chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral haemorrhage, Cerebrovascular disorder
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 10-JAN-2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than two (2) weeks after receiving the ZOSTAVAX vaccine, the patient suffered a right intracerebral hemorrhage/ cerebrovascular incident which required hospitalization, rehabilitation and therapy. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, 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 of the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review, a right intracerebral hemorrhage/cerebrovascular incident was determined to be a medically significant event. A right intracerebral hemorrhage/cerebrovascular incident was considered to be disabling. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Condition aggravated, Phototherapy, Psoriasis, Rash
Clinical narrative: Exacerbation of psoriasis to generalized body. Was only at site of elbows at time of visit. Rash to entire back, abdomen, and arms and legs bilaterally following injection. Patient was seen by his Dermatologist who started phototherapy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Shivering, Headache, Nausea.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site pruritus, Injection site rash, Musculoskeletal pain
Clinical narrative: Nov. 24th experienced itching at site of injection. After scratching she noticed a burning sensation in her arm. Sunday AM she noticed small red spots on left arm around the bend in her arm. Monday AM the same spot increased in size & a couple of new small spots appeared. Her whole arm was sore and pain was moving up her arm into her shoulder and neck. Tuesday AM she went to her doctor and was diagnosed with shingles and started on antiviral FAMVIR.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Nov. 24th experienced itching at site of injection. After scratching she noticed a burning sensation in her arm. Sunday AM she noticed small red spots on left arm around the bend in her arm. Monday AM the same spot increased in size & a couple of new small spots appeared. Her whole arm was sore and pain was moving up her arm into her shoulder and neck. Tuesday AM she went to her doctor and was diagnosed with shingles and started on antiviral FAMVIR.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: The current episode started 11/13/18 (Patient received the pneumococcal 23 vaccine in her left upper arm) Few hours later she noticed redness, swelling and pain. Patient was seen in the office on 11/14/18, and the redness had spread down into her elbow and there was tenderness. The problem had been rapidly worsening since onset. The affected locations include the left arm (left upper arm and spreading down into elbow). The rash was characterized by pain, redness and swelling. Associated with: Pneumococcal 23 vaccine. Associated symptoms include a fever. Patient tried ice and TYLENOL, which were mildly effective. Patient started on KEFLEX and Prednisone, as well as TYLENOL and BENADRYL as needed.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test negative, Dysgeusia, Eyelid function disorder, Facial paralysis, Neck pain
Clinical narrative: 1 week after flu vaccine - 10/29/18 - awakened with onset of pain in left side back of neck into base of skull, left eyelid would not close, altered taste, progressing to left sided facial paralysis, lasting 3 weeks. Went to ER on 10/30/18 - found to have facial nerve paralysis, MRI done, Lyme's test.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve injury, Nuclear magnetic resonance imaging normal
Clinical narrative: 1 week after flu vaccine - 10/29/18 - awakened with onset of pain in left side back of neck into base of skull, left eyelid would not close, altered taste, progressing to left sided facial paralysis, lasting 3 weeks. Went to ER on 10/30/18 - found to have facial nerve paralysis, MRI done, Lyme's test.
