chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: U
Vaccine: MENB
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Trumenba vaccination in an otherwise healthy 9 month old infant.; swelling at area of injection; fever; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A 9-month-old patient received meningococcal group b Rlp2086 (TRUMENBA), at the age of 9 months as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Trumenba vaccination in an otherwise healthy 9 month old infant."; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at area of injection"; PYREXIA (non-serious), outcome "unknown", described as "fever". Additional information: The patient asked if there was any data regarding the safety or possible side effects from Trumenba vaccination in an otherwise healthy 9 month old infant. As per agent, this product was administered to a 9 month old patient who experienced fever and swelling at area of injection. HCP asking for potential side effects after administration to a 9 month old. The caller states a "full dose" of the product was accidently given to an infant last week, a 9 month old. Do we have any information regarding potential side effects for the infant? When asking to clarify "full dose" caller states "it was the one that we normally give to the 11 year olds. I went online and found some studies that Pfizer did with half a dose on infants but I couldn't find anything on a full dose. It was the same dose the 11 year olds were given." When asked what dose he gives an 11 yar old caller states "I'm not in the office right now. My nurse does it so whatever the standard dose is, that we would give to 11 year olds." He's 99% sure they gave 0.5mL dose.   The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Age: 31.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 31 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines without auras" (unspecified if ongoing); "BRCA2 mutation carrier" (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX, start date: Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "recovered" (15Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2023) Positive, notes: initially turned positive on 07Aug2023; (15Aug2023) Negative, notes: negative on day 10 (15Aug). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 07Aug2023 to 11Aug2023. Clinical course: The patient initially turned positive on 07Aug2023 (symptoms day 05Aug). She started paxlovid the same day that she turned positive and completed the 5 day course on 11Aug. She tested negative on day 10 (15Aug) and also had had improvement in symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300279888 same reporter/patient, different product/AE;
Age: 32.0
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) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300279897 same reporter/patient, different drug/event;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech, Vaccine administration date=21Sep2022 / Vaccine brand Other=Moderna, Vaccine administration date=02Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 51 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Lot number: 007M20A), in right arm, on 13Mar2021 as dose 2, single (Lot number: 040A21A), in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 032F21A), in right arm and on 02Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Brazil nuts" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Suspected Mitochondrial disease" (unspecified if ongoing); "autonomic dysfunction" (unspecified if ongoing); "reactive hypoglycemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "recovered", described as "Vaccine brand=Pfizer / BioNTech, Vaccine administration date=21Sep2022 / Vaccine brand Other=Moderna, Vaccine administration date=02Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Patient had Paxlovid Treatment from 05Aug2023 to 09Aug2023; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300279918 Same patient, different product, different event;
Sex: M
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 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), 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), COVID-19 (medically significant) all with onset 02Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment Paxlovid from 02Aug2023 to 06Aug2023. Positive COVID test on 02Aug2023, immediately started Paxlovid the same morning.  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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Pfizer / BioNTech; vaccine administration date=04Oct2022 / vaccine brand other=moderna; vaccine administration date=20Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 73 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 011a21a), in left arm, on 28Oct2021 as dose 2, single (Lot number: 076c21a), in left arm and on 20Apr2022 as dose 3 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine administration date=04Oct2022 / vaccine brand other=moderna; vaccine administration date=20Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 09Aug2023 to 14Aug2023.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Testes for Covid and flu, showed that he was positive for Covid; Testes for Covid and flu, showed that he was positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 17Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing), notes: Gout Recently started medication for that; "high blood pressure" (unspecified if ongoing); "blood thinner" (unspecified if ongoing); "low potassium" (unspecified if ongoing); "diuretic" (unspecified if ongoing). Concomitant medication(s) included: LEVEMIR taken for diabetes mellitus (ongoing); NOVOLIN R taken for diabetes mellitus (ongoing); METFORMIN taken for diabetes mellitus (ongoing); CHLORPHENIRAMINE [CHLORPHENAMINE] (ongoing); TYLENOL (ongoing); LABETALOL taken for blood pressure measurement, start date: Nov2022 (ongoing); PIOGLITAZONE HCL taken for diabetes mellitus (ongoing); LOSARTAN POTASSIUM taken for hypokalaemic syndrome (ongoing); HYDROCHLOROTHIAZIDE taken for polyuria (ongoing); ALLOPURINOL taken for gout (ongoing); ASPIRIN (E.C.) taken for blood disorder (ongoing); GUANFACINE HCL taken for blood pressure measurement (ongoing); ATORVASTATIN CALCIUM (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Aug2023, outcome "unknown" and all described as "Testes for Covid and flu, showed that he was positive for Covid". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5, 11 or 5, 10; Flu test: (unspecified date) Unknown results; SARS-CoV-2 test: (16Aug2023) Positive, notes: Result: positive; Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 10Aug2023 ,stop date: 15Aug2023).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300280047 Same reporter/patient, different drug/event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). 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 22Sep2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 05Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: 30135ba), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measure Paxlovid from 02Aug2023 to 06Aug023 was 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.; Sender's Comments: Based on available information, a lack of efficacy (VACCINATION FAILURE and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2022 as dose 4 (booster), single (Lot number: fj4991) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Aug2023 to 15Aug2023.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 72-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: em9810) at the age of 70 years 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 "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 46.0
