chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 16Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 25Aug2021 as dose 3 (booster), single (Lot number: EW0165) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "ANA positive but no activity" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure well with meds" (unspecified if ongoing), notes: high blood pressure well controlled with meds. Concomitant medication(s) included: SIMVASTATIN, start date: 05May2021, stop date: 26Apr2022; LOSARTAN, start date: Dec2019, stop date: 01Aug2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: May2011, stop date: 01Aug2022; NASACORT, start date: May2011, stop date: 01Aug2022; CALCIUM CITRATE, start date: Dec2019, stop date: 01Aug2022; D3, start date: Dec2019, stop date: 01Aug2022; ALIGN, start date: Dec2019, stop date: 01Aug2022. Past drug history included: Fentanyl, reaction(s): "known allergies: fentanyl (post surgery, got hives)". The following information was reported: COVID-19 (medically significant) with onset 26Apr2022, outcome "not recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "not recovered", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative, notes: tested negative on day 6; (06May2022) Positive, notes: next tested on day 11 and was positive;; (07May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (08May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (10May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (11May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (14May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (26Apr2022) Positive, notes: except also tested positive on PCR test on 26Apr2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Contracted COVID-19 26Apr2022 and started paxlovid for 5 days; tested negative on day 6; next tested on day 11 and was positive; positive also on subsequent tests (days 12, 13, 15, 16 and 19); stopped testing after day 19 so don't know if would have tested positive longer (I have Hypogammaglobulinemia but am not receiving IgG infusions); all of above tests were antigen tests (except also tested positive on PCR test on 26Apr2022)
Age: 66.0
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) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL0140), in right arm, on 18Jan2021 as dose 2, single (Lot number: EK9231), in right arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 21Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID oral. Past drug history included: Trimethoprim, reaction(s): "Known allergies: trimethoprim"; Sulfamethoxazole, reaction(s): "Known allergies: sulfamethoxazole".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication was Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral treatment was started from 20Jul2022 to 25Jul2022 by oral route.; Sender's Comments: Based on the available information, the reported events cannot be excluded for the suspect drug.
Age: 68.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 at 14:00 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 (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient received treatment of Paxlovid for COVID-19 from 21Jul2022 to 25JUL2022.   The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "a-fib" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included/Other medication in 2weeks: DEPAKOTE; AMLODIPINE; METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Known allergies: phenobarbital, reaction(s): "Drug Allergy"; Known allergies: codeine, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (01Aug2022) 101.3, notes: fever of 101.3; SARS-CoV-2 test: (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received the treatment with anti-viral details included: Brand: Pfizer, Treatment start date: 27Jul2022, Treatment stop date: 01Aug2022, Indication: 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: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Alopecia- hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2022 as dose 2, single (Lot number: FL0007) at the age of 5 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FL8094, Location of injection: Arm Right), administration date: 04Feb2022, when the patient was 5-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 02May2022, outcome "not recovered", described as "Alopecia- hair loss". The event "alopecia- hair loss" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccinationPrior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. It was reported that; patient had past drug reaction of allergy to unknown drug.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid from 20Jul2022 to 25Jul2022. The patient had no known allergy.  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 available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound infection after testing negative with a home test for 7days; Rebound infection after testing negative with a home test for 7days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pectus excarvatum" (unspecified if ongoing); "Known allergies: mosquito bites" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sudafed, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Rebound infection after testing negative with a home test for 7days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti viral treatment for Covid 19. Patient received other concomitant medications within 2weeks which includes multivitamin from 30un2022 to 01Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2022 as dose 4 (booster), single (Lot number: 005M21A), 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: "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Jan2019; BUPROPION, start date: Jan2014. 