chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral artery occlusion, Ischaemic stroke, Myocardial infarction, Pneumonia aspiration, Sepsis
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. In or around 31-OCT-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after") receiving the ZOSTAVAX, the patient suffered an ischemic stroke, occlusion of the middle cerebral artery, aspiration pneumonia with sepsis, and myocardial infarction, requiring multiple hospitalizations. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to receiving the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, ischemic stroke/occlusion of the middle cerebral artery; aspiration pneumonia with sepsis; and myocardial infarction were determined to be medically significant. Ischemic stroke/occlusion of the middle cerebral artery; aspiration pneumonia with sepsis; and myocardial infarction were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Eye discharge, Facial paralysis
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. In or around 10-MAY-2017, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately one day after receiving ZOSTAVAX, the patient began to experience right sided ear pain for three days. The patient then suffered sudden and severe right sided facial droop with eye drainage and was hospitalized and diagnosed with Bell's Palsy. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to receiving the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, Bell's Palsy was determined to be medically significant. Bell's Palsy was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-NOV-2018, the patient was vaccinated with VAQTA 25/0.5 (Units not reported) (dose, frequency, route and anatomical location unknown) lot # N026997, Expiration date: 10-NOV-2018 for prophylaxis (expired product administered). No adverse effects reported.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccine of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccines was exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 15 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccine of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 16.0
Sex: U
Vaccine: HEP, HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 17.0
Sex: M
Vaccine: HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 17.0
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided) and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccine of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided). The vaccine were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 15.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 13 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 12.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 12 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 14.0
Sex: M
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 14 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 15 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccine of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 14-NOV-2018 the patient inadvertently vaccinated with expired dose of VAQTA 50/1.0 U/ml (lot # N023953, expiry date: 05-NOV-2018) (dose and frequency were not reported) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-NOV-2018, the patient was vaccinated with varicella VARIVAX (lot # R017944, expiry date: 24-JUN-2020) via intramuscular route rather than subcutaneous route, for prophylaxis (incorrect route of product administration). No adverse effects were reported.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This spontaneous report as received from a registered pharmacist referring to a 72-year old female patient. The patient's current conditions included allergic to sulfa and codeine. Historical drugs included sulfa and codeine. Medical history and concomitant medications were not reported. On 13-NOV-2018, the patient was administered with PNEUMOVAX 23 (Lot: R018741, expiry date: 06-APR-2020) intramuscularly and unspecified influenza vaccine. On 13-NOV-2018, the patient experienced nausea, lightheadedness, swelling and redness at the injection site. No treatment was received for the events. On an unknown date in November 2018, the events was resolving. Causality assessment was not reported for the events.
Sex: U
Vaccine: MMR
Symptoms: Therapy non-responder
Clinical narrative: This retrospective study aimed to assess the prevalence of non-immunity to varicella zoster virus (VZV) and measles in previously immunized pediatric liver transplant (LT) recipients and identify correlative factors. Children who received LT were evaluated for pre-LT immunization and post-LT VZV and measles titers during clinic visits from January 2016 to November 2017. Those who did not receive VZV or measles vaccine prior to LT were excluded from the respective cohort. 72 patients were included in the analysis of measles immunity, and 67 in the analysis of VZV immunity. Median time from LT to titers for measles and VZV were 4.0 (range 0.8-16.3) and 3.2 (0.8-14.0) years, respectively. In the measles cohort, the median age at LT was 3.2 (0.7-16.2) years. Age at LT, age at last pre-LT vaccine dose, number of pre-LT vaccine doses, height and use of whole-liver grafts were each significantly lower for non-immune versus immune patients, and the proportion of patients of ethnicity was greater in the non-immune group. It was concluded that non-immunity to measles and VZV among pediatric LT recipients was common within 3 years after liver transplantation, despite immunization prior to transplant. This literature marketed report as received from the authors of the published literature article, titled as stated above, refers to 16 children of unknown ages and genders. The patients' concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacture unknown) (dose, route, lot# and expiration were not reported) for prophylaxis. On unknown dates, at the post-transplant follow up point, the patients were measles non-immune (therapy non-responder). The outcome of the event was not reported. The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacture unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same literature. Sender's Comments: US-009507513-1811USA005719.
