chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Vital functions abnormal
Clinical narrative: patient fainted; become dizzy; his vitals dropped as well; mild fevers; loss of appetite; lethargic; This spontaneous report was received from a physician and refers to a approximately 16-years-old male patient. The patient's drug reactions or allergies, medical history and concomitant medications were not reported.     On an unknown date in December 2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date, dose and route of administration were not reported) as prophylaxis. He had mild fevers, loss of appetite and was lethargic for the following 4 days. On an unknown date, he recovered from that events.  On 26-FEB-2019 at 15:10, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date and dose were not reported) administered in the left arm as prophylaxis. On that day, he become dizzy and fainted. He was monitored for about 20 minutes afterward because his vitals dropped as well. At the reporting time, he was doing better and on an unknown date in 2019, he recovered from the events. However, reporter was worried about the patient's 3rd dose and whether he should have it because the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) "dose not bode well" with him.  The relatedness between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the syncope was determined to be medically significant.
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 (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JUN-2010, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation on an unknown date, pt was treated by a healthcare provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt 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. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). The outcome of the event was not recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date in 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) in the hospital for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would 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. The outcome of shingles was reported as not recovered.  The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; a patient was asministered improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rha) lot number S013715 with expiration date on 01-NOV-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion from 5  to 46 degrees Fahrenheit (F)  for 6 hours and 15 minutes. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Rash, Rash erythematous, Vaccination complication
Clinical narrative: painfully red acute rash/dermatitis on his left arm diagnosed as an adverse effect to shingles vaccine; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 09-OCT-2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.   On or about 11-OCT-2017 (reported as 2 days after received the vaccine), the patient experienced painfully red acute rash/dermatitis on his left arm diagnosed as an adverse effect to shingles vaccine. The patient did not recover from the event. As per the reporter, the patient sustained severe and permanent personal injuries. The event was disabling.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a consumer (reported as spouse) referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 06-FEB-2011, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported; the patient received a dose of PEDVAXIB instead of MENACTRA today; This spontaneous report was received from a medical assistant concerning to a 17-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 09-OCT-2019 (reported as today), the patient received 1 dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (route of administration and anatomical location were not reported) (lot# R027320, expiration date: 08-JUL-2021) for prophylaxis instead of a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (wrong product administered); nevertheless, it was not a product confusion. No adverse effects and no product quality complaints were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; the patient received her first dose of the GARDASIL 9 on an unspecified date in January 2019 and received the second dose on 09-OCT-2019; This spontaneous report was received from a pharmacist concerning to a female patient of unknown age.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unspecified day in January 2019, the patient received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 09-OCT-2019, the patient received her second dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; an expired dose of VAQTA was administered to the patient; 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, drug reactions/allergies and concomitant medications were not provided.     On 08-OCT-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R021233 (verified to be a valid lot number), expiration date reported and established as 05-SEP-2019, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; received improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-AUG-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) with lot # R019237, expiration date 04-JUL-2020 or lot# S005078, with expiration date 19-FEB-2021 , for prophylaxis (dose and route of administration were not reported) and was reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT).     The administered dose of the vaccine experienced a temperature excursion -14°C to -10°C (-9.74 C) degrees Celsius for an unknown time frame.   There was no adverse effect reported.  This call was because of a data logger and there were no previous temperature excursion.  No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) with lot # R019237, expiration date 04-JUL-2020 or lot# S005078, with expiration date 19-FEB-2021 , for prophylaxis (dose and route of administration were not reported) and was reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT).     The administered dose of the vaccine experienced a temperature excursion -14°C to -10°C (-9.74 C) degrees Celsius for an unknown time frame.   There was no adverse effect reported.  This call was because of a data logger and there were no previous temperature excursion.  No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) with lot # R019237, expiration date 04-JUL-2020 or lot# S005078, with expiration date 19-FEB-2021 , for prophylaxis (dose and route of administration were not reported) and was reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT).     The administered dose of the vaccine experienced a temperature excursion -14°C to -10°C (-9.74 C) degrees Celsius for an unknown time frame.   There was no adverse effect reported.  This call was because of a data logger and there were no previous temperature excursion.  No product quality complaint was involved.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: High Fever; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 9-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number H47PB, expiry date unknown) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season. On an unknown date, couple of days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter came in with sibling and each had flu shot and mother called couple of days later with complaints of high fever 105, 104 degrees F. The reporter agreed to follow up with GlaxoSmithKline. The case has been linked to the case US2019AMR178742, reported by same reporter.  .
