chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Gait inability, Pulmonary thrombosis
Clinical narrative: This case was reported by a consumer via other and described the occurrence of pulmonary thrombosis in a female patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of abdominal pain upper (1st dose received on 29th September 2018, refer case US2019GSK004750 for 1st dose). On 30th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pulmonary thrombosis (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization) and aphasia (serious criteria hospitalization). On an unknown date, the outcome of the pulmonary thrombosis, unable to walk and aphasia were unknown. The reporter considered the pulmonary thrombosis, unable to walk and aphasia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. In the morning after vaccination, the patient could not walk or talk. The patient was transported to the hospital and they found two blood clots in her lungs. The patient believed that, all her medical treatment and recent health problems were related to this vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: This case was reported by a consumer via other and described the occurrence of pulmonary thrombosis in a female patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of abdominal pain upper (1st dose received on 29th September 2018, refer case US2019GSK004750 for 1st dose). On 30th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pulmonary thrombosis (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization) and aphasia (serious criteria hospitalization). On an unknown date, the outcome of the pulmonary thrombosis, unable to walk and aphasia were unknown. The reporter considered the pulmonary thrombosis, unable to walk and aphasia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. In the morning after vaccination, the patient could not walk or talk. The patient was transported to the hospital and they found two blood clots in her lungs. The patient believed that, all her medical treatment and recent health problems were related to this vaccine.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram normal, Eye pain, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Headaches for more than 30 days.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Headache, Nuclear magnetic resonance imaging brain, Ophthalmological examination, Scan with contrast
Clinical narrative: Headaches for more than 30 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Very sore arm, tiredness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Lip swelling, Pain in extremity, Swelling face
Clinical narrative: On 12/19/18, I received facial cosmetic fillers. I have had facial cosmetic fillers in the past with no adverse effects. I had no side effects after receiving the fillers. The specific brand of filler was in my nasolabial area and in my cheeks. On 1/5/19, I received my second dose of the SHINGRIX vaccine, 18 days after having received the facial fillers. The initial side effect from the injection was soreness in my left arm which I had with the first dose. On 1/7/19, I woke up and my lips, nasolabial area and cheeks were swollen and hard. I took 2 Benadryl tablets over the course of the day without any change in symptoms. By the end of the day, the swelling had gone and the cosmetic fillers were gone. My immune system had attacked the fillers and eliminated them.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia, Rash
Clinical narrative: Patient reported with pain at the site, a rash greater than 10 cm and numbness with tingling of the arm.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Severe pain in shoulder and arm that pneumonia vaccination was given in. Unable to move shoulder or arm. Think the vaccine was accidently put into the deltoid because it was give her high up almost to the shoulder.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Abdominal pain, Allergy test, Full blood count, Haematochezia, Lethargy
Clinical narrative: Within 24hrs of vaccine, developed fever to 101, treated with 1 dose of TYLENOL. Within 48hrs, developed projectile vomiting, lethargy, episodes of drawing legs up with intense screaming, blood in stool. Bloody, mucus stools continued intermittently for 3.5 weeks post vaccine administration. Seen by GI specialist who recommended starting probiotic; remained on nutramigen the entire course. After almost 4 weeks, stools returned to normal.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Mucous stools, Pyrexia, Screaming, Vomiting projectile
Clinical narrative: Within 24hrs of vaccine, developed fever to 101, treated with 1 dose of TYLENOL. Within 48hrs, developed projectile vomiting, lethargy, episodes of drawing legs up with intense screaming, blood in stool. Bloody, mucus stools continued intermittently for 3.5 weeks post vaccine administration. Seen by GI specialist who recommended starting probiotic; remained on nutramigen the entire course. After almost 4 weeks, stools returned to normal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: Patient had chills, body aches, and diarrhea for the first 48 hours after receiving SHINGRIX. Those symptoms resolved. Patient has a sharp pain that still persists almost 2 weeks later in her bicep (SHINGRIX was administered in the deltoid). Patient went to see the chiropractor with no improvement in symptoms. She plans to see the reflexologist in the near future.
