chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna on 02Dec2021/vaccine brand other=Moderna on 15Apr2022; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 at 10:30 as dose 1, single (Lot number: EL9269), in left arm and on 25Feb2021 as dose 2, single (Lot number: En6198), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021 at 12:00, outcome "unknown", described as "vaccine brand other=Moderna on 02Dec2021/vaccine brand other=Moderna on 15Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: Positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.   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: Death
Clinical narrative: six people with the same death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "six people with the same death". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173665 same reporter/drug/event, different patient;; Reported Cause(s) of Death: six people with the same death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Had a relative that past away due to getting her booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "Had a relative that past away due to getting her booster shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The causality between the event and BNT162b2, BNT162b2 omi ba.4-5 was reported as not known.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Had a relative that past away due to getting her booster shot
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: experiencing persistent suspected pericarditis after mRna vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 1, single (Batch/Lot number: unknown) and on 15Oct2021 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: PERICARDITIS (medically significant) with onset 2021, outcome "not recovered", described as "experiencing persistent suspected pericarditis after mRna vaccine".  Clinical information: Description of Event Outcome: I've been experiencing persistent suspected pericarditis after mRna vaccine on dates 24Sep2021 and 15Oct2021 (race withheld) born (DOB withheld). Medical Information forwarded : N/A, no medical inquiry asked  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Rash, Suspected COVID-19
Clinical narrative: my 42 year old daughter, who only had 3 Pfizer vaccines/after the 3 doses she did get Covid; my 42 year old daughter, who only had 3 Pfizer vaccines/after the 3 doses she did get Covid; rash behind her ears, scalp, abdomen, under right breast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 42-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "my 42 year old daughter, who only had 3 Pfizer vaccines/after the 3 doses she did get Covid"; RASH (non-serious), outcome "unknown", described as "rash behind her ears, scalp, abdomen, under right breast".  Clinical course: Reported states my 42 year old daughter, who only had 3 Pfizer vaccines (the first 2 and then the 1st booster). She's a school teacher and after the 3 doses she did get Covid and had the recommended infusion at our local hospital. She also has the same type rash behind her ears, scalp, abdomen, under right breast. She had not seen a doctor or dermatologist. Hopefully, once school was out, she will get allergy testing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Product administration error
Clinical narrative: feel tired for a few hours; I think the administer of it the way the guy gave me the shot it wasn't too cool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 76 years 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; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset Sep2022, outcome "unknown", described as "I think the administer of it the way the guy gave me the shot it wasn't too cool"; FATIGUE (non-serious) with onset Sep2022, outcome "recovered" (2022), described as "feel tired for a few hours".  Additional information: Patient received the Bivalent shot way back last Sep. And patient though the administer of it the way the guy gave the shot it was not too cool. Patient stated didn't have an issue with the Bivalent, never had anything happen to patient, patient wasn't happy with the person who gave the shot. Patient felt tired for a few hours and that's the end of it.  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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he got sick; 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), on 07Dec2021 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: ILLNESS (non-serious), outcome "unknown", described as "he got sick".  Additional information: Caller said that he took the dose of the Pfizer COVID-19 vaccine last 07Dec2021 and could not find anywhere the vaccine to get his second dose. He asked if it was safe for him to take the Pfizer COVID-19 vaccine Bivalent. Caller said he took his Pfizer COVID-19 vaccine way back in 07Dec2021 and he got sick although he did not mention if it was before or after taking the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye infection bacterial
Clinical narrative: Bacteria in eye; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group and medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: EYE INFECTION BACTERIAL (non-serious), outcome "unknown", described as "Bacteria in eye". Additional information: As reported, "Bacteria in eye changing with new covid variant. Can the vaccine be the cause of the new covid variant. Covid protein resynthisied then cells dived. Covid protected cells ask other bacteria, stomach or eye bacteria that have existed with humans since the beginning. Then our friendly microbiome changes. No co existant? With body is bad science. Our micro bio is co habit. Quit allowing new covid administration and changes to our microbiome dna over concern before propper science."  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: Muscle atrophy, Muscular weakness
