chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID-19 even though they had all the Pfizer shots; had COVID-19 even though they had all the Pfizer shots; 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.  An 88-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood clots" (unspecified if ongoing), notes: background; "diabetes" (unspecified if ongoing), notes: background. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID-19 even though they had all the Pfizer shots". Additional information: The patient mentioned she and her husband had COVID-19 even though they had all the Pfizer shots. She stated that he passed away on 29Aug. She wanted to know how long to wait to get the new Pfizer COVID-19 vaccine as her doctor told her to wait 6 months. She also wanted to know how often where the blood clots reported as she's concerned with it. She also asked how common it is to still die of COVID-19 pneumonia even with the vaccine.  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-202300414138 same reporter/event; different patient;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID-19 even though they had all the Pfizer shots; had COVID-19 even though they had all the Pfizer shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "had COVID-19 even though they had all the Pfizer shots". The patient date of death was unknown. Reported cause of death: "had COVID-19 even though they had all the Pfizer shots". It was not reported if an autopsy was performed. Additional information: The patient's wife mentioned she and her husband (patient) had COVID-19 even though they had all the Pfizer shots. She stated that he (patient) passed away on 29Aug. She wanted to know how long to wait to get the new Pfizer COVID-19 vaccine as her doctor told her to wait 6 months. She also asked how common it is to still die of COVID-19 pneumonia even with the vaccine.  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-202300414136 same reporter/event; different patient;; Reported Cause(s) of Death: had COVID-19 even though they had all the Pfizer shots; had COVID-19 even though they had all the Pfizer shots
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: coughing; feel terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team..  A 61-year-old female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 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: COUGH (non-serious) with onset 24Nov2023, outcome "unknown", described as "coughing"; MALAISE (non-serious) with onset 24Nov2023, outcome "unknown", described as "feel terrible".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Thrombosis
Clinical narrative: blood clots in right leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Lot number: HF9275) at the age of 67 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 04Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetic" (ongoing); "Issues with walking issues balancing" (ongoing); "Issues with walking issues balancing" (ongoing). The patient took concomitant medications. Vaccination history included: Moderna covid shots (she had previously when covid first came out.), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 23Nov2023, outcome "not recovered", described as "blood clots in right leg". Therapeutic measures were not taken as a result of thrombosis. Additional information: Reporter calling about Pfizer Covid shot. She received the Pfizer Covid Shot on 04Nov2023. The # sent nurses to her home to get this vaccine along with the flu shot which she got on the same day. Then on this passed Thursday, on 23Nov2023 she got blood clots in right leg. No investigations. Attempted to capture exact name of the flu shot and indicated all she sees is MFH Flu High Dosage. Unable to provide exact name of the Flu shot received. Indication was reported as Elderly, high risk. The patient was on other medications (while vaccination). Vaccination directly in her home. The agency sent nurses to her home. No prior vaccinations (within 4 weeks).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: TMJ; sore next and shoulder; earache when chewing; Headache; pain in the arm; numbness of left face; wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 26Nov2023 at 18:00 as dose 6, single (Lot number: FH8030) at the age of 57 years, in left arm for covid-19 immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 2, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 3, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 4, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 5, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 26Nov2023, The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 26Nov2023, outcome "unknown", described as "wrong vaccine administered"; HEADACHE (non-serious) with onset 27Nov2023, outcome "not recovered"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 27Nov2023, outcome "not recovered", described as "TMJ"; EAR PAIN (non-serious) with onset 27Nov2023, outcome "not recovered", described as "earache when chewing"; HYPOAESTHESIA (non-serious) with onset 27Nov2023, outcome "not recovered", described as "numbness of left face"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2023, outcome "not recovered", described as "pain in the arm"; ARTHRALGIA (non-serious) with onset 27Nov2023, outcome "not recovered", described as "sore next and shoulder". Therapeutic measures were not taken as a result of temporomandibular joint syndrome, arthralgia, ear pain, headache, pain in extremity, hypoaesthesia.  Additional information: The patient received any other medications within 2 weeks of vaccination included linzness. Reported Event: All on left side: TMJ, sore next and shoulder, earache when chewing, numbness of left face. Headache.  Reaction to the shot in term of pain in the arm significantly worst then prior shots ON.  Around 12 of 27Nov2023 symptoms started.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Temporomandibular joint syndrome, Wrong product administered
