chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's mom came into the clinic on 08/13/2018 to pick up his shot records. She reported to me at that time that his left leg was red and swollen at the site. She showed me a picture and it was a large red raised area covering most of his upper thigh. She stated that he started complaining about pain late Friday night into Saturday. She also stated she has been giving him BENADRYL for it as well. She said he is doing better and the swelling has gone down but it is still a little red.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Injection site reaction, Irritability, Local reaction
Clinical narrative: Large local reaction, redness induration (possible cellulitis to skin). No fever. Fussiness-involving about 8cm of skin around injection area.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Asthenia, Chest pain, Chills, Headache, Injection site pain
Clinical narrative: Chills, fever, weakness, body aches, sharp shooting pain to (B) lower extremities, chest pain severe headaches, soreness at injection site.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, weakness, body aches, sharp shooting pain to (B) lower extremities, chest pain severe headaches, soreness at injection site.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Chills, fever, weakness, body aches, sharp shooting pain to (B) lower extremities, chest pain severe headaches, soreness at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 7:00 PM Muscle aches. 9:00 PM Chills and fever. 1:00 PM Fever broke. Followed by continued muscle aches and headache. Injection site is red and swollen and painful.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: 7:00 PM Muscle aches. 9:00 PM Chills and fever. 1:00 PM Fever broke. Followed by continued muscle aches and headache. Injection site is red and swollen and painful.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Pyrexia, Vaccination site mass
Clinical narrative: Within 24 hr. of vaccine, pt. stated feeling dizzy and nauseous, and having a fever for 48 hr.  Within 72 hr. of vaccine pt. stated to having a lump at the vaccine site and is still present.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Hypersensitivity, Swelling face, Urticaria, Wheezing
Clinical narrative: Child had allergic reaction two hours after. Immunizations at outside facility. Patient presents to emergency department with hives present on her back, abdomen and legs. She also has facial swelling and wheezing present.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Diarrhoea, Rash macular
Clinical narrative: Generalized macular rash. Looks like a viral exanthem. Happened 1 week after the vaccine administration. Also, mild diarrhea.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Severe case of hives..Sent to ER.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Vaccination complication
Clinical narrative: I had the shot like usual. Went back to work. In the middle of the afternoon, I went for a walk, outside. I began to become itchy. It was almost like a photosynthetic reaction. The itchiness was all over, on my scalp, my thighs, my back, my face.  It wasn't severe, but noticeable. It was definitely a medicine induced weird reaction, as I've had it before from other meds. It wasn't severe enough to seek medical attention. I'm still a bit itchy the second day. I've never had this reaction to a flu shot before. I get them annually since I work at a school.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Allergy to vaccine, Rash generalised
Clinical narrative: MOTHER REPORTED PATIENT BROKE OUT WITH RASH HEAD TO TOE SATURDAY EVENING- 24 HOURS RECEIPT OF VACCINATION. MOTHER TOOK PATIENT TO URGENT CARE THAT EVENING AND WAS INFORMED BY THE URGENT CARE MD THAT IT WAS AN ALLERGIC REACTION TO THE VACCINES RECEIVED ON 8/10/2018. HE RECEIVED PRESCRIPTION FOR ALLEGRA AND BENADRYL. MOTHER REPORTS THAT RASH IS GETTING BETTER WITH THE MEDICINE.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 1.5 hours after receiving vaccine patient broke out into hives all over body. Patient with raised, red wheels on arms, legs, back stomach, neck. No swelling of mouth, tongue, throat. No nausea/vomiting. No shortness of breath. Significant pruritus. Patient was started on BENADRYL 50mg scheduled q6 hours and given prednisone 20mg daily x5 days. Patient was contacted the next day on 8/7 and hives had resolved.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: Patient states that she began with some nausea, fatigue, diarrhea a few days after receiving the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Urticaria
Clinical narrative: Patient received immunizations 8/10/2018 in the afternoon. On the evening of 8/11/2018 began to develop progressive erythema and swelling around the injection site on the left thigh (where the KINRIX had been administered). Starting the evening of 8/13/2018 began to develop intermittent hives throughout trunk and arms, as well as rash on torso and flank. Patient seen in the office for evaluation on 8/14/2018 and physical examination was consistent with erythema and warmth on the left thigh measuring 10.5 cm x 13.cm, as well as scattered rash on torso.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Patient had itchy, scaly bumps on the arm that was vaccinated and her upper chest. They were mildly bothersome but required no treatment. The bumps persisted for about 3 days.
