chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes with no reported adverse event; administration of IPOL post excursion with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 years old male patient and reporter reported temperature excursion for IPV (VERO) [IPOL] as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and administration of vaccine post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.   Caller reported that opened IPV (VERO) [IPOL] Suspension for injection (lot V1A021M, expiry date- 27-FEB-2024) at a dose of 0.5mL once via intramuscular route in unknown administration site for Immunization was exposed to temperature excursion as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) (unknown latency) and On 12-JUN-2023 the patient had administration of vaccine post excursion with no reported adverse event (poor quality product administered) (latency- same day). Human error was involved.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the guidelines. 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: 12.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 year-old boy received a daptacel vaccine, rather than the adacel that was indicated with no reported adverse event; 12 year-old boy received a daptacel vaccine, rather than the adacel that was indicated with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel], rather than the adacel that was indicated with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine for Immunisation.  On 11-Jul-2023, the patient received a dose of 0.5 ml (dose 6) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5969AD; strength: standard) via unknown route in intramuscularadministration site for Immunization.  On 11-Jul-2023, 12 year-old boy received daptacel vaccine, rather than the adacel that was indicated with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  It was reported, "Caller is reaching out regarding a DAPTACEL vaccine that was given to a patient over the age of 7. She is asking for recommendation on how to proceed with the situation or what should be done."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the 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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ACTHIB was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride ACTHIB diluent, with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1-year-old male patient, HIB (PRP/T) VACCINE [ACT-HIB] was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride acthib diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMR II); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 20-Jul-2023, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (lot: UJ735AA, expiry date: 07-Aug-2023) via intramuscular route in unknown administration site for immunization.  On 20-Jul-2023 the patient had an event of acthib was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride acthib diluent, with no reported adverse event (product preparation error) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  It was unknown if any lab data/tests available.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: Unknown.  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 the 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: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: COVID-19 (12+) administered to patient age 11 y.o. No adverse reactions noted or reported by patient or parents to date.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient age 10 y.o. received Pfizer COVID-19 (12+) vaccine dose. No adverse reactions noted or reported by patient or parents to date.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient age 8 y.o. received Pfizer COVID-19 (12+) vaccine dose. No adverse reactions noted or reported by patient and parents to date.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient age 7 y.o. received dose of Pfizer Covid-19 (12+) vaccine. No adverse reactions noted or reported by patient or parents to date.
Age: 11.0
Sex: M
Vaccine: COVID19-2, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 y.o. Male received dose of Pfizer COVID-19 (12+) Vaccine. No s/s of adverse reactions noted or reported by patient and parents to date.
Age: 4.0
Sex: M
Vaccine: COVID19-2, IPV, MMR, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 y.o. Male received Pfizer Covid-19 (12+) Vaccine dose. No adverse reactions noted or reported by patient and parents to date.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: Caller reports that they had a temperature excursion 3/31/2023 which they called into the Center.; the products were labeled but still accidentally administered after the new short dated expiration date; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 30-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection 0.5 milliliter, lot #W031816, original expiration date was reported 05-OCT-2024, upon internal validation, it was established as 16-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (product storage error and expired product administered).  It was reported that the suspect vaccine was exposed to a temperature of 50 Fahrenheit (F), the time frame: 6 F up to 14 F for 4 hours 0 minutes; 14 F up to 46 F for 4 hours 0 minutes; 47 F to 77 F (50 F) for 3 hours 57 minutes (total: 11 hours 57 minutes) (date excursion on 31-MAR-2023). The short dated expiration date from the temperature excursion given was 30-JUN-2023. The vaccine was labeled but still accidentally administered after the new short dated expiration date.   This is one of the several cases reported by the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported.; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2023, the patient was administered an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) oral liquid, at a dose of 2 milliliter (lot number 1968385 has been determined to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), with an expiration date established as 22-MAY-2024), administered for prophylaxis (strength, and route of administration were not provided). The oral vaccine suffered temperature excursion on the following dates: On 20-JUN-2023, with a timeframe of 34.9 Fahrenheit (F) for 6 hours and 34 minutes; on 03-JUL-2023, of 51.4F for 7 hours and 33 minutes; on 04-JUL-2023  of 51.1F for 24 hours and on 05-JUL-2023, of 50.7F for 9 hours and 27 minutes.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional AE; Patient missed 3rd dose of GARDASIL 9, 5 years ago.; This spontaneous report was received from a pharmacist referring to a 25-year-old female patient. The patient's concurrent condition, medical history and concomitant therapies were not reported.  On an unknown date in 2018 (reported as 5 years ago), the patient was vaccinated with first 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dose, lot #, expiry date, anatomical location and route of administration were not provided) and forgot her last dose (product dose omission issue). The patient wanted information on when she could receive her next dose since 3rd dose missing. There was no additional adverse event (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the vaccine shot and three months later came down with a severe case of shingles./Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: received the vaccine shot and three months later came down with a severe case of shingles./Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-JUL-2023 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory details were unknown at a time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: Cleft lip
