chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 5T943, expiry date 30th June 2019). On 26th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 26th September 2018, immediately after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On 27th September 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the injection site pain was not reported. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. Pharmacist reported that they had been giving FLUARIX QUADRIVALENT at work for years. However, this year they had been seeing a lot of local reaction which was not normal. The pharmacist reported this case for herself. A day before the date of reporting at around 3 or 4 pm, the patient was vaccinated with FLUARIX QUADRIVALENT. The injection site was sore right away after vaccination. The patient noticed injection site redness on the morning of reporting date. She had raised round area and redness at the injection site of about 1.5 inches in diameter. The patient had denied permission to contact their physician. This case was linked with case US2018176518 and US2018176519 reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 5T943, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site swelling, erythema and injection site erythema. On an unknown date, the outcome of the injection site swelling, erythema and injection site erythema were not reported. It was unknown if the reporter considered the injection site swelling, erythema and injection site erythema to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. On an unknown date in 2018, the patient was vaccinated with a dose of FLUARIX QUADRIVALENT 2018-2019 season.  Pharmacist reported that they had been giving FLUARIX QUADRIVALENT at work for years. However, this year they had been seeing a lot of local reaction which was not normal. The pharmacist reported this case for one of her employee that she knew. The patient experienced a two inch diameter redness at the injection site and raised area around the injection site. A few inches away the injection site the patient also started seeing some redness. This case was linked with case US2018176517 and US2018176519 reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult patient who received FLUARIX QUADRIVALENT (batch number 5T943, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADIRVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not reported. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional information was reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that they had been giving FLUARIX QUADRIVALENT at work for years. However, this year they had been seeing a lot of local reaction which was not normal. This case was reported for other staff members. In 2018, the patients were vaccinated with a dose of FLUARIX QUADRIVALENT. The patients had seen similar reaction of redness and raised area at the injection site. They had all received the same lot number of the vaccine. This case was linked with case US2018176517 and US2018176518 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash papular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced injection site rash and erythro papular rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the erythro papular rash was unknown. It was unknown if the reporter considered the injection site rash and erythropapular rash to be related to SHINGRIX. Additional details were provided as follows; The health care professional stated that patient developed a rash at injection site after 1st dose of SHINGRIX. The patient reported to health care professional that they developed a red, bumpy rash at injection site 3 days or so after 1st dose of SHINGRIX. It was still un-resolved at the time of reporting. The health care professional was unable to provide very much detail because the vaccine was not administered at their site. The reporter requested to follow-up with health care professional for further details as no other information was provided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister, Ear pain, Facial pain, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of facial pain in a 77-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced skin lesion. On 23rd September 2018, the patient experienced facial pain, pimples, blister, shingles and cold sores. On 26th September 2018, the patient experienced allergic reaction and ear pain. On an unknown date, the outcome of the facial pain, pimples, allergic reaction, shingles, ear pain and cold sores were unknown and the outcome of the blister was recovering/resolving and the outcome of the skin lesion was not recovered/not resolved. It was unknown if the reporter considered the facial pain, pimples, blister, allergic reaction, shingles, ear pain, skin lesion and cold sores to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on 13th September 2018. On the morning of 23rd September 2018, she noted that the right side of her face was sore and she saw a red pimple on the cheek side of her face in front of where the upper part of the ear connected with the face, that afternoon she noted some blisters appearing on her chin. On Tuesday, 25th September 2018, she had developed two blisters on her upper lip which she initially thought were cold sores. Then a blister appeared on the inside of her lip. By Wednesday morning on 26th septmeber 2018, the blisters had spread up the side of her right cheek. She thought she might had come in contact with something that was causing an allergic reaction so she went to her primary care physician. The physician diagnosed her with shingles and sent her to an ear, nose, and throat physician to assess the ear involvement. No blisters were noted in the ear but the inside of her ear was sore and the skin on her right cheek. She was given medication. The blister that initially presented on 23rd September 2018 was resolving and reduced in size. However, the other lesions were still red, raised, and angry looking. Also, she described that the skin on the right side of her nose was sore. The patient gave permission for her physician's physician assistant to be contacted.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 27th September 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain and difficulty sleeping. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the difficulty sleeping was unknown. It was unknown if the reporter considered the injection site pain and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: The patient reported that a few hours after the injection he experienced sore arm where injection was given. The caller stated that he had difficulty sleeping due to the soreness and that it was a little worse this morning.