chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: White blood cell count increased
Clinical narrative: I got my first dose of Moderna on 3/4/21. Reaction the following date was a heavy/sore left arm on the arm of the injection. A red spot on the site if the injection was noticed later on, which grew in size for the next several days. 14 days later (3/18/21), I woke up with strong pain in my annal area and cramps in the abdomen. This was followed with fever for the next days, up to 100.6 degrees. I took Tylenol this past weekend, which took care of the fever; however, the pain in my annal area continues.  It's been difficult to go to the bathroom...I have no diarrhea. I went to see a Doctor yesterday and they did some blood tests, which resulted in high white blood cells count (I have an infection they want me to re do my blood tests), and some issues with my liver enzymes. Today, I noticed some loss in taste. The Doctor said yesterday I didn't need a Covid test; however, I'm wondering if I do or if what I have It's an adverse reaction to the vaccine. Please advise.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Severe flu symptoms lasting for 18 hours
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Coccydynia, Diarrhoea
Clinical narrative: Started to have body aches and brain fogginess at noon 12 p 3/16/21 same day of second vaccine. Severe left arm pain and neck pain.   Several episodes of diarrhea and abdominal cramping.  Severe coccyx bone pain, lower back pain and knee pain at 6 pm 3/16/2021 My daughter who is 17 months old and who still breast feeds had several episodes of diarrhea  and gas pain causing crying for over an hour at 9 pm 3/16/2021 facial swelling bilaterally and hives unilaterally on left side of face  appeared next day 3/17/2021 at 8 am
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Neck pain, Pain, Pain in extremity, Swelling face
Clinical narrative: Started to have body aches and brain fogginess at noon 12 p 3/16/21 same day of second vaccine. Severe left arm pain and neck pain.   Several episodes of diarrhea and abdominal cramping.  Severe coccyx bone pain, lower back pain and knee pain at 6 pm 3/16/2021 My daughter who is 17 months old and who still breast feeds had several episodes of diarrhea  and gas pain causing crying for over an hour at 9 pm 3/16/2021 facial swelling bilaterally and hives unilaterally on left side of face  appeared next day 3/17/2021 at 8 am
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Started to have body aches and brain fogginess at noon 12 p 3/16/21 same day of second vaccine. Severe left arm pain and neck pain.   Several episodes of diarrhea and abdominal cramping.  Severe coccyx bone pain, lower back pain and knee pain at 6 pm 3/16/2021 My daughter who is 17 months old and who still breast feeds had several episodes of diarrhea  and gas pain causing crying for over an hour at 9 pm 3/16/2021 facial swelling bilaterally and hives unilaterally on left side of face  appeared next day 3/17/2021 at 8 am
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue, fever, aches, headache
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Injection of shot was extremely painful with heavy stinging and burning sensation.  Approximately 4 hours after receiving shot on Friday, extreme fatigue, arm ache, full body/joint ache and severe headache. Took Tylenol and slept. Symptoms lasted until Sunday morning, although low grade headache persisted until Monday morning.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Dry eye, Eye irritation
Clinical narrative: Pt presented to the ED with right-sided facial drooping and was diagnosed with Ball's Palsy. Pt was prescribed prednisone in the ED. Evaluated today at our office and was prescribed valtrex. Currently experiencing right eye dryness and irritation.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash papular
Clinical narrative: "covid arm" - raised rash and redness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Constant headache, malaise, nausea, unable to keep food down, extreme fatigue, intermittent low-grade fevers.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Influenza like illness
Clinical narrative: pt states that she developed chills.  She had shivers and was very achy like she had the flu.  After a few hours these symptoms subsided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: Swelling, rash, and mild itching at vaccine site started 8 days after vaccination. I applied steroid cream to affected area.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenia, Fatigue, Flushing
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Cutaneous skin reaction on chest and thighs yellow and purple color
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Cutaneous skin reaction on chest and thighs yellow and purple color
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Skin discolouration
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Cutaneous skin reaction on chest and thighs yellow and purple color
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Cutaneous skin reaction on chest and thighs yellow and purple color
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: RIGHT SHOULDER PAIN. Muscle soreness to right shoulder
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received Moderna 030L2DA on 2/20j/21. Due to a miscommunication between the vaccinator and the vaccinator assistant, the pt was mistakenly given Pfizer EN6204 today.  The pt was notified and counseled regarding the error.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Neck pain
Clinical narrative: severe injection site soreness, headache and neck pain advised patient to take regular strength tylenol as needed and ice pack
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, body aches, chills
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: full hives/uticaria starting 4 days after 2nd shot; mild rash after 1st shot (Pfizer covid vaccine)  Treated with antihistamines & steroids
