chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood cholesterol increased, Blood creatinine increased, Glomerular filtration rate increased, Inflammation, Inflammatory marker increased
Clinical narrative: This spontaneous report was received from a 66 year old consumer regarding herself. The patient's current conditions included unspecified kidney disease, Sjogren's syndrome, chronic anemia and vacuities. The patient was allergic to AUGMENTIN, bacitracin, neomycin and PLAQUENIL. Information on concomitant therapies was not reported. On 18-SEP-2018, the patient was vaccinated with 2nd dose of pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown)) in the upper left arm via intramuscular route for prevention of pneumococcal disease (dose, lot#, expiry date not reported). The patient received 1st dose of pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown)) 4-5 years ago without any adverse reaction. On 18-SEP-2018, the patient underwent routine blood work due to pre-existing kidney disease. The patient's inflammation, cholesterol, creatinine, protein, and glomerular filtration rate (GFR) were all higher than previous results (also reported as "numbers were all worse"). On 23-SEP-2018, the patient experienced inflammation, glomerular filtration rate increased, protein total abnormal, blood creatinine increased and blood cholesterol increased. On 23-SEP-2018 the patient experienced swelling, itchiness, and "mild discomfort" at the injection site, as well as an area of redness at injection site "5 inches by 3 inches" in size. The patient called a nurse and sought advice. On an unknown date in October 2018 (also reported as 2 weeks later), the patient recovered from all the events without any treatment. Causality assessment was unknown. She also reported that she knew some other patient who had the same injection site reaction after receiving a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown)) (MARRS# 1810USA006811). No product quality complaint associated with this report. This is one of the 2 reports from the same reporter. Sender's Comments: US-009507513-1810USA006811.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Protein total abnormal
Clinical narrative: This spontaneous report was received from a 66 year old consumer regarding herself. The patient's current conditions included unspecified kidney disease, Sjogren's syndrome, chronic anemia and vacuities. The patient was allergic to AUGMENTIN, bacitracin, neomycin and PLAQUENIL. Information on concomitant therapies was not reported. On 18-SEP-2018, the patient was vaccinated with 2nd dose of pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown)) in the upper left arm via intramuscular route for prevention of pneumococcal disease (dose, lot#, expiry date not reported). The patient received 1st dose of pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown)) 4-5 years ago without any adverse reaction. On 18-SEP-2018, the patient underwent routine blood work due to pre-existing kidney disease. The patient's inflammation, cholesterol, creatinine, protein, and glomerular filtration rate (GFR) were all higher than previous results (also reported as "numbers were all worse"). On 23-SEP-2018, the patient experienced inflammation, glomerular filtration rate increased, protein total abnormal, blood creatinine increased and blood cholesterol increased. On 23-SEP-2018 the patient experienced swelling, itchiness, and "mild discomfort" at the injection site, as well as an area of redness at injection site "5 inches by 3 inches" in size. The patient called a nurse and sought advice. On an unknown date in October 2018 (also reported as 2 weeks later), the patient recovered from all the events without any treatment. Causality assessment was unknown. She also reported that she knew some other patient who had the same injection site reaction after receiving a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown)) (MARRS# 1810USA006811). No product quality complaint associated with this report. This is one of the 2 reports from the same reporter. Sender's Comments: US-009507513-1810USA006811.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Blindness unilateral, Dizziness, Headache, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male 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 2017, 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 ZOSTAVAX, the patient developed a painful rash, headaches, nausea, dizziness, and balance issues. The patient then began to experience a loss in vision in one eye and a significant decrease in vision in the other. In response to these complaints, on an unknown date, the patient presented to his primary care physician and specialists, and was ultimately diagnosed with postherpetic neuralgia and macular degeneration. The outcome of the events 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. Upon internal review, macular degeneration was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Macular degeneration, Nausea, Post herpetic neuralgia, Rash, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male 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 2017, 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 ZOSTAVAX, the patient developed a painful rash, headaches, nausea, dizziness, and balance issues. The patient then began to experience a loss in vision in one eye and a significant decrease in vision in the other. In response to these complaints, on an unknown date, the patient presented to his primary care physician and specialists, and was ultimately diagnosed with postherpetic neuralgia and macular degeneration. The outcome of the events 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. Upon internal review, macular degeneration was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 31-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-SEP-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 02-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-SEP-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number EF4Z9, expiry date 22nd June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (subcutaneous) .5 ml. On 1st October 2018, unknown after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced intramuscular formulation administered by other route. On 2nd October 2018, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that her co-worker was inadvertently administered FLULAVAL QUADRIVALENT 2018-2019 season subcutaneously instead of the indicated intramuscular route, which led to inappropriate route of vaccination. The HCP stated that the patient had redness, swelling, and tenderness at the injection site on the date of reporting, one day later. The HCP did not provide the patient information for this adverse event but did provide the lot number and expiry date for the adverse. This case is 1 of 15 cases, reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Diarrhoea, Dizziness, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On 26th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 27th September 2018, 1 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue. On an unknown date, the outcome of the fever, dehydration, lightheadedness, muscle pain and fatigue were not recovered/not resolved and the outcome of the nausea, vomiting and diarrhea were recovered/resolved. It was unknown if the reporter considered the fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The patient reported that he had contacted his physician, but had not seen by his physician.