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. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about January 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider 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-NOV-2016, 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 2018, 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, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Dysphonia, Malaise, Pruritus, Rash generalised
Clinical narrative: Mild itching first night, developing gradually to intense itching in one week, feeling sick, rash appearing on 6th day, hives, welts, raised rash over much of the body by 10th day throat closing, hoarse voice. Treatment, BENADRYL taken over the counter, trip to ER, treatment of steroids, BENADRYL, transfer by ambulance to hospital, drugs and prednisone begun, blood tests performed, unknown results.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: Mild itching first night, developing gradually to intense itching in one week, feeling sick, rash appearing on 6th day, hives, welts, raised rash over much of the body by 10th day throat closing, hoarse voice. Treatment, BENADRYL taken over the counter, trip to ER, treatment of steroids, BENADRYL, transfer by ambulance to hospital, drugs and prednisone begun, blood tests performed, unknown results.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Reports that she received a pneumonia shot 11/27/2018 and  she woke up 11/28 in significant pain (hard to get out of bed) and her whole upper arm is red/swollen from the upper arm all the way to the elbow almost.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dry mouth, Fatigue, Nausea
Clinical narrative: EE here today stating that she received the flu vaccine on 10/22 at 9:59am left deltoid Brand: FLULAVAL Preservative Free 7M9A7. Starting 10/24 she had intermittent dizziness where the world was spinning, and she has to hold on to something to keep from falling. Also while laying down she still is dizzy. Around 10/26 began with fatigue. This week was even worse, has no energy to do daily tasks. She also has nausea intermittently, doesn't have to to do with eating or not eating. At least once a day has an episode of nausea. She cannot actively vomit due to having a lap band removed and possible scar tissue, but she does dry heave and has mucous come up. No worsening diarrhea. Also states since 10/22 her mouth is dry all the time, is always feeling thirsty. No doctor visit as of today. No inner ear problems previously. Would like to see her PCP.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Retching, Thirst
Clinical narrative: EE here today stating that she received the flu vaccine on 10/22 at 9:59am left deltoid Brand: FLULAVAL Preservative Free 7M9A7. Starting 10/24 she had intermittent dizziness where the world was spinning, and she has to hold on to something to keep from falling. Also while laying down she still is dizzy. Around 10/26 began with fatigue. This week was even worse, has no energy to do daily tasks. She also has nausea intermittently, doesn't have to to do with eating or not eating. At least once a day has an episode of nausea. She cannot actively vomit due to having a lap band removed and possible scar tissue, but she does dry heave and has mucous come up. No worsening diarrhea. Also states since 10/22 her mouth is dry all the time, is always feeling thirsty. No doctor visit as of today. No inner ear problems previously. Would like to see her PCP.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Pt had a pneumo 23  vaccine yesterday in his right deltoid. He states from his elbow to his shoulder, he has pain, edema, erythema, and it's hot to touch. He states it's severe and it kept him all night. He cannot raise his arm. It is also itchy, but anti-itch cream resolves this. He has also been using ice. No use of any tylenol or benadryl treatment.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Sleep disorder
Clinical narrative: Pt had a pneumo 23  vaccine yesterday in his right deltoid. He states from his elbow to his shoulder, he has pain, edema, erythema, and it's hot to touch. He states it's severe and it kept him all night. He cannot raise his arm. It is also itchy, but anti-itch cream resolves this. He has also been using ice. No use of any tylenol or benadryl treatment.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient called the pharmacy on 11/29/2018 reporting feeling itchy and starting to break out in a rash. I counseled the patient on both signs of a reaction, minor and major allergic reaction. Patient was instructed to take BENADRYL or a antihistamine in the meantime.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Erythema, Fatigue, Hyperhidrosis, Malaise, Skin warm
Clinical narrative: Patient felt unwell and tired at 5 PM and then awoke with sweating and also tactile temp in middle of the night and had redness on arm next day.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm is hot to touch swollen and painful even after more than 1 month.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen to left upper arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt reports 8x9cm area on right deltoid of redness and warmth.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Soreness, severe pain, difficult to lift arm due to discomfort.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills and body aches starting that evening and occurring through the following day.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediate onset of focal pain upon injection of L lateral shoulder; injection was very proximal to tendon.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Discomfort, Hyperhidrosis, Injection site pain
