chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Pulse is been running above a hundred to about 120; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Pulse is been running above a hundred to about 120". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, "My daughter got the Bivalent booster (clarified as Pfizer COVID-19 Vaccine) yesterday and her pulse is been running above a hundred to about 120. We just don't know if that is normal?" Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Reporter further stated, "That's okay I will just call her doctor."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 13:00 as dose 4 (booster), single (Lot number: fj4991) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: dairy" (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 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) negative; (Oct2022) Positive, notes: Next day,  turned positive in 20 seconds; (Oct2022) Positive, notes: positive until day 14,. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jul2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Pre-Diabetic" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ESCITALOPRAM; OLMESARTAN; JARDIANCE; ESTRADIOL; NATURE MADE VITAMIN D3; NATURE MADE VITAMIN B-12; BIOTIN; COLLAGEN; CRANBERRY [VACCINIUM SPP.]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken on 19Mar2023.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Ear disorder, Motion sickness, SARS-CoV-2 test
Clinical narrative: Sudden and severe hearing loss in left ear.; full ear feeling; vertigo; dizziness; motion sickness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 at 15:30 as dose 4 (booster), single (Lot number: GJ6738), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arnold Chiari Malformation" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Avocado" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL. The patient had no other vaccine in four weeks. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), unknown manufacturer), for COVID-19 immunization. The patient had no covid prior vaccination. The following information was reported: DEAFNESS (disability, medically significant) with onset 21Dec2022 at 03:30, outcome "not recovered", described as "Sudden and severe hearing loss in left ear."; DIZZINESS (disability) with onset 21Dec2022 at 03:30, outcome "not recovered"; EAR DISORDER (disability) with onset 21Dec2022 at 03:30, outcome "not recovered", described as "full ear feeling"; MOTION SICKNESS (disability) with onset 21Dec2022 at 03:30, outcome "not recovered"; VERTIGO (disability) with onset 21Dec2022 at 03:30, outcome "not recovered". The events "sudden and severe hearing loss in left ear.", "full ear feeling", "vertigo", "dizziness" and "motion sickness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative. Therapeutic measures were taken as a result of deafness, ear disorder, vertigo, dizziness, motion sickness including steroid injection x3 into the ear and oral medicine.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Sudden and severe hearing loss in left ear.; full ear feeling; vertigo; dizziness; motion sickness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 at 15:30 as dose 4 (booster), single (Lot number: GJ6738), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arnold Chiari Malformation" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Avocado" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL. The patient had no other vaccine in four weeks. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), unknown manufacturer), for COVID-19 immunization. The patient had no covid prior vaccination. The following information was reported: DEAFNESS (disability, medically significant) with onset 21Dec2022 at 03:30, outcome "not recovered", described as "Sudden and severe hearing loss in left ear."; DIZZINESS (disability) with onset 21Dec2022 at 03:30, outcome "not recovered"; EAR DISORDER (disability) with onset 21Dec2022 at 03:30, outcome "not recovered", described as "full ear feeling"; MOTION SICKNESS (disability) with onset 21Dec2022 at 03:30, outcome "not recovered"; VERTIGO (disability) with onset 21Dec2022 at 03:30, outcome "not recovered". The events "sudden and severe hearing loss in left ear.", "full ear feeling", "vertigo", "dizziness" and "motion sickness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative. Therapeutic measures were taken as a result of deafness, ear disorder, vertigo, dizziness, motion sickness including steroid injection x3 into the ear and oral medicine.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Janssen, Dose: 1; Pfizer, Dose: 3, 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FP7135), in left arm and on 10Jun2022 as dose 4 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 1502072), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Janssen, Dose: 1; Pfizer, Dose: 3, 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient does not have other medication in 2 weeks. The patient does not have known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EL9263), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 13May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm and on 28Sep2022 as dose 5 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "PSVT" (unspecified if ongoing); "mild kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: Tested positive on a home test less than 48 hrs later, on Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Decreased appetite, Fatigue, Hot flush
Clinical narrative: Fatigue; weak; chest pain; decrease appetite; cold; hot flashes; Dose 1: Pfizer bivalent; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Mar2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for COVID-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Anxiety anemic and ibs" (unspecified if ongoing); "anemic" (unspecified if ongoing); "ibs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Mar2023, outcome "unknown", described as "Dose 1: Pfizer bivalent"; FATIGUE (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered"; CHEST PAIN (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered"; NASOPHARYNGITIS (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "cold"; DECREASED APPETITE (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "decrease appetite"; HOT FLUSH (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "hot flashes"; ASTHENIA (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "weak". Therapeutic measures were not taken as a result of fatigue, asthenia, chest pain, decreased appetite, nasopharyngitis, hot flush. Additional information: The patient has no other vaccine in four weeks, no other medications in two weeks, no COVID prior vaccination, and not tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Wrong product administered
