chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Feeling abnormal, Influenza
Clinical narrative: This is a spontaneous case, initially received from other non-health professional (reporting on herself) on 28-Nov-2018, concerning a 77-year-old, elderly female patient. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after vaccination, the patient felt bad (didn't feel good) for 1-2 days. In addition, the patient also experienced chills and was diagnosed with flu. At the time of this report, the outcome of the events was not reported. Case Comment: A 77-year-old female patient felt bad, had chills and flu, unspecified period of receipt of INN flu vaccine. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported events, company assessed the causality as unassessable. The company assessed the event (flu) as serious (medically significant).
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pruritus, Scratch
Clinical narrative: Patient had no signs or symptoms of adverse reaction when vaccine was administered. Two days later the patient noticed an approximately palm sized area or redness at the right deltoid where the influenza vaccine was administered. He also complained of pruritus and had a self-inflicted scratch at the site. The following day, redness and itching was reduced on the deltoid, however patient was itching near his right axillae. Miconazole powder was prescribed to apply as needed to the area.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None noted.
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Diarrhoea, Headache, Lethargy, Myalgia
Clinical narrative: Had flu shot (AFLURIA QUAD LOC: RA/LA - Lot YF41108 EXP 6/30/19 IM route MFG: Seqirus VIS 8/7/15 Dosage: 0.5 ml) at Pharmacy at 3 PM on 11/30/18. By 6 PM the same day, feeling symptoms of headache, muscle ache, nausea. Later that night, threw up and the next morning had diarrhea. Felt lethargic the next day 12/1/18, no appetite and continued diarrhea. 12/2/18 appetite returned, so ate "normal food" - threw up again that night. Diarrhea continued through 12/3/18. Ate bland diet 12/3/18 and did not throw up again. Still have a headache 12/4/18. Have had the flu shot every year for many years (20) and have never had any sort of reaction. Very strange, unusual and out of character for me and my body. I realize all symptoms are within the potential "adverse reactions", but wanted to report regardless as has never happened to me before and was relatively "severe", so not sure if something unusual or different with the vaccine this year? Additionally, I rarely get sick.
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Had flu shot (AFLURIA QUAD LOC: RA/LA - Lot YF41108 EXP 6/30/19 IM route MFG: Seqirus VIS 8/7/15 Dosage: 0.5 ml) at Pharmacy at 3 PM on 11/30/18. By 6 PM the same day, feeling symptoms of headache, muscle ache, nausea. Later that night, threw up and the next morning had diarrhea. Felt lethargic the next day 12/1/18, no appetite and continued diarrhea. 12/2/18 appetite returned, so ate "normal food" - threw up again that night. Diarrhea continued through 12/3/18. Ate bland diet 12/3/18 and did not throw up again. Still have a headache 12/4/18. Have had the flu shot every year for many years (20) and have never had any sort of reaction. Very strange, unusual and out of character for me and my body. I realize all symptoms are within the potential "adverse reactions", but wanted to report regardless as has never happened to me before and was relatively "severe", so not sure if something unusual or different with the vaccine this year? Additionally, I rarely get sick.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Laboratory test normal, Petechiae, Viral infection
Clinical narrative: Developed petechial rash 5 days after vaccines. Labs normal. Unclear etiology. Hep B listed petechiae under rare/case report. Dtap and Rota lists thrombocytopenia as possible reactions but labs are normal. Likely viral process.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives covering entire body. Received steroid shot and oral steroids on 12/10/18.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Fall, Head injury, Headache, Loss of consciousness
Clinical narrative: Approx. 2-3 minutes after vaccine administration, child stepped off exam table-+ LOC-fell to the ground in exam room-hit right frontal forehead and back of head. Patient awoke spontaneously-asking what happened. Examination done by Dr. Pt c/o headache, dizziness alert and oriented. Sent to hospital for observation and evaluation v/sign stable.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Dizziness, Dry mouth, Heart rate increased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Hurt to write with pen pick up a plate a fork push a shopping cart open a pkg use a paint brush feet hurt use a pressure washer.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: X-ray
Clinical narrative: Hurt to write with pen pick up a plate a fork push a shopping cart open a pkg use a paint brush feet hurt use a pressure washer.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, X-ray
Clinical narrative: Hurt to write with pen pick up a plate a fork push a shopping cart open a pkg use a paint brush feet hurt use a pressure washer.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Arthralgia, Asthenia, Dizziness postural, Food intolerance, Heart rate increased
Clinical narrative: Hurt to write with pen pick up a plate a fork push a shopping cart open a pkg use a paint brush feet hurt use a pressure washer.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Hurt to write with pen pick up a plate a fork push a shopping cart open a pkg use a paint brush feet hurt use a pressure washer.
