chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Sep2023 at 13:15 as dose 6 (booster), single (Lot number: 3030368), 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Oct2023 to 16Oct2023.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jul2023 at 13:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 72 years 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: SYNTHROID, start date: Jan2000; SERTRALINE, start date: Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Oct2023 to 24Oct2023.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events cannot be excluded,Linked Report(s) : US-PFIZER INC-202300350759 Same patient, different drug/AE;
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Wrong product administered
Clinical narrative: Wrong vaccine administered; I lost all of my hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2023 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 23Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; levothyroxine sodium (SYNTHROID), since 23Oct2023 (Batch/Lot number: unknown). The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: DEAFNESS (medically significant) with onset Oct2023, outcome "unknown", described as "I lost all of my hearing"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 23Oct2023, outcome "unknown", described as "Wrong vaccine administered". Therapeutic measures were not taken as a result of deafness. Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested positive for COVID-19. Patient had no known allergies or reported other medical history. Patient received other medications within 2 weeks of vaccination.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 07:15 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 07Nov2022, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Oct2023 to 22Oct2023. Clinical Course: Patient had no known allergies. After completing five days of paxlovid, patient tested negative for three days.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350761 Same patient, different drug/AE;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1: Moderna/ Dose 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer) from product quality group. The reporter is the patient.  A 73-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 at 09:00 as dose 1, single (Lot number: GJ3268) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Sep2023 at 09:00 as dose 2, single (Lot number: 203E73A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2023 at 09:00, outcome "unknown", described as "Dose 1: Moderna/ Dose 1: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19 from 20Oct2023 to 24Oct2023. Clinical course: It was unknown whether the patient had other medication in 2weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350763 Same patient, different drug/AE;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER2613), on 16Apr2021 as dose 2, single (Lot number: EW0151), on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Jun2022 as dose 4 (booster), single (Lot number: FN7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Allergy" (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 17Oct2023, outcome "recovered" (25Oct2023) and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Positive; (25Oct2023) Negative. Therapeutic measures (Paxlovid therapy start date: 19Oct2023, Stop date 24Oct2023) were taken as a result of vaccination failure, covid-19. Clinical course: Patient was initially positive for Covid on 17Oct2023. Tested negative on 25Oct2023 felt pretty good except tired until 27Oct the late afternoon when she started feeling sick again and then tested positive at night.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350940 same patient, different drug and AE;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna, Astra Zeneca and vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: 9h9693) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Oct2021 as dose 3 (booster), single (Lot number: 039021A), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (ASTRAZENECA COVID-19 VACCINE), on 05Nov2020 as dose 1, single (Lot number: A03324), in right arm and on 04Dec2020 as dose 2, single (Lot number: A03324), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "recovered", described as "vaccine brand other=Moderna, Astra Zeneca and vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative, notes: Tested positive 3 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Oct2023 to 15Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350676 same patient, different drug/event;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: Gh9702) at the age of 49 years 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: "Obesity" (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 Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, included paxlovid treatment from 21Oct2023 to 26Oct2023. Clinical course: Patient did not have known allergies.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events cannot be excluded,Linked Report(s) : US-PFIZER INC-202300350989 same patient, different drug/AE;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 52 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 02Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "GuillianBarr", start date: 1985 (unspecified if ongoing); "Encephalitis", start date: 1985 (unspecified if ongoing). Concomitant medication(s) included: VITAFUSION WOMEN'S, stop date: 13Oct2023; KIRKLAND SIGNATURE VITAMIN C, stop date: 13Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (21Oct2023) Negative, notes: getting two negative covid tests results 48 hrs apart; (24Oct2023) Negative, notes: getting two negative covid tests results 48 hrs apart; (26Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date 17Oct2023, stop date 21Oct2023). Clinical course: The patient had positive Covid Test result and symptoms two days after finishing Paxlovid and getting two negative covid tests results 48 hrs apart. 21Oct2023: last day on Paxlovid 24Oct2023: negative covid test 26Oct2023: negative covid test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351006 same patient, different drug/event;US-PFIZER INC-202300351009 same patient, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling abnormal
