chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Hypertension, Hypoacusis, Hypotension
Clinical narrative: Regarding Covid booster#2. I experienced very high BP for 3 days; now very low BP; weakness; a loss of some hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "have had cardiac bypass" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization; Bnt162b2 (Dose 3, First Booster), for Covid-19 Immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "Regarding Covid booster#2. I experienced very high BP for 3 days"; HYPOTENSION (non-serious), outcome "unknown", described as "now very low BP"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; HYPOACUSIS (non-serious), outcome "unknown", described as "a loss of some hearing".  Additional information: This never happened upon receiving 1st 3 Covid shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Middle insomnia, Neck pain
Clinical narrative: For the last several years, I've had occasional pain in my right knee. After my second booster, the knee pain has increased; For the last several years, I've had occasional pain in my right knee. After my second booster, the knee pain has increased; It's been keeping me awake at night and still lingers today (18 days later); I developed pain in my left shoulder and left side of my neck (my shot was in my left shoulder).; I developed pain in my left shoulder and left side of my neck (my shot was in my left shoulder).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24May2022 as dose number unknown (booster), single (Lot number: FM0173) for covid-19 immunization. The patient's relevant medical history included: "pain in my right knee" (unspecified if ongoing), notes: For the last several years, I've had occasional pain in my right knee. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number -1, Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (Dose number -2, Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (Dose number -3, Manufacturer unknown), for covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 28May2022, outcome "unknown" and all described as "I developed pain in my left shoulder and left side of my neck (my shot was in my left shoulder)."; CONDITION AGGRAVATED (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "For the last several years, I've had occasional pain in my right knee. After my second booster, the knee pain has increased"; MIDDLE INSOMNIA (non-serious), outcome "unknown", described as "It's been keeping me awake at night and still lingers today (18 days later)". Therapeutic measures were taken as a result of arthralgia, neck pain, condition aggravated, arthralgia.  Additional Information: Patient never had a reaction to a Pfizer Covid shot until patient had 2nd booster on 24May2022. About four days after the second booster (Lot # FM0173), developed pain in left shoulder and left side of neck (shot was in patient left shoulder). It's been keeping patient awake at night and still lingers today (18 days later). Tylenol seems to help reduce the pain. For the last several years, patient had occasional pain in his right knee. After second booster, the knee pain has increased.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on COVID-19 rapid antigen test today; tested positive on COVID-19 rapid antigen test today; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 56-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 19May2022 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "not recovered" and all described as "tested positive on COVID-19 rapid antigen test today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Positive. Clinical course: patient tested positive on COVID-19 rapid antigen test today (i.e. 12Jun2022). Her symptoms were tiredness and headache over the last two days and rapid heartbeat today(i.e. 12Jun2022). No other respiratory symptoms. She was a subject in the COVID-19 clinical study.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Encephalitis
Clinical narrative: long COVID symptoms; long COVID symptoms; encephalitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "long COVID symptoms"; ENCEPHALITIS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of covid-19, encephalitis.  Clinical course: After experiencing long COVID symptoms after the vaccine and some signs of encephalitis, it was Vistaril and decongestants which have changed everything. Benadryl was decent in helping but higher doses of Vistaril changed a lot. Looking at research and with patient background in animal science, the patient think it's blocking the H1 histamine receptor as it's known for. Allowing the body to block virus binding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Pain in extremity, Rash
Clinical narrative: extremely fatigued; arm was painful; hot to the touch; slight rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 10Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Jun2022, outcome "unknown", described as "arm was painful"; FATIGUE (non-serious) with onset 12Jun2022, outcome "unknown", described as "extremely fatigued"; FEELING HOT (non-serious) with onset 12Jun2022, outcome "unknown", described as "hot to the touch"; RASH (non-serious) with onset 12Jun2022, outcome "unknown", described as "slight rash". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Additional information: On 10Jun2022, patient received second booster of the COVID-19 vaccine. Two days later patient had a reaction to the vaccine that he/she did not have with the first three. On 12Jun2022, patient was extremely fatigued and the arm was painful, hot to the touch with a slight rash. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Diverticulitis, Drug ineffective, Psoriatic arthropathy
Clinical narrative: On 19May22 I came down with COVID-19; On 19May22 I came down with COVID-19; I was diagnosed with diverticulitis and psoriatic arthritis on my (R) hand; I was diagnosed with diverticulitis and psoriatic arthritis on my (R) hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIVERTICULITIS (medically significant), PSORIATIC ARTHROPATHY (medically significant) all with onset 30Mar2021, outcome "unknown" and all described as "I was diagnosed with diverticulitis and psoriatic arthritis on my (R) hand"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "On 19May22 I came down with COVID-19". The events "on 19may22 i came down with covid-19" and "i was diagnosed with diverticulitis and psoriatic arthritis on my (r) hand" required emergency room visit. Therapeutic measures were taken as a result of covid-19.On 30March the patient went to the ER where the patient was diagnosed with diverticulitis and psoriatic arthritis on the right hand. The patient did not have anyone in  family who ever suffered from diverticulitis. On 19May22  came down with COVID-19, and was prescribed Paxlovid for 5 days. The patient had diarrhea, bad taste in the mouth and vomiting and when finished it, got diverticulitis (more serious > the 1st).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Parkinson's disease, Systemic lupus erythematosus
