chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood pressure increased, Chills, Dizziness, Ear discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included artificial cardiac pacemaker user. Concomitant products included propafenone hydrochloride (Propafenone) and digoxin. On 13th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th November 2018, 1 days after receiving SHINGRIX, the patient experienced ear buzzing, fatigue and shoulder pain. In November 2018, the patient experienced joint pain, tenderness, chills, sensation of pressure in ear and cold. On 16th November 2018, the patient experienced dizziness, ear infection viral, foreign body in ear and increased blood pressure. The patient was treated with methylprednisolone (Medrol). In November 2018, the outcome of the joint pain, tenderness and chills were recovered/resolved. On an unknown date, the outcome of the ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear and increased blood pressure were not recovered/not resolved and the outcome of the shoulder pain and cold were unknown. It was unknown if the reporter considered the joint pain, tenderness, chills, ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear, increased blood pressure, shoulder pain and cold to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient indicated that 4 to 6 hours after receiving SHINGRIX the patient began to feel achy in every joint, sore to the touch, and chills. Approximately 24 hours after receiving the vaccination, these symptoms had resolved. During the middle of the day the patient developed a buzzing in his ears. Also in the evening he started feeling sore and fatigued in his upper shoulders, which had been occurring every evening since it started. He also began to feel like there was pressure in his ears like when he got a cold. On the reporting day, he woke up feeling dizzy. He went to an ear, nose, throat specialist physician and was told that he could have the virus in his ears. The physician also saw crystals in one ear. When the nurse took his blood pressure, it came back with a value of 168/80. He had been taking his blood pressure throughout the day and the upper number has gone down to 135 but has then gone back into the 160s. He said that he had never had blood pressure issues before. The reporter gave consent to follow up. The reporter gave permission for his physician to be contacted.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear infection viral, Fatigue, Foreign body in ear, Musculoskeletal pain, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included artificial cardiac pacemaker user. Concomitant products included propafenone hydrochloride (Propafenone) and digoxin. On 13th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th November 2018, 1 days after receiving SHINGRIX, the patient experienced ear buzzing, fatigue and shoulder pain. In November 2018, the patient experienced joint pain, tenderness, chills, sensation of pressure in ear and cold. On 16th November 2018, the patient experienced dizziness, ear infection viral, foreign body in ear and increased blood pressure. The patient was treated with methylprednisolone (Medrol). In November 2018, the outcome of the joint pain, tenderness and chills were recovered/resolved. On an unknown date, the outcome of the ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear and increased blood pressure were not recovered/not resolved and the outcome of the shoulder pain and cold were unknown. It was unknown if the reporter considered the joint pain, tenderness, chills, ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear, increased blood pressure, shoulder pain and cold to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient indicated that 4 to 6 hours after receiving SHINGRIX the patient began to feel achy in every joint, sore to the touch, and chills. Approximately 24 hours after receiving the vaccination, these symptoms had resolved. During the middle of the day the patient developed a buzzing in his ears. Also in the evening he started feeling sore and fatigued in his upper shoulders, which had been occurring every evening since it started. He also began to feel like there was pressure in his ears like when he got a cold. On the reporting day, he woke up feeling dizzy. He went to an ear, nose, throat specialist physician and was told that he could have the virus in his ears. The physician also saw crystals in one ear. When the nurse took his blood pressure, it came back with a value of 168/80. He had been taking his blood pressure throughout the day and the upper number has gone down to 135 but has then gone back into the 160s. He said that he had never had blood pressure issues before. The reporter gave consent to follow up. The reporter gave permission for his physician to be contacted.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness, Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included artificial cardiac pacemaker user. Concomitant products included propafenone hydrochloride (Propafenone) and digoxin. On 13th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th November 2018, 1 days after receiving SHINGRIX, the patient experienced ear buzzing, fatigue and shoulder pain. In November 2018, the patient experienced joint pain, tenderness, chills, sensation of pressure in ear and cold. On 16th November 2018, the patient experienced dizziness, ear infection viral, foreign body in ear and increased blood pressure. The patient was treated with methylprednisolone (Medrol). In November 2018, the outcome of the joint pain, tenderness and chills were recovered/resolved. On an unknown date, the outcome of the ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear and increased blood pressure were not recovered/not resolved and the outcome of the shoulder pain and cold were unknown. It was unknown if the reporter considered the joint pain, tenderness, chills, ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear, increased