chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 16-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided) reconstituted with properly stored sterile diluent. The vaccines was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA009244: US-009507513-1812USA009242: US-009507513-1812USA009241: US-009507513-1812USA009243.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-OCT-2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 23-JUN-2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2007, a healthcare provider at a family practice administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by a healthcare provider at the family practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-OCT-2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-JUL-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-JAN-2017, the patient was treated by a nurse practitioner for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-DEC-2013, the patient was treated by a healthcare provider at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider/healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2014, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-JAN-2017, the patient was treated by a healthcare provider at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 20 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 13-DEC-2018, the patient was vaccinated with a pediatric formulation dose of VAQTA lot # R021233, expiration date 05-SEP-2019, intramuscularly for prophylaxis (underdose). No adverse reactions were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 16-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided) reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA009243: US-009507513-1811USA009124: US-009507513-1812USA009244: US-009507513-1812USA009241.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 16-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided)reconstituted with properly stored sterile diluent. The vaccines was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA009124: US-009507513-1812USA009242: US-009507513-1812USA009244: US-009507513 1812USA009241.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Mobility decreased
Clinical narrative: Unable to get out of bed. No energy, weakness, red arm. Red arm still present over 1 month after shingles shot. This was all on 2nd shot. Sore arm was only reaction to 1st shot.
Age: 8.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site oedema, Injection site swelling
Clinical narrative: Patient's upper arm swelled and had heat first at the site of injection then it spread and affected her entire upper arm. It was clearly swollen and looked like it was filled with fluid. She called the pharmacy on the morning of 12/19/18 to report the side effects and I instructed her to contact her dr. They could not see her so she went to a walk in clinic. They diagnosed her with post injection inflammatory reaction. She was told to apply cold compress as she felt necessary.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Antinuclear antibody, Blood thyroid stimulating hormone, Full blood count, Glycosylated haemoglobin, Hypoaesthesia
Clinical narrative: Tingly at fingertips; feels numb; all fingerips and similar sensation in toes.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Red blood cell sedimentation rate, Vitamin B12
Clinical narrative: Tingly at fingertips; feels numb; all fingerips and similar sensation in toes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: PATIENT CAME INTO THE PHARMACY ON 12/18/2018. HER CHIEF COMPLAINT WAS DECREASED RANGE OF MOTION IN HER LEFT ARM SINCE SHE HAD THE SHINGRIX VACCINATION. SHE IS UNABLE TO EXTEND HER ARM OUTWARD AND UPWARD.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reports swollen, red, painful, and warm arm. Pt had been icing on and off. Urgent care believes arm may be infected. They gave patient a course of antibiotics.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Lacrimation increased, Nasal congestion, Pain
Clinical narrative: Approximately three hours after receiving the AFLURIA flu vaccine, employee was at home and developed an acute onset of upper respiratory symptoms of nasal congestion, throat irritation, watery eyes and cough with high fever. She denied any episode of SOB, wheezing or stridor. She also developed generalized body aches. She treated at home with oral antihistamines and antipyretics and did not seek emergency medical treatment. Her symptoms resolved within 24 hours except for residual fatigue.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Approximately three hours after receiving the AFLURIA flu vaccine, employee was at home and developed an acute onset of upper respiratory symptoms of nasal congestion, throat irritation, watery eyes and cough with high fever. She denied any episode of SOB, wheezing or stridor. She also developed generalized body aches. She treated at home with oral antihistamines and antipyretics and did not seek emergency medical treatment. Her symptoms resolved within 24 hours except for residual fatigue.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Paraesthesia
Clinical narrative: Patient experienced level 10 pain (on the numeric pain scale) 10 days after receiving the shot. For two weeks the patient was not able to lift arm over his head. Shooting, electric like pain would come and go over the next 3-4 weeks. The intensity of pain would fade over the course of approximately 6 weeks. By 12/13/18 the patient was back to normal and has not reported any symptoms since then.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chapped lips, Lip exfoliation, Oral herpes, Pain, Pyrexia
