chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Influenza like illness, Insomnia, Mental impairment, Mobility decreased, Muscle spasms
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Nerve conduction studies, Nerve stimulation test
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity, Paraesthesia, Paranasal sinus discomfort
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Pyrexia, Tremor, Viral infection, White blood cell count increased, X-ray normal
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blood test, Burning sensation, Chest X-ray, Chest pain, Chills
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Cough, Electrocardiogram, Hypoaesthesia, Insomnia, Lumbar puncture
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Malaise, Muscle spasticity, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Pyrexia, Sinusitis, Tremor, Upper-airway cough syndrome, Viral infection
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Mild fever, mild headache, chills,  malaise/low energy.  Tylenol XS taken every 6 hours with rest.  Continue to feel this way this AM (21 hours post vaccine)
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction noted on patient.  The facility "over vaccinated" the toddler due to incorrectly chart-prepping  and review of ALL medical records prior to patient coming into the office and receiving vaccines. This had been over-looked by the MA working up this toddler and the Provider that day. Family never voiced any concerns at the time the vaccines were reviewed by the Provider and agency.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: This was my second shot of Shingrix, the first having been 9/30/2019.  The first one gave me a sore arm.  My sister got quite sick from her first shot.  My second shot hurt less, so I did not expect to get sick.  At  10 pm and all through the night I had a miserable raging headache and had to fight the sensation of wanting to throw up.  I put a cold wet washcloth on my head.  I called my sister at 6  am to come check on me in case I needed to be seen somewhere.  I was very sick, miserable and could not believe this could be from the shot.  She assured me it was, and gave me aspirin which I then took pretty much every four hours,or so.  I slowly got better over severa? days with today being the first I feel back to normal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Feeling abnormal, Hypersomnia
Clinical narrative: I started to feel very weak and dizzy.  I had cold chills and my temp usually runs low, 96.8 and I had a fever of 100.2.  Slept right through the night which I don't usually do.  This morning I feel all rung out.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I started to feel very weak and dizzy.  I had cold chills and my temp usually runs low, 96.8 and I had a fever of 100.2.  Slept right through the night which I don't usually do.  This morning I feel all rung out.
Age: 8.0
Sex: M
Vaccine: HEPA, IPV, TDAP
Symptoms: Fall, Loss of consciousness, Musculoskeletal stiffness, Nervousness, Pallor
Clinical narrative: Child received all three vaccines. He then stood up and let his sister sit on his mom's lap while he watched. RN was turned toward the counter top and was writing a school note. RN then heard child fall and saw him laying on the ground. RN turned him on his side and he lost consciousness for about 5 seconds and body was very stiff. He was pale but quickly regained consciousness and was able to answer questions. Cool rag applied to neck and child given water. Child said he had ice cream bar for breakfast. He also said he had been very nervous getting the shot. He sat up a few minutes later and was able to walk out of office. RN advised mother to take him to ER since they do not have a primary care provider at this time.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling abnormal, Tremor
Clinical narrative: Suddenly I felt weird and couldn't stop shivering -- it felt like my whole body was shivering and shaking, couldn't control my fingers on iphone, felt as if I had a fever (but I did not).  This lasted about 2 hours, until I went to bed (wearing the warmest clothes I could though heat in house was fine).  I woke a couple of times during the night, noticed the shivering was waning, and this morning it's gone.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted; product storage error; This spontaneous report was received from a registered nurse and refers to a 41 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 25-OCT-2019, the patient was vaccinated with an improperly dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R036582, expiration date 17-DEC-2020 (dose, route and anatomical location were not provided), and on 06-NOV-2019, with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S000132, expiration date 02-JAN-2021 (dose, route, and anatomical location were not provided) for prophylaxis. No adverse events were reported. The vaccines experienced multiple temperature excursions where the highest temperature was 42.2 degree celsius. There was not previous temperature excursion. It was reported that digital data logger was involved.