Clinical narrative: COVID; Parkinson's disease; Lupus syndrome; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4101389-00 (Agency).  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1148312) at citrate free and second regimen (Lot number: 1157582), all subcutaneous for psoriasis, psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset Oct2021, outcome "recovering", described as "Lupus syndrome"; PARKINSON'S DISEASE (medically significant) with onset Oct2021, outcome "not recovered"; COVID-19 (medically significant), outcome "recovering", described as "COVID". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of covid-19.  The reporter's assessment of the causal relationship of "covid", "parkinson's disease" and "lupus syndrome" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: suspect drug to the reported events Parkinson's disease, Systemic lupus erythema , covid 19 cannot be completely excluded based on temporal association.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; 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-163-4431061-00 (Agency).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years intramuscular for covid-19 immunization; adalimumab (HUMIRA), from 18Jan2022 (Batch/Lot number: unknown) to 18Jan2022, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (dose 1, single (1 in 1 Once), Intramuscular route), administration date: 08May2021, when the patient was 67-year-old, for COVID-19 vaccination. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 18Jan2022, outcome "recovered" (18Jan2022), described as "Heart attack". The action taken for adalimumab was dosage permanently withdrawn on 18Jan2022. Clinical course was reported as, Patient experienced COVID-19 from 10Jun2021 to 20Jun2021. It was unknown if patient was enrolled in a COVID-19 vaccine trail. Reported that event abate after stopping drug (Humira).  Causality for BNT162B2: The reporter considered "heart attack" related to BNT162b2 (reported as Possible). Causality for adalimumab (HUMIRA): The reporter's causality for the event (s) of heart attack with Humira (Adalimumab) was no reasonable possibility (Not related) and (as per Manufacturer) Agency's opinion is that the event of heart attack is not assessable.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Covid; caught covid shortly after receiving dose 2  and was unable to come in, he received his second dose on 02-May-2022; Initial information received on 09-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via Nurse.  This case involves a 20 years old male patient who  caught covid shortly after receiving dose 2  and was unable to come in, he received his second dose on 02-May-2022 , after 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 18-Apr-2022 , the patient received a dose 1 of suspect RABIES (HDC) VACCINE, powder and solvent for suspension for injection, 0.2 ml (lot T1E321M: expiry date 16-Sep-2022)  via intramuscular route in the left deltoid  and  On 02-May-2022 he also received 0.25ml dose 2  of the same vaccine  lot T1E321M via intramuscular route in the left deltoid for rabies prophylaxis (rabies immunization).  It was reported that the patient then he caught covid shortly after receiving dose 2  and was unable to come in, he received his second dose on 02-May-2022 (inappropriate schedule of product administration) (covid-19) (onset dat: 2022 ; latency: unknown). The  patient received dose 3  the vaccine on 14-Sep2022 (lot number: T2B23 ; expiry date: not reported) (dose: 1 ml)  via intramuscular route on left deltoid .  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (covid).  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.  Additional information received on 06-Jun-2022 from other health care professional.  Therapy details added. Text amended accordingly
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient of theirs received their first dose of Menactra at age 11 and then age 13 (on accident) with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional.  This case involves Adolescent of unknown gender and age patient received their first dose of menactra at age 11 and then age 13 (on accident) with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past vaccination(s) included Menactra with at age 11. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine Solution for injection (dose, route, strength, frequency, batch lot number and expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization). Information on batch lot number is requested.  On an unknown date the patient developed a non-serious event a patient of theirs received their first dose of menactra at age 11 and then age 13 (on accident) with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (D Conj) Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.    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: DTAP
Symptoms: Death
Clinical narrative: I had a friend who's 6 MONTH OLD DIED from the TDAP shot; Initial information received on 11-Jun-2022 regarding an unsolicited valid social media serious case received via consumer/non-hcp.  This case involves a 6 months old female patient who experienced had a friend who's 6 month old died from the tdap shot while receiving vaccine Diphtheria, Tetanus And Acellular Pertussis 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 a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (dose, route, lot number and administration site: unknown) for prophylactic vaccination.  On an unknown date reportedly had a friend who's 6 month old died from the tdap shot (death) (unknown latency) following the administration of Diphtheria And Tetanus And Acellular Pertussis Vaccine.   This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) i had a friend who's 6 month old died from the tdap shot.  Action taken: not applicable.  Corrective treatment: not reported  Outcome: Fatal   It is unknown if an autopsy was done. The cause of death was reported as Death NOS.; Sender's Comments: Sanofi company comment dated 14-Jun-2022: This case, received from social media, concerns 6 months old female patient who, as reported, died from the shot Diphtheria, Tetanus And Acellular Pertussis Vaccine. The cause of death was unknown. Temporal relationship cannot be established due to lack of information on event onset date and vaccination date. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, corrective treatment/clinical measures, family history, and autopsy findings would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: not provided
