chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Blood creatinine increased, Condition aggravated, End stage renal disease, Haemoglobin decreased
Clinical narrative: Child has end stage renal disease awaiting transplantation. Parents are required to fully immunize patient before he can be listed for transplantation. His creatinine had been increasing and the need for transplantation has intensified. Family agreed to have child vaccinated and received MMR #1 12/8/2018. Monthly labs to follow his renal disease showed an increase in creatinine from 4.39 to 4.90 and a decrease inhemoglobin from 10.5 to 9.4.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Hypertension, Nausea
Clinical narrative: Patient stated that she experienced fever, chills, fatigue nausea and vomiting after the second shot in the SHINGRIX series. ALso stated that her BP was higher than normal at 131/80.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient stated that she experienced fever, chills, fatigue nausea and vomiting after the second shot in the SHINGRIX series. ALso stated that her BP was higher than normal at 131/80.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Dry skin, Pruritus, Wound
Clinical narrative: Grandmother:  brought child to clinic reporting child had reaction from shots giving on 12/12/18. Temp. 99.7(ear), alert and talkative. Grandmother reported child eating and playing good at home. Noted numerous raised dry scalped and open areas to bilateral cheeks, chin, neck, and upper extremities. Right arm worse than left arm. Grandmother reported constantly itching and scratching.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Pain
Clinical narrative: Painful induration in deltoid about 1 mo post shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Intermittent sharp pain at the site of the injection, persisting for a couple of months past the injection date. Pain is not constant and might not be felt for several days and then randomly my arm will hurt for several hours - just at the spot of the injection. No shooting pain, no whole arm pain.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Fatigue, Hypersensitivity, Peripheral swelling, Scab
Clinical narrative: 6 y/o male here to follow up after adverse reaction to flu shot. He got the flu shot here on 12/10/18. He has had flu shot before w/o issue. The next day mom noted his entire upper R arm was pink/hot to touch and swollen. No fevers, no hives/difficulty breathing, no joint aches/pains. He did seem tired. Mom took him to UC where she reports they did not remove the bandaid but just said it was an allergic reaction, but cave him Cephalexin 'just in case'. Mom didn't remove the bandaid until the next day then found that the skin looked like it was 'cut' and one side was blistered where the bandaid adhesive had been in contact with his skin. She says the actual injection site itself looked fine. He has never had an issue with bandaids before, so she thinks that perhaps the skin breakdown was due to the bandaid being on while the arm was swollen. It is looking better now. Exam R upper arm (delt) there is what appears to be an approximately 1 cm unroofed blister there the bandaid adhesive was anteriorly and a scabbed area where is was posteriorly. There is an additional small blister close to posterior axillary fold but mom thinks she caused this one. Injection site not hard or tender, not fluctuant, arm not red or swollen now.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Skin discolouration, Skin disorder, Skin warm
Clinical narrative: 6 y/o male here to follow up after adverse reaction to flu shot. He got the flu shot here on 12/10/18. He has had flu shot before w/o issue. The next day mom noted his entire upper R arm was pink/hot to touch and swollen. No fevers, no hives/difficulty breathing, no joint aches/pains. He did seem tired. Mom took him to UC where she reports they did not remove the bandaid but just said it was an allergic reaction, but cave him Cephalexin 'just in case'. Mom didn't remove the bandaid until the next day then found that the skin looked like it was 'cut' and one side was blistered where the bandaid adhesive had been in contact with his skin. She says the actual injection site itself looked fine. He has never had an issue with bandaids before, so she thinks that perhaps the skin breakdown was due to the bandaid being on while the arm was swollen. It is looking better now. Exam R upper arm (delt) there is what appears to be an approximately 1 cm unroofed blister there the bandaid adhesive was anteriorly and a scabbed area where is was posteriorly. There is an additional small blister close to posterior axillary fold but mom thinks she caused this one. Injection site not hard or tender, not fluctuant, arm not red or swollen now.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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 vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by a physician 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 (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 was considered to be not recovered. Additional information has been requested.
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 the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In May 2012, a healthcare provider at a health department administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a physician 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 (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 was considered to be not recovered. Additional information has been requested.
