chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 91-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 90 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster), Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (Booster), Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 23Jan2024 to 28Jan2024.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Maternal exposure before pregnancy
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; Exposure before pregnancy; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Sep2023 as dose 5 (booster), single), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. The patient was 10 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 03Sep2024. The patient's concomitant medications were not reported. Date of last menstrual period: 28Nov2023. Patient had no known allergies. The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 07Sep2022, outcome "unknown", described as "Exposure before pregnancy"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Jan2024 to 30Jan2024.  Batch/lot number is not provided, and it cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Lot number: HD9835) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Horse serum" (unspecified if ongoing); "Known Allergies: Kiwi fruit" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (2024) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Jan2024 to 23Jan2024  Clinical course: Patient was surprised that there was such a gap between what she thought was a full recovery and the rebound.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He said he got 5 Pfizer vaccines but didn't get the last one./ got COVID on 24Jan and 25Jan; He said he got 5 Pfizer vaccines but didn't get the last one./ got COVID on 24Jan and 25Jan; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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), COVID-19 (medically significant) all with onset 24Jan2024, outcome "unknown" and all described as "He said he got 5 Pfizer vaccines but didn't get the last one./ got COVID on 24Jan and 25Jan". The events "he said he got 5 pfizer vaccines but didn't get the last one./ got covid on 24jan and 25jan" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Clinical course: He reiterated that he and and his wife both got COVID on 24Jan and 25Jan and both took Paxlovid for 5 days. This morning, he woke up with a very bad sore throat and tested positive for COVID. They had young grandchildren that they would like to see and they just didn't know what to do. Their kids didn't want to see them if they test positive. He said he got 5 Pfizer vaccines but didn't get the last one. They finished taking Paxlovid and was told by their doctor to not take a covid test for at least a month (30 days). He wanted to know if they will be contagious after a month of waiting.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: they have had Pfizer booster and vaccines and still caught COVID; they have had Pfizer booster and vaccines and still caught COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 86-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they have had Pfizer booster and vaccines and still caught COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 which include Paxlovid. Clinical course: Patient stated they had Pfizer booster and vaccines and still caught COVID; patient also stated they had bronchitis before.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
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 Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Jan2024 to 02Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 27Jan2024 to 06Feb2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Allergies: Banana" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 23Jan2024 to 27Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Lot number: HF9275) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient has no known allergies. Vaccination history included: comirnaty (Dose 1, Lot number: EN6201, administered in arm right), administration date: 02Mar2021, when the patient was 71-year-old, for Covid-19 Immunization; comirnaty (Dose 2, Lot number: EN6208, administered in arm right), administration date: 27Mar2021, when the patient was 72-year-old, for Covid-19 Immunization; comirnaty (Dose 3 (BOOSTER), Lot number: FF8839, administered in arm right), administration date: 07Oct2021, when the patient was 72-year-old, for Covid-19 Immunization; comirnaty (Dose 4 (BOOSTER), Lot number: FK9895, administered in arm right), administration date: 11Apr2022, when the patient was 73-year-old, for Covid-19 Immunization; comirnaty (Dose 5 (BOOSTER), Lot number: GH9694, administered in arm right), administration date: 07Oct2022, when the patient was 73-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (30Jan2024) and all described as "COVID-19". The clinical course was reported as follows: The patient tested negative on 28Jan2024, positive on 29Jan2024, tested neg 30Jan2024, she never felt completely well. