chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: lost hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-023857 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes (controlled with diet)" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "Allergies: NSAIDs" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "lost hair". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Localised oedema
Clinical narrative: edema in his armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the parent. Other Case identifier(s): 38585 (BioNTech SE).  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: LOCALISED OEDEMA (non-serious), outcome "unknown", described as "edema in his armpit". Additional information: Reporter claims that the nurse who administered the vaccine very quickly. 24 hours later, patient had edema in his armpit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Full blood count, Lymphocyte count decreased, SARS-CoV-2 test
Clinical narrative: Lymphocyte relative 13% low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis", start date: Jun2017 (ongoing), notes: ANA Positive. Concomitant medication(s) included: VUMERITY oral taken for multiple sclerosis (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation. The following information was reported: LYMPHOCYTE COUNT DECREASED (non-serious), outcome "unknown", described as "Lymphocyte relative 13% low". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient received dose 4 (gray cap) on 30Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unknown (booster), single (Lot number: gj5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for Covid-19 immunization. The following information was reported: NERVOUSNESS (non-serious) with onset Sep2022, outcome "unknown", described as "nervous".  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Rash
Clinical narrative: Chills; Nausea; Fatigue; Rash/generalized exanthem; HA; Experienced sore Right arm (at site of immunization); This is a spontaneous report received from contactable reporter(s) (Physician).  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 04, Lot number: FP4554, Manufacturer: Pfizer), administration date: 05Apr2022, when the patient was 69-year-old, for COVID-19 immunization; Bnt162b2 (Dose: 03, Manufacturer: Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 02, Manufacturer: Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 01, Manufacturer: Pfizer), for COVID-19 immunization.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Sep2022, outcome "recovering", described as "Experienced sore Right arm (at site of immunization)"; CHILLS (non-serious) with onset 18Sep2022, outcome "recovering"; FATIGUE (non-serious) with onset 18Sep2022, outcome "recovering"; HEADACHE (non-serious) with onset 18Sep2022, outcome "recovering", described as "HA"; NAUSEA (non-serious) with onset 18Sep2022, outcome "recovering"; RASH (non-serious) with onset 18Sep2022, outcome "recovering". Therapeutic measures were taken as a result of vaccination site pain, chills, nausea, fatigue, rash, headache. Additional information: After the dose of bivalent vaccine administered, patient experienced sore right arm (at site of immunization) with no real limitation of activity within a few hours after administration, followed by generalized exanthem, chills, Headache (HA), nausea, fatigue which did limit activities beginning morning of Sunday, 18Sep. These symptoms were treated with ibuprofen with relief. The main reason for this report is that on 19Sep2022, patient experienced a generalized, blanching red exanthem, particularly prominent on her chest, mid back, thighs (particularly right inner thigh) and extremities. This rash appeared to completely spare her face. There was no redness, rash, or swelling at site of vaccine administration. The rash was non-pruritic and non-tender. Withheld had no respiratory or gastrointestinal symptoms at time of this appearance and was otherwise feeling well. By the morning and time of this report on Tuesday, 20Sep2022, the rash was beginning to fade, but still present.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; Nausea; Fatigue; Rash/generalized exanthem; HA; Experienced sore Right arm (at site of immunization); This is a spontaneous report received from contactable reporter(s) (Physician).  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 04, Lot number: FP4554, Manufacturer: Pfizer), administration date: 05Apr2022, when the patient was 69-year-old, for COVID-19 immunization; Bnt162b2 (Dose: 03, Manufacturer: Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 02, Manufacturer: Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 01, Manufacturer: Pfizer), for COVID-19 immunization.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Sep2022, outcome "recovering", described as "Experienced sore Right arm (at site of immunization)"; CHILLS (non-serious) with onset 18Sep2022, outcome "recovering"; FATIGUE (non-serious) with onset 18Sep2022, outcome "recovering"; HEADACHE (non-serious) with onset 18Sep2022, outcome "recovering", described as "HA"; NAUSEA (non-serious) with onset 18Sep2022, outcome "recovering"; RASH (non-serious) with onset 18Sep2022, outcome "recovering". Therapeutic measures were taken as a result of vaccination site pain, chills, nausea, fatigue, rash, headache. Additional information: After the dose of bivalent vaccine administered, patient experienced sore right arm (at site of immunization) with no real limitation of activity within a few hours after administration, followed by generalized exanthem, chills, Headache (HA), nausea, fatigue which did limit activities beginning morning of Sunday, 18Sep. These symptoms were treated with ibuprofen with relief. The main reason for this report is that on 19Sep2022, patient experienced a generalized, blanching red exanthem, particularly prominent on her chest, mid back, thighs (particularly right inner thigh) and extremities. This rash appeared to completely spare her face. There was no redness, rash, or swelling at site of vaccine administration. The rash was non-pruritic and non-tender. Withheld had no respiratory or gastrointestinal symptoms at time of this appearance and was otherwise feeling well. By the morning and time of this report on Tuesday, 20Sep2022, the rash was beginning to fade, but still present.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive on 24Jan2022; positive on 24Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 26Oct2021 at 16:00 as dose 1, single (Lot number: 301458A), in left arm and on 16Nov2021 at 16:10 as dose 2, single (Lot number: FH8027) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing); "Anxiety" (ongoing); "CRPS" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN taken for thyroid disorder (ongoing); CLONAZEPAM taken for anxiety, start date: 2018 (ongoing). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 24Jan2022, outcome "unknown" and all described as "positive on 24Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2020) Negative, notes: Work; (09Jan2021) Negative, notes: Work; (06Feb2021) Negative, notes: surgery; (24Jan2022) Positive. Clinical course: Patient got 1st Pfizer vaccine on 26Oct2021 within 15-20 mins. She tested metal that lasted for a week. One week after vaccine right ear drum ruptured. On 08Nov2021, patient went to ENT-PA that visit was given ear drops and antibiotic. Patient called ENT on 22Nov2021 made appointment for 2pm ear pain was so annoying. The ENT-PA advised to wait 5 months then come back. Patient called back on 10Jan2022 was not happy so hold for another ENT. On 13Jul2022 she was able to get on appointment with Dr. She was told had a hole at 4 o'clock position in right ear, a hearing test was terrible, scheduled surgery for 01Sep2022. She would go back on 07Oct2022 to see how the surgery helped. Then have another hearing test. She was perfectly healthy under normal care until the incident.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: experienced increased immune system response; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003391.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "experienced increased immune system response". Additional information: On 06Sep2022, it was reported that a patient started treatment on an unspecified date with Pfizer-BioNTech COVID-19 Vaccine at an unspecified dose and frequency for COVID-19 immunization. It was reported the patient experienced increased immune system response that lasted for months following her second dose. No further follow-up is anticipated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstruation irregular, Weight, Weight decreased
Clinical narrative: Since then, she has not had her period; Her period was not regular when she received the booster, however, it is non existent at this time; weight loss; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent. A 16-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 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, Single), for COVID-19 Immunization, reaction(s): "Her period was not regular when she received the booster"; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "Her period was not regular when she received the booster". The following information was reported: AMENORRHOEA (non-serious), outcome "not recovered", described as "Since then, she has not had her period"; MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Her period was not regular when she received the booster, however, it is non existent at this time"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported as, Daughter received the primary series last year. She received the booster in Nov. Since then, she has not had her period. Her period was not regular when she received the booster, however, it is non existent at this time. The daughter also has gone through some weight loss. The only difference from everyday life is the fact that she received the Pfizer BioNTech Covid-19 vaccine booster. 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3249), on 17Feb2021 as dose 2, single (Lot number: 9269), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years 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 25Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (28Jul2022) Negative; (09Aug2022) Positive; (18Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included paxlovid from 25Jul2022 to 29Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart disease". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: booster shot gave her/him covid/popped positive on every one of them/ coughing; booster shot gave her/him covid/popped positive on every one of them/ coughing; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "booster shot gave her/him covid/popped positive on every one of them/ coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive; Positive. Clinical courses: The patient thought our booster shot gave her/him covid. The patient felt fine before the shot. The evening of and ever since she/he had been coughing terribly. The patient took two different at home covid tests, 3 times and popped positive on every one of them. The patient had never had covid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Lupus-like syndrome
Clinical narrative: Drug induced lupus as direct consequence of Covid 19 Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: LUPUS-LIKE SYNDROME (medically significant), outcome "unknown", described as "Drug induced lupus as direct consequence of Covid 19 Pfizer vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered expired vaccination - with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who administered expired vaccination - with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, prefilled syringe (strength: unknown) lot UT7378NA, UT7376JA via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date the patient was administered expired vaccination - with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  There were no lab data/results available. The company suspect product was inappropriately used as per local Marketing authorization. Intentions were no.  Action taken was 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: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Fluzone QIV last injection administered in pregnancy with no reported adverse event; Initial information received  on 15-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 37 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of fluzone qiv last injection administered in pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Fluzone QIV last injection administered in pregnancy with no reported adverse event occurred at 33 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 33 weeks of pregnancy, during third pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 26-Jan-2022. The estimated due date is 18-Nov-2022. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. The patient previous pregnancy was not reported.   On 14-Sep-2022, the patient received a dose one of suspect INFLUENZA QUADRIVAL A-B VACCINE at an unknown dose (lot UT7682KA, expiry date: not reported) via intramuscular route in unknown administration site for immunisation.  