chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2007, the patient was inoculated with ZOSTAVAX at the county health department as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-AUG-2015, the patient was treated at an urgent care for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2009, the patient was inoculated with ZOSTAVAX by a physician at the office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-SEP-2014, the patient was treated at a health center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Plasmapheresis, Strabismus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a elderly male patient who received Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included shingles (8 years ago, prior to receiving ZOSTAVAX). Previously administered products included ZOSTAVAX (8 years ago) and Neurontin.  On an unknown date, the patient received the 1st dose of Flu vaccine. On an unknown date, 7 days after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), numbness in toes (serious criteria hospitalization) and strabismus (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and strabismus were recovered/resolved and the outcome of the tingling of extremity and numbness in toes were not recovered/not resolved.  It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, numbness in toes and strabismus to be related to Flu vaccine. Additional details were provided as follows: This case was reported by the patient for himself. The age at vaccination could be 69 or 70 years. Four years ago, in 2014, the patient received flu vaccine (unknown manufacturer) in the left arm and 1 week after receiving the vaccine, the patient had Guillain-Barre Syndrome. He noticed that his eyes were going in separate directions so he drove himself to the hospital and he was hospitalized for 10 days. He was in the hospital he had to have plasmapheresis to filter his blood. Every now and then he felt a tingling feeling or numbness in his toes. The patient had denied permission to contact their physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Cervical radiculopathy, Chest pain, Dyspnoea, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 24th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 1 day 12 hrs after receiving SHINGRIX, the patient experienced headache, jaw pain, inflammation, cervical neuralgia, nerve pain, chest pain and difficulty breathing. The patient was treated with medication unknown (Tablet). On an unknown date, the outcome of the headache, jaw pain, inflammation, cervical neuralgia and nerve pain were not recovered/not resolved and the outcome of the chest pain and difficulty breathing were unknown. The reporter considered the headache, jaw pain, inflammation, cervical neuralgia and nerve pain to be related to SHINGRI. It was unknown if the reporter considered the chest pain and difficulty breathing to be related to SHINGRIX. Additional details were reported as follows: At 12:40 PM the patient received a dose of SHINGRIX into right deltoid. The patient experienced a headache in her upper and lower jaw, neck and upper chest with inflammation and nerve pain. The patient had to go to the emergency room (ER) 36 hours later. The healthcare professional (HCP) at the ER told the patient that her symptoms were symptoms of a virus due to the live vaccine. They ran blood work and did not find anything, however, the ER thought her symptoms were related to the vaccine. The patient was provided pain tablets for her symptoms. The ER physician had done blood tests, which were normal, and the patient was sent home. On 27th September 2018, at 7:51 pm the patient called and left a massage that she experienced being poisoned by SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced chest pain and had trouble breathing. The patient did not wish to give any demographic information. No additional details were available. This case has been linked to the US2018GSK184729, reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Neuralgia, Pain in jaw
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 24th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 1 day 12 hrs after receiving SHINGRIX, the patient experienced headache, jaw pain, inflammation, cervical neuralgia, nerve pain, chest pain and difficulty breathing. The patient was treated with medication unknown (Tablet). On an unknown date, the outcome of the headache, jaw pain, inflammation, cervical neuralgia and nerve pain were not recovered/not resolved and the outcome of the chest pain and difficulty breathing were unknown. The reporter considered the headache, jaw pain, inflammation, cervical neuralgia and nerve pain to be related to SHINGRI. It was unknown if the reporter considered the chest pain and difficulty breathing to be related to SHINGRIX. Additional details were reported as follows: At 12:40 PM the patient received a dose of SHINGRIX into right deltoid. The patient experienced a headache in her upper and lower jaw, neck and upper chest with inflammation and nerve pain. The patient had to go to the emergency room (ER) 36 hours later. The healthcare professional (HCP) at the ER told the patient that her symptoms were symptoms of a virus due to the live vaccine. They ran blood work and did not find anything, however, the ER thought her symptoms were related to the vaccine. The patient was provided pain tablets for her symptoms. The ER physician had done blood tests, which were normal, and the patient was sent home. On 27th September 2018, at 7:51 pm the patient called and left a massage that she experienced being poisoned by SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced chest pain and had trouble breathing. The patient did not wish to give any demographic information. No additional details were available. This case has been linked to the US2018GSK184729, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: 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 pain in a female patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th September 2018, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced substantial swelling that was noticed in the morning of 29th October 2018. The swelling was the size of her palm and had been improving. The vaccine was not administered at the same location of report.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a child). Concomitant products included medication unknown (Blood Pressure Medication). On 27th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On 27th September 2018, the patient experienced injection site pain. On 28th September 2018, the patient experienced injection site erythema. On 29th September 2018, the patient experienced injection site swelling, injection site lump and injection site inflammation. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site erythema and injection site pain were recovering/resolving and the outcome of the injection site lump, enlargement of lymph nodes and injection site inflammation were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, injection site lump, enlargement of lymph nodes and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: In the morning, the patient received SHINGRIX in the left arm. The patient experienced redness at the injection site that was approximately two inches in diameter. He also experienced soreness at the injection site. On Saturday night, he experienced a small lump approximately the size of an almond that started to swell and then it was approximately two by two in diameter which he described as the size of a cracked egg. He claimed that the swollen lymph node was on the same side of the injection site. The swelling had increased since Saturday. He described the swelling as inflammation and considerable swelling now that it was four days after the injection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a child). Concomitant products included medication unknown (Blood Pressure Medication). On 27th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On 27th September 2018, the patient experienced injection site pain. On 28th September 2018, the patient experienced injection site erythema. On 29th September 2018, the patient experienced injection site swelling, injection site lump and injection site inflammation. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site erythema and injection site pain were recovering/resolving and the outcome of the injection site lump, enlargement of lymph nodes and injection site inflammation were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, injection site lump, enlargement of lymph nodes and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: In the morning, the patient received SHINGRIX in the left arm. The patient experienced redness at the injection site that was approximately two inches in diameter. He also experienced soreness at the injection site. On Saturday night, he experienced a small lump approximately the size of an almond that started to swell and then it was approximately two by two in diameter which he described as the size of a cracked egg. He claimed that the swollen lymph node was on the same side of the injection site. The swelling had increased since Saturday. He described the swelling as inflammation and considerable swelling now that it was four days after the injection.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were reported as follows: This case has been linked to case US2018GSK184858, reported by the same reporter.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were reported as follows: This case has been linked to case US2018GSK184858, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dysgeusia, Facial pain, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mononucleosis. Concurrent medical conditions included diabetes. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue. On an unknown date, the outcome of the pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced arm soreness, itching, redness, and swelling at the injection site, loss of appetite, metallic taste in mouth, and her face hurt. The patient reported that the events began to resolve after 2 days. This is 1 of the 3 linked cases reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, 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 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mononucleosis. Concurrent medical conditions included diabetes. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue. On an unknown date, the outcome of the pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced arm soreness, itching, redness, and swelling at the injection site, loss of appetite, metallic taste in mouth, and her face hurt. The patient reported that the events began to resolve after 2 days. This is 1 of the 3 linked cases reported by the same reporter.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Facial pain, Fatigue, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received the 1st dose of SHINGRIX. On 11th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling. On an unknown date, the outcome of the pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the niece of the patient. The patient received SHINGRIX on right arm. The patient experienced experienced arm soreness, itching, redness, and swelling at the injection site, loss of appetite and her face hurt. The patient reported that the events began to resolve after 2 days. This is 1 of the 3 linked cases reported by the same reporter.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, 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 83-year-old female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received the 1st dose of SHINGRIX. On 11th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling. On an unknown date, the outcome of the pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the niece of the patient. The patient received SHINGRIX on right arm. The patient experienced experienced arm soreness, itching, redness, and swelling at the injection site, loss of appetite and her face hurt. The patient reported that the events began to resolve after 2 days. This is 1 of the 3 linked cases reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (7 years ago). Previously administered products included ZOSTAVAX (received in August 2017). On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On an unknown date, the patient experienced erythematous rash. On an unknown date, the outcome of the pain and erythematous rash were unknown. It was unknown if the reporter considered the pain and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's daughter-in-law. The patient received SHINGRIX on left arm. On the same day of vaccination, the patient experienced pain. On the third day, 3 days after receiving SHINGRIX, the patient noted a rash about an inch below the site of injection. The rash was red and flat in appearance. The area itself was actually traveling downward but the area where it was to begin with was clearing up. Transfered caller to MIS. The healthcare professional had not been made aware, not asked.
Age: 62.0
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 62-year-old male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 1 days 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 provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX on right arm. The day after receiving SHINGRIX, the patient experienced arm soreness. After 1 day, the event resolved. This is 1 of the 3 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received SHINGRIX. On 2nd October 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The day before reporting the patient received SHINGRIX late afternoon and felt great. The patient woke up with a fever in the morning on the day of reporting that keeps going up. At the time of reporting, the patient's body temperature was recorded as 101.5 degrees F.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 8 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had no further information for the patient. No batch number and expiration date of product was given. The healthcare professional might be able to provide further detail once safety follows up with healthcare professional.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Headache, Influenza like illness, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 71-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a day after receiving SHINGRIX, the patient experienced tremor, headache, fever, cold sweat and influenza-like symptoms. On an unknown date, the outcome of the tremor, headache, fever, cold sweat and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the tremor, headache, fever, cold sweat and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX in left arm. The patient planned to continue follow-up with her physician on an unknown date. The patient had denied permission to contact their physician.