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 22Jan2024 until 27Jan2024. The patient underwent the laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Dec2023 as dose 1, single (Lot number: HK3278) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (ongoing), notes: taking tamsolusin. Concomitant medication(s) included: TAMSULOSIN taken for prostatomegaly (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 27Jan2024 to 02Feb2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid before in the past and had all of the Pfizer COVID vaccines; had Covid before in the past and had all of the Pfizer COVID vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "had Covid before in the past and had all of the Pfizer COVID vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment. Clinical course:  Patient had prescription for Paxlovid but does not have Covid right now.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Dec2022 as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies like pollens" (unspecified if ongoing); "mold, mildew" (unspecified if ongoing); "feathers" (unspecified if ongoing); "pet dander" (unspecified if ongoing); "sulpha give me diarrhea" (unspecified if ongoing); "sulpha give me diarrhea" (unspecified if ongoing); "mast cell activation syndrome" (unspecified if ongoing); "allergies" (unspecified if ongoing); "polycystic ovarian syndrome" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "IBS" (unspecified if ongoing); "thyroid nodules" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 04Jul2017; ARMOUR THYROID, start date: 04Sep2016. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: started taking Paxlovid within 3 days of testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 12Jul2022 to 17Jul2022. Clinical course: Patient started taking Paxlovid within 3 days of testing positive and showing symptoms of covid. Patient started feeling better each day.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "Pre-Exposure Prophylaxis (PrEP) for HIV Prevention" (unspecified if ongoing), notes: previously. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, unknown manufacturer.), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 2, unknown manufacturer.), for covid-19 immunization; Covid-19 vaccine (Dose Number: 3, unknown manufacturer.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included nirmatrelvir, ritonavir (PAXLOVID).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Physician from a sales representative.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization.  The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The event "myocarditis" required physician office visit. It was reported that the patient experienced myocarditis within a month of being vaccinated with Pfizer BioNTech vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The information available in this report is very limited. However, based on temporal association and known product safety profile, a possible contributory role of suspect vaccine BNT162b2 omi xbb.1.5 cannot be excluded for the reported event of Myocarditis. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller had taken 3 Pfizer COVID vaccines and tested positive for COVID; Caller had taken 3 Pfizer COVID vaccines and tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller had taken 3 Pfizer COVID vaccines 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 vaccination failure, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 30Jan2024 to 03Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had covid within the last 2 years; Had covid within the last 2 years; This is a spontaneous report received from an Other HCP. Other Case identifier(s): MOD-2023-748532 (Moderna).  A patient (age and gender not 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had covid within the last 2 years".  Additional information: the 8 people who were vaccinated and had covid within the last 2 years. Stated of those, 3 received Moderna vaccine(s) and the others Pfizer.    The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202400017650 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 29Jan2024 to 03Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose 4 (booster), single, lot number GJ6665, vaccine location: right arm), administration date: 04Nov2022, when the patient was 43-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster), single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, single, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received treatment with Paxlovid from 30Jan2024 to 03Feb2024 (lot number GK5745).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Product contamination physical
