chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 5-year-old patient of unknown gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medication. On 17-DEC-2018, the patient was administered an improperly stored dose of PROQUAD (strength, route and dose not provided) lot # R017628 and expiration date 18-DEC-2019, for prophylaxis. The dose was reconstituted with a properly stored sterile water diluent (MERCK) (lot # and expiration date not provided). No adverse effects reported. It was reported that the storage temperature of the vaccines was 6 to 14 Fahrenheit degrees and the time frame was 18 minutes. There was no previous temperature excursion and the call was because of a "data logger". This case is one of two from the same reporter (Information captured in MARRS # 1812USA011856). Sender's Comments: US-009507513-1812USA011856.
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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-JAN-2017, the patient was treated by a healthcare provider at an emergency department 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 her 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 (dates unknown), 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-MAY-2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX) vaccine, and suffered serious physical, emotional, and economic damages as a result of his 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 (dates unknown), 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.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Nodule, Pain
Clinical narrative: Was painful and then bruised. (was away from home next 3 days) - The bruise became lighter. Continued to be painful. Just noticed knots in R arm 1-3-19. Returned to Pharmacy. They ask her to come to our office. PAC- saw her for office visit 1-4-19.
Age: 67.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Terrible muscle pain in pain at injection site which effects whole arm. Can barely put on coat, lift my purse, carry groceries, etc.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram head, Drug screen negative, Electrocardiogram normal, Electroencephalogram
Clinical narrative: SHINGRIX vaccine given at a different facility in the morning of 12/31/2018. Subsequently patient felt ill with malaise, aches and chills throughout the rest of the day. He went to bed and woke up at 1:30 am on 1/1/2018 and had a seizure.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count normal, Malaise, Metabolic function test normal, Pain, Seizure
Clinical narrative: SHINGRIX vaccine given at a different facility in the morning of 12/31/2018. Subsequently patient felt ill with malaise, aches and chills throughout the rest of the day. He went to bed and woke up at 1:30 am on 1/1/2018 and had a seizure.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: SHINGRIX vaccine given at a different facility in the morning of 12/31/2018. Subsequently patient felt ill with malaise, aches and chills throughout the rest of the day. He went to bed and woke up at 1:30 am on 1/1/2018 and had a seizure.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling and redness immediately upon injection which persists two days later; swelling has decreased some. Had zero adverse reactions with dose 1 given in same left arm on 10/01/2018.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash
Clinical narrative: Patient had listed latex allergy on her vaccine administration record. The allergy was questioned and patient was told the tip cap of BOOSTRIX contained natural rubber latex. Patient wanted to proceed with vaccination due to a grand baby on the way. Patient waited in waiting area for us to observe and started to notice her fingers turning red with a little bit of rash/redness forming on her wrist. We immediately gave her two 25mg capsules of diphenhydramine. We observed her for another 30 minutes. Redness subsided and patient went home. We followed up with her the next day and she was fine. She did want us to report the reaction hoping Glaxo would change their tip cap in the future.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Pt developed vomiting and bloody stools on 12/22. He was evaluated in the ED and found to have intussusception. He had an air enema, which reduced the affected area. He was monitored in the hospital overnight, did well and was discharged home.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Cough, Ear haemorrhage, Erythema multiforme, Eye discharge, Otitis media acute
Clinical narrative: LPN 12/31/2018 10:12:54 AM, dad states that child was noted to have a rash in her neck last night; woke up with rash all over body today; not seeming to bother her; rash is differing sizes and some are raised; afebrile. Now really congested and coughing; has eye d/c. Was noted to have some blood in the ear d/c this weekend; still offering FLOXIN.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Otorrhoea, Rash, Rash generalised, Respiratory tract infection, Upper respiratory tract infection