Age: 78.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of decreased appetite in a 78-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 6th September 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced decreased appetite, sleepiness and upset stomach. On an unknown date, the outcome of the decreased appetite, sleepiness and upset stomach were recovered/resolved. The reporter considered the decreased appetite, sleepiness and upset stomach to be related to SHINGRIX. It was unknown if the reporter considered the decreased appetite, sleepiness and upset stomach to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient reported that the next morning after receiving SHINGRIX she did not want to eat anything, her stomach was upset and she slept all day. The symptoms just lasted one full day. The reporter said that she received the flu vaccine the same day of the SHINGRIX vaccine on 5th September 2018. The reporter was relating all events to the SHINGRIX. This case has been linked with case US2018180206 reported by the same reporter.
Age: 80.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Somnolence, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 80-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent (2018-2019 season) for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 6th September 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced tremor. On 7th September 2018, the patient experienced sleepiness. On an unknown date, the outcome of the tremor and sleepiness were recovered/resolved. The reporter considered the tremor and sleepiness to be related to SHINGRIX. It was unknown if the reporter considered the tremor and sleepiness to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient experienced events the following night of having the vaccine, when he was severely shaking for about 45 minutes and he could notstop. Then 2 days after the injection, he was also sleeping most of the day. The reporter said the patient received flu vaccine the same day on 5th September 2018, when he received SHINGRIX vaccine. This case has been linked with case US2018180204 reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Hyperhidrosis, Influenza like illness, Insomnia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included acoustic neuroma (In December 2015, surgical removal of the neuroma). On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating. On an unknown date, the outcome of the influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's cousin. The patient was also a physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included acoustic neuroma (In December 2015, surgical removal of the neuroma). On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating. On an unknown date, the outcome of the influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's cousin. The patient was also a physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced muscle pain and pain localized. On an unknown date, the outcome of the muscle pain and pain localized were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and pain localized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that the patient had received the SHINGRIX vaccine on 1st October 2018 and experienced muscle pain in the area where she had received the vaccine. She also reported that the area felt sore. The pharmacist did not have lot, expiration date or the patient date of birth details.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Lethargy, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of intussusception in a 4-month-old male patient who received ROTARIX lyophilized formulation) (batch number 2J475, expiry date 14th February 2020) for prophylaxis. Co-suspect products included HIBERIX for prophylaxis, PEDIARIX for prophylaxis and PREVNAR 13 for prophylaxis. On 1st October 2018, the patient received the 2nd dose of ROTARIX lyophilized formulation (oral), HIBERIX, PEDIARIX and PREVNAR 13. On 2nd October 2018, 1 days after receiving ROTARIX lyophilized formulation, HIBERIX and PEDIARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), vomiting (serious criteria hospitalization) and lethargy (serious criteria hospitalization). On an unknown date, the outcome of the intussusception, fever, vomiting and lethargy were unknown. It was unknown if the reporter considered the intussusception, fever, vomiting and lethargy to be related to ROTARIX lyophilized formulation, HIBERIX and PEDIARIX. Additional details reported as follows: The physician initially left a voice mail on 4th October 2018 and requested a callback. The physician reported that the patient experienced intussusception, 24 hours after the second dose of ROTARIX. GlaxoSmithKline response center called back and obtained further details from nurse. Nurse reported that the mother of the patient called back the next morning after receiving ROTARIX stated that the patient had fever, felt lethargic and vomited twice. The patient came into the office on that same day and was diagnosed with intussusception.  The patient was hospitalized and had surgery. It was unknown if the reporter considered the fever,vomiting, intussusception and lethargy to be related to PREVNAR 13 as well.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Cognitive disorder, Memory impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cognitive impairment in a 58-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 3rd July 2018, the patient received the 1st dose of SHINGRIX. On 5th July 2018, 2 days after receiving SHINGRIX, the patient experienced cognitive impairment. On an unknown date, the outcome of the cognitive impairment was recovered/resolved. It was unknown if the reporter considered the cognitive impairment to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient was unable to remember numbers or do math in his head. He could normally calculate tips in his head, but he was unable to do so for about a week then his memory and math ability returned. His physician did not know if he should get the 2nd dose of SHINGRIX or not.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported for herself. The age at vaccination was not provided. The pharmacist reported that she developed arm soreness in the arm where she had received the SHINGRIX vaccine. The pharmacist described her arm as super sore.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This case was reported by a pharmacist 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 the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that her patient had rash and swelling following the first dose of SHINGRIX that lasted approximately 1 week. The pharmacist was unable to provide lot nmber and expiry date as the shot was given at a different facility.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Confusional state, Disorientation, Fatigue