Clinical narrative: there is something black that looks like tar in the top part of diluent sterile water syringe; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 25Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report and received from Pharmacists from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9851, Expiration Date: Mar2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAMINATION PHYSICAL (non-serious), outcome "unknown", described as "there is something black that looks like tar in the top part of diluent sterile water syringe".  The reporter considered "there is something black that looks like tar in the top part of diluent sterile water syringe" not related to rsv vaccine prot.subunit pref 2v. Causality for "there is something black that looks like tar in the top part of diluent sterile water syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had covid within the last 2 years; Had covid within the last 2 years; This is a spontaneous report received from an Other HCP. Other Case identifier(s): MOD-2023-748532 (Moderna).  A patient (age and gender not 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had covid within the last 2 years".  Additional information: the 8 people who were vaccinated and had covid within the last 2 years. Stated of those, 3 received Moderna vaccine(s) and the others Pfizer.    The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202400036191 same reporter/drug/event, different patient;US-PFIZER INC-202400037500 same reporter/drug/event, different patient;US-PFIZER INC-202400037499 same reporter/drug/event, different patient;US-PFIZER INC-202400037501 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: they tested positive for covid before but wasn't that bad because they had the vaccine; they tested positive for covid before but wasn't that bad because they had the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  An 88-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they tested positive for covid before but wasn't that bad because they had the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Posititve. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical Course: Patient stated they would like to enroll just in case they tested positive with covid and they tested positive for covid before but wasn't that bad because they had the vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: PNC20
Symptoms: Device breakage, Device leakage, No adverse event
Clinical narrative: when attached the needle there was a crack and all of the vaccine leaked out of it; This is a spontaneous report received from Other HCPs and Nurses from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Lot number: HL3888, Expiration Date: 30Jun2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as "when attached the needle there was a crack and all of the vaccine leaked out of it".  Additional information: Medical Assistant stated when one of nurses attached the needle there was a crack and all of the vaccine leaked out of it. It was confirmed it was not administered to any patient, and there were no adverse events. A sample of the product was available to be returned, and packaging was sealed and intact.  The reporter considered "when attached the needle there was a crack and all of the vaccine leaked out of it" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). The reporter considered "when attached the needle there was a crack and all of the vaccine leaked out of it" associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "when attached the needle there was a crack and all of the vaccine leaked out of it" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: really a lot of soreness at the injection site in their arm; Initial information received on 31-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2024SA037984.  This case involves Elderly female patient who had really a lot of soreness at the injection site in their arm after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  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 0.7 ml of suspect Influenza Quadrival A-B High Dose Hv Vaccine (Injection) (strength, formulation, expiry date, lot number not reported) via intramuscular route in the deltoid nos for Influenza. The information on batch number was requested.  On an unknown date the patient had really a lot of soreness at the injection site in their arm (vaccination site pain) (unknown latency) following the administration of Influenza Quadrival A-B High Dose Hv Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (really a lot of soreness at the injection site in their arm).  At time of reporting, the outcome was Unknown for the event really a lot of soreness at the injection site in their arm.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was prescribed with adacel and flu vaccine, and instead of the flu vaccine, patient was inadvertently administered with tenivac with no reported adverse event; Initial information received on 05-Feb-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 26 years old female patient who patient was prescribed with diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] and flu vaccine, and instead of the flu vaccine, patient was inadvertently administered with tenivac 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, tetanus vaccine toxoid (Tenivac) for Immunisation.  On 05-Feb-2024, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot U79288A via intramuscular route in the left deltoid (strength and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).  