chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-NOV-2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-NOV-2013 and 10-FEB-2014, the patient was treated by a healthcare provider at an urgent care for shingles and neuropathic pain secondary to shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injury, Pain, Physical disability, Quality of life decreased
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided). On unknown dates, as a direct and proximate result of the defective design of the ZOSTAVAX vaccine with which the patient was inoculated, the patient sustained serious personal injuries and related losses (unspecified), including serious physical injury and impairment; mental anguish; pain and suffering; loss of enjoyment of life; diminished capacity for the enjoyment of life; a diminished quality of life; loss of care, comfort, and consortium; lost wages; diminished ability to work; medical and related expenses; economic damages; and other losses and damages. As a direct and proximate result of the defective design of the ZOSTAVAX vaccine with which the patient was inoculated, the patient will continue to suffer such harm, damages, economic damages, and other losses in the future. The defective design of ZOSTAVAX was a substantial, proximate, and contributing factor in causing the patient's injuries. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Acute myocardial infarction, Angina pectoris, Arrhythmia, Asthenia, Dyspnoea
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 27-NOV-2017, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. On an unknown date [reported as shortly after receiving ZOSTAVAX], the patient suffered symptoms of dyspnea, nausea, weakness, shortness of breath, angina and arrhythmia requiring hospitalization. The patient was then diagnosed with an acute myocardial infarction. The outcome of the event is unknown. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. Upon internal review, acute myocardial infarction was determined to be medically significant. Acute myocardial infarction was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Nausea
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 27-NOV-2017, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. On an unknown date [reported as shortly after receiving ZOSTAVAX], the patient suffered symptoms of dyspnea, nausea, weakness, shortness of breath, angina and arrhythmia requiring hospitalization. The patient was then diagnosed with an acute myocardial infarction. The outcome of the event is unknown. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. Upon internal review, acute myocardial infarction was determined to be medically significant. Acute myocardial infarction was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye inflammation, Eye operation, Eye pain, Glaucoma, Iritis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 24-MAY-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In approximately 2017 [reported as shortly after receiving the ZOSTAVAX], the patient suffered recurrent episodes of right eye pain, inflammation, redness, blurred vision and severe visual field loss requiring surgical intervention. The patient was diagnosed with recurrent acute iritis and mixed mechanism glaucoma. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review, mixed mechanism glaucoma requiring surgical intervention was determined to be medically significant. Mixed mechanism glaucoma requiring surgical intervention and recurrent acute iritis requiring surgical intervention were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Vision blurred, Visual field defect
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 24-MAY-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In approximately 2017 [reported as shortly after receiving the ZOSTAVAX], the patient suffered recurrent episodes of right eye pain, inflammation, redness, blurred vision and severe visual field loss requiring surgical intervention. The patient was diagnosed with recurrent acute iritis and mixed mechanism glaucoma. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review, mixed mechanism glaucoma requiring surgical intervention was determined to be medically significant. Mixed mechanism glaucoma requiring surgical intervention and recurrent acute iritis requiring surgical intervention were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 19-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided) reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1812USA009243: US-009507513-1812USA009242: US-009507513-1812USA009244: US-009507513-1811USA009124:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 16-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided)reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA009243: US-009507513-1812USA009242: US-009507513-1811USA009124: US-009507513-1812USA009241.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Death, Vaccination complication
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. During 2009, the patient received the H1N1 FLUMIST (intranasal) once/single vaccine and died from reaction. It is not known whether an autopsy was performed. The cause of death was vaccination adverse reaction. The case was considered as serious due to fatal outcome. Sender's Comments: The fatal event of vaccination complication is not listed in the company core data sheet for FLUMIST. Due to limited information on patient's demographics, medical history, exposure to specific risk factors, concomitant drugs, dose and start date of the suspect drug, onset date and circumstances of the event, diagnostic and aetiologic workup and the absence of autopsy report it is not possible to make a conclusive assessment of the causal relationship between the event and suspect drug. Reported Cause(s) of Death: RECEIVED THE 2009 H1N1 FLUMIST VACCINE AND DIED FROM REACTION.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid serious case received from a physician. This case is link to case 2018SA340739 and 2018SA340772 same reporter. This case involves three patients (6-7 years old) who experienced flu strain A, while he/she received vaccine INFLUENZA VACCINE [Flu vaccine]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, patients received a dose of suspect INFLUENZA VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, patients developed a serious flu strain A (influenza) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that several kids that were properly vaccinated this year have the flu and it's documented strain A. Physician states there were 3 patients who went to the urgent care in the last 3-4 weeks that had been immunized for the flu come down with the flu. (Other relevant tests included no lab data.) Final diagnosis was flu strain A. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by sender: none. Sender's Comments: 6-7 years old patients presented with Influenza type A after and despite receiving FLUZONE QUADRIVALENT vaccine. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, vaccine manufacturer, concomitant medications, lab /radiological investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine and a case of vaccination failure cannot be assessed.