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 the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 07-SEP-2012, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 21-APR-2014, the patient was treated by a healthcare provider 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 (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 was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2011, the patient was treated by a physician at a medical center/health care facility 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 13-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 10-APR-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 05-NOV-2015, the patient was treated by a physician 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 not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 13-DEC-2018 regarding a case in litigation from a lawyer concerning a female 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. In 2009, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by a healthcare provider at a hospital 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 not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a currently 62 year old female patient. The patient's medical history, concomitant medicationsand concurrent conditions were not disclosed. On an unknown date, the patient was vaccinated with  a dose of PNEUMOVAX 23 single 0.5ml dose (anatomical injection site, route of administration, and indication not disclosed), lot # R022249 and expiration date 16-APR-2020. It was reported that this vaccine had been on a temperature excursion, and was stored at or above 32 °F up to 35 °F (0°C to 1°C) (32.5F) during 8 hours; but it was also noted that there had not been a previous temperature excursion. At the time of this report, there were no adverse events reported. Digital data logger was involved. This was one of two cases received from the same reporter. Sender's Comments: US-009507513-1812USA008691.
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 the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-MAR-2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-OCT-2016, the patient was treated by a physician's assistant 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 (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 was considered to be not recovered. Additional information has been requested.
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 the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-JUL-2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-DEC-2016, the patient was treated by a physician 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 (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 was considered to be not recovered. Additional information has been requested.
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 the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 23-DEC-2014, the patient was treated by a physician 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 (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 was considered to be not recovered. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Client passed out. Lost consciousness for approximately 5 seconds. Nurse helped to lying position and put feet up above heart. Prepared to give Epi. No Epi given. Client came around and stated "I'm a fainter".
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Aura, Musculoskeletal stiffness, Seizure, Unresponsive to stimuli, Urticaria
Clinical narrative: Pt was here for first influenza vaccine. Pt noticed 2-3 small hives around abdominal tube a few minutes after flu vaccine. No wheezing/SOB/cough; no lip/tongue swelling. Pt notices an aura and informed MA she thought a seizure was impending. Pt became unresponsive and body was stiff; pt informed us of where her rescue medication was Midazolam 5 mg/mL, 1 mL was administered by me intranasally Pt transferred to the bed. Within about 15 minutes pt because responsive. Hives remained small and few on abdomen; pt given 25 mg diphenhydramine via G-tube. Pt was checked on multiple times and was back to normal before being she left our office (spent over 1 hour in our office being observed before pt left). I have discussed many times with the pt about her ability to safely drive herself; pt tells me that she is more than able to drive safely since she does always get an aura before her seizures and also seizures come in clusters usually within an hour and pt has only had one sz here and was observed for over 1 hour before being released from our care. Pt reports she is able to drive herself safely home and promises to not drive if she develops symptoms that make it unsafe for her to drive.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PT PRESENTED TO PHARMACY 4 DAYS POST-VACCINATION TO REPORT REDNESS AND SWELLING  THAT HAD SPREAD PAST INJECTION SITE TO UNDER THE ARM. PT HAD SELF-TREATED WITH BENADRYL AND HAD SEEN IMPROVEMENT OVER TIME.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Acute motor-sensory axonal neuropathy, Blood creatine phosphokinase, Blood magnesium, Blood thyroid stimulating hormone, C-reactive protein
Clinical narrative: Guillain Barre, AMSAN variant of Acute Demyelinating Polyneuropathy, Flaccid quadriplegia, Acute neuromuscular respiratory failure, Plueral effusion.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Echocardiogram, Electrocardiogram, Full blood count, Gastrointestinal tube insertion
Clinical narrative: Guillain Barre, AMSAN variant of Acute Demyelinating Polyneuropathy, Flaccid quadriplegia, Acute neuromuscular respiratory failure, Plueral effusion.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Gastrostomy, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Lipids
Clinical narrative: Guillain Barre, AMSAN variant of Acute Demyelinating Polyneuropathy, Flaccid quadriplegia, Acute neuromuscular respiratory failure, Plueral effusion.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Mechanical ventilation, Metabolic function test, Paralysis, Plasmapheresis
Clinical narrative: Guillain Barre, AMSAN variant of Acute Demyelinating Polyneuropathy, Flaccid quadriplegia, Acute neuromuscular respiratory failure, Plueral effusion.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pleural effusion, Quadriplegia, Red blood cell sedimentation rate, Respiratory failure, Tracheostomy
Clinical narrative: Guillain Barre, AMSAN variant of Acute Demyelinating Polyneuropathy, Flaccid quadriplegia, Acute neuromuscular respiratory failure, Plueral effusion.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Wheezing
Clinical narrative: Encouraged continued use of ibuprofen/TYLENOL alternating, may use OTC BENADRYL/antihistamine for comfort - encouraged use of ice packs for comfort no more than 20 minutes at a time - DELTASONE 20 MG tablet; Take 2 tablets (40 mg total) by mouth daily for 3 days. Dispense: 6 tablet; Refill: 0.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt reported a red rash with itching that appeared on his arms and torso from head to toe. It started 2 days after the injection and is resolving itself.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Faeces discoloured, Injection site erythema, Injection site induration
Clinical narrative: Scattered light pink erythema over left upper arm, exquisitely tender, 5x5 area of induration, scattered erythematous macules in axilla and left lateral chest wall. Arm Pain (L arm pain 9/10, rash, nausea, body pain, chills, "green diarrhea". ZYRTEC daily. You may also take BENADRYL at night, 50 mg. Ice for 10 minutes every hour if possible. Continue with the scheduled ibuprofen (continue the 600 mg every 6 hours as needed); you may also alternative with acetaminophen (1000 mg every 8 hours as needed).