Age: 12.0
Sex: M
Vaccine: FLU4, MENB, TD
Symptoms: Apathy, Autism spectrum disorder, Depressed mood, Educational problem, Mood altered
Clinical narrative: In December 2010 he got three separate vaccinations (Td booster, Flu, Meningococcal) at exactly the same time. Soon his academic performance began to decline in January 2011. By March 2011 I noticed a significant change in his mood as he looked increasingly more depressed and losing motivation is his regular activities. By April 2011 he had his first "psychotic" episode and was diagnosed as Psychosis NOS after being admitted to Behavioral Health. And NOT autistic. He has continued to regress and today he is diagnosed as autistic also.
Age: 12.0
Sex: M
Vaccine: FLU4, MENB, TD
Symptoms: Psychotic disorder, Regressive behaviour
Clinical narrative: In December 2010 he got three separate vaccinations (Td booster, Flu, Meningococcal) at exactly the same time. Soon his academic performance began to decline in January 2011. By March 2011 I noticed a significant change in his mood as he looked increasingly more depressed and losing motivation is his regular activities. By April 2011 he had his first "psychotic" episode and was diagnosed as Psychosis NOS after being admitted to Behavioral Health. And NOT autistic. He has continued to regress and today he is diagnosed as autistic also.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody positive, Back pain, Blood folate normal
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: C-reactive protein normal, Electromyogram abnormal, HIV test negative, Hepatitis viral test negative, Hyporeflexia
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Immunology test normal, Laboratory test normal, Lumbosacral plexopathy, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Treponema test negative
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vitamin B12 normal
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Back pain, Electromyogram abnormal, Lumbosacral plexopathy, Muscle atrophy
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abdominal normal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angiotensin converting enzyme, Blindness unilateral, Blood homocysteine normal, Borrelia test negative, Cardiolipin antibody negative
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Differential white blood cell count normal, Full blood count normal, Glycosylated haemoglobin increased, Guillain-Barre syndrome, Immunology test
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lipids abnormal, Metabolic function test normal, Muscular weakness, Optic ischaemic neuropathy, Pain in extremity
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Papilloedema, Platelet count normal, Red blood cell sedimentation rate, Treponema test negative, Visual impairment
Clinical narrative: On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Employee stated that several hours after injection the site was reddened raised and sore. She stated that she took Ibuprofen and BENADRYL and had a face time visit with her CRNP, who told her this was a common reaction. The employee stated that the site improved over 3-4 days without treatment. No drainage or purulence reported from site.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Abdominal discomfort, Diet refusal, Enuresis, Glassy eyes, Lethargy
Clinical narrative: Patient was happy and healthy no sign of illness when we arrived at the clinic approx 10 am May 7th 2018.. Within 30-45 min she was complaining of not feeling well and became very sleepy... She felt hot to the touch.. Thinking this was a normal reaction as we were told we went on to get lunch... patient has not napped in 2 years... She became glassy-eyed and then fell asleep at the table. We took her home where she continued to sleep so deep that I had to shake her to wake her. She refused food and water for 24 hours. About 6 pm I woke her to try to record her as I was getting worried. She then went back to sleep and continued to sleep through the night a total of 24 hours. She wet herself in the night and for weeks after (she has been fully potty trained without accidents since age 2). Out of fear of backlash I did not take her to the Dr. I should have. Patient continued to show signs of diabetic reaction, extreme thirst, upset stomach, lethargic etc for a few months after. Her eyes returned to normal about a month later no longer glazed over. I did take her to the Dr later and explained what we had been through and my fears and asked that they document it. Dr decided not to test her sugars.... I showed the physician the video and photos I had taken from her. I suspect it got ignored and was not reported or documented.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Malaise, Skin warm, Somnolence, Thirst
Clinical narrative: Patient was happy and healthy no sign of illness when we arrived at the clinic approx 10 am May 7th 2018.. Within 30-45 min she was complaining of not feeling well and became very sleepy... She felt hot to the touch.. Thinking this was a normal reaction as we were told we went on to get lunch... patient has not napped in 2 years... She became glassy-eyed and then fell asleep at the table. We took her home where she continued to sleep so deep that I had to shake her to wake her. She refused food and water for 24 hours. About 6 pm I woke her to try to record her as I was getting worried. She then went back to sleep and continued to sleep through the night a total of 24 hours. She wet herself in the night and for weeks after (she has been fully potty trained without accidents since age 2). Out of fear of backlash I did not take her to the Dr. I should have. Patient continued to show signs of diabetic reaction, extreme thirst, upset stomach, lethargic etc for a few months after. Her eyes returned to normal about a month later no longer glazed over. I did take her to the Dr later and explained what we had been through and my fears and asked that they document it. Dr decided not to test her sugars.... I showed the physician the video and photos I had taken from her. I suspect it got ignored and was not reported or documented.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Tremor