Clinical narrative: feeling poorly; severe cardiac incident; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 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: FEELING ABNORMAL (hospitalization) with onset 26Oct2023, outcome "recovering", described as "feeling poorly"; CARDIAC DISORDER (hospitalization) with onset 26Oct2023, outcome "recovering", described as "severe cardiac incident". The patient was hospitalized for feeling abnormal, cardiac disorder (start date: 26Oct2023). Therapeutic measures were taken as a result of cardiac disorder. Clinical course: Pharmacist was notified by family member that patient withheld who had received a Covid vaccine at PRIVACY a day before started feeling poorly same afternoon that night admitted to hospital with "severe cardiac incident.describing defibrillator was necessary " patient is still in ICU but stable. It was unknown if patient got other vaccine in four weeks. It was unknown if patient got COVID prior vaccination. It was unknown if patient COVID tested post vaccination.  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: Drug ineffective; getting Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation, on 02Oct2023 as dose number unknown, single; RSV VACCINE PROT.SUBUNIT PREF 2V taken for immunisation, on 23Oct2023 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "getting Covid". Clinical course: patient had a hard time with shots at (withheld). The first 2 shots he got were Covid and Flu on 02Oct. Then he had RSV vaccines 23Oct and felt ill and wound up getting Covid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300178373 same reporter/patient,different drug/AE;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Clinical course: Reporter also knew of two people that had blood clots.  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: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Clinical course: Reporter also knew of two people that had blood clots.  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-2021192614 same reporter/drug, different patients/AE;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 59 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Oct2023 to 17Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351197 same patient, different drug and AE;
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Headache, Pyrexia
Clinical narrative: stomachache; diarrhea; high temperature/fever; headache; 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 female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Oct2023, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset Oct2023, outcome "unknown"; PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "high temperature/fever"; ABDOMINAL PAIN UPPER (non-serious) with onset Oct2023, outcome "unknown", described as "stomachache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper, diarrhoea, pyrexia, headache.  Additional information: Patient called about the Pfizer Covid Vaccine 2023-2024 formula 12 years and up and wanted to know if diarrhea, high temperature, stomachache and headache are side effects of the vaccine. She said she may had other symptoms, said she could not keep anything in her stomach and kept having constant diarrhea. Advised her that Pfizer does not provide treatment recommendations and so they referred her to her doctor/HCP for further management. She understood. She was not sure but believes it was the Pfizer 12 and over covid vaccine that she received about a week ago. She was having a strong reaction which she describe as including high temperature, pooping her brains out and a stomach ache. She had a headache. She may had other symptoms that she cannot think of right now. She was curious because she was having such a strong reaction and she was not sure if it was a side effect and maybe it could be some other sort of virus or stomach virus. Someone just came and brought her medicine. She was not sure it was a reaction to the covid vaccine. She declined report and requested to be transferred to ask if the symptoms that she had were side effects of the covid vaccine. The nurse sent the stool sample. At present she was in a rehab facility and jokingly states since she got a new her. Declined to provide address.  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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of COVID Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), on 20Jan2023 at 12:00 as dose 6 (booster), single (Lot number: GJ67429) at the age of 52 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Mar2021 at 12:00 as dose 1, single (Lot number: ER8727), in right arm, on 12Apr2021 at 12:00 as dose 2, single (Lot number: ER8729), in right arm, on 18Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2593), in right arm and on 01Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Sep2022 at 12:00 as dose 5 (booster), single (Lot number: AS7144B) and on 16Sep2023 at 12:00 as dose 7 (booster), single (Lot number: NOVO3030371), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: managed with treatment.; "high cholesterol" (unspecified if ongoing), notes: managed with treatment. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022 at 12:00, outcome "unknown", described as "Interchange of COVID Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: tested negative on day 9 after symptoms; (2023) Positive, notes: tested positive on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 60.0
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 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer treatment 04May2023; "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: 01Aug2021; LETROZOLE, start date: 10Aug2023. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 26Mar2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE), administration date: 19Apr2021, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE), administration date: 22Nov2021, for COVID-19 immunisation; moderna (DOSE 4 (BOOSTER), SINGLE), administration date: 20May2022, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine location: Right arm), administration date: 13Oct2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 21Oct2023 to 25Oct2023. Also, the patient had COVID 19 Treatment from 19Oct2023 to 24Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350864 same patient, different drug, different event;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Pfizer/BioNTech/Vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Lot number: GH9694) and on 01Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0164) and on 05May2021 as dose 2, single (Lot number: EW0165) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 037C21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism (mild)" (ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Nov2022, outcome "unknown", described as "vaccine brand=Pfizer/BioNTech/Vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: after testing negative twice; Negative, notes: after testing negative twice. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment was given with Paxlovid from 16Oct2023 to 20Oct2023. No Known allergies  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 53 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8727), on 15Apr2021 as dose 2, single (Lot number: EW0162), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2593) and on 10May2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "high bp" (unspecified if ongoing), notes: but controlled w/ medication; "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2021; METOPROLOL SUCCINATE, start date: Jan2021; PRILOSEC [OMEPRAZOLE], start date: Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 20Oct2023 to 24Oct2023.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Post-acute COVID-19 syndrome, Suspected COVID-19
Clinical narrative: I have Long COVID; I have Long COVID; I have Long COVID; moderna vaccine in 2021/ Pfizer booster in November of 2021; 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 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "moderna vaccine in 2021/ Pfizer booster in November of 2021"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown" and all described as "I have Long COVID". Clinical course: Patient had a very harsh and long lasting reaction to the moderna vaccine in 2021. Patient took a Pfizer booster in Nov2021. Patient was only ill for a week and understand that the Pfizer vaccine was not as strong as the moderna. Patient had Long COVID and do not want to be ill for months like was with the moderna vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: very fast heartbeat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient 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 included: "Celiac disease" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing), notes: diagnosed so around 35 or so; "psoriatic arthritis" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high cholesterol" (ongoing). Concomitant medication(s) included: BABY ASPIRIN (ongoing); CRESTOR taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while, sometime months"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while, sometime months"; Flu vaccine (Dose number unknown, single), for Influenza immunisation. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "very fast heartbeat". The event "very fast heartbeat" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was asking if Paxlovid and Pfizer Covid Vaccine Comirnaty 2023-2024 formula had gluten and wants to know if the facility they had made in was gluten-free. She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes she got very fast heartbeat and lasts for quite a while, sometime months. she had a history of strokes and high cholesterol and psoriatic arthritis. Psoriatic arthritis was diagnosed a couple years after psoriasis diagnoses so around 35 or so. Still taking. Patient called her heart doctor and doctor said if got to 150-160 she would go in. The patient was worried about taking another Covid vaccine because of that reaction and so she wanted to know if the Pfizer vaccine had gluten. Caller stated she took the 1st and 2nd, she did not know year, that was when they came out. Took the 3rd and did not think she did the 4th apparently that was not working for whatever reason.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352135 Same patient/vaccine/event, different dose.;
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Pain in extremity
Clinical narrative: soreness in his arm and chills last night; soreness in his arm and chills last night; 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 77-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "soreness in his arm and chills last night". Additional information: the patient received the RSV vaccine yesterday and wants to know how often he should get it.  He has soreness in his arm and chills last night, but it wasn't too bad.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medications included: HYDROCHLOROTHIAZIDE, start date: 03Feb2022; SERTRALINE. Vaccination history included: Moderna COVID-19 vaccine (dose 6 (booster), single; lot number: 067H22A; site: left arm), administration date: 08Dec2022, when the patient was 69-year-old, for COVID-19 immunization; Moderna COVID-19 vaccine (dose 5 (booster), single; lot number: AS7147B; site: left arm), administration date: 19Sep2022, when the patient was 69-year-old, for COVID-19 immunization; Moderna COVID-19 vaccine (dose 4 (booster), single; lot number: unknown; site: left arm), administration date: 05Apr2022, when the patient was 68-year-old, for COVID-19 immunization; Moderna COVID-19 vaccine (dose 3 (booster), single; lot number: 939904; site: left arm), administration date: 28Oct2021, when the patient was 68-year-old, for COVID-19 immunization; Moderna COVID-19 vaccine (dose 2, single; lot number: 025AZ1A; site: left arm), administration date: 25Feb2021, when the patient was 67-year-old, for COVID-19 immunization; Moderna COVID-19 vaccine (dose 1, single; lot number: 007M20A; site: left arm), administration date: 26Jan2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid 300-100 MG pack from 21Oct2023 to 26Oct2023.  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: 73.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin and other cillins" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE, start date: 01Jul1986; LISINOPRIL, start date: 11Aug2021; PEPCID [FAMOTIDINE], start date: 01Sep2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid (NDC0069-0345-30) from 21Oct2023 to 26Oct2023.  