chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
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) (Other HCP).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 as dose 3 (booster), single (Lot number: FJ8762) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Vit D Deficiency" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details for COVID 19 Treatment included PAXLOVID (lot number: unknown), administrated orally, treatment start date was on 30Jul2022 and treatment stop date was on 30Jul2022.; 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 drug ineffectiveness and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She took Pfizer covid vaccine and both boosters; She took Pfizer covid vaccine and both boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), 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: "diabetic" (unspecified if ongoing); "heart condition" (unspecified if ongoing); "sore throat" (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 "She took Pfizer covid vaccine and both boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; positive, notes: She was still positive for COVID.  Clinical course:The doctor and her believe she had an adverse response that put her in the hospital. She came back from being out of the country and got COVID on the plane. A week ago Sunday is when she flew back. She had a sore throat before she came back. She called her HCP office 4 or 5 days after she came back because she tested positive for COVID and her HCP wrote a prescription for Paxlovid. She is fully vaccinated with the Pfizer BioNTech vaccine and two booster shots. She is surprised that she had COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received Paxlovid from 25Jul2022 to 29Jul2022 as COVID 19 Treatment. Patient received other medications within 2 weeks of vaccination.  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 the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: experienced a sharp increase in blood pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "experienced a sharp increase in blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that after the second booster, experienced blood pressure (200/111). Patient had no side effects prior to this from the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive to Covid. Rapid Test used; tested positive to Covid. Rapid Test used; 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 17Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 08Apr2021 as dose 2, single (Lot number: ER829), in right arm and on 20Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lidocaine, reaction(s): "Known allergies: Lidocaine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "not recovered" and all described as "tested positive to Covid. Rapid Test used". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) positive, notes: tested positive to COVID. Rapid Test used. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient did not diagnosed with COVID-19. Other medical history: No.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
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) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 10Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa based drugs" (unspecified if ongoing), notes: Known allergies: sulfa based drugs. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Antiviral details: product=COVID-19 Treatment, Treatment start date=18Jun2022, Treatment stop date=23Jun2022, indication=Treatment of COVID-19. This case assessed as non-serious by the reporter.
Age: 57.0
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) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 at 06:15 as dose 1, single (Lot number: EH9899), in left arm, on 10Jan2021 at 06:15 as dose 2, single (Lot number: EKG231), in left arm, on 06Oct2021 at 06:15 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "autoimmune hypothyroidism" (unspecified if ongoing); "chronic allergic rhinitis" (unspecified if ongoing), notes: chronic allergic rhinitis. Concomitant medication(s) included: LEVOTHYROXIN; ALLEGRA; FLONASE SENSIMIST ALLERGY RELIEF. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022 at 12:15, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Negative, notes: 07:00; (23Jul2022) Negative, notes: 09:00; (27Jul2022) Negative; (28Jul2022) Negative; (30Jul2022) Positive, notes: 20:00; (01Aug2022) Positive; (02Aug2022) Positive; (21Jul2022) Positive, notes: 12:15. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details:COVID-19 Treatment,brand=Paxlovid,treatment start date 28Jul2022,treatment stop date 05Jul2022, other medication in 2 weeks product reported as Levothyroxin, Flonase Sensimist, subcutaneous immunotherapy for allergy desensitization. other medication in 2 weeks brand reported as Allegra 180. started Paxlovid at 1800; 22Jul2022 - two doses paxlovid; 23Jul2022 - two dose paxlovid, neg antigen test at 0900; 24Jul2022 - two doses paxlovid; 25Jul2022 - 2 doses paxlovid; 26Jul2022 - final dose paxlovid 0800; 27Jul2022 negative antigen test; 28Jul2022 - mild runny nose, negative antigen test; 29Jul2022 - mild congestion; 30Jul2022 - congestion worsened suddenly in the evening and sneezing and sinus pressure started, positive antigen test at 2000; 01Aug2022 positive antigen test and worsening congestion and rhinorrhea; 02Aug2022 congestion and clear rhinorrhea improved and positive antigen test this morning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 vaccination failure and COVID-19 cannot be ruled out.