chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received on 25-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In or around October 2015, the patient received the ZOSTAVAX (lot number and expiration unknown) unknown route for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered an outbreak of painful shingles. The patient suffered multiple more outbreaks of shingles since October 2015 to the time of this filing. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX.  Shingles was considered to be disabling.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-OCT-2018 or 22-OCT-2018 the patient was vaccinated with improperly stored VARIVAX (lot # N029628 and expiration date 23-NOV-2019, route, strength, dose and frequency were not reported) for prophylaxis. Medical assistant also reported the MERCK STERILE DILUENT (lot # M041989 and expiration date 03-JUL-2019) used to reconstitute VARIVAX did not undergo a temperature excursion. No adverse effects were reported. The temperature excursion was 6 Fahrenheit to 14 Fahrenheit (also reported as 12 Fahrenheit) for 1 hour and 59 minutes. The previous excursion was 6 Fahrenheit to 14 Fahrenheit for 47 hours and 57 minutes and 15 Fahrenheit to 46 Fahrenheit for 39 hours and 57 minutes. The call was because of a data logger. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA010189: US-009507513-1810USA012249.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), on or about late 2016, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date, shortly after receiving the ZOSTAVAX, the patient developed a painful rash. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from the shingles. The onset of the event is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 25-OCT-2018, the patient was vaccinated with an improperly stored doses of PROQUAD per subcutaneous route (dose was not provided) lot # R002932 expiration date 29-JUL-2018, for prophylaxis. On an unknown date, digital data logger registered a temperature excursion for 15 Fahrenheit degrees to 46 Fahrenheit degrees, for 1 hour.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # R006216 for prophylaxis. On an unknown date the patient experienced product storage error and no adverse event. The outcome of product storage error and no adverse event is unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # R006754 for prophylaxis. On an unknown date the patient experienced product storage error and no adverse event. The outcome of product storage error and no adverse event is unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were no provided. The reporter stated that 26-OCT-2018, the patient received an expired dose of VAQTA, lot # N020689, expiration date: 22-OCT-2018, intramuscular, for prophylaxis, (dosage, frequency and strength were no provided). There were no adverse events reported.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Dizziness, Nasal congestion, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory tract congestion in a 49-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. Previously administered products included INFLUENZA VACCINE with an associated reaction of respiratory tract congestion (received in 2017, for adverse event refer case US2018GSK196442). Concurrent medical conditions included drug allergy (thimerosal). On 17th September 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In September 2018, 5 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever. Rechallenge with FLULAVAL QUADRIVALENT 2018-2019 season was positive. On an unknown date, the outcome of the respiratory tract congestion, cough and nasal congestion were not recovered/not resolved and the outcome of the dizziness, chills, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QIV and it was a prefilled syringe. The patient experienced chest congestion. The patient had denied permission to contact their physician.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory tract congestion in a 49-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. Previously administered products included INFLUENZA VACCINE with an associated reaction of respiratory tract congestion (received in 2017, for adverse event refer case US2018GSK196442). Concurrent medical conditions included drug allergy (thimerosal). On 17th September 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In September 2018, 5 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever. Rechallenge with FLULAVAL QUADRIVALENT 2018-2019 season was positive. On an unknown date, the outcome of the respiratory tract congestion, cough and nasal congestion were not recovered/not resolved and the outcome of the dizziness, chills, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QIV and it was a prefilled syringe. The patient experienced chest congestion. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shivers in a adult 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 shivers. On an unknown date, the outcome of the shivers was recovered/resolved. It was unknown if the reporter considered the shivers to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. After receiving SHINGRIX, the patient experienced shivers for a day.  The pharmacist reported that she did not report this as an adverse event due to shivers being one of the known side effects. No other information of patient was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. The patient's past medical history included fibromyalgia.  On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site lump and injection site induration. On 17th October 2018, the patient experienced injection site pain, injection site warmth, fever, general body pain, headache, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site warmth, injection site lump, general body pain, injection site erythema, injection site swelling and injection site induration were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, fever, injection site lump, general body pain, headache, injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination not reported, but it could be 50 or 51 years. The healthcare professional (HCP) reported that the patient developed pain, redness, hotness to touch, swelling, and a hard lump at the injection site, body aches and pains, headache and a low grade temperature after her a dose of SHINGRIX. Injection site reaction was about 8 cm across. The HCP did not want to provide exact date of birth or initials of patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. The patient's past medical history included fibromyalgia.  On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site lump and injection site induration. On 17th October 2018, the patient experienced injection site pain, injection site warmth, fever, general body pain, headache, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site warmth, injection site lump, general body pain, injection site erythema, injection site swelling and injection site induration were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, fever, injection site lump, general body pain, headache, injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination not reported, but it could be 50 or 51 years. The healthcare professional (HCP) reported that the patient developed pain, redness, hotness to touch, swelling, and a hard lump at the injection site, body aches and pains, headache and a low grade temperature after her a dose of SHINGRIX. Injection site reaction was about 8 cm across. The HCP did not want to provide exact date of birth or initials of patient.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This was reported previously to manufacturer. The age at the vaccination was not reported. The pharmacist reported to field representative the day before reporting that the patient relative of his recently received the SHINGRIX vaccine and developed flu-like symptoms that lasted for 2 to 3 days.  It was unknown what number in the series it was or the exact date of the adverse event. No Product Quality Complaint (PQC) was filed.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information received as follows: This was reported previously to manufacturer. The age at vaccination was not reported. The pharmacist reported to the Field Representative the day before reporting that the patient who was relative of hers recently received the SHINGRIX vaccine and developed flu-like symptoms that lasted 2 to 3 days. It was unknown what vaccine in the series it was or the exact date of the adverse event. No Product Quality Complaint (PQC) was filed.