Clinical narrative: LPN 12/31/2018 10:12:54 AM, dad states that child was noted to have a rash in her neck last night; woke up with rash all over body today; not seeming to bother her; rash is differing sizes and some are raised; afebrile. Now really congested and coughing; has eye d/c. Was noted to have some blood in the ear d/c this weekend; still offering FLOXIN.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Viral rash
Clinical narrative: LPN 12/31/2018 10:12:54 AM, dad states that child was noted to have a rash in her neck last night; woke up with rash all over body today; not seeming to bother her; rash is differing sizes and some are raised; afebrile. Now really congested and coughing; has eye d/c. Was noted to have some blood in the ear d/c this weekend; still offering FLOXIN.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Administration site swelling, Administration site vesicles, Myalgia, Nausea
Clinical narrative: PT HAD A VERY SERIOUS REACTION TO THIS - LARGE SWELLING REDNESS, TERRIBLY SORE ARM, BUBBLING SKIN NEAR THE SITE OF ADMINISTRATION. AFTER 5 DAYS IT IS NOW LOOKING LIKE A SMALL SPIDER BITE... SHE SHOWED ME A PICTURE OF IT FROM 1/3 AND EVEN 4 DAYS AFTER THE VACCINE I CAN AGREE SHE SHOULD NOT RECEIVE THE SECOND DOSE AT THIS POINT. NAUSEA AND MUSCLE ACHES (WITH THE ACHES SPREADING TO HER THIGHS) WERE THE MOST SEVERE SHE HAD NOTICE WITH ANY VACCINE
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: EMPLOYEE RECEIVED THE VACCINE 11:30AM, NO REACTION PER EMPLOYEE UNTIL AFTER LUNCH ABOUT 1 PM.  SHE NOTICED SHE WAS ITCHING AND LOOKED LIKE HAD LITTLE RASH OR WHELP COMING ON HER FORHEAD AND ONE ON HER CHEEK AND WHEN SHE REALIZED IT WAS COMING UP A COUPLE ON HER BACK AS WELL SHE RETURNED TO THE CLINIC AT APPROXIMATELY 1:30PM. SHE WAS IMMEDIATELY GIVEN BENADRYL 25-50MG PO PER STANDING ORDERS AND INSTRUCTED IF HAVING ANY SWELLING IN THROAT OR DIFFICULTY BREATHING WE WOULD BE SEEKING EMERGENCY ASSISTANCE. PATIENT DENIED ANY SYMPTOMS CAUSING DIFFICULTY BREATHING OR SWALLOWING. SHE WAS THEN INSTRUCTED SHE NEEDED TO CONTACT HER PERSONAL PHYSICIAN FOR POSSIBLE FURTHER TREATMENT/ MEDICATIONS. SHE LEFT THE CLINIC WITH INSTRUCTIONS TO CONTACT THEM IMMEDIATELY. 2:00PM I CALLED HER DEPT TO CHECK TO SEE IF SHE HAD LEFT OR FOLLOWED UP WITH PERSONAL PHYSICIAN. SHE WAS UNAVAILABLE AND SUPERVISOR SAID SHE WAS ON HER WAY BACK TO THE DEPARTMENT. 2:15PM PATIENT FINALLY CALLED EMPLOYEE HEALTH OFFICE STATED THAT SHE WAS MUCH BETTER AFTER THE BENADRYL AND SHE HAD CONTACTED HER PHYSICIAN AND THEY TOLD HER IF SHE HAD ANY FURTHER REACTION SHE WAS TO GO TO THE ER FOR FURTHER TREATMENT. SHE WAS GIVEN HER VIS AND I ALSO REMINDED HER SHE COULD REACT FOR HOURS OR COUPLE OF DAYS AND SHE NEEDED TO FOLLOW UP IF ANY REACTION RETURNED AT ALL WHEN THE INITIAL DOSE OF BENDRYL WORE OFF. SHE ACKNOWLEDGED UNDERSTANDING AND SAID SHE WOULD GO TO THE DOCTOR OR ER IF SHE HAD FURTHER REACTIONS.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient stated he had chills and high fever after getting second dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site warmth, Rash pruritic
Clinical narrative: Pt presented 2 days after the immunization, with inflammation, erythema, and pruritic rash localized to area around injection site. Mother reports that rash was hot to the touch and has been itching. Pt's PCP evaluated the reaction and recommended to ice the area as well as using hydrocortisone cream for itchiness. We will follow up via phone call in 3 days. We counseled parent to seek immediate medical attention if symptoms worsen or change in anyway. All questions were answered and parent expressed understanding.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Fevers and  chills, large scarlet red mark/welt around injection site of around 4 inches wide, pain/redness/warmth around injection site. Red welt was settling down on 1/3/19.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fevers and  chills, large scarlet red mark/welt around injection site of around 4 inches wide, pain/redness/warmth around injection site. Red welt was settling down on 1/3/19.
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP, HPV9, TDAP
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: About half hour after visit patients mom called in and stated that they called ambulance due to patient having an anaphylactic reaction. Trouble  breathing and hives.
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP, HPV9, TDAP
Symptoms: Abdominal pain, Anaphylactic reaction, Body temperature increased, Cough, Dyspnoea
Clinical narrative: About half hour after visit patients mom called in and stated that they called ambulance due to patient having an anaphylactic reaction. Trouble  breathing and hives.