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Heart rate, 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 46-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 09:00 as dose 1, single (Lot number: EN6203), in left arm, on 25Mar2021 at 09:00 as dose 2, single (Lot number: ER8732), in left arm and on 09Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement, start date: Jan2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Normal, notes: blood pressure has been normal for the past 10 years; (unspecified date) Normal, notes: my blood pressure went back to normal in just 4 hours after first dosage; (2022) 180/110, notes: my blood pressure was very high 180/110; Body temperature: (2022) 100 Fahrenheit, notes: for 2 days; Heart rate: (2022) 100 bpm, notes: elevated heart rate (100 bpm resting heart rate, 30 BPM above regular) for about 10 days,; SARS-CoV-2 test: (unspecified date) Negative, notes: COVID home test turned negative for 2 days on Thursday and Friday; (2022) Negative, notes: COVID home test turned negative for 2 days on Thursday and Friday; (2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (16Jul2022) positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (17Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (18Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (19Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (20Jul2022) positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (21Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (22Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (23Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (24Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (25Jul2022) Negative, notes: On Monday, 25Jul, I did PCR test and the result was negative. Therapeutic measures were taken as a result of covid-19.  Clinical course information: Patient took other medication in 2weeks.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: 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 46-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 09:00 as dose 1, single (Lot number: EN6203), in left arm, on 25Mar2021 at 09:00 as dose 2, single (Lot number: ER8732), in left arm and on 09Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement, start date: Jan2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Normal, notes: blood pressure has been normal for the past 10 years; (unspecified date) Normal, notes: my blood pressure went back to normal in just 4 hours after first dosage; (2022) 180/110, notes: my blood pressure was very high 180/110; Body temperature: (2022) 100 Fahrenheit, notes: for 2 days; Heart rate: (2022) 100 bpm, notes: elevated heart rate (100 bpm resting heart rate, 30 BPM above regular) for about 10 days,; SARS-CoV-2 test: (unspecified date) Negative, notes: COVID home test turned negative for 2 days on Thursday and Friday; (2022) Negative, notes: COVID home test turned negative for 2 days on Thursday and Friday; (2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (16Jul2022) positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (17Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (18Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (19Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (20Jul2022) positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (21Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (22Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (23Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (24Jul2022) Positive, notes: COVID home test was positive from that Saturday (16Jul) until Sunday (24Jul); (25Jul2022) Negative, notes: On Monday, 25Jul, I did PCR test and the result was negative. Therapeutic measures were taken as a result of covid-19.  Clinical course information: Patient took other medication in 2weeks.
Age: 69.0
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FE3590) at the age of 69 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Additional information: Patient administered Paxlovid for COVID 19 Treatment, treatment start date was 06Jul2022 and treatment stop date was 10Jul2022. patient not taken any other medications/products within 2 weeks of starting COVID-19 treatment, patient previously received a COVID-19 Vaccine, Reported event was Rebound infection occurred 4 days after completing the course of Paxlovid. adverse event start date was 14Jul2022. patient recovered, adverse event stop date was 20Jul2022, no treatment for ae.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 3 (booster), single (Lot number: FL8094) at the age of 45 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative; (02Aug2022) Positive. Therapeutic measures were taken as a result of covid-19. Patient recieved paxlovid as treatment. Clinical course: Paxlovid Rebound. No symptoms and tested negative on 29Jul2022. Runny nose on 02Aug2022 and tested positive again that evening. patient was not taking any other medications within 2 weeks of starting COVID-19 treatment patient received previously receive a COVID-19 Vaccine. patient is Recovering with not ae treatment. Patient had no known allergies.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Nasal congestion, Pain in extremity, Speech disorder
Clinical narrative: sore arm; She is coughing up a lot of stuff and blowing out stuff; congested; hoarse; having a hard time talking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Impaired immune system" (unspecified if ongoing), notes: she has an impaired immune system. There were no concomitant medications. Vaccination history included: moderna (DOSE 1, SINGLE, Lot number: 030L20A,, EXP: 16Jul2021, Dose and Route: Unknown dose; route is left arm , Time: Believes 20:00 because she cashed out of the pharmacy at 20:15), administration date: 26Jan2021, when the patient was 60-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE, LOT: 013M20A, EXP: 31Jul2021, Dose and Route: Unknown dose; route is left arm , Time: About 18:30-18:45), administration date: 23Feb2021, when the patient was 60-year-old, for Covid-19 Immunization; Flu vaccine (Previous Fall had to get flu); Pneumonia vaccine (second pneumonia). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; COUGH (non-serious), outcome "unknown", described as "She is coughing up a lot of stuff and blowing out stuff"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congested"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarse"; SPEECH DISORDER (non-serious), outcome "unknown", described as "having a hard time talking".