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX somewhere else. The healthcare professional reported that, in June or July 2018, the patient experienced shingles. The healthcare professional did not have any further information.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of high temperature in a 85-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received and did not get any reaction). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced high temperature, axillary lymph nodes enlarged and dizziness. On an unknown date, the outcome of the high temperature and dizziness were recovered/resolved and the outcome of the axillary lymph nodes enlarged was recovering/resolving. It was unknown if the reporter considered the high temperature and dizziness to be related to SHINGRIX. The reporter considered the axillary lymph nodes enlarged to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On the same night of vaccination, the patient experienced higher temperature and felt dizzy which lasted only a few hours. The next morning, 1 day after receiving SHINGRIX, the patient saw a swelling on the lymph node under his left arm pit. The patient saw a physician and the physician said that, it was a reaction to the shot. The patient still had this side effect, but it was softer and smaller, but still persisted.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the staff member works for the doctor. The age at vaccination was not reported. But, it could be 58 or 59 years. The patient experienced pain, redness and swelling at the injection site, which measured 6-8 inches in diameter. The symptoms lasted for one month before resolving. No additional details were provided regarding this event. The account representative stated that a staff member reported this to him but he did not know her name. She worked for the doctor listed in this report.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a male patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 13th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, 3 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with steroid cream. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX on left arm. About 3 hours after vaccination, the patient experienced hives on legs, trunk and arms. The patient had used topical steroid cream and taken hot bath to treat and the hives went away and then came back.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Lip erythema, Lip swelling, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 44-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 26th September 2018, the patient received FLUARIX QUADRIVALENT. On 26th September 2018, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling. On an unknown date, the outcome of the allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling were recovering/resolving. The reporter considered the allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient did not have allergic reactions due to flu shots in the past. On Wednesday, the patient received a dose of FLUARIX QUADRIVALENT on left arm. About 1 hour after the vaccination, the patient experienced nausea. About 6 hours after she started noticing that both, her face and lips, got red and puffy. The patient visited to her physician and the physician believed that, it was an allergic reaction due to the flu shot. The contact details of the physician was provided.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 44-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 26th September 2018, the patient received FLUARIX QUADRIVALENT. On 26th September 2018, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling. On an unknown date, the outcome of the allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling were recovering/resolving. The reporter considered the allergic reaction, nausea, red face, lip redness, facial swelling and lip swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient did not have allergic reactions due to flu shots in the past. On Wednesday, the patient received a dose of FLUARIX QUADRIVALENT on left arm. About 1 hour after the vaccination, the patient experienced nausea. About 6 hours after she started noticing that both, her face and lips, got red and puffy. The patient visited to her physician and the physician believed that, it was an allergic reaction due to the flu shot. The contact details of the physician was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Rash pruritic, Rash pustular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 26th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced itchy rash, blotchy rash and pustular rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the itchy rash, blotchy rash and pustular rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, blotchy rash and pustular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was a nurse who was also the patient. The patient had the vaccine on left arm and reported that about 4 hours after the dose she developed an itchy rash that had spread. The patient reported that rash was on her back, mid-section, and left shoulder. The patient stated that rash was itchy and was in blotches and had a center and pustule. The patient had been seen by dermatologist and was prescribed cortisone cream. The dermatologist had taken culture from pustules and did not have results back still at the time of reporting. The contact details of the dermatologist was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Rash pustular, Skin lesion, Varicella
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 26th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced itchy rash, blotchy rash and pustular rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the itchy rash, blotchy rash and pustular rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, blotchy rash and pustular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was a nurse who was also the patient. The patient had the vaccine on left arm and reported that about 4 hours after the dose she developed an itchy rash that had spread. The patient reported that rash was on her back, mid-section, and left shoulder. The patient stated that rash was itchy and was in blotches and had a center and pustule. The patient had been seen by dermatologist and was prescribed cortisone cream. The dermatologist had taken culture from pustules and did not have results back still at the time of reporting. The contact details of the dermatologist was provided.
