chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersensitivity, Impaired driving ability, Injection site inflammation, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, allergy, injection site burning, pain in arm, tiredness and injection site inflammation. On an unknown date, the outcome of the injection site swelling and injection site burning were recovered/resolved and the outcome of the allergy, tiredness and injection site inflammation were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, allergy, injection site burning, pain in arm, tiredness and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX shot at the doctor's office in the left deltoid. The patient stated that, her doctor told her to call GlaxoSmithKline to see if she should get her second shot or not since she had a severe allergy. The patient experienced all-over-body tired. She said that, the injection site (left arm close to the shoulder) had swelling about the size of your palm (big surface) with burning and pain. After about 4 to 5 days, the arm swelling started to fade. One week later the arm swelling resolved. However, the patient felt that, the inflammation inside the muscle was still present because it still hurts inside the muscle when she lift her arm shoulder high. For a while she could not drive due to the arm pain but at the time of reporting she can drive again. She stated that, the arm pain was much better. The reporter gave consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, allergy, injection site burning, pain in arm, tiredness and injection site inflammation. On an unknown date, the outcome of the injection site swelling and injection site burning were recovered/resolved and the outcome of the allergy, tiredness and injection site inflammation were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, allergy, injection site burning, pain in arm, tiredness and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX shot at the doctor's office in the left deltoid. The patient stated that, her doctor told her to call GlaxoSmithKline to see if she should get her second shot or not since she had a severe allergy. The patient experienced all-over-body tired. She said that, the injection site (left arm close to the shoulder) had swelling about the size of your palm (big surface) with burning and pain. After about 4 to 5 days, the arm swelling started to fade. One week later the arm swelling resolved. However, the patient felt that, the inflammation inside the muscle was still present because it still hurts inside the muscle when she lift her arm shoulder high. For a while she could not drive due to the arm pain but at the time of reporting she can drive again. She stated that, the arm pain was much better. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Rash
Clinical narrative: rash; breakout of vaginal herpes; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (10 years before the reporting date). Concurrent medical conditions included herpes simplex (herpes simplex 2). On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and genital herpes. On an unknown date, the outcome of the rash and genital herpes were recovered/resolved. It was unknown if the reporter considered the rash and genital herpes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Field representative was told by a medical assistant or nurse at an HCP office that a patient experienced an adverse event after getting SHINGRIX. The field representative then went to the pharmacy where it was administered and spoke with the pharmacist there. After vaccination she had a little rash and an breakout of vaginal herpes. The representative did not know if the "little rash" was the vaginal herpes rash, or if it was a rash somewhere else on the patient's body. She took a couple days of therapy and the symptoms resolved.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Dysstasia, Gait disturbance, Headache, Muscle strain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle strain in a 51-year-old male patient who received SHINGRIX (batch number LN9TL, expiry date 30th January 2020) for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain. In March 2018, the patient experienced muscle strain. The patient was treated with Steroid Therapy Nos. On an unknown date, the outcome of the muscle strain, shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain were unknown. It was unknown if the reporter considered the muscle strain, shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain to be related to SHINGRIX. Additional details were provided as follows: Fourteen hours after dose of SHINGRIX, he began to experience hamstring pulls and calf muscle pulls in both legs. He had been seen by several doctors and specialists who could not find a cause at the time of reporting. The patient suspected SHINGRIX. The patient reported a worsening of bursitis in his shoulder. The patient also reported that the muscle pulls were spreading. He described the feeling as muscle pulls below the waist, and his upper body as painful. The patient reported that the pain was in the neck and back of the head. He has had some relief, about 80 percent with oral steroid therapy. He also reported that it was hard to stand from a seated position. He also reported difficulty bending over, such as tying his shoes. He also reported that his gait had been measured as only 8 inches apart. The patient consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle strain in a 51-year-old male patient who received SHINGRIX (batch number LN9TL, expiry date 30th January 2020) for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain. In March 2018, the patient experienced muscle strain. The patient was treated with Steroid Therapy Nos. On an unknown date, the outcome of the muscle strain, shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain were unknown. It was unknown if the reporter considered the muscle strain, shoulder bursitis, musculoskeletal stiffness, neck pain, headache, difficulty in standing, gait disturbance and general body pain to be related to SHINGRIX. Additional details were provided as follows: Fourteen hours after dose of SHINGRIX, he began to experience hamstring pulls and calf muscle pulls in both legs. He had been seen by several doctors and specialists who could not find a cause at the time of reporting. The patient suspected SHINGRIX. The patient reported a worsening of bursitis in his shoulder. The patient also reported that the muscle pulls were spreading. He