chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse symptoms reported; the patient was inadvertently administered one dose of improperly stored VAQTA (lot number 025993, expiration date 10/1712020) on 6/5/2020.; This spontaneous report was received from a health care worker referring to a 4 years old male patient. The patient's medical history, concomitant therapies, concurrent condition and drug allergies were not provided.  On 05-JUN-2020, the patient was inadvertently administered one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot# reported as 025993, which was evaluated and changed to the valid lot# S025993, expiration date 17-OCT-2020; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion was above 47 Fahrenheit degree (49.6 Fahrenheit degree) for 11 hours and 40 minutes. There was no previously temperature excursion. There was a data logger involved. No adverse symptoms were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 69.0
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or additional adverse effects reported.; Office manager reporting patient inadvertently received expired first dose in VAQTA immunization series.; This spontaneous report was received from an office manager referring to a 69 years old patient of unknown gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On 08-JUN-2020, the patient was inadvertently received expired first dose in hepatitis a vaccine, inactivated (VAQTA) (lot# S001832, expiration date 12-MAY-2020; dose detail, route and strength were not provided) immunization series for prophylaxis (expired product administered). No symptoms or additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently administered a dose of PROQUAD and VARIVAX on 06/09/2020; Information has been received from a physician referring to a 13 to 14 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication was not provided.      On 09-JUN-2020, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, route, lot # and expiration date were unknown) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis (accidental overdose). The outcome of accidental overdose was unknown.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No symptoms or additional adverse effects reported; unspecified dose in ROTATEQ immunization series inadvertently administered past its expiry; This spontaneous report was received from a medical assistant referring to a 8 weeks old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.     On 09-JUN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) inadvertently past its expiry (lot # R034104, expiration date 08-JUN-2020; strength, dose, route of administration not reported) for prophylaxis ( expired product administered).
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 15 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 07-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 10-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 22-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 13 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 24-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 03-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 03-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 10 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 04-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 21 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 11-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.92
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 23 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 11-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Chills, weakness, low grade fever
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Anaphylactic reaction, Dysphonia, Emotional distress, Lip swelling, Periorbital swelling
Clinical narrative: Within five minutes of the vaccine, patient acutely developed severe periorbital and lip swelling,  with solitary hive and voice changes.  Noted to be tachycardic and inconsolable. Pt treated for anaphylaxis with Epinephrine, Diphenhydramine and Prednisolone with improvement.  Transferred to hospital for monitoring.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Tachycardia, Urticaria
Clinical narrative: Within five minutes of the vaccine, patient acutely developed severe periorbital and lip swelling,  with solitary hive and voice changes.  Noted to be tachycardic and inconsolable. Pt treated for anaphylaxis with Epinephrine, Diphenhydramine and Prednisolone with improvement.  Transferred to hospital for monitoring.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; a patient was administered an improperly stored PROQUAD that was reconstituted with a properly stored DILUENT; This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. The patient's concomitant therapies included sterile diluent.  On 21-FEB-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), lot # S022913, expiration date 19-JAN-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. No additional adverse events. The administered vaccine experienced a temperature from 15 degrees Fahrenheit to 46 degrees Fahrenheit (36.86 F) for 9 hours and 49 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit (19.13 F) for 1 hour and 30 minutes. No data logger was involved.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered improperly stored doses of MMRII and VARIVAX; This spontaneous report as received from an administrator, who was in charge of vaccine storage, refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-JUN-2020, the patient was vaccinated with the improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot # S014430, expiration date 09-MAY-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032354, expiration date 14-OCT-2021 (for both vaccines exact dose, frequency and route of administration were not reported) for prophylaxis. No additional adverse effects reported. The vaccines experienced temperature excursion (exact temperature was unknown) for 20 hours. There was no previous temperature excursion. The data logger was not involved.