Clinical narrative: TMJ; sore next and shoulder; earache when chewing; Headache; pain in the arm; numbness of left face; wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 26Nov2023 at 18:00 as dose 6, single (Lot number: FH8030) at the age of 57 years, in left arm for covid-19 immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 2, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 3, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 4, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm"; Covid-19 vaccine (dose 5, unknown manufacture), for covid-19 immunisation, reaction(s): "pain in the arm". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 26Nov2023, The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 26Nov2023, outcome "unknown", described as "wrong vaccine administered"; HEADACHE (non-serious) with onset 27Nov2023, outcome "not recovered"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 27Nov2023, outcome "not recovered", described as "TMJ"; EAR PAIN (non-serious) with onset 27Nov2023, outcome "not recovered", described as "earache when chewing"; HYPOAESTHESIA (non-serious) with onset 27Nov2023, outcome "not recovered", described as "numbness of left face"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2023, outcome "not recovered", described as "pain in the arm"; ARTHRALGIA (non-serious) with onset 27Nov2023, outcome "not recovered", described as "sore next and shoulder". Therapeutic measures were not taken as a result of temporomandibular joint syndrome, arthralgia, ear pain, headache, pain in extremity, hypoaesthesia.  Additional information: The patient received any other medications within 2 weeks of vaccination included linzness. Reported Event: All on left side: TMJ, sore next and shoulder, earache when chewing, numbness of left face. Headache.  Reaction to the shot in term of pain in the arm significantly worst then prior shots ON.  Around 12 of 27Nov2023 symptoms started.
Sex: F
Vaccine: RSV
Symptoms: Asthma, Condition aggravated, Product administered to patient of inappropriate age
Clinical narrative: she has severe asthma; Patient is 31 year old; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 31-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Bronchiolitis" (unspecified if ongoing), notes: which is a scaring of the lungs; "chronically ill" (unspecified if ongoing); "immuneodeficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "she has severe asthma"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Patient is 31 year old".  Additional information: Caller the patient's mother called on behalf of the patient seeking assistance with the medication Abrysvo. During the call caller stated." I'm calling about my daughter who is 31 years old chronically ill and has Bronchiolitis which is a scaring of the lungs, she has severe asthma she's immuneodeficiency."   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Coagulation test, Glomerulonephritis membranous, Peripheral swelling
Clinical narrative: He first noted swelling in his lower extremities after the first dose of covid vaccine; Membranous nephropathy; This is a literature report for the following literature source(s).  A 56-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "PE" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for pulmonary embolism. The following information was reported: PERIPHERAL SWELLING (hospitalization, medically significant), outcome "recovered", described as "He first noted swelling in his lower extremities after the first dose of covid vaccine"; GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "Membranous nephropathy". The patient underwent the following laboratory tests and procedures: Coagulation test: Negative, notes: PE with negative hypercoagulability work up. Therapeutic measures were taken as a result of peripheral swelling, glomerulonephritis membranous. Patient was treated with supportive measures initially and later switched to Rituximab infusion for two doses after biopsy confirmed MN. He had poor response. Tacrolimus was subsequently added for persistent proteinuria but without sufficient response. He was then started on a cyclical corticosteroids and Cyclophosphamide with successful achievement of remission.; Sender's Comments: The events peripheral swelling, and membranous nephropathy are conservatively assessed as related to the suspect drug based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old patient received bnt162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 18Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 13Jul2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN (ongoing). The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Nov2022, outcome "recovered" (Nov2022), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Nov2022, outcome "recovered" (Nov2022). Clinical Course: Pertinent Details (include surgical procedure and dates): Mild cough, Runny Nose - Lasted 2 weeks. Patient had not done any relevant tests.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347182 same patient, different product/event;
Sex: U
Vaccine: COVID19
Symptoms: Diplegia
Clinical narrative: my third shot it paralyzed my legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DIPLEGIA (medically significant) with onset 2023, outcome "unknown", described as "my third shot it paralyzed my legs". Clinical course: The patient was just wondering that if should get a booster shot because third shot had paralyzed the patient's legs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Aneurysm, Aortic dissection, Cerebrovascular accident, Giant cell arteritis