Sex: F
Vaccine: MNQ
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years old patient who received a dose of vaccine MENACTRA lot number not reported via unknown route in unknown administration site on 20-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was also the case of off label use. It was reported that 64 patient year old patient received MENACTRA on 20Oct2018 and was instructed by her doctor to get another vaccination 8 weeks later. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Neuropathy peripheral
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid serious case received from a health professional (Pharmacy Director). This case was linked to 2018SA388808 (same reporter). This case involves a 54 years old female patient who experienced neuropathy on her arm, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1817 via unknown route. On an unknown date, the patient developed a serious neuropathy on her arm (neuropathy peripheral) approximately 2 weeks following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant as per Important medical event. No lab test was reported. Final diagnosis was neuropathy on her arm. It was not reported if the patient received a corrective treatment. Outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Patient presented with peripheral neuropathy of her arm after vaccination with FLUBLOK QIV. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4
Symptoms: Neuropathy peripheral
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid serious case received from a health professional. (Pharmacy Director). This case is linked with case 2018SA388771 (same reporter). This case involves a 36 years old female patient who experienced neuropathy on her arm, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided. On 02-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1817 via unknown route. On an unknown date, the patient developed a serious neuropathy on her arm 2 weeks following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant as per Important medical event. No lab test was reported. Final diagnosis was neuropathy on her arm. It was not reported if the patient received a corrective treatment. Outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Patient presented with peripheral neuropathy after vaccination with FLUBLOK QIV. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Musculoskeletal disorder, Neck pain
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 81-years old female patient who developed so painful and pain even went down to my hand and up to my head and neck and couldn't move hand, had to have arm close to body while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HIGH DOSE. (It was reported that the patient was received the dose for years and years but not last year because he was sick). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis with (It was reported that the patient have had Rheumatoid for fifty some years, and right hand is all crippled from it). On 08-Dec-2018, the patient received a 0.5 ml single dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (frequency once) lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious couldn't move hand, had to have my arm close to my body (injected limb mobility decreased), so painful and pain even went down to my hand and up to my head (pain localized) (Unknown latency) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. It was reported that patient have more pain due to Rheumatoid, One finger still doesn't feel right. Patient was always so tired. (Other relevant tests included no lab data.) Final diagnosis was pain even went down to my hand and up to my head and neck, so painful and couldn't move it/ had to have my arm close to my body. The patient was treated with DEPO-MEDROL for pain. The patient was recovered from all the events. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 81-years old female patient who developed so painful and pain even went down to my hand and up to my head and neck and couldn't move hand, had to have arm close to body while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HIGH DOSE. (It was reported that the patient was received the dose for years and years but not last year because he was sick). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis with (It was reported that the patient have had Rheumatoid for fifty some years, and right hand is all crippled from it). On 08-Dec-2018, the patient received a 0.5 ml single dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (frequency once) lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious couldn't move hand, had to have my arm close to my body (injected limb mobility decreased), so painful and pain even went down to my hand and up to my head (pain localized) (Unknown latency) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. It was reported that patient have more pain due to Rheumatoid, One finger still doesn't feel right. Patient was always so tired. (Other relevant tests included no lab data.) Final diagnosis was pain even went down to my hand and up to my head and neck, so painful and couldn't move it/ had to have my arm close to my body. The patient was treated with DEPO-MEDROL for pain. The patient was recovered from all the events. List of documents held by sender: none.