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Disorientation, Encephalitis viral, Herpes zoster, Mental status changes
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 (reported as shortly after receiving ZOSTAVAX vaccine), the patient was admitted to a hospital with a sudden decrease in mental status, disoriented and confused. On or about 01-NOV-2016, the patient was diagnosed with viral encephalitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, viral encephalitis was determined to be a medically significant event. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Skin hypertrophy
Clinical narrative: Returned for TB test reading 6-14-18 (L) antero-lateral thigh with a 3 inches x 2 inches (approx.) red oral of skin with mild thickening and mildly tender to touch. No treatment and resolved after incident, next 7 days.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea
Clinical narrative: Diarrhea leaking out of diaper waking my daughter up from her nap. Didn't realize it was a reaction at the time. Was not told this could happen. Not listed on VIS.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lip injury, Loss of consciousness
Clinical narrative: Pt received 2 vaccines  5 minutes later passed out in lobby laceration to lip taken to hospital via ambulance and discharged.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Injection site pain, Injection site swelling
Clinical narrative: Local: Pain and swelling - approx. 60 hrs. General: Myalgia, fatigue, shivering and gastrointestinal symptoms - approx. 36 hrs.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Local: Pain and swelling - approx. 60 hrs. General: Myalgia, fatigue, shivering and gastrointestinal symptoms - approx. 36 hrs.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node swelling /tenderness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site pain, Pyrexia
Clinical narrative: Pt states that she got her second SHINGRIX last week. The night of the injection she developed a low grade fever, was tender at injection site and axillary region. Progressed to bruising down arm and across breast.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Hyperhidrosis
Clinical narrative: Onset of sweats, chills, rigors, aches in hips, knees and elbows as well as sternum starting approx. 11 hr post dose. (Medicated with naproxen approx. 5 hrs prior to onset of Sx). Re-medicated with acetaminophen at 2 AM. Continued sweats and chills until approx. 36 hrs post dose. Decreased appetite and energy for an additional 24 hrs. Some loss of work time. Mild erythema at injection site 48 hrs later (with expected ongoing muscular soreness at injection site). Similar (but less intense) response without anorexia and sternal ache after 1st dose in series which had resolved after 24 hrs.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: Onset of sweats, chills, rigors, aches in hips, knees and elbows as well as sternum starting approx. 11 hr post dose. (Medicated with naproxen approx. 5 hrs prior to onset of Sx). Re-medicated with acetaminophen at 2 AM. Continued sweats and chills until approx. 36 hrs post dose. Decreased appetite and energy for an additional 24 hrs. Some loss of work time. Mild erythema at injection site 48 hrs later (with expected ongoing muscular soreness at injection site). Similar (but less intense) response without anorexia and sternal ache after 1st dose in series which had resolved after 24 hrs.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Loss of personal independence in daily activities, Muscular weakness, Neck pain, Pain
Clinical narrative: On 8/9/18 The client called me and reported the following information: The client received rabies #4 dose on 7/16/18 and it hurt while the nurse gave it to her. The client states it was given high on the Lt arm next to the shoulder and it left a bruise. The client told the nurse it hurt. The nurse told her "I am having a hard time pushing it in." The client states the Lt arm became increasingly painful from 1-4 PM. At approximately 4PM she developed radiation of pain into her neck and down the Lt arm. Since 7/16/18, the Lt arm pain continues. She has sharp pain that can be an "8" and intermittent tooth like achy pain a "4". She states pressure will trigger the sharp pain. States has difficulty putting on a shirt over her head. She doesn't have strength in her Lt arm to pick things up. Advised to see her physician and that I will fill out a VAERS report. The client will call me back once the appointment is scheduled. Appt scheduled at 1:30 on 8/10/18. She would like a copy of the VAERS report. RN. 8/9/18 Section #22; Please see the attached ER record for the administration for rabies immunoglobulin and Rabies IM fibroblast culture, RN. 8/9/18 the client received rabies dose #4 on 7/23/18 and Tdap on 7/23/18 and given both in the Rt deltoid, RN. 8/10/18 Client came in and signed consent for release of confidential information. Client given a copy of the VAERS report. Client stated made an appointment with Dr. for Monday 8/13/18, instead of other. RN. 8/14/18 Client called and she states Dr. is not sure but thinks it was given in the tendon. It appears like a rotator cuff tear. She is going to make a referral to an orthopedic physician. The physician states she may need ultrasound and should get physical therapy. I asked the client to let me know how she's doing - RN.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Pain in extremity
