chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Musculoskeletal pain, Pain, Post herpetic neuralgia
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. In or around 12-SEP-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. Shortly after receiving the ZOSTAVAX, the patient suffered a right anterior shoulder pain and developed skin lesions in the anterior aspect of his shoulder and was diagnosed with herpes zoster. The patient has continued to suffer from recurrent herpes zoster and later diagnosed with post herpetic neuralgia and chronic pain. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Herpes zoster and post herpetic neuralgia were considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
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. In or around 12-SEP-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. Shortly after receiving the ZOSTAVAX, the patient suffered a right anterior shoulder pain and developed skin lesions in the anterior aspect of his shoulder and was diagnosed with herpes zoster. The patient has continued to suffer from recurrent herpes zoster and later diagnosed with post herpetic neuralgia and chronic pain. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Herpes zoster and post herpetic neuralgia were considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Angiopathy, Carotid artery occlusion, Deafness neurosensory, Deafness unilateral, Hypoacusis
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. In or around 08-MAR-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX. the patient suffered sudden idiopathic hearing loss of right ear with restricted hearing of contralateral ear and bilateral sensorineal hearing loss. The patient was also diagnosed with chronic microvascular changes within the supratentorial compartment with interval development of occlusion of the right internal carotid artery. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, idiopathic hearing loss of right ear with restricted hearing of contralateral ear and bilateral sensorineal hearing loss; and chronic microvascular changes within the supratentorial compartment with interval development of occlusion of the right internal carotid artery were determined to be medically significant. Idiopathic hearing loss of right ear with restricted hearing of contralateral ear and bilateral sensorineal hearing loss; and chronic microvascular changes within the supratentorial compartment with interval development of occlusion of the right internal carotid artery were considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Sudden hearing loss
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. In or around 08-MAR-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX. the patient suffered sudden idiopathic hearing loss of right ear with restricted hearing of contralateral ear and bilateral sensorineal hearing loss. The patient was also diagnosed with chronic microvascular changes within the supratentorial compartment with interval development of occlusion of the right internal carotid artery. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, idiopathic hearing loss of right ear with restricted hearing of contralateral ear and bilateral sensorineal hearing loss; and chronic microvascular changes within the supratentorial compartment with interval development of occlusion of the right internal carotid artery were determined to be medically significant. Idiopathic hearing loss of right ear with restricted hearing of contralateral ear and bilateral sensorineal hearing loss; and chronic microvascular changes within the supratentorial compartment with interval development of occlusion of the right internal carotid artery were considered disabling. 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/physician 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, the healthcare provider/physician at physician's office administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2015, 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, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 05-NOV-2015, a healthcare provider at an internal medicine office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 29-SEP-2016, the patient was treated by a physician at the internal medicine office for post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs 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 not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 01-JAN-2012, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 01-JAN-2016, the patient was treated by healthcare providers at a family medicine office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs 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 not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for himself. This 66-year-old male consumer received PREVNAR 13 on an unspecified date, at single dose, in arm, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the consumer experienced pain and limitation of arm movement in the arm where the injection was received. He had some pain also in his other arm, but not as much as the pain where he received Prevnar 13 injection. Events outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced pain, redness, swelling at the injection site on an unspecified date. Outcome of the events was unknown. Information on the lot number has been requested.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site joint movement impairment, Injection site joint pain, Injection site reaction, Purulent discharge
Clinical narrative: Severe pain in the (L) Shoulder Joint with reddening and pus exodus material. Reduced ROM in (L) Shoulder. Symptoms began within 8 hours of administration and continue now 5 days post injection. Injection site is still raw/red with pus still exiting the injection site. First medical appointment with patient provider is scheduled for 14 December 2018 at 1600.