Age: 0.83
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Anal incontinence, Cyanosis, Eye movement disorder, Hypotonia, Seizure
Clinical narrative: Spell concerning for seizure with eyes rolling back, limpness, perioral cyanosis, and fecal incontinence.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient reports arm pain and decreased range of motion persisting after 3 weeks.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fever, injection site soreness, fatigue. Fever and fatigue subsided within 24 hours of onset. Soreness persisted for 48 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Tuesday at 3 am she noticed redness, and swelling. Then at 7pm she noticed the redness spread to under her arm and it was sensitive to touch.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Decreased appetite, Headache, Injection site pain
Clinical narrative: Elevation in body temperature (recorded @ 100.1° F. by oral thermometer), chills, headache, diminished appetite, pain @ injection site. These symptoms presented within 12 to 14 hours after the injection.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Lethargy, Mobility decreased, Nightmare
Clinical narrative: PATIENT CAME INTO PHARMACY TWO DAYS AFTER SECOND SHINGRIX VACCINATION. PATIENT HAS 10-12 CM RED AREA AROUND INJECTION SITE; SLIGHTLY RAISED BUT NOT WARM TO TOUCH. PATIENT COMPLAINED OF EXCESSIVE LETHARGY THE DAY FOLLOWING INJECTION - UNABLE TO LEAVE BED. PATIENT ALSO COMPLAINED OF UNUSUALLY BAD NIGHTMARES THE NIGHT OF INJECTION. REACTIONS SEEMED TO BE LESS AS OF TWO DAYS POST INJECTION, SO PATIENT WAS NOT GOING TO SEE PHYSICIAN BUT ENCOURAGED VISIT IF SYMPTOMS BECAME WORSE. NOTIFIED PCP AFTER PATIENT REPORTED.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: Had flu shot on 11/2/18, and initially thought I had normal post-shot pain, but eventually began to worsen and has yet to go away. Shot felt normal when administered. Constant pain in left shoulder, worsens with movement. Very limited range of motion and arm is weak. Is particularly bad in the evening, through to morning. Causes discomfort during sleep, as well. Sometimes tingling goes to elbow and palm of hand.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan normal, X-ray normal
Clinical narrative: Had flu shot on 11/2/18, and initially thought I had normal post-shot pain, but eventually began to worsen and has yet to go away. Shot felt normal when administered. Constant pain in left shoulder, worsens with movement. Very limited range of motion and arm is weak. Is particularly bad in the evening, through to morning. Causes discomfort during sleep, as well. Sometimes tingling goes to elbow and palm of hand.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Patient reports muscle soreness going on 20 days and weakness in the arm.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site, muscle pain, tiredness, shivering, fever, queasy stomach. Have been taking Extra Strength TYLENOL as soon as symptoms started and will continue until symptoms subside.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site, muscle pain, tiredness, shivering, fever, queasy stomach. Have been taking Extra Strength TYLENOL as soon as symptoms started and will continue until symptoms subside.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Neuralgia, Pain in extremity, Skin warm
Clinical narrative: Experiencing intermittent burning/warm and intermittently lancinating pain starting in deltoid and traveling down to elbow and wrist, moderate intensity at times. No worsening or improvement of symptoms since injection. Exam at clinic 12/18/18. Will treat the symptom of neuropathic pain and follow up in 4 weeks.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient's mom email provider through the portal stating school nurse had call her that patient had welts on both her arms on injection sites. Per school nurse had drawn a circle on raised areas and continued to monitor to make sure welts continued to grow/spread. Followed up with patient's mother on 12/19/18 stated she was doing "just fine".
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had pain and redness at injection site that required a doctor visit.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia, Vaccination complication
Clinical narrative: Patient called today 12/19 stating that he is having a fever, shivering, and general body weakness. I explained to the patient that those are adverse events of the shingles shot and if symptoms are severe he can seek medical attention, patient has no itching or difficulty breathing.
Age: 58.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient stated she started to feel ill on Tuesday morning 12/18/2018. She had a fever of approximately 102.00 F as well as nausea, shaking, and muscle pain all over. As of Wednesday morning her fever has stopped however she was still experiencing chills and muscle pain all over. She was planning on going home to rest and drink plenty of fluids. If she did not start feeling better by Wednesday evening or if she felt worse she would go to urgent care.