Sex: U
Vaccine: FLU4
Symptoms: Blood pressure increased, Dyspnoea, Headache, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number Y79A5, expiry date unknown) for prophylaxis. On 19th October 2018, the patient received FLULAVAL QUADRIVALENT2018-2019 season .5 ml. On 19th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT2018-2019 season, the patient experienced shortness of breath, increased blood pressure, hives and headache. On an unknown date, the outcome of the shortness of breath, increased blood pressure, hives and headache were unknown. It was unknown if the reporter considered the shortness of breath, increased blood pressure, hives and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced some side effects like shortness of breath, headache, elevated blood pressure and hives. The patient was sent to the emergency room. This is 1 of the 12 linked cases, reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, 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 70-year-old male patient who received SHINGRIX for prophylaxis. On 6th October 2018, the patient received SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's spouse.  The arm where the patient got the injection was sore.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever, muscle pain, weakness and headache. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, weakness and headache were unknown. It was unknown if the reporter considered the fever, muscle pain, weakness and headache to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, the fever was went as high as 103.5 degrees F.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Gait disturbance
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever, muscle pain, weakness and headache. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, weakness and headache were unknown. It was unknown if the reporter considered the fever, muscle pain, weakness and headache to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, the fever was went as high as 103.5 degrees F.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever, muscle pain, weakness and headache. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, weakness and headache were unknown. It was unknown if the reporter considered the fever, muscle pain, weakness and headache to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, the fever was went as high as 103.5 degrees F.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever, muscle pain, weakness and headache. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, weakness and headache were unknown. It was unknown if the reporter considered the fever, muscle pain, weakness and headache to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, the fever was went as high as 103.5 degrees F.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms, Tonic clonic movements
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tonic clonic movements in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tonic clonic movements (serious criteria GSK medically significant). On an unknown date, the outcome of the tonic clonic movements was unknown. It was unknown if the reporter considered the tonic clonic movements to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The nurse reported patient had tonic-clonic spasms in the arms and legs after receiving the SHINGRIX vaccine. The health care professional did not have vaccine or patient information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of adverse event (experienced after receiving 1st dose, refer linked case US2018GSK195620). In October 2018, the patient received the 2nd dose of Shingrix. In October 2018, 1 day 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: This case was reported by an Office Manager. The age at vaccination was not reported. Last Thursday before the date of reporting, the patient received Shingrix. On Friday after receiving Shingrix, the patient did not have any of the symptoms that she had the last time other than her arm hurt. The reporter agreed to receive follow up. This case has been linked with the case US2018GSK111832, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced Shingrix reaction that included arm swollen and redness for a period of 4 to 5 days, then the shape changed and it lasted for another 4 to 5 days. The reporter had agreed to follow up with GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event 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, less than a year after receiving Shingrix, 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 Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that the patient received shingles shot, and experienced severe side effects and said that no one in the pharmacy told him /her about. The patient want to talk someone. The patient received severe side effects after the both doses for tolerance of 2nd dose refer case US2018GSK194783.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received SHINGRIX 2 weeks before the date of reporting to other manufacturer. The patient experienced unspecified flu like symptoms. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of confusion in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced confusion. On an unknown date, the outcome of the confusion was unknown. It was unknown if the reporter considered the confusion to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced confusion, hours after receiving a dose of SHINGRIX and she did not find this adverse event as a listed. This was a common side effect. The patient asked if confusion was also a side effect not listed.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of varicella-like rash in a elderly patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Parkinson's disease. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced varicella-like rash and blister. On an unknown date, the outcome of the varicella-like rash and blister were unknown. It was unknown if the reporter considered the varicella-like rash and blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had advanced Parkinson's disease. Five months before the date of reporting, the patient received SHINGRIX in the arm. The patient's wife noted that few days later that lower down on his arm, he developed pox like blisters in a semicircular arc small blisters about size of drop of water in a linear ring like arc a few inches below the injection site. The reporter asked whether the patient could get booster dose at the time of reporting or this reaction was contraindication.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, tiredness and feeling abnormal. On an unknown date, the outcome of the muscle pain, tiredness and feeling abnormal were recovered/resolved. It was unknown if the reporter considered the muscle pain, tiredness and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked if he experienced the side effects of the SHINGRIX shot, was there any concern about being around his grandchildren or pregnant daughter who did not have chicken pox. The patient reported that his side effects were not any different then what was listed on GlaxoSmithKline's website. The patient experienced muscle pain, tired and just not real ambitious feeling. The patient did not receive the second shot till the of reporting. The patient agreed to be contacted to their physician for follow up and provided the contact details for the same.
