chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 05-JAN-2011, the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On unknown date, the patient experienced shingles and in approximately 14-NOV-2011, the patient was treated 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 patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; 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 included 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. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. On or about 27-OCT-2010 and 05-NOV-2010, the patient was inoculated with the ZOSTAVAX (strength, dose, frequency, route, lot # and expiry date were not reported) by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries. On unspecified date, the patient was diagnosed with shingles and/or other zoster-related injuries despite being inoculated with the ZOSTAVAX (vaccination failure), and suffered serious physical, emotional, and economic damages as a result of injuries. On or about 02-DEC-2015, the patient was treated by a healthcare provider for herpes zoster opthalmicus. It was reported that, as a direct and proximate result of cine live ZOSTAVAX, the patient had and would continue to suffer ongoing injuries, including but not limited to mental and physical pain and suffering; extensive medical care and treatment of these injuries. The outcome of the events was unknown. The causality assessment was related. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Severe pain in left deltoid within hours with limited range of motion. Pain continuing for three+ weeks with movement of arm or contact with area of injection. Initial pain was 8 out of 10; continuing pain 6 out of 10 with no lessening over time.
Age: 53.0
Sex: M
Vaccine: FLUR4, HEPA, PNC13, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric Hep A given to an adult patient.
Age: 35.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose given to adult patient.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, aches in my whole body, headache, fatigue that sent me to bed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Muscle spasms
Clinical narrative: Shoulder mobility decreased, unable to lift vertically or horizontally up past breast height/ muscle spasms in shoulder area and occasionally radiating  to neck/fingers on let hand are curling inward towards palm.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Severe swelling from shoulder to elbow on back of arm. Moderate pain at injection site. Itches. Hot to touch.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood test, Depression, Fatigue, Hypersomnia
Clinical narrative: This spontaneous report was received from a consumer via company representative and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On 04-APR-2009, 02-JUN-2009 and 24-SEP-2009, the patient was vaccinated with GARDASIL dose (lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient began feeling extremely tired and would need to take frequent naps. The patient was playing softball and dancing at the time and was previously very active. Through high school and into collage, she had several blood work-ups, referrals to the endocrinologist, multiple therapist looking at depression, a sleep study and nutritionist. She gained weight and her hair thinned. She was diagnosed with hypersomnia. The outcome of hypersomnia, fatigue, alopecia, weight increased and depression was reported as recovering. The causality assessment was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep study, Weight increased
Clinical narrative: This spontaneous report was received from a consumer via company representative and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On 04-APR-2009, 02-JUN-2009 and 24-SEP-2009, the patient was vaccinated with GARDASIL dose (lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient began feeling extremely tired and would need to take frequent naps. The patient was playing softball and dancing at the time and was previously very active. Through high school and into collage, she had several blood work-ups, referrals to the endocrinologist, multiple therapist looking at depression, a sleep study and nutritionist. She gained weight and her hair thinned. She was diagnosed with hypersomnia. The outcome of hypersomnia, fatigue, alopecia, weight increased and depression was reported as recovering. The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning about a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 28-SEP-2018, the patient was vaccinated with the first dose of GARDASIL 9. On 26-OCT-2018, the patient was vaccinated with the second dose of GARDASIL 9, indicated as prophylaxis (lot number: R023608, expiration date: 30-APR-2021). On 02-NOV-2018, the patient was vaccinated with the third dose of GARDASIL 9 (lot number: R023608, expiration date: 30-APR-2021), all the doses indicated for prophylaxis (strength, dose, route of administration, and anatomical site were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. On 03-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (dose not reported, lot # R017900, expiration date 26-MAR-2020) for prophylaxis. The prefilled syringes he was vaccinated with contained multiple black pinpoint specks under the labels. No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant referring to an adult patient of an unknown age and unknown gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date the patient received a dose of a pediatric (25/0.5) VAQTA intramuscularly (lot# and expiration date were unknown by the reporter) instead of the adult VAQTA. The reporter did not report any adverse effects and did not provide further information. The action taken in regards of the event was not applicable. At the time of the report the outcome of the event was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received on 12-NOV-2018 from a pharmacist regarding a patient, of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications, drug reactions, allergies or concurrent conditions reported at the time of this report. On 10-NOV-2018 the patient received a (the fourth dose) of GARDASIL 9 for prophylaxis (lot #N035032, expiration date 24-SEP-2020) (strength, anatomical location, route of administration were not reported). The reporter does not have the dates of administration, lot numbers and expiration dates of the previous three doses. At the time of this report, the causality assessment, the outcome and the action taken were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-NOV-2015, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, 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 patient's injuries. The patient was treated by a healthcare provider for shingles on or about 05-JAN-2017. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2015, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was vaccinated with a ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2012, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 12-DEC-2012 and 09-JAN-2017, the patient was treated for shingles and neuralgia along with post-herpetic neuralgia. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-JUN-2009, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, 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 patient's injuries. The patient was treated by a healthcare provider for shingles in 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In February 2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In November 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication provided. On 12-NOV-2018, the patient was vaccinated with an expired dose of VAQTA lot # N030286, expiry date 10-NOV-2018, intramuscularly for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA009194.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication provided. On 14-NOV-2018, the patient was vaccinated with an expired dose of VAQTA lot # N030286, expiry date 10-NOV-2018, intramuscularly for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA009191.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 11-JUL-2014, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff). This case involves a 54 years old male patient who received a 0.5 ml dose of FLUZONE QUADRIVALENT intramuscularly in left deltoid on 16-Nov-2018 (lot number: QFAA1835, expiry date: 30-Jun-2019). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy reported. It was actual medication error (Incorrect product storage) because it was reported that vaccine refrigerator experienced a temperature excursion, which reached a low temperature of -0.78 degrees celsius and was out of range for 1 hour, the patient was administered fluzone quad only, as well as potential medication error as other vaccines ADACEL, MENACTRA, FLUBLOK QIV, FLUZONE HIGH DOSE and FLUZONE QUADRIVALENT and TUBERSOL were exposed to temperature excursion only and not administered. It was not reported if the patient experienced any adverse event. 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. List of document held: none.