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involving punctured Ipol and administered to 3 patients after the excursion.; Initial information received on 23-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA192000(CLUSTER).  This case involves a 8 years old female patient with event as  temperature excursion involving punctured ipol and administered to 3 patients after the excursion. 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 measles vaccine, mumps vaccine, rubella vaccine (MMR); and hepatitis a vaccine (Hepatitis A).  On 09-May-2022, the patient received a  dose of suspect ipv (vero) lot T1E871M via intramuscular route in the right deltoid(formulation unknown, strength: standard and  expiry date : 10-Oct-2022)  On 09-May-2022 the patient was part of a non-serious event of "temperature excursion involving punctured ipol and administered to 3 patients after the excursion." (poor quality product administered) following the administration of ipv (vero).  Action taken with poliomyelitis vaccine (inactivated) (Ipol) was not applicable.  At time of reporting, the outcome was Unknown for the event "temperature excursion involving punctured ipol and administered to 3 patients after the excursion."  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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: received only the liquid DTAP-IPV component of PENTACEL vaccine with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who  received only the liquid dtap-ipv component of pentacel vaccine with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine  (formulation, strength, route, anatomical location, batch number and expiry date Unknown) for proplylactic vaccination (Immunisation).   the patient "received only the liquid dtap-ipv component of pentacel vaccine with no reported adverse event" (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with diphtheria, tetanus, ac pertussis, ipv and hib vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event "received only the liquid dtap-ipv component of pentacel vaccine with no reported 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 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: U
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Accidentally received a YF-VAX mixed with sterile water instead of sodium chloride/wrong diluent administered with no reported adverse event; Initial information received on 27-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who accidentally received a yf-vax mixed with sterile water instead of sodium chloride/wrong diluent administered 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 a dose of suspect yellow fever vaccine unknown formulation and strength lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date it was reported that a patient accidentally received a YF-VAX mixed with Sterile water instead of Sodium Chloride /wrong diluent administered with no reported adverse event (product preparation error) (unknown latency) following the administration of yellow fever vaccine. Action taken: Not applicable  Corrective treatment: 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: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired dose of TENIVAC with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] 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 an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot U6669AA; expiry date:15-May-2022)  via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event received an expired dose of tenivac with no reported 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 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: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist states that Adacel expired on 04Apr2022 it was accidentally given to a patient with no reported Adverse Event.; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 53 years old male patient it was reported by pharmacist states that diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] expired on 04apr2022 it was accidentally given to a patient 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 VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.  On 31-May-2022, the patient received a  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (lot U6628AA: expiry date 04-Apr-2022) via intramuscular route in the left deltoid for Immunization it was reported by pharmacist adacel expired on 04apr2022 it was accidentally given to a patient with no reported adverse event. (expired product administered). It was asked by reporter that "if the patient needs to be revaccinated and if so, when"  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event pharmacist states that adacel expired on 04apr2022 it was accidentally given to a patient with no reported 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: 8.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 8 year old on catch up schedule for vaccines with no adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an 8-year-old on catch up schedule for Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] vaccines with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 8 years old patient on catch up schedule received a dose of suspect Quadracel vaccine (formulation, strength, dose, lot number, expiration date, route of administration and administration site: unknown) as prophylactic vaccination (product use issue, latency unknown)   There will be no information available on the batch number for this case.  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 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: M
Vaccine: UNK
Symptoms: COVID-19, Exposure to SARS-CoV-2, Product dose omission issue, SARS-CoV-2 test negative