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Intermittent pain at top of head - about the size of a dime in area.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient reported a very sore arm and neck, such that she did not want to get out of bed. Recommended rest, ice packs, and Tylenol/Motrin. Upon follow up on 3/23/2021, the patient was fully recovered with no further sequalae.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram abnormal, Laboratory test, Magnetic resonance imaging
Clinical narrative: Intractable Pain at L Hip 48 hours after injection given pain meds and Hospitalized for 5 days.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102-103 for over 24 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal bleeding
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram normal, Dehydration, Gait inability, Magnetic resonance imaging normal
Clinical narrative: Unable to walk since the vaccine has been administered
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect route of product administration, Interchange of vaccine products
Clinical narrative: This patient arrived 03/2 for a Covid-19 shot.  The patient lives in a group home for residents with intellectual disabilities, and insisted he had been given the Covid-19 vaccine.  We looked in VAMS, called VAMS to verify that a dose had not been given, and contacted the homeless shelter where he had been found by the resident coordinator.  The patient had gone missing for a single day, and was dropped off by police officers at the shelter.  The shelter stated that no vaccinations had been done, but that the residents had all been tested for Covid-19 that day.  The resident coordinator believed that the resident had not received the shot, but was exhibiting
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome, Urticaria
Clinical narrative: I started developing hives first down my right leg, then on my stomach and on my tailbone starting 4 days after receiving the vaccine.  So far, I continue to develop them slowly.  No anaphylaxis, but  a strange systemic reaction.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Incoherent, Pallor, Syncope
Clinical narrative: Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: A few minutes after the shot the patient had trouble breathing/wheezing, confused, pale, incoherent, and was possibly faint (was falling out of the chair they were sitting). The patient was diabetic and had diarrhea the morning of the shot. At the time of filing the report the patient was taken to the hospital in an ambulence
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Wheezing
Clinical narrative: Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: A few minutes after the shot the patient had trouble breathing/wheezing, confused, pale, incoherent, and was possibly faint (was falling out of the chair they were sitting). The patient was diabetic and had diarrhea the morning of the shot. At the time of filing the report the patient was taken to the hospital in an ambulence
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram abnormal, Facial paralysis, Full blood count, Hypoaesthesia
Clinical narrative: No reaction to first shot on January21.  After 2nd shot on February 23, had one day of  soreness in arm, feeling achy and ill. Then on March14 face started going numb on left side, eye drooping.  Went to ER and after tests, diagnosed Bell?s Palsey. Was given Valacyclovir Hcl and Prednisone 20 mg. for  5 days.  Still experiencing these symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Metabolic function test, Pain, Pain in extremity
Clinical narrative: No reaction to first shot on January21.  After 2nd shot on February 23, had one day of  soreness in arm, feeling achy and ill. Then on March14 face started going numb on left side, eye drooping.  Went to ER and after tests, diagnosed Bell?s Palsey. Was given Valacyclovir Hcl and Prednisone 20 mg. for  5 days.  Still experiencing these symptoms.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Erythema, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: Symptoms began 2 days after second dose. Patient noticed a small lump on right breast, swollen lymph nodes, fever of 103, and redness on lower and inner side of breast. The lump grew in size to 5cm over the course of one week and redness spread to left side. Was prescribed Hydrocortisone and Bactrim for one week, and then Bactrim was D/C'd and was changed to Clindomycin and Hydrocortisone for 2 weeks. Was diagnosed with breast abscess and went to surgeon for incision and drainage. Wound was packed. Patient was instructed to continue antibiotics and to continue packing the wound. Wound has scabbed over and patient has completed antibiotics. Ultrasound has been scheduled for observation of lump.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 after 2nd vaccination.  Son tested positive first and went to get tested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Glossodynia, Lip swelling, Mouth swelling, Swelling of eyelid
Clinical narrative: Shortly  after the first dose of Pfizer vaccine, my upper lip, upper gums ,nose, eyelids got swollen and the back of my tongue felt sore. At 11:00 pm same day , when I went to take my low dose aspirin and vitamin D gel caps with water, I had difficulty swallowing them. The side effects lasted until the following day by early evening. I left several ,messages with VAERS, to report these symptoms and never got a call back.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Renal failure
Clinical narrative: Kidney failure and death. Patient heart labs were good.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Cardiac flutter, Contusion, Fatigue, Headache
Clinical narrative: Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Tongue disorder
Clinical narrative: Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient passed away unrelated to covid vaccination Narrative: The patient received his first dose of Pfizer vaccine on 1/20. Patient was on hospice and passed away at his home with family on 1/26. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Incomplete course of vaccination