Age: 29.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 29 year old patient. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a properly stored but expired dose of M-M-R II lot # M045400 and expiry date 14-NOV-2018,route via subcutaneously for prophylaxis(expired product administered and no adverse event). No adverse effects and no additional information was provided.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Insomnia, Spinal pain
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 45 years old female patient who experienced burning pain and arm was red from the upper arm injection site to the shoulder, pain in upper spine usually on the left side left but goes to the right and cannot sleep or lay down, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included CELEBREX for unknown indication. On 17-Sep-2018, the patient received a dose of suspect ADACEL lot number and Exp. date not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious burning pain and arm was red from the upper arm injection site to the shoulder (inflammation), pain in upper spine usually on the left side left but goes to the right (spinal pain) and cannot sleep or lay down (insomnia) following the administration of ADACEL. It was reported that, severe pain that lasted for 10-15 days post injection and severe pain still persists. Details of lab data not provided. Final diagnosis was burning pain and arm was red from the upper arm injection site to the shoulder (inflammation), pain in upper spine usually on the left side left but goes to the right (spinal pain) and cannot sleep or lay down (insomnia). It was not reported if the patient received a corrective treatment. The event outcome was not reported. List of documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Exposure via skin contact, Needle issue
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 24-years old male patient who experienced the vaccine squirts out the side and runs down their arm and when they attach the needle it feels loose or jiggly, while he received vaccine TYPHIM VI. The patients past medical history, concomitant medication and family history were not provided. On 10-Nov-2018, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number: NIK911M expiry: 27-Oct-2019 via skin exposure in the left deltoid. On 10-NOV-2018, the patient developed a non-serious the vaccine squirts out the side and runs down their arm (exposure via skin contact) and when they attach the needle it feels loose or jiggly (needle issue) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. (Other relevant tests included no lab data.) Final diagnosis was the vaccine squirts out the side and runs down their arm and when they attach the needle it feels loose or jiggly. It was unknown whether patient experienced any adverse reaction. The patient outcome was reported as Not applicable for all the events. List of documents held by sender- none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA313571and 2018SA314539. This case involves an two-months old patient (gender not reported) who received only liquid portion of PENTACEL, while received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate reconstitution technique. (It was reported that the patient received only liquid portion of PENTACEL). It was not reported that 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 holders 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: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to cases 2018SA313571 and 2018SA314537 (same reporter). This case involves 06 Month- old- patient (gender not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 08-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that patient received only liquid portion of PENTACEL.  It was not reported if the patient experienced any adverse event or not.  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: M
Vaccine: DTAPIPVHIB, HEP, PNC, RVX
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a five- months old male patient who was vaccinated with a third dose of PENTACEL (lot C5447AA; expiry date: 18-Oct-2019 via intramuscular route on 13-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PREVNAR for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that only gave the liquid diluent portion of the suspect and did not mix the ACTHIB dry powder portion with it before administering the vaccine. The patient did not show any signs of any AE's at the time. 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 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: 0.17
Sex: U
Vaccine: DTAPIPVHIB, HIBV, PNC13, RVX
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient who received dose of each vaccines PENTACEL (HIB lot number C5507AA, expiration date: 05-Sep-2019, IPV lot number C5324AC, expiration date: 05-Sep-2019) via unknown route in the right thigh and ACTtHIB (lot UI910AA, expiration date: 18-Nov-2019) via unknown route in the left thigh on 13-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The subject received concomitant medication with ROTAVIRUS VACCINE and PREVNAR 13 on 13-Nov-2018. It was a case of actual medication error due to extra dose administered. It was not reported if patients had any adverse event. It was also reported that child did not receive Hep B at this appointment. This was the child's first dose in the series of PENTACEL. 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: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a four months old female patient who was vaccinated with the components of PENTACEL separately and mixed the HIB with sterile water rather than 0.4% saline on 13-Nov-2018 (HIB batch number: C55428A, Expiry date: 08-SEP-2019 and IPV lot number: C5408AA, expiry date: 08-Sep-2019). The subject received the vaccine in the left thigh The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was an actual medication error due to inappropriate reconstitution technique. The patient had no 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.
