chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got the Pfizer booster yesterday and I just have a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-512561 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization, reaction(s): "headache", "nausea", "spasmodic dysphonia", "vomiting"; Moderna (Dose 1, Near death experience,), for COVID-19 immunization, reaction(s): "I felt like I was going to die"; Moderna (Dose 2), for COVID-19 immunization, reaction(s): "headache", "nausea", "spasmodic dysphonia", "vomiting"; Moderna (dose 2, I felt like I was going to die), for COVID-19 immunization, reaction(s): "I felt like I was going to die"; Moderna (Dose 3 (Booster)), for COVID-19 immunization, reaction(s): "headache", "nausea", "spasmodic dysphonia", "vomiting"; Moderna (Dose 3 (Booster), I felt like I was going to die), for COVID-19 immunization, reaction(s): "I felt like I was going to die". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "got the Pfizer booster yesterday and I just have a sore arm". Additional information: Moderna Tx. received a report of the below events experienced with the use of Moderna COVID-19 Vaccine: diagnosed with spasmodic dysphonia, headache/The headaches were so bad that I felt like I was going to die, vomiting, nausea. patient asked to treat horrible headache and barfing that I endured three different times for my three shots and got response as no worries now. Patient got the Pfizer booster yesterday and just have a sore arm. No vomiting or horrendous headache. It's a miracle! and doesn't some put out a news release to switch. Three Moderna shots and patient thought I'd die each time.Kindly find the response received from the reporter upon follow-up for the case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Colitis ulcerative
Clinical narrative: Ankylosing spondylitis; Colitis ulcerative aggravated; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4462705-00 (Company Pharmacovigilance).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose numner unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown"; COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "Colitis ulcerative aggravated". The action taken for adalimumab was unknown.  The reporter considered "ankylosing spondylitis" and "colitis ulcerative aggravated" related to BNT162b2.  Clinical course: The reporter's causality for the event(s) of ANKYLOSING SPONDYLITIS and ULCERATIVE COLITIS FLARE UP IN BACK was not provided for HUMIRA(ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomyopathy, Fatigue, Hypervolaemia
Clinical narrative: Autopsy confirmed myocardial event and fluid around her heart and lungs; Autopsy confirmed myocardial event and fluid around her heart and lungs; Prior symptoms included fatigue; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 19-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: CARDIOMYOPATHY (death), HYPERVOLAEMIA (death), outcome "fatal" and all described as "Autopsy confirmed myocardial event and fluid around her heart and lungs"; FATIGUE (non-serious), outcome "unknown", described as "Prior symptoms included fatigue". The patient date of death was 09Jul2022. Reported cause of death: "Autopsy confirmed myocardial event and fluid around her heart and lungs". The autopsy revealed "myocardial event" (cardiomyopathy); "fluid around her heart and lungs" (hypervolaemia).  Clinical course: Patient died in her sleep 09Jul2022. Autopsy confirmed myocardial event and fluid around her heart and lungs. Prior symptoms included fatigue. Mother mentioned cause of death 13Jul2022 and that daughter was vaccinated, primary series and booster. Patient passed away in (withheld) and was taken to coroner on 09Jul2022. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Autopsy confirmed myocardial event and fluid around her heart and lungs; Autopsy confirmed myocardial event and fluid around her heart and lungs; Autopsy-determined Cause(s) of Death: myocardial event; fluid around her heart and lungs
Age: 0.33
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Tenderness, Vomiting
Clinical narrative: tenderness; fever; vomit; Initial information received on 08-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 months old female patient who experienced tenderness, fever and vomit ,while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot number not reported at an unknown dose via unknown route in unknown administration site for immunization.  On an unknown date (latency: unknown) ,the patient developed a non-serious events of  tenderness , fever (pyrexia) and vomit (vomiting) .   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events (tenderness, fever, vomit).  At time of reporting, the outcome was Unknown for the event tenderness, was Unknown for the event fever and was Unknown for the event vomit.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Max/Low Temperature reached: 8.56 C, Duration out of labelled range: 45 minutes, with no reported adverse event; patient was administered with vaccines that was exposed to excursion, with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered IPV (vero) [IPOL] after it was exposed to a temperature excursion of 8.56 degree Celsius for 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL dose of suspect IPV (vero) (lot: U1A601M, expiry date: 27-Feb-2023; formulation not reported) via subcutaneous route in the left thigh for immunization.  On an unknown date, the patient was administered IPV (vero) [IPOL] after it was exposed to a temperature excursion of 8.56 degree Celsius for 45 minutes with no reported adverse event (product storage error) and (circumstance or information capable of leading to medication error).  Action taken 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.