Clinical narrative: Patient passed away unrelated to covid vaccination Narrative: The patient had diabetes, hypertension and coronary atherosclerosis. Patient received his first dose of Moderna on 1/7/2021. Patient elected to not receive 2nd dose vaccination following clinical discussion with provider. Patient was diagnosed with pancreatic cancer and ws place on hospice care. Patient passed away on 2/21.No indication that death was related to COVID 19 vaccination.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient passed away unrelated to covid vaccine Narrative: The patient received his first dose of Moderna on 1/14 and he was rushed to the hospital at 4 am on 1/15. The patient tested positive for COVID and is hospitalized in the hospital. The patient passed away on 2/8. Cause of death not documented, possibly due to COVID complication. No indication that death was related to COVID 19 vaccination.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient passed away unrelated to covid vaccination Narrative: The patient had COPD and history of prostate cancer. Patient was placed on hospice care. Patient received his first dose Moderna on 2/9. Patient passed away on 2/16. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hypertensive heart disease
Clinical narrative: DEATH Narrative: 73 y.o. male with pmh severe COPD, CAD, HTN, hypothyroidism, OSA treated with CPAP, obesity. Noted to have engaged with Pulmonary clinic in December 2020 for worsening respiratory status. No PFTs since 2015. Was found slumped over deceased in his home on the afternoon of 2/24/2021. Medical Examiner notified. Request sent to ME office for report if one exists. No drugs or alcohol were found on the scene andno sign of trama. Hypertensive cardiovascular disease were reported as an adequate cause for death. "pathologist" reported that Covid vaccine does not need to be listed as it was "more than 24 hours since the shot".
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 60-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JUN-2011, the patient was administrated zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis by unspecified provider at the clinic. On 29-MAR-2012, the patient suffered shingles, including any and all of its sequeale.. As a result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of zoster vaccine live (ZOSTAVAX), the patient required and/or would require more health care and services and did incur medical, health, and would in the future be required to obtain further medical and/or hospital care, attention, and services. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses, continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The outcome of the event was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an approximately 67-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-JAN-2012, the pt was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) at clinic for prophylaxis. On an unknown date in 2015, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. She was caused to suffer serious, dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required or would require more health care and services and did incur medical, health, she would in the future be required to obtain further medical and/ or hospital care, attention, and services. In addition, she suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Her direct medical losses and costs included physician care, monitoring, and treatment. She incurred and would continue to incur mental and physical pain and suffering. The outcome of the event of shingles was considered to be not recovered. The lawyer considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).   The event of shingles was considered to be disabling.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 71-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unspecified date in 2009, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis by unspecified provider at the drug store. On unspecified date in 2009, as a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles, including any and all of its sequelae. As a result of the patient's receipt of the zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, and would in the future be required to obtain further medical and/or hospital care, attention, and services. The patient has incurred and will continue to incur medical and related expenses. The patient suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The outcome of the event of shingles was determined to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 63-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-SEP-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis by unspecified provider at the pharmacy. On 07-JUL-2016, the patient suffered shingles , including any and all of its sequelae as a result of her receipt of zoster vaccine live (ZOSTAVAX). As a result of the patient's receipt of the zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result, the patient  was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, she would in the future be required to obtain further medical and/or hospital care, attention, and services. The patient had incurred and would continue to incur medical and related expenses. The patient suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event of shingles was determined to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 78-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-APR-2013, the pt was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified), at the clinic for prophylaxis. On 23-JUL-2013, the pt suffered shingles, including any and all of its sequelae, as a result of zoster vaccine live (ZOSTAVAX). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result, the pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment monitoring and/or medications. As a result, the pt required and/or would require more health care and services and did incur medical, health, she would in the future be required to obtain further medical and/or hospital care, attention, and services. She incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Her direct medical losses and costs included physician care, monitoring, and treatment. She incurred and would continue to incur mental and physical pain and suffering. The outcome of the event of shingles was considered to be not recovered. The lawyer considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; inappropriate schedule of vaccine administered; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a an approximately 59-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 06-OCT-2009, the pt was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for prophylaxis. On an unspecified date in 2012, the pt suffered shingles, including any and all of its sequelae as a result of her receipt of zoster vaccine live (ZOSTAVAX). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result, the pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment monitoring and/or medications. As a result, the pt required and/or would require more health care and services and did incur medical, health, she would in the future be required to obtain further medical and/or hospital care, attention, and services. She incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Her direct medical losses and costs included physician care, monitoring, and treatment. She incurred and would continue to incur mental and physical pain and suffering. The outcome of the event of shingles was considered to be not recovered. The lawyer considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered the event of shingles to be disabling.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAR-2021, the patient was vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiration date: 04-DEC-2021, 0.5 milliliter (formulation, strength and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025945, expiration date: 30-JUL-2022, 0.5 milliliter (formulation, strength and route of administration were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at -1.6 Celsius degrees (C) for 1 hour and 36 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAR-2021, the patient was vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiration date: 04-DEC-2021, 0.5 milliliter (formulation, strength and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025945, expiration date: 30-JUL-2022, 0.5 milliliter (formulation, strength and route of administration were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at -1.6 Celsius degrees (C) for 1 hour and 36 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAR-2021, the patient was vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiration date: 04-DEC-2021, 0.5 milliliter (formulation, strength and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # T022315, expiration date: 30-JUN-2022, 0.5 milliliter (formulation, strength and route of administration were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at -1.6 Celsius degrees (C) for 1 hour and 36 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: F
Vaccine: SMALL
Symptoms: Eczema vaccinatum, Physical examination abnormal, Rash, Rash vesicular, Secondary transmission
Clinical narrative: vaccinia contamination on eczema; Secondary transmission from husband; This case was obtained from a scientific literature titled "Contact transmission of vaccinia to an infant diagnosed by viral culture and metagenomic sequencing", on date 11MAR2021.  Literature citation: Contact transmission of vaccinia to an infant diagnosed by viral culture and metagenomic sequencing. Open Forum Infect Dis. 2020.  This case refers to a female patient (infant's mother) whose "rash may have been a mild form of eczema vaccinatum" (PT: Eczema vaccinatum). It was reported that "an occult transmission from a recent vaccinee was considered" (PT: Secondary transmission). ACAM2000 (smallpox vaccine, live) was suspected of the infection.  The female had a history of moderate to severe atopic dermatitis and reported a recent illness and flare of her skin disease. On exam, she had numerous circular collarettes of scale over her forearms and arms from a vesicular eruption that began the week prior. Her rashes might be a mild form of eczema vaccinatum that were resolving without any intervention. She had not received any recent live-virus vaccinations and the possible transmission occurred  from her husband. As many military members in the father's workplace receive ACAM2000 vaccine, it was theoretically possible that contact transmission resulted in unrecognized secondary vaccinia infection.  Based on the available information in the article, 3 individual case safety reports 21000032LT (infant), 21000033LT (mother) and 21000034LT (father) were created and cross linked in the database.  Company Comment: The company agrees with the author that there was a secondary transmission from the father to the mother. A secondary transmission from other military personnel recently vaccinated, contamination is possible and cannot be ruled out; then tertiary contamination to a patient's history of eczema, the development of eczema vaccinatum is also possible. ACAM2000 is a live virus vaccine and has a potential to cause secondary transmission to household members and close contacts by accidental (contact) inoculation. The causality of eczema vaccinatum and secondary transmission is assessed as possible. The case does not meet the seriousness criteria but it will be submitted to the FDA as required.; Sender's Comments: The company agrees with the author that there was a secondary transmission from the father to the mother. A secondary transmission from other military personnel recently vaccinated, contamination is possible and cannot be ruled out; then tertiary contamination to a patient's history of eczema, the development of eczema vaccinatum is also possible. ACAM2000 is a live virus vaccine and has a potential to cause secondary transmission to household members and close contacts by accidental (contact) inoculation. The causality of eczema vaccinatum and secondary transmission is assessed as possible. The case does not meet the seriousness criteria but it will be submitted to the FDA as required.