Sex: F
Vaccine: MMR
Symptoms: Exposure to communicable disease, Mumps, Parotitis, Tenderness
Clinical narrative: waning of vaccine-induced immunity; This literature marketed report was received from  authors and articles as stated below, referring to a 25 year old female patient. The patient's medical history, concurrent condition, concomitant therapy was not provided.  In August 2019, 30 attendees at a wedding developed mumps after being exposed to one asymptomatic index patient who was fully vaccinated according to Practices recommendations, resulting in a multistate outbreak. Overall, there were 62 confirmed and probable mumps cases due to onset of parotitis among persons (39 confirmed and 23 probable). This case was regarding to the index patient. On unknown date, the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)(lot#, expiration date, strength, frequency and route unknown; only reported was fully vaccinated) for prophylaxis.  The index patient attended the wedding on 03-AUG-2019 and reported extensive social interactions, including sharing drinks and dancing. She developed left ear and jaw tenderness the next day (04-AUG-2019) and parotitis on 05-AUG-2019; she sought medical care on 09-AUG-2019. She received treatment with corticosteroids, but because no diagnostic testing was performed, she was classified as having a probable case of mumps (vaccination failure). The outcome of event was unknown.  The authors considered a mumps outbreak involving six states occurred following exposure to an asymptomatic, fully vaccinated index patient who reported extensive social interaction during the peak period of infectivity, in an environment where potentially susceptible persons were densely clustered. Mumps immunity after childhood vaccination can wane by early adulthood. It was likely that waning of vaccine-induced immunity contributed to this outbreak, because approximately two thirds of patients had received not less than 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), and the median patient age was 35 years. Specific viral factors (e.g., mutations increasing pathogenicity and shedding) were not a likely contributor because mumps genotype G is commonly. However, mumps is most infectious just before and during onset of parotitis, and the timing of the event likely contributed to transmission among exposed attendees because the index patient developed parotitis the day after the wedding.  This is one of several reports received from the same article (MARRS# 2006USA004632).  A copy of the published article is attached as further documentation of the patient's experience.  Sender's Comments:  US-009507513-2006USA004632:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Loss of personal independence in daily activities, Malaise, Social problem
Clinical narrative: Flu-like symptoms; Sick; felt like she was going to die; spent the entire day in bed; Not been able to take the second dose; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) (batch number 2CP9B, expiry date 30th April 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, sickness, feeling lifeless, activities of daily living impaired and social problem. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the feeling lifeless, activities of daily living impaired and social problem were unknown.   It was unknown if the reporter considered the influenza-like symptoms, sickness, feeling lifeless and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix shot a little over six months ago and became sick with flu-like symptoms and felt like she was going to die. The patient spent the entire day in bed the day after receiving the vaccine. The consumer also reported that she had not been able to take the second dose of Shingrix due to the Covid 19 epidemic which lead to social problem. The report did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020089531:same reporter
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on his chest, right elbow, and legs.; This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema.   On 2nd January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, 14 days after receiving Shingrix, the patient experienced rash. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experience rash on his chest, right elbow, and legs.  The patient used an over the counter cream that seemed to help, but has not fully resolved at time of report. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2019, the patient received the 1st dose of Shingrix. On 22nd December 2019, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient developed a fever the following day.  The fever went up to 102 degree F and only lasted a day. The reporter did not consent to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Severe shaking and chills lasting 2 hours
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Quarter sized pink lump at injection site. Afebrile.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: The pentacel powder was mixed with a sterile diluent from the MMR vaccine and given to the patient, no AE; Initial information was received on 04-Jun-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves a patient of unknown demography who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] where the powder was mixed with a sterile diluent from the MMR vaccine (Product preparation error )  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.   It was a case of an actual medication error due to Wrong solution used in drug reconstitution. It was reported that the diluent was given and the powder was not mixed. The powder was mixed with a sterile diluent from the MMR vaccine and given to the patient.  At the time of report, 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 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.  There will be no information available on lot number
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient received expired doses of Daptacel, no adverse event; Initial information was received on 04-Jun-2020 regarding an unsolicited valid non-serious case from a nurse   This case is linked to 2020SA147720 (same reporter)  This case involves a four-months-old female patient who was administered a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included a dose of HEPATITIS A VACCINE INACT (HAVRIX) and a dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX)  On 04-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5367AA, expiry 30-Jan-2020) (frequency-once) via intramuscular route in right vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, 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.