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: (20Jul2022) Negative, notes: My symptoms started on 20Jul2022, although I tested negative (home test) that day; (20Jul2022) Positive, notes: My symptoms started on 20Jul2022, although I tested negative (home test) that day and positive (strong red line) the following day; (27Jul2022) Positive, notes: On the 27th I tested positive (faint line) with a home test; (28Jul2022) Negative, notes: On the 28th I tested negative with a home test; (31Jul2022) Positive, notes: On the morning of the 31st I definitely felt worse and tested strongly positive on a home test; (28Jul2022) Positive, notes: On the 28th I tested negative with a home test but also tested positive with a lab PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course includes, adverse event: Patient's symptoms started on 20Jul2022, although patient tested negative (home test) that day and positive (strong red line) the following day; started a 5 day course of Paxlovid that Evening. Patient's symptoms had mostly subsided before the end of treatment (last dose was the morning of 26Jul). On the 27th I tested positive (faint line) with a home test; on 28th I tested negative with a home test but also tested positive with a lab PCR test. On the 30th patient was concerned symptoms were returning, on the morning of the 31st patient felt worsened and tested strongly positive on a home test. The illness has been milder than the initial illness to date.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male 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: THROMBOSIS (medically significant; death), outcome "fatal", described as "blood clots". The patient date of death was unknown. Reported cause of death: "blood clots".  Clinical course: why Pfizer have the covid-19 vaccine and Paxlovid which are approved under an EUA at the same time. When will the FDA-approved vaccine labeled as "Comirnaty" be available. Will the Pfizer-BioNTech COVID-19 Vaccine product distributed under an EUA still be useable since the FDA has approved for Comirnaty. why Pfizer have the covid-19 vaccine and Paxlovid which are approved under an EUA at the same time. Caller is consumer that is asking "How can Pfizer have 2 EUA approved products Paxlovid, and Pfizer COVID 19 vaccine, that treat the same thing at the same time is there a loop hole here". Reporter stated that his wife's grandfather died of blood clots from a COVID vaccine. Reporter mentioned that many Conspiracy Theories during call and frustration with the system. Transmitting A/E information. Is there any information on the study that states people who received the vaccine had restructured DNA in their liver or Kidney cells, Does the MRNA shot alter the DNA of those that have been given it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: blood clots
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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: "Hyperthyroidism" (unspecified if ongoing); "elevated rheumatoid factor" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
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) (Pharmacist).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known drug allergies.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The device timestamp was reported as 01Aug2022. The patient was treated with Paxlovid orally for 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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: simply felt overall unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2021 as dose 1, single (Lot number: EW0183) at the age of 45 years, in left arm for covid-19 immunisation. The patient relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin and albuterol. Concomitant medication(s) included: L-LYSINE [LYSINE]. Past drug history included: Albuterol, reaction(s): "Known allergies: albuterol", notes: Known allergies: Penicillin and albuterol. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "simply felt overall unwell". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical Information: With the second dose, she had extreme fatigue for 6 months and a 28-day headache at the base of my skull. After the booster (3rd dose) she suffered from ongoing extreme fatigue, a deep itch/pain at the injection sight, and cysts in my left breasts. She had herpes that was under control for years. Less than 48 hrs after the booster she suffered an outbreak and has continued to have outbreaks (that have now spread to other parts of her body) every 10-14 days. All of the symptoms have remained ongoing even though it's been over 6 months. She had simply felt overall unwell since receiving these vaccines. She was normally a very healthy, energetic, and active woman. She did not covid prior to vaccination. She was covid tested post-vaccination. Patient received vaccine Facility from Pharmacy or Drug Store.