Clinical narrative: Day 1...11/27/2018   Pain at injection site, then later in the evening, pain in the shoulder/ collarbone area. Day 2... 11/28/2018. Start of general body aches, worse injection site pain, onset of severe joint and body aches, general feeling of malaise, shingles like rash on right ankle, both sides with moderate swelling, onset of severe chills in the late evening.. Chills continued thru the night, finally breaking by morning. Day 3... 11/29/2018 Chills gone, now moderate sweating. Rash on right ankle still present with minor discomfort and moderate swelling.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Malaise, Pain, Rash vesicular
Clinical narrative: Day 1...11/27/2018   Pain at injection site, then later in the evening, pain in the shoulder/ collarbone area. Day 2... 11/28/2018. Start of general body aches, worse injection site pain, onset of severe joint and body aches, general feeling of malaise, shingles like rash on right ankle, both sides with moderate swelling, onset of severe chills in the late evening.. Chills continued thru the night, finally breaking by morning. Day 3... 11/29/2018 Chills gone, now moderate sweating. Rash on right ankle still present with minor discomfort and moderate swelling.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 11-28-18 - Red, itchy non-raised rash began on chest then moved to shoulders, arms and face. Went home around 2 pm and took Benadryl 50mg (25mg x 2 capsules) and applied OTC Bendryl cream to chest. Repeated both at bedtime. 11-29-18 - Rash still present but less prevalent. Benadryl  PO and cream continued.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness, severe pain in left arm, inability to lift arm due to amount of pain. Onset the next day after vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Appendicectomy
Clinical narrative: Patient was seen in physicians office 11/6/18 and received vaccinations; 3 days later had appendectomy procedure performed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Peripheral swelling
Clinical narrative: Swollen arm, large red patch and hard knot at the injection site. Extremely painful to touch. Some pain is relieved with TYLENOL or Ibuprofen but never completely goes away.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: I had mild side effects after SHINGRIX #1 in August 18 but significantly stronger side effects after this 2nd dose. Within 8 hours I began having a headache and muscle soreness and fatigue. Within 12 hours after the injection I began having significant joint pain and chills/shivering. It was comparable to a BAD case of influenza. I took Ibuprofen (600mg q 6 hours) which provides some relief from the muscle aches and joint pain. Maximum oral temp was 100.2.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: I had mild side effects after SHINGRIX #1 in August 18 but significantly stronger side effects after this 2nd dose. Within 8 hours I began having a headache and muscle soreness and fatigue. Within 12 hours after the injection I began having significant joint pain and chills/shivering. It was comparable to a BAD case of influenza. I took Ibuprofen (600mg q 6 hours) which provides some relief from the muscle aches and joint pain. Maximum oral temp was 100.2.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Vertigo
Clinical narrative: Severe dizziness, vertigo, malaise which continues 10 days after receiving the vaccine. Patient placed on Prednisone 20 mg for 5 days and ATIVAN 0.5 mg as needed for dizziness or anxiety.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient's husband called on 11/27/2018 to inform us they are going to the doctor for increased pain in her left harm at injection site of PNEUMOVAX 23. He states she has had pain (1 or 2 on the pain scale) in that arm since her shot, but the last couple of days it has increased to a 3 or 4 on the pain scale. Her arm is not red or hot, but she reports it is warm to the touch. She reports an "achy" pain (not burning or shooting).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Urticaria
Clinical narrative: Extreme fatigue and tiredness lasting three days. Hives around neck front to back, chest down to breasts, back down to lower shoulders.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Day 1 - headache starting in the evening; notable soreness at injection site. Day 2 - headache continued throughout the day; muscle aches; continued soreness at injection site. Day 3 - some achiness; significant chills in the evening; soreness at injection site. Day 4 - slight remaining headache.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Insomnia, Pharyngeal erythema, Rash
Clinical narrative: Rash on back/chest/belly/face/hairline and diaper area. Loss of appetite. Fatigue /unable to sleep. Throat is red. Tested for strep-negative.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: Rash on back/chest/belly/face/hairline and diaper area. Loss of appetite. Fatigue /unable to sleep. Throat is red. Tested for strep-negative.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Chills, Nausea
Clinical narrative: Injection site and muscle soreness, expected, had that last time. This was second shot. Hit with upset stomach, shivering, naseau that did not occur after first shot. Read on site can take a few days so will take pain reliever and rest.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient states that injection site has been hurting since the injection and has now radiated from the arm all the way to the elbow for the past 3 weeks even after applying compressors and taking ibuprofen. No redness or swollen at the site.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pain, Swelling