Clinical narrative: On 8/9/18 The client called me and reported the following information: The client received rabies #4 dose on 7/16/18 and it hurt while the nurse gave it to her. The client states it was given high on the Lt arm next to the shoulder and it left a bruise. The client told the nurse it hurt. The nurse told her "I am having a hard time pushing it in." The client states the Lt arm became increasingly painful from 1-4 PM. At approximately 4PM she developed radiation of pain into her neck and down the Lt arm. Since 7/16/18, the Lt arm pain continues. She has sharp pain that can be an "8" and intermittent tooth like achy pain a "4". She states pressure will trigger the sharp pain. States has difficulty putting on a shirt over her head. She doesn't have strength in her Lt arm to pick things up. Advised to see her physician and that I will fill out a VAERS report. The client will call me back once the appointment is scheduled. Appt scheduled at 1:30 on 8/10/18. She would like a copy of the VAERS report. RN. 8/9/18 Section #22; Please see the attached ER record for the administration for rabies immunoglobulin and Rabies IM fibroblast culture, RN. 8/9/18 the client received rabies dose #4 on 7/23/18 and Tdap on 7/23/18 and given both in the Rt deltoid, RN. 8/10/18 Client came in and signed consent for release of confidential information. Client given a copy of the VAERS report. Client stated made an appointment with Dr. for Monday 8/13/18, instead of other. RN. 8/14/18 Client called and she states Dr. is not sure but thinks it was given in the tendon. It appears like a rotator cuff tear. She is going to make a referral to an orthopedic physician. The physician states she may need ultrasound and should get physical therapy. I asked the client to let me know how she's doing - RN.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Severe pain trying to move upper arm and shoulder. (Left shoulder upper arm). Limited movement and pain for month and still sometimes. Called Doctor and saw him May 1, 2018. Pain still. They called Doc - May 14, 2018 said nothing they can do. SHINGRIX is a series of two shots. This was 1st one. According to GSK shot is to be given in Deltoid IM muscular. It was given in bicep (I have pictures). Clinic trial was for Deltoid only. I'm concerned the second shot of the series will also cause adverse effects and severe pain and loss of movement as the first one did. The first shot was given in the wrong spot on my arm. GSK can not tell me if second shot will be effective. If I should fill out more forms-Please mail to me. I am not good with computers, Patient. Aug 13, 2018.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Child received vaccines at clinic 7/31/18. Child then broke out in head to toe rash and fever. Symptoms started 8/9/18. No itching. No wheezing noted.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 81-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypothyroidism (complex history), Factor XI deficiency, vasculitis (uncharacterized), herpes zoster ophthalmic and drug allergy. 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 myalgia, malaise and lightheadedness. On an unknown date, the outcome of the myalgia, malaise and lightheadedness were unknown. It was unknown if the reporter considered the myalgia, malaise and lightheadedness to be related to SHINGRIX. Additional details were provided as follows: This case was received via webform email. The age at vaccination was not reported. The patient had a truly miserable 5 days of systemic symptoms after her initial dose. She wanted to proceed with the booster, but was leery of repeating the suffering.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was calling for a family member. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional did not administer vaccine herself and did not provide patient information. The patient experienced a shingles outbreak following vaccination with SHINGRIX. This case was considered a suspected vaccination failure since the details regarding completion of vaccination schedule, exact time to onset and laboratory confirmation of shingles were unknown.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site ulcer
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 78-year-old male patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were unchanged. It was unknown if the reporter considered the pain and pruritus to be related to SHINGRIX. Additional details were provided as follows: The day of or the day after the patient's dose of SHINGRIX, he developed a sore located in the area left and lower of the injection site. The sore was very itchy. The patient also said it was not getting any better but remained the same. The reporter's call was transferred to medical information (MI) for further assistance. The contact details of the physician was provided.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included wheelchair user. Concomitant products included medication unknown (Cholesterol Medication (Nos)). In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown. It was unknown if the reporter considered the pain in arm and neck pain to be related to SHINGRIX. Additional details were provided as follows: GlaxoSmithKline employee reported that the patient took high blood pressure medication, cholesterol and pain medication as concomitant medications. He had the SHINGRIX dose earlier previous week of reporting and a couple of days later, he reported that his arm was very sore and was still sore and his neck was sore within an hour of the injection. He had received no medical help yet.