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: refrigerator door was left open; low temperature reached: 8.56 Celsius (C) /duration out of labelled range: 45 minutes (punctured Ipol) with no reported adverse event; administered with vaccines that was exposed to excursion with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse  This case involves a 4 years old female patient who was administered with vaccines that was exposed to excursion with no reported adverse event and reported Product storage error (refrigerator door was left open; low temperature reached: 8.56 Celsius (C) /duration out of labelled range: 45 minutes (punctured Ipol)  with no reported adverse event ) while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS A VACCINE INACT (HAVRIX); HIB VACCINE (HIB); INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) all for immunization.  On 29-Apr-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot U1A601M, expiry date: 27-Feb-2023, strength, form: not reported) via subcutaneous route in the left arm for immunisation..  On an unknown date the patient refrigerator door was left open; low temperature reached: 8.56 C; duration out of labelled range: 45 minutes (punctured Ipol) with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).   On 29-Apr-2022 the patient developed a non-serious was administered with vaccines that was exposed to excursion with no reported adverse event (poor quality product administered) (latency: same day). Nurse also inquired if they need to revaccinate patient that was administered with vaccines that was exposed to excursion.  Action taken : not applicable for both the events.  Outcome: 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.; Sender's Comments:  01176068:other 01176155:other
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Adacel (03Jul2022) was administered  to a patient with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 81 years old female patient and it was reported that expired Adacel (03-Jul-l2022) was administered  to a patient with no reported adverse event , and the vaccine involved was  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history included laceration to her foot (Skin laceration). The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 05-Jul-2022, the patient received 0.5 ml  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE,  (lot: U6706AA ; expiry date: 03-Jul-2022) via intramuscular route in the left deltoid for immunization.  It was reported that patient came to the clinic on 05-Jul-2022 for a tetanus shot after a laceration to her foot while she was inventorying the clinic vaccines. She had not yet gotten to the ADACEL, and  it was still on the shelf for someone to inadvertently give. On the same day, it was later noted that , an expired Adacel (expiry date: 03-Jul-2022) was administered  to a patient with no reported adverse event (expired product administered). Vaccine was noted  to have expired 2 days ago. Treatment would be repeated  Action taken :  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 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: 62.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Injection site pain, Musculoskeletal chest pain, Pain
Clinical narrative: weakness/has massive bouts of weakness; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. She states that then it affected her legs as well; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. She states that then it affected her legs as well; she received a TENIVAC from Sanofi-Pasteur and it hurt really bad; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via call center. This case involves a 62 years old female patient who received a TENIVAC from sanofi-pasteur and it hurt really bad; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. she states that then it affected her legs as well and weakness/has massive bouts of weakness after receiving vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided. On 19-Mar-2022, the patient received a 0.5 ml (total) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U6922AA, frequency: once (unknown: strength, formulation and expiry date) via intramuscular route in the right deltoid for immunization. On 19-MAR-2022 the patient developed a non-serious event she received a TENIVAC from sanofi-pasteur and it hurt really bad (injection site pain) latency: same day. On 20-MAR-2022 the patient developed non-serious events the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. she states that then it affected her legs as well (pain) with symptom Pain worsened (pain) and weakness/has massive bouts of weakness (asthenia) latency: 1 day following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. It was reported that the patient cut her hand in clean dishwater and she went to urgent care. Patient states that she was always had a high tolerance for pain but patient said "that is definitely not the case". The patient states that she has massive bouts of weakness which reduces her functionality as well. The patient states that this has been happening since 19Mar2022 but it has only gotten worse and it was worse towards the middle of May but it has never gotten better. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for the events asthenia, injection site pain and Not Recovered / Not Resolved for pain.