blood pressure, shoulder pain and cold to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient indicated that 4 to 6 hours after receiving SHINGRIX the patient began to feel achy in every joint, sore to the touch, and chills. Approximately 24 hours after receiving the vaccination, these symptoms had resolved. During the middle of the day the patient developed a buzzing in his ears. Also in the evening he started feeling sore and fatigued in his upper shoulders, which had been occurring every evening since it started. He also began to feel like there was pressure in his ears like when he got a cold. On the reporting day, he woke up feeling dizzy. He went to an ear, nose, throat specialist physician and was told that he could have the virus in his ears. The physician also saw crystals in one ear. When the nurse took his blood pressure, it came back with a value of 168/80. He had been taking his blood pressure throughout the day and the upper number has gone down to 135 but has then gone back into the 160s. He said that he had never had blood pressure issues before. The reporter gave consent to follow up. The reporter gave permission for his physician to be contacted.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Product supply issue, Tendon disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tendinopathy in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 18th November 2018, 223 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced tendinopathy. On an unknown date, the patient experienced arm discomfort and product supply issue. On an unknown date, the outcome of the tendinopathy and arm discomfort were not recovered/not resolved and the outcome of the product supply issue was unknown. The reporter considered the tendinopathy and arm discomfort to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient reported that she received the SHINGRIX vaccine on right arm. The patient has been unable to secure the 2nd dose due to availability issues. Less than a year after receiving SHINGRIX, the patient also reported that she has been having difficulties with her right arm and later, she was diagnosed with Tendinopathy of the right rotary cup. The patient believed that this issue started the last couple of weeksbefore reporting. The patient believed that the issue was totally unrelated to the SHINGRIX vaccine, although she did get her 1st dose in her right arm she thought. The reporter gave consent to follow up. The patient was sorry that, she could not receive SHINGRIX which she need. The patient had the 1st shot in April, and unfortunately has been trying since August to get a 2nd shot, and it has been unavailable, so she thought this time she would call to find out if some way she could get it. And she sated that, she could not make one available, but she certainly was helpful.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Fall
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fall in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Co-suspect products included belimumab (Benlysta) solution for injection in pre-filled pen (batch number EX7Y, expiry date 2nd November 2020) for product used for unknown indication. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. In October 2018, the patient started Benlysta (subcutaneous) 200 mg weekly. In 2018, not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season and unknown after starting Benlysta, the patient experienced missed dose. In November 2018, the patient experienced fall and contusion of thigh. The action taken with Benlysta was unknown. In November 2018, the outcome of the fall was recovered/resolved. On an unknown date, the outcome of the contusion of thigh and missed dose were unknown. It was unknown if the reporter considered the fall and contusion of thigh to be related to Influenza vaccine Quadrivalent 2018-2019 season and Benlysta. Additional details were provided as follows: The age at vaccination was not provided. The patient who had been on weekly Benlysta subcutaneous (SC) injections using the auto Injector for the last four months. Her last injection was the first or second week of October. She had missed doses since she received her flu vaccination. About one week ago from the reporting date, she had a fall and then developed a bruise about the size of her fist on her thigh. The patient gave consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient experienced an itchy rash after SHINGRIX. The first dose was given at the end of June 2018 and the rash began about a week later on the left arm. During the daytime, the rash was tolerable but it worsens after showering in the evening. Hydrocortisone cream was being used with success but symptoms have not fully abated. The patient visited dermatologist after the first dose who confirmed it was not herpes zoster. The reporter consented to follow up. The member of public adverse event collected by medical affairs contact center (MACC). For tolerance after 2nd dose refer case US2018GSK221233.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a female patient who received SHINGRIX for prophylaxis. On 23rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th September 2018, 1 days after receiving SHINGRIX, the patient experienced localized erythema and injection site pain. On an unknown date, the outcome of the localized erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the localized erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced redness right below the injection site. The patient stated that it was red for a long time, however, she was not sure how long the redness lasted. Pain lasted for 1 to 2 weeks before subsiding. The patient required Emergency room visit. The reporter did not consent to follow up. The patient did not wish to provide any contact information or health care professional information.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erosion, Injection site exfoliation, Injection site extravasation, Injection site scab