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a elderly male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The reporter stated that the patient called about 3 days post-vaccination and reported that his vaccinated arm was red, painful, and swollen. He came back into the pharmacy 5 days post vaccination to show it to her and she also spoke to the patient's doctor who was not concerned. The events did not affect his activities of daily living. The symptoms lasted about 7 or 8 days. The reporter could be contacted.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza, Myalgia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of influenza in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza, chills, headache and muscle pain. On an unknown date, the outcome of the influenza, chills, headache and muscle pain were unknown. The reporter considered the influenza, chills, headache and muscle pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, muscle pain and headache. The patient stated that she had seen her physician and was diagnosed with the flu, but she thought it was just related to the SHINGRIX injection.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test normal, Chills, Fatigue, Gait disturbance, Myalgia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of influenza in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza, chills, headache and muscle pain. On an unknown date, the outcome of the influenza, chills, headache and muscle pain were unknown. The reporter considered the influenza, chills, headache and muscle pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, muscle pain and headache. The patient stated that she had seen her physician and was diagnosed with the flu, but she thought it was just related to the SHINGRIX injection.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, X-ray limb normal
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of influenza in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza, chills, headache and muscle pain. On an unknown date, the outcome of the influenza, chills, headache and muscle pain were unknown. The reporter considered the influenza, chills, headache and muscle pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, muscle pain and headache. The patient stated that she had seen her physician and was diagnosed with the flu, but she thought it was just related to the SHINGRIX injection.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Dysstasia, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of influenza in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza, chills, headache and muscle pain. On an unknown date, the outcome of the influenza, chills, headache and muscle pain were unknown. The reporter considered the influenza, chills, headache and muscle pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, muscle pain and headache. The patient stated that she had seen her physician and was diagnosed with the flu, but she thought it was just related to the SHINGRIX injection.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Walking aid user, White blood cell count decreased
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of influenza in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza, chills, headache and muscle pain. On an unknown date, the outcome of the influenza, chills, headache and muscle pain were unknown. The reporter considered the influenza, chills, headache and muscle pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, muscle pain and headache. The patient stated that she had seen her physician and was diagnosed with the flu, but she thought it was just related to the SHINGRIX injection.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza, Myalgia
Clinical narrative: Acute muscle aches, unable to walk unaided, shivering, fatigue all within 5 days of injection. All symptoms commenced 08/05/2018 at which time my daughter took me to the Clinic, to see Dr. They took 3 vials of blood. The doctor did not believe this was an adverse reaction to the injection. All blood tests came back normal. I continued with the acute pain, shivering and fatigue through to 08/13/2018 at which time my daughter took me to the Urgent Care. My knees which were replaced with medical devices in 2008 were of concern that this had affected the implants. I met with a PA who took x-rays and said all was well. She recommended lots of water to flush out what was left of the injection and to rest. They could not find anything abnormal other than the symptoms I indicated to the PA.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test normal, Chills, Fatigue, Gait disturbance, Myalgia
Clinical narrative: Acute muscle aches, unable to walk unaided, shivering, fatigue all within 5 days of injection. All symptoms commenced 08/05/2018 at which time my daughter took me to the Clinic, to see Dr. They took 3 vials of blood. The doctor did not believe this was an adverse reaction to the injection. All blood tests came back normal. I continued with the acute pain, shivering and fatigue through to 08/13/2018 at which time my daughter took me to the Urgent Care. My knees which were replaced with medical devices in 2008 were of concern that this had affected the implants. I met with a PA who took x-rays and said all was well. She recommended lots of water to flush out what was left of the injection and to rest. They could not find anything abnormal other than the symptoms I indicated to the PA.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, X-ray limb normal
