chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm 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 had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (unspecified date) negative, notes: Tested positive again for covid after 2 negative tests; (unspecified date) negative, notes: Tested positive again for covid after 2 negative tests; (27Jan2023) positive, notes: Tested positive again for covid after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 23Jan2023 to 27Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Sep2022 as dose 4 (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), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had several negative rapid tests after the Paxlovid course was completed; Positive, notes: followed by a new positive test 7 days after completion of treatment. 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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), 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. COVID 19 Treatment with paxlovid from 21Jan2023 to 25Jan2023, received other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
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; Moderna, Date: 27Feb2022, Dose Number: 4 / Pfizer, Date: 24Aug2021, Dose Number: 3; 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 77-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9265), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 24Aug2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2022 as dose 4 (booster), single (Lot number: 026121B), in right arm and on 08Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer (in remission)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iv iodine, reaction(s): "Known allergies: IV iodine"; Clindamycin, reaction(s): "Known allergies: Clindamycin"; Zantac, reaction(s): "Known allergies: Zantac"; Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Feb2022, outcome "not recovered", described as "Moderna, Date: 27Feb2022, Dose Number: 4 / Pfizer, Date: 24Aug2021, Dose Number: 3"; 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, notes: Treatment of COVID-19; Positive, notes: My COVID antigen test became positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rapid Test Nasal Swab Positive; Rapid Test Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: FF2153) at the age of 37 years, in left arm and on 30Oct2021 as dose 2, single (Lot number: FJ1618) at the age of 37 years, in left arm for covid-19 immunisation. Facility type vaccine other: Vaccination Center. The patient's relevant medical history included: "Known allergies: Cherries" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: Dust mites" (unspecified if ongoing). There were no concomitant medications (patient had no other medication in two weeks). The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Rapid Test Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047485 same patient, different dose/drug/event;US-PFIZER INC-202300047486 same patient, different dose/drug/event;
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Rash, Ultrasound scan
Clinical narrative: Rapid Test Nasal Swab Positive; Rapid Test Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: FF2153) at the age of 37 years, in left arm and on 30Oct2021 as dose 2, single (Lot number: FJ1618) at the age of 37 years, in left arm for covid-19 immunisation. Facility type vaccine other: Vaccination Center. The patient's relevant medical history included: "Known allergies: Cherries" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: Dust mites" (unspecified if ongoing). There were no concomitant medications (patient had no other medication in two weeks). The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Rapid Test Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047485 same patient, different dose/drug/event;US-PFIZER INC-202300047486 same patient, different dose/drug/event;
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Pruritus
Clinical narrative: Caller states he has a history of eczema and this itching is interfering with his daily life; primary series vaccine a year ago and has been itching more than a year.; 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 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "Caller states he has a history of eczema and this itching is interfering with his daily life"; PRURITUS (non-serious), outcome "unknown", described as "primary series vaccine a year ago and has been itching more than a year.". Additional information: Pfizer-BioNTech COVID-19 Vaccine reported as Gray cap. Caller is asking if there is any Information about how to stop his itching. Caller states he has a history of eczema and this itching is interfering with his daily life. He states he received his primary series vaccine a year ago and has been itching more than a year. Localized to "my arms and under my calves."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
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; 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.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 21Aug2021 as dose 3 (booster), single (Lot number: fd8448) and on 22Jul2022 at 13:00 as dose 4 (booster), single (Lot number: fj4991) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Dec2022 at 13:00 as dose 5 (booster), single (Lot number: a57167b), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (ASTRAZENECA COVID-19 VACCINE), on 05Nov2020 at 11:00 as dose 1, single (Lot number: a03324) and on 03Dec2020 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "known allergies sulfa" (unspecified if ongoing), notes: known allergies sulfa. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2021, stop date: 16Jan2023; OMEPRAZOLE, start date: Jan2022; METOPROLOL TARTRATE, start date: Jan2020; CELECOXIB, start date: 16Nov2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2018. Past drug history included: Avelox, reaction(s): "known allergies avelox". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Aug2021, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive 15 days; Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 17Jan2023 to 21Jan2023 for treatment of COVID-19.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 5; Moderna, Dose Number: 4; 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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 042L20A), in right arm, on 18Feb2021 as dose 2, single (Lot number: 015M20A), in right arm, on 17Nov2021 as dose 3 (booster), single (Lot number: 013F21A), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: 046L21A), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "High blood pressure, controlled" (unspecified if ongoing), notes: High blood pressure, controlled; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: LISINOPRIL/HYDROCHLOORTHIAZIDE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 5; Moderna, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Positive 3 days after 2nd negative test; Negative, notes: Tested Positive 3 days after 2nd negative test. Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Age: 65.0
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 non-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 22Oct2022 as dose 5 (booster), single (Lot number: Cj6665) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 23Dec2022 to 27Dec2022 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 28 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: "pre-diabetic" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: dust mites" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Gardasil vaccine, reaction(s): "known allergies: Gardasil vaccine". 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 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Suspected COVID-19