On 14-Sep-2022 the patient developed a non-serious fluzone qiv last injection administered in pregnancy with no reported adverse event (maternal exposure during pregnancy) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant prenatal testing after exposure not reported.  Action taken: Not applicable.  Outcome: Unknown   Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnancy with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnancy with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date is 03-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UT7682KA and expiry date: unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of pregnancy with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient had no adverse event. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken : not applicable.  Outcome: Unknown  Additionally, at time of reporting, the pregnancy was still ongoing.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine was involved in a temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2022SA377287(CLUSTER) and 2022SA377293(CLUSTER).  This case involves a 47 years old male patient who was administered Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] vaccine after temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.7 ml, once dose of suspect Influenza quadrival A-B high dose HV vaccine unknown formulation (lot UJ875AD, Exp date: 30-Jun-23) via intramuscular route in the left deltoid for immunization.  On 07-Sep-2022 (latency: same day), the patient developed a non-serious "vaccine was involved in a temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event (poor quality product administered).  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.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received IPOL instead of the intended TUBERSOL with no reported adverse event; patient received IPOL intradermally with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient who received ipol instead of the intended tubersol with no reported adverse event and received IPOL intradermally with no reported adverse event, after receiving vaccine IPV (VERO) [IPOL].  The patient's past vaccination(s) included IPV. The patient's past medical history, medical treatment(s) and family history were not provided.   On 12-Sep-2022, the patient received a dose of suspect IPV (VERO)( lot V1A121M and expiration date: 30-Jun-2023) at a dose of 0.1ml once via intradermal route in the left arm  for prophylactic vaccination.  On 12-Sep-2022 (latency: same day),the patient developed a non-serious events "patient received ipol instead of the intended tubersol with no reported adverse event "(wrong product administered) and "patient received IPOL intradermally with no reported adverse event "following the administration .The patient has not reported any adverse reaction  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event  Outcome: 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.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Ipol was administered to 3 patients after excursion with no reported adverse event; on 11-AUG-2022 with the highest temp. being 47.5 degrees F for 10 minutes due to unknown reason but possibly due to the door being opened for too long with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. number: 01276952  This case involves an unknown age/gender patient who experienced ipol was administered to 3 patients after excursion with no reported adverse event and on 11-aug-2022 with the highest temp. being 47.5 degrees f for 10 minutes due to unknown reason but possibly due to the door being opened for too long 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.   On an unknown date, Ipol was administered to 3 patients after excursion with no reported adverse event (lot Z1A024M, expiry date: 17-Feb-2024) at unknown dose via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered) (unknown latency).  It was reported that on 11-aug-2022 with the highest temp. being 47.5 degrees f for 10 minutes due to unknown reason but possibly due to the door being opened for too long with no reported adverse event (product storage error) (latency same day) following the administration of IPV (VERO).  Action taken: Not applicable.  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 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: 3.0
Sex: M
Vaccine: HIBV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse eventreceived both a pentacel dose and a dose of acthib, on the same day with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 3 years old male patient who received both a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose and a dose of HIB (PRP/T) VACCINE [ACT-HIB], on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication 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) (MMRVAXPRO) both for Prophylactic vaccination.  On 09-Aug-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ575AAA, expiry date: 20-Sep-2022) and suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ614AAA, expiry date: 25-Feb-2023) both via intramuscular route in the left arm for immunisation.  On 09-Aug-2022 the patient received both a pentacel dose and a dose of acthib, on the same day with no reported adverse event (extra dose administered) same day latency. It was unknown if the consumer was to receive the combo of DTAP and Hib in the same vaccine or if the consumer was to receive a stand alone DTap and a stand alone HIB vaccine.  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.; Sender's Comments:  01275067:
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: TENIVAC administration too early with no adverse event; Initial information received  on 14-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 79 years old female patient for whom tenivac administration was too early with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) for Immunisation.  On 13-Sep-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml total (lot U7549AA, expiry date: 04-Nov-2024) via intramuscular route in the left deltoid for immunisation.  On 13-Sep-2022 the tenivac administration was too early with no adverse event (inappropriate schedule of product administration) same day latency following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken: Not applicable.  Corrective treatment: Not reported.  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: Incorrect dose administered, Incorrect route of product administration
