chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (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), 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: "Pmr" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Treatment of COVID-19; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: other medication in 2weeks: Yes. Other medication in 2 weeks product reported as Prednisone 3 mg. Rebound five days after finishing paxlovid and tearing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic decreased, Blood pressure measurement
Clinical narrative: He said he wanted to report a drop in his blood pressure the next day and his normal blood pressure is 120 or 125 over 70 and his blood pressure went down to 70/50.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: BLOOD PRESSURE DIASTOLIC DECREASED (non-serious), outcome "unknown", described as "He said he wanted to report a drop in his blood pressure the next day and his normal blood pressure is 120 or 125 over 70 and his blood pressure went down to 70/50.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Calling about the Covid-19 second booster shot. The reporter said he wanted to report a drop in his blood pressure the next day and his normal blood pressure is 120 or 125 over 70 and his blood pressure went down to 70/50. reporter said no when asked to complete report and said he just wanted to let Pfizer know. reporter declined to complete a report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-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 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; PROZAC; CHLORTHALIDONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Treatment of COVID-19; (17Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient started the treatment with Paxlovid for Covid-19 from 11Jul2022 to 16Jul2022 (Saturday). Tested negative on rapid antigen Sunday and Monday. The patient had congestion and mild cough on Wednesday, 20Jul. Tested positive on 21Jul.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 53 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: "IBS" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid". The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown resluts, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication within 2 weeks of vaccination. The patient received Anti-viral drug (Paxlovid) as COVID 19 treatment from 08Jul2022 to 12Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Aug2021 as dose 2, single (Lot number: pf13er) at the age of 70 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 had no relevant medical history. There were no concomitant medications. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received other medication in 2weeks. Product: COVID 19 Treatment. Brand: paxlovid. Treatment start date: 15Jul2022. Treatment stop date: 18Jul2022. Lot number: 1917995A. Patient did not have known allergies.; Sender's Comments: As per available information the causality of the event covid-19 and the suspect product BNT162B2 can't be ruled out.
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Other medication in 2 weeks/Concomitant medication(s) included: TRAZODONE; VENLAFAXINE. 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: Unknown result, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, anti-viral details product: COVID 19 Treatment, Brand: Paxlovid treatment started 19Jul2022, indication: Treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 12Jan2021 at 12:00 as dose 1, single (Lot number: EL1283), on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9264), in left arm, on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 30Mar2022 at 12:00 as dose 4 (booster), single (Lot number: FS9943) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (18Jul2022) Positive, notes: still testing positive on the home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received Paxlovid, treatment from 03Jul2022 to 08Jul2022 for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: FH8020), in left arm, on 24Feb2021 as dose 2, single (Lot number: E6198), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EL9261) at the age of 53 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Patient received vitamins as other medications within 2 weeks of vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022 at 17:00, outcome "not recovered" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as a treatment for Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: FH8020), in left arm, on 24Feb2021 as dose 2, single (Lot number: E6198), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EL9261) at the age of 53 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Patient received vitamins as other medications within 2 weeks of vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022 at 17:00, outcome "not recovered" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as a treatment for Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
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 24Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Tab Paxlovid.  Clinical course: Other medication in 2weeks yes. Reported in split case, became ill again 5 days after completion of Paxlovid. Terrible acidic, bitter taste in mouth, diarrhea, general feeling of malaise .She had no known allergies and no relevant medical history. Covid-19 treatment was done with Paxlovid from 09Jul2022 to 15Jul2022.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Malaise, Smoke sensitivity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0191) at the age of 64 years for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Relevant Medical History and Concurrent Conditions (not including reaction / event):, Comments: High blood pressure. Concomitant medication(s) included: METOPROLOL SUCCINATE taken for hypertension. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches all the time"; SMOKE SENSITIVITY (non-serious), outcome "unknown", described as "when I am at work it make this worse 'smoke' and now my body feels like it heats up"; FEELING HOT (non-serious), outcome "unknown", described as "when I am at work it make this worse 'smoke' and now my body feels like it heats up and in end I just have to take the smoke and everything just like get out of it and 'quit' the smoke because it feels like I am too hot"; MALAISE (non-serious), outcome "unknown", described as "I didn't feel right".
