chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Lot number: 026A21A), in left arm and on 05Apr2021 as dose 2, single (Lot number: 032B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing); "Dose 1 and 2: Moderna/ Dose 3: Pfizer BioNTech" (unspecified if ongoing), notes: Dose 1 and 2: Moderna/ Dose 3: Pfizer BioNTech. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient had Anti-viral product Paxlovid (Lot number GA1190) for Treatment of COVID-19 started from 22Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had 3 phizer vaccinations/ Treatment of COVID-19; Had 3 phizer vaccinations/ 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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Hashimotos disease" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Overweight (not obese)" (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 "Had 3 phizer vaccinations/ Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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: ZOLOFT.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course :The patient  no allergies,no other medical history.The patient received treatment for covid-19 with Paxlovid from 15Jun2022 to 19Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sick with COVID; Sick with COVID; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported:  COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant),  all with onset Jun2022, outcome "unknown" and all described as "Sick with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: test at home and he was positive as well.  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 current available limited information in the case provided, the causal association between the events Drug ineffective, COVID-19 and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 72.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 02Jun2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Transgender MTF. See Rx list." (unspecified if ongoing), notes: Transgender MTF. See Rx list. Concomitant medication(s) included: LOVASTATIN oral; FINASTERIDE oral; TADALAFIL; ESTRADIOL; NORTRIPTYLINE; SPIRONOLACTONE; TAMSULOSIN. Past drug history included: Benzocaine ointment, reaction(s): "Known allergies: Benzocaine ointment", notes: Known allergies: Benzocaine ointment; Terbinafine, reaction(s): "Known allergies: Terbinafine", notes: Known allergies: Terbinafine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Positive COVID home test on 14Jun2022; (21Jun2022) Negative, notes: Negative COVID home test on 21Jun2022; (24Jun2022) Positive, notes: Positive COVID home test on 24Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Product Positive COVID home test on 14Jun2022. Took Paxlovid tabs for 5 days starting 14Jun2022 as COVID 19 Treatment and stopped on 18Jun2022. Negative COVID home test on 21Jun2022. Mild symptoms of runny nose stared 23Jun2022. Positive COVID home test on 24Jun2022.
Age: 71.0
Sex: M
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) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EL0140), in left arm, on 12Jan2021 as dose 2, single (Lot number: EL3302), in left arm, on 05Oct2021 at 15:00 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 29Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: I tested positive for COVID-19; (Jun2022) Negative, notes: I tested negative 3 days after completion of 5 day Paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: 025-402), in left arm, on 18Apr2021 as dose 2, single (Lot number: 025-402), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, 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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; Sars Cov2 infection; mild fever; aches; severe soar throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "Sars Cov2 infection"; PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "aches"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "mild fever"; OROPHARYNGEAL PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "severe soar throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received other medication in past 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID 19 Treatment; Sars Cov2 infection; mild fever; aches; severe soar throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "Sars Cov2 infection"; PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "aches"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "mild fever"; OROPHARYNGEAL PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "severe soar throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received other medication in past 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN 6202), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER 8427), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FF 2589) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "spondlyoarthritis" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; SULFASALAZINE; DICLOFENAC SODIUM; FLONASE [FLUTICASONE PROPIONATE]; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Ceclor, reaction(s): "Known allergies:Ceclor", notes: Known allergies:Ceclor. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, 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 treatment of COVID-19 with Paxlovid. Patient received other medication in 2 weeks product as:  Breo, Sulfasalazine, Diclofenac Sodium, Flonase, Aspirin. She has known allergy of Ceclor and other medical history Asthma, spondlyoarthritis. Device Date : 25Jun2022 No follow-up attempts were possible. No further information was expected.