Sex: M
Vaccine: VARZOS
Symptoms: 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 adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter's husband received the first shot over 2 months ago and had soreness at injection site. The patient was administered SHINGRIX in the left arm. The second day was worst than the first and it resolved after 2 days. For the tolerance of 2nd dose refer case, US2018GSK182027 for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: 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 elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported but could be 71 or 72 years old. The patient's husband could not remember the vaccination date for the 1st dose of SHINGRIX. The reporter's wife experienced injection site pain for a day after vaccination. This case was linked with case US2018GSK181366 (2nd dose), reported by the same reporter for the same patient.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Eye pain, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX. On 28th September 2018, 1 days after receiving SHINGRIX, the patient experienced headache, skin warm, sore throat, eye pain, joint pain and polymyalgia. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the skin warm, sore throat, eye pain, joint pain and polymyalgia were unknown. It was unknown if the reporter considered the headache, skin warm, sore throat, eye pain, joint pain and polymyalgia to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. The physician was unable to provide any further details. The vaccine was not administered by the reporting physician. No further information was provided by the healthcare professional. The reporter stated to follow-up with the healthcare professional for further details.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX. On 28th September 2018, 1 days after receiving SHINGRIX, the patient experienced headache, skin warm, sore throat, eye pain, joint pain and polymyalgia. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the skin warm, sore throat, eye pain, joint pain and polymyalgia were unknown. It was unknown if the reporter considered the headache, skin warm, sore throat, eye pain, joint pain and polymyalgia to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. The physician was unable to provide any further details. The vaccine was not administered by the reporting physician. No further information was provided by the healthcare professional. The reporter stated to follow-up with the healthcare professional for further details.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 72-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 27th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 28th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site induration and injection site swelling. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site warmth, injection site induration, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site warmth, injection site induration and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: The patient was inadvertently vaccinated with SHINGRIX by subcutaneous route instead of intramuscular route, which led to intramuscular administered by other route. The morning after vaccination with SHINGRIX, the patient noticed injection swelling, injection site warmth and hardness at injection site.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Fatigue, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of stomach pain in a 5-year-old male patient who received FLULAVAL QUADRIVALENT (batch number Y7985 ?, expiry date 30th June 2019. GSK note: the reported batch number did not match with any GSK batch number. Clarification has been requested) for prophylaxis. Previously administered products included FLUARIX, FLUZONE and FLUMIST. On 26th September 2018, the patient received FLULAVAL QUADRIVALENT. On 26th September 2018, several minutes after receiving FLULAVAL QUADRIVALENT, the patient experienced stomach pain, pale skin, sweating, vomiting, nausea and fatigue. The patient also experienced low blood pressure and hard to awaken. On an unknown date, the outcome of the stomach pain, pale skin, hard to awaken, sweating, vomiting, low blood pressure, nausea and fatigue were unknown. It was unknown if the reporter considered the stomach pain, pale skin, hard to awaken, sweating, vomiting, low blood pressure, nausea and fatigue to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT on left arm. The healthcare professional stated that the patient received FLULAVAL and minutes later experienced stomach pain, nausea, pale skin, fatigue, and severe sweating. The healthcare professional provided patient with soda water and after taking a sip patient vomited but was a foamy vomit. Less than a day, after receiving FLULAVAL QUADRIVALENT, the patient had a hard time staying awake and when they checked his blood pressure, it was lower than what it was when he first came for the appointment. The patient has received other flu vaccines (FLUARIX, FLUZONE, and FLUMIST) in the past but never had FLULAVAL before. The patient was taken to the hospital by ambulance but they are unsure if the adverse events were cause from the vaccine.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Somnolence, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of stomach pain in a 5-year-old male patient who received FLULAVAL QUADRIVALENT (batch number Y7985 ?, expiry date 30th June 2019. GSK note: the reported batch number did not match with any GSK batch number. Clarification has been requested) for prophylaxis. Previously administered products included FLUARIX, FLUZONE and FLUMIST. On 26th September 2018, the patient received FLULAVAL QUADRIVALENT. On 26th September 2018, several minutes after receiving FLULAVAL QUADRIVALENT, the patient experienced stomach pain, pale skin, sweating, vomiting, nausea and fatigue. The patient also experienced low blood pressure and hard to awaken. On an unknown date, the outcome of the stomach pain, pale skin, hard to awaken, sweating, vomiting, low blood pressure, nausea and fatigue were unknown. It was unknown if the reporter considered the stomach pain, pale skin, hard to awaken, sweating, vomiting, low blood pressure, nausea and fatigue to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT on left arm. The healthcare professional stated that the patient received