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site scab in a 67-year-old female patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) and (batch number 5S34K, expiry date 13th March 2021) for prophylaxis. On 19th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In November 2018, 7 days after receiving SHINGRIX, the patient experienced injection site scab, injection site extravasation, injection site abrasion and injection site exfoliation. On an unknown date, the outcome of the injection site scab, injection site extravasation, injection site abrasion and injection site exfoliation were not recovered/not resolved. It was unknown if the reporter considered the injection site scab, injection site extravasation, injection site abrasion and injection site exfoliation to be related to SHINGRIX. Additional details were provided as follows: The reported batch number for SHINGRIX adjuvant was 5F34K, which was changed to 5S34K, as per sales data sheet. About a week later after receiving SHINGRIX, the patient experienced that the injection site had dead skin that peeled off and now site of injection looks oozy and raw.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccines with an associated reaction of pain in extremity (received in the past, refer case US2018GSK221456). On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In August 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: Within 24 hours after receiving SHINGRIX, the patient's arm was sore and it lasted 2 to 2.5 days. The soreness was minor. The reporter did not consent to follow-up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old male patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 8th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reported batch number for SHINGRIX was P45MN, which was changed to P45M9, as per sales data sheet. The patient received SHINGRIX on the left arm. The patient experienced redness at the injection site, approximately the size of their hand which lasted for five days.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis. Concurrent medical conditions included alpha-gal allergy (allergy to alpha galactose). In September 2016, the patient received Influenza vaccine Quadrivalent 2016-2017 season (intramuscular). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced injection site itching and injection site swelling. The patient was treated with prednisone. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site itching and injection site swelling to be related to Influenza vaccine Quadrivalent 2016-2017 season. Additional details were provided as follows: The age at vaccination was not provided. In September 2016, the patient received an unknown flu vaccination at her place of employment, and she reported that the injection site began to itch and swell. The patient went to employee health and was given prednisone and then sent the emergency room and was there for four hours. It took several days for the itching and swelling to resolve. The patient did not give consent to follow-up. The patient did not think the vaccine was a GSK product but she could not remember. She was unable to provide additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 42-year-old female patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, muscle pain, cold and nausea. On 29th November 2018, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the tiredness, muscle pain, cold, nausea and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the tiredness, muscle pain, cold and nausea to be related to SHINGRIX. Additional details were provided as follows: On 29th November 2018 in the late evening the 42-years-old patient received a dose of SHINGRIX vaccine in the left arm, which led to inappropriate age at vaccination. On 30th November 2018 in morning, the patient woke up and experienced tiredness, muscle ache, felt cold and nauseated. The patient called while she was waiting to see her doctor at her doctor's office. The patient did not give consent to follow-up. Emergency room (ER) visit required. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 42-year-old female patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, muscle pain, cold and nausea. On 29th November 2018, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the tiredness, muscle pain, cold, nausea and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the tiredness, muscle pain, cold and nausea to be related to SHINGRIX. Additional details were provided as follows: On 29th November 2018 in the late evening the 42-years-old patient received a dose of SHINGRIX vaccine in the left arm, which led to inappropriate age at vaccination. On 30th November 2018 in morning, the patient woke up and experienced tiredness, muscle ache, felt cold and nauseated. The patient called while she was waiting to see her doctor at her doctor's office. The patient did not give consent to follow-up. Emergency room (ER) visit required. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Appendicitis, Arthralgia, Bladder disorder, Constipation, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of appendicitis in a elderly male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included knee pain (presented before receiving SHINGRIX). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced appendicitis (serious criteria GSK medically significant), injection site pain, bladder disorder and constipation. On an unknown date, the outcome of the appendicitis, injection site pain, bladder disorder and constipation were unknown. It was unknown if the reporter considered the appendicitis, injection site pain, bladder disorder and constipation to be related to SHINGRIX. Additional details were reported as follows: This case was reported via online chat. The age at vaccination was not reported. The patient had a knee replacement surgery after receiving SHINGRIX. After vaccination, the patient experienced post-surgical constipation, appendicitis, and bladder complications. After the patient was transferred to a Medical Engagement Specialist, he experienced injection site pain after vaccination. The reporter was not sure if the patient's surgery or experiences after surgery were reportable adverse events. The reporter had given consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Knee arthroplasty, Post procedural constipation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of appendicitis in a elderly male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included knee pain (presented before receiving SHINGRIX). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced appendicitis (serious criteria GSK medically significant), injection site pain, bladder disorder and constipation. On an unknown date, the outcome of the appendicitis, injection site pain, bladder disorder and constipation were unknown. It was unknown if the reporter considered the appendicitis, injection site pain, bladder disorder and constipation to be related to SHINGRIX. Additional details were reported as follows: This case was reported via online chat. The age at vaccination was not reported. The patient had a knee replacement surgery after receiving SHINGRIX. After vaccination, the patient experienced post-surgical constipation, appendicitis, and bladder complications. After the patient was transferred to a Medical Engagement Specialist, he experienced injection site pain after vaccination. The reporter was not sure if the patient's surgery or experiences after surgery were reportable adverse events. The reporter had given consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter had reported this adverse event on behalf of another unknown patient. The reporter stated that while he was visiting his doctor's office, he was informed that, the patient received the SHINGRIX vaccine in the doctor's office and the patient passed out very soon after receiving the vaccine. The patient passed out at the doctor's office. The reporter did not have any additional information regarding the patient or the event. Please note that this was the reporter's healthcare professional information and this was the office that mentioned the patient in this case.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal chest pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th August 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, rash and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the shingles, rash and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Three days later experienced the shingles including rash and pain on the right side of her back and rib cage. The patient planned to continue follow-up with her physician on an unknown date. Consent to follow up was given. This was 1 of 3 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received SHINGRIX. On an unknown date, unknown 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 and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that she was aware of two other patients that got the shingles after getting the SHINGRIX, the same day that she received the SHINGRIX. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. Consent to follow up was given. Limited information was provided. This was 1 of 3 cases reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received SHINGRIX. On an unknown date, unknown 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 and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that she was aware of two other patients that got the shingles after getting the SHINGRIX, the same day that she received the SHINGRIX. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. Consent to follow up was given. Limited information was provided. This was 1 of 3 cases reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number B57NG, expiry date 16th September 2021) for prophylaxis. On 28th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness, redness, and warmth at the injection site about the size of orange. The reported batch number for SHINGRIX was BS7NG, which was changed to B57NG, as per sales data sheet.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein increased, Fatigue, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Fatigue, congestion, muscle aches, intermittent fever.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site mass, Injection site pain, Pain, Peripheral swelling
Clinical narrative: Red arm day after and swollen. Used ice pack and IBU. Swelling and redness went away. Where injected arm has a dull ache where injected and when you push on that area it feels like lump is there under the skin. Hurts when moving at the point of injection.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Sweating than cold bad head aches which lasted for a week. Than symptoms lessened.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Dyspnoea, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient was vaccinated on 10/26/18. Returned on 11/2/18 to give ins cards and reported to me he experienced on 10/26/18 soreness in legs and shoulders and shortness of breath on day vaccinated.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Dark red area 6cm around injection site left deltoid, raised swelling, slightly raised area. Reaction noted 48 hrs following injection 72 hrs. following redness 11cm x 6cm.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, X-ray
Clinical narrative: Extreme pain in right shoulder. Treatment: Prescribed to take two (2) ALEVE twice a day. Treatment:  Physical Therapy. Treatment: Cortisone Injection to right shoulder.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Fear of injection, Loss of consciousness
Clinical narrative: After reviewing the Consent and Release form, the MMR vaccination was administered first and then the BOOSTRIX. After the BOOSTRIX administration, the patient loss consciousness on the chair for less than 1 minute. Patient stated that she is afraid of needles.