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: Moderna, Dose 4: Pfizer; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 46 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8732), in right arm and on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 032h21a), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). Concomitant medications included: FLUTICASONE PROPRIONATE, start date: 01Nov2021. Past drug history included: Amoxicillin, reaction: "Known allergies: amoxicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Oct2022, outcome "unknown", described as "Dose 3: Moderna, Dose 4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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 which included Paxlovid from 08Aug2023 to 13Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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; Vaccine brand other: Moderna/ Vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 12:00 as dose 4 (booster), single (Lot number: 069f21a) at the age of 34 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose 1, single (Lot number: EN6206), in right arm and on 31Mar2021 at 12:00 as dose 2, single (Lot number: ER8732), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Dec2021 at 12:00 as dose 3 (booster), single (Lot number: GJ6665), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other: Moderna/ Vaccine brand: Pfizer / BioNTech". 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.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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; Positive; Negative, notes: then negative 5 days later; Positive, notes: then positive again 2 and 3 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 10Aug2023 to 15Aug2023.  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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 38 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 was not reported. 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: Positive, notes: COVID rebound- tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 38-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 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2021 as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 03Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2023) Positive; (11Aug2023) Negative; (13Aug2023) Positive; (14Aug2023) Positive; (15Aug2023) Positive; (16Aug2023) Positive; (17Aug2023) Positive; (18Aug2023) Positive; (19Aug2023) Positive; (20Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Aug2023 to 08Aug2023.  Clinical course: Tested positive for Covid on 03Aug. Started taking Paxlovid the same day. Got a negative test result on 11Aug23. Got a scratchy throat the following day and tested positive again on 13Aug. Tested positive for a full 7 more days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Pfizer / BioNTech dose 1, dose2, dose 3; Moderna, dose 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9809), on 24Feb2021 as dose 2, single (Lot number: EM9809) and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 35 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 as dose 4 (booster), single (Lot number: AS7143C) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Pfizer / BioNTech dose 1, dose2, dose 3; Moderna, dose 4"; COVID-19 (disability, medically significant), VACCINATION FAILURE (disability, medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure with Paxlovid.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure(LOE), covid-19, interchange of vaccine products  cannot be ruled out.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 50 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6200), on 10Apr2021 as dose 2, single (Lot number: EN6200), in right arm and on 30Aug2021 as dose 3 (booster), single (Lot number: EW0168), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Neuroendocrine/carcinoid cancer with syndrome" (unspecified if ongoing); "polymyositis" (unspecified if ongoing); "systemic scleroderma" (unspecified if ongoing); "MS" (unspecified if ongoing). Concomitant medication(s) included: SOMATULINE DEPOT, start date: 03Jan2017; GABAPENTIN, start date: 02Jan2020; BACLOFEN, start date: 02Apr2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment was Paxlovid from 10Aug2023 to 15Aug2023.
Age: 32.0
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 33-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 04Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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's relevant medical history included: "Asthma" (unspecified if ongoing); "bilateral mastectomy with implant reconstruction" (unspecified if ongoing); "bilateral mastectomy with implant reconstruction" (unspecified if ongoing); "capsular contracture" (unspecified if ongoing); "endometriosis diagnosed through laparoscopy" (unspecified if ongoing); "endometriosis diagnosed through laparoscopy" (unspecified if ongoing); "Alllergies: Tree nuts" (unspecified if ongoing); "Allergies: Eggplant" (unspecified if ongoing); "Allergis: seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 12Jan2022; ALBUTEROL HFA, start date: 01May1995. Past drug history included: Vicodin, reaction(s): "Allergies: Vicodin". 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: (Aug2023) Positive, notes: Rebound in symptoms and positive test after 4 days of negative tests; (Aug2023) Negative, notes: Rebound in symptoms and positive test after 4 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient treated with Paxlovid from 10Aug2023 to 14Aug2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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).  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 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's relevant medical history included: "Known allergies: Sulfa-containing antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was given treatment of Paxlovid from 06Aug2023 to 10Aug2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Known allergies: Latex" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: wool" (unspecified if ongoing); "Known allergies: honey" (unspecified if ongoing); "Known allergies: cumin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin". 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: Never stopped testing positive between onset and rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 included nirmatrelvir, ritonavir (PAXLOVID), from 09Aug2023 (Lot number: GF9998) to 13Aug2023.   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: 45.0
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) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose 4 (booster), single (Lot number: AS7184B) at the age of 45 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (18Aug2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2023) Negative; (19Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 12Aug2023 to 16Aug2023. Clinical courses: Covid rebound (19Aug2023) after paxlovid. Symptoms disappeared completely for 2 days with multiple negative tests, sore throat and congestion symptoms along with positive covid test came back following day. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PRASCOLEND, start date: 12Jul2023; BREO ELLIPTA, start date: 12Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 08Aug2023 to 14Aug2023. The 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.
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) (Nurse). 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) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2023) Negative; (17Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received nirmatrelvir, ritonavir (PAXLOVID) as COVID 19 treatment from 09Aug2023 to 13Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: cj6739) at the age of 67 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: "a fib" (unspecified if ongoing). Concomitant medication(s) included: FLECAINIDE ACETATE, start date: 2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (12Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received paxlovid from 07Aug2023 to 12Aug2023.. Clinical courses: Other medication in 2weeks product=flecainide acetate. Covid 19 rebound (14Aug2023) 2 days after testing negative. No known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Tested positive; Treatment of COVID-19/Tested positive; Moderna Dose Number: 1/Pfizer / BioNTech Dose Number: 2 & 3.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left leg and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Mar2021, outcome "unknown", described as "Moderna Dose Number: 1/Pfizer / BioNTech Dose Number: 2 & 3."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Tested positive". 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, treatment was Paxlovid for 5 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: 80777027399) 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: "Obese" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Hyperlipidemia" (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 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 09Aug2023 to 13Aug2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result=postive; covid test result=postive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result=postive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300280960 same patient, different vaccine dose/event;
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 12Aug2023 to 16Aug2023. No known allergies. No other medication in 2weeks.  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: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 10Aug2023 to 15Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.