chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
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 contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: p220395-0022l), in left arm, on 21Jan2021 as dose 2, single (Lot number: p220395-0022l), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: p220395-0090l), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: fp4554), in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ZYDUS, start date: 01Jun2022, stop date: 28Dec2022; PRINZIDE, start date: 01Jun2022; NORVASC, start date: 01Jun2022; ABILIFY, start date: 01Dec2021, stop date: 28Dec2022; PROTONIX [OMEPRAZOLE], start date: 01Dec2021, stop date: 28Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  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: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".,Linked Report(s) : US-PFIZER INC-202300015921 same patient and suspect vaccine; different dose and event;
Age: 67.0
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) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 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: "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "DDD" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "PCN" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid (anti-viral) for COVID-19 treatment from 05Jan2023 to 09Jan2023. She was taking any other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 65.0
Sex: M
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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: Gj6739) at the age of 65 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: Ep7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: Er8732), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: Ff2593), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: Fm9992), in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2022, outcome "recovered with sequelae" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive; (31Dec2022) Negative; (07Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient tested positive for COVID on 22Dec2022. The patient started 5 day course of Paxlovid. Completed Paxlovid course as directed on 28Dec2022. Symptoms resolved and tested negative on 31Dec2022. Rebound COVID symptoms begin to reappear on 05Jan2023. Symptoms continued to get worse and tested positive for COVID again on 07Jan2023. Treated COVID symptoms with OTC cold flu medicine and slept 18 hours per day. The patient was beginning to feel much better on 11Jan2023.The patient had no known allergies.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy
Clinical narrative: is pregnant: pregnant; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 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. Date of last menstrual period: 01Oct2022. The patient was 9 weeks pregnant at the time of exposure to BNT162b2, BNT162b2 omi ba.4-5. The patient was 10 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 08Jul2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 09Dec2022, outcome "unknown", described as "is pregnant: pregnant"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient has no other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events COVID-19, DRUG INEFFECTIVE and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient 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: Bnt162b2 (He mentioned that he took the first and second shots of the COVID-19 vaccine and has health problems; he has lupus), for COVID-19 Immunization, reaction(s): "Lupus".  The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus".  Clinical course: The caller was tried to schedule an in-home booster shot from Pfizer for him and for his fiancé. He mentioned that he took the first and second shots of the COVID-19 vaccine and has health problems; he has lupus. No, medical inquiry was not forwarded.  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-PV202300006935 same patient, same event, different dose of vaccine;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: memory loss; fog; administration date: 09Jul2021, dose number: 2/prev dose administration date: 03May2021, prev dose dose number: 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2021 as dose 2, single (Lot number: Ew0196) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "known allergies: Seafood" (unspecified if ongoing), notes: known allergies: Seafood; "known allergies: tomato" (unspecified if ongoing), notes: known allergies: tomato. There were no concomitant medications. Past drug history included: Reglan, reaction(s): "known allergies: regland", notes: known allergies: regland. Vaccination history included: BNT162b2 (Dose lot number: Ew017, Dose number: 1, Vaccine location: Left arm), administration date: 03May2021, when the patient was 27-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Jul2021, outcome "unknown", described as "administration date: 09Jul2021, dose number: 2/prev dose administration date: 03May2021, prev dose dose number: 1"; FEELING ABNORMAL (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fog"; AMNESIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "memory loss". Therapeutic measures were not taken as a result of amnesia, feeling abnormal.  Additional information: Prior to the vaccine, patient a sharp memory. Since the vaccine she has been experiencing memory loss and fog. Patient did not take other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 1, single (Batch/Lot number: unknown), in left arm and on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) 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 26Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "known allergies Macrobid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received nirmatrelvir, ritonavir (PAXLOVID) as COVID 19 treatment from 28Dec2022 to 02Jan2023.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a 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 13Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported as patient took treatment for Covid-19 with Paxlovid from 02Jan2023 to 06Jan2023. Vaccine lot was unknown as it was Misplaced/discarded. It was reported as No known allergies.  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: 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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: gh9694) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: tl9262), in left arm, on 18Feb2021 as dose 2, single (Lot number: en6200), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301308), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: fj4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure; "heart disease" (unspecified if ongoing), notes: Other medical history: heart disease. The patient's concomitant medications were not reported. Past drug history included: Opioids, reaction(s): "Known allergies: most opioids", notes: Known allergies: most opioids.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 51.0
Sex: M