Clinical narrative: loss of muscle; muscle weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: MUSCLE ATROPHY (non-serious), outcome "unknown", described as "loss of muscle"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness".  Additional Information: It was reported that event took place after the use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his wife might have received the Covid-19 vaccine and tested positive for Covid; his wife might have received the Covid-19 vaccine and tested positive for Covid; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A female patient received BNT162b2 (BNT162B2 NOS), as single dose 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 "his wife might have received the Covid-19 vaccine and tested positive for Covid". Patient had taken Paxlovid and she's feeling good and everything and wanted to know as far as the virus went, how long did it take to be not contagious to other people. Patient might have received the Covid-19 vaccine and tested positive for Covid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Poor quality vaccine administered, Products were not good with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant patient of unknown gender who had poor quality vaccine administered, products were not good with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date poor quality vaccine administered to the patient, products were not good with no reported adverse event (poor quality product administered) (latency: same day).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.   Action taken was 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: HIBV
Symptoms: Medication error, Product storage error
Clinical narrative: received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves Infant and unknown gender patient who had received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] (HAEMOPHILUS TYPE B (HIB) VACCINE).  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength, lot/batch number and expiration date: not provided) for Prophylactic vaccination.  On an unknown date the patient received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event (poor quality product administered) (latency- same day) following the administration of HIB (PRP/T) VACCINE.  It was reported "Thirty children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window. On outbound call with physician, he provided that the 30 children were within 2, 4, and 6 months of age".  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: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: cold chain break is reported with no reported adverse event; poor quality vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713 and 2023SA129811.  This case involves Infant and unknown gender patient for whom poor quality vaccine HIB (PRP/T) vaccine [ACT-HIB] administered of which cold chain break with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date the cold chain break is reported with no reported adverse event (product storage error) and patient received a dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for prophylactic vaccination was administered with no reported adverse event (poor quality product administered) (latency: same day). Batch number was requested.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: The HIB itself was ok with exp date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event; Initial information received on 26-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1-year-old male patient, the hib (HIB (PRP/T) VACCINE [ACT-HIB]) itself was ok with exp (expiry) date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 14-Mar-2023, the patient received a dose number: 3  of an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (expiry date: o4-Jan-2023) (lot: UJ646AA / U7251AA) via intramuscular route in unknown administration site for prophylactic vaccination.  On 20-Mar-2023 the patient had an event of the hib itself was ok with exp date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event (expired product administered) (latency: 6 days) following the administration of HIB (PRP/T) VACCINE.  There were no lab data/results available.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: U
Vaccine: YF
Symptoms: Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding; 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding; Initial information received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 49 years old and unknown gender patient for whom 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding after receiving 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. Solution for injection (lot number, strength, dosage, expiry date- not reported) via subcutaneous route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested  On an unknown date, the patient developed a non-serious event of 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding (vaccination site pain) (vaccination site pruritus) (latency: 2-3 days approximately) following the administration of yellow fever vaccine. No significant systemic reactions noted.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments:  US-SA-2023SA129044:
Sex: U
Vaccine: YF
Symptoms: Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: days post vaccination, at the site, were somewhat tender and indurated; localized, pruritic skin reactions at the site; 2-3 days post vaccination, at the site, were somewhat tender and indurated initially; Initial information received from United States on 21-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 18 years old and unknown gender patient who experienced localized, pruritic skin reactions at the site, days post vaccination, at the site, were somewhat tender and indurated and 2-3 days post vaccination, at the site, were somewhat tender and indurated initially  after receiving vaccine Yellow Fever Vaccine - Us [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 - US (lot number, expiry date: not reported) via subcutaneous route in unknown administration site (form strength: unknown) for prophylactic vaccination. (immunization).  On an unknown date the patient developed a non-serious event of localized, pruritic skin reactions at the site (vaccination site pruritus), days post vaccination, at the site, were somewhat tender and indurated (vaccination site pain) and days post vaccination, at the site, were somewhat tender and indurated (vaccination site pain) latency unknown following the administration of Yellow Fever Vaccine - US.  It was reported, "This information localized, pruritic skin reactions at the site of SQ Yellow Fever vaccine injection The 3 individuals were 17,18, and 49 years old. They began 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding This case is created for 18 year old patient.".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.; Sender's Comments:  US-SA-2023SA129044:
Age: 70.0
