chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine_brand_other=moderna/vaccine_dose_number=4; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Lot number: gj5342), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Jan2021 at 12:00 as dose 1, single (Lot number: EL1283), in left arm, on 30Jan2021 at 12:00 as dose 2, single (Lot number: en5318), in left arm and on 27Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ew0191), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 002m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Apr2022 at 11:00, outcome "unknown", described as "vaccine_brand_other=moderna/vaccine_dose_number=4"; VACCINATION FAILURE (medically significant) with onset Dec2022, outcome "unknown", 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) Negative, notes: Negative tests on day 7 and 9; (2022) Positive; (2022) Negative, notes: Negative tests on day 7 and 9. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Rebound COVID symptoms on day 10 with positive test after w negative tests on day 7 and 9.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and interchange of vaccine products and BNT162B2.
Age: 72.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 at 17:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Jan2021 at 15:45 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Aug2021 at 03:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Feb2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; 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 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 60 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 at 12:30 as dose 1, single (Lot number: EN6198), in right arm, on 17Mar2021 at 11:15 as dose 2, single (Lot number: EN6206), in right arm, on 04Oct2021 as dose 3 (booster), single (Lot number: EW0217), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IRBESARTAN.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 61 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: "Coronary Artery Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Overweight" (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 Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Bounce back of positive COVID after 2 days of negative test; (Dec2022) Positive, notes: Bounce back of positive COVID after 2 days of negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Bounce back of positive COVID after 2 days of negative test.  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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; Vaccine brand other: Moderna/vaccine brand: Pfizer / BioNTech; 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 56-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Ee8727), on 16Apr2021 as dose 2, single (Lot number: Er8735) and on 06Nov2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02May2022 as dose 4 (booster), single (Lot number: 057m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyper cholesterol" (unspecified if ongoing), notes: other medical history: Hyper cholesterol; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medication(s) included: SIMVASTATIN. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin", notes: known allergies: aspirin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02May2022, outcome "unknown", described as "Vaccine brand other: Moderna/vaccine brand: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (19Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 07Dec2022 to 12Dec2022 for Covid-19. Cold- like symptoms and positive lateral flow test on 19Dec2022.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Feb2021 at 10:00 as dose 2, single (Lot number: 006m20a), in left arm, on 26Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 012f21a), in left arm and on 28Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 048l21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension, cholesterol" (unspecified if ongoing); "hypertension, cholesterol" (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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Vaccine previously and was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 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: "Hypothyroid" (unspecified if ongoing); "Fibromuscular dysplasia" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder, start date: Jun1990. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Positive; (18Dec2022) negative; (24Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid from 13Dec2022 to 18Dec2022 for the treatment of COVID-19. The patient had COVID rebound. The patient tested positive for COVID on 13Dec2022 and started Paxlovid on 13Dec2022. Tested negative after treatment on 18Dec2022. Symptoms restarted on 23Dec2022. Tested positive on 24Dec2022. Reported rebound to my MD on 26Dec2022. 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 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 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa 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 "not recovered" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 Treatment, Paxlovid from 15Dec2022 to 19Dec2022.  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: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (pregnant) 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'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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound COVID 7 days after treatment of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose number: 4/Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 44 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 18Mar2021 as dose 2, single (Lot number: EN6207) and on 26Sep2021 as dose 3, (booster) single (Lot number: FD8448) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31May2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "One Lung" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pulmonic Stenosis" (unspecified if ongoing); "Hiatal Hernia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Deafness" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; TRINTELLIX; RITALIN [METHYLPHENIDATE]; XANAX; STRATTERA; ESOMEPRAZOLE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2022, outcome "unknown", described as "dose number: 4/Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid treatment from 13Dec2022 to 17Dec2022 for Covid-19.  Clinical course:The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. The patient previously receive a COVID-19 Vaccine was reported as yes. No Known Allergies.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Cold symptoms returned and then I tested positive again after 2 negative tests at days 7 & 9.; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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 included: "allergies" (unspecified if ongoing), notes: Name of Drug as Reported: No, Reaction: Allergy, . The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2022, outcome "unknown", described as "Cold symptoms returned and then I tested positive again after 2 negative tests at days 7 & 9."; COVID-19 (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive again after 2 negative tests at days 7 & 9; Negative, notes: I tested positive again after 2 negative tests at days 7 & 9; Negative, notes: I tested positive again after 2 negative tests at days 7 & 9. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: the patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment. patient previously receive a COVID-19 Vaccine. Other medication in 2weeks: No.  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 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 12:00 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: "Asthma" (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 Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) positive, notes: symptoms returned and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-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: GH9702) for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: er8737), on 26Apr2021 as dose 2, single (Lot number: ew0171) and on 05Jan2022 as dose 3 (booster), single (Lot number: fl3198) for covid-19 immunisation.  The patient's relevant medical history included: "allergies (multiple)" (unspecified if ongoing), notes: allergies (multiple); "asthma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Known Allergies: some topical antibiotic preparations" (unspecified if ongoing), notes: allergies to some topical antibiotic preparations; "Known Allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR SODIUM; MONTELUKAST; FEXOFENADINE; DIPHENHYDRAMINE; MELOXICAM; ESTRADIOL; MEDROXYPROGESTERONE. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19. Course of events: Known Allergies: some topical antibiotic preparations, latex. Patient received anti viral treatment with Paxolovid for Covid 19 infection from 15Dec2022 to 20Dec2022.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 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: "Pre-existing autoimmune disease" (unspecified if ongoing); "congenital heart disease" (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 Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Nasal swab; (Dec2022) Negative, notes: for three days; (Dec2022) Negative, notes: for three days; (Dec2022) Negative, notes: for three days. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand: Pfizer/BioNTech, Dose number: 3; Vaccine brand other: Moderna, Dose number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Apr2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech, Dose number: 3; Vaccine brand other: Moderna, Dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given for COVID 19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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 was not reported. Concomitant medication(s) included: METFORMIN; GLIPIZIDE; AMLODIPINE; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Immune thrombocytopenia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; HYDROXYCHLOROQUIN; PREDNISONE; MYCOPHENOLATE. Vaccination history included: Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  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
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "Hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 15Dec2022 to 19Dec2022 for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6665) for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0175) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: 067F21A) and on 05Jun2022 as dose 4 (booster), single (Lot number: 037A22B) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: treated with linosipril / HCTZ; "Known allergies: Sulfonamides" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "dose #1: UNKNOWN/ dose #2: Pfizer / dose #3: Moderna / dose #4: Moderna / dose #5:Pfizer"; 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: (26Dec2022) Positive, notes: lateral flow. Antigen test on 26Dec; (19Dec2022) Negative, notes: First day with negative lateral flow after the Paxlovid course was 19Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19.