Clinical narrative: symptomatic for COVID-19 after being exposed during a wedding; patient was scheduled to come in to the office this week to take the second dose but is not able to because of COVID; Initial information received on 01-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves an unknown age male patient who experienced patient was scheduled to come in to the office this week to take the second dose but is not able to because of covid and symptomatic for covid-19 after being exposed during a wedding while receiving vaccine ipv (vero) [Imovax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-May-2022, the patient received a dose of suspect ipv (vero) [Imovax] (unknown batch lot number ,dosage.formulation and expiry date)via unknown route in unknown administration site for immunization.  On 02-Jun-2022 (latency :unknown) the patient developed a non-serious event of patient was scheduled to come in to the office this week to take the second dose but is not able to because of covid (product dose omission issue) and symptomatic for covid-19 after being exposed during a wedding (exposure to sars-cov-2)   Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date:  [negative]  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: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: what to do moving forward after they have administered expired MENACTRA with no reported adverse event; Initial information received on 01-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who experienced what to do moving forward after they have administered expired menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2022, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine [Menactra] (batch lot : U6921AA,Expiry date : 17-Apr-2022) (unknown strength, formulation) via unknown route in unknown administration site for immunization.  On 20-May-2022 (latency :same day) the patient developed a non-serious event of  what to do moving forward after they have administered expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) 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 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: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of pentacel administered to a patient with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 9-month-old male patient who administered expired dose of pentacel with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel].  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) for Immunisation.  On 25-May-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine unknown: strength and formulation, lot UJ465AA, expiry date: 21-MAY-2022, frequency: once, via intramuscular route in the left thigh as immunization.  On 25-MAY-2022 the patient developed a non-serious event expired dose of pentacel administered to a patient with no reported adverse event (expired product administered) latency: same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired 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 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: MNQ
Symptoms: Intercepted product storage error, Medication error, No adverse event
Clinical narrative: Vaccine stored for 10 hours at high temperature due to human error with no adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age male patient who experienced vaccine stored for 10 hours at high temperature due to human error with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7483AA (expiry date 20-Oct-2023) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious vaccine stored for 10 hours at high temperature due to human error with no adverse event (intercepted product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Vaccine stored for 10 hours at high temperature due to human error with no adverse event).  At time of reporting, the outcome was Unknown for the event vaccine stored for 10 hours at high temperature due to human error 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: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: only administered the liquid component to the patient, states the patient only required DTAP-IPV and the HIB was not necessary, with not reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who experienced only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   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); and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 02-Jun-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ528AAA (10-Jul-2022)  via intramuscular route in the right thigh for prophylactic vaccination.  On 02-JUN-2022 (latency: Same day) the patient developed a non-serious only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (only administered the liquid component to the patient, states the patient only required DTAP-IPV and the HIB was not necessary, with not reported adverse event).  At time of reporting, the outcome was Unknown for the event only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported 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 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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Pentacel that was reconstituted with 0.7 mL sterile water/ reconstituted with invalid diluent with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom pentacel that was reconstituted with 0.7 ml sterile water/ reconstituted with invalid diluent with no reported adverse event whilst vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-May-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) suspension for injection (dose, strength, lot number, expiry date: not reported) via unknown route in unknown administration site as Immunization.  On 31-May-2022, the patient was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine that was reconstituted with 0.7 ml sterile water/ reconstituted with invalid diluent with no reported adverse event (product preparation error) (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 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: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine undergone temperature excrusion adminstered to patient with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced vaccine undergone temperature excrusion adminstered to patient with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 15-MAY-2022 the patient developed a non-serious vaccine undergone temperature excrusion adminstered to patient with no reported adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccine undergone temperature excrusion adminstered to patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event vaccine undergone temperature excrusion adminstered to patient with no reported 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 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.