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Allergy; Initial information received on 27-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 70 years old female patient who experienced allergy after receiving vaccine Tetanus Toxoid.  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 Tetanus Toxoid produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious allergy (hypersensitivity) (unknown latency) following the administration of Tetanus Toxoid.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event Allergy.  At time of reporting, the outcome was Unknown for the event allergy.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: swelling on the injection site; The area is red and warm to touch; It also itched in the beginning but is now light pink.; The area is red and warm to touch; Initial information received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA128665 and 2023SA130929.  This case involves a 17 years old female patient who experienced swelling on the injection site, the area is red and warm to touch, it also itched in the beginning but is now light pink while receiving vaccine Yellow Fever Vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 14-Apr-2023, the patient received at dose 0.5 ml at standard strength of suspect Yellow Fever Vaccine(lot: UJ782AA, Expiry date: 17-Feb-2024) via subcutaneous route in unknown administration site for Prophylactic Vaccination (Immunization).  On an unknown date the patient developed swelling on the injection site (vaccination site swelling), the area is red and warm to touch (vaccination site erythema) & (vaccination site warmth) and it also itched in the beginning but is now light pink. (pruritus) (unknown latency) following the administration of Yellow Fever Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Immunisation reaction
Clinical narrative: adverse reactions on their arms after YF-VAX administration; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 18 years old female patient who reported that adverse reactions on their arms after yf-vax administration 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.  Concomitant medications included typhoid vaccine (TYPHOID) for Prophylactic vaccination.  On 14-Apr-2023, the patient received a dose of 0.5 ml of suspect yellow fever vaccine (Solution for injection) (lot UJ782AA, Expiry date : 17-Feb-2024) (with unknown strength) via subcutaneous route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of adverse reactions on their arms after yf-vax administration (adverse reaction) (unknown latency) following the administration of yellow fever vaccine.  Action taken with yellow fever vaccine (Yf-Vax) was not applicable.  It was not reported if the patient received a corrective treatment for the event (adverse reactions on their arms after Yf-Vax administration).  At time of reporting, the outcome was Recovered on an unknown date for the event adverse reactions on their arms after yf-vax administration.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old received a dose of the Flubok last year with no reported adverse event; Initial information was received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 17 year old male patient received a dose of the flubok last year with no reported adverse event..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Nov-2022, the patient received a dose of 0.5 ml of suspect influenza quadrivalent recombinant vaccine (strength, expiry date: unknown) (lot UJ931AA) via intramuscular route in the left deltoid for Immunization.  On 22-Nov-2022 the patient developed a non-serious event of 17 year old received a dose of the flubok last year with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 17 year old received a dose of the flubok last year 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: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administration of vaccines off schedule in order to catch the patient up on vaccineswith no reported adverse event; Initial information was received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age/gender patient who involved in administration of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] off schedule in order to catch the patient up on vaccines with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (dose, strength, lot number, route, administration site, expiration date: Unknown) for Immunization (immunisation) off schedule in order to catch the patient up on vaccines with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (administration of vaccines off schedule in order to catch the patient up on vaccines with no reported adverse event).  Outcome: Unknown for the event administration of vaccines off schedule in order to catch the patient up on vaccines 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: 1.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: 15-month-old patient received PENTACEL and DAPTACEL on the same day, with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15-month-old and unknown gender patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and daptacel on the same day, 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection (strength, expiry date, lot number: unknown)  via unknown route in unknown administration site for Immunization.  On an unknown date the patient had an event of 15-month-old patient received pentacel and daptacel on the same day, with no reported adverse event (contraindicated product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was unknown if any lab data/ tests available.  It was reported, Physician reported that a 15 month old patient received PENTACEL and DAPTACEL on the same day. The caller was not able to provide any patient specific information due to time constraints and declined to provide any further information about the event at the time of the call. The caller stated that she currently has patients waiting in her office and did not have time to provide any further information. The physician was not aware of any adverse reactions and noted that the baby went to sleep for their usual nap time.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: extra of ACTHIB that was administered/administration of an extra dose with no reported AE; Initial information was received on 26-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 7 months old female patient who reported that extra of vaccine hib (prp/t) vaccine [ACT-HIB] that was administered/administration of an extra dose with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR); and DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix).  On 26-Apr-2023, the patient received a dose 5 of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot UJ756AA, Expiry date :12-Aug-2023) (with unknown strength) via intramuscular route in the right thigh for Immunization.  