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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: patient experienced the arm pain at the injection site for all of her Pfizer Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 89-year-old female patient received bnt162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6203) at the age of 86 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes diagnosed many years ago; "Hypertension" (ongoing), notes: Hypertension diagnosed many years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "patient experienced the arm pain at the injection site for all of her Pfizer Covid vaccines".  Additional information: The caller's mother experienced arm pain at the injection site after the Pfizer covid vaccines and the patient did not seek medical help and only took Tylenol. The caller has the patient's shot information from 2021. The caller had three covid vaccines and the booster. Both the caller's mother and she both had the same shot on same day but the caller's mother is ok except for arm and body discomfort at the injection site and the caller is not concerned about that. For the injection site pain, reporter states it is unknown for the dosages for those vaccines as the dose is not written down and it was probably 0.1 but she would have to find out. Clarified that the patient and the caller both experienced pain with all of the Pfizer covid vaccines which is normal and the patient's first Pfizer dose was on 07Mar2021 with lot EN6203; the next was on 28Mar2021 with lot that starts with EL926 and the caller can't make out the rest of the information and thinks it says 60 but it is not that legible. States for the patient, the rest of the dates, lots and other vaccine information is not handy but then states the patient had a 3rd Pfizer vaccine on 30Sep2021 and it has lot 30145BA. Due to the caller stated the patient experienced the arm pain at the injection site for all her Pfizer Covid vaccines, the patient's first dose is populated into the formal suspect product field. The reporter and the reporter's mother both had the Pfizer covid vaccine on 16Oct2023 so it is probably the same lot number.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353420 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300353419 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300347242 same reporter/patient/vaccine/event, different dose;
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site discomfort, Vaccination site pain
Clinical narrative: arm and body discomfort at the injection site; arm and body discomfort at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 86-year-old female patient received bnt162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Lot number: EL926) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: diagnosed many years ago; "hypertension" (unspecified if ongoing), notes: diagnosed many years ago. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1,SINGLE, Batch: EN6203), administration date: 07Mar2021, when the patient was 86-year-old, for COVID-19 immunization, reaction(s): "arm and body discomfort at the injection site", "arm and body discomfort at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "arm and body discomfort at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site discomfort.  Additional Information: The caller's mother experienced arm pain at the injection site after the Pfizer covid vaccines and the patient did not seek medical help and only took Tylenol. The caller has the patient's shot information from 2021. The caller had three covid vaccines and the booster. Both the caller's mother and she both had the same shot on same day but the caller's mother is ok except for arm and body discomfort at the injection site and the caller is not concerned about that. For the injection site pain, reporter states it is unknown for the dosages for those vaccines as the dose is not written down and it was probably 0.1 but she would have to find out. Other products were reported as "no". Clarified that the patient and the caller both experienced pain with all of the Pfizer covid vaccines which is normal and the patient's first Pfizer dose was on 07Mar2021 with lot EN6203; the next was on 28Mar2021 with lot that starts with EL926 and the caller can't make out the rest of the information and thinks it says 60 but it is not that legible. The patient experienced the arm pain at the injection site for all her Pfizer Covid vaccines. The patient has been covid negative and has been fine except for that discomfort she thinks at the site and they have been pretty lucky.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353410 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300353420 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300347242 same reporter/patient/vaccine/event, different dose;
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Severe redness and itchy  on upper left arm  from under vaccination site down to elbow  all over top and sides  of arm and pain when moving arm.to full length position.
Age: 20.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Pharyngeal swelling, Pruritus, Rash, Swelling, Swelling face
Clinical narrative: 20 y/o M presents to clinic for swelling and itchiness on face and throat x 20 minutes ago. PT states while playing soccer on the field he drank the field water during a quick break and started feeling slight itchiness and swelling around the throat and numbness in his arms. After game ended the patient drank some more water and the symptoms began to get worse with increase of previous symptoms along with rashes and swelling on his body. PT had food before the game but denies any food allergies and denies any trauma. PT has no further complains or concerns.
Age: 20.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Throat irritation
Clinical narrative: 20 y/o M presents to clinic for swelling and itchiness on face and throat x 20 minutes ago. PT states while playing soccer on the field he drank the field water during a quick break and started feeling slight itchiness and swelling around the throat and numbness in his arms. After game ended the patient drank some more water and the symptoms began to get worse with increase of previous symptoms along with rashes and swelling on his body. PT had food before the game but denies any food allergies and denies any trauma. PT has no further complains or concerns.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was pick up & sent to the Hospice.