chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: 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=Pfizer / BioNTech, vaccine dose number=4; vaccine brand other=Moderna, vaccine dose number=3; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 029A21A), in left arm, on 05May2021 as dose 2, single (Lot number: 030B21A), in left arm and on 06Dec2021 as dose 3 (booster), single (Lot number: 045J21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE, start date: 01May2019; LEVOTHYROXINE SODIUM, start date: 01May2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, vaccine dose number=4; vaccine brand other=Moderna, vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Feb2024) Positive; (14Feb2024) Negative; (19Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Glioblastoma, Laboratory test
Clinical narrative: Glioblastoma; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EW0162), administration date: 17Apr2021, when the patient was 50-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/lot number: EW0182), administration date: 12May2021, when the patient was 50-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FD0809), administration date: 14Nov2021, when the patient was 51-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: FP4554), administration date: 30Apr2022, when the patient was 51-year-old, for COVID-19 immunisation. The following information was reported: GLIOBLASTOMA (medically significant) with onset 20Sep2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: Lab test: Unknown Results, notes: within the 3 weeks of the shot or within 3 weeks of now, has because it's being treated of cancer (Glioblastoma). Therapeutic measures were taken as a result of glioblastoma. Clinical course: Reporter stated she called on behalf on her husband as he was not able to speak, and thought those all were received in the right arm she thought, and then the second shot was received in the buttock. Patient had no medical issues up until the brain cancer (Glioblastoma). Patient received treatment for Glioblastoma. Reporter stated that it is type of brain cancer, Glioblastoma and patient was diagnosed on 20Sep2023.
Age: 69.0
Sex: U
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 69-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Covid 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. Vaccine was received. No other medication in 2 weeks. Patient got covid and took Paxlovid medication. Patient started Paxlovid since 02Feb2024 to 07Feb2024 for COVID 19 treatment.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2022 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, stop date: 09Feb2024; ATORVASTATIN, stop date: 09Feb2024; BETA SITOSTEROL, stop date: 09Feb2024; LIPO FLAVONOID PLUS, stop date: 09Feb2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment".  Therapeutic measures were taken as a result of drug ineffective, covid-19. with paxlovid from 09Feb2024 to 14Feb2024. Clinical course: No known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 70.0
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.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "chronic indigestion" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "belching" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: 02Nov2016, stop date: 19Feb2024. 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 Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 10Feb2024 to 14Feb2024. Clinical course: The patient had not known any allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 08Nov2022, when the patient was 66-year-old, for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid treatment start date: 05Feb2024, stop date: 09Feb2024) were taken as a result of vaccination failure, covid-19. Clinical course: Patient felt better after five days of taking Paxlovid.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 42.0
Sex: M
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 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LOPERAMIDE, start date: 2023, stop date: 07Feb2024. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid treatment from 11Feb2024 to 15Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: VALTREX, start date: Jan2004; LEVOTHYROXINE, start date: Jan2004. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL1284), administration date: 22Dec2020, when the patient was 52-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Lot number: EL3248), administration date: 15Jan2021, when the patient was 52-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 30155BA), administration date: 07Oct2021, when the patient was 52-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FM9992), administration date: 20Apr2022, when the patient was 53-year-old, for COVID-19 immunisation; moderna (DOSE 5 (BOOSTER), SINGLE), administration date: 15Oct2022, when the patient was 53-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (13Feb2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2024) Negative, notes: Tested negative day after Paxlovid complete. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 08Feb2024 to 12Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 21 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes (type 1)" (unspecified if ongoing); "Gluten sensitivity" (unspecified if ongoing); "Wheat allergy" (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 Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) negative, notes: 2 days after completing the 5 days of Paxlovid and testing negative; (Feb2024) Positive, notes: Severity of symptoms was equal to that of when patient was originally tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 11Feb2024 to 16Feb2024.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reported adverse events.  Vaccine was given passed expiration date of 1.18.24 (administered on 2.16.24)
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Blood test, Electromyogram abnormal, Lumbar puncture, Muscle spasms
Clinical narrative: weakness in left leg (drop foot), spasms and twitches, tingling, severe cramps in left leg
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Muscular weakness, Paraesthesia, Peroneal nerve palsy