Sex: F
Vaccine: SMALL
Symptoms: Viral test positive
Clinical narrative: vaccinia contamination on eczema; Secondary transmission from husband; This case was obtained from a scientific literature titled "Contact transmission of vaccinia to an infant diagnosed by viral culture and metagenomic sequencing", on date 11MAR2021.  Literature citation: Contact transmission of vaccinia to an infant diagnosed by viral culture and metagenomic sequencing. Open Forum Infect Dis. 2020.  This case refers to a female patient (infant's mother) whose "rash may have been a mild form of eczema vaccinatum" (PT: Eczema vaccinatum). It was reported that "an occult transmission from a recent vaccinee was considered" (PT: Secondary transmission). ACAM2000 (smallpox vaccine, live) was suspected of the infection.  The female had a history of moderate to severe atopic dermatitis and reported a recent illness and flare of her skin disease. On exam, she had numerous circular collarettes of scale over her forearms and arms from a vesicular eruption that began the week prior. Her rashes might be a mild form of eczema vaccinatum that were resolving without any intervention. She had not received any recent live-virus vaccinations and the possible transmission occurred  from her husband. As many military members in the father's workplace receive ACAM2000 vaccine, it was theoretically possible that contact transmission resulted in unrecognized secondary vaccinia infection.  Based on the available information in the article, 3 individual case safety reports 21000032LT (infant), 21000033LT (mother) and 21000034LT (father) were created and cross linked in the database.  Company Comment: The company agrees with the author that there was a secondary transmission from the father to the mother. A secondary transmission from other military personnel recently vaccinated, contamination is possible and cannot be ruled out; then tertiary contamination to a patient's history of eczema, the development of eczema vaccinatum is also possible. ACAM2000 is a live virus vaccine and has a potential to cause secondary transmission to household members and close contacts by accidental (contact) inoculation. The causality of eczema vaccinatum and secondary transmission is assessed as possible. The case does not meet the seriousness criteria but it will be submitted to the FDA as required.; Sender's Comments: The company agrees with the author that there was a secondary transmission from the father to the mother. A secondary transmission from other military personnel recently vaccinated, contamination is possible and cannot be ruled out; then tertiary contamination to a patient's history of eczema, the development of eczema vaccinatum is also possible. ACAM2000 is a live virus vaccine and has a potential to cause secondary transmission to household members and close contacts by accidental (contact) inoculation. The causality of eczema vaccinatum and secondary transmission is assessed as possible. The case does not meet the seriousness criteria but it will be submitted to the FDA as required.
Sex: M
Vaccine: SMALL
Symptoms: Rash vesicular, Secondary transmission, Vaccinia virus infection
Clinical narrative: This case was obtained from a scientific literature. Contact transmission of vaccinia to an infant diagnosed by viral culture and metagenomic sequencing. This case refers to a male patient, an active-duty military member who had secondary vaccine infection from an unknown source, although presumable by contact from other military members recently vaccinated with ACAM2000 vaccine (PTs: Vaccinia virus infection and Secondary transmission). The patient developed a 1-cm vesicular, crusted plaque above his right upper lip, which he attributed to a cold sore. He had not received any recent live-virus vaccinations. At the time of this report, he had not undergone testing for vaccinia exposure, and a follow-up epidemiologic investigation failed to identify another potential source of exposure. The author deducted that the JYNNEOS vaccine was not available at the time of these events and therefore, ACAM2000 vaccine was in use during the time this patient developed infection. As many military members in the father's workplace receive ACAM2000 vaccine. Then, it was also possible a secondary vaccinia infection in the father to the mother and the infant. Based on the available information in the article, 3 individual case safety reports 21000032LT (infant), 21000033LT (mother), and 21000034LT (father) were created and cross linked in the database. Company Comment: The company agrees with the author that their patient developed a secondary vaccine infection and contaminated the mother and subsequently the infant. The causality of vaccinia virus infection and secondary transmission is assessed as possible. The case does not meet the seriousness criteria, but it will be submitted to the FDA as required. Sender's Comments: The company agrees with the author that there patient developed a secondary vaccinia infection and contaminated the mother and subsequently the infant. The causality of vaccinia virus infection and secondary transmission is assessed as possible. The case does not meet the seriousness criteria, but it will be submitted to the FDA as required.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; received both doses /in 2018 / has had multiple cases of shingles since vaccination; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 75 or 76 years. In 2018, the patient received both the doses of Shingrix and since vaccination the patient had multiple cases of shingles. First case of shingles was in 2019. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were  unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Get shingles after the shot/Suspected vaccination failure; Shingles; Painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient get shingles after the shot, however it was mild case but it was still painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Essential tremor, Hyperhidrosis, Nervous system disorder
Clinical narrative: problems with nerves and perspiration; problems with nerves; hadEssential Tremors for13 months; This case was reported by a consumer via interactive digital media and described the occurrence of tremor in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor, sweating abnormal and neurological disorder nos. On an unknown date, the outcome of the tremor was recovered/resolved and the outcome of the sweating abnormal and neurological disorder nos were not recovered/not resolved.   It was unknown if the reporter considered the tremor, sweating abnormal and neurological disorder nos to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 1st dose of Shingrix and experienced tremor for 13 months, and still had problems with nerve and perspiration. The patient visited to neurologist.