Sex: U
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a different nurse of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the nurse got some M-M-R II (strength, dose detail, batch/lot # and expiration date were not reported) in the eyes while preparing the dose of M-M-R II (exposure via eye contact, inadvertent exposure to vaccine and occupational exposure while preparing product for administration). No known adverse effects were reported.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a physician referring to a 14-year-old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with PROQUAD for prophylaxis (strength, dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported) (inappropriate age at vaccine administration). No adverse symptoms were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a one year old patient of unknown gender. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported. On 26-DEC-2018, the patient started use of M-M-R II (lot#, expiration date, strength, dose and frequency were not reported) intramuscularly rather than subcutaneous, for prophylaxis (Incorrect route of product administration). No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-JAN-2019, the patient was vaccinated with one dose of improperly stored M-M-R II) lot # R000550 with expiration date on 08-JAN-2020 (exact dose and route of administration were not reported) for prophylaxis. The vaccine underwent temperature excursion of above 47 degrees Fahrenheit (48.9 degrees Fahrenheit) for 2 hours. There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. As a result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. As a direct and proximate result of ZOSTAVAX the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. The patient sustained severe and permanent personal injuries. Further permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including but not limited to the following: The patient required and will continue to require healthcare and services. The patient incurred and will continue to incur medical and related expenses. The patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Vaccination failure and herpes zoster were reported to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2017, a healthcare provider at a medical group practice administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a physician at the medical group practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at an outpatient clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider at the outpatient clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a medical center administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider at a hospital (different from the place where he received vaccination) for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider at a hospital administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2015, the patient was treated by a physician at the hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 22-OCT-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 16-NOV-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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.  The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the  ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In NOVEMBER 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In FEBRUARY 2016, the patient was treated by a physician at a medical group practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On 11-JAN-2019, the patient was vaccinated with an improperly stored second dose of PROQUAD (lot # R020677, expiry date 15-JAN-2020) for prophylaxis. The suspect vaccine was reconstituted with an properly stored sterile diluent. The vaccine was exposed to the temperature of -14.6 degree Celsius (C) for 30 minutes. Previous excursion included exposure to 0.1 C for 2 hours and -13.7 C for 45 minutes. A data logger was involved. No adverse effects were reported. No product quality complaint was present. This is one of the several reports received from same reporter source. Sender's Comments: US-009507513-1901USA006695: US-009507513-1901USA006696: US-009507513-1901USA006698: US-009507513-1901USA006697.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On 14-JAN-2019, the patient was vaccinated with an improperly stored first dose of PROQUAD (lot # R020677, expiry date 15-JAN-2020) for prophylaxis. The suspect vaccine was reconstituted with an properly stored sterile diluent. The vaccine was exposed to the temperature of -14.6 degree Celsius (C) for 30 minutes. Previous excursion included exposure to 0.1 C for 2 hours and -13.7 C for 45 minutes. A data logger was involved. No adverse effects were reported. No product quality complaint was present. This is one of the several reports received from same reporter source. Sender's Comments: US-009507513-1901USA006017.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On 14-JAN-2019, the patient was vaccinated with an improperly stored second dose of PROQUAD (lot # R020677, expiry date 15-JAN-2020) for prophylaxis. The suspect vaccine was reconstituted with an properly stored sterile diluent. The vaccine was exposed to the temperature of -14.6 degree Celsius (C) for 30 minutes. Previous excursion included exposure to 0.1 C for 2 hours and -13.7 C for 45 minutes. A data logger was involved. No adverse effects were reported. No product quality complaint was present. This is one of the several reports received from same reporter source. Sender's Comments: US-009507513-1901USA006017.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On 11-JAN-2019, the patient was vaccinated with an improperly stored second dose of PROQUAD (lot # R020677, expiry date 15-JAN-2020) for prophylaxis. The suspect vaccine was reconstituted with an properly stored sterile diluent. The vaccine was exposed to the temperature of -14.6 degree Celsius (C) for 30 minutes. Previous excursion included exposure to 0.1 C for 2 hours and -13.7 C for 45 minutes. A data logger was involved. No adverse effects were reported. No product quality complaint was present. This is one of the several reports received from same reporter source. Sender's Comments: US-009507513-1901USA006017.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 24th December 2018, the patient received the 1st dose of SHINGRIX. On 25th December 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient ran a temperature of 104 degree F on next day of vaccination. The patient was following up with her primary care physician.
