chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Past lot that had also been expired that was administered to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients).    Patient age was reported as 71 year 5 months.  No concomitant medication was provided.  NDC ID number was reported as 80777027398.   It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022).    No Concomitant medications were provided.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller reported that beyond use date was on 12 Dec 2022 but they discovered it on 17 Dec 2022 and 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2022: Live Follow-up received included suspect product information batch/lot number, patient information and narrative comments.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got a Covid really made me sick; got a Covid really made me sick; The initial case was missing the following minimum criteria: reporter. Upon receipt of follow-up information on 16Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 "got a Covid really made me sick".  Additional information: Patient recently got booster about 3 weeks ago, they take patient out for about 3 or 4 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years 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: "Anxiety" (unspecified if ongoing); "Known allergies: Allergic to walnuts" (unspecified if ongoing), notes: Known allergies: Allergic to walnuts; "Known allergies: Allergic to pecans" (unspecified if ongoing), notes: Known allergies: Allergic to pecans. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) positive, notes: COVID 19 Treatment I retested positive; (13Dec2022) positive, notes: I retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Gestational period was provided as 22. Other medication in 2weeks: No. The patient received Paxlovid treatment from 06Dec2022 to 10Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, in left 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. There were no concomitant medications. The following information was reported: 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: (unspecified date) Positive, notes: Treatment of COVID-19; (05Dec2022) Negative, notes: negative test; (13Dec2022) Positive, notes: positive Covid test on day 15. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: vaccine received and no other medication in 2weeks. Paxlovid rebound, positive Covid test on day 15 after starting Paxlovid, and 8 days after first negative test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 contactable reporter (Other HCP). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing), notes: Other medical history: High bp; "thyroid" (unspecified if ongoing), notes: Other medical history: thyroid; "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; LEVOTHYROXINE; LIOTHYRONINE; IRBESARTAN; VITAMIN E [TOCOPHEROL]; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19.  Therapeutic measures were taken as a result of drug ineffective, covid-19 includes 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.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (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), 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: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Negative, notes: good improvement with paxlovid and negative test 08Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received paxlovid for COVID 19 treatment on 04Dec2022. Other medication in 2weeks was Yes.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL3249), in right arm and on 10Feb2021 as dose 2, single (Lot number: EM9810) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: .; "Coronary artery disease." (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Aug2019; METOPROLOL, start date: 01Aug2019; PROTONIX [OMEPRAZOLE]; ATORVASTATIN; ESCITALOPRAM; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had other medication in 2weeks. The patient had COVID 19 Treatment with paxlovid, Treatment start date was 13Dec2022, Treatment start date was 15Dec2022. The patient had no known allergies. No known allergies.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Pfizer / BioNTech  Dose Number 5 / Moderna Dose Number 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jun2022 at 16:00 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's relevant medical history included: "High blood pressure, treated" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; FAMOTIDINE; ASPRIN; LOSARTIN; BENZONATATE; CETIRIZINE; VITAMIN B12 [VITAMIN B12 NOS]; MONTELUKAST; MELATONIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech  Dose Number 5 / Moderna Dose Number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine Lot Unknown Reason was unable To Locate Or Read The Details. Patient had no Known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 08Oct2021 as dose 2, single (Batch/Lot number: unknown) and on 10Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "allergic asthma since childhood" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2021, stop date: Dec2022. The following information was reported: 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: Negative, notes: Was testing negative for 4 days then sick and testing positive again; Positive, notes: Was testing negative for 4 days then sick and testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 02Dec2022 to 07Dec2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9266), in right arm, on 08Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FF8841), in right arm and on 09Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN; ESCITALOPRAM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  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 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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), 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". 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 course: There were no other medication in 2weeks. Vaccine lot unknown reason was misplaced/discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number:4; Pfizer, 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 as dose 2, single (Lot number: EIV62508), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 065K21A), 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 07Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 13Mar2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Moderna, Dose Number:4; Pfizer, Dose Number 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid start date: 07Dec2022, stop date: 11Dec2022 for COVID 19 treatment. Patient received other medication in 2 weeks product: Lisinopril and start date was 13Mar2018. Patient had no known allergies. Had Paxlovid after getting Covid; rebound infection quite harsh.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2020 as dose 1, single (Batch/Lot number: unknown), in 2020 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in 2022.  Patient has had 4 total Covid-19 shots and had a flu shot about 4 weeks ago. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2022, outcome "unknown" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Positive, notes: Unit: Not Provided. Home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201378688 same reporter/patient/drug, different doses/AE;
Age: 45.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: No. Treatment for covid-19 started on 09Dec2022, stop date: Dec2022. No known allergies. Other medical history: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19-2
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) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose 1, single (Lot number: EN6206), in left arm, on 30Mar2021 at 12:00 as dose 2, single (Lot number: ER8727), in left arm, on 29Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FP4554), in left arm and on 15Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 03Dec2022 to 07Dec2022.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: Gtt9695) 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: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Product: COVID 19 Treatment; Brand: Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 29Nov2022, Treatment stop date: 05Dec2022, Lot number: Ge3010).