Clinical narrative: Cleft lip; This literature-non-study case was reported in a literature article and describes the occurrence of CLEFT LIP (Cleft lip) in a foetus patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy.    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Transplacental) 1 dosage form. On an unknown date, the patient experienced CLEFT LIP (Cleft lip) (seriousness criteria medically significant and congenital anomaly). At the time of the report, CLEFT LIP (Cleft lip) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Transplacental) was unknown.   For mRNA-1273 (Spikevax) (Transplacental), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The patient's mother was having a gestation period of 29 years at the time of childbirth and the genetic diagnosis of the patient was not confirmed.  No treatment information was reported.  Company comment: This literature non study case concerns a foetal patient with no medical history information reported, who experienced the unexpected serious (congenital anomaly and medically significant) event of cleft lip. The event was diagnosed after patient's birth. Patient's mother was vaccinated with first dose of mRNA-1273 when the foetus was at gestational age of 29 weeks. As reported, by the authors all participants with fetal anomalies were vaccinated after completion of embryogenesis (ie, in the second or third trimester), supporting that the presence of anomalies was independent of maternal vaccination. Considering the afore mentioned and that cleft lip is a common birth anomaly seen in general population causality for the event is assessed as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2023-734505 (Parent-Child Link).   See case MOD-2023-734505 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Follow up received included: Updated event term, updated patient details and narrative updated
Age: 0.42
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL (opened) was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: Yes, with no reported adverse event; IPOL (opened) exposed to a temperature excursion was administered to the patient with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old female patient who was administered IPV (VERO) [IPOL] (opened), which was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine for Prophylactic vaccination.  On 12-Jul-2023, the patient received 0.5 ml dose of suspect IPV (VERO) (frequency: once; strength: standard) Suspension for injection of lot V1A021M and expiry: 27-Feb-2024 via intramuscular route in unknown administration site for immunization.  On an unknown date, it was reported that the suspect IPV (VERO) (opened) was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event (product storage error) (unknown latency).  On 12-Jul-2023, the patient was administered IPV (VERO) (opened) exposed to temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was provided.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events product storage error and poor quality product administered.  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 the 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: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: pentacel was not mixed before administration with no reported adverse event; patient was administered with just the liquid portion of the Pentacel without the Hib component with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 month old male patient who was administered with just the liquid portion of the diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] without the hib component with no reported adverse event and was not mixed before administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13), Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) And Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) for Prophylactic vaccination.  On 19-Jul-2023, the patient received a Dose 2 at a dose of 0.5 ml of suspect /tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (expiry date: 19-Oct-2023; lot UJ785AA) via intramuscular route in the right thigh for immunization and administered with just the liquid portion of the pentacel without the hib component with no reported adverse event (single component of a two-component product administered) (latency: same day).  On an unknown date the pentacel was not mixed before administration with no reported adverse event (product preparation error) (latency: same day).  It was reported "she called in together with the doctor to report that they have a patient who was administered with just the liquid portion of the PENTACEL; they have the patient back today to administer the Hib component and they ask which diluent is appropriate to prepare the dose; provided information to the practice manager and the doctor."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the 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: 0.17
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Wrong technique in product usage process
Clinical narrative: 2 months old child was only given half of the vaccine dose as DTaP-IPV & ActHIB were given separately with no reported adverse event; 2 months old child was only given half of the vaccine dose with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old patient of unknown gender who was only given half of the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] vaccine dose as DTaP-IPV & ActHIB were given separately with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date, the patient was only given half of the vaccine dose as DTaP-IPV & ActHIB were given separately with no reported adverse event (wrong technique in product usage process) (incorrect dose administered) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event wrong technique in product usage process and incorrect dose administered.   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 the 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Cough, Nausea, SARS-CoV-2 test positive
Clinical narrative: Presented to the emergency w c/o cough, nausea, epigastric pain x 3 days.  She was tested for COVID-19 and found to be positive.  Tx w/O2, remdesivir therapy, in addition to Solu-Medrol, doxycycline, and Singulair.  She was eventually weaned off oxygen.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea exertional
Clinical narrative: Presented to the emergency room because of exertional dyspnea; admitted for COVID-19 infection; tx w/abx, steroids, remdesivir, O2, zinc; weaned to RA for dc to home.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Elective procedure, Labour induction, Pregnancy, SARS-CoV-2 test positive
Clinical narrative: IUP at 39. 5 weeks; admitted for elective induction.  Incidental COVID-19 positive finding. Asymptomatic.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Product packaging confusion, Wrong product administered