Clinical narrative: I had the expected low grade fever and body pains as with the first vaccine. On the following Friday, I had a huge fever blister on my lower right lip. I have NEVER had a fever blister in my life before. My lips cracked and all the skin shed on my lips by the following Sunday.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Cough, Discomfort, Epstein-Barr virus test negative, Full blood count normal, Influenza A virus test negative
Clinical narrative: On 12/6, patient awoke with a generalized erythematous maculopapular rash. He also had developed fever and cough. He was seen in ER that day and was diagnosed with a LLL pneumonia and viral exanthem was started on OMNICEF. He had been started on Amoxicillin on 11/28 for an acute right AOM and had missed 3 doses by the ER visit. I saw patient in the office on 12/7 for ER follow-up. The rash had dramatically worsened, and patient was still febrile and uncomfortable. The rash looked just like a measles rash. He was switched to Azithromycin.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Influenza B virus test, Influenza virus test negative, Measles antibody negative, Metabolic function test normal, Otitis media acute
Clinical narrative: On 12/6, patient awoke with a generalized erythematous maculopapular rash. He also had developed fever and cough. He was seen in ER that day and was diagnosed with a LLL pneumonia and viral exanthem was started on OMNICEF. He had been started on Amoxicillin on 11/28 for an acute right AOM and had missed 3 doses by the ER visit. I saw patient in the office on 12/7 for ER follow-up. The rash had dramatically worsened, and patient was still febrile and uncomfortable. The rash looked just like a measles rash. He was switched to Azithromycin.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Parvovirus B19 test negative, Penicillium test negative, Pneumonia, Pyrexia, Rash erythematous
Clinical narrative: On 12/6, patient awoke with a generalized erythematous maculopapular rash. He also had developed fever and cough. He was seen in ER that day and was diagnosed with a LLL pneumonia and viral exanthem was started on OMNICEF. He had been started on Amoxicillin on 11/28 for an acute right AOM and had missed 3 doses by the ER visit. I saw patient in the office on 12/7 for ER follow-up. The rash had dramatically worsened, and patient was still febrile and uncomfortable. The rash looked just like a measles rash. He was switched to Azithromycin.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Rash maculo-papular, Rash morbilliform, Red blood cell sedimentation rate increased, Respiratory viral panel, Streptococcus test negative
Clinical narrative: On 12/6, patient awoke with a generalized erythematous maculopapular rash. He also had developed fever and cough. He was seen in ER that day and was diagnosed with a LLL pneumonia and viral exanthem was started on OMNICEF. He had been started on Amoxicillin on 11/28 for an acute right AOM and had missed 3 doses by the ER visit. I saw patient in the office on 12/7 for ER follow-up. The rash had dramatically worsened, and patient was still febrile and uncomfortable. The rash looked just like a measles rash. He was switched to Azithromycin.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Urine analysis normal, Viral rash
Clinical narrative: On 12/6, patient awoke with a generalized erythematous maculopapular rash. He also had developed fever and cough. He was seen in ER that day and was diagnosed with a LLL pneumonia and viral exanthem was started on OMNICEF. He had been started on Amoxicillin on 11/28 for an acute right AOM and had missed 3 doses by the ER visit. I saw patient in the office on 12/7 for ER follow-up. The rash had dramatically worsened, and patient was still febrile and uncomfortable. The rash looked just like a measles rash. He was switched to Azithromycin.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Influenza virus test negative, Pyrexia
Clinical narrative: Fever started same evening and continued into next day. Pt had viral URI symptoms prior to vaccination but no fever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Redness, swelling, and a signficant pain. Patient states that vaccine was administered too high which caused these symptoms.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Pt developed painful endurated edema of left upper at site on injection persisting for more than 5 days after injection.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: On 12/11/18- both vaccines given IM Left Deltoid with no adverse reaction at that time. On 12/19/18- Patient seen in our office for injection site pain on left arm. Dr. evaluated patient. Left arm injection site oval shape, firm, slightly warm to touch. The mounded area measured 4cm long by 5cm wide. No redness or discoloration noted. Pt reports symptoms started 3 days ago on 12/16/18. Patient reports that the pain is migrating to other joints on both sides of her body.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 11-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history. On 05-DEC-2018, the patient mistakenly received a dose of LIQUID PEDVAXHIB injection, via intramuscular route, lot number: R013569, expiration date on: 18-MAR-2021 (strength, dose number, anatomical location, and indication, were not reported) instead of the "scheduled Meningococcal Vaccine".
