chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Electrocardiogram normal, Feeling jittery, Headache, Palpitations
Clinical narrative: He started getting extremely jittery. Heart was racing and his heart rate lying down was around 120 bpm and as he rolled around in bed and shook it would go to 170-180 bpm -- per apple watch that I had him wear. He head hurt also and felt very anxious. He wore a fitbit charge for days afterward to watch his heart rate. It took about 3 days for his heart to get back to normal beats. Its slowly went down with in 8 hours or so, but was still much higher than normal. Even the next morning his heart rate was around 115 bpm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Aching in joints, pain at injection site, tiredness, Fever over 101 degrees.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Duplicate vaccines given and incorrect recording. Mom questioned the number of vaccines given but denied any reactions. 5 shots given - child not behind in vaccines.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a medical assistant referring to a currently 19-year-old female patient. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date (reported as when the patient was 1-year-old), the patient was vaccinated with the first dose of M-M-R II (dose detail, route, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination). On an unknown date (reported as prior to elementary school), the patient was vaccinated with the second dose of M-M-R I) (dose detail, route, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination). On an unknown date in 2018 (reported as recently), the patient had titers drawn for nursing school and the measles portion came back as negative. The outcome of event was not reported. The causality assessment between the event and the M-M-R II were also not reported.
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 14-JUN-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On or about 25-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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In October 2013, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In February 2017, the patient was treated by a physician at a medical group 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: 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 2016, a healthcare provider at a medical center 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 04-JUN-2018, the patient was treated by a healthcare provider at the Army 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 03-FEB-2014, a healthcare provider at a family practice administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by a healthcare provider at an express care facility 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 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 05-JUN-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). 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, 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 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 healthcare provider administered the ZOSTAVAX to the patient. On or about 17-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 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.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: H1N1 influenza, Intensive care, Myocarditis
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 09-Jan-2019 (processed together with follow-up received on 10-Jan-2019), concerning a 38-year-old, adult, female patient. The patient had no historical or current condition. The patient did not receive any concomitant medications. On 21-Dec-2018, the patient was administered FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252685 and expiry date: 30-Jun-2019) for influenza prophylaxis. On 05-Jan-2019, 15 days after vaccination, the patient was diagnosed with H1N1 influenza. On the same day, the patient was hospitaliszd. At the time of this report, the patient was in intensive care unit (ICU) and was diagnosed with fulminant myocarditis. The reporter was concerned about the quality of the product the patient was given (explicitly coded as suspected product quality issue). The patient had not recovered from the events. The reporter assessed the case as serious (hospitalization).; Reporter's Comments: A 38-year-old, female patient was diagnosed with H1N1 influenza, 15 days after administration of FLUCELVAX QIV followed by fulminant myocarditis. Considering the implausible temporal relationship, the event of H1N1 influenza was assessed as not related to suspect vaccine as vaccination usually requires minimum 2-3 weeks to provide immune protection against influenza. Despite temporal association between vaccination and event of fulminant myocarditis, the clinical course suggests the reported H1N1 influenza as a more plausible explanation for the event. Hence, the company assessed the causality as not related to suspect vaccine. There is lack of information with respect to nature/cause of the reported event of suspected product quality issue and the company assessed the event as unassessable. The case will be further assessed upon receipt of follow up information. The company assessed the case as serious (medically significant).
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed pain, swelling, patchy erythema of left upper arm.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was due for second flu shot to complete first FLUZONE Quadrivalent series. Patient received 0.5 ml was to receive 0.25 ml.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives on left cheek, on right gluteus and on left arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Musculoskeletal stiffness, Pain, Skin warm
Clinical narrative: Parent noticed on 1/15/19 at approximately 12:00 PM that the patients arm was hot to the touch and red. Patient complained of stiffness, swelling and pain. Patient was taken to the Emergency Room.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling
Clinical narrative: Parent noticed on 1/15/19 at approximately 12:00 PM that the patients arm was hot to the touch and red. Patient complained of stiffness, swelling and pain. Patient was taken to the Emergency Room.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Cartilage injury, Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient experienced immediate pain upon administration of the vaccine and explained that it hurt worse than any flu shot she had received in the past. Patient is still experiencing pain after over a year, but it has regressed in severity.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Tendon disorder, X-ray limb
Clinical narrative: Patient experienced immediate pain upon administration of the vaccine and explained that it hurt worse than any flu shot she had received in the past. Patient is still experiencing pain after over a year, but it has regressed in severity.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A pediatric dose was administered instead of Hep A adult dose.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: Unknown which shots went into which thigh and which one was an oral drink. We are currently going through the symptoms and can post more later.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor
Clinical narrative: Vasovagal syncope- immediately after injection of the vaccine, patient felt light-headed and transiently loss consciousness (experienced vasovagal syncope). Pt regained consciousness within 1minute of episode and subsequently felt nauseous and turned pale. Pt was laid done on exam table and his blood pressure was immediately taken. First two readings were inconclusive/unable to detect BP either due to machine error or hypotension. After 5 minutes BP. Reading was 85/43. Pt was given water and elevated his legs. Waited in the exam room for another 10 minutes. Physician rechecked his vital signs and observed as being normotensive (90/57) with a pulse of 68 bpm. No further complications or adverse affects were noted when patient left office 25 minutes after the injection was given.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Vasovagal syncope- immediately after injection of the vaccine, patient felt light-headed and transiently loss consciousness (experienced vasovagal syncope). Pt regained consciousness within 1minute of episode and subsequently felt nauseous and turned pale. Pt was laid done on exam table and his blood pressure was immediately taken. First two readings were inconclusive/unable to detect BP either due to machine error or hypotension. After 5 minutes BP. Reading was 85/43. Pt was given water and elevated his legs. Waited in the exam room for another 10 minutes. Physician rechecked his vital signs and observed as being normotensive (90/57) with a pulse of 68 bpm. No further complications or adverse affects were noted when patient left office 25 minutes after the injection was given.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Patient became lightheaded diaphoretic with complaint of nausea after vaccine at 1053 VS 93/60 O2 sat 97 P 78 Given juice and crackers. 1055 VS 107/67 P 56 O2 sat 99 denies lightheadedness.