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: weakness/has massive bouts of weakness; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. She states that then it affected her legs as well; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. She states that then it affected her legs as well; she received a TENIVAC from Sanofi-Pasteur and it hurt really bad; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via call center. This case involves a 62 years old female patient who received a TENIVAC from sanofi-pasteur and it hurt really bad; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. she states that then it affected her legs as well and weakness/has massive bouts of weakness after receiving vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided. On 19-Mar-2022, the patient received a 0.5 ml (total) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U6922AA, frequency: once (unknown: strength, formulation and expiry date) via intramuscular route in the right deltoid for immunization. On 19-MAR-2022 the patient developed a non-serious event she received a TENIVAC from sanofi-pasteur and it hurt really bad (injection site pain) latency: same day. On 20-MAR-2022 the patient developed non-serious events the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. she states that then it affected her legs as well (pain) with symptom Pain worsened (pain) and weakness/has massive bouts of weakness (asthenia) latency: 1 day following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. It was reported that the patient cut her hand in clean dishwater and she went to urgent care. Patient states that she was always had a high tolerance for pain but patient said "that is definitely not the case". The patient states that she has massive bouts of weakness which reduces her functionality as well. The patient states that this has been happening since 19Mar2022 but it has only gotten worse and it was worse towards the middle of May but it has never gotten better. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for the events asthenia, injection site pain and Not Recovered / Not Resolved for pain.
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PENTACEL and VAXELIS were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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] were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Jul-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, strength unknown  (lot UJ621AAA and expiry date 20-Jan-2023) via intramuscular route in the right thigh and on same day the patient received a  dose of suspect 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 not produced by Sanofi Pasteur (formulation, dose, strength ,lot number and expiry date not reported) via unknown route in unknown administration site both for immunization was administered at different sites on the same day, causing an extra dose to occur with no reported adverse event (extra dose administered).  Action taken : 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 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.
Sex: U
Vaccine: TYP
Symptoms: Incorrect route of product administration
Clinical narrative: TYPHIM VI was administered to a patient subcutaneously instead of intramuscularly with no adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient to whom typhoid VI polysaccharide vaccine (Typhim VI) was administered to a patient subcutaneously instead of intramuscularly with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect TYPHOID VI POLYSACCHARIDE VACCINE at a dose of 0.5 ml (lot number, expiry date, strength: not reported) via subcutaneous route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious typhim vi was administered to a patient subcutaneously instead of intramuscularly with no adverse event (incorrect route of product administration) (unknown latency) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. They just wanted to know if they need to repeat the dosage.  Action taken: Not applicable.  Outcome: Unknown for the event typhim vi was administered to a patient subcutaneously instead of intramuscularly with no adverse event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Accidental exposure to product, Medication error, No adverse event
Clinical narrative: 2 year old child inadvertently was given a quadracel injection with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who was inadvertently given a quadracel injection with no reported adverse event ,while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 21-Jun-2022, the patient received a  dose number 3 of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE ( lot C5970AA and expiration date:02-Feb-2024)  at a dose of 1 ml via intramuscular route in the thigh nos(vastus lateralis) for immunization.  On 21-Jun-2022, it was reported that the 2 year old child inadvertently was given a quadracel injection with no reported adverse event (accidental exposure to product) (latency: same day)following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: given the vaccine with wrong diluent with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient of an unknown  age and gender and was given the vaccine with wrong diluent with no reported adverse event , while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].   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 YELLOW FEVER VACCINE - (with an unknown strength, formulation and route)  ( lot number and expiry date: not reported) for immunization.  The reporter informed that  immunization nurses called regarding the potential use of YF-VAX using a different diluent. Upon inventory, they found extra diluent without its corresponding vaccine and they are assuming that maybe it was given with saline water.  