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On 26th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 27th September 2018, 1 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue. On an unknown date, the outcome of the fever, dehydration, lightheadedness, muscle pain and fatigue were not recovered/not resolved and the outcome of the nausea, vomiting and diarrhea were recovered/resolved. It was unknown if the reporter considered the fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The patient reported that he had contacted his physician, but had not seen by his physician.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, rash and injection site swelling. On an unknown date, the outcome of the injection site erythema, rash and injection site swelling were not reported. It was unknown if the reporter considered the injection site erythema, rash and injection site swelling to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The batch number and expiry date was not reported. The patient had swelling and redness at the injection site after receipt of FLUARIX, also a rash on her abdomen and trunk. The reporter did not have any patient information, did not receive any other vaccines the day of FLUARIX administration. The reporter would report the VAERS when she had all the information. The adverse event was collected via chat.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Ear pruritus, Eye pain, Eye pruritus, Gait inability
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of dysgeusia in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. Concurrent medical conditions included temporomandibular joint syndrome, macular degeneration and bursitis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, immediately after receiving SHINGRIX, the patient experienced dysgeusia. In September 2018, the patient experienced eye pruritus, ear pruritus, pruritus facial, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk. On an unknown date, the patient experienced muscle pain and throat tightness. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the dysgeusia, swollen joints, periorbital pain and unable to walk were recovered/resolved and the outcome of the eye pruritus, ear pruritus, pruritus facial, throat tightness, itchy rash and generalized pruritus were not recovered/not resolved and the outcome of the muscle pain was unknown and the outcome of the general body pain was recovering/resolving. It was unknown if the reporter considered the dysgeusia, eye pruritus, ear pruritus, pruritus facial, muscle pain, throat tightness, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Shortly after receiving SHINGRIX, the patient experienced a bad taste in her mouth. The patient later felt pain around her eyes, but thought it was due to allergies and/or temporomandibular joint syndrome (TMJ) and the pain would come and go. A few days after the receiving SHINGRIX, the patient noticed itching in her eyes, ears, chin and neck. She also had pains all over her body, but she had a history of fibromyalgia. About 1.5-2 weeks after the receiving SHINGRIX, the patient noticed 6 spots on her leg that she thought were bites at first that itched. The itching then went all over her body, so she thought those spots were a rash instead. The patient had an incident where the joint around her big toe suddenly swelled up and became so painful that she could not walk. Those were resolved at the reporting time. The itching and the rash have persisted and the patient started a Medrol pack day before reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Myalgia, Pain, Pruritus, Pruritus generalised
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of dysgeusia in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. Concurrent medical conditions included temporomandibular joint syndrome, macular degeneration and bursitis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, immediately after receiving SHINGRIX, the patient experienced dysgeusia. In September 2018, the patient experienced eye pruritus, ear pruritus, pruritus facial, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk. On an unknown date, the patient experienced muscle pain and throat tightness. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the dysgeusia, swollen joints, periorbital pain and unable to walk were recovered/resolved and the outcome of the eye pruritus, ear pruritus, pruritus facial, throat tightness, itchy rash and generalized pruritus were not recovered/not resolved and the outcome of the muscle pain was unknown and the outcome of the general body pain was recovering/resolving. It was unknown if the reporter considered the dysgeusia, eye pruritus, ear pruritus, pruritus facial, muscle pain, throat tightness, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Shortly after receiving SHINGRIX, the patient experienced a bad taste in her mouth. The patient later felt pain around her eyes, but thought it was due to allergies and/or temporomandibular joint syndrome (TMJ) and the pain would come and go. A few days after the receiving SHINGRIX, the patient noticed itching in her eyes, ears, chin and neck. She also had pains all over her body, but she had a history of fibromyalgia. About 1.5-2 weeks after the receiving SHINGRIX, the patient noticed 6 spots on her leg that she thought were bites at first that itched. The itching then went all over her body, so she thought those spots were a rash instead. The patient had an incident where the joint around her big toe suddenly swelled up and became so painful that she could not walk. Those were resolved at the reporting time. The itching and the rash have persisted and the patient started a Medrol pack day before reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Throat tightness