Sex: F
Vaccine: VARZOS
Symptoms: Facial neuralgia, Incomplete course of vaccination, Trigeminal neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cancer. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced trigeminal neuralgia and facial neuralgia. On an unknown date, the outcome of the trigeminal neuralgia was not recovered/not resolved and the outcome of the facial neuralgia was unknown. It was unknown if the reporter considered the trigeminal neuralgia and facial neuralgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed trigeminal neuralgia or face nerve pain after receiving a dose of SHINGRIX and because of this, the patient did not take 2nd dose of SHINGRIX. The patient believed that because she had cancer, the cancer was pressing against the nerve which was why she was diagnosed with this condition. The patient refused to provide any additional details or answer any further questions.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Incomplete course of vaccination, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 20th July 2018, several hours after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever, tiredness and loss of energy. On an unknown date, the patient experienced incomplete course of vaccination. On 21st July 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness and loss of energy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the fever, tiredness and loss of energy to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in the morning. On the day of vaccination, at night she had fever which lasted about a day. The patient also noted that, she was tired and had no energy. The patient stated she knew it could cause the adverse events she experienced. The reporter declined pharmacy information and follow up with herself or healthcare professional.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site reaction, Lethargy, Musculoskeletal stiffness, Myalgia
Clinical narrative: Myalgia throughout my muscles and joints. Severe myalgia and stiffness at injection site. Chills and fever. Lethargy.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Myalgia throughout my muscles and joints. Severe myalgia and stiffness at injection site. Chills and fever. Lethargy.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Insomnia, Myalgia
Clinical narrative: Pain at site of injection. Fever, chills, shakes and sweating beginning 10 hours afterwards and lasting for more than 10 hours. Unable to sleep. Muscle pain, not solely at injection site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Pain at site of injection. Fever, chills, shakes and sweating beginning 10 hours afterwards and lasting for more than 10 hours. Unable to sleep. Muscle pain, not solely at injection site.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1 DAY POST VACCINATION - CLIENT COMPLAINT OF ITCHY AREA WHERE VARICELLA VACCINE GIVEN, SLIGHTLY RAISED AND RED. TYLENOL GIVEN BY PARENT AND ICE WAS APPLIED TO AREA. DENIED  FEVER. 2 DAY POST VACCINATION - CLIENT COMPLAINT OF NON ITCHY RED RAISED AREA 4 INCHES X 6 INCHES WHERE VARICELLA VACCINE WAS ADMINISTERED. AREA IS WARM TO THE TOUCH AND PAINFUL TODAY. PARENT DENIES THAT CHILD HAS FEVER. AREA WHERE MENVEO VACCINE GIVEN INDICATES A SMALL SWOLLEN AREA OF LESS THAN 3/4 INCH.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Injection site pain, Injection site rash, Myalgia
Clinical narrative: Muscle aches, fatigue, shortness of breath, 6 inch rash/pain at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On 11-JAN-2019, the patient was vaccinated with improperly stored varicella VARIVAX (dose and route of administration not reported, lot # R018931 with expiration date 02-JUL-2020) for prophylaxis. Nurse also reports the sterile diluent (unknown lot number and expiration date) used to reconstitute VARIVAX did not undergo a temperature excursion. The vaccine was stored at a temperature of 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.7 degrees Fahrenheit) for 6 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: 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 prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date later in 2014, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Herpes zoster. The patient claims damages including: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2008, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Nephrolithiasis
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-MAY-2016, the female patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 08-MAR-2017, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses.The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Nephrolithiasis
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, the male patient was administered the ZOSTAVAX by a pharmacist in a pharmacy (lot number, dosage and route of administration not provided). On an unknown date later in 2015, the patient was treated by a healthcare provider at a hospital for the following injury resulting from his ZOSTAVAX use: shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Complication of pregnancy, Delivery, Exposure during pregnancy, Foetal disorder, Hypertension