Age: 58.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Tremor
Clinical narrative: Patient stated she started to feel ill on Tuesday morning 12/18/2018. She had a fever of approximately 102.00 F as well as nausea, shaking, and muscle pain all over. As of Wednesday morning her fever has stopped however she was still experiencing chills and muscle pain all over. She was planning on going home to rest and drink plenty of fluids. If she did not start feeling better by Wednesday evening or if she felt worse she would go to urgent care.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: -Patient said his arm hurts, especially when he moves or touches it. His arm is not red, swollen or warm to touch. He said he's been icing it all night, he said the pain is better compared to last night. I recommended patient to take Mortin if needed for the pain and also monitor his symptoms. He will also follow up with his primary care doctor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red swelling and sore but not at injection site, moved down the arm she received it in.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER, CHILLS.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Pain in extremity, Skin warm
Clinical narrative: My arm became extremely red, blistered, hot, and very sore. It continued to spread and covered an area the size of my palm and fingers. This continued for 2 weeks when I returned to pharmacy where I received the PREVNAR 13 and was told to contact the doctor. The following morning, I emailed pictures and dr called me in antibiotic with follow up in 4 days, where I was told to finish the 10-day course and contact her if no better. To date, it is still visible, but not hot or painful and lighter in color. The doctor is aware.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying, Crystalluria, Decreased appetite, Irritability, Rash
Clinical narrative: Monday (day of shot): Baby was sleepy and fussy evening after vaccination and didn't want to nurse. Baby was reluctant in nursing and went 6 hrs between nursings and 8 hrs without a wet diaper.  Tuesday: baby was sleepy and fussy, continued lack of wanting to nurse and low urine output.  Tuesday evening noticed urate crystals in diaper. Baby again nursed poorly in the evening and throughout the night. Only 1 wet diaper in overnight (tues to wed) 12 hours, which contained more urate crystals. Baby was fussy/crying and no tears being produced. Called baby's Dr's office and no appointments were available so talked to triage nurse and was advised to take baby to ER. Took baby to ER Wed afternoon. While at ER, nurse noticed baby also had rash covering trunk and abdomen with rash being more concentrated on left side.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Urine analysis, Urine output decreased
Clinical narrative: Monday (day of shot): Baby was sleepy and fussy evening after vaccination and didn't want to nurse. Baby was reluctant in nursing and went 6 hrs between nursings and 8 hrs without a wet diaper.  Tuesday: baby was sleepy and fussy, continued lack of wanting to nurse and low urine output.  Tuesday evening noticed urate crystals in diaper. Baby again nursed poorly in the evening and throughout the night. Only 1 wet diaper in overnight (tues to wed) 12 hours, which contained more urate crystals. Baby was fussy/crying and no tears being produced. Called baby's Dr's office and no appointments were available so talked to triage nurse and was advised to take baby to ER. Took baby to ER Wed afternoon. While at ER, nurse noticed baby also had rash covering trunk and abdomen with rash being more concentrated on left side.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Swelling
Clinical narrative: The patient reported that her arm was hurting at night while sleeping and it seemed to migrate up her neck. When she awoke the next morning, she had a painful bump on her neck. She reports that the bump has gone down and seems to be better now--4 days later.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Patient came home from school 1 day after immunization with minor injection site swelling, irritation and redness. Today (x2days after immunzation) the patient has redness from knee to hip on the injection leg with swelling, firmness, warm to touch and pain with palpation and weight-bearing.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site warmth, Weight bearing difficulty
Clinical narrative: Patient came home from school 1 day after immunization with minor injection site swelling, irritation and redness. Today (x2days after immunzation) the patient has redness from knee to hip on the injection leg with swelling, firmness, warm to touch and pain with palpation and weight-bearing.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Presyncope
Clinical narrative: HEMORRHAGIC RASH, PROFOUND FATIGUE, WEAKNESS, DIZZINESS NEAR SYNCOPE, NAUSEA.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Purpura
Clinical narrative: HEMORRHAGIC RASH, PROFOUND FATIGUE, WEAKNESS, DIZZINESS NEAR SYNCOPE, NAUSEA.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reports rash at site of injection which developed about 6-7 days following administration. No treatment sought by patient, merely monitoring per conversation on 12/18/18.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient describes severe pain in the shoulder and has difficulty moving in the arm, mostly occurring at night when going to sleep/laying down.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Somnolence, Vein discolouration
Clinical narrative: Within 12 hours of the vaccination my blood vessels on my left upper arm turned color from blue to red. It was very strange looking. I took photographs and sent one to Dr. a few weeks later. After the shot I felt ill and very tired for more than 3 days, so I stayed home and slept a lot.
Age: 1.08
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Large raised itchy hives.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Rash erythematous
Clinical narrative: Experienced one red rash on chest area but it did not progress to anything more.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Skin lesion, Tenderness
Clinical narrative: Had tenderness to Left arm on 12/15/18. Patient developed red lesions to left arm on 12/19/18.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash generalised, Rash macular, Urticaria
Clinical narrative: "Hands started itching at 22:00". :By morning I was covered over with rashes, red blotches, and whelps from scratching" - per employee.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Fatigue, Flushing, Pyrexia, Skin warm
Clinical narrative: Pt noted local erythema approx 12-18 hrs after injection. On 12/19/18 erythema on mid upper arm measured 12 cm by 10 cm. Area warm to touch area well defined. Pt felt fatigued, flushed and subjectively febrile. Placed on prednisone taper.
