chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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.   On 20-DEC-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions(for prophylaxis). Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation, patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and referred to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided. On or about 13-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided), as prescribed and/or administered by a health care provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, he was treated at a primary care at for shingles (Herpes zoster). As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, he had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the pt had not recovered from herpes zoster. The causal relationship between zoster vaccine live (ZOSTAVAX) and herpes zoster was reported as related.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer, regarding a case in litigation and refers to a male patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   On or about 26-JAN-2011, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (strength, dosage regimen, route, lot number and expiration date were not reported) for the long-term prevention of shingles and/or zoster related conditions.   On an unspecified date, subsequent to patient's inoculation, he experienced shingles and was treated for a physician due to the event. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the patient had not recovered from the event.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On an unspecified date in 2012, the patient was vaccinated as prescribed with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and/or zoster-related conditions (dose, strength, route of administration and lot number were not reported).  On an unspecified date, the patient developed shingles and was treated by a doctor in an hospital. According to reporter, as a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, 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, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future.  At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for  the long term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future.The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symtoms being reported; the patient had received 3 doses of GARDASIL 9; some of the doses were adminitered off-schedule; This spontaneous report has been received from a pharmacist, concerning a 22 year old female patient.      The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  In approximately August 2018 (also reported as "18 months ago"), the patient was vaccinated  with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot number, expiration date and anatomical location not reported).   In approximately October 2019 (also reported as "4 months ago"), she was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot number, expiration date and anatomical location not reported).   Then on 08-FEB-2020 (reported as 2 days ago, 16 weeks from second dose), she received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number 1602284 has been verified to be valid, expiration date 26-SEP-2021). All the doses were adminitered as prophylaxis. In addition, some of the doses were administered off schedule (inappropriate schedule of product administration). No symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Myasthenic syndrome, Post herpetic neuralgia, Rash vesicular, Vertigo
Clinical narrative: Lambert-Eaton myasthenic syndrome (LEMS); vertigo; migraines; postherpetic neuralgia; zoster like rash in the bilateral breasts; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 11-SEP-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe vertigo and migraines. The patient was hospitalized and diagnosed with Lambert-Eaton myasthenic syndrome (LEMS). A short time later, the patient experienced a zoster like rash in the bilateral breasts and continued to experience postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX).The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, 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 of Company's conduct, 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 reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of vertigo, migraines, LEMS, zoster like rash in the bilateral breasts and postherpetic neuralgia were considered to be disabling. Upon internal review, the event of Lambert-Eaton myasthenic syndrome (LEMS) was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was adminsitered an improperly store dose of Varivax; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 07-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) lot number S024362 with expiration date in 06-AUG-2021 (strength, dosage schedule, route of administration, and anatomical site, were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (DILUENT MRK) lot#S015086, expiration date reported as 06-FEB-2022.  The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature range of -9°C to 8°C (-6.6°C) for the time frame of 2 hours and 38 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was administered an expired dose of PROQUAD; No additional adverse event; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 04-FEB-2020, the patient was administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD), one dosage form as prophylaxis (expired product administered) (lot number R020678 has been verified to be a valid lot number, expiration date reported and validated as 15-JAN-2020) (concentration, dose number, frequency of vaccination scheme, route and anatomical location of vaccination were not reported). Other suspect therapy included the sterile diluent (indication, concentration, dose, frequency, lot number and expiry date were not reported).   No additional adverse events were reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: the patient experienced pain and stiflness in her arm.; the patient experienced pain and stiflness in her arm/the arm is stiff and difficult to move 2 months later; This spontaneous report has been received from a pharmacist, concerning a 71-year-old female patient. Her historical vaccines included FLU vaccine, PREVNAR 13, and ZOSTAVAX. Information about the patient's medical history, as well as concomitant therapies and allergies were not reported.  On 05-DEC-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dosage form, intramuscularly in the right arm, lot number R034248, expiration date 07-AUG-2020 (concentration, and frequency were not reported) as prophylaxis (reported as to complete the pneumonia series recommendation); the patient was also vaccinated with influenza virus vaccine (reported as FLU vaccine) on the left arm.  On the same day (reported as later on 05-DEC-2019), the patient experienced pain (vaccination site pain) and stiffness (injected limb mobility decreased) in her arm. The pharmacist advised patient to ice and took ibuprofen for the pain. The pain has subsided, but the arm was stiff and difficult to move two months later. The patient was seen in February 2020 by the physician who has ordered physical therapy. At the time of this report, the patient was not recovered from the events.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurred events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored dose of varivax; This spontaneous case was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot number S024366, expiry date was reported as 02-MAR-2021 but upon internal validation it was established as 06-AUG-2021 (dose, strength and route of administration were not reported) for prophylaxis (product storage error). The lot underwent a temperature excursion at -14 degree Celsius to -10 degree Celsius for 2 hours 30 minutes and -9 degree Celsius to 8 degree Celsius for 5 hours 40 minutes. There was no previous temperature excursion. The call was placed because of a data logger. There was no product quality complaint (PQC) was present.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Overdose, Pain