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Rash
Clinical narrative: Scattered light pink erythema over left upper arm, exquisitely tender, 5x5 area of induration, scattered erythematous macules in axilla and left lateral chest wall. Arm Pain (L arm pain 9/10, rash, nausea, body pain, chills, "green diarrhea". ZYRTEC daily. You may also take BENADRYL at night, 50 mg. Ice for 10 minutes every hour if possible. Continue with the scheduled ibuprofen (continue the 600 mg every 6 hours as needed); you may also alternative with acetaminophen (1000 mg every 8 hours as needed).
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Urine analysis
Clinical narrative: Scattered light pink erythema over left upper arm, exquisitely tender, 5x5 area of induration, scattered erythematous macules in axilla and left lateral chest wall. Arm Pain (L arm pain 9/10, rash, nausea, body pain, chills, "green diarrhea". ZYRTEC daily. You may also take BENADRYL at night, 50 mg. Ice for 10 minutes every hour if possible. Continue with the scheduled ibuprofen (continue the 600 mg every 6 hours as needed); you may also alternative with acetaminophen (1000 mg every 8 hours as needed).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: SORE ARM--EVEN NOW THAT IS IT A MONTH AFTER VACCINE HER ARM IS STILL SORE.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Myositis, Rotator cuff syndrome
Clinical narrative: Pain to shoulder that's become chronic in nature. Diagnosed as impingement syndrome involving rotator cuff tendons and deltoid muscle inflammation.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: At 5:15 PM the day after receiving the DTaP vaccine my son vomited thick clear liquid every 5-10 minutes until 6:30 PM. He vomited a total of 7 times.
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient says his arm hurts randomly, but inconsistently.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: 4 hours after the booster of SHINGRIX the patient experienced chills, a fever of 101 degrees for 24 hours.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Muscle ache, headache, nausea, chills, pain at site of injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling stage 3 (>100 mm), severe itching.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria, Rash, Rash pruritic, Vomiting
Clinical narrative: Vomiting x1, followed about 1 hour later by large 17cm x 10cm hive at injection site. Hive still present at time of report (14 hours) but improving. Rash was painful and itchy.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: The shot felt painful as it was administered. Her arm has been very sore every since. No physical swelling is present.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Insomnia, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Received vaccine 12/17/18; Patient experienced sore throat on evening of 12/18/18 and on 12/19/18 at bedtime patient's symptoms progressed to tongue swelling and tingling with cough. This kept patient up most of night and had trouble breathing. Today 12/20/18 (event reported), pt better able to breath but tongue still swollen. RPh recommended pt to be evaluated by physician today and if continue to worsen call 911 or go to ER.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Swollen tongue
Clinical narrative: Received vaccine 12/17/18; Patient experienced sore throat on evening of 12/18/18 and on 12/19/18 at bedtime patient's symptoms progressed to tongue swelling and tingling with cough. This kept patient up most of night and had trouble breathing. Today 12/20/18 (event reported), pt better able to breath but tongue still swollen. RPh recommended pt to be evaluated by physician today and if continue to worsen call 911 or go to ER.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Body temperature increased, Dyskinesia, Eye movement disorder, Febrile convulsion
Clinical narrative: Mom called and LM stating pt had temp 103.5 when he left the office 12/17/18. Mom gave ibuprofen and about 2 hours later he had temp of 102-something. Around 11pm he had temp of 104.5, mom started to call nurse triage 12/17/18 and pt had febrile seizure. Mom took pt to hospital. Mom said they are home now and he is fine. Mom sched f/u for Thurs 12/20/18. 12/20/18 providers note from ER f/u-he start running fever after visit. He had temp 104.5 that night. His eye rolled in the back of head and arms jerked. He went to ED. He had normal exam. He has not had fever medication today. He seems fine.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient developed headache, nausea and vomiting approximately 1 hour after vaccine and then fever.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Enema administration, Intussusception, Ultrasound scan, Vomiting