They were not sure who of the 11 patients that received the vaccine that day were given the vaccine with wrong  diluent.  On an unknown date the patient was given the vaccine with wrong diluent with no reported adverse event (product preparation error) (unknown latency) . The reporter claimed to have found an article stating that the vaccine is stable in sterile water for 1 hour and wanted to know if there was any  information that correlates to that.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (given the vaccine with wrong diluent with no reported adverse event).  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 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.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Temperature excursion of Unopened IPOL at 24.4 F for 13 hours with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01180402   This case involves report of temperature excursion of unopened IPV (VERO) [IPOL] at 24.4 f for 13 hours with no reported adverse event while receiving vaccine.  This case is linked to case 2022SA271987(Tenivac).   On an unknown date, temperature excursion of unopened: ipol (lot UIA451M and expiry date: 28-FEB-2023) at 24.4 f for 13 hours with no reported adverse event (product storage error).  It was reported that Caller was reporting a temperature excursion. The cause of the temperature excursion was unknown. Caller is requesting stability information on these products.  Confirmed with caller that products were not administered to any patients post temperature excursion This situation is reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data the cause of the excursion was unknown.    Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 15.0
Sex: F
Vaccine: HEP, HEPA, IPV, MEN, MMR, UNK
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patients received the vaccine post excursion with no reported adverse event; The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who received the vaccine post excursion with no reported adverse event and the maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees celsius with no reported adverse event ,while receiving vaccines MMR, VARICELLA VACCINE (LIVE), MENINGOCOCCAL VACCINE, HEPATITIS B VACCINE, HEPATITIS A VACCINE and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jun-2022, the patient received a  dose of suspect IPV (VERO)( lot V1A024M and expiration date: 17-Feb-2024) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.   On an unknown date , the reporter states that temperature excursion due to leaving the door ajar. The excursion occurred on numerous dates from 14Jun22-25Jun22. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius  (product storage error) (unknown latency) and on 22-Jun-2022, the patient received the vaccine post excursion(poor quality product administered)(latency: same day).   Action taken :was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for both 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.; Sender's Comments:  01180622:
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to leaving the door ajar. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius with no reported adverse event; two patients received the vaccine post excursion with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17-year-old female patient who received the vaccine post excursion with no reported adverse event and there was temperature excursion due to leaving the door ajar. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees celsius with no reported adverse event. The vaccine used was IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) all for Immunisation.  On 22-Jun-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot V1A024M, expiration date: 17-Feb-2024, via intramuscular route in the left deltoid as Immunisation. The patient used the product previously.  In JUN-2022 there was temperature excursion due to leaving the door ajar. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  On 22-JUN-2022 the two patients received the vaccine post excursion with no reported adverse event (poor quality product administered) same day following the administration of IPV (VERO). This situation was reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data and was due to human error. This situation was reported as a misuse as per local labelling due to administration post excursion  Action taken was not applicable.  At time of reporting, the outcome was Unknown for all.  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.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave a patient expired IMOVAX with no adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who was given expired imovax with no adverse event ,while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2022, the patient received a dose number 1 of suspect RABIES (HDC) VACCINE( lot 76894 and expiration date:17-Jun-2022) at a dose of 1 ml once via intramuscular route in unknown administration site as post exposure Immunization.  On 07-Jul-2022(latency: same day) , it was reported that the patient given a expired imovax with no adverse event (expired product administered) and asked what they should do, should they re-do the vaccination.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (gave a patient expired IMOVAX with no adverse event).  At time of reporting, the outcome was Unknown for the event gave a patient expired imovax with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired ADACEL to a patient with no reported adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 44 years old male patient was administered an expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-May-2022, the patient was administered an expired 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection, (strength unknown) (lot U6638AA and expiry date: 12-Apr-2022) via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered).  Action taken : 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 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: F