Clinical narrative: malaise; soreness; two doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 39KB3, expiry date 11th April 2022) for prophylaxis.   On 1st February 2020, the patient received Shingrix. On 1st February 2020, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the patient experienced malaise and pain. On an unknown date, the outcome of the malaise, pain and overdose were unknown.   It was unknown if the reporter considered the malaise and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On the same day the patient received two doses of Shingrix, which led to overdose. HCP reports less than a week after vaccination, the patient experienced malaise and soreness following administration of 2 doses of Shingrix at the same visit. Only one suspect coded as it was given on same day.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain after receipt; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, every patient he gave Shingrix vaccine to, complained about pain after receipt. There were no details about patients or vaccines collected. The reporter called to show how much he disliked Shingrix and made the above blanket statement.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness that is about a dime size or quarter size in diameter in the site of the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter was a pharmacist reporting on behalf of a consumer. Pharmacist stated that generally, with patients administered the Shingrix vaccine, she saw redness that was about a dime size or quarter size in diameter in the site of the injection. This report was for the anonymous group. No other information was provided on this event. This case is linked with US2020019142, reported by same reporter.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient who is pregnant has been administered with ADACEL/ No AE; Initial information was received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old female patient who during pregnancy received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6628AA) via intramuscular route in the right arm on 04-Feb-2020 for prophylactic vaccination (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The vaccination occurred at 29 weeks of pregnancy, during second pregnancy trimester.  The date of last menstrual period was reported as 12-Jul-2019.  The estimated due date was 17-Apr-2020.  The patient's past medical history, medical treatment(s) and family history were not provided.    It was a case of vaccine exposure during pregnancy.  Laboratory details were not reported.  The patient had no adverse reactions at the time of report.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: a staff member had given ActHib diluted with sterile water instead of normal saline/no ae; Initial information received on 05-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 month old female patient who received 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [Act-HIB] diluted with sterile water instead of normal saline (Product preparation error) (lot UJ118AA, of unknown Expiration date) via unknown route at  the left thigh for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient recieved DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [Daptacel] on 04-Feb-2020 as concomitant medication   It was an actual medication error due to Wrong solution used in drug reconstitution.  At the time of reporting 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 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
Sex: F
Vaccine: FLUX
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA; Initial information was received on 05-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves female patient (unknown age) who experienced SIRVA (shoulder injury related to vaccine administration), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious SIRVA (shoulder injury related to vaccine administration) on an unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  Final diagnosis was shoulder injury related to vaccine administration.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of shoulder injury related to vaccine administration.  Information on the batch number was requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: Red rash; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 53 years old female patient who experienced red rash, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious red rash (rash erythematous) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was provided.  Final diagnosis was red rash.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for red rash.  Information on the batch number was requested.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: pentacel and ActHib was administered on same day/no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and 0.5 ml single dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ098AAA) on 07-FEB-2020 (Extra dose administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) on 07-FEB-2020.  It was of actual medication error due to Extra dose administered.  It was unknown whether adverse event was noted or not.  Information on the batch number of ACT-HIB was requested.  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.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient received just the liquid component of this vaccine without ActHIB portion/no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old male patient who received only DTap and IPV component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without HIB component .(Product preparation issue )  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy included Hepatitis A and influenza vaccines.   On 06-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6257AB via intramuscular route in the left thigh for prophylactic vaccination.  It was of actual medication error due to Inappropriate reconstitution technique.  It was unknown whether adverse event was noted 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.