Clinical narrative: This is a serious observational study case, concerning a 31-year-old, adult pregnant female, subject of body weight: 128 lbs and height: 62 inches, body mass index (BMI): 23.4, enrolled in a prospective observational safety study. The subject's obstetrical history included a total 6 previous pregnancies with 4 previous full-term births (no birth defects reported) and 2 spontaneous abortions. The subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's current conditions included vaginitis and anemia (since unspecified dates). The subject's concomitant medications included Prenatal vitamins for pregnancy, METROGEL for vaginitis and ferrous sulphate for anemia. The subject's last menstrual period (LMP) date was 07-Apr-2018. The type of pregnancy was singleton. On 21-May-2018, the subject had an ultrasound which showed no major congenital malformations. On 01-Jun-2018, the subject had an ultrasound which showed no major congenital malformations. On 30-Jul-2018, the prenatal spinal muscular atrophy test, cystic fibrosis mutation analysis and Maternal Serum Alpha-Fetoprotein (serum markers) was performed which showed no major congenital malformations. On 19-Oct-2018, at gestational age of 28 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication. On an unspecified date in 2018, the subject was noted with pregnancy complications which included echogenic foci and pericardial effusion at gestational age of 32 weeks and chronic hypertension. The subject delivered a full-term female infant at gestational age of 37.6 weeks via vaginal method of delivery. The infant's birth weight was 2155 grams (low birth weight), body length was 45.7 cm and head circumference was 30.5 cm. The APGAR scores were 8 (one minute) and 9 (five minutes). The subject's estimated delivery date (EDD) was reported as 12-Jan-2019. This case linked to 201900314 (baby case). The outcome of the events was not reported. Reporter's Comments: A 31-year-old female pregnant subject experienced chronic hypertension, abnormal USG scan (echogenic cardiac foci and pericardial effusion) at 32 weeks of pregnancy, after receipt of Flu Vaccine Cell Subunit QIV NVD. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event chronic hypertension, the company assessed the causality as unassessable. The event vaccine exposure during pregnancy assessed as not related considering the special case scenario. The company assessed the case as serious (medically significant).
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound foetal abnormal
Clinical narrative: This is a serious observational study case, concerning a 31-year-old, adult pregnant female, subject of body weight: 128 lbs and height: 62 inches, body mass index (BMI): 23.4, enrolled in a prospective observational safety study. The subject's obstetrical history included a total 6 previous pregnancies with 4 previous full-term births (no birth defects reported) and 2 spontaneous abortions. The subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's current conditions included vaginitis and anemia (since unspecified dates). The subject's concomitant medications included Prenatal vitamins for pregnancy, METROGEL for vaginitis and ferrous sulphate for anemia. The subject's last menstrual period (LMP) date was 07-Apr-2018. The type of pregnancy was singleton. On 21-May-2018, the subject had an ultrasound which showed no major congenital malformations. On 01-Jun-2018, the subject had an ultrasound which showed no major congenital malformations. On 30-Jul-2018, the prenatal spinal muscular atrophy test, cystic fibrosis mutation analysis and Maternal Serum Alpha-Fetoprotein (serum markers) was performed which showed no major congenital malformations. On 19-Oct-2018, at gestational age of 28 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication. On an unspecified date in 2018, the subject was noted with pregnancy complications which included echogenic foci and pericardial effusion at gestational age of 32 weeks and chronic hypertension. The subject delivered a full-term female infant at gestational age of 37.6 weeks via vaginal method of delivery. The infant's birth weight was 2155 grams (low birth weight), body length was 45.7 cm and head circumference was 30.5 cm. The APGAR scores were 8 (one minute) and 9 (five minutes). The subject's estimated delivery date (EDD) was reported as 12-Jan-2019. This case linked to 201900314 (baby case). The outcome of the events was not reported. Reporter's Comments: A 31-year-old female pregnant subject experienced chronic hypertension, abnormal USG scan (echogenic cardiac foci and pericardial effusion) at 32 weeks of pregnancy, after receipt of Flu Vaccine Cell Subunit QIV NVD. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event chronic hypertension, the company assessed the causality as unassessable. The event vaccine exposure during pregnancy assessed as not related considering the special case scenario. The company assessed the case as serious (medically significant).