described the feeling as muscle pulls below the waist, and his upper body as painful. The patient reported that the pain was in the neck and back of the head. He has had some relief, about 80 percent with oral steroid therapy. He also reported that it was hard to stand from a seated position. He also reported difficulty bending over, such as tying his shoes. He also reported that his gait had been measured as only 8 inches apart. The patient consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old male patient who received SHINGRIX for prophylaxis. On 23rd November 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 23rd November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, fever, general body pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, fever and general body pain were recovering/resolving and the outcome of the injection site erythema and injection site pain were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, fever and general body pain to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm, subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced swelling, redness and pain at the injection site, fever and body aches. The swelling was down at the time of reporting, but the site was red and sore. It was stated that, the pain was migrating down to his elbow. The reporter gave consent to follow up.
Age: 52.0
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 swelling in a 52-year-old male patient who received SHINGRIX for prophylaxis. On 23rd November 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 23rd November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, fever, general body pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, fever and general body pain were recovering/resolving and the outcome of the injection site erythema and injection site pain were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, fever and general body pain to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm, subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced swelling, redness and pain at the injection site, fever and body aches. The swelling was down at the time of reporting, but the site was red and sore. It was stated that, the pain was migrating down to his elbow. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information received as follows: The healthcare professional reported that, the pharmacist mentioned his patient had pain following the administration of SHINGRIX and refused to receive the 2nd dose because of it. The reporter was unsure if this had been reported previously. The reporter was not able to provide any demographics of the patient or vaccine lot number and expiry date. The reporter did not give consent to follow up.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 49-year-old female patient who received BOOSTRIX (batch number 33T42, expiry date 1st February 2021) for prophylaxis. On 28th November 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by an occupational health nurse at GlaxoSmithKline. The patient received the BOOSTRIX vaccine on the right arm. The patient called to report swelling, itching and redness at the injection site.
Sex: U
Vaccine: HEPA
Symptoms: Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a patient who received HAVRIX for prophylaxis. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. It was unknown if the reporter considered the nausea to be related to HAVRIX. Additional details were received as follows: The age at vaccination was not reported. The reporter consented to follow up. No additional information was obtained.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain in extremity, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included lung cancer (surgery to remove lung cancer, left lower lobe was removed). Previously administered products included Flu vaccine with an associated reaction of pain in extremity (refer case US2018GSK221241). Concurrent medical conditions included emphysema and stent placement. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 1 day after receiving SHINGRIX, the patient experienced itchy rash, pain in arm and allergic reaction. On 16th August 2018, the outcome of the itchy rash was recovered/resolved. On an unknown date, the outcome of the pain in arm and allergic reaction were recovered/resolved. It was unknown if the reporter considered the itchy rash, pain in arm and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient reported that her arm was sore for about one day. A day after receiving SHINGRIX, the patient experienced an itchy rash that was almost gone on 16th August 2018 when she had to go for a preop exam. At the time of the exam, the nurse practitioner told her that she should not get the second dose of the SHINGRIX because of the rash because she thought it was an allergic reaction. Additional information was not reported. The patient consented to follow up with her physician and herself. The patient reported that her question was not resolved because her healthcare provider needs to call and more medical information needs to be given to get a correct response for the pruritis.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site discoloration, fever and sickness. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the fever and sickness were recovered/resolved. The reporter considered the injection site discoloration, fever and sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm approximately 2 months ago from the date of reporting. The patient received both vaccines in the same arm and location. The patient developed a skin discoloration, the size smaller than a dime, at her injection site on her left upper arm after she received her 2nd dose of the SHINGRIX. The patient also states she developed a 102 degree F fever, was very sick but did not elaborate. The reporter did not consent to follow-up. No product quality complaint (PQC) was reported. The limited information was provided. The reporter was angry, did not want to provide further information, disconnected call prior to finishing safety report. Lab Comments: On an unknown date, body temperature was checked.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 58-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown. It was unknown if the reporter considered the feels awful to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the SHINGRIX and felt awful afterwards. The reporter did not consent to follow-up. The reporter was unable to provide any additional information.