Clinical narrative: patient was given IPOL intradermally with no reported adverse event; patient was given IPOL intradermally 0.1 ml with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid non-serious case received via Clinic Supervisor. GMI Inquiry Number: 01278936, 01279155.  This case involves an unknown age female patient who was given IPV (VERO) [IPOL] intradermally 0.1 ml with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2022, the patient received suspect IPOL at 0.1 ml via intradermal route (unknown: lot number, administration site) for prophylactic vaccination with no reported adverse event (incorrect route of product administration, incorrect dose administered) at latency same day.  It was reported that "Reporter states the patient was given IPOL intradermally 0.1 ml instead of the TB test but didn't say which product name for the TB. Caller wants to know what to know what they should look for with the patient and what to do? Caller doesn't have lot or any information. This situation is reported as a misuse as per local labelling due to incorrect route and dose. Caller states it was given today and the consumer was a female but that is all she knows."  Action taken: Not applicable.  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.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB component of PENTACEL given with sterile water instead of being reconstituted with the DTaP-IPV component.- with no reported adverse event; Initial information was received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who experienced acthib component of pentacel given with sterile water instead of being reconstituted with the dtap-ipv component.- with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].   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; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 13-Sep-2022, the patient received 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ641AAA and expiry-28-02-2024) (strength and administration site: unknown) via intramuscular route for immunization.    On 13-SEP-2022 the patient developed a non-serious acthib component of pentacel given with sterile water instead of being reconstituted with the dtap-ipv component.- with no reported adverse event (product preparation error) (latency same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event acthib component of pentacel given with sterile water instead of being reconstituted with the dtap-ipv component.- 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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: a PENTACEL vaccine was administered, then noted to have expired a few days ago with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administered a pentacel vaccine , then noted to have expired a few days ago with no reported adverse event ,after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 14-Sep-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE( lot UJ578AAA and expiration date: 10-Sep-2022) at a dose of 0.5ml  via intramuscular route in the right thigh for immunization.   On 14-Sep-2022(latency: same day), the patient was administered a pentacel vaccine , then noted to have expired a few days ago with no reported adverse event (expired product administered) following the administration.   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the 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.
Age: 17.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered a dose of flublok to a 17 year old in error with no reported adverse event; Initial information received  on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old patient of an unknown gender and reported that they administered a dose of Influenza Quadrivalent Recombinant Vaccine [Flublok] to a 17 year old in error with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a  dose of 0.5 ml suspect Influenza Quadrivalent Recombinant Vaccine, once (1X) ( strength, formulation, route, lot number  and expiry date: not reported)  in unknown administration site for immunization. Information regarding batch number details has been requested.  The reporter stated that  they administered a dose of Flublok to a 17 year old in error with no reported adverse event (product administered to patient of inappropriate age) (onset date: 15-Sep-2022; latency: same day).  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 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: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: medical assistant says she gave an expired adacel with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient who reported  medical assistant says she gave an expired adacel with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Prophylactic vaccination; HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Prophylactic vaccination; and HPV VACCINE (HPV VACCINE) for Prophylactic vaccination.  On 15-Sep-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (lot U6807BB; expiry date: 10-sep-2022) via unknown route in the right arm for prophylactic vaccination.  On 15-SEP-2022 the patient developed a non-serious event medical assistant says she gave an expired adacel with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.   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 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: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: received a flu product when she was pregnant with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid non-serious case received from health professional and patient. Agency number: 01280972  This case involves a 31-year-old female patient who was exposed to vaccine flu product (Influenza Vaccine) in context of received a flu product when she was pregnant with no reported adverse event. Data regarding this pregnancy were received retrospectively, i.e., after pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On unknown date in 2016, the patient during pregnancy received a dose of suspect flu product produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (exposure during pregnancy) same day latency. Patient had a flu product about 6 years ago when she was pregnant and had a normal Pregnancy/ delivery. It was reported that patient was currently 37 years old and was pregnant. The patient has some questions regarding the flu vaccine. Patient enquired about which SANOFI FLUZONE product; she should receive. Patient would also like some information regarding risk involved for the fetus. Patient had not received the vaccine product yet but is planning to receive it tomorrow on 16Sep2022. Patient had last menstrual period of sometime in April 2022. The estimated due date for current pregnancy was 13-Mar-2023.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event received a flu product when she was pregnant with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown with, and fetal outcome was reported as Normal/No Defect.