Clinical narrative: weakness in left leg (drop foot), spasms and twitches, tingling, severe cramps in left leg
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Rhinorrhoea, Sneezing
Clinical narrative: Shivering, coughing, chills, sneezing, running nose.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Chest pain, Chills, Cough
Clinical narrative: CHILLS,PAIN,CHEST PAIN,BURNING KNEES,LEGS,FEET,BURNING LOWER BACK PAIN.CAN'T SLEEP,COUGH
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain
Clinical narrative: CHILLS,PAIN,CHEST PAIN,BURNING KNEES,LEGS,FEET,BURNING LOWER BACK PAIN.CAN'T SLEEP,COUGH
Age: 34.0
Sex: M
Vaccine: COVID19, SMALL
Symptoms: Asthenia, COVID-19, Chronic fatigue syndrome, Cognitive disorder, Fatigue
Clinical narrative: Adverse Event(s) Description:  The patient experienced a range of symptoms consistent with Long COVID following the vaccination. Symptoms included profound fatigue, cognitive difficulties, sleep disturbances, and muscle pain. The onset of these symptoms persisted and evolved over the months following the acute phase of COVID-19, indicating Chronic Fatigue Syndrome (CFS), ME-CFS.  Time Course:  The symptoms of severe fatigue began to manifest around the vaccination time and have persisted for several months, with varying degrees of intensity. The patient's condition has shown fluctuating periods of improvement and exacerbation, particularly noted in cognitive functions and energy levels depending on the exertion levels causing crashes and Post-Exertional Malaise (PEM).
Age: 34.0
Sex: M
Vaccine: COVID19, SMALL
Symptoms: Malaise, Myalgia, Post-acute COVID-19 syndrome, Sleep disorder
Clinical narrative: Adverse Event(s) Description:  The patient experienced a range of symptoms consistent with Long COVID following the vaccination. Symptoms included profound fatigue, cognitive difficulties, sleep disturbances, and muscle pain. The onset of these symptoms persisted and evolved over the months following the acute phase of COVID-19, indicating Chronic Fatigue Syndrome (CFS), ME-CFS.  Time Course:  The symptoms of severe fatigue began to manifest around the vaccination time and have persisted for several months, with varying degrees of intensity. The patient's condition has shown fluctuating periods of improvement and exacerbation, particularly noted in cognitive functions and energy levels depending on the exertion levels causing crashes and Post-Exertional Malaise (PEM).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-GAD antibody, Anti-islet cell antibody, Antibody test, Laboratory test, Type 1 diabetes mellitus
Clinical narrative: Type 1 diabetes.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported. No additional AE/no PQC reported; a dose of VARIVAX was administered to 1 patient since being involved in a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  Previous temperature excursion for the product was reported as 10.78F for 0 hours 40 minutes 0 seconds.   On 17-FEB-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dosage form administered for prophylaxis (lot #X012267, expiration date: 30-APR-2025; route of administration, vaccination scheme frequency, and anatomical location, were not reported) since being involved in a temperature excursion (Product storage error) at a temperature of 7.81F, for 0 Hours 40 minutes 0 seconds.   No patient symptoms have been reported. No additional adverse event reported.
Age: 68.0
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 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing); "known allergies: silicone adhesive" (unspecified if ongoing); "Diabetes ML" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hbp" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "breast cancer - inSitu" (unspecified if ongoing); "obesity" (unspecified if ongoing); "NSAIDS allergy" (unspecified if ongoing); "metformin allergy" (unspecified if ongoing). Concomitant medication(s) included: EXEMESTANE, start date: 01Apr2019; MAGNESIUM OXIDE, start date: 12Jul2023. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical location:Left arm, Batch/Lot number: GJ3275), administration date: 10Dec2022, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location:Left arm, Batch/Lot number: FM0698), administration date: 19Apr2022, when the patient was 66-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location:Left arm, Batch/Lot number: FF2590), administration date: 27Oct2021, when the patient was 66-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical location:Left arm, Batch/Lot number: EW0171), administration date: 22Apr2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Anatomical location:Left arm, Batch/Lot number: ER8737), administration date: 01Apr2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 11Feb2024 to 15Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "mitral valve prolapse" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Known allergies: cephalosporins" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose number unknown, single), administration date: 01May2023, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 07Feb2024 to 12Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
Sex: M
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 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 10:00 as dose 1 (toppac), single (Lot number: HG4671) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: j&j (Dose Number: 1, Batch/Lot No: 041A21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 02Apr2021, when the patient was 61-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 032F21A, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Nov2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 31Mar2022, when the patient was 62-year-old, for COVID-19 immunization; moderna (Dose Number: 4, Batch/Lot No: AS7143C, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 14Sep2022, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (15Feb2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Feb2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid for COVID-19 treatment from 09Feb2024 to 14Feb2024. No Known allergies. Rebound Covid. Positive test five days after completion of Paxlovid course and four days after negative test.