Clinical narrative: Fatigue; weak; chest pain; decrease appetite; cold; hot flashes; Dose 1: Pfizer bivalent; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Mar2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for COVID-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Anxiety anemic and ibs" (unspecified if ongoing); "anemic" (unspecified if ongoing); "ibs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Mar2023, outcome "unknown", described as "Dose 1: Pfizer bivalent"; FATIGUE (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered"; CHEST PAIN (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered"; NASOPHARYNGITIS (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "cold"; DECREASED APPETITE (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "decrease appetite"; HOT FLUSH (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "hot flashes"; ASTHENIA (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "weak". Therapeutic measures were not taken as a result of fatigue, asthenia, chest pain, decreased appetite, nasopharyngitis, hot flush. Additional information: The patient has no other vaccine in four weeks, no other medications in two weeks, no COVID prior vaccination, and not tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic Syndrome; This is a spontaneous report received from contactable reporter(s) (Physician).  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Nov2021, outcome "unknown", described as "Anaphylactic Syndrome".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of subject product, BNT162B2 vaccine,  cannot be excluded for the reported event of Anaphylactic reaction, based on temporal relationship and the known product safety profile. There is limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. 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 "COVID 19". Therapeutic measures were taken as a result of drug ineffective and COVID-19 with PAXLOVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The first time I got the vaccine I had monoclonal antibodies and I had COVID really bad I might be dead without them; The first time I got the vaccine I had monoclonal antibodies and I had COVID really bad I might be dead without them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 06Dec2020 as dose 1, single (Lot number: EW0173) 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 "The first time I got the vaccine I had monoclonal antibodies and I had COVID really bad I might be dead without them".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130070 same reporter/patient/product, different dose/event.;US-PFIZER INC-202300130069 same reporter/patient/product, different dose/event.;US-PFIZER INC-202300130071 same reporter/patient/product, different dose/event.;
Sex: M
Vaccine: PNC20
Symptoms: Cardiac arrest, Death
Clinical narrative: Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 68-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03Oct2022 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: CARDIAC ARREST (death), outcome "fatal", described as "Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest". The patient date of death was 31Oct2022. Reported cause of death: "Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest". No autopsy was performed.  Clinical course details: Patient had no health issues prior to receipt of vaccine and no chronic conditions. No other vaccines were given at that time.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Cardiac arrest leading to death occurred nearly 4 weeks after a single dose of PREVERNA 20 is considered as unrelated to the vaccine use but more likely associated with the old age patient underlying medical condition. Follow-up information such medical history, concomitant medications and event term details especially death cause and autopsy results are needed for meaningful assessment.  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.; Reported Cause(s) of Death: Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Slept a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: astrazeneca coviD-19 vaccine (Dose: 01, Time: 10:00am, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Lot number: A-03324), administration date: 22Dec2020, when the patient was 62-year-old, for COVID-19 Immunization; astrazeneca coviD-19 vaccine (Dose: 02, Time: 10:00am, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Lot number: A-03468), administration date: 19Jan2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (Booster), Time: 02:00pm, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Lot number: FE3590), administration date: 24Oct2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 04, Time: 01:00pm, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: FM9992), administration date: 23May2022, when the patient was 64-year-old, for COVID-19 Immunization.  The following information was reported: HYPERSOMNIA (non-serious) with onset 29Jan2023, outcome "unknown", described as "Slept a lot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypersomnia.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Antinuclear antibody, Autoantibody test, Cellulitis, Myositis
Clinical narrative: Myositis; cellulitis; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOSITIS (medically significant), outcome "unknown"; CELLULITIS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown results; Antinuclear antibody: Unknown results; Autoantibody test: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162b2 cannot be excluded. This case will be re-evaluated upon receipt of additional information.  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 RAs, Ethics Committees, and investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300128901 Same article/patient/drug and same event;
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Systemic Lupus Erythematosus; This is a literature report for the following literature source(s):   A 27-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), 14 days after the suspect product(s) administration, outcome "unknown".  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the systemic lupus erythematosus  and suspect drug. This case will be reassessed upon receipt of full publication. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient in his 40's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems".  Additional Information: It was reported that the patient had heart problems after getting two doses of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Weight
Clinical narrative: DVT; This is a spontaneous report received from non-contactable reporter (physician) from a sales representative. The reporter is the patient.  A male patient in his 50's received BNT162b2 (BNT162B2), 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: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". The patient underwent the following laboratory tests and procedures: Weight: Normal. Clinical course: Physician himself developed DVT after taking initial dose of COVID vaccine. It was reported that he was healthy with normal weight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of DEEP VEIN THROMBOSIS due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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: Ageusia, Anosmia
Clinical narrative: Lost my taste and smell/ there are thousands of us; Lost my taste and smell/ there are thousands of us; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Lost my taste and smell/ there are thousands of us".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300055322 same suspect drug and AE/different patient;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: sweating; fever; body aches; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 28 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, SINGLE; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "sweating"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hyperhidrosis, pyrexia, pain. Additional information: Patient experienced adverse events same day after received dose 2. S/S-Covid-like symptoms-fever, body aches, sweating. Resolved with OTC meds and rest.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Back pain, Muscular weakness, Myalgia