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Bad reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he patient had bad reactions to the Shingrix vaccine. The reporter did not consent to follow up. The reporter has no other information for this adverse event. This case linked with US2019179915, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Tetanus with an associated reaction of pain in extremity (had sore arm like a tetanus shot).   On 3rd October 2019, the patient received the 1st dose of Shingrix. On 3rd October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. After vaccination with dose of Shingrix, the patient had sore arm like a tetanus shot. The patient wanted to know the average time for those who do get side effects. The patient did not contact to physician for the sore arm experienced.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Headache, Malaise, Nausea, Product administered at inappropriate site
Clinical narrative: Vomited; Fatigue; Nausea; Headache; Not feeling well; Wrong Injection Technique; Wrong Injection Technique; This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 15-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of RabAvert. On 27th September 2019, the patient received the 1st dose of RabAvert. On an unknown date, less than a day after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced vomiting, fatigue, nausea, headache, feeling unwell, vaccine administered at inappropriate site and vaccine administered at inappropriate site. On an unknown date, the outcome of the vomiting and headache were recovered/resolved and the outcome of the fatigue, nausea, feeling unwell, vaccine administered at inappropriate site and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the vomiting, fatigue, nausea, headache and feeling unwell to be related to RabAvert.  Aditional details were provided as follows: The batch number and expiry date of RabAvert was unknown. The nurse reported that, the patient received 1st and 2nd dose of RabAvert (post-exposure) in the buttocks, which led to vaccine administered at inappropriate site. After vaccination with dose of RabAvert, the patient had fatigue, vomited one time, nausea, headache and overall was not feeling good. On the day of reporting, the patient's mother reported that, the patient had no further vomitting, he was hungry and the headache has improved. The RabAvert administered in the emergency room, and not at office contact was calling from. No further contact information provided for hospital. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Vomited; Fatigue; Nausea; Headache; Not feeling well; Wrong Injection Technique; Wrong Injection Technique; This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 15-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of RabAvert. On 27th September 2019, the patient received the 1st dose of RabAvert. On an unknown date, less than a day after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced vomiting, fatigue, nausea, headache, feeling unwell, vaccine administered at inappropriate site and vaccine administered at inappropriate site. On an unknown date, the outcome of the vomiting and headache were recovered/resolved and the outcome of the fatigue, nausea, feeling unwell, vaccine administered at inappropriate site and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the vomiting, fatigue, nausea, headache and feeling unwell to be related to RabAvert.  Aditional details were provided as follows: The batch number and expiry date of RabAvert was unknown. The nurse reported that, the patient received 1st and 2nd dose of RabAvert (post-exposure) in the buttocks, which led to vaccine administered at inappropriate site. After vaccination with dose of RabAvert, the patient had fatigue, vomited one time, nausea, headache and overall was not feeling good. On the day of reporting, the patient's mother reported that, the patient had no further vomitting, he was hungry and the headache has improved. The RabAvert administered in the emergency room, and not at office contact was calling from. No further contact information provided for hospital. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness at injection site; warmth at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were resolved with sequelae.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional case details were provided as follows: The patient reported for herself. The patient developed redness and warmth at the injection site after receiving Shingrix. She disconnected the call before providing mailing address, date of birth or any additional details regarding event. For tolerance after 2nd dose refer case US2019178944. The case US2019AMR179518 has been identified as duplicate of  US2019178944, will be deleted.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Bad reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he patient had bad reactions to the Shingrix vaccine. The reporter did not consent to follow up. The reporter has no other information for this adverse event. This case linked with US2019AMR180518, reported by same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Muscle soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4RR52, expiry date 7th December 2021) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm and had injection site muscle pain. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field of Argus (not recovered) and the outcome reported in the source document (recovering).