Age: 75.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient reports injection site redness, induration, warmth, pain. Was referred back to doctor.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysstasia, Fatigue, Headache, Joint range of motion decreased, Malaise
Clinical narrative: 6:30 Am 2018 - Next day after injection all my joints were not moveable, could hardly stand up. Went to bathroom, back to bed, tried to move arms legs-could do very little. By noon some movement. Felt sick, head hurt nose running-felt very tired, arm very sore.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Rhinorrhoea
Clinical narrative: 6:30 Am 2018 - Next day after injection all my joints were not moveable, could hardly stand up. Went to bathroom, back to bed, tried to move arms legs-could do very little. By noon some movement. Felt sick, head hurt nose running-felt very tired, arm very sore.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, swollen, warm to the touch (area = 9"w x 15"L). Dx: Cellulitis.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Since receiving vaccination patient experienced pain that radiates to back upper arm. Unable to move arm fully back or fully extend over head since vaccination. Recommended use to NSAIDs and ice or heat on arm to see if any relief.
Sex: M
Vaccine: TDAP
Symptoms: Death
Clinical narrative: death; This case was reported by a consumer via interactive digital media and described the occurrence of death nos in a 20-month-old male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced death nos (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death nos to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccinatin was not reported. The reporter stated that the registered nurse lost her son to DTaP.; Reported Cause(s) of Death: death NOS
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypertension, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: The evening of vaccination my arm began to hurt. Every evening for the next 7 days my arm hurt so bad it felt like it was going to explode. Ibuprofen 800 mg did not help, neither did heat or cold. After the 7th night I noticed limited range of motion of my arm; I could not raise it in front of me. MD said to give it time which I did. Range of motion improved a little but then, early April, I noticed that my shoulder blade was sticking out at odd angles when I made certain movements. In May, I had a nerve conduction and Electromyography study done and started physical therapy which I have attended weekly for 8 months. Diagnosis: Long Thoracic Nerve damage/inflammation with Scapular Winging.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Insomnia, Movement disorder, Muscular weakness
Clinical narrative: The evening of vaccination my arm began to hurt. Every evening for the next 7 days my arm hurt so bad it felt like it was going to explode. Ibuprofen 800 mg did not help, neither did heat or cold. After the 7th night I noticed limited range of motion of my arm; I could not raise it in front of me. MD said to give it time which I did. Range of motion improved a little but then, early April, I noticed that my shoulder blade was sticking out at odd angles when I made certain movements. In May, I had a nerve conduction and Electromyography study done and started physical therapy which I have attended weekly for 8 months. Diagnosis: Long Thoracic Nerve damage/inflammation with Scapular Winging.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: The evening of vaccination my arm began to hurt. Every evening for the next 7 days my arm hurt so bad it felt like it was going to explode. Ibuprofen 800 mg did not help, neither did heat or cold. After the 7th night I noticed limited range of motion of my arm; I could not raise it in front of me. MD said to give it time which I did. Range of motion improved a little but then, early April, I noticed that my shoulder blade was sticking out at odd angles when I made certain movements. In May, I had a nerve conduction and Electromyography study done and started physical therapy which I have attended weekly for 8 months. Diagnosis: Long Thoracic Nerve damage/inflammation with Scapular Winging.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electromyogram abnormal, Inflammation, Joint range of motion decreased, Nerve conduction studies abnormal, Nerve injury
Clinical narrative: The evening of vaccination my arm began to hurt. Every evening for the next 7 days my arm hurt so bad it felt like it was going to explode. Ibuprofen 800 mg did not help, neither did heat or cold. After the 7th night I noticed limited range of motion of my arm; I could not raise it in front of me. MD said to give it time which I did. Range of motion improved a little but then, early April, I noticed that my shoulder blade was sticking out at odd angles when I made certain movements. In May, I had a nerve conduction and Electromyography study done and started physical therapy which I have attended weekly for 8 months. Diagnosis: Long Thoracic Nerve damage/inflammation with Scapular Winging.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Winged scapula
Clinical narrative: The evening of vaccination my arm began to hurt. Every evening for the next 7 days my arm hurt so bad it felt like it was going to explode. Ibuprofen 800 mg did not help, neither did heat or cold. After the 7th night I noticed limited range of motion of my arm; I could not raise it in front of me. MD said to give it time which I did. Range of motion improved a little but then, early April, I noticed that my shoulder blade was sticking out at odd angles when I made certain movements. In May, I had a nerve conduction and Electromyography study done and started physical therapy which I have attended weekly for 8 months. Diagnosis: Long Thoracic Nerve damage/inflammation with Scapular Winging.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to 20-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA008995: US-009507513-1812USA008996: US-009507513-1812USA007804.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Pain, Pyrexia, Rash, Swelling, Tenderness
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to 20-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA008995: US-009507513-1812USA008996: US-009507513-1812USA007804.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to 20-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA008995: US-009507513-1812USA008996: US-009507513-1812USA007804.