chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry).    No concomitant medication was reported.  Vaccine was administered on 13-JUN-2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731904:same reporter
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Headache, Influenza, Myalgia, Nausea
Clinical narrative: flu; headache; muscle ache; chills; Queasy stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jun2023 at 09:15 as dose 1, single (Lot number: GT0538, Expiration Date: 31Oct2024) at the age of 65 years intramuscular, in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 28Jun2023, outcome "unknown", described as "Queasy stomach"; CHILLS (non-serious) with onset 28Jun2023, outcome "unknown"; INFLUENZA (non-serious) with onset 28Jun2023, outcome "unknown", described as "flu"; HEADACHE (non-serious) with onset 28Jun2023, outcome "unknown"; MYALGIA (non-serious) with onset 28Jun2023, outcome "unknown", described as "muscle ache". Therapeutic measures were taken as a result of influenza, headache, myalgia, chills, nausea.  Additional information: He took Tylenol as treatment for side effects.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough COVID illness; Breakthrough COVID illness/ Suspected Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old male patient received 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) with onset 30Jun2023, outcome "recovering", described as "Breakthrough COVID illness"; SUSPECTED COVID-19 (medically significant) with onset 30Jun2023, outcome "recovering", described as "Breakthrough COVID illness/ Suspected Covid-19". The events "breakthrough covid illness" and "breakthrough covid illness/ suspected covid-19" required physician office visit. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient diagnosed with COVID-19 prior to vaccination was unknown. The adverse event resulted in any of the following Doctor or other healthcare professional office/clinic visit.  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: Genital odour, Skin odour abnormal, Smegma accumulation
Clinical narrative: A very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there; A very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there; I suffer with something called Smegma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization.  The following information was reported: GENITAL ODOUR (non-serious), SKIN ODOUR ABNORMAL (non-serious), outcome "unknown" and all described as "A very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there"; SMEGMA ACCUMULATION (non-serious), outcome "unknown", described as "I suffer with something called Smegma". The events "a very strong odor; coming from my genitals and its more complicated than that; from my penis head like from the skin there" and "i suffer with something called smegma" required physician office visit. Therapeutic measures were not taken as a result of genital odour, skin odour abnormal, smegma accumulation.  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.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 at 17:30 as dose 4 (orange cap; booster), single (Lot number: FK5127) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST, start date: 01Jun2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 21Jun2023 to 25Jun2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300238451 Same patient and product, Different dose and events;US-PFIZER INC-202300237631 Same patient, Different product and events;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: G15342) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jun2022 as dose 4 (booster), single (Lot number: FM0992), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 028120A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 01A21A) and on 22Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Jun2022, outcome "unknown"; COVID-19 (medically significant) with onset Jun2023, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jun2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid treatment from 21Jun2023 to 26Jun2023. Unknown allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229539 Same patient, different event/drug;
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance
Clinical narrative: Dysautonomia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: FC3180) at the age of 20 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot Number: ewo181), for COVID-19 immunisation. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability) with onset 2021, 2 weeks after the suspect product(s) administration, outcome "not recovered", described as "Dysautonomia". The event "dysautonomia" required emergency room visit. Therapeutic measures were not taken as a result of autonomic nervous system imbalance. Clinical course: Dysautonomia after 2 weeks of receiving 2nd dose. Almost 2 years later and no improvement. Patient had no COVID prior to the vaccination.    No follow-up attempts are possible. No further information is expected..