Clinical narrative: Swollen lymph nodes in right armpit, swelling, and pain.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Rotator cuff syndrome, Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: Flu shot of September 19th in the morning at my employer. Shoulder pain starting day after, was unable to raise my left arm and limited movement in my left shoulder without experiencing pain. Had a Dr appointment on Oct 23rd to see if the shoulder pain was related to my previous sore neck. Neck has mild spinal stenosis. Dr. examined and said the location of the neck spinal stenosis would not affect my shoulder. Referred me to see an Orthopedic. Made an appointment with Dr. Xray were completed and examination. Small tear in my left rotator cuff, cortisone injection was given. Provided relief for a few weeks.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash maculo-papular, Skin lesion
Clinical narrative: Varicella vaccine given 11-13-2018 due to non-immune status. Patient had titers drawn for employment. Patient began with localized maculopapular rash on evening of 11-25-2018 at injection site. Patient developed lesions on stomach and face throughout the day 11-26-2018. On 11-27-2018 patient reportedly had "about 20" lesions throughout torso, arms, face, and head. No other signs or symptoms. Patient was advised by MD reaction is due to vaccine and not disease. No lab testing done and no treatment.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Bursa injury, Injection site pain
Clinical narrative: Patient complained of arm pain on the injection site. She decided to consult the doctor about it and after further examinations doctor said that her bursa got punctured.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Employee received vaccine 12:30p on 10/17/18, she felt her RUA itching on her drive home. On the 10/18 @ 7:30 AM she had redness and hives on her arm. She took her own BENADRYL every four hours. On 10/22/18 the hospital resource nurse sent her to the ED for hives on her face and neck.
Age: 35.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Nausea, Pyrexia, Swelling
Clinical narrative: Localized redness/swelling, fever, chills, nausea.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-OCT-2018, the patient was vaccinated with dose of M-M-R II lot # N008366 with expiration date 13-MAR-2019 (dose, dose number, site and route of administration were not reported) which was reconstituted with SHINGRIX sterile diluent for prophylaxis. No adverse effects was reported.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 15-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, strength, dose, frequency and anatomical location were not provided) for prevention of pneumonia. On an unspecified date, the patient developed redness (localized erythema) and swelling that was spreading to the elbow area (peripheral swelling). The patient used ice and paracetamol (TYLENOL) as treatment. Additionally, it was reported that an unspecified flu shot was administered in the same arm. At the reporting time, the outcome of the events was not reported. No product quality complain (PQC) was involved. The causal relationship between localized erythema and peripheral swelling with PNEUMOVAX 23 was not provided.
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 ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 25-OCT-2014, 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 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, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of muscle pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced muscle pain, fatigue, fever, chills and headache. On an unknown date, the outcome of the muscle pain, fatigue, fever, chills and headache were unknown. It was unknown if the reporter considered the muscle pain, fatigue, fever, chills and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced events (severity: severe) within 8 hours after receiving the shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood uric acid normal, Gout, Grip strength decreased, Hypokinesia
Clinical narrative: This case was reported by a consumer and described the occurrence of gout in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a child). Previously administered products included Shingles vaccine (received the old vaccine several years ago without problems). On 20th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth. On 23rd October 2018, the patient experienced gout, degenerative joint disease and wrist pain. The patient was treated with NSAIDS. On an unknown date, the outcome of the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth were unknown. It was unknown if the reporter considered the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth to be related to SHINGRIX. Additional details were provided as follows: The patient never had shingles in past. The patient received SHINGRIX on the right deltoid. The patient experienced pain in right wrist. Over the next few days symptoms progressed to a pain level of 8 by 10, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, heat in the joint, and total loss of grip strength. Pain was a constant ache at 3 to 5 by 10 level with sharp pain on movement. White blood cell count result was 6.4, uric acid result was 6.2, and X-ray result was degenerative joint disease. The patient was diagnosed with gout by MD received from physician of gout or pseudo gout. Splinting, NSAIDS and heat have all proved helpful. The patient asked if she should expect the same reaction to the second dose. If so, was it likely to recur in the same joint. The patient also asked would it help to have next dose in left arm her non-dominant arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint warmth, Osteoarthritis, Pain, Swelling, White blood cell count normal