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The patient did not experience any symptoms; reconstituted with 0.5 ml of sterile diluent, rather than the entire deliverable volume in the vial of diluent; This spontaneous report has been received from a phlebotomist, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 18-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, subcutaneous, lot # R030612, expiration date 23-OCT-2020, prophylaxis; Strength and frequency were unknown) that was reconstituted with 0.5 ml of sterile diluent, rather than the entire deliverable volume in the vial of diluent (product preparation issue). The entire vial of  varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted and was administered. The patient did not experience any symptoms.  This is a non-valid case due to lack of patient identifier.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; 14 year old patient was administered properly stored Proquad; This spontaneous report was received from a nurse referring to a 14 years old patient of unknown gender. The patient's concomitant medications included sterile diluent. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies were not reported. On 20-SEP-2019, the patient was vaccinated with properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, strength, frequency and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was reconstituted with properly stored sterile diluent. No additional adverse effects were reported (no adverse event). Outcome of the event product administered to patient of inappropriate age was unknown. No product quality complaint (PQC) was present.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported.   In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions.   Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue sufferring ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 23-JUN-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the patient suffered a severe and painful rash to the abdomen and back and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 18-MAY-2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. The patient reported that she relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced her to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for herpes zoster. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown. The reporter considered the event to be related to zoster vaccine live(ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Anaphylactic shock, Dizziness, Fatigue, Tongue discomfort
Clinical narrative: "The patient felt tired and dizzy and her tongue got tight"/anaphylactic shock; This spontaneous report has been received from a medical assistant referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.         On an unknown date, the patient experienced anaphylactic shock, the reporter stated that the patient "felt tired and dizzy and her tongue got tight". The patient used an unspecified dose of diphenhydramine (BENADRYL), and subsequelty, recovered from the adverse event. The medical assistant, reported that the reaction was not life-threatening. At the reporting time, the causality assessment was not provided.  Upon internal review, anaphylactic shock was deteremined to be medically significant.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: B-lymphocyte count, C-reactive protein normal, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count decreased
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a previously healthy 14-year-old boy presented with a 2-day history of malaise, anorexia, and a painful, pruritic rash and a 1-day history of severe headache. Physical examination revealed more than 70 papulovesicular lesions over the lateral aspect of his left thigh in an L1 to L2 dermatomal distribution, photophobia, and meningismus without focal neurologic deficits or altered mental status. The patient had no recent varicella-zoster virus (VZV) exposure and had received 2 varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot # and expiration date unknown) at 1 and 4 years of age.  Laboratory studies revealed normal peripheral blood white blood cell (WBC) and platelet counts, liver transaminases, and C-reactive protein level. Cerebrospinal fluid (CSF) had a Gram-stain result negative for organisms, glucose of 60 mg/dL, protein of 64 mg/dL, red blood cell count of 268/cubic millimetre, and WBC count of 140/cubic millimetre with 88% lymphocytes and 10% monocytes. CSF and a scraping of a vesicular lesion resulted positive for VZV by polymerase chain reaction (PCR); virus from both specimens genotyped as vOka. VZV seroconversion was confirmed, and CSF tested negative for VZV IgG. The patient was human immunodeficiency virus (HIV) negative with normal numbers and percentages of T- and B-cell subsets. He was treated for 7 days with intravenous (IV) acyclovir. Pain resolved, and no new lesions developed after 3 days of treatment; headache, photophobia, and meningismus resolved after 5 days; neurologic examination was normal at discharge. Malaise resolved 2 weeks later. The authors considered meningitis to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).  Upon internal review, meningitis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature.; Sender's Comments:  US-009507513-1912USA005082:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Decreased appetite, Gram stain