Clinical narrative: Started vomiting on 11-12-18, took to ER on 11-13-18 had U/S then Ba Enema. Dx. with intussusception. Discharged on 11-16-18.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Started with stiffness and pain in left arm, then overnight on 12/19/18 became extremely sore red, hot, swollen 10in x 10in square. Treated with cephalexin 500mg 1 QIDx7days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: Information has been received on 19-DEC-2018 regarding a case in litigation from a lawyer concerning a female 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. In 2012, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2012 and 2015, the patient was treated by a physician at the physician's office and another physician at a neurology physician's office for shingles and peripheral neuropathy respectively. 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 not recovered. The causality of the events is related. Upon internal review, peripheral neuropathy has been considered to be medically significant. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Flushing, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Shiver - lasted 10 minutes 9-4-18 at 01:00 AM. (R) swollen lymph nodes - 9-4-18. (R) knee and leg pain 12-10-18. Myalgia/arthralgia in (R) arm, shoulder, neck. 9-6-18. Edema of bilateral feet, ankles, and 5 pounds of weight gain 9-4-18.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness, Tremor
Clinical narrative: Shiver - lasted 10 minutes 9-4-18 at 01:00 AM. (R) swollen lymph nodes - 9-4-18. (R) knee and leg pain 12-10-18. Myalgia/arthralgia in (R) arm, shoulder, neck. 9-6-18. Edema of bilateral feet, ankles, and 5 pounds of weight gain 9-4-18.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Lymphadenopathy, Myalgia, Oedema peripheral
Clinical narrative: Shiver - lasted 10 minutes 9-4-18 at 01:00 AM. (R) swollen lymph nodes - 9-4-18. (R) knee and leg pain 12-10-18. Myalgia/arthralgia in (R) arm, shoulder, neck. 9-6-18. Edema of bilateral feet, ankles, and 5 pounds of weight gain 9-4-18.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Weight increased
Clinical narrative: Shiver - lasted 10 minutes 9-4-18 at 01:00 AM. (R) swollen lymph nodes - 9-4-18. (R) knee and leg pain 12-10-18. Myalgia/arthralgia in (R) arm, shoulder, neck. 9-6-18. Edema of bilateral feet, ankles, and 5 pounds of weight gain 9-4-18.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Feeling abnormal, Fluid retention, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from an other reporter via company representative and refers to a 67-year-old male patient. Information comes from an online article. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with unspecified pneumonia vaccine (manufacturer unknown) (also reported as PNEUMOVAX (possible) for prophylaxis. From an unknown date, the patient was hospitalized due to fluid in his bicep. Duration of hospitalization was not reported. The outcome of the event was unknown. The relatedness between the event and suspected vaccine was not reported.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Injection site inflammation, Joint range of motion decreased, Myositis
Clinical narrative: This spontaneous report was received from an other reporter via company representative and refers to a 67-year-old male patient. Information comes from an online article. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with unspecified pneumonia vaccine (manufacturer unknown) (also reported as PNEUMOVAX (possible) for prophylaxis. From an unknown date, the patient was hospitalized due to fluid in his bicep. Duration of hospitalization was not reported. The outcome of the event was unknown. The relatedness between the event and suspected vaccine was not reported.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema
Clinical narrative: This spontaneous report was received from an other reporter via company representative and refers to a 67-year-old male patient. Information comes from an online article. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with unspecified pneumonia vaccine (manufacturer unknown) (also reported as PNEUMOVAX (possible) for prophylaxis. From an unknown date, the patient was hospitalized due to fluid in his bicep. Duration of hospitalization was not reported. The outcome of the event was unknown. The relatedness between the event and suspected vaccine was not reported.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema, Vaccination complication, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from an other reporter via company representative and refers to a 67-year-old male patient. Information comes from an online article. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with unspecified pneumonia vaccine (manufacturer unknown) (also reported as PNEUMOVAX (possible) for prophylaxis. From an unknown date, the patient was hospitalized due to fluid in his bicep. Duration of hospitalization was not reported. The outcome of the event was unknown. The relatedness between the event and suspected vaccine was not reported.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Pain, Vomiting
Clinical narrative: Patient stated the first night he threw up and had pain in chest and side of body. It has been two weeks since the vaccination and patient is stating he is still having pain in back and on the side of his body. Patient went to see doctor and doctor stated it shouldn't be from the shingles shot.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Nausea, Post herpetic neuralgia, Vomiting