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). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid (anti-viral) for COVID-19 treatment from 03Jan2023 to 07Jan2023.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19/positive at-home test for COVID-19; COVID-19/positive at-home test for COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). 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 23Nov2022 as dose 4 (booster), single (batch/lot number: GH693) at the age of 42 years intramuscular, in left arm for covid-19 immunization; BNT162b2 (COMIRNATY), on 26Jan2021 as dose 1, single (batch/lot number: EL3247), in left arm, on 16Feb2021 as dose 2, single (batch/lot number: EL3247), in left arm and on 09Sep2021 as dose 3 (booster), single (batch/lot number: EW0217), in left arm, all intramuscular for covid-19 immunization. The patient's relevant medical history included: "polycystic ovarian syndrome" (unspecified if ongoing). Concomitant medication included: FLU VACCINE VII taken for immunization, on 21Nov2022 as dose 1, single; METFORMIN; SPIRONOLACTONE; JUNEL; LEXAPRO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2023 at 06:00, outcome "recovering" and all described as "COVID-19/positive at-home test for COVID-19". The patient underwent the following laboratory tests and procedures: microflex: (11Jan2023) positive, notes: nasal swab/at-home test for COVID. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient informed that the adverse event (COVID-19) started on 10Jan2023 at 06:00 AM and was positive at-home test for COVID-19 on 11Jan2023.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 17:45 as dose 4 (booster), single (Lot number: GJ3275) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen; Methotrexate, reaction(s): "Known allergies: Methotrexate", notes: Known allergies: Methotrexate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: I originally started testing negative on day 8-11; Negative, notes: I originally started testing negative on day 8-11; Negative, notes: I originally started testing negative on day 8-11; Negative, notes: I originally started testing negative on day 8-11; Positive, notes: Tested on day 13 from original positive test and tested Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral Paxlovid for COVID 19 Treatment from 29Dec2022 to 03Jan2023.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient. A 33-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 (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: FL3198), in left arm for covid-19 immunisation. The patient's relevant medical history included: "historic pnemonia and plural effusion", start date: 2017 (unspecified if ongoing), notes: Other medical history: historic pnemonia and plural effusion (2017); "historic pnemonia and plural effusion", start date: 2017 (unspecified if ongoing), notes: Other medical history: historic pnemonia and plural effusion (2017). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: continuing to test positive for COVID with at home tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 02Jan2023 to 06Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Positive test 4 days after negative test with recurrence of symptoms; Positive, notes: Positive test 4 days after negative test with recurrence of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment received as Paxlovid from 03Jan2023 to 08Jan2023. Positive test 4 days after negative test with recurrence of symptoms.   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: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 20.0
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 vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 20 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm 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 Nov2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
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) (Consumer or other non HCP).  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of colon cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: mild chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (BNT162B2), on 26Mar2021 at 10:00 as dose 1, single (Lot number: ER8732) at the age of 49 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 11Apr2021, outcome "unknown", described as "mild chest pain".  Additional information: The patient received first dose on 26Mar2021. Went on a vacation to Withheld 05Apr2021 to 11Apr2021. Began feeling mild chest pain on 11Apr2021 on drive to airport. Pain progressively worsened.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200708649 same patient and drug, different dose and event;US-PFIZER INC-202300013382 same patient and drug, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle discomfort
Clinical narrative: Caller is having a problem with her arms and muscles after receiving the COVID-19 vaccine last 2021; Caller is having a problem with her arms and muscles after receiving the COVID-19 vaccine last 2021; 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), in 2021 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: MUSCLE DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "Caller is having a problem with her arms and muscles after receiving the COVID-19 vaccine last 2021".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster".  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: Systemic lupus erythematosus
Clinical narrative: Lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus".  Clinical course: The caller is trying to schedule an in-home booster shot from Pfizer for him and for his fiance. He mentioned that he took the first and second shots of the COVID-19 vaccine and has health problems; he has lupus. Gathered caller's concern/inquiry, Gathered callers Demographics (Unable to verify the name of the caller's name since were not allowed to spell out their name back), Privacy statement Provided, Provided FAQ response can you assist with scheduling my vaccine appointment, After referring to the local health department caller hung up. The caller has health issues, has lupus, and got the first and second shots of the COVID-19 vaccine. Medical inquiry was not forwarded.  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-202300015124 same patient, same event, different dose of vaccine;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had both shots and boosters and got Covid and passed away; had both shots and boosters and got Covid and passed away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "had both shots and boosters and got Covid and passed away". The patient date of death was unknown. Reported cause of death: "had both shots and boosters and got Covid and passed away". It was not reported if an autopsy was performed.  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.; Reported Cause(s) of Death: had both shots and boosters and got Covid and passed away; had both shots and boosters and got Covid and passed away
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.  This case involves a male patient of unknown age who had flu after receiving influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date in Nov-2022, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date - not reported) via unknown route in unknown administration site for influenza immunization.  On 01-Jan-2023, the patient had flu (influenza) (latency: 2 months approximately) following the administration of influenza vaccine.  Reportedly, My wife and I took the flu shot, nov 2022..caught the flu jan. 1st...still trying to get rid of it.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: caught the flu; Initial information received on 09-Jan-2023 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age female patient who caught the flu after receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date in Nov-2022, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 01-Jan-2023 the patient developed a non-serious caught the flu (influenza) (approximately 2 months latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Not Recovered / Not Resolved for the event caught the flu.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 10-Jan-2023 regarding an unsolicited valid Social Media serious case received  via consumer/non-hcp.  This case involves adult female patient who was diagnosed with flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a serious flu (influenza) (unknown latency) following the administration of influenza vaccine.   The patient was hospitalized for this event.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown; Sender's Comments: Sanofi Company Comment dated 13-Jan-2023: This case involves adult female patient who was diagnosed with flu after receiving vaccine influenza vaccine. The patient was hospitalized for this event. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, therapy details, any family history and any relevant medical history any concurrent conditions precludes comprehensive case assessment.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product formulation administered, Medication error, No adverse event, Product preparation error