On 26-Apr-2023 the patient developed a non-serious event of extra of acthib that was administered/administration of an extra dose with no reported ae (extra dose administered) (latency: same day) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event extra of acthib that was administered/administration of an extra dose with no reported ae.  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: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered the 5th dose to a patient earlier than the schedule with no reported adverse event; Initial information received on 27-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who got administered the 5th dose to a patient earlier than the schedule with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, route, strength and expiration date: not provided) for prophylactic vaccination.  On an unknown date the patient got administered the 5th dose to a patient earlier than the schedule with no reported adverse event (inappropriate schedule of product administration) (latency- same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test, Liver disorder, Malaise
Clinical narrative: Was a little sick after the shot. I now have liver disease.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Gait inability, Laboratory test, Tinnitus
Clinical narrative: When I woke up in the morning on February 8, I felt dizzy the moment I rolled right and face down.  I felt I could not walk. After a while, dizziness calmed down a little and I was able to walk. Then I went to the urgent care.  I was diagnosed with "Benign paroxysmaI positional vertigo, unspecified laterality". The instructions from the doctor were to watch social media and try it several times until my issue resolves. And I got a prescription for meclizine 25mg Tab. I didn't know if the exercise was effective. I felt meclizine was a little effective. It almost healed in a few days.  And I felt it completely recovered in about 2 weeks. But I felt dizzy on 04/30/2023 again. I woke up at 5:30am and went to the bathroom.  At that time, I suddenly had a ringing in my ears, and I felt dizzy.  When I got back to bed, my dizziness soon subsided. I took meclizine 25mg 1 Tab just in case.  I didn't have any dizziness after the morning event.  But I was tired that day, maybe because of the medicine.  I recovered next day.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo positional
Clinical narrative: When I woke up in the morning on February 8, I felt dizzy the moment I rolled right and face down.  I felt I could not walk. After a while, dizziness calmed down a little and I was able to walk. Then I went to the urgent care.  I was diagnosed with "Benign paroxysmaI positional vertigo, unspecified laterality". The instructions from the doctor were to watch social media and try it several times until my issue resolves. And I got a prescription for meclizine 25mg Tab. I didn't know if the exercise was effective. I felt meclizine was a little effective. It almost healed in a few days.  And I felt it completely recovered in about 2 weeks. But I felt dizzy on 04/30/2023 again. I woke up at 5:30am and went to the bathroom.  At that time, I suddenly had a ringing in my ears, and I felt dizzy.  When I got back to bed, my dizziness soon subsided. I took meclizine 25mg 1 Tab just in case.  I didn't have any dizziness after the morning event.  But I was tired that day, maybe because of the medicine.  I recovered next day.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; PROQUAD that had undergone temperature excursion was administered to patients; This spontaneous report has been received from a medical assistant and refers to a 4-year-old male patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2023, a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number W019628 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and established as 19-DEC-2023) suffered a temperature excursion and was administered  intramuscularly to the patient on 08-DEC-2022 for prophylaxis (strength was not provided) (product storage error).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No other AE; Caller reported an AE for PROQUAD. The caller said PROQUAD was administered to a patient after the labeled expiration date; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 18-APR-2023, the patient was vaccinated with the first dose of a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, after its labeled expiration date (expired product administered) (lot number U031564 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and established as 06-APR-2023), administered for prophylaxis (strength, and anatomical site of administration were not provided).
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Boostrix was not given in a complete dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 21-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 24-APR-2023, the patient received Boostrix. On 24-APR-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: Boostrix was not given in a complete dose). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2023 The reporter was medical assistant. The reporter reported that a needle cracked and Boostrix was not given in a complete dose. The vaccine administration facility was the same as primary reporter. No additional adverse event details were reported at that time. The reporter consented for safety team follow up.  The vaccine was not given in a complete dose as the needle cracked, which lead to incomplete dose administered.
Age: 9.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 year received Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Dtap vaccine (around 6 years of age) and Td vaccine (dose received in august 2022 at 8 years of age).   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 9 year received Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 26-APR-2023 A nurse called in to ask for information about a 9 year old patient who received Boostrix vaccine.  The health care practitioner mentioned that patient received a Dtap at around 6 years of age and last August at 8 years of age patient got a Td vaccine. The health care practitioner asked why Boostrix could not be used in persons younger than 10 years of age. The reporter declined sharing information about the patient and the vaccine given lot number, expiry date. The reporter consented to follow up. The 9 year old patient who received Boostrix vaccine, which led to Inappropriate age at vaccine administration.