Clinical narrative: Patient stated the first night he threw up and had pain in chest and side of body. It has been two weeks since the vaccination and patient is stating he is still having pain in back and on the side of his body. Patient went to see doctor and doctor stated it shouldn't be from the shingles shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Terrible headache.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Decreased appetite, Injection site pain
Clinical narrative: Day of immunization: Pain at injection site preventing sleep approximately 10pm, so took two extra strength TYLENOL. Day after immunization: Woke up at 3:30am with moderate pain at injection site, but shivering, thirsty, no appetite, no energy, and temperature of 100.7 degrees. At approximately 0530 took two more extra strength TYLENOL and will attempt to go back to sleep.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Thirst
Clinical narrative: Day of immunization: Pain at injection site preventing sleep approximately 10pm, so took two extra strength TYLENOL. Day after immunization: Woke up at 3:30am with moderate pain at injection site, but shivering, thirsty, no appetite, no energy, and temperature of 100.7 degrees. At approximately 0530 took two more extra strength TYLENOL and will attempt to go back to sleep.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen from elbow to shoulder. Extreme pain. Can't lift arm more that 10 degrees.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on the same date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA009925: US-009507513-1812USA009926: US-009507513-1812USA009927: US-009507513-1812USA009928: US-009507513-1812USA009929: US-009507513-1812USA009930: US-009507513-1812USA009931: US-009507513-1812USA009932: US-009507513-1812USA009933: US-009507513-1812USA009934: US-009507513-1812USA009924: US-009507513-1812USA009923: US-009507513-1812USA009921: US-009507513-1812USA009922.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site cellulitis, Injection site inflammation, Injection site warmth
Clinical narrative: This is a spontaneous report was received  from a registered nurse via a field representative concerning an 11-old-year male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 30-OCT-2018 (reported as "about one month ago"), the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided). On an unspecified date in 2018, the patient experienced "inflammation, heat, and a cellulitis like appearance" in the injection site area. The outcome of the inflammation, heat, and a cellulitis like appearance at the injection site was unknown. The causality assessment between GARDASIL 9 and inflammation, heat, and a cellulitis like appearance at the injection site was not reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Anterior chamber inflammation, Blood test normal, Chorioretinal atrophy, Inflammatory marker test, Intraocular pressure test normal
Clinical narrative: This spontaneous case was received from healthcare professionals on an unpublished manuscript regarding a 64-year-old male patient. Concurrent conditions included metabolic syndrome and impaired gluocose tolerance. Information on patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, unit, dose number, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date (16 months post vaccination), the patient was presented with six days of floaters and cloudy vision in his left eye that persisted despite topical prednisolone treatment. The patient was not otherwise immunocompromised. The patient's vision acuity was 20/200 and intraocular pressure was 10 mmHg. On an unknown date, the patient underwent unspecified examination which revealed significant anterior chamber and vitreous inflammation and superotemporal retinitis with a "headlight in the fog" appearance. Empiric treatment with trimethoprim/sulfamethoxazole was started for presumed toxoplasmosis for the patient. A course of oral prednisone was also initiated and topical prednisone was increased. On an unknown date, at one week follow-up, another region of retinitis was noted and unspecified blood tests were performed which was negative for infectious and inflammatory etiologies, including toxoplasma. On an unknown date, polymerase chain reaction (PCR) test of his aqueous fluid was performed which was positive for Varicella Zoster Virus (VZV). Antibiotics were discontinued and the patient was treated with oral valacyclovir 2 grams 3 times per day for three weeks, followed by 1 gram 3 times per day for three weeks with a steroid taper. On an unknown date, upon completion of therapy, retinitis (necrotizing retinitis) had resolved (recovered) and visual acuity was 20/30 and at six months follow-up, visual acuity was 20/25 with a stable region of chorioretinal atrophy on examination. The outcome of the event varicella zoster virus infection was unknown. Causality assessment of the events was unknown. The reporters also mentioned that the patient experienced milder disease and longer latency periods. It was also reported that longer latency periods may be associated with wild-type virus in ARN due to VZV as well as systemic disease and the patient may have been relatively immunocompromised from metabolic syndrome. Upon internal review, the event necrotizing retinitis was determined to be medically significant. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1812USA005657.