Sex: U
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a patient who received FLUARIX QUADRIVALENT for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT. On 18th October 2018, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced vomiting, nausea and diarrhea. On an unknown date, the outcome of the vomiting, nausea and diarrhea were unknown. It was unknown if the reporter considered the vomiting, nausea and diarrhea to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The reporter was reached out to by their medical director because they had a patient presented the day before reporting within 1 hour of receiving the vaccine with what was considered grade 3 gastrointestinal symptoms (vomiting, nausea and diarrhea). This typically was not a side effect they had seen with flu vaccine, but they realized it was listed. This case was linked to the case US2018GSK192197, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a patient who received FLUARIX QUADRIVALENT for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT. On 18th October 2018, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced vomiting, nausea and diarrhea. On an unknown date, the outcome of the vomiting, nausea and diarrhea were unknown. It was unknown if the reporter considered the vomiting, nausea and diarrhea to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The reporter was reached out to by their medical director because they had a patient presented the day before reporting within 1 hour of receiving the vaccine with what was considered grade 3 gastrointestinal symptoms (vomiting, nausea and diarrhea). This typically was not a side effect they had seen with flu vaccine, but they realized it was listed. This case was linked with the case US2018GSK192188, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Skin sensitisation, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 63-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had some 40 years before the time of reporting). On 16th October 2018, the patient received the 1st dose of SHINGRIX. On 18th October 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash, skin warm and skin sensitization. On an unknown date, the outcome of the injection site rash and skin sensitization were unknown and the outcome of the skin warm was recovering/resolving. It was unknown if the reporter considered the injection site rash, skin warm and skin sensitization to be related to SHINGRIX. Additional details were reported as follows. On Tuesday 16th October 2018, the patient received a dose of SHINGRIX on the upper left arm. On Thursday morning 18th October 2018, the patient experienced a rash of sorts starting at the injection site, extending 4 to 6 inches down his left arm and moving towards the front (bicep area). The area was sensitive but not nearly as sensitive to touch. On Thursday evening, the rash area seemed warm to the touch, but at the time of reporting not as warm. The patient was measured temperature of the rash area and it was 93.2 degrees F, while adjacent skin was 88 degrees F. On Thursday the rash was warmer than at the time of reporting. The patient was plan to contact his health care provider on 21st October 2018, but the patient wanted to submit this report and seeking any input from GlaxoSmithKline. The patient was agreed for email and call at any time, if needed.
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Vaccination complication
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of chest tightness in a adult female patient who received Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included FLOVENT HFA (220 mcg per spray, was started taking the product more than 10 years). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness was unknown. It was unknown if the reporter considered the chest tightness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. This case was reported by a consumer via vaccine patient support programs. The patient had chest tightness due to reaction to flu shot. The caller had been informed that they had reported an experience with a GlaxoSmithKline product that needs to be shared with GlaxoSmithKline. The reporter had agreed to had GlaxoSmithKline safety team follow-up with them via postal mail. This event did not include the product complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site rash and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site rash and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site rash and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain, redness, swelling, rash, and heat at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date for tolerance refer case US2018GSK189845). 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 adverse event. Rechallenge with SHINGRIX was positive. 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 SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that the patient received shingles shot, and experienced severe side effects and said that no one in the pharmacy told him /her about.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Injection site bruising
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 18th June 2018, refer case US2018GSK111832). On 11th October 2018, the patient received the 2nd dose of SHINGRIX. On 12th October 2018, 1 days after receiving SHINGRIX, the patient experienced lightheadedness, injection site pain, injection site bruising, nausea, headache and appetite absent. In October 2018, the patient experienced chills and unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, lightheadedness, injection site pain, injection site bruising, nausea, headache and appetite absent were not recovered/not resolved and the outcome of the unwell was unknown. It was unknown if the reporter considered the chills, lightheadedness, injection site pain, injection site bruising, nausea, headache, appetite absent and unwell to be related to SHINGRIX. Additional details were reported as follows: This case was reported by an office manager. The age at vaccination was not reported. In October 2018, less than a day after vaccination the patient experienced cold chills beginning at 2 am Friday morning. The cold chills lasted through the night until about 6 am. When the patient got up on Friday morning at 6:30 am the patient was