Clinical narrative: Acute muscle aches, unable to walk unaided, shivering, fatigue all within 5 days of injection. All symptoms commenced 08/05/2018 at which time my daughter took me to the Clinic, to see Dr. They took 3 vials of blood. The doctor did not believe this was an adverse reaction to the injection. All blood tests came back normal. I continued with the acute pain, shivering and fatigue through to 08/13/2018 at which time my daughter took me to the Urgent Care. My knees which were replaced with medical devices in 2008 were of concern that this had affected the implants. I met with a PA who took x-rays and said all was well. She recommended lots of water to flush out what was left of the injection and to rest. They could not find anything abnormal other than the symptoms I indicated to the PA.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Dysstasia, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: Acute muscle aches, unable to walk unaided, shivering, fatigue all within 5 days of injection. All symptoms commenced 08/05/2018 at which time my daughter took me to the Clinic, to see Dr. They took 3 vials of blood. The doctor did not believe this was an adverse reaction to the injection. All blood tests came back normal. I continued with the acute pain, shivering and fatigue through to 08/13/2018 at which time my daughter took me to the Urgent Care. My knees which were replaced with medical devices in 2008 were of concern that this had affected the implants. I met with a PA who took x-rays and said all was well. She recommended lots of water to flush out what was left of the injection and to rest. They could not find anything abnormal other than the symptoms I indicated to the PA.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Walking aid user, White blood cell count decreased
Clinical narrative: Acute muscle aches, unable to walk unaided, shivering, fatigue all within 5 days of injection. All symptoms commenced 08/05/2018 at which time my daughter took me to the Clinic, to see Dr. They took 3 vials of blood. The doctor did not believe this was an adverse reaction to the injection. All blood tests came back normal. I continued with the acute pain, shivering and fatigue through to 08/13/2018 at which time my daughter took me to the Urgent Care. My knees which were replaced with medical devices in 2008 were of concern that this had affected the implants. I met with a PA who took x-rays and said all was well. She recommended lots of water to flush out what was left of the injection and to rest. They could not find anything abnormal other than the symptoms I indicated to the PA.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were provided as follows: The patient's age group was taken based on the product indication as no other patient details were provided. The age at vaccination was not reported. The patient received a dose of SHINGRIX yesterday 6th August 2018, after which the patient reported having diarrhea for 8 hours. No further information was reported regarding the event.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, tiredness, injection site itching, general body pain, upset stomach, headache, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling, tiredness, general body pain, upset stomach, headache, injection site erythema and injection site warmth were recovering/resolving and the outcome of the injection site itching was unchanged. It was unknown if the reporter considered the injection site pain, injection site swelling, tiredness, injection site itching, general body pain, upset stomach, headache, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 68 or 69 years. On 3rd August 2018, at 11:00 hours, the patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient experienced pain, redness, swelling, soreness and hot area at the injection site. The red area at the injection site was 5 inches by 2.5 inches in size. The patient also experienced body aches, stomach upset, headache and felt tired. On day 3, the patient experienced itching at the injection site. The patient was scheduled to receive cortisone injections on the day after reporting. The patient had denied permission to contact their physician. No further details were provided. The patient was referred to their health care provider.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, tiredness, injection site itching, general body pain, upset stomach, headache, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling, tiredness, general body pain, upset stomach, headache, injection site erythema and injection site warmth were recovering/resolving and the outcome of the injection site itching was unchanged. It was unknown if the reporter considered the injection site pain, injection site swelling, tiredness, injection site itching, general body pain, upset stomach, headache, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 68 or 69 years. On 3rd August 2018, at 11:00 hours, the patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient experienced pain, redness, swelling, soreness and hot area at the injection site. The red area at the injection site was 5 inches by 2.5 inches in size. The patient also experienced body aches, stomach upset, headache and felt tired. On day 3, the patient experienced itching at the injection site. The patient was scheduled to receive cortisone injections on the day after reporting. The patient had denied permission to contact their physician. No further details were provided. The patient was referred to their health care provider.