Clinical narrative: Chills including shaking, headache, lethargy.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from an office manager referring to a patient of unknown age and gender. The concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and pertinent medical history was not provided. On 13-NOV-2018, the patient received VARIVAX (strength, dose, lot# and expiration date were not reported) via intramuscular route (incorrect route of product administration) for prophylaxis. Lot# and expiration date for sterile diluent used to reconstitute VARIVAX was unknown by the reporter. No adverse effects reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 05-JUL-2018 the patient was vaccinated with improperly stored RECOMBIVAX HB (dose and frequency were unknown; lot # R006746 and expiration date was on 09-NOV-2020) intramuscularly for prophylaxis (product storage error). The administered doses experienced a temperature excursion ranged from 32 degree Celsius to 35 degrees Celsius for 25 hour and 22 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 15-NOV-2018 the patient received an expired dose of RECOMBIVAX HB (lot # M026309, expiration date was on 12-NOV-2018) intramuscularly for prophylaxis(expired product administered). No adverse effect was reported.
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash, Rash generalised
Clinical narrative: This spontaneous report was received from a registered nurse regarding a male patient of unknown age. The patient's medical history, concurrent conditions or concomitant medication were not reported.   On an unspecified date in 2015 (also reported as three years ago), the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported); and experienced a localized rash in the area of the injection and then a generalized rash all in the body. The outcome of the events was unknown. The relationship between the vaccine and the events was unknown.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding on herself. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 20-NOV-2018, also reported as on 29-NOV-2018 (conflicting information as it was also reported as the onset date of the event), the patient was vaccinated with PNEUMOVAX 23 subcutaneous injection, lot number R009408, expiry date 07-MAR-2020 (strength, dose and frequency were not reported) for immunization for the prevention of pneumococcal disease. On 29-NOV-2018, the patient experienced an "anaphylaxis reaction" (unspecified). The outcome of anaphylaxis reaction was reported as not recovered. The causality assessment between with PNEUMOVAX 23 and the aforementioned event was not provided. Upon internal review anaphylaxis reaction was determined to be serious due to medically significant.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event
Clinical narrative: This spontaneous report was received from a female nurse of unknown age, reporting on herself.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the nurse was attempting to withdraw the vaccine from the single dose vial of PNEUMOVAX 23 lot # R022879, expiring on 02-AUG-2020 , when it "exploded" and the liquid forcefully expelled from the vial and hit the nurse in the hands and face (accidental exposure while preparing drug for administration). At the time of the report, the nurse was completely fine, and suffered no adverse effects from the incident.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-OCT-2011, a healthcare provider at a medical facility/hospital administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 08-NOV-2016, the patient was treated by a physician (The address that was provided is a physician's office address, however, a hospital name (not at same address as office) was also provided. It is unclear if the pt was seen on 08-NOV-2016 in a hospital (ER) or at the physician's office.) for 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, 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 was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-DEC-2009, the patient's healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 30-DEC-2016, the patient was treated by the patient's healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, 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, 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 include care for hospitalization, 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes ophthalmic, Herpes zoster
Clinical narrative: Information has been received on 04-DEC-2018 regarding a case in litigation from a lawyer and the administrator of the estate concerning a deceased female patient of unknown age. There was no information provided regarding the patient's prior concurrent conditions, medical history or concomitant medications. The patient's healthcare providers, a pharmacist at a pharmacy, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist at a pharmacy, administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 16-NOV-2016 and 17-NOV-2016, the patient was treated by the patient's healthcare provider at a hospital prompt care for shingles and an eye physician's office for ocular shingles. On 23-JUN-2017, the patient passed away. The cause of death was not reported. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, 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, 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 include care for hospitalization, 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of passed away is fatal and the causality of passed away is unknown. The outcome of the other events is unknown. The causality of the other events is related. Upon internal review, passed away and ocular shingles were considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: passed away.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in 2018, the patients were vaccinated with PROQUAD lot number R017629 expiration date 18-DEC-2018 and VARIVAX lot number involved R007695 expiration date 14-MAR-2020 and R012531 expiration date 01-MAY-2020. Concomitant therapies included (DILUENT MRK INJ). On an unknown date in 2018, the patients' experienced product storage error and no adverse event. Temperature 6° Fahrenheit to 14° Fahrenheit (11.6 Fahrenheit) the time frame was 10 minutes No previous temperature excursion and there was no data logger. This is a non-valid case due to lack of patient identifiers.