Age: 23.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient ran fever greater than 102 degrees, muscles aches, nausea, headache, chills lasting until 11/19/18.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Malaise, Nausea
Clinical narrative: Immediately after receiving vaccine in right arm, patient felt nauseated and ill. The next day she reported a rash wrapping around the right arm with swelling, had sharp pain, and cannot lift right arm per mother's report. Her left arm had burning in the fingers and was sore. She had a fever of 102 for two days. Mother called on 11/16/2018 to report incident and that she was taking her daughter to the ER that night. A student nurse administered the vaccines. Called mother on 11/19/2018 to see if she took her daughter to the ER and the outcome. Left mother a message.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Immediately after receiving vaccine in right arm, patient felt nauseated and ill. The next day she reported a rash wrapping around the right arm with swelling, had sharp pain, and cannot lift right arm per mother's report. Her left arm had burning in the fingers and was sore. She had a fever of 102 for two days. Mother called on 11/16/2018 to report incident and that she was taking her daughter to the ER that night. A student nurse administered the vaccines. Called mother on 11/19/2018 to see if she took her daughter to the ER and the outcome. Left mother a message.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Extreme soreness two weeks later. Sharp pains when lifting arm. The pain is keeping me awake at night.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Injection site pain
Clinical narrative: Painful at time of injection nauseous headache up shivering all night feel like I have a fever feel like I might have diarrhea general feeling of the bad flu.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: Painful at time of injection nauseous headache up shivering all night feel like I have a fever feel like I might have diarrhea general feeling of the bad flu.
Age: 1.42
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received Dtap, Influenza on 11/14/2018 and returned to the site with her left leg red with swelling noted around the injection site. Swelling is increasing after home interventions, ice and ointment.
Age: 35.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Staff reported that her arm swelled at the injection site left arm the evening of receiving the injection. Her arm was swollen (at the injection site, warm to touch with a hard knot.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Body temperature increased, Erythema, Hypersensitivity, Injection site reaction, Rash
Clinical narrative: Immunizations were given. Mom got baby dressed left the room and noticed infant's face was red/blotchy (approx within 3 min or less). Face remained red/blotchy and had a few red raised bumps on forehead. There were a few red raised pinpoint bumps around vaccination site (where INFANRIX was given). Infant was stable, no respiratory issues. Mom took infant to pediatrician. They told her it was an allergic reaction. No meds or interventions given. They gave her advice of symptoms that would require emergency attention. After immunization was given infant's mother stated mother was allergic to DTAP immunization and mother has had hives in the past after receiving it.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Immunizations were given. Mom got baby dressed left the room and noticed infant's face was red/blotchy (approx within 3 min or less). Face remained red/blotchy and had a few red raised bumps on forehead. There were a few red raised pinpoint bumps around vaccination site (where INFANRIX was given). Infant was stable, no respiratory issues. Mom took infant to pediatrician. They told her it was an allergic reaction. No meds or interventions given. They gave her advice of symptoms that would require emergency attention. After immunization was given infant's mother stated mother was allergic to DTAP immunization and mother has had hives in the past after receiving it.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Severe injection site pain began about four hours later, spread across to involve the whole shoulder. By evening it was pain level 8/10 and needed oxycodone for some relief (1 pill every 4 hours X3). Pain slowly improved over the next 48 hours and is now level 1-2.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pain in extremity
Clinical narrative: RECEIVED T/C FROM PATIENT ON 11/15/18, REPORTING HAS BEEN EXPERIENCING BAD PAIN ON LEFT ARM, SINCE RECEIVING HEPATITIS A & FLU VACCINE ON 10/20/18, ADMINISTERED BY US; REPORTED PAIN HAS BEEN ONGOING SINCE VACCINES RCVD, DENIED ANY OTHER SYMPTOMS, STATED HAS NEVER TAKEN ANY PAIN MED OR APPLIED ANY COMFORT MEASURES TO ALLEVIATE PAIN. SHE WAS ADVISED TO TAKE MOTRIN (otc) & SCHEDULE MD APPT ASAP FOR EVALUATION; SHE AGREED TO SEE MD TODAY(11/15) & CALL BACK WITH OUTCOME OF VISIT.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Child broke out with facial hives the same evening the vaccines were administered. According to the ED report the reaction was mild and could have been a result of an allergic reaction to his vaccinations. Child was given a prescription for Prednisolone 4 mg PO Q 8 hr for 2 days.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Patient reported on 11/16/18 that he has had soreness in left arm since 10/15/18.