Clinical narrative: We are dying of strokes, aneurysms and dissected aortas; We are dying of strokes, aneurysms and dissected aortas; Giant Cell Arteritis; We are dying of strokes, aneurysms and dissected aortas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: GIANT CELL ARTERITIS (medically significant) with onset 2023, outcome "unknown"; CEREBROVASCULAR ACCIDENT (medically significant), AORTIC DISSECTION (medically significant), ANEURYSM (medically significant) all with onset 2023, outcome "unknown" and all described as "We are dying of strokes, aneurysms and dissected aortas". Clinical course: Reporter reported that how do those of us who took the covid vaccine rid our bodies of whatever was in the injection that had left them with Giant Cell Arteritis, an auto immune vasculitis. They were dying of strokes, aneurysms and dissected aortas. Help us.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: My husband was vaccinated and caught it twice.; My husband was vaccinated and caught it twice.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My husband was vaccinated and caught it twice."  Clinical information : The reporter reported that I had not been vaccinated against Covid nor had I contracted it. My husband was vaccinated and caught it twice. I nursed him and also shared a drink with him.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Cardiac failure, Viral myocarditis
Clinical narrative: viral myocarditis/ almost died/ was rushed to the hospital after collapsing at home; heart failure from myocarditis; Prescribed Entresto along with another blood pressure medications; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NUS2023US211318_NC.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: VIRAL MYOCARDITIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "viral myocarditis/ almost died/ was rushed to the hospital after collapsing at home"; CARDIAC FAILURE (medically significant, life threatening), outcome "unknown", described as "heart failure from myocarditis"; BLOOD PRESSURE ABNORMAL (medically significant), outcome "recovering", described as "Prescribed Entresto along with another blood pressure medications". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown Results, notes: Prescribed Entresto along with another blood pressure medications and his blood pressure. Therapeutic measures were taken as a result of blood pressure abnormal.  Clinical information : The reporter reported that Covid vaccine caused viral myocarditis in her husband. He almost died, thank God he was rushed to the hospital after collapsing at home. ICU for a week. Diagnosed with heart failure from myocarditis. Prescribed Entresto along with another blood pressure medications and his blood pressure, heart and overall heart health had so far been better than it ever was.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test came positive; test came positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Nov2023, outcome "unknown" and all described as "test came positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2023) Positive. Clinical course: The patient was in the trial for Covid-19. Patient had been rejected this last time for 5th Booster. Tomorrow, patient is planning to receive this booster, Pfizer, at (Pharmacy name withheld), but today the test came positive. The patient asked if he/she need to contact the research company.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Illness, SARS-CoV-2 test
Clinical narrative: no appetite since that day can't eat at all; sick; 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 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reaction(s): "no adverse effect". The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite since that day can't eat at all"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had Pfizer COVID and has been sick since then. The patient had no appetite since that day and can't eat at all. All the patient's shots thought were Pfizer with no problems. The patient doesn't know what to do because the patient was so sick. The patient did COVID test and showed no COVID. The patient was asking if it is possible that the patient received the wrong vaccine.   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: Vaccination site pain
Clinical narrative: pain from my first Pfizer injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  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: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain from my first Pfizer injection". The action taken for bnt162b2 was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Toxicity to various agents
Clinical narrative: it's poison that I don't want in my body.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOXICITY TO VARIOUS AGENTS (non-serious), outcome "unknown", described as "it's poison that I don't want in my body.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products, Off label use