Clinical narrative: Myalgia; Muscle weakness; Pain in the lower back; Has not regained all his physical strength back; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 60-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), in Nov2022 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: MYALGIA (non-serious), outcome "unknown"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Muscle weakness"; BACK PAIN (non-serious), outcome "not recovered", described as "Pain in the lower back"; ASTHENIA (non-serious), outcome "not recovered", described as "Has not regained all his physical strength back".  Additional information: Patient in good physical condition. He was able to do 50 pushups before receiving the two vaccines.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: B-lymphocyte count, B-lymphocyte count abnormal, Inappropriate schedule of product administration
Clinical narrative: doesn't have any B cells; started treatment with 2 primary dose of Pfizer in Dec2020 and one booster in Jan2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier(s):   A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), administration date: Dec2020, for COVID-19 immunization; BNT162B2 (DOSE 2, SINGLE), administration date: Dec2020, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Jan2021, outcome "unknown", described as "started treatment with 2 primary dose of Pfizer in Dec2020 and one booster in Jan2021"; B-LYMPHOCYTE COUNT ABNORMAL (non-serious), outcome "unknown", described as "doesn't have any B cells". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s): 2023NVX-US-000000288.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown".  Additional information: On 09Mar2022, it was reported that a patient stated treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose/frequency for covid 19 vaccination. It was reported the patient developed myocarditis as a result of the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 16 year old patient was given second dose of MENQUADFI. The first dose was one month ago with no adverse event; Initial information received on 21-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who was given second dose of  MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. however, the first dose was one month ago with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Prophylactic vaccination; and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for Prophylactic vaccination.  On 21-Mar-2023, the patient received dose 2 (once) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (lot U7447AB, expiry date: 20-Sep-2024) (unknown strength)via intramuscular route in the left deltoid for immunization.  On 21-Mar-2023 reporter reported that 16 year old patient was given second dose of menquadfi. the first dose was one month ago with no adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-VAX was reconstituted with sterile water and administered to a patient with no adverse event reported; Initial information received on 21-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient, reporter reported that yellow fever vaccine [YF-VAX] was reconstituted with sterile water and administered to a patient with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect yellow fever vaccine, solution for injection, (strength, lot number and expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date, YF-VAX was reconstituted with sterile water and administered to a patient with no adverse event reported (product preparation error) (latency: same day) following the administration of yellow fever vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired ACTHIB was administered to a patient with no reported adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 1 years old female patient who received an expired 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and influenza vaccine (Fluzone) for Prophylactic vaccination.  On an unknown date, the patient received 0.25 ml (dose 4) of suspect HIB (PRP/T) vaccine (strength - standard, frequency - once, lot UJ648ABA, expiry date - 16-Mar-2023) via intramuscular route in site for prophylactic vaccination which was expired with no reported adverse event (expired product administered) (latency: same day) .  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: reconstituted with the incorrect diluent of sterile water instead of the supplied 0.6 mL Sodium Chloride, with no reported adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from Non-Healthcare Professional.  This case involves two patients (demographics unknown) for whom YELLOW FEVER VACCINE [YF-VAX], reconstituted with the incorrect diluent of sterile water instead of the supplied 0.6 ml sodium chloride, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE Solution for injection (strength, route: unknown) (lot number: UJ782AA, expiry date: 17-Feb-2024) (Sodium chloride Diluent lot: U7056AA Expiry date: Oct-2024) in unknown administration site for Immunization and it was reconstituted with the incorrect diluent of sterile water instead of the supplied 0.6 ml sodium chloride, with no reported adverse event (product preparation error) (unknown latency).  It was reported, caller is wanting to know next steps to take. Caller does not have patient's information at time of call. This situation is reported as a medication error due to two patients being administered YF-VAX that was reconstituted with sterile water instead of the supplied diluent.  Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of Adacel was administered with no reported adverse event; Initial information received on 23-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Immunisation.  On 23-Mar-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (frequency - total (1x), strength - standard, lot - U6984AA, expiry date - 18-Mar-2023) via intramuscular route in right deltoid for prophylactic vaccination (immunization) that was expired with no adverse event  (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia oral, Mouth swelling, Pharyngeal hypoaesthesia
Clinical narrative: Hard to breath, swollen throat and mouth, numb throat and mouth, dizziness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Hard to breath, swollen throat and mouth, numb throat and mouth, dizziness
Age: 1.5
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix given to a 18-month-old; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 18-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix given to a 18-month-old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 16-MAR-2023 The reporter would like to report an adverse event.  The provider was busy with another patient so the information collected was limited but the health care professional (HCP) was willing to provide more information over a follow up later. The Boostrix vaccine was inadvertently administered to 18 month old patient, which led to inappropriate age at vaccine administration.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE REACTIONS. PATIENT GIVEN EXPIRED VACCINATION (EXP DATE 9-21-21)
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and rash (Verbatim: Rash). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the rash was not reported.   The reporter considered the vaccination failure, shingles and rash to be possibly related to Shingles vaccine.     The company considered the vaccination failure, shingles and rash to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 21-Mar-2023 This case was reported by a patient via interactive digital media. The patient developed shingles a year after having the shot and did even know that she had shingles until the physician notice the rash. The patient reported that the shingles shot was one of the best shots to get no matter what the cost.  The reporter think that the event might have been related to the Product/Device. The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.