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 11th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue (serious criteria disability), feeling unwell (serious criteria disability) and general body pain (serious criteria disability). On an unknown date, the outcome of the fatigue, feeling unwell and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, feeling unwell and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fatigue, body aches and feeling very sick for 2 months following SHINGRIX administration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lower respiratory tract infection viral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lower respiratory tract infection viral in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, less than a year after receiving SHINGRIX, the patient experienced lower respiratory tract infection viral (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the lower respiratory tract infection viral was recovering/resolving.  The reporter considered the lower respiratory tract infection viral to be unrelated to SHINGRIX. Additional details were provided as follows: The patient developed a viral lung infection. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shoulder operation (right shoulder surgery). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and fever. On an unknown date, the outcome of the injection site pain and fever were unknown. It was unknown if the reporter considered the injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was received via chat. The age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX a few months before the reporting date. The patient had severe pain in the area that she was given the SHINGRIX vaccine and also experienced a low grade fever. No additional information was provided. The patient gave contact details of the healthcare provider.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood alcohol, Blood lactic acid, Blood magnesium, Drug screen, Fall
Clinical narrative: Was out shopping with parent about 11/2 hrs after office visit and vaccines. Mom said pt fell to ground and was moaning. Shaking noted. EMS was called and pt transported to ED. Pt was referred to neurologist - will have ECG and MRI.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Full blood count, Metabolic function test, Moaning, Tremor, Urine analysis
Clinical narrative: Was out shopping with parent about 11/2 hrs after office visit and vaccines. Mom said pt fell to ground and was moaning. Shaking noted. EMS was called and pt transported to ED. Pt was referred to neurologist - will have ECG and MRI.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site discolouration, Injection site reaction, Vasodilatation
Clinical narrative: Patient developed prominence of blood vessel near injection site - left leg - blue discoloration - along posterior leg. Possible injury of blood vessel.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose increased, Chills, Fatigue, Heart rate increased
Clinical narrative: Patient went to bed around 2030 because was feeling very tired. Around 2300, he was shivering and his wife noted his forehead was warm. She checked his oral temperature and it was 100.1 and his pulse was about 100 (baseline is usually around 60-70). He was not diaphoretic and did not have problems breathing or any rashes. When wife tried to direct patient, he said just leave me alone. (She was trying to get him to drink fluids. His blood sugar was >150 when he went to bed.  When patient tried to get up to the bathroom, he had difficulty going from lying to sitting and from sitting to standing. He did not complain of dizziness, but felt very weak and wife describes as "listless". Wife decided to take to ER and had to assist patient getting dressed and getting into the car; patient could not even buckle his seat belt, but was interacting appropriately and did follow directions. Upon arrival at ER, VS were reported to be temperature high and pulse fast. Patient and spouse waited for 1 1/2 hours without being seen. Patient reported feeling a little better and was able to go from sitting in wheelchair to standing. Wife accompanied to rest room and when patient came out of rest room, they left without being seen. He slept longer than usual that night and felt a little stronger the next day. On 14 Aug, patient was able to carry out a "light work out". However, his fasting blood sugars have been elevated since 8 Aug. Normally his fasting blood sugars run around 100 and for the past 4 days, his FBGs have been running 150 -200. Patient had to increase his Glargine and has modified his diet trying to get BGs done.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Listless, Loss of personal independence in daily activities, Mobility decreased, Pyrexia, Skin warm