Age: 1.58
Sex: M
Vaccine: DTAPIPV, FLU4, HEP, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given QUADRACEL which is intended for 4-6 years old and they are 19 months old. According to the CDC, "if a dose of QUADRACEL is inadvertently administered for an earlier dose of the DTaP and/or IPV series, the dose should be counted as valid and does not need to be repeated."
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site rash
Clinical narrative: Donor appeared with a rash with raised bumps on his right upper arm, a few on his right antecubital fossa area and a small patch on his right inner forearm. Donor states that he has the rash for about a week now. After speaking with donor on 12/11/2018, donor states that the areas have cleared up on 12/09/2018.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Confusional state, Dry mouth, Erythema, Fatigue
Clinical narrative: 12 hours after both shots administered, I had fever (90.5), extreme headache, back-neck-leg-arm aches, very sore & swollen upper left arm, uncoordinated walked, very dry mouth & thirsty, very low energy, confused mental state. Took Ibuprofen 600 mg every 4-6 hours, only relief. Slept most the time. An hour aware doing simple tasks made me exhausted. These symptoms lasted through Saturday afternoon, 12/8 (3+ days), when I first noticed a large ca. 4 by 6 in hot to touch, red raised area on left arm below injection site (at bicep muscle); except for red bicep area, symptoms began to diminish on Sunday (4 days), visited Dr. on Monday (day 5, 12/10) who prescribed Doxycycline Hyclate 100 mg (1 ea 12 hrs) and Prednisone 20 mg (1/day). Been on those for 16 hrs and continuing to feel better, but large red hot bicep on left arm still present.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Gait disturbance, Headache, Limb discomfort, Pain, Peripheral swelling
Clinical narrative: 12 hours after both shots administered, I had fever (90.5), extreme headache, back-neck-leg-arm aches, very sore & swollen upper left arm, uncoordinated walked, very dry mouth & thirsty, very low energy, confused mental state. Took Ibuprofen 600 mg every 4-6 hours, only relief. Slept most the time. An hour aware doing simple tasks made me exhausted. These symptoms lasted through Saturday afternoon, 12/8 (3+ days), when I first noticed a large ca. 4 by 6 in hot to touch, red raised area on left arm below injection site (at bicep muscle); except for red bicep area, symptoms began to diminish on Sunday (4 days), visited Dr. on Monday (day 5, 12/10) who prescribed Doxycycline Hyclate 100 mg (1 ea 12 hrs) and Prednisone 20 mg (1/day). Been on those for 16 hrs and continuing to feel better, but large red hot bicep on left arm still present.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Skin warm, Thirst
Clinical narrative: 12 hours after both shots administered, I had fever (90.5), extreme headache, back-neck-leg-arm aches, very sore & swollen upper left arm, uncoordinated walked, very dry mouth & thirsty, very low energy, confused mental state. Took Ibuprofen 600 mg every 4-6 hours, only relief. Slept most the time. An hour aware doing simple tasks made me exhausted. These symptoms lasted through Saturday afternoon, 12/8 (3+ days), when I first noticed a large ca. 4 by 6 in hot to touch, red raised area on left arm below injection site (at bicep muscle); except for red bicep area, symptoms began to diminish on Sunday (4 days), visited Dr. on Monday (day 5, 12/10) who prescribed Doxycycline Hyclate 100 mg (1 ea 12 hrs) and Prednisone 20 mg (1/day). Been on those for 16 hrs and continuing to feel better, but large red hot bicep on left arm still present.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Confusional state, Coordination abnormal, Dizziness, Erythema, Gait disturbance