Age: 21.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: Ers737), in left arm and on 11May2021 as dose 2, single (Lot number: Fw0171) at the age of 21 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 032h21a), in left arm 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 May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received vaccine. The patient received other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: 331308A) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Mar2021 as dose 1, single (Lot number: 011Az1A) and on 01Apr2021 as dose 2, single (Lot number: 017B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Juvenile RA" (unspecified if ongoing), notes: Other medical history: Juvenile RA; "Psoriatic Arthritis", start date: 2019 (unspecified if ongoing), notes: Other medical history: Psoriatic Arthritis (2019); "ADHD" (unspecified if ongoing), notes: Other medical history: ADHD; "Reocurring Pregnancy Loss" (unspecified if ongoing), notes: Other medical history: Reocurring Pregnancy Loss; "POS" (unspecified if ongoing), notes: Other medical history: POS. Concomitant medication(s) included: PREDNISONE, start date: 19Apr2019; TIZANIDINE, start date: 01Apr2020; TRAZODONE, start date: 01Apr2021. Past drug history included: Plaquinil, reaction(s): "Allergy: PLAQUINIL", notes: Known allergies: PLAQUINIL; Methotrexate, reaction(s): "Allergy: Methotrexate", notes: Known allergies: Methotrexate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details for COVID 19 treatment included Paxlovid, Treatment start date: 26Jul2022, Treatment stop date: 30Jul2022.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: tree nuts" (unspecified if ongoing); "known allergies: Sulfa drugs" (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 Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Negative test for two days following treatment; (Jul2022) Negative, notes: Negative test for two days following treatment; (01Aug2022) Positive, notes: Three days after, I was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:Report about COVID treatment was yes.vaccine was received. No Other medication in 2 weeks.Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid,Treatment start date was  24Jul2022 and Treatment stop date was 28Jul2022.Indication was 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: 70.0
Sex: M
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 71-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 at 13:15 as dose 1, single (Lot number: EL9265), in left arm, on 24Feb2021 at 13:15 as dose 2, single (Lot number: EN6201), in right arm and on 21Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "NASH" (unspecified if ongoing); "Stage 2; arthritis (hands Lumbar Spine)" (unspecified if ongoing), notes: Stage 2; arthritis (hands Lumbar Spine); "dupuytren's contracture/Dup" (unspecified if ongoing), notes: dupuytren's contracture/Dup; "Blood Pressure" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Elevated Cholesterol" (unspecified if ongoing), notes: Elevated Cholesterol; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: ACETAMINOPHEN, start date: 21Sep2021; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jul2021, stop date: Jul2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (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: Antiviral details: Paxlovid from 30Jul2022 to 31Jul2022, lot number=GD3007, 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Electrocardiogram ambulatory, Pain assessment
Clinical narrative: Cardiac dysrhythmias; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse). Other Case identifier(s): 2022US002147 (Health).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Itching" (ongoing); "Skin lesions" (ongoing); "Redness" (ongoing); "Chest mass NOS" (unspecified if ongoing); "Mass excision" (unspecified if ongoing); "Surgical scar" (ongoing); "Sulfonamide allergy" (unspecified if ongoing); "Skin irritation" (unspecified if ongoing); "Sores" (unspecified if ongoing); "Blisters" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAMAZEPINE; PYRIDOXINE HCL; VITAMIN C [ASCORBIC ACID]; PROLIA; CANNABIDIOL; TERIPARATIDE; METOPROLOL SUCCINATE; CALCIUM. Past drug history included: Fosamax, reaction(s): "Allergy:Fosamax"; Dilantin, reaction(s): "Allergy:Dilantin"; Lamictal, reaction(s): "Allergy: Lamictal"; Keppra, reaction(s): "Allergy: Keppra"; Aspirin, reaction(s): "Allergy: Aspirin"; Thimerosal, reaction(s): "Allergy:Thimerosal"; Topamax, reaction(s): "Allergy: Topamax"; Bactrim, reaction(s): "Allergy: Bactrim"; Sulfadiazine, reaction(s): "Allergy: Sulfadiazine". The following information was reported: ARRHYTHMIA (medically significant), outcome "not recovered", described as "Cardiac dysrhythmias". The patient underwent the following laboratory tests and procedures: Electrocardiogram ambulatory: (04Jun2021) Result not provided; (05Jun2021) Result not provided; (06Jun2021) Result not provided; (07Jun2021) Result not provided; (08Jun2021) Result not provided; (09Jun2021) Result not provided; (10Jun2021) Result not provided; (11Jun2021) Result not provided; Pain assessment: (unspecified date) Pain is a 10 N/A.  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-202201026333 same reporter/patient/drug/event, different dose;US-PFIZER INC-202201026333 same reporter/patient/drug/event, different dose;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Electrocardiogram ambulatory, Pain assessment