Age: 0.33
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a four months old patient received an expired dose of Daptacel  vaccine, no adverse event; Initial information was received on 04-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a four month old patient (gender unspecified) who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) and INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for prophylactic vaccination on 09-Mar-2020.   On 09-Mar-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5367AA, expiry 30-Jan-2020) once via intramuscular route in left vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, adverse event was not 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.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: 11 year-old girl was administered a Menactra vaccine that had expired on 31May2020,No AE; Initial information was received on 05-Jun-2020 regarding an unsolicited valid non-serious case from a consumer (medical student).  This case involves an 11 years old female patient who was administrated with 0.5 ml dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported, expiration date 31-May-2020) via intramuscular route in unknown administration site on 04-Jun-2020 for prophylactic vaccination.  The patient medical history, medical treatment, past vaccination, concomitant therapy and family history were not provided.  It was a case of actual medication error case due to expired vaccine used. An 11 year-old girl was administered a Menactra vaccine that had expired on 31-May-2020.  At the time of report, adverse event was not 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a19 months old female patient received a dose of Adacel insted of Daptacel vaccine, no AE; a19 months old female patient received a dose of Adacel vaccine, no AE; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 19 months old female patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U66688A Expiry date: 30-Apr-2022) via intramuscular route in the left thigh for prophylactic vaccination on 08-Jun-2020 at 11:15am instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due wrong vaccine administered and inappropriate age at vaccine administration.  It was reported that the child had a cut on the head and has never had any vaccinations before and they wanted her to have the tetanus.   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.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 4 year old patient received an expired Ipol 3 weeks ago, no adverse event; Initial information was received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient's mother).  This case involves a four-years-old female patient who received a dose of expired IPV (VERO) [IPOL] 3 weeks ago (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number and expiry date not reported, multi dose vial) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The patient received an expired IPV (VERO) [IPOL] 3 weeks ago. It was reported that it was just a regular Polio dose. The patient received other vaccines which were not specified.  At the time of report, 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.  There will be no information available on lot number.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Breath odour, Decreased appetite, Diarrhoea, Gingival bleeding, Pyrexia
Clinical narrative: On June 1, he began to have a high fever (up to 103.1° F) and later developed into Gingivostomatitis. He has had several sores in his mouth that have caused diarrhea, bad breath, blood on his gums, little appetite, etc.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Stomatitis
Clinical narrative: On June 1, he began to have a high fever (up to 103.1° F) and later developed into Gingivostomatitis. He has had several sores in his mouth that have caused diarrhea, bad breath, blood on his gums, little appetite, etc.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site bruising, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, hard, bruising and warm at the site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: 1. Nurse made error giving a third Men B. GSK MenB is a series of 2 vaccines. 2.  Patient presented  to clinic the next morning with facial numbness on left, dx Bell's palsy.  It can not be ruled out that it was due to vaccine being given in error.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Neoplasm malignant
Clinical narrative: start radiation for cancer; This case was reported by a consumer via call center representative and described the occurrence of cancer in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient was overdue for 2nd dose. The patient had trips and surgeries in last 6 months and due to that the patient did not received 2nd dose. It was reported that the patient was going to start radiation for cancer. The patient wanted to know if it was too late and if it was possible to take 2nd dose before radiation. The patient was advised to consult physician regarding 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: very little discomfort with that one; This case was reported by a consumer and described the occurrence of discomfort in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019 (refer case US2020AMR095999)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of vaccine and had very little discomfort with that 2nd dose. The patient wanted to know that if other people experienced the same type of pain after vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR095999:same reporter
