arms and legs jerked throughout the night and she would not stop moving her legs.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Irritability, Lethargy, Neck pain, Pain in extremity, Screaming
Clinical narrative: Around 6 pm began acting lethargic. She didn't want to eat dinner and asked to go to bed. I gave her a warm bath and put her pajamas on her. By 7 pm I had to carry her to bed. She was "whiny" and didn't want to read stories or do any of her bedtime routine. I took her temperature via forehead temperature was 99.9. I also took her pulse and oxygen with a finger pulse oximeter. Her heart rate was 147. I went downstairs to talk to my husband about how she was feeling. Approximately 10 minutes later we heard her screaming. I went in her room and she was screaming that her legs, arms, neck, head hurt. I picked her up and help her and she quickly went back to sleep. I took her temperature again 100.9/pulse still in the 140s. I stayed with her to monitor her. Between 12-1 am she woke up screaming and saying "I don't know where I am" I turned on lights. She was laying looking up. I yelled her name and after 3 times she looked at me. I picked her up and held her. She fell back asleep. Approx 10 minutes after she fell asleep I took her temperature again which was normal and heart rate which was still in the 140s. No fever and elevated heart rate continued through morning.  Also it should be noted that her arms and legs jerked throughout the night and she would not stop moving her legs.
Age: 47.0
Sex: F
Vaccine: CHOL, HEPA, TDAP, TYP
Symptoms: Feeling hot, Oral pruritus, Paraesthesia oral
Clinical narrative: Symptoms reported: tingling tongue around perimeter, on second day on right side predominately; right side of face warm as if "hives" though no hives, no raised skin; itchy around mouth past lip area, below lower lip. Client reports taking benadryl, relief for 2 hours then symptoms presented again and were constant throughout day (day after receiving vaccine).