Clinical narrative: powdered portion was mixed with a sterile water diluent rather than the DTap-IPV component with no adverse event; powdered portion was mixed with a sterile water diluent rather than the DTap-IPV component with no adverse event; Initial information received on 10-Jan-2023 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender and reporter reported powdered portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was mixed with a sterile water diluent rather than the dtap-ipv component with no adverse event.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, lot number and expiry date) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date, reporter reported powdered portion Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was mixed with a sterile water diluent rather than the dtap-ipv component with no adverse event (product preparation error) (incorrect product formulation administered).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  It was reported I have replied to customer asking for lot, date of incident, and age of patient. No response at this time. I also directed them to call Medical Affairs. Copied original email from customer below #79934474 "Good afternoon , Last week we had a med error occur with a VFC provided Pentacel. I need to know whether Hib was effectively reconstituted or should be considered invalid. The parent has been notified by the NP of our error. I realize this is a VFC immunization rather than private stock, which removes this from your realm of responsibility. Was the company suspect product inappropriately used as per local Marketing authorization: Unknown    Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick after the flu shot and have been sick for a month now; Initial information received on 10-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.  This case involves a patient of unknown age and gender who got sick after the flu shot and have been sick for a month now after receiving influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date - not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient got sick after the flu shot and have been sick for a month now (illness) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events   Reportedly,  It's funny I got sick after the flu shot and have been sick for a month now I will never get another flu shot.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient was administered only the HIB portion of the pentacel vaccine and used sterile water to dilute the HIB portion of the vaccine with no adverse event; Initial information received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient who was administered only the hib portion of the pentacel vaccine and used sterile water to dilute the hib portion of the vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) for Prophylactic vaccination; INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Prophylactic vaccination; MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 04-Jan-2023, the patient received 0.5 ml (once) dose 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ666AAA, expiry date: 04-Jan-2023)  via intramuscular route in the left thigh as prophylactic vaccination.   On 04-Jan-2023 (latency: same day) the patient was administered only the hib portion of the pentacel vaccine and used sterile water to dilute the hib portion of the vaccine with no adverse event (product preparation error)  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUC3
Symptoms: Cough, Influenza, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: Influenza A disease (verified by nasal swab); Influenza A disease (verified by nasal swab) / Lack of efficacy; This spontaneous case was received on 08-Jan-2023 from other healthcare professional (consumer) (reference number: SEQW23-00109) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.   On 15-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) for prevention of influenza disease. The batch number reported was 942370 and expiry date was 23-May-2023.   On 01-Jan-2023, in the late afternoon, one month and 17 days after receiving Flucelvax Quadrivalent, the patient experienced cough and slight fever.   On an unspecified date in Jan-2023, the patient underwent nasal swab that verified influenza A disease (explicitly coded as 'Vaccination failure'). The source of the infection was most likely the patient's roommate.   On 04-Jan-2023, in the late afternoon, the patient's fever disappeared.  The outcome of event 'influenza A virus infection' was unknown.  The reporter did not provide causality assessment.  The events of 'influenza A virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department  Company comment: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. One month and 17 days after vaccination, the patient experienced cough and slight fever. The patient underwent nasal swab that verified influenza A disease (explicitly coded as 'Vaccination failure'). Causal role of the suspect vaccine is assessed as possibly related for the events Influenza and vaccination failure, due to plausible temporal relationship.; Sender's Comments: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. One month and 17 days after vaccination, the patient experienced cough and slight fever. The patient underwent nasal swab that verified influenza A disease (explicitly coded as 'Vaccination failure'). Causal role of the suspect vaccine is assessed as possibly related for the events Influenza and vaccination failure, due to plausible temporal relationship.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood test, Catheterisation cardiac, Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: Heart attack.   1 stent inserted during cardiac cath
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dysarthria, Facial paralysis, Ischaemic stroke
Clinical narrative: Had a stroke Saturday morning- Oct. 22nd 2022  Ischemic Stroke on the left side.  It effected his right side of his face.  He has slurred speech and his face was drooping down.  He was unsure what time it happened but he felt it was when he was sleeping.  Took him to the ER around 10am.   He was admitted for a stroke.  Discharged from the hospital - Monday - 24th   Local Hospital
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Neurological examination
Clinical narrative: Had a stroke Saturday morning- Oct. 22nd 2022  Ischemic Stroke on the left side.  It effected his right side of his face.  He has slurred speech and his face was drooping down.  He was unsure what time it happened but he felt it was when he was sleeping.  Took him to the ER around 10am.   He was admitted for a stroke.  Discharged from the hospital - Monday - 24th   Local Hospital
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Neuropathy peripheral, Paraesthesia
Clinical narrative: Peripheral Neuropathy.  No history of diabetes or cancer treatment chemotherapy that would cause this.