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: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: patient was administered pentacel instead of act-hib with no reported adverse event; Initial information received on 05-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] instead of HIB (PRP/T) Vaccine [ACT-HIB] 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 HEPATITIS A VACCINE INACT (HAVRIX); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On an unknown date, the patient received a dose 4 with dosage 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection (lot UJ973AA, Expiry: 19-Nov-2024 with unknown strength) via intramuscular route in left thigh as Prophylactic vaccination instead of HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number, strength, dose, expiry date not reported) with no reported adverse event (wrong product administered) (latency: same day).   It was reported "wants to find out what their next step should be. Reporting that the 4th dose of PENTACEL was administered too early."   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 and Regulatory Authority 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: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Vertigo
Clinical narrative: VERTIGO APPROXIMATELY 2HOURS AFTER TDAP VACCINE ADMINISTRATION.  PATIENT STATES LAID DOWN AND VERTIGO PASSED AFTER ABOUT 1&1/2 HOURS
Age: 1.83
Sex: M
Vaccine: HIBV
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Febrile seizure (generalized tonic clonic, 3-4 minutes). Febrile to 102.7 at time of EMS arrival.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Alopecia, Anxiety, Arthralgia, Autoimmune disorder, Balance disorder
Clinical narrative: 1. Joint pain 2. Hypothyroidism  3. Anxiety 4. Depression 5. Hair Loss 6. Muscle Pain 7. Autoimmune Disease 8. Brain Fog 9. Balance Issues 10. Bursitis 11. Numbness and pain in fingers on right hand
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Brain fog, Bursitis, Depression, Hypoaesthesia, Hypothyroidism
Clinical narrative: 1. Joint pain 2. Hypothyroidism  3. Anxiety 4. Depression 5. Hair Loss 6. Muscle Pain 7. Autoimmune Disease 8. Brain Fog 9. Balance Issues 10. Bursitis 11. Numbness and pain in fingers on right hand
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: 1. Joint pain 2. Hypothyroidism  3. Anxiety 4. Depression 5. Hair Loss 6. Muscle Pain 7. Autoimmune Disease 8. Brain Fog 9. Balance Issues 10. Bursitis 11. Numbness and pain in fingers on right hand
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Arthritis
Clinical narrative: 2 weeks after the patient received the vaccination the patient's shoulder started hurting and has been hurting sin 11/21/23 (over 2 months). patient has been to an orthopedic dr and the dr thought it was arthritis in the shoulder and patient has been given steroids to help with the pain.  patient states the steroids have been helping with the pain
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: patient reported 3 days after immunization, pain, swelling, redness at injection site and radiating down arm
Age: 63.0
Sex: M
Vaccine: COVID19-2, FLUC4, RSV, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: pt was diagnosed with Guillain-Barre syndrome. Was admitted to the hospital 01/12 and there for 15 days, was then moved to a rehab center before being discharged 02/10.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Back pain, Bacterial test positive, Blood urine present, Diarrhoea
Clinical narrative: Diarrhea, severe low back pains n with radiation, UTI, fatigue and weakness
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Urinary tract infection
Clinical narrative: Diarrhea, severe low back pains n with radiation, UTI, fatigue and weakness
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Antineutrophil cytoplasmic antibody negative, Blood urea nitrogen/creatinine ratio increased, C-reactive protein increased, Herpes simplex test positive
Clinical narrative: Received Covid vaccine on 10/24/2023. Beginning 10/28/2023 noticed trouble seeing text in a book, on 10/30/2023 realized I had a vision deficit lower half of my left eye,  all I could see in bottom half of my vision was cloudy to opaque grayness. Seen by Retina specialist, she referred me to a neuro-ophthalmologist Eye Institute I was seen on 11/07/2023
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lysozyme, Mean cell haemoglobin increased, Mycobacterium tuberculosis complex test negative, Red blood cell sedimentation rate increased
Clinical narrative: Received Covid vaccine on 10/24/2023. Beginning 10/28/2023 noticed trouble seeing text in a book, on 10/30/2023 realized I had a vision deficit lower half of my left eye,  all I could see in bottom half of my vision was cloudy to opaque grayness. Seen by Retina specialist, she referred me to a neuro-ophthalmologist Eye Institute I was seen on 11/07/2023
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, Toxicologic test normal, Treponema test, Vision blurred, Visual acuity tests