Clinical narrative: Patient went to bed around 2030 because was feeling very tired. Around 2300, he was shivering and his wife noted his forehead was warm. She checked his oral temperature and it was 100.1 and his pulse was about 100 (baseline is usually around 60-70). He was not diaphoretic and did not have problems breathing or any rashes. When wife tried to direct patient, he said just leave me alone. (She was trying to get him to drink fluids. His blood sugar was >150 when he went to bed.  When patient tried to get up to the bathroom, he had difficulty going from lying to sitting and from sitting to standing. He did not complain of dizziness, but felt very weak and wife describes as "listless". Wife decided to take to ER and had to assist patient getting dressed and getting into the car; patient could not even buckle his seat belt, but was interacting appropriately and did follow directions. Upon arrival at ER, VS were reported to be temperature high and pulse fast. Patient and spouse waited for 1 1/2 hours without being seen. Patient reported feeling a little better and was able to go from sitting in wheelchair to standing. Wife accompanied to rest room and when patient came out of rest room, they left without being seen. He slept longer than usual that night and felt a little stronger the next day. On 14 Aug, patient was able to carry out a "light work out". However, his fasting blood sugars have been elevated since 8 Aug. Normally his fasting blood sugars run around 100 and for the past 4 days, his FBGs have been running 150 -200. Patient had to increase his Glargine and has modified his diet trying to get BGs done.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Severe body aches. Chills and sweats. Fatigue. Fever 100.9.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain, Rash, Swelling
Clinical narrative: Large amount of swelling, and pain which limited rotation. Faint rash still present 48 hours later.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Headache, nausea, chills, joint and back pain, fatigue, soreness at injection site.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: Headache, nausea, chills, joint and back pain, fatigue, soreness at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm
Clinical narrative: Note; Pt had her shingles vaccine yesterday. She is having a reaction pain all over her body, aches and pains, type of pain and she has a fever near the area where the shot was given. Her instructions on the paper work from pharmacy were to call the doctor if she had side effects.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pyrexia
Clinical narrative: Woke up in middle of the night feeling cold for body, fever 102 degrees detected in the next morning. Patient is going to take acetaminophen for fever.
Age: 3.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Lethargy, Pyrexia, Rash, Vomiting
Clinical narrative: Vomiting, lethargic, headache, fever, rash.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Irritability, Mobility decreased, Pain, Pyrexia
Clinical narrative: Swelling, Redness, Excessive fussiness, fever, and pain severe enough to affect mobility.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Swelling
Clinical narrative: Swelling, Redness, Excessive fussiness, fever, and pain severe enough to affect mobility.
Age: 40.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Blood bilirubin normal, Blood urine absent, Glucose urine absent, Injection site pruritus, Injection site scab
Clinical narrative: Vaccine was administered in left deltoid on 12 June 2018. Pt reported that there was a scab present at administration site that resolved on 8/6/2018. Pt reported to continue having itchiness at the site. On the evening of 8/10/2018, pt reported having tingling in bilateral feet. It is continuous in nature. Also, currently experiencing tenderness on bilateral oblique areas.
Age: 40.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Nitrite urine absent, Paraesthesia, Protein urine absent, Specific gravity urine normal, Tenderness
Clinical narrative: Vaccine was administered in left deltoid on 12 June 2018. Pt reported that there was a scab present at administration site that resolved on 8/6/2018. Pt reported to continue having itchiness at the site. On the evening of 8/10/2018, pt reported having tingling in bilateral feet. It is continuous in nature. Also, currently experiencing tenderness on bilateral oblique areas.
Age: 40.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Urine analysis normal, Urine ketone body absent, Urobilinogen urine, White blood cells urine negative
Clinical narrative: Vaccine was administered in left deltoid on 12 June 2018. Pt reported that there was a scab present at administration site that resolved on 8/6/2018. Pt reported to continue having itchiness at the site. On the evening of 8/10/2018, pt reported having tingling in bilateral feet. It is continuous in nature. Also, currently experiencing tenderness on bilateral oblique areas.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: It has been 10 days since the injection, the patient is experiencing erythema and itching at the injection site and is continuing to get larger from what the patient is saying.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: It has been 10 days since the injection, the patient is experiencing erythema and itching at the injection site and is continuing to get larger from what the patient is saying.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Injection site pain
Clinical narrative: Headache, shivering, upset stomach, muscle and joint pain...injection site pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Headache, shivering, upset stomach, muscle and joint pain...injection site pain.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Pain, fatigue, malaise, and possibly fever.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient complained of a sore arm that began 1-2 days post vaccination, and patient believes that this may have been due to vaccination. Patient is still has lingering soreness 48 days post vaccination.