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: titers were drawn; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional information was provided as follows: The age at vaccination was not reported, but the patient was in his early 20s. The patient received three doses of Engerix-B in 2018 but titers were drawn and did not show the patient received Engerix-B vaccinations. The health care professional did not provide patient demographics. No lot numbers or expiration dates for all three doses of Engerix-B. HCP did not provide email address at the time of this report.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Genital herpes, Hypoaesthesia, Neuropathy peripheral, Oral herpes
Clinical narrative: fever blister; fever blister in the genital area; neuropathy; numbness; tingling; pain; burning sensation in her both feet; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th June 2019 and experienced no side effects.).   On 4th September 2019, the patient received the 2nd dose of Shingrix. On 4th September 2019, less than a day after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), numbness, tingling, pain and burning sensation. On an unknown date, the patient experienced fever blister and genital herpes. On an unknown date, the outcome of the neuropathy, numbness, tingling, pain and burning sensation were unknown and the outcome of the fever blister and genital herpes were recovered/resolved.   It was unknown if the reporter considered the neuropathy, numbness, tingling, pain, burning sensation, fever blister and genital herpes to be related to Shingrix.  Additional information was provided as follows: The patient experienced numbness, tingling, pain and a burning sensation in her both feet that started that evening. The patient later was referred to a neurologist who did a conduction study and diagnosed her with neuropathy. Less than a year, after receiving vaccine, the patient also experienced a fever blister in the genital area and oral area that had resolved. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: fever blister; fever blister in the genital area; neuropathy; numbness; tingling; pain; burning sensation in her both feet; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th June 2019 and experienced no side effects.).   On 4th September 2019, the patient received the 2nd dose of Shingrix. On 4th September 2019, less than a day after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), numbness, tingling, pain and burning sensation. On an unknown date, the patient experienced fever blister and genital herpes. On an unknown date, the outcome of the neuropathy, numbness, tingling, pain and burning sensation were unknown and the outcome of the fever blister and genital herpes were recovered/resolved.   It was unknown if the reporter considered the neuropathy, numbness, tingling, pain, burning sensation, fever blister and genital herpes to be related to Shingrix.  Additional information was provided as follows: The patient experienced numbness, tingling, pain and a burning sensation in her both feet that started that evening. The patient later was referred to a neurologist who did a conduction study and diagnosed her with neuropathy. Less than a year, after receiving vaccine, the patient also experienced a fever blister in the genital area and oral area that had resolved. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Aphasia, Blindness, Deafness, Dysarthria
Clinical narrative: passed out; loss of hearing and vision; loss of hearing and vision; bad headache; tingling; difficulty to process words and thoughts and difficult to speak; difficulty to process words and thoughts and difficult to speak; Nausea; Slurred speech; was acting weird like she could not process her thoughts; This is a spontaneous report from a contactable consumer (mother). A female patient of unspecified age received meningococcal group b rlp2086 (TRUMENBA) on unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. Mother calls for information about for how long does the symptoms presented after the administration of the vaccine meningococcal group b rlp2086 will pass on patient. She reported that patient was administered today with the vaccine meningococcal group b rlp2086 and after 15 minutes of the administration the patient passed out, reporting a bad headache, tingling, loss of hearing and vision, difficulty to process words and thoughts and difficult to speak. She reported that the patient was administered with the vaccine on an empty stomach. She said that her daughter also had lost vision in one eye, was acting weird like she could not process her thoughts, and had slurred speech. She said that she called the physician back to ask them what they should do and they said to bring her back to the office so they could look at her. She said that she took her back to the doctor's office and her blood pressure was good and her daughter started feeling better and the vision in her eye was coming back. She said that her daughter took the vaccine on an empty stomach. She went to feed her and her daughter felt like she was going to throw up again. She told her daughter to eat and she got an extremely bad headache. She said that her daughter was trying to text and her daughter could not get her words to keep up with her texts. She took her daughter to the hospital and it was really busy so they left and her daughter is currently laying down with her head in her lap. She said that her daughter's symptoms started with nausea. The outcome of events was unknown.  Information about batch/lot number has been requested.