chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JUL-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-SEP-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, the patient was inoculated with ZOSTAVAX at a physician's office by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-May-2016, the patient was treated at Community Hospital Oncology Physician's Network by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
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. On an unknown date in 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-JUL-2016, the patient was treated for a vesicular outbreak, accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A female patient, age unspecified, was inoculated with ZOSTAVAX on 11-MAR-2008 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. In 2010 the patient was treated at a hospital for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A male patient, age unspecified, was inoculated with ZOSTAVAX on 10-DEC-2008 at a medical center as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. On or about 20-NOV-2014  the patient was treated by a physician at a medical center for a blistering vesicular outbreak which was then diagnosed as shingles. The patient was treated with acyclovoir, lidocaine, and gabapentin for management of his painful symptoms and excruciating pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2013, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2013, the patient was treated at urgent care center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. In 2013, the patient was treated at the same medical office for a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-OCT-2009, the patient was inoculated with the ZOSTAVAX vaccine at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 04-AUG-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 06-FEB-2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX and betamethasone dipropionate for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a medical center (considered a hospital) as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at the same medical center (not specified whether admitted; considered Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-JAN-2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 12-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2014, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-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 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2014, the patient was treated at a health center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine at pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-MAY-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, 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 received the ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 15-APR-2017 for its intended purpose: the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately April 2017 [reported as within 30 days of receiving ZOSTAVAX], the patient developed and was diagnosed with facial paralysis. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. Upon internal review, facial paralysis was determined to be medically significant. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster, and facial paralysis were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history and drug reactions or allergies was provided. On 10-JUL-2018, the patient was vaccinated with a dose of improperly stored VARIVAX lot # N031004, expiration date 03-NOV-2019 (exact dose, route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 37 minutes. Previous temperature excursion included storage of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 minutes two times and once for 1 hour. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA002917: US-009507513-1807USA003518.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 week old female patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA010964; US-009507513-1807USA006808; US-009507513-1807USA006809; US-009507513-1807USA006810.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 week old female patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was invloved. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA010964: US-009507513-1807USA006807: US-009507513-1807USA006809: US-009507513-1807USA006810:
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old male patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of VAQTA lot # N023953, expiration date 05-NOV-2018 for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was invloved. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA010964: US-009507513-1807USA006807: US-009507513-1807USA006808: US-009507513-1807USA006810:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old male patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA010964: US-009507513-1807USA006807: US-009507513-1807USA006808: US-009507513-1807USA006809.
Sex: U
Vaccine: HPVX, MENB
Symptoms: Incomplete course of vaccination, Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (1st dose received a year before the reporting date). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: No patient identifiers were provided. The age at vaccination was not applicable for this report. The healthcare professional (HCP) reported that the patient never received the 2nd dose of BEXSERO, which led to incomplete course of vaccination. No side effects were reported. Follow up information received from a nurse on 6th July 2018: The reporting nurse had received acknowledgement letter and would like to provide additional information but wanted confirmation of who the patient was.  Without a date of birth or other patient identifier, the nurse was unable to provide further details and was wondering if perhaps the patient was the reporter. The nurse did not provide the patient's name and was unable to locate original report. Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis and BEXSERO for prophylaxis. The nurse believed it was the patient who experienced flu-like symptoms after having BEXSERO and HPV vaccine on same day, a couple weeks before the date of reporting. 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 BEXSERO and HPV vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly male patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site lump, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, injection site lump, injection site warmth and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site lump, injection site warmth and fever to be related to SHINGRIX. Additional details were reported as follows: The wife of the patient was the reporter. The patient experienced injection site reactions consisting of redness, warmth and a lump at the injection site. The patient also felt feverish.   The patient had denied permission to contact their physician. Could not obtain all adverse event information caller hung up on the representative when the representative told her we could not provide medical advice about symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia, Rash macular, Rash vesicular
Clinical narrative: This case was reported by a nurse via out of hour services and described the occurrence of chickenpox in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (in past). On an unknown date, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash. On an unknown date, the outcome of the chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash were unknown. It was unknown if the reporter considered the chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. According to the message left in after hours voice mail, the nurse who was the reporter stated that 1 day post vaccination with SHINGRIX, the patient experienced malaise, fever and chills. On 2 day post vaccination with SHINGRIX, the patient experienced vesicular erythematosus macular rash potentially similar to chicken pox. No further details were left in the after hours voice mail.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This case was reported by a nurse via out of hour services and described the occurrence of chickenpox in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (in past). On an unknown date, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash. On an unknown date, the outcome of the chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash were unknown. It was unknown if the reporter considered the chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. According to the message left in after hours voice mail, the nurse who was the reporter stated that 1 day post vaccination with SHINGRIX, the patient experienced malaise, fever and chills. On 2 day post vaccination with SHINGRIX, the patient experienced vesicular erythematosus macular rash potentially similar to chicken pox. No further details were left in the after hours voice mail.
Sex: U
Vaccine: VARZOS, FLUX
Symptoms: Myalgia, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in an unspecified number of patients 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 muscle pain and swelling. On an unknown date, the outcome of the muscle pain and swelling were unknown. It was unknown if the reporter considered the muscle pain and swelling to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not applicable for this report. The pharmacist reported that multiple patients had experienced muscle pain after SHINGRIX. The pharmacist stated that, some patients reported swelling after SHINGRIX and the pharmacist knows the adverse events were going to deter some patients from wanting to get that second dose. The pharmacist stated that there seems to be more adverse events with SHINGRIX vs ZOSTAVAX. This case has been linked with US2018GSK126112, reported by same reporter. The pharmacist rushed off phone so no further details could be provided.