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a previously healthy 14-year-old boy presented with a 2-day history of malaise, anorexia, and a painful, pruritic rash and a 1-day history of severe headache. Physical examination revealed more than 70 papulovesicular lesions over the lateral aspect of his left thigh in an L1 to L2 dermatomal distribution, photophobia, and meningismus without focal neurologic deficits or altered mental status. The patient had no recent varicella-zoster virus (VZV) exposure and had received 2 varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot # and expiration date unknown) at 1 and 4 years of age.  Laboratory studies revealed normal peripheral blood white blood cell (WBC) and platelet counts, liver transaminases, and C-reactive protein level. Cerebrospinal fluid (CSF) had a Gram-stain result negative for organisms, glucose of 60 mg/dL, protein of 64 mg/dL, red blood cell count of 268/cubic millimetre, and WBC count of 140/cubic millimetre with 88% lymphocytes and 10% monocytes. CSF and a scraping of a vesicular lesion resulted positive for VZV by polymerase chain reaction (PCR); virus from both specimens genotyped as vOka. VZV seroconversion was confirmed, and CSF tested negative for VZV IgG. The patient was human immunodeficiency virus (HIV) negative with normal numbers and percentages of T- and B-cell subsets. He was treated for 7 days with intravenous (IV) acyclovir. Pain resolved, and no new lesions developed after 3 days of treatment; headache, photophobia, and meningismus resolved after 5 days; neurologic examination was normal at discharge. Malaise resolved 2 weeks later. The authors considered meningitis to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).  Upon internal review, meningitis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature.; Sender's Comments:  US-009507513-1912USA005082:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Gram stain negative, HIV test negative, Headache, Malaise, Meningism
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a previously healthy 14-year-old boy presented with a 2-day history of malaise, anorexia, and a painful, pruritic rash and a 1-day history of severe headache. Physical examination revealed more than 70 papulovesicular lesions over the lateral aspect of his left thigh in an L1 to L2 dermatomal distribution, photophobia, and meningismus without focal neurologic deficits or altered mental status. The patient had no recent varicella-zoster virus (VZV) exposure and had received 2 varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot # and expiration date unknown) at 1 and 4 years of age.  Laboratory studies revealed normal peripheral blood white blood cell (WBC) and platelet counts, liver transaminases, and C-reactive protein level. Cerebrospinal fluid (CSF) had a Gram-stain result negative for organisms, glucose of 60 mg/dL, protein of 64 mg/dL, red blood cell count of 268/cubic millimetre, and WBC count of 140/cubic millimetre with 88% lymphocytes and 10% monocytes. CSF and a scraping of a vesicular lesion resulted positive for VZV by polymerase chain reaction (PCR); virus from both specimens genotyped as vOka. VZV seroconversion was confirmed, and CSF tested negative for VZV IgG. The patient was human immunodeficiency virus (HIV) negative with normal numbers and percentages of T- and B-cell subsets. He was treated for 7 days with intravenous (IV) acyclovir. Pain resolved, and no new lesions developed after 3 days of treatment; headache, photophobia, and meningismus resolved after 5 days; neurologic examination was normal at discharge. Malaise resolved 2 weeks later. The authors considered meningitis to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).  Upon internal review, meningitis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature.; Sender's Comments:  US-009507513-1912USA005082:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Meningitis, Neurological examination normal, Photophobia, Platelet count normal, Polymerase chain reaction positive
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a previously healthy 14-year-old boy presented with a 2-day history of malaise, anorexia, and a painful, pruritic rash and a 1-day history of severe headache. Physical examination revealed more than 70 papulovesicular lesions over the lateral aspect of his left thigh in an L1 to L2 dermatomal distribution, photophobia, and meningismus without focal neurologic deficits or altered mental status. The patient had no recent varicella-zoster virus (VZV) exposure and had received 2 varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot # and expiration date unknown) at 1 and 4 years of age.  Laboratory studies revealed normal peripheral blood white blood cell (WBC) and platelet counts, liver transaminases, and C-reactive protein level. Cerebrospinal fluid (CSF) had a Gram-stain result negative for organisms, glucose of 60 mg/dL, protein of 64 mg/dL, red blood cell count of 268/cubic millimetre, and WBC count of 140/cubic millimetre with 88% lymphocytes and 10% monocytes. CSF and a scraping of a vesicular lesion resulted positive for VZV by polymerase chain reaction (PCR); virus from both specimens genotyped as vOka. VZV seroconversion was confirmed, and CSF tested negative for VZV IgG. The patient was human immunodeficiency virus (HIV) negative with normal numbers and percentages of T- and B-cell subsets. He was treated for 7 days with intravenous (IV) acyclovir. Pain resolved, and no new lesions developed after 3 days of treatment; headache, photophobia, and meningismus resolved after 5 days; neurologic examination was normal at discharge. Malaise resolved 2 weeks later. The authors considered meningitis to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).  Upon internal review, meningitis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature.; Sender's Comments:  US-009507513-1912USA005082:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rash pruritic, T-lymphocyte count normal, Transaminases