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred, Visual acuity reduced, Vitreous floaters, Vitritis
Clinical narrative: This spontaneous case was received from a health care professional on an unpublished manuscript and refers to a 62-year-old male patient. The patient's concurrent conditions included end-stage liver disease and diabetes mellitus type 2 without retinopathy. Information on patient's medical history and concomitant medications were not reported. It was also reported that the patient did not have other immune-related disorders or frequent infections. On an unknown date (also reported as 7 months ago), the patient was vaccinated with ZOSTAVAX for prophylaxis (dosing details, lot # and expiration date were not reported). On an unknown date, the patient presented with two day history of floaters and blurred vision in the left eye. The patient's vision acuity was 20/60 (units not reported) and intraocular pressure was 16 mmHg. On an unknown date (7 months after vaccination), the patient underwent an unspecified examination which showed inflammation in anterior chamber and vitreous, multiple white retinal lesions and necrosis on presentation in the left eye. Late phase fluorescein angiogram showed late leakage and staining inferonasally corresponding to the area of CMV retinitis in the left eye and a normal appearing angiogram of the right eye. The patient was initially treated with oral valganciclovir and topical difluprednate for presumed cytomegalovirus (CMV) retinitis. On an unknown date, the patient also underwent unspecified blood tests for infectious and inflammatory etiologies which were negative apart from a borderline acute retinal necrosis (ARN). On an unknown date, subsequent polymerase chain reaction (PCR) test of his aqueous humor was positive for varicella zoster vaccine (VZV). The patient was treated with valacyclovir 1 gram 3 times per day which replaced valganciclovir. It was reported that after 10 weeks, his visual acuity improved to 20/50 (units not reported), vitritis resolved and retinal lesions became inactive. The treatment with valacyclovir was decreased to 1 gram daily and topical steroids were tapered. On an unknown date, the patient died from complications of his cirrhosis 6 months following his initial diagnosis of ARN (Hepatic cirrhosis). The patient had recovered from necrotizing retinitis was recovered. The outcome of varicella zoster virus infection was unknown. The causality assessment of the events was not provided. The reporters stated that the patient experienced milder disease and longer latency periods. The longer latency periods might be associated with wild-type virus in ARN due to VZV as well as systemic disease. The reporter stated that immunocompetence might play a role in ARN after VZV vaccination and the patient might have been relatively immune compromised due to end stage liver disease and diabetes. Upon internal review, necrotizing retinitis and hepatic cirrhosis were determined to be medically significant. This is one of the two reports received from the same source. Reported Cause(s) of Death: The patient died from complications of his cirrhosis.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2013, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 13-DEC-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-DEC-2012, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-FEB-2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In SEPTEMBER 2012, a healthcare provider, at a clinic, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-APR-2013, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist at a pharmacy recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-MAR-2016, the patient was treated by a physician assistant at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-FEB-2014, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-JAN-2017, the patient was treated by a healthcare provider at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2007, a healthcare provider at the office of a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-JAN-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-SEP-2009, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 07-AUG-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-JUL-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-FEB-2016, the patient was treated by a physician for shingles and post herpetic neuralgia. The patient was diagnosed with shingles, post herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.