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of thinking reduced in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced thinking reduced (serious criteria GSK medically significant), headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability. On an unknown date, the outcome of the thinking reduced, headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability were recovered/resolved. It was unknown if the reporter considered the thinking reduced, headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability to be related to SHINGRIX. Additional details reported as follows:  Few days after receiving SHINGRIX, the patient experienced confusion, disorientation and inability to think for an unknown duration. Less than a year after receiving SHINGRIX, the patient experienced a constant headache, joint aches, and overall tiredness that lasted for one month. Also, the patient had weakness for an unknown duration, and a stiff neck for several weeks.The patient missed ten days of work. The field representative was unable to provide additional information.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Mental impairment, Musculoskeletal stiffness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of thinking reduced in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced thinking reduced (serious criteria GSK medically significant), headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability. On an unknown date, the outcome of the thinking reduced, headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability were recovered/resolved. It was unknown if the reporter considered the thinking reduced, headache, tiredness, weakness, confusion, disorientation, joint pain, stiff neck and impaired work ability to be related to SHINGRIX. Additional details reported as follows:  Few days after receiving SHINGRIX, the patient experienced confusion, disorientation and inability to think for an unknown duration. Less than a year after receiving SHINGRIX, the patient experienced a constant headache, joint aches, and overall tiredness that lasted for one month. Also, the patient had weakness for an unknown duration, and a stiff neck for several weeks.The patient missed ten days of work. The field representative was unable to provide additional information.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Rash vesicular, Skin burning sensation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 54-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced vesicular rash, burning skin and pruritus. On an unknown date, the outcome of the vesicular rash was recovering/resolving and the outcome of the burning skin and pruritus were recovered/resolved. It was unknown if the reporter considered the vesicular rash, burning skin and pruritus to be related to SHINGRIX. Additional details were reported as follows: The reporter was patient. The patient received the SHINGRIX in the first week of September. In 2018, a few days after she started getting little dots on her skin that were spread out and were itchy. They look like chickenpox and they look viral. The patient developed them on her right side, which was opposite to where she got the SHINGRIX vaccine. The patient had them on her upper arm, lower arm, hand, upper leg and lower leg. The patient also said that the dots on her leg were burning when they came out. At the reporting time, the dots did not itch anymore but she still had them and she could see them. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 1st October 2018, the patient received SHINGRIX .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced injection site burning and burning sensation. On an unknown date, the outcome of the injection site burning and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the injection site burning and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced burning at the injection site a couple days after getting SHINGRIX. The burning had spread throughout her shoulder and into her neck.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Injection site swelling, Pruritus generalised, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of generalized pruritus in a 9-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 4DY9K, expiry date 7th June 2019) for prophylaxis. On 18th September 2018, the patient received FLULAVAL QUADRIVALENT. In September 2018, less than a week after receiving FLULAVAL QUADRIVALENT, the patient experienced generalized pruritus, injection site swelling, injection site tenderness, erythema and welts. The patient was treated with MOTRIN. On an unknown date, the outcome of the generalized pruritus, injection site swelling, injection site tenderness, erythema and welts were recovered/resolved. It was unknown if the reporter considered the generalized pruritus, injection site swelling, injection site tenderness, erythema and welts to be related to FLULAVAL QUADRIVALENT. Additional details reported as follows: The patient never had any breathing difficulties. After receiving FLULAVAL QUADRIVALENT, the patient woke up and the site where the vaccine was given swelled up in the morning (further unspecified). The nurse gave her some MOTRIN because it was tender. The patient went to school and was informed by nurse that she was itchy all over. The patient's mother sent a photo and there was a 2-3 inches area of redness with a circle of welts around the outside edge. It was resolved by the next day. The reporter agreed for follow up contact. This case has been linked with case US2018GSK173210 and US2018GSK176895 reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse event in a adult patient who received FLULAVAL QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLULAVAL QUADRIVALENT. Additional details reported as follows: The age at vaccination was not reported. The patient complained (unspecified reaction) after vaccination with FLULAVAL QUADRIVALENT. This case has been linked with case US2018GSK173210 and US2018GSK173218, reported by same reporter.
Age: 60.0
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 60-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 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 patient experienced soreness at the injection site for a few days. The reporter gave permission for her physician to be contacted. For tolerance to 2nd dose refer linked case US2018178369.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hair loss in a 84-year-old patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not reported. It was unknown if the reporter considered the hair loss to be related to SHINGRIX. Additional details were reported as follows: This case was reported via click to chat. The reporter work at a clinic and a patient just reported to her receiving SHINGRIX vaccine one week before the reporting date and at the time of reporting her hair was falling out. The reporter was asking that was this a common side effect.