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who was vaccinated with ADACEL on 26-Oct-2018 and inadvertently intramuscular dose was vaccinated with the same vaccine in the left arm (lot number: U5980DA, expiry date: 22-Jun-2020) instead of INFLUENZA VACCINE on 16-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and Extra dose administered. The patient did not experience any side effects from his injection 3 weeks ago. 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. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to case 2018SA320304 (same reporter). This case involves a 3 years old (reported as 3 years and 7 months) female patient who was vaccinated with 0.5 ml once dose of FLUBLOK (Batch number: QFAA1804 and expiration date: 01-Jun-2018) in the right deltoid instead of FLUZONE QUADRIVALENT on 17-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the 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: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 30 months old male patient who had received today 0.5 ml instead of the 0.25 ml dose im rt thigh, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose instead of 0.25 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ070AA via intramuscular route in the right thigh. It was a case of actual medication error due to overdose. The patient outcome is reported as Not Applicable for 30 month old male child today 0.5 ml instead of the 0.25 ml dose im rt thigh. 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.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 24 years old male patient who experienced seizure, while he received vaccine FLUZONE. The patient's concomitant medical condition included Bipolar disorder and Anxiety (patient stated that he has a history of being bipolar and having anxiety for which he takes Lamotrigine). Concomitant therapy included LAMOTRIGINE (details not reported). The patient is not complaint with his lamotrigine. The patient's past vaccination(s) and family history were not provided. Concomitant medication was none. Reported other vaccine none. On 12-Nov-2018, the patient received a First dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AC via unknown route. On 15-Nov-2018, the patient developed a serious seizure 3 days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. It was also reported that seizure to be due to his non-compliance with this therapy. (Other relevant tests included No lab data.) Final diagnosis was seizure. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for seizure. List of documents held by sender: none. Sender's Comments: 24 years old male Patient experienced seizure 3 days after vaccination. Time to onset is compatible with the role of vaccine. Patient had medical history of being bipolar and having anxiety for which he takes lamotrigine.  However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to case 2018SA320066 (same reporter). This case involves a 14 years old female patient who was vaccinated with 0.5 ml once dose of FLUBLOK (Batch number: QFAA1804 and expiration date: 01-Jun-2019) instead of FLUZONE QUADRIVALENT, on 17-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred following the 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.
Sex: F
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves female patient who was vaccinated with ADACEL (batch number, expiration date, dose, route and site of administration was not reported) each week for five week, on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Wrong technique in product usage process. It was unknown whether the patient had any adverse event. 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: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 68 years old male patient who was vaccinated with a 0.5 ml dose of ADACEL (Batch number: U6103AA, expiration date: 25-Oct-2020, site of administration: left deltoid and route was not reported) on 19-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. ADACEL was shipped to them and then they received something stating that the arrival time was longer than normal and that ADACEL is no good and the invalid ADACEL vaccine was vaccinated. It was unknown whether patient experienced any adverse event following vaccination. 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.
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 57 years old male patient who was vaccinated with 0.5 ml FLUBLOK QIV (batch number: QFAA1830, expiration date: 30-Jun-2019, route of administration was not reported) in left deltoid, on 19-Nov-2018. Some time later, the ordering department contacted the medical staff and informed them that this shipment took longer than the allotted 2 days. The patient's medical history was not reported. Concomitant medications included PNEUMOVAX 23 for Immunisation. It was an actual medication error due to incorrect product storage. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Syringe issue
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient (age and gender was not reported) and reported where you screw the needle on, there is a circular plastic piece, separate from the syringe itself that is very loose, while he/she received vaccine TYPHIM VI (lot number: N1K81 and expiry date: 19-Oct-2019) (dose, dose in series, route and site of administration was not reported). It was case of potential medication error due to needle issue. 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 35 years old female patient who received vaccine FLUZONE QUADRIVALENT lot number UJ069AA, expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine underdose. It was reported that to give a nonpregnant female patient her flu shot 0.5 ml IM in the left deltoid and some drops came out. They are concerned she didn't get her full dose. It was unknown if any adverse event was 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 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.