Age: 51.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Lack of appetite, Achy, Stiff, mild headache and tired entire body. No fever, No nausea, No vomiting.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pruritus, Swelling
Clinical narrative: I noticed significant swelling bilaterally in my supraclavicular areas that started approximately 18 hours after the vaccine. I have never had any swelling like this before so I completely attribute this to the vaccine. My fellow medical staff coworkers also noticed it too and were concerned. It was itchy like and palpated spongy and felt very uncomfortable. I was also concerned for my airway as it was very close to the neck. It took about 36-48 hours to go away. I contacted my employee health staff. This makes me very concerned for future flu vaccines.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient called and reports arm is still sore and pain at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, headache, fatigue.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The area was inflamed, itchy, raised and warm to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event- wrong immunizations given. Zoster instead of VARIVAX.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: PT HAD MENVEO 11/14/18 AT VACCINATION FAIR. PT C/O FEVER, HEADACHE, AND SORE ARM AT SITE OF INJECTION. SUBJECTIVE FEVER AND CHILLS AT HOME. HIGHEST DOCUMENTED TEMP IN CLINIC IS 100.7; SUPPORTIVE CARE AND MONITORED SYMPTOMS. NSAIDS AS NEEDED. REASSURANCE. F/U IF SYMPTOMS WORSEN. PT COMFORTABLE WITH PLAN AND AGREES TO RTC IF NOT IMPROVING. RTC TOMORROW FOR PPD READ.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: She had redness and rash and itching at the site of injection ~30 minutes after injection. BENADRYL 1mg/kg PO was given in office with plan to continue BENADRYL 0.5mg/kg q6 hours for 24 hours. No wheezing, true hives, or other signs of anaphylaxis were noted.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: Tingling/numbness on left side of body, extreme pain at area surrounding injection site, difficulty moving left side extremities.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Saturday morning woke up with painful swollen injection site - about the size of 3" x 1". Warm to touch, hard lump, tender to touch. Still there but reduced on Monday.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Saturday morning woke up to muscle ache and poor temperature regulation (Hot then cold then hot then cold)  as day progressed had headache and fatigue - by end of day Saturday had swollen area at injection site (red, hard lump about 2.5" x 1") other symptoms resolved by Sunday morning.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Temperature regulation disorder
Clinical narrative: Saturday morning woke up to muscle ache and poor temperature regulation (Hot then cold then hot then cold)  as day progressed had headache and fatigue - by end of day Saturday had swollen area at injection site (red, hard lump about 2.5" x 1") other symptoms resolved by Sunday morning.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Rash
Clinical narrative: ON SATURDAY 11/17/18. You received a FLUZONE IM injection. A rash started Sunday (next day) about 5 inches long and 4 inches wide and soreness and redness.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, very tired, low fever, dizzy.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea
Clinical narrative: Feels anthrax immunization caused chronic diarrhea. Causality Assessment: Indeterminate.
Age: 57.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Severe body aches, chills, fever, and nausea started one day after vaccination and have continued for past 24 hours.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram cerebral normal, Aphasia, Arteriogram carotid normal, Asthenia, Atrial fibrillation
Clinical narrative: She didn't feel well when driving from Pharmacy (where she received the vaccines) to coffee shop. When she got home she felt "really ill." She states she was unable to take her dog out and never drank her coffee. She went to the den to lie down and husband found her at 530pm "wiped out." She had a metallic taste in her mouth and was "freezing." She went to bed at 7pm and had chills. Saturday she continued to have chills and the metallic taste and no energy. Sunday was the same. She was unable to go to church. She went back to bed at 1:30 pm and got up at 3:30 pm. Her husband said her face was drawn and she was slurring her speech. He took her to the ER. CT Head and CTA Head and Neck were unremarkable. An MRI 9/2/18 showed a small acute ischemic infarct in the left insular cortex and tiny focal acute ischemic infarct in the left cerebellum. She was transferred to Medical Center for further care. Overnight on 9/3/18 she had episodes of atrial fibrillation and was started on ELIQUIS. Metoprolol was started as well for elevated heart rate. Echocardiogram and EKG were normal. She was discharged 9/4/18. She is doing well except some difficulty with words if she is tired. She also tires more easily. 10/16/2018 The patient is a 73 year old female who presents for a follow up visit. The patient's last visit was 1 month ago. The patient's chronic conditions included Dysthymia and hyperlipidemia. The patient feels well with minor complaints. The patient was here in September for a hospital follow up for CVA. The patient reports she is not experiencing any side effects on her new medications: ELIQUIS, Metoprolol, Fish Oil, and LIPITOR. She was experiencing a lot of fatigue with the Metoprolol 1/2 BID so Dr. changed it to 1 tab QHS and that has helped. The patient would like to know when she will be cleared to drive. She was referred to Dr. at her last visit, but has not been seen yet. The patient also states there are times she feels like she can't take a deep breath. The patient is declining the flu vaccine and further vaccinations because she the SHINGRIX made her "deathly ill." 11/19/2018 It has been 6 weeks since her stroke and she is doing very well. I have told her today that she can drive.