Sex: U
Vaccine: VARZOS, FLUX
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in an unspecified number of patients 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 muscle pain and swelling. On an unknown date, the outcome of the muscle pain and swelling were unknown. It was unknown if the reporter considered the muscle pain and swelling to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not applicable for this report. The pharmacist reported that multiple patients had experienced muscle pain after SHINGRIX. The pharmacist stated that, some patients reported swelling after SHINGRIX and the pharmacist knows the adverse events were going to deter some patients from wanting to get that second dose. The pharmacist stated that there seems to be more adverse events with SHINGRIX vs ZOSTAVAX. This case has been linked with US2018GSK126112, reported by same reporter. The pharmacist rushed off phone so no further details could be provided.
Sex: U
Vaccine: VARZOS, FLUX
Symptoms: Myalgia, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of patients who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. 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 pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the other vaccines such as the flu vaccine (brand not mentioned) do not seem to hurt as much as SHINGRIX. For adverse event after SHINGRIX vaccine, refer linked case US2018120788, reported by same reporter. The pharmacist rushed off phone so no further details could be provided.
Sex: U
Vaccine: VARZOS, FLUX
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of patients who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. 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 pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the other vaccines such as the flu vaccine (brand not mentioned) do not seem to hurt as much as SHINGRIX. For adverse event after SHINGRIX vaccine, refer linked case US2018120788, reported by same reporter. The pharmacist rushed off phone so no further details could be provided.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Discomfort, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received SHINGRIX for prophylaxis. Concomitant products included atorvastatin calcium (Atorvastatin), tamsulosin hydrochloride (Flomax) and oxycodone. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, headache, foggy feeling in head, sinus pain, weakness, chills, neck pain, restlessness, sleeplessness and discomfort. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the headache, foggy feeling in head, sinus pain, weakness and neck pain were recovering/resolving and the outcome of the restlessness, sleeplessness and discomfort were unknown. It was unknown if the reporter considered the fever, headache, foggy feeling in head, sinus pain, weakness, chills, neck pain, restlessness, sleeplessness and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was the patient who received first dose of SHINGRIX about one week ago from the date of reporting. The caller reported that he experienced fever and chills which had resolved. The caller reported that he had also experienced headache, severe neck pain, sinus pain that started behind the right eye and moved across to behind the brow ridge of both eyes, weakness and feels like he was in a fog. The caller reported that each day the events were getting better, but still present. The caller reported that he had taken oxycodone to help with the neck and sinus pain but that did not resolve it either. The caller reported that he was unable to get good sleep and rest due to the discomfort.
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Neck pain, Pyrexia, Restlessness, Sinus pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received SHINGRIX for prophylaxis. Concomitant products included atorvastatin calcium (Atorvastatin), tamsulosin hydrochloride (Flomax) and oxycodone. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, headache, foggy feeling in head, sinus pain, weakness, chills, neck pain, restlessness, sleeplessness and discomfort. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the headache, foggy feeling in head, sinus pain, weakness and neck pain were recovering/resolving and the outcome of the restlessness, sleeplessness and discomfort were unknown. It was unknown if the reporter considered the fever, headache, foggy feeling in head, sinus pain, weakness, chills, neck pain, restlessness, sleeplessness and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was the patient who received first dose of SHINGRIX about one week ago from the date of reporting. The caller reported that he experienced fever and chills which had resolved. The caller reported that he had also experienced headache, severe neck pain, sinus pain that started behind the right eye and moved across to behind the brow ridge of both eyes, weakness and feels like he was in a fog. The caller reported that each day the events were getting better, but still present. The caller reported that he had taken oxycodone to help with the neck and sinus pain but that did not resolve it either. The caller reported that he was unable to get good sleep and rest due to the discomfort.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Pain of skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling of warmth in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 12th April 2018, the patient received the 2nd dose of SHINGRIX. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced feeling of warmth. On an unknown date, the outcome of the feeling of warmth was not recovered/not resolved. The reporter considered the feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX on left arm. The patient reported feeling like he had sunburn. There was no redness just the sunburn feel. The feeling started on his feet a day following the shot and by the 2nd day it progressed to the top of his head down his whole body to his feet. At the time of reporting, the patient rated the intensity as a 3 but prior to it that had been an 8 or 9 at times. The patient was treated in urgent care and also the emergency room but not admitted to the hospital. The patient described it as feeling like his skin had been in the sun all day and was sunburned. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness. On an unknown date, the outcome of the injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness to be related to SHINGRIX. Additional details were provided as follow: This case was reported by the patient's husband. The age at vaccination was not reported. The patient was experiencing pain and redness around the injection site as well as muscle pain, tiredness, headache, shivering and fever after her SHINGRIX injection.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative 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 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness. On an unknown date, the outcome of the injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness to be related to SHINGRIX. Additional details were provided as follow: This case was reported by the patient's husband. The age at vaccination was not reported. The patient was experiencing pain and redness around the injection site as well as muscle pain, tiredness, headache, shivering and fever after her SHINGRIX injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, 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 78-year-old female patient who received SHINGRIX for prophylaxis. On 27th February 2018 10:00, the patient received the 1st dose of SHINGRIX. On 27th February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. In March 2018, the outcome of the pain in arm and injected limb mobility decreased were recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient reported having a very sore left arm following the injection. It was so sore that she could not lift it for days. The soreness lasted 3 to 4 days. The patient had denied permission to contact their physician. This case has been linked with US2018120811 (reporter's niece), reported by the same reporter.