lightheaded, the patient's arm was painful at the injection site and it was bruised. Through the day on Friday, the patient felt like the patient was nauseated and had a bad headache. The patient had no appetite, took a long nap and went to bed early. The chills lasted on and off until Saturday morning. The headache lasted until Sunday morning. The patient didn't feel well until Sunday. The patient was feeling good as she did not have to have another dose of SHINGRIX. The patient stated that the received doses were not fun. The patient told her sister each time about her own experience, as she was 65 and would like to also have the vaccine. But she said the patient was not a walking advertisement for getting the injection and although she was having second thoughts, she still wanted to go forward with it. This case has been linked with US2018GSK195620, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 18th June 2018, refer case US2018GSK111832). On 11th October 2018, the patient received the 2nd dose of SHINGRIX. On 12th October 2018, 1 days after receiving SHINGRIX, the patient experienced lightheadedness, injection site pain, injection site bruising, nausea, headache and appetite absent. In October 2018, the patient experienced chills and unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, lightheadedness, injection site pain, injection site bruising, nausea, headache and appetite absent were not recovered/not resolved and the outcome of the unwell was unknown. It was unknown if the reporter considered the chills, lightheadedness, injection site pain, injection site bruising, nausea, headache, appetite absent and unwell to be related to SHINGRIX. Additional details were reported as follows: This case was reported by an office manager. The age at vaccination was not reported. In October 2018, less than a day after vaccination the patient experienced cold chills beginning at 2 am Friday morning. The cold chills lasted through the night until about 6 am. When the patient got up on Friday morning at 6:30 am the patient was lightheaded, the patient's arm was painful at the injection site and it was bruised. Through the day on Friday, the patient felt like the patient was nauseated and had a bad headache. The patient had no appetite, took a long nap and went to bed early. The chills lasted on and off until Saturday morning. The headache lasted until Sunday morning. The patient didn't feel well until Sunday. The patient was feeling good as she did not have to have another dose of SHINGRIX. The patient stated that the received doses were not fun. The patient told her sister each time about her own experience, as she was 65 and would like to also have the vaccine. But she said the patient was not a walking advertisement for getting the injection and although she was having second thoughts, she still wanted to go forward with it. This case has been linked with US2018GSK195620, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse event in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced 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 SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case has been linked with US2018GSK195619 and US2018GSK111832, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of general body pain in a adult female patient who received SHINGRIX (batch number EH9Z7, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance to the 1st dose refer case US2018158666). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced general body pain, nausea and pain in arm. The patient was treated with CORICIDIN HBP (Nos). On an unknown date, the outcome of the general body pain, nausea and pain in arm were unknown. It was unknown if the reporter considered the general body pain, nausea and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. One hour before shot 2nd dose of SHINGRIX and 4 hours after shot, the patient received CORICIDIN HBP. Next morning, the patient experienced slight body aches, slight nausea and arm soreness. It was not really as bad as 1st shot of SHINGRIX. The reporter provided the details of the physician who was most familiar with the reported event and consent to contact the physician.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Dizziness, Loss of consciousness, Nasal congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Flu Seasonal QIV Dresden for prophylaxis. Concurrent medical conditions included drug allergy (thimerosal). On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced loss of consciousness (serious criteria GSK medically significant), respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever. On an unknown date, the outcome of the loss of consciousness, respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever were recovered/resolved. It was unknown if the reporter considered the loss of consciousness, respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: Last year in 2017, the patient had flu vaccine. She did not know the brand name. The patient said that she experienced similar symptoms to what she experienced in the reporting year (refer case US2018188513).  The patient experienced chest congestion. The patient was knocked out for about 2 to 3 weeks after receiving flu vaccine. The patient had denied permission to contact their physician.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Flu Seasonal QIV Dresden for prophylaxis. Concurrent medical conditions included drug allergy (thimerosal). On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced loss of consciousness (serious criteria GSK medically significant), respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever. On an unknown date, the outcome of the loss of consciousness, respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever were recovered/resolved. It was unknown if the reporter considered the loss of consciousness, respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: Last year in 2017, the patient had flu vaccine. She did not know the brand name. The patient said that she experienced similar symptoms to what she experienced in the reporting year (refer case US2018188513).  The patient experienced chest congestion. The patient was knocked out for about 2 to 3 weeks after receiving flu vaccine. The patient had denied permission to contact their physician.