Clinical narrative: This case was reported by a consumer and described the occurrence of gout in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a child). Previously administered products included Shingles vaccine (received the old vaccine several years ago without problems). On 20th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth. On 23rd October 2018, the patient experienced gout, degenerative joint disease and wrist pain. The patient was treated with NSAIDS. On an unknown date, the outcome of the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth were unknown. It was unknown if the reporter considered the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth to be related to SHINGRIX. Additional details were provided as follows: The patient never had shingles in past. The patient received SHINGRIX on the right deltoid. The patient experienced pain in right wrist. Over the next few days symptoms progressed to a pain level of 8 by 10, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, heat in the joint, and total loss of grip strength. Pain was a constant ache at 3 to 5 by 10 level with sharp pain on movement. White blood cell count result was 6.4, uric acid result was 6.2, and X-ray result was degenerative joint disease. The patient was diagnosed with gout by MD received from physician of gout or pseudo gout. Splinting, NSAIDS and heat have all proved helpful. The patient asked if she should expect the same reaction to the second dose. If so, was it likely to recur in the same joint. The patient also asked would it help to have next dose in left arm her non-dominant arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of gout in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a child). Previously administered products included Shingles vaccine (received the old vaccine several years ago without problems). On 20th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth. On 23rd October 2018, the patient experienced gout, degenerative joint disease and wrist pain. The patient was treated with NSAIDS. On an unknown date, the outcome of the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth were unknown. It was unknown if the reporter considered the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth to be related to SHINGRIX. Additional details were provided as follows: The patient never had shingles in past. The patient received SHINGRIX on the right deltoid. The patient experienced pain in right wrist. Over the next few days symptoms progressed to a pain level of 8 by 10, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, heat in the joint, and total loss of grip strength. Pain was a constant ache at 3 to 5 by 10 level with sharp pain on movement. White blood cell count result was 6.4, uric acid result was 6.2, and X-ray result was degenerative joint disease. The patient was diagnosed with gout by MD received from physician of gout or pseudo gout. Splinting, NSAIDS and heat have all proved helpful. The patient asked if she should expect the same reaction to the second dose. If so, was it likely to recur in the same joint. The patient also asked would it help to have next dose in left arm her non-dominant arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th September 2018, 63 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced rash and burning sensation. The patient was treated with valacyclovir hydrochloride. On an unknown date, the outcome of the shingles, rash and burning sensation were recovered/resolved. It was unknown if the reporter considered the shingles, rash and burning sensation to be related to SHINGRIX. Additional details were received as follows: There were no concomitant vaccinations given with the SHINGRIX vaccine. The patient was diagnosed with shingles. She also experienced rash on her back with burning sensation. The patient was diagnosed early and great with valacyclovir. The patient did not require further treatment. The reporter gave consent to follow up from GlaxoSmithKline.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th October 2018, 56 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with famciclovir (Famvir). On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient's initials were not reported. The patient received SHINGRIX on left deltoid. The patient developed mild case of Shingles. The patient (nurse practitioner) visited her doctor and was treated with antiviral (Famvir 500mg TID for 7 days) and was already doing better at the reporting time. The pharmacist had consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Depressed mood, Malaise
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of general malaise in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX.5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general malaise. On an unknown date, the outcome of the general malaise was recovered/resolved. It was unknown if the reporter considered the general malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called medical science liaison (MSL) to ask about 1 dose efficacy of the vaccine. He had the patient who got her first dose of SHINGRIX and reported general malaise and feeling down for about a month. He was not sure if the malaise was due to vaccine and did not want to report the adverse event. He did not have information on patient's initials, date of birth, age, vaccine lot number and expiration, date administered or any additional details on the adverse event reported. The healthcare professional stated if he thought that it was due to the vaccine, he would call MSL back. The reporter did not agree for follow up contact.