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 3 (booster), single (Lot number: 039D21A), in right arm and on 03May2022 as dose 4 (booster), single (Lot number: 019L21A), in right arm 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 included: "Arterial heart stents" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "joint replacements" (not ongoing); "back surgery" (not ongoing); "obesity" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Cephalosporins" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". 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 which included treatment with Paxlovid from 25Jun203 to 29Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300238421 same patient, different event/drug;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Hypertension
Clinical narrative: High BP; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Marcaine, reaction(s): "Drug allergy"; Morphine, reaction(s): "Drug allergy"; Fentanyl, reaction(s): "Drug allergy"; Codeine, reaction(s): "Drug allergy"; Doxycycline, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "not recovered" and all described as "COVID 19 Treatment"; HYPERTENSION (non-serious), outcome "unknown", described as "High BP". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Patient had Paxlovid Treatment from 21Jun2023 to 25Jun2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300238444 same patient/different drug and AE;
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 30Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Jan2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "spinal cord injury" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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-202300237641 Same patient, different drug/AE.;
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in right arm 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) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". 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.Clinical course: Patient had Paxlovid Treatment from 23Jun2023 to 27Jun2023  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300239328 Same reporter/patient, different product/AE.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 21Jun2023 to 25Jun2023.  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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 11Sep2022 at 12:00 as dose number unknown, single at the age of 62 years, in left arm 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) with onset Jun2023, outcome "recovering", COVID-19 (medically significant) with onset Jun2023, 9 months 21 days 12 hrs after the suspect product(s) administration, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered for COVID-19 treatment from 24Jun2023 to 28Jun2023. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Chills, Feeling abnormal, Malaise
Clinical narrative: chills; felt horrible; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A male patient in his 50's received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing), notes: hospitalized in his early 30s with severe pneumonia requiring intubation; "hospitalized" (unspecified if ongoing), notes: in his early 30s; "intubation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered"; MALAISE (non-serious), outcome "recovered", described as "felt horrible".  Additional information: the patient is male, currently 50+ years old. No underlying medical conditions (UMCs) but was hospitalized in his early 30s with severe pneumonia requiring intubation. The nurse reporter was the patient's wife. The patient received the vaccine at an early morning appointment. He felt fine all day but had chills all night beginning early evening which lasted through the night without any other complaints except felt horrible and was resolved by morning.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 18.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: a dose of Menquadfi was administered to a patient that was supposed to receive meningococcal b (Bexsero) with no reported adverse event; a dose of Menquadfi was administered to a patient on 27jun2023, a previous dose of MCV4 was administered to the patient on 21jul2022 with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old male patient to whom a dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered who was supposed to receive meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) and a dose of Menquadfi was administered on 27-Jun-2023, a previous dose of mcv4 was administered on 21-Jul-2022 with no reported adverse event.  The patient's past vaccination(s) included Meningococcal vaccine on 21-JUL-2022. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Tetanus Vaccine for Prophylactic vaccination.  On 27-Jun-2023, the patient received 0.5ml  (dose 3) once of suspectmeningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (strength: not reported) (lot U7616AB; Expiration date: 11-APR-2025) via intramuscular route in the left deltoid for Immunization who was supposed to receive meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) with no reported adverse event (wrong product administered) and previous dose of mcv4 was administered to the patient on 21-Jul-2022 with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired Daptacel, with no reported adverse event; Initial information received on 29-Jun-2023 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 5 years old male patient who was administered an expired Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Jun-2023, the patient received 0.5 ml dose (strength: standard; frequency: once) of expired suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot C5893AA and expiry: 21-Jun-2023 via intramuscular route in the right thigh for immunization, with no reported adverse event (expired product administered) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered an expired daptacel, 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: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired DAPTACEL with no reported adverse event; Initial information received on 29-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 months old male patient who was administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Jun-2023, the patient was administered an expired standard total dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 mL (lot C5893AA, expiry date:21-JUN-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  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 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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired MENACTRA injection with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient and it was reported patient was given an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] injection with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-JUN-2023, patient was given 0.5 mL of expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection (batch/lot number: U6824AA; expiry date: 01-jun-2023; strength: standard; frequency: once; 1X) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 74.0
Sex: F
Vaccine: COVID19-2, PNC20, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: RED SWELLING SORE ARM