Clinical narrative: 1st dose Moderna, 2nd dose Pfizer; 1st dose Moderna, 2nd dose Pfizer; second shot sicker than ever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly female patient (unknown if pregnant) 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: Moderna covid-19 vaccine (1st dose, because she had to fly), for COVID-19 immunisation, reaction(s): "No adverse effect". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "1st dose Moderna, 2nd dose Pfizer"; ILLNESS (non-serious), outcome "unknown", described as "second shot sicker than ever". Additional information: the patient had very negative feelings about Covid shot. She will not be taking anything for Covid again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: allergic to covid shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly female patient (unknown if pregnant) 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to covid shots". Additional information: the patient considered the event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US213730_NS (Novartis).  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, on 06Nov2023; CORTISONE intra-articular; LEQVIO, start date: 06Nov2023, stop date: 06Nov2023. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was a little sore".  Additional information: Patient stated they received their latest injection on 06Nov2023 of Leqvio. Then also got their Covid-19 Vaccine, Flu shot and two cortisone shots in their knee and shoulder. Patient stated their arm was a little sore from what they believe was the Covid Vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: can barely walk after she got vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 08Jan2021 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 immunisation. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can barely walk after she got vaccinated".  Additional information: Consumer wanted to know if there is a way or we have developed something to take the booster out from her body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: loss of consciousness/blacked out; fall/fell twice; dizziness/light headed; Initial information received on 20-Nov-2023 regarding Courtesy case an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 68 years old female patient who experienced loss of consciousness/blacked out, fall/fell twice and dizziness/light headed while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing AUGMENTINE [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM].  Concomitant medications included SERTRALINE and ATORVASTATIN.  On 06-Oct-2023, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, formulation, strength, lot and expiry date: unknown) via intramuscular route in the right arm for prophylactic vaccination (immunization).  On 07-OCT-2023 the patient developed a serious loss of consciousness/blacked out (loss of consciousness) (latency same day)   On 07-OCT-2023 the patient developed a non-serious fall/fell twice (fall) and dizziness/light headed (dizziness) (latency same day)  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events (loss of consciousness/blacked out, dizziness/light headed, fall/fell twice).  At time of reporting, the outcome was Recovered / Resolved on 07-Oct-2023 for the events (loss of consciousness/blacked out, dizziness/light headed, fall/fell twice).  Seriousness criteria: medically significant for loss of consciousness; Sender's Comments: Sanofi company comment dated 24-NOV-2023: This case involves a 68 years old female patient who experienced loss of consciousness/blacked out, fall/fell twice and dizziness/light headed while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of suspect cannot be assessed.
Age: 1.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: medication error due to a 1-year old male patient received an extra dose of IPOL with no reported adverse event; Initial information received on 17-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who had medication error due to patient received an extra dose of IPV (Vero) [Ipol] 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 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 13-Nov-2023, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot V1B902M, with unknown strength and expiry date) via intramuscular route in the left thigh as Immunization and had a medication error as patient received an extra dose of ipol with no reported adverse event (extra dose administered) (Latency: same day)  It was reported "that a patient had already received 3 doses of Pediarix in a different state; they did not realize this and they gave him an extra dose of IPOL at his 18-month visit. The nurse asks what action needs to be taken? The nurse explains that when the patient presented to the office, they thought that he had no prior IPV vaccination; they thought that the dose of IPOL administered on 13Nov2023 was his first dose in the IPV series. Later, they found out that the patient had already received 3 doses of Pediarix in a different state."   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: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: aches and pains all over; cough; was febrile, temperature was a highest of 102 degrees F; terrible sore throat; trouble breathing; Initial information with live follow-up was received on 20-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 79 years old male patient who experienced aches and pains all over, cough, was febrile, temperature was a highest of 102 degrees f, terrible sore throat and trouble breathing after receiving vaccine Influenza Quadrival A-B High Dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B High dose HV vaccine (strength, formulation, route, administration site , lot number and expiry: not reported) for immunization. Information on the batch number was requested.  On an unknown date, the patient developed aches and pains all over (pain), cough, terrible sore throat (oropharyngeal pain) and trouble breathing (dyspnoea) (unknown latency) following the administration of Influenza Quadrival A-B High dose HV vaccine.  On an unknown date, the patient was febrile, temperature was a highest of 102 degrees F (pyrexia) (latency: 1 day) following the administration of Influenza Quadrival A-B High dose HV vaccine.  Relevant laboratory test results included:  Body temperature - On an unknown date: 102 F; on 20-Nov-2023: 98 F  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Recovered / Resolved on 20-Nov-2023 for the event was febrile, temperature was a highest of 102 degrees f, was Unknown for rest of events.