Age: 52.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dizziness
Clinical narrative: Client screened for vaccinations and determined to need above vaccinations. Consent form read to client and answers marked by office screener. RN reviewed consent and client information.  Immunizations given to client  turned around and became dizzy. RN helped client to sit on floor. 12:00 pm BP Right side 120/90 R 15, P 80, awake and answering questions of date, place and time appropriately. Client reports Hx of seizures and current medications taking, Client denies SOB, chest pain, nausea and  had breakfast this am but had not taken Humilin. 12:08 BP Left side 120/90 P 80 Skin warm and dry client. 12:10 Client sitting in chair eating skittles from pocket says "I feel much better" 12: 15 Client walks to parking lot and given ride home per local sheriff just sitting in parking lot after meeting at courthouse. Client will return for bicycle.
Age: 17.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient reported extreme arm soreness in his right arm where the Tdap vaccine was given compared to his left arm.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a 41 year old female registered nurse reporting on herself. No patient's pertinent medical history was reported. The patient's current condition and allergies included drug hypersensitivity to clindamycin, DARVOCET, KEFZOL and REGLAN. Concomitant therapies included EFFEXOR and sumatriptan succinate. On unknown dates in 1977, the patient was vaccinated with 2 doses of M-M-R II for routine vaccination and nursing school (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided). Subsequently, on an unspecified date in approximately February 1995 (also reported as on February or March), the patient was found to have negative titers. Therefore, on unspecified dates in June and July 1995, the patient was vaccinated with a 2 doses of M-M-R II, respectively, for routine vaccination and nursing school (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided). Later on 14-DEC-2018, the patient was found to have negative titers again. The outcome of antibody test negative was reported as not resolved. The reporter's causality assessment between M-M-R II with antibody test negative was not reported.
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. On or about 20-MAR-2014, the patient's health care provider 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. On or about 02-APR-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 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male 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. On or about November 2013, a pharmacist 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. On or about 18-NOV-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 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male 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 2013, a pharmacist 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. On or about 10-DEC-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 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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-MAR-2011, a healthcare provider at a clinic administered the ZOSTAVAX to the patient. On an unknown date in 2012, the patient was treated by a nurse practitioner 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: Vestibular neuronitis
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 06-MAY-2015, a pharmacist at a pharmacy 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 02-AUG-2016, the patient was treated by a physician at a family practice for vestibular neuronitis The patient was diagnosed with vestibular neuronitis 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: 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 29-NOV-2011, a healthcare provider administered the ZOSTAVAX to the patient. 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 providers recommended and/or prescribed ZOSTAVAX to the patient to obtain permanent prevention of shingles and zoster-related injuries. On or about 14-NOV-2007, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 10-MAR-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 zoster vaccine live (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.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UI999AA and expiry date: 06-Apr-2019) via intramuscular route in the right deltoid on 28-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. The patient did not receive any other vaccine. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown if any adverse event occurred or not following the administration of vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Malaise, No adverse event
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who received a second dose of FLUZONE vaccine (batch no: UJ005AF, Expiry: 30-JUN-2019) via intramuscular route in left deltoid on 10-Jan-2019 and also received same vaccine on Oct-2018. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date following vaccination patient came for sick visit. It was actual medication error due to extra dose administered. No adverse effect was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.25
Sex: U
Vaccine: FLUX, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 15 months old two patients (gender unknown) who received vaccine ACT-HIB with an expired diluent. The patient's past medical history and family history were not provided. Concomitant medications included PREVNAR and INFLUENZA VACCINE. On 10-Jan-2019, the patients received a 0.5ml dose of suspect HIB (PRP/T) VACCINE, Lot- diluent U5962AA expiry date- 05-Jan-2019; powder lot UI822AA, expiry date 02-Jun-2019 via unknown route in the left thigh. It was an actual medication error due to Expired product administered. It was reported that two 15 month old patients received ACTHIB with an expired diluent. It was unknown whether patients experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RVX
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who received only the DTAP & IVP portion of vaccine PENTACEL without the HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; PREVNAR; and ROTAVIRUS VACCINE. On 19-Dec-2018, the patient received a third dose of suspect PENTACEL lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to Inappropriate reconstitution technique. Liquid portion of the PENTACEL was used only and didn't give the Lyophilized powder. It was reported that no adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Hypersensitivity, Throat irritation, Urticaria