Sex: F
Vaccine: MNQ
Symptoms: Hypertension
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer by the patient via an affiliate. This case involves an unknown age female patient who experienced intermittent high blood pressure, while she received vaccine MENACTRA and SOLIRIS. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On 06-Sep-2018, the patient started taking SOLIRIS 300 mg intravenous (with an unknown batch number) for myasthenia gravis. On 28-Oct-2018, the patient experienced a non-serious intermittent high blood pressure 1 month 22 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and SOLIRIS. Other relevant tests included no lab data. Final diagnosis was intermittent high blood pressure. It was not reported if the patient received a corrective treatment. On 30-Oct-2018, the patient was recovered from the events. List of documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Dizziness, Vision blurred
Clinical narrative: Pt provided with lollipop before vaccines. Pt c/o of dizziness, blurred vision after HPV vaccine. OJ and water provided, pt placed in Trendelenburg position, cool compress to head. BP taken, 105/86, 96/58, 108/71. Pt observed for 25 min, verbalizes dizziness is gone, vision is improving. Spoke with mom 11/23, states pt felt better 11/22, arm is sore, no more c/o dizziness or blurred vision.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rotator cuff syndrome
Clinical narrative: Four plus weeks after injection still experiencing pain particular at night. Per a surgeon consulted the symptoms are those of a rotator cuff problem. Believe that the injection may not have been properly done.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: Pt started having nausea and vomiting and diarrhea about 24 hours after the vaccine. The patient feels tired and weak. Pt was advised to take IMODIUM, Gatorade, eat crackers/soup and go to the doctors if it doesn't resolve in 24 hours. Since it was the holiday pt wanted to wait it out. Since then pt has vomiting only (11/23/18) and was again advised that pt should seek MD care if it hasn't resolved as it may be a stomach bug or other issue. Pt is thinking it is related to the vaccine. No fever/cough or any other issue.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: FEVER OF 103, EXTREME SORENESS, SWELLING AND REDNESS (WHICH WENT DOWN PAST ELBOW). PATIENT STATES TOOK ORAL PAIN RELIEVER. SYMPTOMS SUBSIDED. PATIENT WILL CONTACT FAMILY PHYSICIAN.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient 's left arm was warm to touch, erythematous, edematous, pruritic and painful. Dr. ordered DURICEF 500mg x 5 days.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient stated arms was sore at injection site next morning (11-20-18), and red and swollen from site to about halfway to elbow. On 11-22-18, was more swollen and red to elbow. Today, 11-23-18, patient states arm better, swelling and redness less. Patient stated his doctor was out, but that he would see him tomorrow if not resolved.
Age: 89.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nodule, Pain in extremity
Clinical narrative: Wed. I got the shot at 11:00 am - at 6:30 PM I got a pain in my shoulder. On Sat night 7:00 PM my muscle froze into a hard knot. The pain in my shoulder and arm remained. I used Aspirin for pain and a heating pad 3 times a day. Today is next Sat., the pain is slight.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 07-NOV-2018, the patient was vaccinated with PROQUAD lot # N010865 with an expiration date on 01-OCT-2018 (expired product administered) for prophylaxis, reconstituted in a sterile diluent (lot# 014020 and expiration date: 23-JUL-2019). No adverse effects were reported. The outcome of the events was unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-NOV-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB intramuscularly (dose was not provided, lot # R013569, expiration date 18-MAR-2021) for prophylaxis. No adverse effects reported. Digital data logger was involved. The vaccine experienced temperature excursions below 32 degrees Fahrenheit (28.4 degrees Fahrenheit) for 80 hours. There were no previous temperature excursions.
Age: 1.0
Sex: M
Vaccine: DTAP, FLUX, MMR, VARCEL
Symptoms: Measles post vaccine, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report was received from patient's great grandmother concerning his 1-year old male great grandson. Concomitant medication included Flu shot and DtAP. The patient had no pertinent medical history or drug reactions/allergies. The patient's current conditions were not reported. On 02-NOV-2018 (after his first birthday), the patient was vaccinated with M-M-R II injection, 0.5 ml once, indicated as routine vaccination (prophylaxis) (anatomical injection site was not provided). The reported lot number was N009799 and expiration date was 24-MAR-2019. Other suspect therapy included varicella virus vaccine live (Oka/Merck) (manufacturer unknown) administered on the same (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided). In November 2018 (reported as 09-NOV-2018 or 10-NOV-2018), the patient developed a measles rash starting on his buttocks and back which has since spread to the rest of his body. Also, the patient developed a fever of 100.4 degrees. The patient sought for medical attention and received treatment for the adverse events by seeing the doctor. There were no lab diagnostic studies performed. At the time of this report, the patient recovered from the fever, but the patient still had the measles rash. The causality assessment between the suspect therapies and the adverse events was not reported. Upon internal review, Measles was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, 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 patient's injuries. The patient was treated by a healthcare provider for shingles in November 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.