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: Ear congestion, Ear pain, Tinnitus
Clinical narrative: Ringing in both my ears onset 3 hours after FLU shot, severe ear pain and pressure. Doctor prescribed diclofenac potassium 50mg.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Erythema, Pain, Swelling face, Swelling of eyelid
Clinical narrative: Patient stated face was swollen, red and eyes were puffy for 4 days. Also stated that opposite area was sore and had pain radiating into her back.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Had patient stay to be monitored. Patient stated her heart rate was 95. She said she felt she couldn't catch her breath a little bit. I asked if she wanted me to call ambulance and she denied. She went to urgent care and we called to tell them she was on her way. Called again to confirm she made it their safely.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, aches.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Chills, Erythema, Influenza like illness, Injection site swelling
Clinical narrative: On Friday 12-07-2018 at 3pm flu-like symptoms, headache, fever, chills, body aches. On Sunday 12-09-2018 at 1:00pm swollen arm at injection site, cellulitis from elbow to forearm then moved above elbow, redness from shoulder to mid forearm circling around arm all on left arm.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: On Friday 12-07-2018 at 3pm flu-like symptoms, headache, fever, chills, body aches. On Sunday 12-09-2018 at 1:00pm swollen arm at injection site, cellulitis from elbow to forearm then moved above elbow, redness from shoulder to mid forearm circling around arm all on left arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Nausea, Pain
Clinical narrative: Nausea, Stomach Pains, Chills, Fever, Light headedness, Body Aches and Pains.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Nausea, Stomach Pains, Chills, Fever, Light headedness, Body Aches and Pains.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count, Full blood count, Injected limb mobility decreased, Myocardial necrosis marker, Pain in extremity
Clinical narrative: Severe pain in left arm, severe limited range of motion a few days after administration. Have seen Dr. 4 times since. Took steroids for 10 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysstasia, Pain, Pyrexia
Clinical narrative: Low grade temperature 99.4. Shivers until I literally shook so hard I could not stand up, ache for about 36 hours.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Polymerase chain reaction, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient has received two doses of varicella. One at age 14 months of age and second dose at age 4 years old. He developed a case of chicken pox on 12/3/2018 with multiple lesions at the age of 8 years old. The disease was confirmed by the state lab.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
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. In or around December 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered hearing loss. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, hearing loss was determined to be medically significant. Hearing loss was considered disabling. 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 ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-NOV-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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash, Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-JUL-2013, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (lot #, route, and dose not provided). As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of her body. She had her shingles outbreaks on 09-JUL-2016. She was diagnosed with neuropathic disorder causing her pain and was prescribed tramadol for the pain. As a direct result of the vaccine, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and serious of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the Company's negligence, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. The outcome of the events was considered not resolved. Causality assessment was related. The lawyer considered the shingles outbreak and neuropathic disorder to be disabling. Upon internal review, neuropathic disorder causing her pain was considered to be medically significant. 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 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 15-DEC-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-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, 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 09-FEB-2011, a healthcare provider at a medical group administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 23-MAR-2012, the patient was treated by a healthcare provider at the same medical group office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs 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 not recovered. Causality assessment was related. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Palpitations, Pyrexia
Clinical narrative: Twelve hours after shot, had shivering, fever, and heartbeat racing, lasted twelve hours.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis
Clinical narrative: Subacromial bursitis.
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Dyspnoea, Hypertension, Lower respiratory tract congestion
Clinical narrative: Extreme difficulty breathing, high blood pressure, bronchial congestion treatments include prednisone, VENTOLIN HFA.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Beginning 12/11 morning after administration, on awaking: fatigue, muscle aches, chills, fever (99.9), headache.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-NOV-2018, the patient was vaccinated with a expired VAQTA (dose, strength were unknown; lot# N026997 and expiration date 10-NOV-2018) intramuscularly for prophylaxis (expired product administered). No adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a nurse refers to a 76-year-old female patient with asthma, iodine and codeine allergy. Concomitant therapies included levothyroxine sodium, simvastatin, aspirin, cholecalciferol, budesonide (PULMICORT), gabapentin, rabeprazole sodium, pioglitazone hydrochloride and "Nebulizer"(no details about the product were provided). On 12-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, 1 dose (0,5ml)(lot # R012976, expiration date 25-JAN-2020) for prevention of pneumonia. On the same day, the patient experienced redness, soreness and swelling in her arm. The patient's arm was hot to the touch, descending towards her elbow. The patient also reported fever and body aches. Unspecified treatment was given for adverse events. The patient sought medical attention by visiting the doctor. No laboratory diagnostics and studies were performed. The outcome of the events was reported as recovering/resolving. The relatedness between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 76-year-old female patient with asthma, iodine and codeine allergy. Concomitant therapies included levothyroxine sodium, simvastatin, aspirin, cholecalciferol, budesonide (PULMICORT), gabapentin, rabeprazole sodium, pioglitazone hydrochloride and "Nebulizer"(no details about the product were provided). On 12-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, 1 dose (0,5ml)(lot # R012976, expiration date 25-JAN-2020) for prevention of pneumonia. On the same day, the patient experienced redness, soreness and swelling in her arm. The patient's arm was hot to the touch, descending towards her elbow. The patient also reported fever and body aches. Unspecified treatment was given for adverse events. The patient sought medical attention by visiting the doctor. No laboratory diagnostics and studies were performed. The outcome of the events was reported as recovering/resolving. The relatedness between the events and PNEUMOVAX 23 was not provided.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. On an unknown date in 2012, the patient was vaccinated with a dose of an unspecified pneumococcal vaccine (manufacturer unknown), reported as a "booster pneumonia shot" (dose, route of administration, lot # and expiry date not provided). On an unknown date in 2012, the patient experienced pneumonia. The consumer reported the patient was admitted to an unspecified hospital in 2012 due to pneumonia. The relatedness between the event of pneumonia and unspecified pneumococcal vaccine was not reported. Upon internal review, the event of pneumonia was determined to be medically significant. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA001825.