Clinical narrative: 12 hours after both shots administered, I had fever (90.5), extreme headache, back-neck-leg-arm aches, very sore & swollen upper left arm, uncoordinated walked, very dry mouth & thirsty, very low energy, confused mental state. Took Ibuprofen 600 mg every 4-6 hours, only relief. Slept most the time. An hour aware doing simple tasks made me exhausted. These symptoms lasted through Saturday afternoon, 12/8 (3+ days), when I first noticed a large ca. 4 by 6 in hot to touch, red raised area on left arm below injection site (at bicep muscle); except for red bicep area, symptoms began to diminish on Sunday (4 days), visited Dr. on Monday (day 5, 12/10) who prescribed Doxycycline Hyclate 100 mg (1 ea 12 hrs) and Prednisone 20 mg (1/day). Been on those for 16 hrs and continuing to feel better, but large red hot bicep on left arm still present.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: 12 hours after both shots administered, I had fever (90.5), extreme headache, back-neck-leg-arm aches, very sore & swollen upper left arm, uncoordinated walked, very dry mouth & thirsty, very low energy, confused mental state. Took Ibuprofen 600 mg every 4-6 hours, only relief. Slept most the time. An hour aware doing simple tasks made me exhausted. These symptoms lasted through Saturday afternoon, 12/8 (3+ days), when I first noticed a large ca. 4 by 6 in hot to touch, red raised area on left arm below injection site (at bicep muscle); except for red bicep area, symptoms began to diminish on Sunday (4 days), visited Dr. on Monday (day 5, 12/10) who prescribed Doxycycline Hyclate 100 mg (1 ea 12 hrs) and Prednisone 20 mg (1/day). Been on those for 16 hrs and continuing to feel better, but large red hot bicep on left arm still present.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Confusional state, Dry mouth, Erythema, Fatigue
Clinical narrative: Patient had fever, muscle aches on legs, back, neck, arms. Swelling and redness in arm. She also had a confused mental state, dizziness, and uncoordinated walking. She also reported a moderate to severe headache. She was treated with prednisone and doxycyline on 12/10.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Gait disturbance, Headache, Limb discomfort, Pain, Peripheral swelling
Clinical narrative: Patient had fever, muscle aches on legs, back, neck, arms. Swelling and redness in arm. She also had a confused mental state, dizziness, and uncoordinated walking. She also reported a moderate to severe headache. She was treated with prednisone and doxycyline on 12/10.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Skin warm, Thirst
Clinical narrative: Patient had fever, muscle aches on legs, back, neck, arms. Swelling and redness in arm. She also had a confused mental state, dizziness, and uncoordinated walking. She also reported a moderate to severe headache. She was treated with prednisone and doxycyline on 12/10.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Confusional state, Coordination abnormal, Dizziness, Erythema, Gait disturbance
Clinical narrative: Patient had fever, muscle aches on legs, back, neck, arms. Swelling and redness in arm. She also had a confused mental state, dizziness, and uncoordinated walking. She also reported a moderate to severe headache. She was treated with prednisone and doxycyline on 12/10.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Patient had fever, muscle aches on legs, back, neck, arms. Swelling and redness in arm. She also had a confused mental state, dizziness, and uncoordinated walking. She also reported a moderate to severe headache. She was treated with prednisone and doxycyline on 12/10.