Clinical narrative: Received Covid vaccine on 10/24/2023. Beginning 10/28/2023 noticed trouble seeing text in a book, on 10/30/2023 realized I had a vision deficit lower half of my left eye,  all I could see in bottom half of my vision was cloudy to opaque grayness. Seen by Retina specialist, she referred me to a neuro-ophthalmologist Eye Institute I was seen on 11/07/2023
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Received Covid vaccine on 10/24/2023. Beginning 10/28/2023 noticed trouble seeing text in a book, on 10/30/2023 realized I had a vision deficit lower half of my left eye,  all I could see in bottom half of my vision was cloudy to opaque grayness. Seen by Retina specialist, she referred me to a neuro-ophthalmologist Eye Institute I was seen on 11/07/2023
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Cutaneous calcification, Induration, Nodule
Clinical narrative: 1cm calcified  nodule with 1cm of induration surrounding, no erythema or tenderness.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting,  diarrhea, significant pain in the shoulder of injection
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: REDNESS AT THE SITE OF INJECTION, ITCHY AREA, SWELLING, WARM, AND  PINK, PATIENT DESCRIBED " SUNSET PINK".  THE PATIENT CALLED THE 24 HOUR NURSE HOTLINE PROVIDED BY HER PLAN. THIS WAS SATURDAY THE DAY AFTER THE VACCINATION.  AT THAT TIME THE NURSE DIDN'T CONSIDERED IT URGENT ; BUT SHE DID INSTRUCT THE PATIENT IF IT GOT WORSE TO SEEK MEDICAL ATTENTION . BY WEDNESDAY THE CONDITION HAD WORSEN , THE SWEALLING WASN'T GOING DOWN AND CHANGED COLORS. SHE DECIDED TO GO TO URGENT CARE. THE PROVIDER AT THE URGENT CARE SAID IT COULD BE RELATED TO THE FACT THAT IT WAS A PUNCTURE, BUT THE PATIENT KNOWS THIS IS TRUE FOR ALL VACCINATIONS, IT'S UNCLEAR WHY JUST THE LEFT ARM WAS AFFECTED SINCE SHE ALSO RECEIVED AREXVY ON THE RIGHT ARM ON THE SAME DAY, AND SHE DIDN'T HAVE A REACTION ON HER RIGHT ARM. THE PROVIDER DECIDED BECAUSE THE PATIENT HAS HAD CELLULITIS TWICE IN THE PAST, (FOOT AND TOES), THEY DECIDED TO TREAT AND PRESCRIBED CEPHALEXIN 500MG 4 TIMES A DAY FOR 7 DAYS.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: REDNESS AT THE SITE OF INJECTION, ITCHY AREA, SWELLING, WARM, AND  PINK, PATIENT DESCRIBED " SUNSET PINK".  THE PATIENT CALLED THE 24 HOUR NURSE HOTLINE PROVIDED BY HER PLAN. THIS WAS SATURDAY THE DAY AFTER THE VACCINATION.  AT THAT TIME THE NURSE DIDN'T CONSIDERED IT URGENT ; BUT SHE DID INSTRUCT THE PATIENT IF IT GOT WORSE TO SEEK MEDICAL ATTENTION . BY WEDNESDAY THE CONDITION HAD WORSEN , THE SWEALLING WASN'T GOING DOWN AND CHANGED COLORS. SHE DECIDED TO GO TO URGENT CARE. THE PROVIDER AT THE URGENT CARE SAID IT COULD BE RELATED TO THE FACT THAT IT WAS A PUNCTURE, BUT THE PATIENT KNOWS THIS IS TRUE FOR ALL VACCINATIONS, IT'S UNCLEAR WHY JUST THE LEFT ARM WAS AFFECTED SINCE SHE ALSO RECEIVED AREXVY ON THE RIGHT ARM ON THE SAME DAY, AND SHE DIDN'T HAVE A REACTION ON HER RIGHT ARM. THE PROVIDER DECIDED BECAUSE THE PATIENT HAS HAD CELLULITIS TWICE IN THE PAST, (FOOT AND TOES), THEY DECIDED TO TREAT AND PRESCRIBED CEPHALEXIN 500MG 4 TIMES A DAY FOR 7 DAYS.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Discomfort, Pruritus
Clinical narrative: At 20 minute evaluation time, donor admitted to itching at right of neck mid line and later a sense of pressure. EMS called, evaluated donor. Stated donor was fine and did not feel she needed transported to hospital. Vital signs remained stable throughout evaluation, BP 102/systolic, 110/systolic and 107/76 pulse 87. Donor was awake, alert, oriented to time, place, person and purpose. Moved all extremities without difficulty. Denies dizziness. Gait steady.  Donor advised to rest and relax remained of day and to go directly to hospital if any other symptoms or issues arose. She voiced understanding.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site mass, Injection site muscle atrophy, Injection site warmth
Clinical narrative: Muscle in upper arm that was injected has become atrophied to where I was unable to raise left arm. Day after injection the site developed warm sensation and a large hard lump in muscle. Loss of use of arm developed. Dr prescribed physical therapy. Have been doing PT for six weeks, continuing as of this date. Strength and mobility is returning slowly. The hard lump persists but is slowly diminishing.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal disorder
Clinical narrative: Muscle in upper arm that was injected has become atrophied to where I was unable to raise left arm. Day after injection the site developed warm sensation and a large hard lump in muscle. Loss of use of arm developed. Dr prescribed physical therapy. Have been doing PT for six weeks, continuing as of this date. Strength and mobility is returning slowly. The hard lump persists but is slowly diminishing.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The MMR vaccine was expired and given to patient.  No treatment was needed as patient did not show any signs and symptoms of an adverse affect.  Patient was seen for a follow up and given a lab order to test for antibodies.  Merck customer service was called.  Rep stated there was not a need to revaccinate as the  vaccine had  recently expired