Age: 71.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt states that she had a swollen arm, just below immunization spot. It was painful and reddened for 7 days. It became itchy for the last 3 of the 7 days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling, Injection site warmth, Weight bearing difficulty
Clinical narrative: 5 year old received a flu vaccine on 12/5/18 in Left Thigh. One hour after injection he began to have pain and swelling of left leg. Mother applied cold compress. The following day swelling progressed and he presented back to clinic on 12/6/18 with extensive leg swelling of his left leg, warmth, tenderness and inability to bear weight. No fevers.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came to the pharmacy to complain. She told me that after she received the vaccination, her arm became swollen, warm and it hurt. She did what the immunizator pharmacist told her at the time of vaccination and it help her a little.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: IMMUNIZATION WAS GIVEN AND PATIENT HAD AN EXCESS OF BLEEDING. PRESSURE WAS APPLIED TO THE SITE AND THE BLEEDING STOPPED. THE IMMUNIZATION SITE LOOKED LIKE IT WAS STARTING TO BRUISE.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pustule, Injection site swelling
Clinical narrative: 19 yo who received primary SPV, AVA, Typhoid and JEV on 9/17/2018. He had site pain immediately after AVA and sore rt arm x3 days and mild fever x 1 day which resolved on own. Day 7 he went to clinic with reports of increased redness and swelling around SPV site from shoulder to bicep-pectoris which limited his ability to do push ups. Smallpox site had a yellow quarter size pustule. He was dx with robust site reaction. About 3 days ago (10/1/18 or 2 weeks after SPV) he noticed several small bumps to palms of both hands and dorsal aspect and on 10/2 they spread to both elbows. Currently he describes pruritic pale red bumps to left index finger to webbing, top right middle and index fingers and thumb with red bumps to creases of most fingers and on palms. He states these nodules are tender and feels like pins/needles in fingers. He states his hands were tender/hurt when he carries his duffle bag. He denies any lesions to knees, ankles or elsewhere on body. He denies any fever, ha, chest pain, SOB, arthralgia, myalgia, or any systemic symptom. Denies any insect bites, new soaps, detergents, etc, trauma, or travel. Pictures received and reviewed. Pt reaction suggestive of BAPE per pictures and description of reaction ... Urgent Care MD advised this was a rare non-contagious self-resolving reaction seen about day 4-19 days after vaccination with clearance of benign eruptions from 2-70 days (average is 10-20 days). No specific treatment is needed however antihistamines, NSAIDS and topical or oral steroids have been reported to provide some symptomatic relief. Suggested they hold steroids for now and pt to f/u with clinic in 24/48 hours via phone with me---- see Support center call. Symptoms: PRURITUS, UNSPECIFIED(L299), UNSPECIFIED SKIN CHANGES(R239), EDEMA, UNSPECIFIED(R609).
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Paraesthesia, Pyrexia, Rash
Clinical narrative: 19 yo who received primary SPV, AVA, Typhoid and JEV on 9/17/2018. He had site pain immediately after AVA and sore rt arm x3 days and mild fever x 1 day which resolved on own. Day 7 he went to clinic with reports of increased redness and swelling around SPV site from shoulder to bicep-pectoris which limited his ability to do push ups. Smallpox site had a yellow quarter size pustule. He was dx with robust site reaction. About 3 days ago (10/1/18 or 2 weeks after SPV) he noticed several small bumps to palms of both hands and dorsal aspect and on 10/2 they spread to both elbows. Currently he describes pruritic pale red bumps to left index finger to webbing, top right middle and index fingers and thumb with red bumps to creases of most fingers and on palms. He states these nodules are tender and feels like pins/needles in fingers. He states his hands were tender/hurt when he carries his duffle bag. He denies any lesions to knees, ankles or elsewhere on body. He denies any fever, ha, chest pain, SOB, arthralgia, myalgia, or any systemic symptom. Denies any insect bites, new soaps, detergents, etc, trauma, or travel. Pictures received and reviewed. Pt reaction suggestive of BAPE per pictures and description of reaction ... Urgent Care MD advised this was a rare non-contagious self-resolving reaction seen about day 4-19 days after vaccination with clearance of benign eruptions from 2-70 days (average is 10-20 days). No specific treatment is needed however antihistamines, NSAIDS and topical or oral steroids have been reported to provide some symptomatic relief. Suggested they hold steroids for now and pt to f/u with clinic in 24/48 hours via phone with me---- see Support center call. Symptoms: PRURITUS, UNSPECIFIED(L299), UNSPECIFIED SKIN CHANGES(R239), EDEMA, UNSPECIFIED(R609).