Clinical narrative: No additional AEs; HCP reports patient received PROQUAD and VARIVAX at same visit. / "The MMR II and PROQUAD vials have the same color metal on the vial once the flip cap is removed and look the same without the flip cap in place"; patient received PROQUAD and VARIVAX at same visit.Caller states error was human error; The MMR II and PROQUAD vials have the same color metal on the vial once the flip cap is removed and look the same without the flip cap in place; This spontaneous report has been received from a registered nurse referring to a patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 06-JUL-2023, at the same vasit, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W034213, expiration date: 24-APR-2024, administered subcutaneously (SQ) at right thigh for prophylaxis (strength was not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011625, expiration date reported as 11-OCT-2024 but upon internal validation established as 06-APR-2024, administered SQ at right thigh for prophylaxis (strength and dose was not provided) (accidental overdose). The reporter stated it was a human error, but also stated the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vials had the same color metal on the vial once the flip cap removed and looked the same without the flip cap in place (product packaging confusion, wrong product administered). No other information was provided. No additional adverse events or PQC was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored vaccine was administered; This spontaneous report was received from an administrator and refers to a patient of unknown age an gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On  07-JUL-2023, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1925936, (expiration date: 28-MAR-2024), administered orally for prophylaxis (strength was not provided) (product storage error). The suspect vaccine was exposed to a temperature above 9 degree Celsius (C) (10.17 C) for a time frame of 1hour and 15 minutes 0 seconds. Previous temperature excursion was not provided. The patient no experienced any adverse event (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient did not experience any other adverse event; patient received a dose of MMRII on 6/29/2023, after the product was involved in a temperature excursion.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication included varicella virus vaccine live (oka/merck)(VARIVAX). The patient's pertinent medical history and drug reactions/allergies were not reported.   On 29-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection (therapy type: recombinant Human albumin [Rha], a dose, lot # W039699, expiration date 25-MAY-2024, strength and route not reported) for prophylaxis. Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was involved in a temperature excursion (Product storage error). The temperature excursion was 48.8 Fahrenheit for 7 hours and 45 minutes. It was unknown if there were previous temperature excursions. No additional adverse event (AE) was reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2307USA006147: US-009507513-2307USA006131: US-009507513-2307USA006253: US-009507513-2307USA006038: US-009507513-2307USA006117: US-009507513-2307USA006048: US-009507513-2307USA006043: US-009507513-2307USA005725:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; VARIVAX was administered after it experienced a supported temperature excursion.; This spontaneous report has been received from a health business professional (HBP) (administrator) referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not provided. Concomitant medication included diluent.  On 12-JUL-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 ml; lot # W025277 has been verified to be valid, expiration date reported and established as 10-AUG-2024; strength and route were not reported) for prophylaxis, which underwent a supported temperature excursion of -8.6 degrees Celsius for a time frame of 51 minutes (product storage error). There was a previous temperature excursion of -11.5 degrees Celsius for 1 hour and 16 minutes. No side effects were reported. No further details were given. No additional adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2307USA007068: US-009507513-2307USA006778: US-009507513-2307USA006784: US-009507513-2307USA007708: US-009507513-2307USA006760: US-009507513-2307USA006854: US-009507513-2307USA006846: US-009507513-2307USA006990:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported; HCP calling to report that a patient was administered a improperly stored vaccine; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (product storage error) (lot number W035460, has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with an expiration date established as 06-MAY-2024, therapy type rHA), administered for prophylaxis (strength, and anatomical site of administration were not provided). No additional Adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Inbound call from medical assistant who reports products that experienced temperature excursion were administered to patients. See below for details:         ?    Names of vaccines involved (including lot/exp) VAQTA  X004813  7/28/2024        ?; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 12-JUL-2023, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot # X004813, expiration date 28-JUL-2024; strength, dose, route were not reported) for prophylaxis. The temperature excursion was ABOVE 47 Fahrenheit degree (46.7 Fahrenheit degree) for 0 hours 25 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No adverse event was reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: No additional AE; products that experienced temperature excursion were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 17-JUL-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (lot#: X004813, expiration date: 28-JUL-2024; strength, dose, and route of administration were not reported); and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (rHA) (lot#: W017556, expiration date: 07-JAN-2024; strength, dose, and route of administration were not reported) both for prophylaxis. The vaccines administered experienced temperature excursion before with temperature above 46.7 degree Celsius for 25 minutes (product storage issue). No additional adverse events (AE) (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC.; HCP calling to report AE for MMRII being given after its expiration date.; This spontaneous report was received from a medical assistant and referred to a 49-year-old female patient. The patient's concurrent conditions, pertinent medical history and drug reactions/allergies were not reported. Concomitant medications included sterile diluent.   On 06-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (therapy type: Albumin status rHA (recombinant Human albumin)), 0.5 milliliter, lot #U011149, expiration date: 08-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Product has had no previous temperature excursions. Patient had no side effects reported. No additional adverse event (AE) (No adverse event).