Age: 1.17
Sex: F
Vaccine: FLU4
Symptoms: Dysstasia, Pyrexia, Screaming
Clinical narrative: Mother of patient reported that patient had fever 103, woke up screaming around 5.30 am the morning after the day she received flu shot. When she tried to stand up, her both knee were wobbly and collapsed. But she was full conscious for the whole time, mother knew that because she was crying all the time. She had fever for a couple day and now she is doing fine. But mother was worried about the second booster influenza vaccination that she would need to get by the end of the week if she might have the symptom again.
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 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). Later in 2009, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare 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 03-JAN-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-OCT-2013, 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.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Adverse reaction, Pain, Pyrexia
Clinical narrative: Adverse reaction to SHINGRIX 50 mcg/0.5 inj glas - 101.4 fever upset stomach and aches.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Appendicitis
Clinical narrative: Appendicitis on third day post immunization.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Woke up 0200 on 12/4 with (L) arm hurting clear down to hand, positive chills and headache. Then developed body aches. Denies any fevers. No redness or itching or swelling to injection site. Called patient next day and was feeling better. Thinks it was part of the flu. Denied any other concerns.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: According to pt.'s chart, Pt's mom called office the next day stating that pt. had a headache and a low grade fever and requested a school excuse for the day. Client did not come to office to be seen.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient fainted after injection was given. Came to after 4 minutes of Dr. trying to have her come out of the spell. After patient woke up, she stayed in the office for 20 minutes so that the Dr. could monitor her post fainting health. She left 20 minutes later and suffer no other effect from the injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza virus test negative, Loss of personal independence in daily activities, Neck pain, Pain
Clinical narrative: Sudden onset of severe neck pain and severe headache as well as upper body aches making it almost impossible to get out of bed. Almost unable to even hold head up. Fever up to 102.6 taking a while to get it down with ibuprofen. Got Toradol 60mg for pain and headache. Unable to do anything at all and neck and head pain continued and kept from doing daily activities
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Pyrexia, Streptococcus test negative
Clinical narrative: Sudden onset of severe neck pain and severe headache as well as upper body aches making it almost impossible to get out of bed. Almost unable to even hold head up. Fever up to 102.6 taking a while to get it down with ibuprofen. Got Toradol 60mg for pain and headache. Unable to do anything at all and neck and head pain continued and kept from doing daily activities
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Three hours after the injection, my arm is so sore that I can barely move it. I'm now developing body aches, headache, and diarrhea. This vaccine is AWFUL and I seriously doubt that I will get the second injection of the series.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Condition aggravated, Confusional state, Extrasystoles, Heart rate increased
Clinical narrative: Complained of heart beat being extremely accelerated, exacerbated the premature heart beat illness, felt clammy, extreme mental confusion, flu like symptoms after 24 hours from the injection and soreness at injection site. Flu like symptoms went away after 48 hours. Patient says symptoms are better but continues to have some mental confusion at times since vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Complained of heart beat being extremely accelerated, exacerbated the premature heart beat illness, felt clammy, extreme mental confusion, flu like symptoms after 24 hours from the injection and soreness at injection site. Flu like symptoms went away after 48 hours. Patient says symptoms are better but continues to have some mental confusion at times since vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Burning sensation, Hypoaesthesia, Nerve injury, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Pt started having burning, tingling, pain and numbness in his right arm about a week and a half after he received these vaccines in the same arm. He said at first he didn't think about the shots because his wife didn't have any adverse effects and she had gotten the same ones on the same day and in the same arm. However nothing has shown up on x-ray. His Dr couldn't see that anything was physically wrong. When he asked his Dr about the possibility of it being the vaccines they told him it was not at all likely. He has tried several OTC pain meds: Ibuprofen, APAP, and naproxen. He has tried topical pain relievers as well and nothing has really helped at all. He is planning to go back to the Dr next week with some additional information I gave him regarding another case I have seen with similar effects. That patient finally went to a neurologist and they determined it was from the vaccine being given too high in the arm and damaging a nerve.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: X-ray
Clinical narrative: Pt started having burning, tingling, pain and numbness in his right arm about a week and a half after he received these vaccines in the same arm. He said at first he didn't think about the shots because his wife didn't have any adverse effects and she had gotten the same ones on the same day and in the same arm. However nothing has shown up on x-ray. His Dr couldn't see that anything was physically wrong. When he asked his Dr about the possibility of it being the vaccines they told him it was not at all likely. He has tried several OTC pain meds: Ibuprofen, APAP, and naproxen. He has tried topical pain relievers as well and nothing has really helped at all. He is planning to go back to the Dr next week with some additional information I gave him regarding another case I have seen with similar effects. That patient finally went to a neurologist and they determined it was from the vaccine being given too high in the arm and damaging a nerve.