Clinical narrative: cardiac dysrhythmias; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse). Other Case identifier(s): 2022US002147.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Itching (Pruritus)" (ongoing), notes: Itching (Pruritus); "Skin lesion" (ongoing); "Redness" (ongoing); "Chest mass NOS" (unspecified if ongoing); "Mass Excision" (ongoing); "Surgical scar" (ongoing); "frequent PVCs and PACs" (unspecified if ongoing), notes: frequent PVCs and PACs; "frequent PVCs and PACs" (unspecified if ongoing), notes: frequent PVCs and PACs; "skin irritation" (unspecified if ongoing); "blisters" (unspecified if ongoing); "Sores" (unspecified if ongoing), notes: Sores. The patient's concomitant medications were not reported. Past drug history included: Fosamax, reaction(s): "Drug allergy: Fosamax"; Dilantin, reaction(s): "Drug allergy: Dilantin", notes: Dilantin; Lamictal, reaction(s): "Drug allergy: Lamictal"; Keppra, reaction(s): "Drug allergy: Keppra", notes: Keppra; Aspirin, reaction(s): "Drug allergy: Aspirin"; Thiomersal, reaction(s): "Drug allergy: Thiomersal"; Topamax, reaction(s): "Drug allergy: Topamax"; Bactrim, reaction(s): "Sulfonamide allergy: Bactrim"; Sulfadiazine, reaction(s): "Sulfonamide allergy: Sulfadiazine", notes: Sulfonamide allergy: Sulfadiazine. Vaccination history included: BNT162b2 (Dose 1, SINGLE), administration date: 07Apr2021, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "Cardiac dysrhythmias". The following information was reported: ARRHYTHMIA (medically significant), outcome "not recovered", described as "cardiac dysrhythmias". The patient underwent the following laboratory tests and procedures: Electrocardiogram ambulatory: (04Jun2021) Results not provided; (05Jun2021) Results not provided; (06Jun2021) Results not provided; (07Jun2021) Results not provided; (08Jun2021) Results not provided; (09Jun2021) Results not provided; (10Jun2021) Results not provided; (11Jun2021) Results not provided; Pain assessment: (unspecified date) Pain is a 10 N/A. 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-202201026332 same reporter/patient/drug/event, different dose;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL 9264), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: Ff2588), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: F7. 4554) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative; (30Jul2022) Negative; (01Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, treatment start date=21Jul2022 and treatment stop date=19Jul2022. . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
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 72-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 at 13:00 as dose 2, single (Lot number: ER2613), in left arm and on 14Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bradycardia pacemaker" (unspecified if ongoing), notes: Bradycardia pacemaker. The patient's concomitant medications were not reported. Past drug history included: Cephalosporins, reaction(s): "Allergy_Cephalosporins". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Feeling abnormal, Limb discomfort, Pain
Clinical narrative: worse with the swelling and heat; worse with the swelling and heat; ache in her arm where she got the injection is there all the time; with the second booster it was worse/arm was worse; tiredness; feeling bad; heaviness/her arm was lead due to the heaviness/she has trouble lifting her arm when scratching her head; continual achiness; 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.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL taken for blood pressure abnormal; LEVOTHYROXINE taken for thyroid disorder; ECOTRIN. Vaccination history included: BNT162b2 (DOSE 1, Lot: EL8982, Anatomical location: Arm left), administration date: 30Jan2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "red swollen area", "red swollen area that itched a lot"; BNT162b2 (DOSE 2, Lot: EL9269 or EL9264, Anatomical location: Arm left), administration date: 20Feb2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "red swollen area", "red swollen area that itched a lot"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FF8839, Anatomical location: Arm left), administration date: 01Oct2021, when the patient was 80-year-old, for COVID-19 Immunization, reaction(s): "red swollen area", "red swollen area that itched a lot"; flu shot, administration date: 01Oct2021, when the patient was 80-year-old, for Immunization; Pneumonia shot, for Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "ache in her arm where she got the injection is there all the time"; PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "continual achiness"; FEELING ABNORMAL (non-serious) with onset Apr2022, outcome "unknown", described as "feeling bad"; LIMB DISCOMFORT (non-serious) with onset Apr2022, outcome "unknown", described as "heaviness/her arm was lead due to the heaviness/she has trouble lifting her arm when scratching her head"; FATIGUE (non-serious) with onset Apr2022, outcome "unknown", described as "tiredness"; CONDITION AGGRAVATED (non-serious) with onset Apr2022, outcome "unknown", described as "with the second booster it was worse/arm was worse"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Apr2022, outcome "unknown" and all described as "worse with the swelling and heat".