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: Upon administration of the shot, the expected stiffness and tender injection site I was told to expect for a few days,  has never gone away.  Instead,  the shoulder and bicep area of the injected,  right arm has maintained, and gradually increased in stiffness,  and increased pain during movement.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Contusion, Disorientation, Dizziness
Clinical narrative: Same day Flu Like symptoms - In bed & needing to urinate, but feeling too wobbly to get up. Made it into bathroom, urinated, felt dizzy, held on to vanity counter - next thing I was aware of I was on the floor - felt throw rug so I knew I was near my bed, but couldn't find it. Around 1 AM (teeth chattering) low grade fever felt light-headed, disoriented, must have passed out; no idea how long. Got back in bed. Felt awful next day - noticed my right hip was sore & discovered a large bruise. No idea what I came in contact with. I reported this incident to Dr. (my PC) via the medical portal. Her response was she was "so sorry". Few weeks later called her office & inquired if this incident was in my medical records - they said no, since I wasn't seen by Doctor. I go to Allergist for Dupixent shots - I explained to Dr. my reaction to covid shot & he advised me to not get another one. Also I discussed this w/ PA, & she gave me this form to submit, saying it needs to be documented. I certainly will not take the risk of another COVID vaccine. Felt sick the next couple days.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Gait disturbance, Influenza like illness, Loss of consciousness, Malaise
Clinical narrative: Same day Flu Like symptoms - In bed & needing to urinate, but feeling too wobbly to get up. Made it into bathroom, urinated, felt dizzy, held on to vanity counter - next thing I was aware of I was on the floor - felt throw rug so I knew I was near my bed, but couldn't find it. Around 1 AM (teeth chattering) low grade fever felt light-headed, disoriented, must have passed out; no idea how long. Got back in bed. Felt awful next day - noticed my right hip was sore & discovered a large bruise. No idea what I came in contact with. I reported this incident to Dr. (my PC) via the medical portal. Her response was she was "so sorry". Few weeks later called her office & inquired if this incident was in my medical records - they said no, since I wasn't seen by Doctor. I go to Allergist for Dupixent shots - I explained to Dr. my reaction to covid shot & he advised me to not get another one. Also I discussed this w/ PA, & she gave me this form to submit, saying it needs to be documented. I certainly will not take the risk of another COVID vaccine. Felt sick the next couple days.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Micturition urgency, Pyrexia
Clinical narrative: Same day Flu Like symptoms - In bed & needing to urinate, but feeling too wobbly to get up. Made it into bathroom, urinated, felt dizzy, held on to vanity counter - next thing I was aware of I was on the floor - felt throw rug so I knew I was near my bed, but couldn't find it. Around 1 AM (teeth chattering) low grade fever felt light-headed, disoriented, must have passed out; no idea how long. Got back in bed. Felt awful next day - noticed my right hip was sore & discovered a large bruise. No idea what I came in contact with. I reported this incident to Dr. (my PC) via the medical portal. Her response was she was "so sorry". Few weeks later called her office & inquired if this incident was in my medical records - they said no, since I wasn't seen by Doctor. I go to Allergist for Dupixent shots - I explained to Dr. my reaction to covid shot & he advised me to not get another one. Also I discussed this w/ PA, & she gave me this form to submit, saying it needs to be documented. I certainly will not take the risk of another COVID vaccine. Felt sick the next couple days.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: Itchy rash at injection site.  Used hydrocortisone cream and it is relieving.   Pt didn't  need medical attention and didn't think he needed to call his doctor.  Unsure of when rash officially started so just put the day after but pt should be able to answer that if contacted.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash pruritic, Skin warm, Vaccination site rash
Clinical narrative: Has red circular rash at vaccine site in both the right and left arm. The left arm site is larger (7 cm x 5 cm) and is warm to touch, with itchiness. Right arm is not warm to touch and is smaller.  Still not resolved at time of appointment.   Benedryl 25 mg prescribed, advise to apply ice.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Increased dyspnea and wheezing 3 days after vaccine administration, required ED visit and prednisone course
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Rash on head potential shingles -  patient given zoster vaccine despite the potential viral infection.  Patient returned 2 more times in 3 days before being told there was nothing more they could do.  Patient presented at ED on June 30th for shingles diagnosis and pain management.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Periods are irregular and were never irregular before the vaccine. I have missed periods, sometimes I bleed multiple times in a month.
Age: 68.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Gait disturbance, Groin pain, Impaired driving ability, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: I am not sure if the TDAP was Boostrix or something else. it is not noted on my online chart.  My arms had the typical soreness, nothing too bad, but the day after shots, I had severe pain in my groin area (specifically where the legs connect to torso) - had difficulty moving to put on pants and I had neck stiffness. The groin pain eventually stopped (although I feel still that my hips are not working properly when I walk) but more than a week later, I am still having difficulty with range of motion in my neck, specifically when I turn my head to the R. Some days are better than others, but yesterday I couldn't turn my head more than 1/2 inch without pain. This makes driving (and everything else) extremely difficult. I saw my dr a few days ago and she suggested I file a report. I saw my chiropractor today and he felt everything was tensed up. He and the PT I see at his office said that many of their patients had similar side effects after a tetanus shot.
Age: 68.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Pain, Pain in extremity, Tension
Clinical narrative: I am not sure if the TDAP was Boostrix or something else. it is not noted on my online chart.  My arms had the typical soreness, nothing too bad, but the day after shots, I had severe pain in my groin area (specifically where the legs connect to torso) - had difficulty moving to put on pants and I had neck stiffness. The groin pain eventually stopped (although I feel still that my hips are not working properly when I walk) but more than a week later, I am still having difficulty with range of motion in my neck, specifically when I turn my head to the R. Some days are better than others, but yesterday I couldn't turn my head more than 1/2 inch without pain. This makes driving (and everything else) extremely difficult. I saw my dr a few days ago and she suggested I file a report. I saw my chiropractor today and he felt everything was tensed up. He and the PT I see at his office said that many of their patients had similar side effects after a tetanus shot.