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Vomiting
Clinical narrative: 4 month old patient receiving the Fluzone HD; fever upto 99.4  degree Celsius; patient had experience vomiting; Initial information received on 05-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who experienced fever up to 99.4 degree celsius (pyrexia) and vomiting (vomiting), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); and HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]).  On 04-Feb-2020, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ307AB  and expiry date: 29-Jun-2020) via unknown route in the left thigh.  On 04-Feb-2020, the patient a non-serious experienced fever up to 99.4 degree Celsius (pyrexia) and vomiting (vomiting), same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, the patient was kept for 15 minutes observation.  Relevant laboratory test results included: Body temperature - On an unknown date: 99.4 Cel  Final diagnosis was vomiting and pyrexia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for both events.  It was actual medication error due to Inappropriate age at vaccine administration .  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.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest X-ray, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: chills,  fever, lightheadedness, chest pain, shortness of breath.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Echocardiogram, Pyrexia
Clinical narrative: chills,  fever, lightheadedness, chest pain, shortness of breath.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: flu like symptoms: beginning with body aches and stiffness, then pain at injection site, then feeling of a fever (though no actual fever) with extreme chills, painful injection site, difficulty raising arm. Feelings started around 5 pm; by 8 PM i had to get into bed. By 1 AM started to feel better, then by 7 AM nearly better except still achy and stiff feeling.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: flu like symptoms: beginning with body aches and stiffness, then pain at injection site, then feeling of a fever (though no actual fever) with extreme chills, painful injection site, difficulty raising arm. Feelings started around 5 pm; by 8 PM i had to get into bed. By 1 AM started to feel better, then by 7 AM nearly better except still achy and stiff feeling.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Face injury, Loss of consciousness
Clinical narrative: After administration of vaccines I had student and mom come in my office to make follow up appointment.  Student did not complain she was not feeling well.  Student was standing  to my left when suddenly student collapse and hit face with floor. Mom picked student up and sat her on the chair, student was in and out, and started projectile vomiting x4.  Student was noted to be pale.  After a few minutes student became more alert. BP 92/70 P 89 R 20  T 98.3.  EMS was called. By the time EMS came in student was alert and oriented, she verbalized everything suddenly went black, she denies any symptoms prior to fainting.  Mom verbalized student becomes very nervous when she is getting vaccines, and feels dizzy but she has never fainted before.  student sent to the ER via stretcher.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, TDAP, VARCEL
Symptoms: Pallor, Pregnancy test negative, Syncope, Vomiting projectile
Clinical narrative: After administration of vaccines I had student and mom come in my office to make follow up appointment.  Student did not complain she was not feeling well.  Student was standing  to my left when suddenly student collapse and hit face with floor. Mom picked student up and sat her on the chair, student was in and out, and started projectile vomiting x4.  Student was noted to be pale.  After a few minutes student became more alert. BP 92/70 P 89 R 20  T 98.3.  EMS was called. By the time EMS came in student was alert and oriented, she verbalized everything suddenly went black, she denies any symptoms prior to fainting.  Mom verbalized student becomes very nervous when she is getting vaccines, and feels dizzy but she has never fainted before.  student sent to the ER via stretcher.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE AND REDNESS ON ARM PROGRESSIVELY WORSENED AFTER FIRST 24-48 HOURS.  NO TREATMENT UP TO NOW. WILL RECOMMEND ICING AND ANTI-INFLAMMATORY MEDICATION.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had shingles after 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date unknown) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left deltoid. The reporter wanted to know, how to proceed with 2nd dose. The reporter did not consent to follow up.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Seizure, Wrong product administered