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: SWELLING REDNESS AND EXTREME PAIN LEADING TO IMMOBILITY OF THE RIGHT ARM. PAIN HAS CONTINUED IN THE RIGHT ARM SINCE THE INJECTION IN EARLY NOVEMBER. THE NURSING HOME, LISTED EARLIER, KNOWS THE EXACT DATE OF THE INJECTION AND THE DOSE GIVEN. THE REACTION STARTED THE SAME DAY THAT THE VACCINE WAS ADMINISTERED. THE PAIN HAS AFFECTED MY MOTHER'S ABILITY TO DO PHYSICAL THERAPY, AND SHE HAS NOT BEEN ABLE TO ATTAIN THE STRENGTH NEEDED TO RETURN TO INDEPENDENT LIVING BECAUSE OF THE REACTION SHE HAD TO THIS VACCINE. SHE HAS BEEN TOLD PHYSICAL THERAPY WILL BE DISCONTINUED 12-12-18 BECAUSE OF THIS.
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, X-ray
Clinical narrative: SWELLING REDNESS AND EXTREME PAIN LEADING TO IMMOBILITY OF THE RIGHT ARM. PAIN HAS CONTINUED IN THE RIGHT ARM SINCE THE INJECTION IN EARLY NOVEMBER. THE NURSING HOME, LISTED EARLIER, KNOWS THE EXACT DATE OF THE INJECTION AND THE DOSE GIVEN. THE REACTION STARTED THE SAME DAY THAT THE VACCINE WAS ADMINISTERED. THE PAIN HAS AFFECTED MY MOTHER'S ABILITY TO DO PHYSICAL THERAPY, AND SHE HAS NOT BEEN ABLE TO ATTAIN THE STRENGTH NEEDED TO RETURN TO INDEPENDENT LIVING BECAUSE OF THE REACTION SHE HAD TO THIS VACCINE. SHE HAS BEEN TOLD PHYSICAL THERAPY WILL BE DISCONTINUED 12-12-18 BECAUSE OF THIS.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Papule, Rash, Scab
Clinical narrative: 12/5/18 diffuse erythema and edema noted to the uper lateral arm, wheals noted with papules, no drainage noted; pt took benadry every 6 hrs since reaction began.. She is to take the zyrtec daily apply etamethasone cream daily to affected area and add benadryl every 6 hrs as well until arm better; If sxs persist or worsen she is to rtc; 12/11 pt reurned to clinic today for worsening left arm skin rash - now has red,scabbed lesions to area and skin peeling near site. redness is still present. It has improved and is not worse.  .
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation, Skin lesion, Urticaria
Clinical narrative: 12/5/18 diffuse erythema and edema noted to the uper lateral arm, wheals noted with papules, no drainage noted; pt took benadry every 6 hrs since reaction began.. She is to take the zyrtec daily apply etamethasone cream daily to affected area and add benadryl every 6 hrs as well until arm better; If sxs persist or worsen she is to rtc; 12/11 pt reurned to clinic today for worsening left arm skin rash - now has red,scabbed lesions to area and skin peeling near site. redness is still present. It has improved and is not worse.  .