Age: 55.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Hypertension" (unspecified if ongoing); "ankylosing spondylitis" (unspecified if ongoing); "kyphoscoliosis" (unspecified if ongoing); "disc abnormalities" (unspecified if ongoing), notes: Other medical history: disc abnormalities; "autoimmune hepatitis" (unspecified if ongoing); "reflux disease" (unspecified if ongoing); "mild anemia" (unspecified if ongoing); "vitamin D Deficiency" (unspecified if ongoing). Concomitant medication(s) included: COZAAR and an unspecified medication. Past drug history included: Remicade, reaction(s): "known allergies: Remicade"; Gabapentin, reaction(s): "known allergies: Gabapentin"; Methylprednisolone, reaction(s): "long term use issue", notes: possible methylprednisoline long term use issues. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Postive; (18Jul2022) Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient tested positive on 03Jul2022, when there for what patient thought might be signs of heart attack. No cold symptoms. Patient took Paxlovid and completed. 16Jul2022, started feeling some nasal congestion and increased fatigue. 18Jul2022, had positive antigen again which was either rebound or infection for 15 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive again after previously testing negative; Negative, notes: Tested positive again after previously testing negative; Positive, notes: Tested positive again after previously testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid-19 treatment was done with paxlovid from 23Jul2022 to 28Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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), on 03Apr2021 as dose number unknown, single (Lot number: FR8734), in left arm, on 24Apr2021 as dose number unknown, single (Lot number: EW0170), in left arm and on 17Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Sulfur, reaction(s): "Allergies: Sulfur". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had COVID-19 with Paxlovid, Treatment start date: 01Aug2022. Patient had no other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Psoraisis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 15Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Jul2022 to 17Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201032788 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Dizziness, Headache
Clinical narrative: Mild headache; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". The events "mild headache" and "dizzy" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient never got her booster vaccine. The patient and her husband had COVID shots, they had symptoms such as mild headaches and getting dizzy and his primary doctor sent them to get CT scans of their heads to make sure nothing was going on and there was not. This was why the patient decided not to get the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies: sulfa/septra" (unspecified if ongoing), notes: Known allergies: sulfa/septra. Concomitant medication(s) included: ROBITUSSIN 12 HOUR COUGH RELIEF, start date: 27Jul2022, stop date: 02Aug2022. Past drug history included: Allergies: sulfa/septra, reaction(s): "Allergy", notes: Known allergies: sulfa/septra.  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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported as On 01Aug2022, I started feeling itchy on my torso/back; no sign of hives or a rash. Breathing normal. By the evening of 02Aug2022, the itchiness extended to extremities; event the palms and bottoms of feet. I could not sleep. treatment provided as Aveeno Oatmeal bath, Benadryl 15mL, moisturizer. Anti-viral detail was provided as Paxlovid for Treatment of COVID-19 from 27Jul2022 to 02Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 68.0
Sex: F
Vaccine: 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), in Apr2022 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknon results; Negative; Positive, notes: paxlovid rebound infection. This occurred after about 3 -4 days of testing negative.  Clinical course: It was reported that patient was not received any other medication in two weeks. Patient started treatment for COVID-19 from 21Jul2022 with paxlovid and stopped on 26Jul2022. Patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 2, single (Lot number: FF 2593), in right arm and on 29Apr2022 as dose 3 (booster), single (Lot number: FJ 4989), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 01Apr2021 as dose 1, single (Lot number: 1805031), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Arthritis" (unspecified if ongoing); "irritable bowel" (unspecified if ongoing); "lower back pain" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Positive; (19Jul2022) Positive; (25Jul2022) negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid rebound. Covid symptoms started 19Jul22. Positive PCR test same day. Started 5-day course of Paxlovid 20Jul22. Covid Symptoms greatly improved after 48 hours. Finished full five-day course. First negative rapid test on 25Jul. Felt fully recovered by 28Jul and rapid tested negative again. Started feeling sick again, 30Jul. Rapid test positive. Still sick and testing positive as of today 03Aug.