Clinical narrative: Seizure; Fever; Inadvertently given a dose of Pediarix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of seizure in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included Hib (Hiberix) (batch number S000355 ?, expiry date 10th October 2021) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 15th January 2020, the patient received Pediarix, Hiberix and PREVNAR. On 15th January 2020, unknown after receiving Pediarix and not applicable after receiving Hiberix, the patient experienced wrong vaccine administered. On 16th January 2020, the patient experienced seizure (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the seizure, fever and wrong vaccine administered were unknown.   It was unknown if the reporter considered the seizure and fever to be related to Pediarix and Hiberix.  Additional case details were reported as follows: The patient was inadvertently given a dose of Pediarix instead of Infanrix, which led to wrong vaccine administered.  This should have been dose 4 of DTaP for the patient. The patient also administered Prevenar and Hiberix. The patient experienced a seizure the next morning after vaccination, had fever and taken to the ambulance. It was unknown if the reporter considered the seizure and fever to be related to Prevenar. No further details were provided during the call. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Injection site erythema, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: PT REPORTS ONLY SORE ARM NOTHING UNUSUAL ON FIRST SHOT-2ND SHOT SHE REPORTS SEVERE REDNESS SWELLING AND PAIN (TYPICAL INJXN SITE RXN) LASTING 3-5 DAYS SHE ONLY TOOK OTC PAIN RELIEVERS AND CALLED NO ONE-SHE WENT TO MEDICAL CARE FOR TX FOR CONT. PAIN AROUND THE 5TH OF FEB.  SHE REPORTS ONLY TEMPORARY RELIEF FROM MASSAGE-MUSCLE RELAXERS-ADVIL-TYLENOL. "NOTHING RELIEVES PAIN IN SHOULDER AND UP TOWARD THE NECK" WORSENS W/ TENSION & STRESS
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, X-ray abnormal
Clinical narrative: PT REPORTS ONLY SORE ARM NOTHING UNUSUAL ON FIRST SHOT-2ND SHOT SHE REPORTS SEVERE REDNESS SWELLING AND PAIN (TYPICAL INJXN SITE RXN) LASTING 3-5 DAYS SHE ONLY TOOK OTC PAIN RELIEVERS AND CALLED NO ONE-SHE WENT TO MEDICAL CARE FOR TX FOR CONT. PAIN AROUND THE 5TH OF FEB.  SHE REPORTS ONLY TEMPORARY RELIEF FROM MASSAGE-MUSCLE RELAXERS-ADVIL-TYLENOL. "NOTHING RELIEVES PAIN IN SHOULDER AND UP TOWARD THE NECK" WORSENS W/ TENSION & STRESS
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Condition aggravated, Eczema, Irritability, Rash vesicular
Clinical narrative: elevated temp (Tmax 99); fussiness, varicella rash; flare of eczema;
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site discolouration, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Mom said infant was crying nonstop & vomited 2-3 times after receiving vaccines. He cried himself to sleep around 5pm. He woke up around 7pm and began crying again. Mom changed his diaper and noticed that from his hips down he had bluish-purple discoloration  of his skin and appeared swollen from hips down. Infant had redness and swelling that was hot to touch at injection site in both legs, no fever. Infant was taken to ER via ambulance. Mom stated ER doctor could not determine if infant was having an adverse reaction to vaccines or not. ER doctor did  say the swelling was causing loss of circulation. Infant received Tylenol, a breathing treatment and Pedialyte at ER and was released home around 09:20 PM. Mom said he calmed down after they returned home and began to play. Around 11PM he became fussy again. He took bottle and went to sleep for the night. Tuesday morning  his thighs were still a little swollen and did not want to play much. Mom gave Tylenol as instructed through out the day and his swelling went down and his color returned to normal. Today she can still feel a knot in both legs but are no longer red at injection site. Child is feeling back to normal and playing. Mom plans to take him to see PCP Dr soon. Mom will bring documentation from PCP regarding future vaccines.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site warmth, Irritability, Poor peripheral circulation, Vomiting
Clinical narrative: Mom said infant was crying nonstop & vomited 2-3 times after receiving vaccines. He cried himself to sleep around 5pm. He woke up around 7pm and began crying again. Mom changed his diaper and noticed that from his hips down he had bluish-purple discoloration  of his skin and appeared swollen from hips down. Infant had redness and swelling that was hot to touch at injection site in both legs, no fever. Infant was taken to ER via ambulance. Mom stated ER doctor could not determine if infant was having an adverse reaction to vaccines or not. ER doctor did  say the swelling was causing loss of circulation. Infant received Tylenol, a breathing treatment and Pedialyte at ER and was released home around 09:20 PM. Mom said he calmed down after they returned home and began to play. Around 11PM he became fussy again. He took bottle and went to sleep for the night. Tuesday morning  his thighs were still a little swollen and did not want to play much. Mom gave Tylenol as instructed through out the day and his swelling went down and his color returned to normal. Today she can still feel a knot in both legs but are no longer red at injection site. Child is feeling back to normal and playing. Mom plans to take him to see PCP Dr soon. Mom will bring documentation from PCP regarding future vaccines.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Aspiration, Influenza virus test negative, Pyrexia, Viral test, Vomiting projectile
Clinical narrative: Patient had episode of projectile vomiting with suspected aspiration and subsequent fever on the night of vaccines.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Blood glucose normal, Cold sweat, Discomfort, Dizziness, Electrocardiogram abnormal