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Lymphadenopathy, Neck pain, Respiratory disorder
Clinical narrative: This is a spontaneous case, reported by other non-health professional and initially retrieved on 09-Jan-2019, concerning a 44-year-old, adult female patient. The patient did not have any medical history. The concomitant medication included unspecified vitamins for unknown indication. On 26-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF42809 (NDC 33332-0318-01) and expiry date: 30-Jun-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. On an unspecified date in 2018, reported as starting several days after receiving the vaccine, the patient felt pain at the injection site. Two days later after the injection site pain, the patient also had pain up to the neck, on the injection side and after that also up to the elbow. On 30-Oct-2018, 4 days after vaccination, the patient developed a lymph node and noticed the lymph node pumped up, that was then smaller, but the patient could still feel it a little bit swollen. Since 31-Oct-2018, 5 days after vaccination, the patient also started having breathing issues. The patient had several times and the worst time she went to the emergency room and was referred to two medical doctor (MD) specialists. Last time the patient had breathing issues was on holiday. As of now, the patient was being was followed-up by a doctor. On 06-Nov-2018, the patient had recovered from the event injection site pain (reported as for 1 week). The outcome of the events lymph node and breathing issues and were not recovered. The outcome of the events neck pain and pain in elbow was not reported. The reporter assessed the case as non-serious and causality of the events as related to the suspect vaccine (reported as adverse reactions). Reporter's Comments: A 44-year-old female patient experienced lymphadenopathy and breathing issues (dyspnoea), 4 days and 5 days after vaccination with AFLURIA QUAD respectively. Considering the plausible temporal relationship between vaccination to events onset and absence of alternate aetiologies, the events lymphadenopathy and dyspnoea were considered as related to suspect vaccine. The patient also experienced injection site pain with neck pain and pain in elbow later, unspecified period after vaccination. However, considering these reactions relating to injection site, the company assessed causality as related to suspect vaccine. The company assessed the case as serious (medically significant).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Erythema, Fatigue, Gingival pain, Headache
Clinical narrative: The day after the SHINGRIX, 01/11/2019, I felt tired and soreness of the injection site, which was expected. It was 6 days after the injection, 01/16/2019, that I developed a headache above my right eye, reddness at the base of my right nostril followed by swelling and redness of my right upper lip with pain along the upper right gumline and teeth, radiating to my right ear. It is currently painful, swollen and tender to the touch in all the above mentioned areas. I saw my dentist to rule out a dental issue an she diagnosed me with a viral infection, likely Herpes. I have been using over the counter ABREVA Cream (docosanol 10%) and KANKA softbrush antiseptic/astringent. My Oncologist Dr. will see me on 01/22/2019 if I am still having problems or worse.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Injection site pain, Lip erythema, Lip swelling, Pain
Clinical narrative: The day after the SHINGRIX, 01/11/2019, I felt tired and soreness of the injection site, which was expected. It was 6 days after the injection, 01/16/2019, that I developed a headache above my right eye, reddness at the base of my right nostril followed by swelling and redness of my right upper lip with pain along the upper right gumline and teeth, radiating to my right ear. It is currently painful, swollen and tender to the touch in all the above mentioned areas. I saw my dentist to rule out a dental issue an she diagnosed me with a viral infection, likely Herpes. I have been using over the counter ABREVA Cream (docosanol 10%) and KANKA softbrush antiseptic/astringent. My Oncologist Dr. will see me on 01/22/2019 if I am still having problems or worse.