Age: 57.0
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 contactable reporter(s) (Pharmacist). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Sleep apnea" (unspecified if ongoing); "Prostatic hypertrophy" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin"; Diclofenac, reaction(s): "Known allergies: Diclofenac". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 06Dec2022 to 10Dec2022; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events,Linked Report(s) : US-PFIZER INC-202201378557 Same patient, different product and event;
Age: 53.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: OMEPRAZOLE; TYLENOL. The following information was reported: 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: (unspecified date) positive, notes: Treatment of COVID-19; (unspecified date) negative, notes: Day 10 Had negative test on day 8; (15Dec2022) positive, notes: positive test 4 days after  stopping Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Therapeutic measures for covid 19 included anti-viral Paxlovid from 07Dec2022 to 11Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment with Paxlovid from 07Dec2022 to 12Dec2022; COVID-19 Treatment with Paxlovid from 07Dec2022 to 12Dec2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 08:00 as dose 1, single (Lot number: E6202), in right arm, on 26Mar2021 at 14:00 as dose 2, single (Lot number: FR8727), in left arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 20May2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Exercise-induced asthma" (unspecified if ongoing); "coronary disease" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). The patient has no known allergies.The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment with Paxlovid from 07Dec2022 to 12Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Dec2022) Positive, notes: positive test 3 days after finishing Paxlovid medication. Therapeutic measures were taken as a result of covid-19, vaccination failure including 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm, Weight
Clinical narrative: aortic aneurysms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8734) at the age of 56 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing). The following information was reported: AORTIC ANEURYSM (medically significant), outcome "not recovered", described as "aortic aneurysms". The patient underwent the following laboratory tests and procedures: Weight: About 130 pounds. Therapeutic measures were taken as a result of aortic aneurysm.  Clinical information: It was reported that patient had aortic aneurysms after getting the 3 Pfizer covid-19 vaccine. She is looking for more information and if there is a correlation between them. It was reported that patient Going to have to have open heart surgery, confirmed has not had open heart surgery yet. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). caller asked if a clinical trial going on to see if there is a correlation for the aortic aneurysm and vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm, Weight
Clinical narrative: aortic aneurysms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 2, single (Lot number: EW0172) at the age of 56 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: ER8734, Time: Unknown, in afternoon sometime, Anatomical Site of injection: In arm via intramuscular route), administration date: 06Apr2021, when the patient was 56-year-old, for COVID-19 Immunization, reaction(s): "Aortic aneurysm". The following information was reported: AORTIC ANEURYSM (medically significant) with onset 18Oct2022, outcome "not recovered", described as "aortic aneurysms". The patient underwent the following laboratory tests and procedures: Weight: About 130 pounds. Therapeutic measures were taken as a result of aortic aneurysm.  Clinical course: Patient reported, she had aortic aneurysms after getting the 3 Pfizer covid-19 vaccine. She was looking for more information if we know anything about this and if there was a correlation between them. Additional Information for Other medicines Levothyroxine: Manufacturer: AbbVie Start date: Years ago. Transfer agent has a patient on the other line calling reporting that caller had an aortic aneurysm after getting 3 of the Pfizer COVID-19 vaccines. Caller asked about the correlation between an aortic aneurysm and the vaccine, transfer agent told caller that Pfizer had no information to provide in regards to that. Going to have to have open heart surgery, confirmed has not had open heart surgery yet. Feels caller was giving a lot of confidential information, wants to make sure this information is kept confidential. Takes medication for caller's thyroid. Clarified, takes Levothyroxine for thyroid. Received 2nd dose in afternoon sometime. No Prior Vaccinations (within 4 weeks). The event require the initiation of new medication/other treatment/ procedure and going to have to have open heart surgery, confirmed has not had open heart surgery yet.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm
Clinical narrative: aortic aneurysms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 56 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing). Vaccination history included: BNT162b2 (1st dose: Date: 06Apr2021 NDC number, lot number, expiration date: Lot number ER8734.), administration date: 06Apr2021, when the patient was 56-year-old, for Covid-19 immunization, reaction(s): "aortic aneurysms"; BNT162b2 (2nd dose: Date: 27Apr2021 NDC number, lot number, expiration date: EW0172), administration date: 27Apr2021, when the patient was 56-year-old, for Covid-19 immunization, reaction(s): "aortic aneurysms". The following information was reported: AORTIC ANEURYSM (medically significant) with onset 18Oct2022, outcome "unknown", described as "aortic aneurysms". Therapeutic measures were taken as a result of aortic aneurysm.  Clinical course: It was reported by the patient that she had aortic aneurysms after getting the 3 Pfizer covid-19 vaccine. She was looking for more information if we know anything about this and if there was a correlation between them. Caller noted that if google searched the reports of aortic aneurysms are available, and that they're also doing a clinical trial about this. Start date of adverse event was initially stated maybe 18Oct2022, then caller clarified caller was not sure, not a medical professional, does not know what day aortic aneurysm started. The reporter also stated that going to have to have open heart surgery, confirmed has not had open heart surgery yet. The event requires the initiation of new medication/other treatment/ procedure was provided as yes. Vaccination facility type was pharmacy. Vaccine was not administered at Military Facility. No prior Vaccinations within 4 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201380747 Same reporter, same patient/AE and  different dose;US-PFIZER INC-202201380791 Same reporter, same patient/AE and  different dose;
Age: 64.0
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) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 64 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 05Dec2022 to 09Dec2022, for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID; On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Lot number: GJ6737) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2012 (unspecified if ongoing), notes: Consumer stated, I do not know, 10 years ago; "Heart problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID; (07Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  On 30Nov2022, the patient accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time he contracted COVID. Will that virus negate the bivalent booster (Event and Suspect captured conservatively as per verbatim), or the booster just was not, did not have enough time to grab a hold off and benefit him and then Paxlovid, he did not know, was it the symptom or a side effect but while he was taking the 3 in the morning, 3 in the evening for 5 days, he felt my facial cheeks were hot and my eyes were slightly burning and since Monday, which is the last day of the dosage, the dose imaginings or symptom have vanished. Consumer stated, The COVID Booster, the Bivalent. He just wanted to know was 30Nov2022 not enough time for the vaccine (As further clarification were not available over the call hence suspect captured as Unspecified Vaccine) to help him, since he had contracted COVID.
Age: 31.0
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; Dose #3: Johnson and Johnson / Dose #2: Pfizer / Dose #1: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 01Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 01May2022 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01May2022, outcome "unknown", described as "Dose #3: Johnson and Johnson / Dose #2: Pfizer / Dose #1: Pfizer"; 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: (unspecified date) Positive, notes: Treatment of COVID-19; (03Feb2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (01Dec2022) Negative, notes: Tested negative after exposure through 01Dec2022; (02Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (04Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (05Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (06Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (07Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (08Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (09Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (10Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (11Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (12Dec2022) Positive; (14Dec2022) Negative, notes: Tested negative on 14Dec2022; (16Dec2022) Positive, notes: Tested positive again on 16Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 05Dec2022 to 09Dec2022 for the treatment of COVID-19. Infection started 02Dec2022. Tested negative after exposure through 01Dec2022 positive 02Dec2022 positive 02Dec2022 - 12Dec2022. Symptoms resolved after initial infection on 10Dec2022. Cough and congestion came back on 14Dec2022. Tested negative on 14Dec2022 and then tested positive again on 16Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), 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: "Breast cancer" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VALTREX, start date: Feb2019, stop date: 16Dec2022. Past drug history included: Ciproflaxin, reaction(s): "known allergies: Ciproflaxin". 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 course: Patient received other medications in 2 weeks. Patient treated with Paxlovid for Covid-19 from 14Dec2022 to 16Dec2022. Further stated that Feeling like she was in a slightly altered state - like she had taken a small amount of illicit drugs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.