Age: 70.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Inflammation, Pain, Skin warm
Clinical narrative: Patient reported soreness, warmth, and minor inflammation first day, and subsided. But two days later, the symptoms returned in the right arm. Instructed patient to continue to massage and move the arm, take some tylenol, and continue to ice as needed.  Patient is uncertain which vaccine was given in that arm (heplisav-b or prevnar 20).  Patient reported the incident.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Hypoaesthesia, Inflammation, Limb discomfort
Clinical narrative: The patient suffered a local reaction approximately 1 hour after administration which presented itself as red, hot,  inflammed area which was warm to the touch. Patient started with very mild numbness and pain in her little  and four fingers which progressively got worse. After 2 and 1/2 weeks pain intensified in the elbow  and down the arm. The patient described the feeling as if her arm felt very heavy and she needed to rest it on a support.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Pain in extremity, Skin warm
Clinical narrative: The patient suffered a local reaction approximately 1 hour after administration which presented itself as red, hot,  inflammed area which was warm to the touch. Patient started with very mild numbness and pain in her little  and four fingers which progressively got worse. After 2 and 1/2 weeks pain intensified in the elbow  and down the arm. The patient described the feeling as if her arm felt very heavy and she needed to rest it on a support.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Anxiety, Back pain, Fatigue, Headache, Neck pain
Clinical narrative: Lots of pain in the head, sadness, tiredness, pain/throbbing in the neck, back pain. Patient suffered from (OCD) but had it controlled & after the vax, she started to feel anxious. She is better than the 1st couple of days, but wanted to inform you.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Lots of pain in the head, sadness, tiredness, pain/throbbing in the neck, back pain. Patient suffered from (OCD) but had it controlled & after the vax, she started to feel anxious. She is better than the 1st couple of days, but wanted to inform you.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac ablation, Cardiac stress test normal, Cardioversion
Clinical narrative: 3 days after receiving shot 1 on 7 April 2021, I developed severe shortness of breath while doing trivial tasks. On April 13th, 2021, I went to my PCM for a scheduled appointment and told him how I was feeling. He listened to my heart and lungs and suspected I was in Afib. He confirmed his  suspicions by conducting a 12 lead EKG. I was then referred to an Electrophysiologist who conducted a full work up to include stress test and  CT scan with contrast. All normal. Electrophysiologist felt was an isolated incident as I had never had any heart issues prior. Worked for 25 years where my health was monitored regularly including yearly heart work ups once I turned 40 with no heart issues ever recorded. On 27 April 2021 received shot 2. On 30 April 2021 I went into Afib again with Tachycardia. Heart rate exceeded 200 BPM. Ended up in the ER of a local Hospital where I spent the weekend. Heart converted through medication to sinus rhythm on that Sunday. Decision was made to conduct cardiac ablation after continued repeated episodes of Afib with Tachycardia when treatment with Propophenon did not control. Was ablated in August of 2021 and continued treatment for the following year with Flecanide twice daily. After medication withdrawal in November of 2022 the Afib returned. Underwent 2nd Ablation in January of 2023 and it was discovered heart was continuing to make new pathways versus previous ablation reconnections. Treatment is continuing with Flecanide and Diltiazem but still having frequent episodes of Afib, severe atrial flutter, and Tachycardia.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Dyspnoea, Electrocardiogram abnormal, Scan with contrast normal, Sinus rhythm
Clinical narrative: 3 days after receiving shot 1 on 7 April 2021, I developed severe shortness of breath while doing trivial tasks. On April 13th, 2021, I went to my PCM for a scheduled appointment and told him how I was feeling. He listened to my heart and lungs and suspected I was in Afib. He confirmed his  suspicions by conducting a 12 lead EKG. I was then referred to an Electrophysiologist who conducted a full work up to include stress test and  CT scan with contrast. All normal. Electrophysiologist felt was an isolated incident as I had never had any heart issues prior. Worked for 25 years where my health was monitored regularly including yearly heart work ups once I turned 40 with no heart issues ever recorded. On 27 April 2021 received shot 2. On 30 April 2021 I went into Afib again with Tachycardia. Heart rate exceeded 200 BPM. Ended up in the ER of a local Hospital where I spent the weekend. Heart converted through medication to sinus rhythm on that Sunday. Decision was made to conduct cardiac ablation after continued repeated episodes of Afib with Tachycardia when treatment with Propophenon did not control. Was ablated in August of 2021 and continued treatment for the following year with Flecanide twice daily. After medication withdrawal in November of 2022 the Afib returned. Underwent 2nd Ablation in January of 2023 and it was discovered heart was continuing to make new pathways versus previous ablation reconnections. Treatment is continuing with Flecanide and Diltiazem but still having frequent episodes of Afib, severe atrial flutter, and Tachycardia.