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP, HPV9, TDAP
Symptoms: Nausea, Oral pruritus, Pruritus, Rash, Swollen tongue
Clinical narrative: About half hour after visit patients mom called in and stated that they called ambulance due to patient having an anaphylactic reaction. Trouble  breathing and hives.
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP, HPV9, TDAP
Symptoms: Urticaria, Wheezing
Clinical narrative: About half hour after visit patients mom called in and stated that they called ambulance due to patient having an anaphylactic reaction. Trouble  breathing and hives.
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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 30-DEC-2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a physician 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 her 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 (dates unknown), 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-MAR-2014, 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 his 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 (dates unknown), 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, 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 his 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 (dates unknown), 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-JAN-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-JAN-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 her 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 (dates unknown), 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In June 2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider at a 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 her 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 (dates unknown), 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: Cardiac failure
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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In September 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2017, the patient was treated by a physician for heart failure. The patient was diagnosed with heart failure 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 his 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 (dates unknown), 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. Upon internal review, heart failure and/or other zoster-related injuries was determined to be medically significant. 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider at an urgent care facility 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 her 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 (dates unknown), 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-JUL-2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 09-DEC-2016, the patient was treated by a physician 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 her 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 (dates unknown), 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-AUG-2016, the patient was treated by a physician 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 his 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: 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In November 2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In December 2016, 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 his 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: 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-JAN-2013, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-OCT-2016, 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 his 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. In 2014, a healthcare provider at an internal medicine office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 20-JAN-2017, the patient was treated by a physician at the same internal medicine office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, 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 not recovered. Causality assessment was related. 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2013, 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 his 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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. On or about 19-FEB-2016, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 17-JUN-2016, the patient was treated by a physician at the physician's office 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, 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. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. On or about 29-JAN-2007, a healthcare provider at a medical facility administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 26-DEC-2014, the patient was treated by a healthcare professional at the same medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, 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 not recovered. Causality assessment was related. 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-FEB-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In April 2016, 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 his 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 (dates unknown), 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: FLUR3
Symptoms: Bone pain, Herpes zoster
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK Trivalent (528). This is an initial report of a non-serious adverse event, received on 31/Oct/2014, by a 59 year old female patient/consumer. The patient received FLUBLOK Intramuscular (IM) on 21/Oct/2014 at an unknown location. The patient stated that she received her vaccine on 21/Oct/2014 and developed pain in her clavicle on the same arm as the vaccine was administered. She was seen in the emergency room on 29/Oct/2014 and later by her primary care physician (PCP) and was diagnosed with shingles. She believed she developed shingles from the flu vaccine. She was unsure of the time or date this occurred. The events required a visit to the emergency visit (no further details provided). At the time of this report, the outcome of the events was unknown. Medical history reported an allergy to eggs. There was no current illness at the time of vaccination. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported. This report was received from a consumer therefore; no medical confirmation or assessment of causality is available. Further information is unavailable at the time of this report. The Company's assessment of the causal relationship between Herpes Zoster, pain and FLUBLOK is not reasonably possibly related considering the days of onset of the events to the vaccine administration. Addendum 31 Dec 2018. Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK Trivalent (528).
Sex: F
Vaccine: FLUR4
Symptoms: Dysphagia, Dyspnoea, Flushing, Immediate post-injection reaction, Rash
Clinical narrative: This is an initial report of a serious adverse event, received on 17/Oct/2014, by a 35-year-old female patient/consumer. The patient received FLUBLOK TRIVALENT Intramuscular on 17/Oct/2014 at an unknown location. The patient developed an immediate reaction of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath (SOB), all of which resulted in an emergency room visit. The duration of the events was 0 days and all of the events were considered recovered. Medical/surgical history reported no known drug allergy (NKDA) and egg allergy. Any illnesses at the time of vaccination were not reported. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported. This report was received from a consumer therefore; no medical confirmation or assessment of causality is available. Further information is unavailable at the time of this report. The Company's assessment of the causal relationship between these events and FLUBLOK is that there may be a possible relationship based on the reported information that the reactions of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath occurred immediately after post injection. Addendum: significant correction was performed on 28-DEC-2018 to correct product FLUBLOK TRIVALENT (528) from FLUBLOK QIV (529). Sender's Comments: This case concerns a 35 years old patient who developed an immediate reaction of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath. Time to onset is compatible. Etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.