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a previously healthy 14-year-old boy presented with a 2-day history of malaise, anorexia, and a painful, pruritic rash and a 1-day history of severe headache. Physical examination revealed more than 70 papulovesicular lesions over the lateral aspect of his left thigh in an L1 to L2 dermatomal distribution, photophobia, and meningismus without focal neurologic deficits or altered mental status. The patient had no recent varicella-zoster virus (VZV) exposure and had received 2 varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot # and expiration date unknown) at 1 and 4 years of age.  Laboratory studies revealed normal peripheral blood white blood cell (WBC) and platelet counts, liver transaminases, and C-reactive protein level. Cerebrospinal fluid (CSF) had a Gram-stain result negative for organisms, glucose of 60 mg/dL, protein of 64 mg/dL, red blood cell count of 268/cubic millimetre, and WBC count of 140/cubic millimetre with 88% lymphocytes and 10% monocytes. CSF and a scraping of a vesicular lesion resulted positive for VZV by polymerase chain reaction (PCR); virus from both specimens genotyped as vOka. VZV seroconversion was confirmed, and CSF tested negative for VZV IgG. The patient was human immunodeficiency virus (HIV) negative with normal numbers and percentages of T- and B-cell subsets. He was treated for 7 days with intravenous (IV) acyclovir. Pain resolved, and no new lesions developed after 3 days of treatment; headache, photophobia, and meningismus resolved after 5 days; neurologic examination was normal at discharge. Malaise resolved 2 weeks later. The authors considered meningitis to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).  Upon internal review, meningitis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature.; Sender's Comments:  US-009507513-1912USA005082:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test positive, White blood cell count normal
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a previously healthy 14-year-old boy presented with a 2-day history of malaise, anorexia, and a painful, pruritic rash and a 1-day history of severe headache. Physical examination revealed more than 70 papulovesicular lesions over the lateral aspect of his left thigh in an L1 to L2 dermatomal distribution, photophobia, and meningismus without focal neurologic deficits or altered mental status. The patient had no recent varicella-zoster virus (VZV) exposure and had received 2 varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot # and expiration date unknown) at 1 and 4 years of age.  Laboratory studies revealed normal peripheral blood white blood cell (WBC) and platelet counts, liver transaminases, and C-reactive protein level. Cerebrospinal fluid (CSF) had a Gram-stain result negative for organisms, glucose of 60 mg/dL, protein of 64 mg/dL, red blood cell count of 268/cubic millimetre, and WBC count of 140/cubic millimetre with 88% lymphocytes and 10% monocytes. CSF and a scraping of a vesicular lesion resulted positive for VZV by polymerase chain reaction (PCR); virus from both specimens genotyped as vOka. VZV seroconversion was confirmed, and CSF tested negative for VZV IgG. The patient was human immunodeficiency virus (HIV) negative with normal numbers and percentages of T- and B-cell subsets. He was treated for 7 days with intravenous (IV) acyclovir. Pain resolved, and no new lesions developed after 3 days of treatment; headache, photophobia, and meningismus resolved after 5 days; neurologic examination was normal at discharge. Malaise resolved 2 weeks later. The authors considered meningitis to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).  Upon internal review, meningitis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature.; Sender's Comments:  US-009507513-1912USA005082:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional symptoms reported; patient received second dose of VARIVAX series that was improperly stored; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergies/drug reactions, concurrent conditions and concomitant medications were not reported. On 02-DEC-2019, the patient was vaccinated with second dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, route of administration, anatomical location were not reported) (lot # S008692 and expiration date: 21-MAR-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent.It was reported that the vaccine was exposed to a temperature 6.5 Fahrenheit degrees for 20 minutes. Previous temperature excursion was reported as 8.1Fahrenheit degrees for 25 minutes. It was reported that digital data logger was involved. No additional symptoms reported. No product quality complaints were reported.