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Rash erythematous, Rash pruritic, Robust take following exposure to vaccinia virus, Tenderness
Clinical narrative: 19 yo who received primary SPV, AVA, Typhoid and JEV on 9/17/2018. He had site pain immediately after AVA and sore rt arm x3 days and mild fever x 1 day which resolved on own. Day 7 he went to clinic with reports of increased redness and swelling around SPV site from shoulder to bicep-pectoris which limited his ability to do push ups. Smallpox site had a yellow quarter size pustule. He was dx with robust site reaction. About 3 days ago (10/1/18 or 2 weeks after SPV) he noticed several small bumps to palms of both hands and dorsal aspect and on 10/2 they spread to both elbows. Currently he describes pruritic pale red bumps to left index finger to webbing, top right middle and index fingers and thumb with red bumps to creases of most fingers and on palms. He states these nodules are tender and feels like pins/needles in fingers. He states his hands were tender/hurt when he carries his duffle bag. He denies any lesions to knees, ankles or elsewhere on body. He denies any fever, ha, chest pain, SOB, arthralgia, myalgia, or any systemic symptom. Denies any insect bites, new soaps, detergents, etc, trauma, or travel. Pictures received and reviewed. Pt reaction suggestive of BAPE per pictures and description of reaction ... Urgent Care MD advised this was a rare non-contagious self-resolving reaction seen about day 4-19 days after vaccination with clearance of benign eruptions from 2-70 days (average is 10-20 days). No specific treatment is needed however antihistamines, NSAIDS and topical or oral steroids have been reported to provide some symptomatic relief. Suggested they hold steroids for now and pt to f/u with clinic in 24/48 hours via phone with me---- see Support center call. Symptoms: PRURITUS, UNSPECIFIED(L299), UNSPECIFIED SKIN CHANGES(R239), EDEMA, UNSPECIFIED(R609).
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pain
Clinical narrative: (0940) pt had 2nd SHINGRIX on 11-15-18 called clinic 11-16-18 at 0940 states "started having chills and body aches and joint pain at 12 mdn. Taken Ibuprofen with any results pain was at 10 now at 940 rates at 4-5'. Recommended TYLENOL 1,000 mg and will call pt back (1230) called pt back chills gone pain at 4 will call at 4 again. (1600) called back rates pain at 2. 11-19-18 0940 pt denies pain. Returned to her ADL's no discomfort.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash pruritic, Rash pustular, Skin reaction, Urticaria
Clinical narrative: Patient presented to primary care clinic on 12-3-18 with complaints of developing a skin reaction beginning the day after receiving the shingles (SHINGRIX) vaccine (11-30-18). The patient complained of an itchy rash on right side (flank) area. The patient also complained of systematic itching. Small pustule with surrounding urticaria wheal was observed.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Dyspnoea, Feeling of body temperature change
Clinical narrative: Pt was given the influenza vaccine on Nov. 30, 2018 at 4 pm or so. Not sure which one, but not nasal spray. At about 24 hours, he began to experience heavy and difficulty breathing, almost gasping, dizziness, numbness in hands feet and entire body at times. He began to feel very hot and cold, but experienced no fever. He was listless and seemed like he would pass out and speech became mumbling. After several hours he got a bit better in terms of the numbness and breathing. Still experienced headaches for a few days and general weakness for several days.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Hypoaesthesia, Listless, Speech disorder
Clinical narrative: Pt was given the influenza vaccine on Nov. 30, 2018 at 4 pm or so. Not sure which one, but not nasal spray. At about 24 hours, he began to experience heavy and difficulty breathing, almost gasping, dizziness, numbness in hands feet and entire body at times. He began to feel very hot and cold, but experienced no fever. He was listless and seemed like he would pass out and speech became mumbling. After several hours he got a bit better in terms of the numbness and breathing. Still experienced headaches for a few days and general weakness for several days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, headache, fatigue.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness at the injection site, 1 week following. Itching.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Peripheral swelling, Urticaria