Clinical narrative: Within 1 hour of the vaccination, patient was feeling lightheaded and dizzy, but this dissipated within the subsequent 30-60min The night of the vaccine he woke feeling uncomfortable, "clammy", and with diffuse myalgias.  He then went back to sleep and awoke around 1am with "drenching sweats".  Tried to walk to parents' room but peripheral vision became black, ears were ringing, and he felt like he couldn't do anything, then fainted.  No feelings of chest pain or palpitations preceding event. Parents report that he was unresponsive for 3-4 minutes, uncertain if he had a pulse, appeared "blanched" in his face.  Called EMS EMS reports HR 30-40 upon arrival, consciousness returning slowly.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Hyperhidrosis, Myalgia, Pallor, Syncope, Tinnitus
Clinical narrative: Within 1 hour of the vaccination, patient was feeling lightheaded and dizzy, but this dissipated within the subsequent 30-60min The night of the vaccine he woke feeling uncomfortable, "clammy", and with diffuse myalgias.  He then went back to sleep and awoke around 1am with "drenching sweats".  Tried to walk to parents' room but peripheral vision became black, ears were ringing, and he felt like he couldn't do anything, then fainted.  No feelings of chest pain or palpitations preceding event. Parents report that he was unresponsive for 3-4 minutes, uncertain if he had a pulse, appeared "blanched" in his face.  Called EMS EMS reports HR 30-40 upon arrival, consciousness returning slowly.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Unresponsive to stimuli, Visual field defect
Clinical narrative: Within 1 hour of the vaccination, patient was feeling lightheaded and dizzy, but this dissipated within the subsequent 30-60min The night of the vaccine he woke feeling uncomfortable, "clammy", and with diffuse myalgias.  He then went back to sleep and awoke around 1am with "drenching sweats".  Tried to walk to parents' room but peripheral vision became black, ears were ringing, and he felt like he couldn't do anything, then fainted.  No feelings of chest pain or palpitations preceding event. Parents report that he was unresponsive for 3-4 minutes, uncertain if he had a pulse, appeared "blanched" in his face.  Called EMS EMS reports HR 30-40 upon arrival, consciousness returning slowly.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Photopsia, Vision blurred
Clinical narrative: Blurred/Cloudy Vision Flashing lights in the periphery vision.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Nausea, Night sweats, Pain
Clinical narrative: Nausea became constant at 3:00a on 2/11/2020 & still persists; vomited at 4:30a & again at 5:20p on 2/11/2020 & none since; constant headache began on 2/11/2020 after my first vomit at 4:30a & headache still persists; night sweats on 2/11 & 2/12/2020 when in deep sleep;  sore, hot, red & swollen left arm spreading downward half-way to elbow.  Been taking Aleve for headache but not helping
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm, Vomiting
Clinical narrative: Nausea became constant at 3:00a on 2/11/2020 & still persists; vomited at 4:30a & again at 5:20p on 2/11/2020 & none since; constant headache began on 2/11/2020 after my first vomit at 4:30a & headache still persists; night sweats on 2/11 & 2/12/2020 when in deep sleep;  sore, hot, red & swollen left arm spreading downward half-way to elbow.  Been taking Aleve for headache but not helping
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, body ache, nausea
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discolouration, Nodule, Pain
Clinical narrative: Initially it was sore and had a knot which persisted for days. After about a week the area became black and blue and went toward the inside of the arm. He put heating pad when hurting. Latest status, today, Feb 13 is that it is finally getting better per patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Patient presented to clinic on 2/7/2020 with right arm vaccination site redness, swelling, redness.  States redness started one day after the vaccination and spread.  She was treated with 10-day course of doxycycline.  She followed up with pcm on 2/13/2020 and redness had resolved.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: "redness, swelling, warmth, and pain" at the injection site; "redness, swelling, warmth, and pain" at the injection site; "redness, swelling, warmth, and pain" at the injection site; "redness, swelling, warmth, and pain" at the injection site; This spontaneous report was received from a nurse via company representative and refers to a 74-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included: simvastatin (manufacturer unknown), aspirin (reported as baby aspirin) and estrogens, conjugated (PREMARIN). On 08-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route of administration, lot number, expiry date were not provided). On 10-JAN-2020, she experienced redness, swelling, warmth, and pain at the injection site. During the same day, the patient was seen at the office by the physician in which he prescribed sulfamethoxazole (+) trimethoprim (BACTRIM).  Outcome of the events was reported as resolving. Causality assessment between the events and the suspect therapy was not provided.