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old female patient who experienced a severe allergic reaction, while she received vaccine FLUZONE. The patient's past vaccination(s) included FLUARIX with no reactions and never got the flu and everything was fine. The patient's past medical history, concomitant medication and family history were not provided. Notes: Patient has no egg allergy and states that before that she had the flu vaccine for 8 years in a row with no problem. On 30-Nov-2016, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot 41673AB, expiry date 30-Jun-2017 via unknown route in unknown site. On an unknown date, the patient developed a non-serious a severe allergic reaction with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date, the patient developed a non-serious hives with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date, the patient developed a non-serious scratchy throat with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date, the patient developed a non-serious triggered asthma attack with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient had a ER visit to doctor. Lab data was not provided. Final diagnosis was a severe allergic reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a severe allergic reaction, as Unknown for hives, as Unknown for scratchy throat and as Unknown for triggered asthma attack. List of documents held by sender- none.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years 10 month old patient of unknown gender who had swelling and redness while he/she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines. On 03-Dec-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AC via unknown route in the left thigh. On an unknown date, (reported as following day) the patient developed a non-serious swelling and redness following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was also reported that on 05-Dec-2018 patient was returned to the doctor's office. (Other relevant tests included No lab data.). Final diagnosis was had swelling and redness. The patient was treated with HYDROCORTISONE and ANTIHISTAMINES. The patient outcome is reported as Recovered / Resolved on an unknown date swelling and redness. List of documents held by sender- none.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Paralysis
Clinical narrative: Client reported extreme muscle pain and paralysis, she was unable to lift her arm. Reports that she still has muscle pain.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Rash
Clinical narrative: On Friday 1/11/19 developed spots on chest. Went to the doctor and it undetermined if they were due to the SHINGRIX. Saturday developed a rash on chest, side and back. Went to the doctor on Monday where it was determined I definitely  had shingles. I was given a prescription Gabapentin 300 mg and also Lidocaine patches. It is one week today and the rash has increased on back, side and chest and is very painful. and debilitating. Had the original shingles shot on 4/17/2013 without side effects.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Hives and itching at injection site and down to the wrist on the left arm. Patient instructed to take 1-2 tablets of diphenhydramine 25mg and to call back if symptoms are not resolved or become worse.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This serious spontaneous case, initially received on 20-Jun-2018, reported by other health professional and concerns an elderly male patient. The patient's historical condition included sickness (gets sick the same time every year, as reported). On an unspecified date in 2016, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported). On an unspecified date, after the administration of vaccine, the patient experienced serious flu. At the time of this report, the outcome of the event was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, CSF test abnormal, Full blood count, Gait inability, Guillain-Barre syndrome
Clinical narrative: This is serious spontaneous case, initially received on 17-Nov-2017, from other non-health professional (consumer), concerning a 72-year-old, elderly, male patient. The patient's medical history included: cholesterol and high blood pressure (since an unspecified dates). The patient's concomitant medications included atorvastatin calcium for high cholesterol, BYSTOLIC for high blood pressure and hydrochlorothiazide for bladder (as reported). On 02-Dec-2016, the patient was administered with FLUVIRIN Thiomersal (route of administration: intramuscular, anatomical location: left arm and dose, batch number and expiry date: not reported). The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2016. On an unspecified date in Dec-2016, after a week of vaccination, the patient got up but could not walk, had numbness and weakness in his ankles, feet and hands. He also started to experience tingling in hands and sickness. When he walked, he couldn't feel his feet. He did not know where he was going, so he had to pay attention. On 30-Jan-2017, the patient was hospitalized. On an unspecified date, cerebrospinal fluid (CSF) examination was performed, in which Guillain-Barre syndrome was diagnosed, complete blood count test was performed, results were not provided. The patient stayed in hospital for 10 weeks. The patient was treated with intravenous plasma, immunoglobulin and spinal fluids. He could walk with assistance (cane), which had not got over. On 07-Apr-2017, the patient was discharged from the hospital. At the time of this report, the patient had not yet recovered from the event Guillain-Barre syndrome. The reporter assessed the event as serious due to hospitalization and considered the causality of the event as related. Follow-up received on 14-Dec-2017: Indication of the concomitant drug Atorvastatin calcium was changed from cholesterol to high cholesterol. The event numbness of upper extremities was changed to numbness of extremities. Added new symptoms weakness of hands, tingling and malaise. The outcome of the events (hands weakness of, tingling feet/hands and sickness) was not recovered. The reporter confirmed that the patient had no gastrointestinal infection or any other viral infections from Dec-2017. The narrative was amended accordingly. Follow up report received from the reporter on 19-Jan-2018: The patient's relevant lab tests (cerebrospinal fluid [CSF] and complete blood  count test) were  added. The patient's concomitant drug (hydrochlorothiazide) was added. The narrative was amended accordingly.