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain barre after receiving the dose; Initial information received on 20-Nov-2023 regarding an unsolicited valid serious case received from a pharmacist.  This case involves an unknown age female patient who had guillain barre after receiving the dose of influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: no other vaccines.  On an unknown date, the patient received 0.5 mL dose of suspect influenza quadrival A-B vaccine, Suspension for injection (Frequency: once; Strength: standard) (lot number, expiry date unknown) via intramuscular route in unknown administration site for Influenza immunisation. Information on the batch number was requested.  On an unknown date the patient had guillain barre (guillain-barre syndrome) (latency: within a week) following the administration of influenza quadrival A-B vaccine.   Reportedly, Pharmacist reported that a coworker received FLUZONE QIV and was diagnosed with Guillain Barre after receiving the dose. Caller was unsure of the exact time frame but stated that she was diagnosed within a week of receiving the flu vaccine. The patient is currently being treated in the hospital. Caller had limited information available in regard to the situation.  Action taken: not applicable.  Treatment: The person is currently being treated in the hospital for Guillain Barre.  At time of reporting, the outcome was Unknown for the event guillain barre after receiving the dose.  Seriousness Criteria: The event guillain-barre syndrome was assessed as medically significant. The patient was hospitalized for this event from 16-NOV-2023.; Sender's Comments: Sanofi Company Comment dated 26-Nov-2023: This case involves an unknown age female patient who had guillain barre after receiving the dose of influenza quadrival A-B vaccine [Fluzone QIV]. Based upon the reported information, the role of the vaccine cannot be assessed. However, lack of information regarding past medical treatment(s), family history information precludes comprehensive case assessment.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Fridge got too cold /Max/Low temp reached: 32.2 F about 15 hours max with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information was received on 21-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA367565.  This case involves a 4 years old female where fridge got too cold /max/low temp reached: 32.2 f about 15 hours max and IPV (VERO) [IPOL] was administered post excursion 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 measles vaccine, mumps vaccine, rubella vaccine (MMR).  On 15-Nov-2023, the patient received a 0.5 ml, once, total (dose 4) of suspect IPV (VERO) (Suspension for injection) (lot W1A191M, expiry date: 16-Feb-2025, strength: standard) via subcutaneous route in Right Arm for Immunisation and vaccine administered post excursion with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date, fridge got too cold /max/low temp reached: 32.2 f about 15 hours max with no reported adverse event (product storage error).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the patient was given FLUZONE QIV-NP and was just documented as a COVID VACCINE with no reported adverse event; Initial information received on 21-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves the patient of unknown age and gender who was given influenza quadrival A-B vaccine [Fluzone QIV] and was just documented as a covid vaccine 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 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot number; strength; expiry date not reported) via unknown route in unknown administration site for Immunization. Information regarding batch number will be requested in this case.  On an unknown date the patient was given influenza quadrival A-B vaccine and was just documented as a covid vaccine with no reported adverse event (transcription medication error) (unknown latency).  It was reported, "that they have a patient who wanted to get FLUZONE QIV-NP but as per the patient's record, the vaccine that was given was a COVID vaccine. Clinic Supervisor would like to have any information if flu vaccine can be given with COVID vaccine and if multiple influenza vaccines can be given in one season."  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: 16.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient was accidentally administered with quadracel with no reported adverse event; Initial information received on 21-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who was accidentally administered with 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 Influenza vaccine (FLU VACCINE VII) and Meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Prophylactic vaccination.  On 21-Nov-2023, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection of lot U7675DB and Expiry: 30-Sep-2025 via intramuscular route in the right arm as prophylactic vaccination (immunization).  On 21-Nov-2023, the patient was accidentally administered with Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data was reported.  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: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: 5th shot of acthib was administered with no reported adverse event; Initial information was received on 22-Nov-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 4 years old female patient to whom 5th shot of HIB (PRP/T) vaccine [ACT-HIB] was administered 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 polio vaccine inact (IPV) for prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for prophylactic vaccination.  On an unknown date, the patient received a 0.5 ml, once (dose 5) of suspect HIB (PRP/T) vaccine (Powder and suspension for suspension for injection) (lot UJ806AB, expiry date:18-Feb-2024, strength: standard) via intramuscular route in unknown administration site for Immunisation and 5th shot of act-hib was administered with no reported adverse event (extra dose 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.