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of dysgeusia in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. Concurrent medical conditions included temporomandibular joint syndrome, macular degeneration and bursitis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, immediately after receiving SHINGRIX, the patient experienced dysgeusia. In September 2018, the patient experienced eye pruritus, ear pruritus, pruritus facial, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk. On an unknown date, the patient experienced muscle pain and throat tightness. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the dysgeusia, swollen joints, periorbital pain and unable to walk were recovered/resolved and the outcome of the eye pruritus, ear pruritus, pruritus facial, throat tightness, itchy rash and generalized pruritus were not recovered/not resolved and the outcome of the muscle pain was unknown and the outcome of the general body pain was recovering/resolving. It was unknown if the reporter considered the dysgeusia, eye pruritus, ear pruritus, pruritus facial, muscle pain, throat tightness, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Shortly after receiving SHINGRIX, the patient experienced a bad taste in her mouth. The patient later felt pain around her eyes, but thought it was due to allergies and/or temporomandibular joint syndrome (TMJ) and the pain would come and go. A few days after the receiving SHINGRIX, the patient noticed itching in her eyes, ears, chin and neck. She also had pains all over her body, but she had a history of fibromyalgia. About 1.5-2 weeks after the receiving SHINGRIX, the patient noticed 6 spots on her leg that she thought were bites at first that itched. The itching then went all over her body, so she thought those spots were a rash instead. The patient had an incident where the joint around her big toe suddenly swelled up and became so painful that she could not walk. Those were resolved at the reporting time. The itching and the rash have persisted and the patient started a Medrol pack day before reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and Flu vaccine with an associated reaction of influenza.  In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the erythema of extremities, shingles and swelling arm were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, shingles, swelling arm and pain in arm to be related to SHINGRIX. Additional information was received as follows: This was reported previously to the doctor. The patient received SHINGRIX on the left arm. The patient stated that at the beginning of August 2018, she received the 1st dose of SHINGRIX. The patient stated that later that same evening of vaccination day, she experienced redness and swelling in her left arm. At the injection site, there was red dot that was the size of a thumbtack. Approximately 3 inches below the injection site, there was an oval-shaped reddened area that was swollen and the size of the red, swollen area was approximately 1.5 inches long and 2.5 inches wide. There was a straight line connecting the injection site to the red, swollen area that was 3 inches below the injection site. The patient stated that her left arm got sore every once in a while. The patient stated that she had a case of the shingles a couple of weeks before the reporting date, and it was one spot on her neck. The patient did not wish to provide her physical address.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and Flu vaccine with an associated reaction of influenza.  In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the erythema of extremities, shingles and swelling arm were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, shingles, swelling arm and pain in arm to be related to SHINGRIX. Additional information was received as follows: This was reported previously to the doctor. The patient received SHINGRIX on the left arm. The patient stated that at the beginning of August 2018, she received the 1st dose of SHINGRIX. The patient stated that later that same evening of vaccination day, she experienced redness and swelling in her left arm. At the injection site, there was red dot that was the size of a thumbtack. Approximately 3 inches below the injection site, there was an oval-shaped reddened area that was swollen and the size of the red, swollen area was approximately 1.5 inches long and 2.5 inches wide. There was a straight line connecting the injection site to the red, swollen area that was 3 inches below the injection site. The patient stated that her left arm got sore every once in a while. The patient stated that she had a case of the shingles a couple of weeks before the reporting date, and it was one spot on her neck. The patient did not wish to provide her physical address.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. Concomitant products included FLUZONE VACCINE. On 3rd October 2018, the patient received SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.  It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional information was reported as follows: The patient experienced fever and chills at night following administration of SHINGRIX and FLUZONE QIV concomitantly.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bone pain, Diarrhoea, Dizziness, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, diarrhea, dizziness, upset stomach, injection site pain, general body pain and bone pain. On 26th September 2018, the outcome of the dizziness, general body pain and bone pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the diarrhea and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, diarrhea, dizziness, upset stomach, injection site pain, general body pain and bone pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the arm. The next day she had redness and pain at the injection site. Every bone in her body hurt, she felt dizzy and she had an upset stomach and diarrhea. She spent the day in bed. By that evening the body aches and dizziness were resolved. The redness resolved after about one week and the pain a little after that.  She has continued to have an upset stomach and diarrhea since getting the injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, diarrhea, dizziness, upset stomach, injection site pain, general body pain and bone pain. On 26th September 2018, the outcome of the dizziness, general body pain and bone pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the diarrhea and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, diarrhea, dizziness, upset stomach, injection site pain, general body pain and bone pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the arm. The next day she had redness and pain at the injection site. Every bone in her body hurt, she felt dizzy and she had an upset stomach and diarrhea. She spent the day in bed. By that evening the body aches and dizziness were resolved. The redness resolved after about one week and the pain a little after that.  She has continued to have an upset stomach and diarrhea since getting the injection.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) 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 itching and injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site itching and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 69 or 70 year. The healthcare professional (HCP)reported that following a dose of SHINGRIX, the patient experienced a sore arm, redness and some itching at the injection site. Within 2 days, the intensity of all event were decreasing.