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: worse with the swelling and heat; worse with the swelling and heat; ache in her arm where she got the injection is there all the time; with the second booster it was worse/arm was worse; tiredness; feeling bad; heaviness/her arm was lead due to the heaviness/she has trouble lifting her arm when scratching her head; continual achiness; 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.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL taken for blood pressure abnormal; LEVOTHYROXINE taken for thyroid disorder; ECOTRIN. Vaccination history included: BNT162b2 (DOSE 1, Lot: EL8982, Anatomical location: Arm left), administration date: 30Jan2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "red swollen area", "red swollen area that itched a lot"; BNT162b2 (DOSE 2, Lot: EL9269 or EL9264, Anatomical location: Arm left), administration date: 20Feb2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "red swollen area", "red swollen area that itched a lot"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FF8839, Anatomical location: Arm left), administration date: 01Oct2021, when the patient was 80-year-old, for COVID-19 Immunization, reaction(s): "red swollen area", "red swollen area that itched a lot"; flu shot, administration date: 01Oct2021, when the patient was 80-year-old, for Immunization; Pneumonia shot, for Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "ache in her arm where she got the injection is there all the time"; PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "continual achiness"; FEELING ABNORMAL (non-serious) with onset Apr2022, outcome "unknown", described as "feeling bad"; LIMB DISCOMFORT (non-serious) with onset Apr2022, outcome "unknown", described as "heaviness/her arm was lead due to the heaviness/she has trouble lifting her arm when scratching her head"; FATIGUE (non-serious) with onset Apr2022, outcome "unknown", described as "tiredness"; CONDITION AGGRAVATED (non-serious) with onset Apr2022, outcome "unknown", described as "with the second booster it was worse/arm was worse"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Apr2022, outcome "unknown" and all described as "worse with the swelling and heat".
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Pyrexia, Somnolence
Clinical narrative: Tiredness/fatigue; Sleepiness; Diarrhea; Joint pain; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 26Jul2022 as dose number unknown, single (Lot number: FN2908) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness/fatigue"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepiness"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: Consumer reported, that he was basically trying to figure out how long these side effects last. He had the COVID shot the Lot# FN2908 on the 26th of July that was Tuesday. Queried for how long these side effects last. Consumer stated, that well it was just on the side effects listed its mentioned to report the side effects and report them to the Pfizer account. Reporter stated that he got the shot on Tuesday, 4 days ago and tiredness, sleepiness, fatigue, diarrhea, joint pain, fever. Reporter stated that patient had no Medical history and not had received any other medication and had not undergone any laboratory test.
Age: 50.0
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 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: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2022, stop date: 01Aug2022; MONTELUKAST, start date: 01Jan2022, stop date: 01Aug2022; ALLEGRA, start date: 01Jan2022, stop date: 01Aug2022; ADVAIR, start date: 01Jan2022, stop date: 25Jul2022. Past drug history included: Known allergies: morphine, reaction(s): "Known allergies: Morphine"; Known allergies: vicodin, reaction(s): "Known allergies: Vicodin"; Known allergies: demerol, reaction(s): "Known allergies: Demerol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has taken Paxlovid for the treatment of COVID-19 from 25Jul2022 to 29Jul2022. The patient has experienced adverse event on 26Jul2022 at 01:00 AM, Recovering, treatment received: IV Fluids. The patient developed extreme diarrhea and nausea by the second day on Paxlovid. He spent two days in the ER being evaluated. His covid symptoms also did not fully resolve during treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.