Sex: F
Vaccine: HPV4
Symptoms: Death, Injury, Neoplasm progression
Clinical narrative: This spontaneous report was received from a non-healthcare professional via social media concerning a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, unit, route, lot # and expiration unknown) for prophylaxis. On an unknown date, the patient had tumor growth and serious injuries. On an unknown date, the patient died (cause of death was not reported). It was unknown if autopsy performed. The outcome of the events neoplasm progression and injury was unknown. The reporter did not provide the causality assessment for the events. The reporter considered the event injury to be medically significant. Reported Cause(s) of Death: Unknown cause of death.
Sex: F
Vaccine: HPV4
Symptoms: Death, Epilepsy, Seizure
Clinical narrative: This spontaneous report as received from a non-healthcare professional via social media regarding a 14-year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot, expiry date, dose, strength were not reported) for prophylaxis. On an unknown date, the patient experienced seizure and epilepsy. On an unknown date, the patient died due to unknown cause (medically significant). It was unknown if autopsy was performed. Outcome of seizure and epilepsy was unknown. Causality for the events was not reported. Upon internal review, the events seizure and epilepsy were determined to be medically significant. This is one of the three reports from the same reporter. Reported Cause(s) of Death: unknown cause of death.
Sex: M
Vaccine: HPVX
Symptoms: Death, Nervous system injury
Clinical narrative: This spontaneous social media report was received from an unspecified reporter who posted an information on the internet referring to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an unspecified human papillomavirus vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced serious permanent neurological injuries and passed away (reason unspecified). The outcome of the event of serious permanent neurological injuries was not reported. The relatedness between the events and an unspecified human papillomavirus vaccine (manufacturer unknown) was not reported. According to the reporter, the event of permanent neurological injuries was considered to be serious (medically significant).
Age: 65.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 65 year old female patient, reporting on herself. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, in May 2018,  the patient was vaccinated with the first dose of GARDASIL 9, then, the second dose in approximately July 2018, reported a 2 months later and finally, the third dose on 06-NOV-2018, intramuscularly for prophylaxis (lot number and expiration date were not reported). However, no adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 07-DEC-2018, the patient was vaccinated with a properly stored but expired dose of VAQTA 25/0.5 (units were not provided), lot # N028743, expiration date 23-NOV-2018 (dose, route and anatomical location were not provided) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: M
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome, Lyme disease, Narcolepsy, Post viral fatigue syndrome
Clinical narrative: This spontaneous report as received from a non-health care professional via social media regarding a 14-year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot, expiry date, dose, strength and indication were not reported) for prophylaxis. On an unknown date, the patient experienced Lyme disease, post viral fatigue syndrome (myalgic encephalomyelitis) narcolepsy and chronic fatigue syndrome (CFS). The outcome of narcolepsy, post viral fatigue syndrome, chronic fatigue syndrome and Lyme disease was unknown. Causality for the events was not reported. Upon internal review the events Lyme disease and narcolepsy were determined to be medically significant. This is one of the three reports from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome, Epstein-Barr virus infection, Lyme disease, Narcolepsy, Post viral fatigue syndrome
Clinical narrative: This spontaneous report as received from a non-health care professional via social media regarding a 14-year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot, expiry date, dose and strength were not reported) for prophylaxis. On an unknown date, the patient experienced chronic fatigue syndrome, Lyme disease, Epstein-Barr virus infection, narcolepsy and post viral fatigue syndrome. Causality for the events was not reported. Upon internal review the events Lyme disease and narcolepsy were determined to be medically significant. This is one of the three reports received from the same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Alpha 1 globulin normal, Alpha 2 globulin normal, Beta 2 globulin, Beta globulin, Blood albumin normal
Clinical narrative: I have developed peripheral neuropathy in both lower legs. Terrible burning, aching, etc., particularly at night.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Burning sensation, Electromyogram normal
Clinical narrative: I have developed peripheral neuropathy in both lower legs. Terrible burning, aching, etc., particularly at night.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Glycosylated haemoglobin normal, Hepatitis C antibody negative, Immunoglobulins, Nerve conduction studies normal, Neuropathy peripheral
Clinical narrative: I have developed peripheral neuropathy in both lower legs. Terrible burning, aching, etc., particularly at night.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Protein total normal, Thyroxine free normal, Vitamin B1
Clinical narrative: I have developed peripheral neuropathy in both lower legs. Terrible burning, aching, etc., particularly at night.