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: 3 days after receiving shot 1 on 7 April 2021, I developed severe shortness of breath while doing trivial tasks. On April 13th, 2021, I went to my PCM for a scheduled appointment and told him how I was feeling. He listened to my heart and lungs and suspected I was in Afib. He confirmed his  suspicions by conducting a 12 lead EKG. I was then referred to an Electrophysiologist who conducted a full work up to include stress test and  CT scan with contrast. All normal. Electrophysiologist felt was an isolated incident as I had never had any heart issues prior. Worked for 25 years where my health was monitored regularly including yearly heart work ups once I turned 40 with no heart issues ever recorded. On 27 April 2021 received shot 2. On 30 April 2021 I went into Afib again with Tachycardia. Heart rate exceeded 200 BPM. Ended up in the ER of a local Hospital where I spent the weekend. Heart converted through medication to sinus rhythm on that Sunday. Decision was made to conduct cardiac ablation after continued repeated episodes of Afib with Tachycardia when treatment with Propophenon did not control. Was ablated in August of 2021 and continued treatment for the following year with Flecanide twice daily. After medication withdrawal in November of 2022 the Afib returned. Underwent 2nd Ablation in January of 2023 and it was discovered heart was continuing to make new pathways versus previous ablation reconnections. Treatment is continuing with Flecanide and Diltiazem but still having frequent episodes of Afib, severe atrial flutter, and Tachycardia.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Migraine
Clinical narrative: Consistent migraines since vaccination, two years later and I still get them once every two months. I never had migraines before. I use Advil to treat them and cannot work or function when they occur.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, COVID-19 pneumonia, Chills, Cough, Dyspnoea
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;  10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS;  10043088:TACHYPNEA;  10084380:COVID-19 PNEUMONIA; Narrative:  Patient has received two Pfizer COVID 19 Vaccines (Jan/Feb 2021). The patient presented to the ED on 5 Nov 2022 with fever, chills, cough, and shortness of breath.  The patient was admitted to the hospital with sepsis, covid pneumonia, respiratory failure, and afib.  The patient was treated with remdesivir and dexamethasone.  The patient was discharged on 9 November 2022 in stable condition.  Reported per EUA. Other Relevant HX:  Other: COVID Pneumonia, sepsis
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Respiratory depression, Respiratory failure, Sepsis
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;  10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS;  10043088:TACHYPNEA;  10084380:COVID-19 PNEUMONIA; Narrative:  Patient has received two Pfizer COVID 19 Vaccines (Jan/Feb 2021). The patient presented to the ED on 5 Nov 2022 with fever, chills, cough, and shortness of breath.  The patient was admitted to the hospital with sepsis, covid pneumonia, respiratory failure, and afib.  The patient was treated with remdesivir and dexamethasone.  The patient was discharged on 9 November 2022 in stable condition.  Reported per EUA. Other Relevant HX:  Other: COVID Pneumonia, sepsis
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachypnoea
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;  10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS;  10043088:TACHYPNEA;  10084380:COVID-19 PNEUMONIA; Narrative:  Patient has received two Pfizer COVID 19 Vaccines (Jan/Feb 2021). The patient presented to the ED on 5 Nov 2022 with fever, chills, cough, and shortness of breath.  The patient was admitted to the hospital with sepsis, covid pneumonia, respiratory failure, and afib.  The patient was treated with remdesivir and dexamethasone.  The patient was discharged on 9 November 2022 in stable condition.  Reported per EUA. Other Relevant HX:  Other: COVID Pneumonia, sepsis
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Dyspnoea, Paranasal sinus discomfort, Scan normal, Sinus congestion
Clinical narrative: My Sinus was closed, I could not breath for one month & a half (1.1/2). I had pressure, sinus. I had a Clot in my menstrual period, the clot was severe, it was the size of my hand, for 4 months I had different clots.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix: only diluent administered; Shingrix: only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number Y7PP4, expiry date 07-MAY-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix: only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The healthcare professional narrowed it down to 10 patients but not sure which of the 2 received only the diluent. No other information available of patient was available. The reporter consented to follow up. The reporter believed that the patient received only the diluent portion of the Shingrix vaccine and not the powder as they found 2 vial of antigen left in the box, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 2 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023090639:same reporter