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Flushing, Headache
Clinical narrative: Dizziness for approximately 30 minutes, flushed, erythema on head, trunk and arms x 2days, and severe headache x 2days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: The daughter explained her mother is now having trouble moving her arm since the shot and it has only gotten worse not better. At the time of contact (12/10) she explained her mother could barely move her arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Pain, Pyrexia
Clinical narrative: Fever, chills, achy, tired.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm within a couple of hours. Woke up next morning feeling tired and stiff. Temperature was 100. Temperature climbed to 101 by 2pm.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive
Clinical narrative: The patient acquired laboratory confirmed vaccine-strain measles.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Diarrhoea, Dizziness
Clinical narrative: Patient got dizzy after the shot. Then a bout of diarrhea.
Age: 1.42
Sex: F
Vaccine: FLU4
Symptoms: Eczema
Clinical narrative: Eczema flare up. Last flare up was following a vaccine as well. No changes in food or routines.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Injection site discolouration, Injection site reaction
Clinical narrative: Blue discoloration at injection site (approx. 1cm diameter), irregularly shaped) appearing "1-2 weeks after" administration. Residual hypopigmentation at injection site still visible today.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Skin discolouration, Swelling
Clinical narrative: Bruising, swelling, discoloration.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose normal, Eye movement disorder, Feeling abnormal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Presented to clinic for Hep B vaccine was sitting in chair and upon giving vaccination patient reports not feeling well. She was given water and feet were elevated on a 2nd chair. She proceeded to become diaphoretic and then eyes rolled in back in head and she was mildly shaking (head and BUE and BLE), nonverbal. She would've fallen on the floor but I kept her upright and held her face as well. She came to about 15 seconds after beginning and felt off. Her blood sugar was checked it was 127 and her blood pressure was 100/60 and then after 10 minutes it was 110/62. I was having the asst. call 911 and she told us to hold off and then she refused. Recommended she have someone come and get her as I didn't want her driving on her own. Her neighbor came and took her home.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Tremor
Clinical narrative: Presented to clinic for Hep B vaccine was sitting in chair and upon giving vaccination patient reports not feeling well. She was given water and feet were elevated on a 2nd chair. She proceeded to become diaphoretic and then eyes rolled in back in head and she was mildly shaking (head and BUE and BLE), nonverbal. She would've fallen on the floor but I kept her upright and held her face as well. She came to about 15 seconds after beginning and felt off. Her blood sugar was checked it was 127 and her blood pressure was 100/60 and then after 10 minutes it was 110/62. I was having the asst. call 911 and she told us to hold off and then she refused. Recommended she have someone come and get her as I didn't want her driving on her own. Her neighbor came and took her home.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was not an adverse event to the vaccine. The dose was given at 1 yr old which is 3-6 months earlier than recommended.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: There was not an adverse event. The dose was give at 1 yr old which is 3-6 mo earlier than recommended.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain on left arm, body pain.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site paraesthesia
Clinical narrative: One day after the injection patient began to feel a tingling at injection site. It is not a constant tingling but comes and goes throughout the day. The patient came to the pharmacy complaining of pain today almost 2 months after initial injection.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Blood iron normal, Endocrine test normal
Clinical narrative: I developed alopecia areata in three spots on my head.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. In approximately June 2017 (reported as 18 months ago) when the patient was 12 year old, the patient was vaccinated with GARDASIL 9, intramuscularly for vaccination prophylaxis (dose, anatomical location, lot number and expiration date were not reported). In approximately January 2018 (reported as 7-8 months later), the patient developed a mild case of Guillain-Barre syndrome. The patient saw an unknown neurologist and was given an unknown treatment. At the reporting time, the patient did not recover from Guillain-Barre syndrome. The causal relationship between therapy with GARDASIL 9 and Guillain-Barre syndrome was not provided. Upon internal review, Guillain-Barre syndrome was determined to be medically significant.
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 07-MAY-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 20-JUN-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.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Feeling cold, Nausea, Vomiting
Clinical narrative: 5:00 pm. Became very cold. Started shivering uncontrollably. Went to bed. Couldn't get warm. Shivered 4 hours. Temp was 99.5. Became nauseous. Gagged and threw up a small amount. Lasted 4 hours. Ok in AM.