Sex: M
Vaccine: DTAP
Symptoms: Respiratory symptom
Clinical narrative: respiratory symptoms; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA272879 (same reporter).  This case involves a male patient of unknown age who experienced respiratory symptoms (respiratory symptoms), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following morning the patient experienced respiratory symptoms after the vaccination.  (Other relevant tests included no lab data.)  Final diagnosis was respiratory symptoms.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administering Adacel instead of Fluzone Quadrivalent / no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA272526 and 2019SA272536.  This case involves a 4 years old male who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6378AA, expiry date: 04-Jul-2021 via unknown route in unknown administration site on 28-Sep-2019and was supposed to give the consumers a flu shot vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administering Adacel instead of Fluzone Quadrivalent / no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA272526 and 2019SA272535.  This case involves a 6 years old male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6378AA, expiry date: 04-Jul-2021 via unknown route in unknown administration site on 28-Sep-2019and was supposed to give the consumers a flu shot vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient who received the ActHIB component of a Pentacel vaccine that was given by diluting it with an unknown diluent, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who received the ACT-HIB component of a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number not reported via unknown route in unknown administration site) vaccine that was given by diluting it with an unknown diluent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate reconstitution technique.  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 error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired Daptacel / no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old patient who received 0.5 ml dose of  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254aa (Expiry date 18-Sep-2019) via intramuscular route in the right arm on 30-Sep-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Expired vaccine used.  At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Office mistakenly gave flublok to a 3 year old patient, no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a 3 years old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number, route and site of administration were not reported) on an unknown date.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was reported that 3 years old patient received mistakenly flublok.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: TYP
Symptoms: Anaphylactic reaction, Butterfly rash, Chest discomfort, Dyspnoea, Headache
Clinical narrative: Anaphylactic reaction; she was going to faint; severe headache; pressure in chest; trouble breathing; fever; throat was closing up; butterfly rash on face; rash on chest; Initial information received on 01-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp (office staff).  This case involves a female patient who experienced anaphylactic reaction (anaphylactic reaction), faint (syncope), severe headache (headache), pressure in chest (chest discomfort), trouble breathing (dyspnoea), throat was closing up (throat tightness), fever (pyrexia), butterfly rash on face (butterfly rash) and rash on chest (rash), while she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot R2A262M via unknown route in unknown administration site.  On an unknown date, the patient had anaphylactic reaction (anaphylactic reaction), faint (syncope), severe headache (headache), pressure in chest (chest discomfort), trouble breathing (dyspnoea), throat was closing up (throat tightness) immediately following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  On an unknown date, the patient had butterfly rash on face (butterfly rash) and rash on chest (rash) (within 24 hours) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  On an unknown date, the patient had fever (pyrexia) (within 48 hours) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. These events were assessed as medically significant.  Lab data was not reported.  Final diagnosis was anaphylactic reaction based upon the reported symptoms.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the reactions.  List of document held by sender: none.; Sender's Comments: This case concerns a female patient who had possible anaphylactic reaction with its reported symptoms of syncope, headache, chest discomfort, dyspnoea, throat tightness, pyrexia, butterfly rash and rash on trunk following the vaccination with TYPHIM VI. The time to onset is compatible. The patient's past allergic history, concomitant medications and lab data ruling out predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: TYP
Symptoms: Immediate post-injection reaction, Pyrexia, Rash, Syncope, Throat tightness