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 2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-MAR-2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, 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: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer via pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history, historical medications, concomitant medications and drug reactions/allergies were not reported. On an unknown date in March 2018, the patient was vaccinated with GARDASIL 9 shot (dosing details, route, lot # and expirations date were not reported) as prophylaxis, but had not had her second dose yet (at the time of this report) (circumstance or information capable of leading to medication error). The patient planned to administer the remaining two shots this year. No adverse experience reported. Product quality complaint was not involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-OCT-2016, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (lot #, dose, and route # not provided). As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of her body. The patient had her first shingles outbreaks on 01-JAN-2018 and was diagnosed with zoster ocular disease, causing her pain and loss of vision. As a direct result of the vaccine, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and serious of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered not resolved. Causality assessment was related. The lawyer considered the shingles outbreak and zoster ocular disease to be disabling. Upon internal review, zoster ocular disease was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-OCT-2016, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (lot #, dose, and route # not provided). As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of her body. The patient had her first shingles outbreaks on 01-JAN-2018 and was diagnosed with zoster ocular disease, causing her pain and loss of vision. As a direct result of the vaccine, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and serious of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered not resolved. Causality assessment was related. The lawyer considered the shingles outbreak and zoster ocular disease to be disabling. Upon internal review, zoster ocular disease was considered to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Chills, Decreased appetite, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2018170973). On 23rd November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain and injection site tenderness. On 24th November 2018, the patient experienced headache, generalized aching and influenza like illness. Rechallenge with SHINGRIX was positive. On 25th November 2018, the outcome of the injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain, headache, generalized aching and influenza like illness were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain, headache, generalized aching, influenza like illness and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on her left arm at 11:30 am. Within two hours after receiving the vaccination, the patient developed severe soreness in her left arm and that extended from her left shoulder almost to her left hand. Also, the injection site began to swell. Four hours after the vaccination she began to feel extremely tired and had an upset stomach, causing her to lose her appetite and not be able to eat her dinner. Eight hours after the injection, the patient started shivering and went to bed having soreness in both shoulders and her back. On 24th November 2018, 1 day after receiving SHINGRIX, the patient was shivering, felt severely tired, had a headache, and had to take naps all day. She had aches all over her upper body and described that she felt like she had the flu. On 25th November 2018, Sunday, the patient woke up and all symptoms had resolved other than the injection site is a little sore if she presses on it. The reporter gave permission for her physician to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2018170973). On 23rd November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain and injection site tenderness. On 24th November 2018, the patient experienced headache, generalized aching and influenza like illness. Rechallenge with SHINGRIX was positive. On 25th November 2018, the outcome of the injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain, headache, generalized aching and influenza like illness were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain, headache, generalized aching, influenza like illness and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on her left arm at 11:30 am. Within two hours after receiving the vaccination, the patient developed severe soreness in her left arm and that extended from her left shoulder almost to her left hand. Also, the injection site began to swell. Four hours after the vaccination she began to feel extremely tired and had an upset stomach, causing her to lose her appetite and not be able to eat her dinner. Eight hours after the injection, the patient started shivering and went to bed having soreness in both shoulders and her back. On 24th November 2018, 1 day after receiving SHINGRIX, the patient was shivering, felt severely tired, had a headache, and had to take naps all day. She had aches all over her upper body and described that she felt like she had the flu. On 25th November 2018, Sunday, the patient woke up and all symptoms had resolved other than the injection site is a little sore if she presses on it. The reporter gave permission for her physician to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Somnolence, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2018170973). On 23rd November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain and injection site tenderness. On 24th November 2018, the patient experienced headache, generalized aching and influenza like illness. Rechallenge with SHINGRIX was positive. On 25th November 2018, the outcome of the injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain, headache, generalized aching and influenza like illness were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site swelling, tiredness, upset stomach, appetite lost, shivering, shoulder pain, back pain, headache, generalized aching, influenza like illness and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on her left arm at 11:30 am. Within two hours after receiving the vaccination, the patient developed severe soreness in her left arm and that extended from her left shoulder almost to her left hand. Also, the injection site began to swell. Four hours after the vaccination she began to feel extremely tired and had an upset stomach, causing her to lose her appetite and not be able to eat her dinner. Eight hours after the injection, the patient started shivering and went to bed having soreness in both shoulders and her back. On 24th November 2018, 1 day after receiving SHINGRIX, the patient was shivering, felt severely tired, had a headache, and had to take naps all day. She had aches all over her upper body and described that she felt like she had the flu. On 25th November 2018, Sunday, the patient woke up and all symptoms had resolved other than the injection site is a little sore if she presses on it. The reporter gave permission for her physician to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a elderly female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown. It was unknown if the reporter considered the hearing loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was the reported for reporter's grandmother. The patient stated that the patient was given SHINGRIX, and after vaccination, the patient had lost the hearing (a woman who could hear anything prior to the injection). The reporter was curious if the company had any way to help them since it was this product that caused the issues. This case has been linked with case US2018GSK219942, reported by the same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Flu vaccine for prophylaxis. The patient's past medical history included lung cancer (surgery to remove lung cancer, left lower lobe was removed). Concurrent medical conditions included emphysema and stent placement. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness in her arms which lasted for approximately one week. Additional information was not reported. The patient consented to follow up with her physician and herself. This case has been linked with the case US2018218491, reported by the same reporter for the same patient.