Age: 37.0
Sex: M
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 38-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Lot number: FC1526) and in Jun2021 as dose 2, single (Lot number: FE7010) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Dec2021 as dose 3 (booster), single (Lot number: 068H21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) negative; (24Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 15Jun2022 to 19Jun2022 as a treatment of COVID-19. The patient previously received a COVID-19 Vaccine. It was reported that patient had been symptom-free for the past 5 days, testing negative on the rapid antigen test while still positive at PCR. Today patient had intense nasal congestion with a running nose, and patient positive also on the rapid antigen test. patient had no known allergies. patient was not Hospitalized for the reported events.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergy: amoxicillin", notes: Known allergy: amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) negative, notes: 2 days of negative tests; (Jun2022) positive, notes: Third positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
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) (Physician). The reporter is the patient.  A 33 year old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; SULFASALAZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), 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), 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: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, patient took Paxlovid (lot number: Fw4118) from 16Jun2022 to 21Jun2022 as COVID 19 Treatment. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Reported events were Covid rebound after paxlovid completion, increased symptoms of fatigue, coughing. Rapid test + on day 10. Adverse event started on 23Jun2022. Patient not recovered for the reported adverse events and no treatment were received. 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.
Age: 31.0
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 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Stone fruits" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
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 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 07Feb2021 as dose 1, single (Lot number: Em9809), in left arm, on 10Mar2021 as dose 2, single (Lot number: En6208), in left arm, on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25Apr2022 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: "Asthma related cough" (unspecified if ongoing); "Asthma related cough" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2021) Positive, notes: strongly positive; (Jun2022) test line very faint; (17Jun2022) Negative; (26Jun2022) Positive, notes: Still positive with dark line. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Other medication in 2 weeks product=Atorvastastin 40, stop date=10Jun2022, Encruse illipta, stop date=10Jun2022, Flovent 54, stop date=10Jun2022. Adverse event Paxlovid rebound. Original COVID test line very faint. Prescribed Paxlovid 11Jun. Finished Paxlovid 15Jun. Tested negative 17Jun. Started symptoms 22Jun which progressively worsened. Tested strongly positive 23Jun. Still positive with dark line as of 26Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
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). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing), notes: known allergies: Gluten. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive, notes: faded/light antigen tests; (21Jun2022) Positive, notes: faded/light antigen tests; (22Jun2022) Negative; (23Jun2022) Negative; (25Jun2022) Positive, notes: Instant, dark red positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 13Jun2022 to 18Jun2022. Clinical Course: The patient previously received a covid19 vaccine. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Influenza like illness, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever, achy body, felt like I was coming down with the flu. Lasted about 3 hours. This happened the same time the next day too. Fever over 100 degrees both days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Medium, Additional Details: unsure if actual seizure. EMS was called, pts bp, pulse and HR normal when they arrived. pt agreed to go to the hospital for further evaluation.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Medium, Additional Details: unsure if actual seizure. EMS was called, pts bp, pulse and HR normal when they arrived. pt agreed to go to the hospital for further evaluation.
Age: 69.0
Sex: M
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 69-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL1284), in right arm, on 01Feb2021 as dose 2, single (Lot number: EL2263), in right arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FC3184), in right arm and on 19Mar2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing), notes: Known allergies:Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive; (15Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information: The patient received vaccine. Anti-viral product included Paxlovid for Treatment of COVID-19 started from 10Jun2022 till 15Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Hypertension, Swelling face
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Mild, Additional Details: called emergency. the EMT's took her to the ER. She thinks they gave her some epinephrine and steroid shots. She is ok now. She is home and doing better.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Mild, Additional Details: called emergency. the EMT's took her to the ER. She thinks they gave her some epinephrine and steroid shots. She is ok now. She is home and doing better.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 44.0