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Nurse called to report a T/E, multiple patients with unknown demographics and on unknown dates received improperly stored vaccines.; No adverse effects; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).   On 01-JUN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968386, expiration date: 23-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided) which underwent multiple temperature excursion before administration (Product storage error).  This one of several reports received from the same reporter.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HBV vaccine on 28-MAY-2011, 02-AUG-2011 and 02-MAR-2012; HBV vaccine on 28-MAY-2011, 02-AUG-2011 and 02-MAR-2012; This spontaneous report was received from a physician referring to a 9-week-old female patient. The patient's pertinent medical history, drug reactions or allergies were not provided. Concomitant vaccines included rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).  On 28-MAY-2011, 02-AUG-2011 and 02-MAR-2012, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, route of administration, exact dose, lot number and expiration date were not provided) for prophylaxis, respectively (inappropriate schedule of product administration for the second and third doses).   This is one of several reports from the same reporter. This is one of two reports for the same patient.; Sender's Comments:  US-009507513-2306USA013096: US-009507513-2307USA010001:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional information provided. No AE; VARIVAX was administered to a patient on 7/11. Caller then stated MMRII vaccine was administered on 7/18 instead of 4-week period between administrations; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, and on 18-JUL-2023, instead of 4-week period between administrations, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, both vaccines administered as prophylaxis (exact doses, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided) (Inappropriate schedule of product administration). The reporter confirmed that patient has not had any symptoms. No additional adverse events (AEs) nor information were provided.
Age: 5.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE; an expired MMRII vaccine and expired DILUENT were given to a patient inadvertently; This spontaneous report was received from a registered nurse concerning a 5-year-old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported.  On 25-JUL-2023, the patient was inadvertently vaccinated with expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5 mL (lot #U022175, expiration date: 14-JUL-2023, route of administration and anatomical location not provided); and with expired sterile diluent solution for injection/infusion, 0.5 mL, once (lot #U002746, expiration date: 25-JUN-2023, strength, and route of administration not provided) as prophylaxis (expired product administered). Neither products had experienced a temperature excursion. No additional adverse event (AE).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported / No additional information provided; HCP calling to report GARDASIL 9 was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided.         ?    Names of vaccines involved (including lot/exp): GARD; This spontaneous report was received from an medical assistantand refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). On 27-JUL-2023, this vaccine udnerwent temperature excursion before administration to a patient in 50 Farenheit (F) for 1 hour 40 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, No adverse event, Product administration error, Underdose
Clinical narrative: No additional AE/; HCP called to report she went to give 3rd dose  of RECOMBIVAX HB, to a 5 years old patient and he jumped. The needle came out and some of vaccine still in syringe and some of the vaccine liquid seen running down the patients arm. MIR on case 02437720; some of the vaccine liquid seen running down the patients arm; HCP called to report she went to give 3rd dose  of RECOMBIVAX HB, to a 5 years old patient and he jumped. The needle came out and some of vaccine still in syringe and some of the vaccine liquid seen running down the patients arm; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 27-JUL-2023 the patient was vaccinated with third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # W022795 and expiration date 19-MAY-2025, 0.5 milliliter for prophylaxis (route and site of administration were not provided). During administration of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) the patient jumped, and the needle came out (product administration error) and some of vaccine was still in syringe and some of the vaccine liquid was running down the patients arm (incorrect dose administered, exposure via skin contact and no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 8 months later shingles /Suspected Vaccination Failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: 8 months later shingles /Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient got both shingle shots and 8 months later shingles. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have gotten the shingles vaccine and I'm glad I did but a week ago I developed shingles/suspected vaccination failure; I have gotten the shingles vaccine and I'm glad I did but a week ago I developed shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have gotten the shingles vaccine and I'm glad I did but a week ago I developed shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have gotten the shingles vaccine and I'm glad I did but a week ago I developed shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient had gotten the shingles vaccine and he/she was glad that he/she did but a week ago he/she developed shingles in My eye like in his/her internal lie and it really sucks but he/she was glad that he/she got the shingles vaccine cause he/she could only imagine what this would be like if he/she had not had gotten it. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I was vaccinated and a month later I got shingles/suspected vaccination failure; I was vaccinated and a month later I got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I was vaccinated and a month later I got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I was vaccinated and a month later I got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-Jul-2023 The case was received from the patient via interactive digital media. The patient stated that did not trust vaccines too much. The patient was vaccinated and a month later he or she got shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.