Clinical narrative: Patients arm was red and swollen, hives and large blister.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient presented to the clinic with father with a red, raised bumps varying in size that were itching. Majority located in a cluster on right proximal posterior arm. Small clusters noted around waist line and on back of bilateral legs.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Slight rash, soreness, stiffness, patient reported 3 days after vaccine, slight shortness of breath.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Pruritus
Clinical narrative: Patient arm swelled up and was not painful but stiff. It itched constantly and lasted for about 3-4 weeks. Onset occurred within a day or two.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Pt reports that she had a high fever (patient did not have a thermometer), chills, diminished appetite, sensitive skin, and fatigue. She took NYQUIL and slept 15 hours. When she woke up she felt weak. She ate something (her appetite was small )and took TYLENOL then she rested the rest of the day. Her chills were gone at that time but she continued to feel exhausted. She took NYQUIL again that night and slept another 9 hours. She continues to feel weak and have a headache.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperaesthesia, Pyrexia
Clinical narrative: Pt reports that she had a high fever (patient did not have a thermometer), chills, diminished appetite, sensitive skin, and fatigue. She took NYQUIL and slept 15 hours. When she woke up she felt weak. She ate something (her appetite was small )and took TYLENOL then she rested the rest of the day. Her chills were gone at that time but she continued to feel exhausted. She took NYQUIL again that night and slept another 9 hours. She continues to feel weak and have a headache.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient complains of severe body pain and aches the morning and day following SHINGRIX vaccine.
Age: 22.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Underdose
Clinical narrative: I was not aware that I gave an adult a pediatric dose of Hep A until the billing specialist notified me on 12/5/18. Patient was unaware of the medication error until notified on 12/6/18.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Large localized reaction at injection site--bright red, painful spot expanding to over 8 cm in diameter by day 2. Arm extremely sore for 4 days. Fever of 100.2 on Day 2, including body aches. 8 days after injection, pale reddish brown spot 8 cm in diameter is still visible.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor, Pyrexia
Clinical narrative: Large localized reaction at injection site--bright red, painful spot expanding to over 8 cm in diameter by day 2. Arm extremely sore for 4 days. Fever of 100.2 on Day 2, including body aches. 8 days after injection, pale reddish brown spot 8 cm in diameter is still visible.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness postural, Flushing, Injection site pain, Pyrexia
Clinical narrative: Onset of flushing, dizzy upon position change and severe site reaction/pain reported 12 hours post vaccination. Recurring symptoms with chills, fever, site reaction/pain reported at 10 am that same morning, relieved some with ibuprofen and hydration. Fever and site reaction again that evening at 10 pm. Reports feeling better by 9 am today, 12-07-2018, 2 days post vaccination.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient had hives on face and spreading down neck. No breathing difficulties noted two hours after injection. Mother brought patient back to clinic to be evaluated. Patient given 4mg IM DECADRON.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Impaired work ability, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, congestion, general feeling of illness, missed work.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Pain, Vomiting
Clinical narrative: Patient called to mention that he had pain at the injection site, severe headache, vomiting, and body aches.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patients Left arm was swollen- red at injection site, Site measured to be a 4cm X 6cm.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Neck pain
Clinical narrative: Severe Aches in back neck hips, Severe headache, High fever, Lassitude.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe Aches in back neck hips, Severe headache, High fever, Lassitude.