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Rheumatoid Arthritis" (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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative; (24Jun2022) Positive, notes: a faint positive test; (25Jun2022) Positive, notes: the test was very positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment: Paxlovid from 15Jun2022 to 19Jun2022, Adverse event Rebound infection after testing negative. Congestion and sore throat returned on 24Jun2022 followed by a faint positive test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 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. Patient took medication within 2 weeks. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 20Jun2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm 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: "Autoimmune disorder" (unspecified if ongoing); "Walnuts allergy" (unspecified if ongoing), notes: Walnuts allergy. Concomitant medication(s) included: SYNTHROID, start date: Aug2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had other medication in 2 weeks. Patient had taking any other medications/products within 2 weeks of starting COVID-19 treatment & Patient had previously receive a COVID-19 Vaccine. Patient had Known allergies was walnuts and Other medical history: Autoimmune disorder. Patient did not had seriousness criteria-results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Patient had COVID treatment with Proprietary medicinal product name: Paxlovid, indication for use in the case: treatment of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
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 a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 12:30 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 at 13:00 as dose 2, single (Lot number: EW0158), in right arm and on 20Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FH0827) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hashimoto's" (unspecified if ongoing), notes: hashimoto's. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19; was treated with Paxlovid from 10Jun2022 to 15Jun2022.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug 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 contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient received vaccine. Other medication in 2weeks were Unknown. The patient had anti-viral Paxlovid for COVID 19 Treatment.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vaccine dose number=2 pfizer, Vaccine dose number=1 Moderna" (unspecified if ongoing), notes: Vaccine dose number=2 pfizer, Vaccine dose number=1 Moderna. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that the patient received the treatment. The patient did no received any other medication within 2 weeks. It was reported that the adverse event Rebound COVID-19 symptoms within 2 days of stopping Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9261) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing), notes: Meniere's disease years ago; "Had a reaction to penicillin" (unspecified if ongoing), notes: Had a reaction to penicillin many years ago and got a rash.; "rash" (unspecified if ongoing), notes: Had a reaction to penicillin many years ago and got a rash. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The caller reported that with the first one, he did not have any adverse effects, just a sore arm, which of course, was normal. Years ago, had Meniere's disease and they thought he had would get loss of balance and he used to take Antivert for that. The patient had a reaction to penicillin many years ago and got a rash. It was about 40 years ago. The patient's brother and wife both got the shots and had no problems. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations (within 4 weeks). There were no relevant tests.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Dose Number: 5; Dose Number: 5; 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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: "Laryngopharyngeal reflux" (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 Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment"; OFF LABEL USE (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "Dose Number: 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Positive tests and symptoms worsening after negative test on day after treatment ended; (20Jun2022) Negative, notes: Positive tests and symptoms worsening after negative test on day after treatment ended. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had not received any Other medication in 2 weeks. Patient had received anti-viral treatment from 16Jun2022 to 20Jun2022 for the treatment of COVID-19. Positive tests and symptoms worsening after negative test on day after treatment ended on 16Jun2022. Patient had no known allergies. The patient had not received any other medications and products within 2 weeks of starting COVID-19 treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Maternal exposure during pregnancy, Myalgia
Clinical narrative: Is pregnant: Yes/delivery date: 30Dec2022; Nausea; Vomited; Diarrhea; Headache; Muscle ache; Tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 23Jun2022 at 16:30 as dose 3 (booster), single (Lot number: FP4554) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Date of last menstrual period: 27Mar2022. The patient was 13 weeks pregnant at the time of exposure to BNT162b2. The patient was 12 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Dec2022. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose 2, Location of injection: Arm Left, Vaccine Administration Time: 13:00), administration date: 27Jul2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Location of injection: Arm Left, Vaccine Administration Time: 13:00), administration date: 09Jun2021, when the patient was 41-year-old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Diarrhea"; HEADACHE (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022); MYALGIA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Muscle ache"; NAUSEA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022); FATIGUE (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Tired"; VOMITING (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Vomited"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes/delivery date: 30Dec2022". Therapeutic measures were not taken as a result of nausea, vomiting, diarrhoea, headache, myalgia, fatigue. Additional information: 24 hours after the vaccine, she started getting strong nausea, she vomited and had diarrhea. Also headache, muscle ache and very tired. No known allergies reported. No other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination: Amoxicillin, Prenatal vitamins. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Device date: 25Jun2022.   No follow-up attempts are possible. No further information is expected.