FLULAVAL and minutes later experienced stomach pain, nausea, pale skin, fatigue, and severe sweating. The healthcare professional provided patient with soda water and after taking a sip patient vomited but was a foamy vomit. Less than a day, after receiving FLULAVAL QUADRIVALENT, the patient had a hard time staying awake and when they checked his blood pressure, it was lower than what it was when he first came for the appointment. The patient has received other flu vaccines (FLUARIX, FLUZONE, and FLUMIST) in the past but never had FLULAVAL before. The patient was taken to the hospital by ambulance but they are unsure if the adverse events were cause from the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported redness the size of a cigarette pack located an inch next to the injection site. Caller refused to answer any question and hung up. No additional details was provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, C-reactive protein increased, Fatigue, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of C-reactive protein increased in a 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis and rheumatoid arthritis (rheumatology issues with joint pain). In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced joint pain, tiredness, influenza-like symptoms, pain and pain in arm. On 18th September 2018, the patient experienced C-reactive protein increased and sedimentation rate increased. On an unknown date, the outcome of the C-reactive protein increased and sedimentation rate increased were not reported and the outcome of the joint pain was not recovered/not resolved and the outcome of the tiredness, influenza-like symptoms, pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the C-reactive protein increased, joint pain, tiredness, influenza-like symptoms, pain, sedimentation rate increased and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to anyone. Specific vaccination date was unknown. The patient experienced arm soreness, flu like symptoms consisting of achiness all over and tiredness. On 18th September 2018, the patient had routine blood work done and it was discovered that he had a high C-Reactive Protein count and his sedimentation rate was high. The patient reported joint pain that would not resolve. The contact details of the physician was provided. This case was linked with case US2018177087, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of C-reactive protein increased in a 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis and rheumatoid arthritis (rheumatology issues with joint pain). In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced joint pain, tiredness, influenza-like symptoms, pain and pain in arm. On 18th September 2018, the patient experienced C-reactive protein increased and sedimentation rate increased. On an unknown date, the outcome of the C-reactive protein increased and sedimentation rate increased were not reported and the outcome of the joint pain was not recovered/not resolved and the outcome of the tiredness, influenza-like symptoms, pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the C-reactive protein increased, joint pain, tiredness, influenza-like symptoms, pain, sedimentation rate increased and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to anyone. Specific vaccination date was unknown. The patient experienced arm soreness, flu like symptoms consisting of achiness all over and tiredness. On 18th September 2018, the patient had routine blood work done and it was discovered that he had a high C-Reactive Protein count and his sedimentation rate was high. The patient reported joint pain that would not resolve. The contact details of the physician was provided. This case was linked with case US2018177087, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient's brother. The patient received SHINGRIX sometime in June 2018 and had arm pain and soreness. The event was resolved after a few days. This case was linked with case US2018177084, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (started in October 2017). Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on 27th March 2018 refer case US2018GSK182175). On 26th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced shoulder pain, headache, fever, erythema, injection site rash, sore throat, esophageal acid reflux, shingles, tingling, blisters and eye pruritus. On 26th September 2018, the patient experienced shivering. On 28th September 2018, the patient experienced pruritus. On an unknown date, the patient experienced blotchy and back pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering, shoulder pain, headache, fever, erythema, injection site rash, blotchy, pruritus, sore throat, esophageal acid reflux, shingles, tingling, blisters, eye pruritus and back pain were unknown. It was unknown if the reporter considered the shivering, shoulder pain, headache, fever, erythema, injection site rash, blotchy, pruritus, sore throat, esophageal acid reflux, shingles, tingling, blisters, eye pruritus and back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose on right arm at 10:30 hours. The patient reported she received the second dose, she said she shivered all night long. On a scale from 1 to 10, she said the side effects were a 6 or 7 when they occurred. With the second dose, she said the side effects that were more intense, like a 9 or a 10. In September 2018, less than a week after vaccination, the patient had shoulder pain, excruciating headache, redness and fever. The patient said there were blotches around the injection site on her right arm. On 26th September 2018 at morning the middle of her back was red and itchy. The patient thought the blotches looked like they might be the start of a breakout. Her sore throat might not be from the vaccine, there was a probability it might be acid reflux but she was not sure. During the conversation, she said it might feel like shingles because her face and chest feel tingly. Additional comments from call discussion. The caller stated pain, shivering and chills with first dose. With second dose she had extreme headache and the site of injection on her right shoulder looked like a shingles outbreak is occurring. Little red blisters were also on her cheek. She had tingling under her skin on her face, chest and back. She had itching of her inner eye, and upper back with pain in her lower back. She had been referred to see a physician, although she was visiting. This case has been linked with case US2018GSK182175 reported by the same reporter for the same patient.