Sex: U
Vaccine: PNC20
Symptoms: Product physical issue
Clinical narrative: there were particles in the vaccine and wasn't able to give it; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "there were particles in the vaccine and wasn't able to give it".  Causality for "there were particles in the vaccine and wasn't able to give it" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: pharmacy intern calling in for Prevnar 20 went to go and use, there were particles in the vaccine and wasn't able to give it. Looking for a refund or replacement.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: severe carditis; This is a spontaneous report received from a Pharmacist.  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. The following information was reported: CARDITIS (hospitalization, medically significant), outcome "unknown", described as "severe carditis". The patient was hospitalized for carditis (hospitalization duration: 21 day(s)). The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on limited information available the causal association between the event carditis and suspect drug BNT162b2 omi xbb.1.5 cannot be excluded completely. 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: F
Vaccine: COVID19
Symptoms: Gait disturbance, Neuromyelitis optica spectrum disorder
Clinical narrative: Neuromyelitis Optica; can't walk very well; This is a spontaneous report received from a Consumer or other non HCP from legal division.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 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: NEUROMYELITIS OPTICA SPECTRUM DISORDER (hospitalization, medically significant) with onset 02Nov2023, outcome "unknown", described as "Neuromyelitis Optica"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can't walk very well". Clinical course: Caller was a consumer calling in regard to Pfizer COVID19 vaccine and mentioned that on 26Sep2023 she had a covid shot and on 02Nov2023, she came down with Neuromyelitis Optica. She spent the whole month of November in the hospital and in rehab. She said that Pfizer should be aware of that and she's probably one of those that have come down with it. She also mentioned that she can't walk very well and didn't know whether she has to fill something out or she was hoping she didn't have to go to an attorney because she's really kind of beyond that stage of being able to do that.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a Consumer or other non HCP from legal division.  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. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Clinical courses: Patient suffered a massive heart attack after getting the covid 19 vaccine. He/she had never had blood clots before. Nor did he/she have a family history of this. He /she lost his/her job and everything he/she owned due to this.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 1.25
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was supposed to get DAPTACEL but ADACEL was given instead with no reported adverse event; Initial information received on 15-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was supposed to get diphtheria-15/tetanus/5 AC pertussis vaccine [daptacel] but diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] was given instead 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for Prophylactic vaccination; and HIB VACCINE (HIB VACCINE) for Prophylactic vaccination.  On an unknown date, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in the right thigh as immunization instead of diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, strength and expiry date not reported) with no reported adverse event (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: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of mQUADRACEL was inadvertently administered with no reported adverse event; Initial information received on 19-Feb-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 years old female patient who had received an expired dose of diphtheria-15/tetanus/5 Hybrid AC Pertussis/IPV (Mrc5) Vaccine [Quadracel] 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) And Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation.  On 19-Feb-2024, the patient received a 0.5 ml (dose 1) expired dose of suspect diphtheria-15/tetanus/5 Hybrid AC Pertussis/IPV (Mrc5) Vaccine Suspesnion for injection (strength: standard, frequency: once, expiry date: 02-Feb-2024 and lot C5970AA) via intramuscular route in the right arm as immunization (expired product administered) (same day latency).   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: 10.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal chest pain
Clinical narrative: Upper arm and bilateral lateral chest wall pain and tenderness. Patient had difficulty lowering arms to sides and kept them raised above his head.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10067923:VACCINE BREAKTHROUGH INFECTION;  10084268:COVID-19     Narrative:   Other Relevant HX:   Other:  COVID-19 BREAKTHROUGH
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Reported Symptoms:  10825182:LYMPH NODE PAIN;  10025186:LYMPH NODES ENLARGED; Narrative:  Other Relevant HX:  Other: swollen painful axillary lymph nodes
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Face oedema, Ocular discomfort, Oedema peripheral, Peripheral swelling