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: was given MENACTRA today and had prior dose on 21SEP2021 with no adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. GMI Inquiry Number: 01182535  This case involves a 12-year-old female patient who experienced was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] today and had prior dose on 21sep2021 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2021, patient received dose of Menectra at unknown (formulation, strength, dose, frequency, route, lot, administration site) for prophylactic vaccination.  On 08-Jul-2022, the 12-year-old patient received another dose of suspect Menectra vaccine at dose 0.5ml once (lot U7190AA, expiry date: 16-JAN-2023) via intramuscular route in the left deltoid for prophylactic vaccination (extra dose administered, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 0.33
Sex: U
Vaccine: MNQ
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: MENQUADFI administered to patient under 2 years of age with no adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid non-serious case from a physician.  This case involves a 4-month-old and unknown gender patient to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] administered to patient under 2 years of age with no adverse event.  The patient's past medical history, medical treatment(s), family history and no other vaccination were provided.   On an unknown date, the patient received 0.5ml total dose (frequency: once) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength: standard, formulation, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization.  On 08-Jul-2022 a non-serious event of, menquadfi administered to patient under 2 years of age with no adverse event (off label use) (unknown latency).  It was reported, Caller requesting information for the parents of the patient.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received ActHIB with expired diluent with no reported adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01182877  This case involves a 1-year-old female patient who experienced patient received HIB (PRP/T) VACCINE [ACT-HIB] with expired 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 (Jeryl Lynn), Rubella Vaccine Live (Wistar RA 27/3) (Mmrvaxpro) for Prophylactic vaccination; Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination; and Pneumococcal Vaccine (Pneumococcal Vaccine) for Prophylactic vaccination.  On an unknown date in 2022, the patient received ACT-HIB vaccine ACCINE (lot: UJ524AA, expiry: 11-Jul-2022, lot: U6998BA, expiry: 25-Jun-2022) at unknown dose once intramuscular route in the right thigh for immunization (expired product administered, same day latency).  It was reported that "Health care professional (HCP) reports patient received Act-HIB with expired diluent. She said she thought the year was 2025 but that the day was 25."  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 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.
Sex: U
Vaccine: YF
Symptoms: Wrong product administered
Clinical narrative: has a problem with a single family member of 4 that received a dose of saline instead of the yellow fever vaccine with no reported adverse event; Initial information received on 10-Jul-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient, reportedly has a problem with a single family member of 4 that received a dose of sodium chloride (Saline) instead of the YELLOW FEVER VACCINE - [YF-VAX] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect YELLOW FEVER VACCINE (strength, formulation, route, frequency: unknown) (lot: UJ563AA and expiry date: 23-May-2023) in unknown administration site for Immunization.  On an unknown date, the patient started taking sodium chloride (strength, formulation, route, frequency, dose: unknown) (with an unknown batch number and expiry date).  On an unknown date the patient developed a non-serious event, has a problem with a single family member of 4 that received a dose of saline instead of the yellow fever vaccine with no reported adverse event (wrong product administered) (unknown latency).  It was reported, after hours call received at 12:10pm on 10jul2022. Doctor states that he has a problem with a single family member of 4 that received a dose of saline instead of the yellow fever vaccine. "Do I need to give a dose to every family member?" After hours call returned at 12:30pm on 10jul2022. Caller states that a family of 4 came in and introspect he counted the vials and determined that probably they gave one of the 4-member saline only and not the yellow fever vaccine. "Do I need to repeat the dose for all 4?" Do you know where they can receive a yellow fever titer?" What happens if they receive an extra dose?"   Action taken with YELLOW FEVER VACCINE (YF-VAX) and SODIUM CHLORIDE (SODIUM CHLORIDE) was not applicable.  At time of reporting, the outcome was 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.