Clinical narrative: Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; 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 45-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318) and on 21Apr2021 as dose 2, single (Lot number: EW0169) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma When 4-years-old.; "had her gallbladder out" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "had issues with her pancreas" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "Tested positive for COVID-19", start date: 01Feb2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 25Apr2021, outcome "unknown" and all described as "Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021". The events "got her second dose of covid-19 vaccine and was diagnosed with covid-19 a second time 25apr2021" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19: (01Feb2021) Positive, notes: Tested positive for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047499 same patient. different dose number/event;US-PFIZER INC-202300050587 same patient/drug, different dose number/event;
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Blood test, Body temperature, COVID-19, Illness
Clinical narrative: Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; 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 45-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318) and on 21Apr2021 as dose 2, single (Lot number: EW0169) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma When 4-years-old.; "had her gallbladder out" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "had issues with her pancreas" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "Tested positive for COVID-19", start date: 01Feb2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 25Apr2021, outcome "unknown" and all described as "Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021". The events "got her second dose of covid-19 vaccine and was diagnosed with covid-19 a second time 25apr2021" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19: (01Feb2021) Positive, notes: Tested positive for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047499 same patient. different dose number/event;US-PFIZER INC-202300050587 same patient/drug, different dose number/event;
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Influenza, Investigation, Pain, Pancreatic disorder
Clinical narrative: Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; 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 45-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318) and on 21Apr2021 as dose 2, single (Lot number: EW0169) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma When 4-years-old.; "had her gallbladder out" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "had issues with her pancreas" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "Tested positive for COVID-19", start date: 01Feb2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 25Apr2021, outcome "unknown" and all described as "Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021". The events "got her second dose of covid-19 vaccine and was diagnosed with covid-19 a second time 25apr2021" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19: (01Feb2021) Positive, notes: Tested positive for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047499 same patient. different dose number/event;US-PFIZER INC-202300050587 same patient/drug, different dose number/event;
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rheumatoid factor, Synovial cyst, Weight increased
Clinical narrative: Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021; 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 45-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318) and on 21Apr2021 as dose 2, single (Lot number: EW0169) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma When 4-years-old.; "had her gallbladder out" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "had issues with her pancreas" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "Tested positive for COVID-19", start date: 01Feb2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 25Apr2021, outcome "unknown" and all described as "Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021". The events "got her second dose of covid-19 vaccine and was diagnosed with covid-19 a second time 25apr2021" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19: (01Feb2021) Positive, notes: Tested positive for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047499 same patient. different dose number/event;US-PFIZER INC-202300050587 same patient/drug, different dose number/event;
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for Covid-19 after vaccination.; Tested Positive for Covid-19 after vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EN6207), in left arm, on 16Jun2021 as dose 2, single (Lot number: EN6207), in left arm and on 09Jun2022 as dose 3 (booster), single (Lot number: FN2908) at the age of 15 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Jan2023 at 07:00, outcome "recovering" and all described as "Tested Positive for Covid-19 after vaccination.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2023) Positive, notes: nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient has no covid prior vaccination and no other vaccine in four weeks. The patient has no known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Joint stiffness, Muscular weakness
Clinical narrative: stiffening of the joints; soreness in the hips and other Lower joints/ soreness in my upper back & shoulders; soreness in my upper back & shoulders; I cannot make a fist both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization.  The following information was reported: JOINT STIFFNESS (non-serious), outcome "unknown", described as "stiffening of the joints"; ARTHRALGIA (non-serious), outcome "unknown", described as "soreness in the hips and other Lower joints/ soreness in my upper back & shoulders"; BACK PAIN (non-serious), outcome "unknown", described as "soreness in my upper back & shoulders"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "I cannot make a fist both hands". The events "stiffening of the joints", "soreness in the hips and other lower joints/ soreness in my upper back & shoulders", "soreness in my upper back & shoulders" and "i cannot make a fist both hands" required physician office visit. Therapeutic measures were taken as a result of joint stiffness, arthralgia, back pain, muscular weakness.  Additional information: Two- three days after patient received the booster shot, patient started having feelings of stiffening of the joints, soreness in the hips and other Lower joints. Now, when year later, patient have stiffness in joints, soreness in upper back & shoulders and patient cannot make a fist both hands. doctor prescribed prednisone in an anti-inflammatory, patient looking for a cure & back to the good health patient had before the vaccine. Any suggested assistance for relief would be appreciated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Despite all the vaccine and boosters, we did finally catch it; Despite all the vaccine and boosters, we did finally catch it; 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 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 (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Despite all the vaccine and boosters, we did finally catch it". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid. The symptoms were mild.