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor nerve in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 22nd September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 16 hrs after receiving SHINGRIX, the patient experienced tremor nerve. On 23rd September 2018, the patient experienced pain. On an unknown date, the outcome of the tremor nerve and pain were recovered/resolved. The reporter considered the tremor nerve to be related to SHINGRIX. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: At 10:30, the patient received SHINGRIX. The patient experienced tremor that awoke early in the morning on the day after the vaccination date. He stated it lasted a few hours and resolved. He did believe it was neurological in nature. The patient also had the usual soreness and achiness that lasted a little longer than 2 to 3 days but had resolved. The internist was not made aware of the events.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tremor of hands (right hand) and arthritis. On 27th June 2018, the patient received the 2nd dose of SHINGRIX. On 28th June 2018, 1 days after receiving SHINGRIX, the patient experienced erythema, pain, pain in arm, tenderness and mobility decreased. In July 2018, the outcome of the tenderness was recovered/resolved. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the pain, pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the erythema, pain, pain in arm, tenderness and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed redness, extreme tenderness and soreness the day after receiving the SHINGRIX. The tenderness and redness resolved within a week, but the soreness had persisted. The patient could not lift his arm above his shoulder without experiencing pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Feeling abnormal, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 66-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a month after receiving SHINGRIX, the patient experienced hives, feeling abnormal, chills, burning sensation, rash and fever. On an unknown date, the outcome of the hives, feeling abnormal, chills, burning sensation, rash and fever were unknown. It was unknown if the reporter considered the hives, feeling abnormal, chills, burning sensation, rash and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient came into the pharmacy on the day of reporting and told the pharmacist that, in June, he experienced rash, hives, fever, chills, burning and general feeling of blah.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 66-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a month after receiving SHINGRIX, the patient experienced hives, feeling abnormal, chills, burning sensation, rash and fever. On an unknown date, the outcome of the hives, feeling abnormal, chills, burning sensation, rash and fever were unknown. It was unknown if the reporter considered the hives, feeling abnormal, chills, burning sensation, rash and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient came into the pharmacy on the day of reporting and told the pharmacist that, in June, he experienced rash, hives, fever, chills, burning and general feeling of blah.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX about 5 months before the date of reporting.   The patient was unable to recall specific date of shot and was unable to provide phone number for the pharmacy. The patient requested to be anonymous. The patient stated, at some point after receiving SHINGRIX, she developed shingles which lasted for about one month. The patient was treated with Valtrex and Shingles was resolved. She had a 2nd outbreak of shingles later on and was again treated with Valtrex. The patient was unsure if the shingles had resolved yet or not.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, 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 63-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. On 27th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills, headache and fatigue. On an unknown date, the outcome of the pain in arm, chills, headache and fatigue were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, headache and fatigue to be related to SHINGRIX. Additional details were reported as follows: About 6 to 7 hours later, the patient experienced events which resolved within 48 hours. This case has been linked with US2018178314, reported by same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, 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 63-year-old male patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX. On 28th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills, headache and fatigue. On an unknown date, the outcome of the pain in arm, chills, headache and fatigue were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, headache and fatigue to be related to SHINGRIX. Additional details were reported as follows: About 6 to 7 hours later, the patient experienced events which resolved within 48 hours. This case has been linked with US2018178313, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a female patient who received SHINGRIX (batch number MY2B2, expiry date 20th February 2021) for prophylaxis. On 30th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, several hours after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced SHINGRIX vaccine in right arm. The health care professional (HCP) reported that after few hours later after vaccination with SHINGRIX, the patient experienced shivering which lasted all through the night and into on the day of reporting and the patient still experiencing it. The reporter did not want to disclose patient information.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering 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 day after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were received as follows: This report was received via a chat. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) stated his patient was given SHINGRIX before the date of reporting and she had shivering since then. The health care professional (HCP) left chat before any additional information could be collected. No physical address was provided for HCP.