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 (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (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 cholesterol" (unspecified if ongoing). No known allergies. Concomitant medications included: ATORVASTATIN MYLAN, stop date: 17Dec2022; TUMS [CALCIUM CARBONATE]; ADVIL [IBUPROFEN] and daily vitamins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Negative, notes: tested negative for Covid 8 days ago; (27Dec2022) Positive, notes: test positive again 8 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  On 17Dec2022, the patient started Paxlovid for the treatment of COVID-19 and stopped at 21Dec2022. Finished taking Paxlovid on 21Dec2022 (7 days ago) and tested negative for Covid-19 on 20Dec2022 (8 days ago). Sore throat again and home test positive again on 27Dec2022 (8 days later).  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: F
Vaccine: COVID19
Symptoms: Malaise, Porphyria
Clinical narrative: Porphyria Attack; she is still not feeling that well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Porphyria" (ongoing), notes: Porphyria; "respiratory failure" (unspecified if ongoing), notes: She states she has been in respiratory failure. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PORPHYRIA (medically significant), outcome "unknown", described as "Porphyria Attack"; MALAISE (non-serious), outcome "not recovered", described as "she is still not feeling that well". 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: 59.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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 was not reported. There were no concomitant medications. Past drug history included: Biaxin, reaction(s): "known allergies: biaxin"; Ceftin, reaction(s): "known allergies: ceftin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID 19 Treatment; (23Dec2022) Negative, notes: tested negative 23Dec2022; (26Dec2022) Positive, notes: tested positive again 26Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had rebound coughing and runny nose which began 24Dec2022 tested negative 23Dec2022, tested positive again 26Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE , COVID 19  and The suspected drug cannot be ruled out.
Age: 67.0
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 04Apr2021 as dose 2, single (Lot number: ER8734) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Aug2022, stop date: 27Dec2022; ALENDRONATE SODIUM, start date: 01Sep2022, stop date: 27Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: after 5-day Paxlovid, still tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid (Lot number: GF4083) 22Dec2022 to 26Dec2022 as COVID-19 Treatment. The patient had no known allergies.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid after experiencing mild flu-like symptoms; Tested positive for Covid after experiencing mild flu-like symptoms; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6203), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2022, outcome "recovering" and all described as "Tested positive for Covid after experiencing mild flu-like symptoms". Prior to vaccination, no Covid-19 was reported. Post vaccination, Covid-19 was tested positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 75 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Vasculitis" (unspecified if ongoing), notes: Other medical history: Vasculitis; "Giant cell arteritis" (unspecified if ongoing), notes: Other medical history: Giant cell arteritis. Concomitant medication(s) included: PREDNISONE..  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: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound of mild symptoms after completing 5-day course of Paxlovid and feeling very well. Positive test. Slight body aches, cold symptoms. Low grade fever. Took treatment from 14Dec2022 to 18Dec2022. No Known allergies.
Age: 47.0
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 contactable reporter(s) (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 23Oct2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 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: "Known allergies: Penicillin" (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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient became Covid positive with mild symptoms 5 days after stopping Plaxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jul2022, stop date: 15Dec2022; MONTELUKAST, start date: May2014. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "not recovered"; 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: (21Dec2022) Negative, notes: 2 days after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had no known allergies. Patient was treated with Paxlovid on 14Dec2022 to 18Dec2022 for COVID-19. Covid symptoms mostly cleared and tested negative 2 days after completing Paxlovid treatment.   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: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Severe itching; Severe Rash; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus and rash. On an unknown date, the outcome of the pruritus and rash were unknown.   It was unknown if the reporter considered the pruritus and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had severe itching and rash after shot and would not get second shot. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-DEC-2022 Reporter's comments: The reporter reported that the patient received one dose of Shingrix. The reporter asked did she have to restart series. No additional information provided.  The reporter was consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.