Age: 70.0
Sex: F
Vaccine: VARZOS
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 70-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient's arm became sore for a couple of days after receiving the SHINGRIX vaccine. She did not remember in which arm she received the vaccine. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information. For tolerance after 2nd dose refer case US2018206746.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (For tolerance to 1st dose please refer case US2018183733). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 days after receiving SHINGRIX, the patient experienced fever and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the fever and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be around 64 or 65 years. The patient had 2nd dose and the side effects were not as bad, just low grade fever the next day. Less than a year after receiving SHINGRIX, the patient experienced sore arm for about 5 days.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. After receiving SHINGRIX, the patient felt slightly tired. This case had been linked with case US2018GSK216203, reported by same reporter for same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. Co-suspect products included FLUAD for prophylaxis. On 17th October 2018, the patient received SHINGRIX. In October 2018, the patient received FLUAD. On 20th October 2018, 3 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was stated that, the patient experienced shingles approximately 14 days after vaccination with FLUAD. It was unknown if the reporter considered the shingles to be related to FLUAD as well. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 13th April 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced generalized rash and hives. On an unknown date, the outcome of the generalized rash and hives were unknown. It was unknown if the reporter considered the generalized rash and hives to be related to SHINGRIX. Additional details were provided as follows: The patient did not want to provide date of birth. The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX in February 2018. The patient did not recall the site of injection. Approximately 3 weeks before the date of reporting, the patient developed hives and a rash all over her body, even on her scalp after vaccination with 2nd dose. The patient had reported this to her doctor and they were trying to figure out where the symptoms were coming from. The patient called to see if this could be a possible side effect of SHINGRIX. Consent to follow-up was not given. Emergency visit was required.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. On 9th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site lump and injection site pain. On 11th August 2018, the patient experienced nausea and fever. On 12th August 2018, the outcome of the nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The following day after vaccination, the patient experienced soreness, redness and swelling in the form of a big lump on the injections site. Those symptoms were resolved after 3 days. On Saturday, the patient felt slightly nauseous and feverish. Those symptoms were resolved after 24 hours. The reporter had given consent for follow up. The patient's girlfriend also experienced all of the same symptoms but less severe (refer case US2018GSK212697).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. On 9th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site lump and injection site pain. On 11th August 2018, the patient experienced nausea and fever. On 12th August 2018, the outcome of the nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The following day after vaccination, the patient experienced soreness, redness and swelling in the form of a big lump on the injections site. Those symptoms were resolved after 3 days. On Saturday, the patient felt slightly nauseous and feverish. Those symptoms were resolved after 24 hours. The reporter had given consent for follow up. The patient's girlfriend also experienced all of the same symptoms but less severe (refer case US2018GSK212697).
Age: 63.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Lethargy, Liver function test abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lethargy in a 63-year-old male patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. The patient's past medical history included allergic to dogs. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (received In 1971, and had a reaction to an unknown influenza vaccine which required hospitalization for two days). Additional patient notes included none. On 10th August 2010, the patient received Flu trivalent vaccine. On 10th August 2010, less than a day after receiving Flu trivalent vaccine, the patient experienced lethargy, weakness, decreased white cell count and liver function test abnormal. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the lethargy, weakness, decreased white cell count and liver function test abnormal were recovered/resolved. It was unknown if the reporter considered the lethargy, weakness, decreased white cell count and liver function test abnormal to be related to Flu trivalent vaccine. Additional details were reported as follows: This case was reported by the patient who himself was a physician. The age at vaccination was not reported, however it could be 62 or 63. On 10th August 2010, the patient experienced lethargy and weakness. The patient had blood work two days after the Flu trivalent vaccine, and his AST (aspartate aminotransferase) levels were 38 and his ALT (alanine aminotransferase) was at 72. The patient's WBC (white blood cells) was down to 2.3. The patient had recovered and did not have a flu shot since.