Clinical narrative: Reported Symptoms:  10014222:EDEMA FACE; 10042680:SWELLING ARM; 10042700:SWELLING OF LEGS;  Narrative: Pt reported to nurse ***COVID vaccine (11/06/23) - edema all over (face, arms, legs) Patient states he is still having some eye pressure - recommend he follow up with eye clinic - stated he was told he can go as a walk-in (recommend he do this ASAP). Patient states he received these 3 vaccines @ pharmacy. Other Relevant HX:  Other:  FACE, ARMS, LEGS EDEMA
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10001497:AGITATION;  10067923:VACCINE BREAKTHROUGH INFECTION;  10084268:COVID-19;     Narrative:  Other Relevant HX:  Other: COVID-19 BREAKTHROUGH
Sex: F
Vaccine: RSV, RSV
Symptoms: Cough, Oropharyngeal pain, Sputum discoloured
Clinical narrative: mildly sore arm; a sore throat starting on the 3rd day (Wednesday) that lasted for 3 days.; The vaccination gave me a cough that lasted for 3 weeks; This non-serious case was reported by a other health professional and described the occurrence of cough in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-JAN-2024, the patient received the 1st dose of Arexvy. On 08-JAN-2024, 1 days after receiving Arexvy, the patient experienced cough (Verbatim: The vaccination gave me a cough that lasted for 3 weeks). On 10-JAN-2024, the patient experienced sore throat (Verbatim: a sore throat starting on the 3rd day (Wednesday) that lasted for 3 days.). On an unknown date, the patient experienced pain in arm (Verbatim: mildly sore arm). On 13-JAN-2024, the outcome of the sore throat was resolved (duration 3 days).  On 27-JAN-2024, the outcome of the cough was resolved. The outcome of the pain in arm was not reported.   The reporter considered the cough and sore throat to be related to Arexvy. It was unknown if the reporter considered the pain in arm to be related to Arexvy.     The company considered the cough and sore throat to be related to Arexvy. It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 14-FEB-2024 For more than 5 years prior to the RSV shot, the patient never had a cough, cold, flu, cold or any other respiratory problems.  The vaccination gave the patient a cough that lasted for 3 weeks and a sore throat starting on the 3rd day (Wednesday) that lasted for 3 days.  The reporter did not had any other side effects from the shot except a mildly sore arm. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: RSV, RSV
Symptoms: Cough, Oropharyngeal pain, Pain in extremity
Clinical narrative: mildly sore arm; a sore throat starting on the 3rd day (Wednesday) that lasted for 3 days.; The vaccination gave me a cough that lasted for 3 weeks; This non-serious case was reported by a other health professional and described the occurrence of cough in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-JAN-2024, the patient received the 1st dose of Arexvy. On 08-JAN-2024, 1 days after receiving Arexvy, the patient experienced cough (Verbatim: The vaccination gave me a cough that lasted for 3 weeks). On 10-JAN-2024, the patient experienced sore throat (Verbatim: a sore throat starting on the 3rd day (Wednesday) that lasted for 3 days.). On an unknown date, the patient experienced pain in arm (Verbatim: mildly sore arm). On 13-JAN-2024, the outcome of the sore throat was resolved (duration 3 days).  On 27-JAN-2024, the outcome of the cough was resolved. The outcome of the pain in arm was not reported.   The reporter considered the cough and sore throat to be related to Arexvy. It was unknown if the reporter considered the pain in arm to be related to Arexvy.     The company considered the cough and sore throat to be related to Arexvy. It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 14-FEB-2024 For more than 5 years prior to the RSV shot, the patient never had a cough, cold, flu, cold or any other respiratory problems.  The vaccination gave the patient a cough that lasted for 3 weeks and a sore throat starting on the 3rd day (Wednesday) that lasted for 3 days.  The reporter did not had any other side effects from the shot except a mildly sore arm. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: PNC20, PNC20, PNC20
Symptoms: Peripheral swelling
Clinical narrative: hand started to swell and couldn't move her fingers up and down.; hand started to swell and couldn't move her fingers up and down.; Caller states today it is a little better but in the middle of her hand, she can't lift it and it is painful/her arm hurt a tiny bit; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 82-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Feb2024 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious), outcome "recovering" and all described as "hand started to swell and couldn't move her fingers up and down."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller states today it is a little better but in the middle of her hand, she can't lift it and it is painful/her arm hurt a tiny bit". Additional information: Caller went yesterday for a shot for pneumococcal and she went to her doctor and he said that she should get that vaccination. So, she got the shot yesterday (20Feb2024) right away in her left arm and that was fine. But in the evening (date unspecified), afternoon, her hand started to swell and couldn't move her fingers up and down. So today, it is a little better but not 100 percent. It is a little better but in the middle of her hand, she can't lift it and it is painful. She added that her arm hurt a tiny bit in the late afternoon and then she felt her hand swelling and she couldn't move her fingers and now she can't lift her hand up. She can move most of the things but cannot move them up, so she was wondering if it is normal.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20, PNC20, PNC20