Age: 42.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PPV
Symptoms: Injection site pain, Injection site rash, Pain in jaw, Peripheral swelling, Pyrexia
Clinical narrative: Right arm is swollen 2 hours post injections. Swollen area is warm to the touch area about 6 inches with rash on right deltoid. Pain in right deltoid, mild fever. Took naproxen for pain. Initial pain first 4 hours 3-4, Overnight pain about 7-8 scale. Mild jaw pain and deltoid pain.
Age: 42.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PPV
Symptoms: Skin warm
Clinical narrative: Right arm is swollen 2 hours post injections. Swollen area is warm to the touch area about 6 inches with rash on right deltoid. Pain in right deltoid, mild fever. Took naproxen for pain. Initial pain first 4 hours 3-4, Overnight pain about 7-8 scale. Mild jaw pain and deltoid pain.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Hyperaesthesia
Clinical narrative: Fever--about 101 degrees, achy all over, sensitive skin, stomach upset  (not nauseous), chills and sweats, shivering, fatigue, headache. Fever broke during the night, around 3 am (15 hours after injection). 2nd day, still feels achy, but not as bad. Does not usually have reactions to vaccinations. First SHINGRIX injection went very well.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Fever--about 101 degrees, achy all over, sensitive skin, stomach upset  (not nauseous), chills and sweats, shivering, fatigue, headache. Fever broke during the night, around 3 am (15 hours after injection). 2nd day, still feels achy, but not as bad. Does not usually have reactions to vaccinations. First SHINGRIX injection went very well.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Pain and swelling. Given diphenhydramine and famotidine.
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED OUT - RECOVERED QUICKLY.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesicle like rash on back and torso resembling chicken pox.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt had complaint of arm soreness the day following vaccination. She said she has been having issues lifting her arm and is worried the pharmacist that gave her the vaccination administered it too high. I had her show me where the shot was given and it was in the place it should have been given. She showed me her range of motion with both arms. I told her if this does not improve to let her primary care doctor know.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysphagia, Palpitations, Paraesthesia oral, Pharyngeal oedema, Sensory disturbance
Clinical narrative: Patient reports an instantaneous reaction of an abnormal sensation in throat followed by lip tingling, heart racing, sensation of throat swelling and difficulty swallowing. Drove herself to ER within 10 min of leaving the Family Practice office. Was treated in the ER with EPI and steroid.  Observed x 4 hrs and discharged. ER notes show no objective swelling, rash or chest findings on exam.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Back pain, Dyspnoea
Clinical narrative: Patient stated that starting the Friday after the vaccine, he felt weak and some shortness of breath. Of note, the shortness of breath is a problem that has occured previously in his medical history. He called the office today, 12/11/18 complaining of back pain and that was his concern. He denied any fever or other symptoms. He tried TYLENOL without relief and his PERCOCET has helped some. Patient was advised to use a heating pad to help relieve back pain and to call if things did not improve.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: I saw her result on Nov 27, 2018 for pain in the right shoulder and arm. She indicated at that time that the injection was placed high on the right arm, suggestive of an improper placement of an IM injection. She did not have pain at the time of the injection the pain started later that night. She reported the pain at that time was 10 out of 10 and she wore a sling and rested the arm for a few days and the pain became mild but did not go away completely. On November 23 she reports the pain became severe again and she scheduled the appointment with me on the 27th. She had called the nurse advice line and they suggested there could possibly be a bursitis or infection. There was no acute erythema or warmth the patient completed a 7 day course of dicloxacillin empirically, 500 mg 4 times a day. She was last evaluated on Dec 3, 2018 by her primary provider and the pain was improving though not gone completely. The plan is to have her follow-up in the next few weeks and if she is still having significant pain additional imaging such as an MRI may be ordered by her primary.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: Headaches, nausea; extremely sore arm - unable to sleep for several nights.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Unable to lift left arm over head.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-DEC-2018, the patient was vaccinated with an improperly stored ROTATEQ, orally, lot # R002516,  expiration date 13-SEP-2019 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 1 degrees Celsius (also reported as from 0 to 1 degrees Celsius) for 15 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.