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Despite all the vaccine and boosters, we did finally catch it; Despite all the vaccine and boosters, we did finally catch it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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 included: "Parkinsons" (unspecified if ongoing), notes: perhaps 12 years now. 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 "Despite all the vaccine and boosters, we did finally catch it". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-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; 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 (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "recovered" and all described as "Covid-19". The event "covid-19" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient went to doctor and was given 5 days 6 pills a day of Paxlovid from 20Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: still got sick; still got sick; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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; 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 had serious health issues. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2023, outcome "unknown" and all described as "still got sick". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 17Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown".  Additional information: Reported as, AE 24 hours after the bivalent booster. Symptoms of chills and fatigue. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: we all get infected with a severe symptoms; we all get infected with a severe symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "we all get infected with a severe symptoms".  Additional Information: reporter stated that, have three children: 17-year-old son vaccinated. 15-year-old daughter vaccinated. 13-year-old son not vaccinated. For the second winter after got the vaccine we all get infected with a severe symptom but the non-vaccinated son. If you care about your business (let alone your families if you have any) then you may not neglect my message. I'm sure it was not a unique one. Forwarded, no medical inquiry asked.  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: Hip arthroplasty
Clinical narrative: hip replacement; 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), on 05Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Time (24 hr): 2 P.M, Anatomical site of injection: Left arm, Batch/Lot number: EN6198), administration date: 26Feb2021, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 1, SINGLE, Time (24 hr): 7 P.M, Anatomical site of injection: Left arm, Batch/Lot number: EL9262), administration date: 01Feb2021, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 23Feb2022, outcome "unknown", described as "hip replacement".  Clinical Course: Drug lot number and expiration date: Do not have I was given the' 'Renal''-friendly dosage. Patient age at time of vaccination: 71-years-old.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300004786 Same reporter/patient, different vaccine dose number/AE;
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Herpes zoster
Clinical narrative: His eye is in horrendous shape; Got shingles right away; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "His eye is in horrendous shape"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Got shingles right away".  Additional information: Caller was calling because Pfizer research doing was absolutely horrendous and they're thinking. She also mentioned that her husband got a covid shot and got shingles right away and now his eye is in horrendous shape. She was told by pharmacist that a lot of people had had shingles after the covid shot and his husband was om bad shape.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 30-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.   This case involves an unknown age female patient who had sore arm after receiving Influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   Concomitant medications included Covid-19 vaccine for Prophylactic vaccination.   On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (with unknown formulation, strength, route, lot number, expiration and at unknown administration site) for prophylactic vaccination (immunization).   On an unknown date, the patient had sore arm (pain in extremity) (unknown latency) following the administration of Influenza vaccine.   It was also reported that Got me my husband and grandson that lived with us got our flu shot in October me my grandson got two covid one booster and fixtung to get our updated one he got his at Pharmacy the Phyfer I got my two covds at health center and my booster at another Pharmacy.   No lab data were reported.   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.; Sender's Comments:  SanofiPVPortal20230131000336: SanofiPVPortal20230131000326:
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 30-Jan-2023 regarding an unsolicited valid social media non-serious case received from a Non-Healthcare Professional.  This case involves an unknown age male patient who experienced sore arm 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 (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, got me my husband and grandson that lived with us got our flu shot in October me my grandson got two covd one (COVID-19 VACCINE; concomitant) booster and fixtung to get our updated one, we didn't have one side affect from all of them, no fever.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sore arm).  At time of reporting, the outcome was Unknown for the event sore arm.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: got the flu shot and still got the flu; was sick for 3 weeks; Initial information was received on 31-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Adult and unknown gender patient who stated got the flu shot and still got the flu and was sick for 3 weeks after receiving influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of events got the flu shot and still got the flu (influenza) and was sick for 3 weeks (illness) (unknown latency) following the administration of influenza vaccine.  It is 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 events.  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the FLU; Initial information received on 30-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves patient of unknown age and demographics who experienced i got the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) 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, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event i got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the FLU).  At time of reporting, the outcome was Unknown for the event i got the flu.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error, Product storage error
Clinical narrative: using an alternate diluent from an MMR vaccine that had been kept at room temperature with no reported adverse event; using an alternate diluent from an MMR vaccine with no reported adverse event; Initial information received on 30-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient who received HIB (PRP/T) Vaccine [ACT-HIB] using an alternate diluent from an mmr vaccine that had been kept at room temperature with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine]) for Prophylactic vaccination.  On 27-Jan-2023, the patient received a dose of 0.5 ml Total dose 1 of suspect HIB (PRP/T) Vaccine using an alternate diluent from an mmr vaccine that had been kept at room temperature with no reported adverse event (product storage error), (product preparation error) Powder and solvent for solution for injection: form (lot: UJ679AAA) via intramuscular route in the left thigh for immunization with expiry date: 07-Apr-2023 with unknown strength.  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.