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: hand started to swell and couldn't move her fingers up and down.; hand started to swell and couldn't move her fingers up and down.; Caller states today it is a little better but in the middle of her hand, she can't lift it and it is painful/her arm hurt a tiny bit; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 82-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Feb2024 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious), outcome "recovering" and all described as "hand started to swell and couldn't move her fingers up and down."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller states today it is a little better but in the middle of her hand, she can't lift it and it is painful/her arm hurt a tiny bit". Additional information: Caller went yesterday for a shot for pneumococcal and she went to her doctor and he said that she should get that vaccination. So, she got the shot yesterday (20Feb2024) right away in her left arm and that was fine. But in the evening (date unspecified), afternoon, her hand started to swell and couldn't move her fingers up and down. So today, it is a little better but not 100 percent. It is a little better but in the middle of her hand, she can't lift it and it is painful. She added that her arm hurt a tiny bit in the late afternoon and then she felt her hand swelling and she couldn't move her fingers and now she can't lift her hand up. She can move most of the things but cannot move them up, so she was wondering if it is normal.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20, PNC20, PNC20
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: hand started to swell and couldn't move her fingers up and down.; hand started to swell and couldn't move her fingers up and down.; Caller states today it is a little better but in the middle of her hand, she can't lift it and it is painful/her arm hurt a tiny bit; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 82-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Feb2024 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious), outcome "recovering" and all described as "hand started to swell and couldn't move her fingers up and down."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller states today it is a little better but in the middle of her hand, she can't lift it and it is painful/her arm hurt a tiny bit". Additional information: Caller went yesterday for a shot for pneumococcal and she went to her doctor and he said that she should get that vaccination. So, she got the shot yesterday (20Feb2024) right away in her left arm and that was fine. But in the evening (date unspecified), afternoon, her hand started to swell and couldn't move her fingers up and down. So today, it is a little better but not 100 percent. It is a little better but in the middle of her hand, she can't lift it and it is painful. She added that her arm hurt a tiny bit in the late afternoon and then she felt her hand swelling and she couldn't move her fingers and now she can't lift her hand up. She can move most of the things but cannot move them up, so she was wondering if it is normal.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE/PQC; HCP called to report TE where products have been administered to patients. TE case number: 02551934. Operator of device = HCP. No additional AE/PQC.      PROQUAD: x022923    exp; 03/12/2025   5.8F for 0 hours 15 minutes 0 seconds   no previous excurs; This spontaneous report was received from a certified medical assistant and refers to a 12-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-FEB-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #x022923, expiration date: 12-MAR-2025 (strength, and route of administration were not provided) for prophylaxis. The temperature excursion was 5.8 Fahrenheit for 15 minutes (Product storage error). There were no previous excursions. No additional adverse event was reported.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Product prescribing issue
Clinical narrative: prescribed a total of 4 doses, whereas in the package insert it states 5 doses for post-exposure prophylaxis only with no reported adverse event; Initial information was received on 16-Feb-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 57 years old female patient who was prescribed a total of 4 doses, whereas in the package insert it states 5 doses for post-exposure prophylaxis only rabies (HDC) vaccine [Imovax rabies] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect RABIES (HDC) vaccine (Powder and solvent for suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for post-exposure prophylaxis(Immunization) and prescribed a total of 4 doses, whereas in the package insert it states 5 doses for post-exposure prophylaxis only rabies (HDC) vaccine (product prescribing issue) (unknown latency).  The information on the batch number was requested.  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.