Clinical narrative: Anaphylactic reaction; she was going to faint; severe headache; pressure in chest; trouble breathing; fever; throat was closing up; butterfly rash on face; rash on chest; Initial information received on 01-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp (office staff).  This case involves a female patient who experienced anaphylactic reaction (anaphylactic reaction), faint (syncope), severe headache (headache), pressure in chest (chest discomfort), trouble breathing (dyspnoea), throat was closing up (throat tightness), fever (pyrexia), butterfly rash on face (butterfly rash) and rash on chest (rash), while she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot R2A262M via unknown route in unknown administration site.  On an unknown date, the patient had anaphylactic reaction (anaphylactic reaction), faint (syncope), severe headache (headache), pressure in chest (chest discomfort), trouble breathing (dyspnoea), throat was closing up (throat tightness) immediately following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  On an unknown date, the patient had butterfly rash on face (butterfly rash) and rash on chest (rash) (within 24 hours) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  On an unknown date, the patient had fever (pyrexia) (within 48 hours) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. These events were assessed as medically significant.  Lab data was not reported.  Final diagnosis was anaphylactic reaction based upon the reported symptoms.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the reactions.  List of document held by sender: none.; Sender's Comments: This case concerns a female patient who had possible anaphylactic reaction with its reported symptoms of syncope, headache, chest discomfort, dyspnoea, throat tightness, pyrexia, butterfly rash and rash on trunk following the vaccination with TYPHIM VI. The time to onset is compatible. The patient's past allergic history, concomitant medications and lab data ruling out predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Dyspnoea, Pertussis, Rhinorrhoea
Clinical narrative: Pertussis; complaints of ongoing cough for 2 weeks with 2-3 days of increased nasal drainage; complaints of ongoing cough for 2 weeks with 2-3 days of increased nasal drainage/coughing spasms; unable to take full breaths; Initial information received on 01-Oct-2019 regarding an unsolicited valid serious case received from a consumer (Office Staff).  This case involves a 12 years old female patient who experienced pertussis (pertussis), complaints of ongoing cough for 2 weeks with 2-3 days of increased nasal drainage/coughing spasms (cough and Rhinorrhoea) and unable to take full breaths (dyspnoea), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) were not provided.  Patient was previously exposed to walking pneumonia from family member 2 weeks prior.  On 06-Jun-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5829AB (Expiry date unknown)  via intramuscular route in the left deltoid.  On an unknown date, the patient developed a serious pertussis, complaints of ongoing cough for 2 weeks with 2-3 days of increased nasal drainage/coughing spasms (cough and Rhinorrhoea) and unable to take full breaths (dyspnoea) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  (Other relevant tests included Final positive results for Pertussis was received on 30Sep2019.) Final diagnosis was pertussis.  The patient was treated with AZITHROMYCIN (AZITHROMAX) and ALBUTEROL [SALBUTAMOL] (ALBUTEROL [SALBUTAMOL]).  The event outcome is reported as Unknown for all the events.  List of documents held by sender: none.; Sender's Comments: This case concerns a young patient who presented with pertussis after and despite vaccination with ADACEL (a Pertussis containing vaccine). The time to onset is unknown. Moreover, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: double dose of Adacel  administered to patient/ no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 52 years old male patient who received two doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5640AA (Expiry date 27-Jun-2021) via intramuscular route in the left arm on 27-Sep-2019 and first dose of same vaccine with an unknown batch number via unknown route in unknown administration site on 26 March 2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) on 27-Sep-2019 .   It was an actual medication error case due extra dose administered.   It was reported that double dose of Adacel received by patient. Medical assistant stated they had a patient who was give the vaccination earlier this year in March and again on 27Sep2019.  At a time of vaccination No adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: dose of 0.25 mL Fluzone Quad was inadvertently administered to a 3 yr 11 month patient, no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 3 years and 11 month old female patient who was vaccinated with a 0.25 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Quadrivalent] (frequency once) lot UT6647JA, exp date 30 June 2020 via intramuscular route in the left thigh on 30-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to vaccine underdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 3 year old patient inadvertently received Flublock instead of Fluzone, no AE; 3 year old patient inadvertently received Flublock instead of Fluzone, no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Pharmacy-Other).  This case involves a 3 years old patient who inadvertently received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number, expiry date, route and site was not reported) instead of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 30-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administered and wrong vaccines administered.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 60 year old male was administered with Fluzone High-Dose/no AE; 60 year old male was administered with Fluzone High-Dose/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA274359 (same reporter).  This case involves a 60 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age) and overdose (overdose).  It was unknown whether adverse event was noted or not.  Information on the batch number 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 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.