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 13:00 as dose 1, single (Lot number: EL9264), in right arm, on 19Feb2021 at 16:30 as dose 2, single (Lot number: Eng198), in left arm, on 14Aug2021 at 08:00 as dose 3 (booster), single (Lot number: Fd8448), in left arm and on 20May2022 at 17:00 as dose 4 (booster), single (Lot number: Fj4991) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "High cholesterol controlled by statins" (unspecified if ongoing). Concomitant medication(s) included: SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE], start date: 24Jul2022, stop date: 02Aug2022; ALLEGRA; TALTZ; VITAMIN C [ASCORBIC ACID]; ROSUVASTATIN, start date: 01Feb2022, stop date: 24Jul2022. Past drug history included: Keflex, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (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: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical details include: Treatment was given as Paxlovid from 24Jul2022 to 28Jul2022. The patient reported, she was suck again with covid symptoms. Had bad cold symptoms, horrible sinus congestion, dry cough, achy, headaches, very tired and had fever again (100.6) tonight. She started feeling congested on July 31st and it was much worse.
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 a contactable reporter(s) (Other HCP).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years 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 was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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-19 Treatment; positive, notes: rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid, orally from 26Jul2022 to 31Jul2022 for COVID-19 treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2022 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative tests for 3 days; Positive, notes: Rebound of positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound of positive test and covid symptoms after being free of symptoms and negative tests for 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
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) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2021 at 07:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. 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: Positive, notes: Indication: Treatment of COVID-19; Negattive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications in two weeks: Unknown. The patient took Paxlovid from 20Jul2022 to 24Jul2022 for treatment of 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 the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 and drug ineffective.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Erythema, Eye swelling, Pruritus, SARS-CoV-2 test
Clinical narrative: After my third shot, my whole face turned red; my eyes were swelled; insanely itchy all the time; I am in a constant flare with eczema all over my body ever since I got the third dosage of the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: Ff2589) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "eczema as a child." (unspecified if ongoing); "Known allergies: Eggs" (unspecified if ongoing), notes: Known allergies: Eggs, hazelnuts; "Known allergies: hazelnuts" (unspecified if ongoing), notes: Known allergies: Eggs, hazelnuts; "Ibs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6202), administration date: 02Mar2021, for Covid-19 immunization, reaction(s): "After my second dose, a red patch started showing up under my left eye"; BNT162b2 (Dose Number: 1, Batch/Lot No: EM9810), administration date: 09Feb2021, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 19Oct2021, outcome "not recovered", described as "After my third shot, my whole face turned red"; ECZEMA (non-serious) with onset 19Oct2021, outcome "not recovered", described as "I am in a constant flare with eczema all over my body ever since I got the third dosage of the vaccine."; PRURITUS (non-serious) with onset 19Oct2021, outcome "not recovered", described as "insanely itchy all the time"; EYE SWELLING (non-serious) with onset 19Oct2021, outcome "not recovered", described as "my eyes were swelled". The events "after my third shot, my whole face turned red", "my eyes were swelled", "insanely itchy all the time" and "i am in a constant flare with eczema all over my body ever since i got the third dosage of the vaccine." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, eye swelling, pruritus, eczema.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201033392 Same patient and drug, different event separated in time;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2021 at 14:30 as dose 3 (booster), single (Lot number: FH8020) 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 was not reported. Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Jul2022 to 25Jul2022.  Clinical course: Patient received other medications within 2 weeks of vaccination.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK5443) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chron's Disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Tested positive again - 5 days after testing negative; (03Aug2022) Positive, notes: Tested positive again - 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19  Clinical course: Patient did not take other medication in 2 weeks. Anti-viral treatment details, product Covid 19 treatment start date was reported as 23Jul2022 and treatment stop date was 27Jul2022. Adverse event reported that Tested positive again 5 days after testing negative. Device timestamp: 03Aug2022.   No follow-up attempts are possible. No further information is expected.