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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: "IPF" (unspecified if ongoing), notes: Other medical history: IPF. Concomitant medication(s) included: CRESTOR, start date: Jan2003, stop date: 11Jul2022; OFEV, start date: Jan2020, stop date: 11Jul2022. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (14Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (Jul2022) strong red line, notes: antigen tests show a strong red line; (15Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (16Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (17Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (18Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received other medication in 2weeks. product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 11Jul2022, Treatment stop date: 15Jul2022, Indication: Treatment of COVID-19. After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days and then antigen tests show a strong red line I do not fever nor major symptoms (only a bit of fatigue).  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: husband tested positive; husband tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose  1, single (Batch/Lot number: unknown), on 01Mar2021 as dose  2, single (Lot number: FE3590) and on 12Oct2021 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "husband tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: her husband tested positive. 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: 47.0
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) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: If vaccine received: Yes. Other medication in 2weeks: Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19 and the suspect drug BNT162b2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Calling about the Pfizer BioNTech Covid 19 vaccine. She started taking Paxlovid; Calling about the Pfizer BioNTech Covid 19 vaccine. She started taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 99-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing), notes: She does have a pacemaker and takes high blood pressure medication.; "high blood pressure" (unspecified if ongoing), notes: She does have a pacemaker and takes high blood pressure medication. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Calling about the Pfizer BioNTech Covid 19 vaccine. She started taking Paxlovid". 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 16Feb2021 as dose 2, 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: "mild hypertension" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "known allergies: white fish" (unspecified if ongoing), notes: known allergies: white fish; "known allergies: jalapeno peppers" (unspecified if ongoing), notes: known allergies: jalapeno peppers; "Allergy: sulfa" (unspecified if ongoing), notes: Allergy: sulfa. The patient took concomitant medications. Past drug history included: Emycin, reaction(s): "Allergy: Emycin"; Betadine, reaction(s): "Allergy: betadine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, 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: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks of vaccine. Anti viral details included COVID 19 Treatment, brand was Paxlovid, started on 11Jul2022 to 16Jul2022, lot number was 00069-1085-30.   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, 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 73-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergies: amoxicillin". 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: very positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received vaccine. No other medication in 2 weeks. Patient received treatment with Anti-viral for COVID 19 from 08Jul2022 to 12Jul2022. Rebound 4 days after completing course of Paxlovid, developed heavy sinus congestion, sneezing, runny nose and very positive antigen test.
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) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ITP" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 01Apr2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: COVID 19 Treatment; (12Jul2022) Negative, notes: After taking Paxlovid and testing negative on 12Jul2022; (19Jul2022) Positive, notes: tested on 19Jul and was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 06Jul2022 to 10Jul2022 for treatment of covid-19. After taking Paxlovid and tested negative on 12Jul2022, she became symptomatic again on 18Jul. After feeling worse, she tested on 19Jul and was positive again and for which she did not receive any treatment. It was reported that the patient had no known allergies.
Sex: F
Vaccine: COVID19, 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. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "blood clots".  Clinical course: Patient wanted to know if it is recommended that she get the 2nd booster dose of Pfizer-Biontech Covid vaccine given her history of getting blood clots and being hospitalized after getting previous the doses.  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-2021229915 Same patient and drug, different event separated in time;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Ultrasound scan, Vaccination failure
Clinical narrative: blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "blood clots".  Clinical course: Patient wanted to know if it is recommended that she get the 2nd booster dose of Pfizer-Biontech Covid vaccine given her history of getting blood clots and being hospitalized after getting previous the doses.  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-2021229915 Same patient and drug, different event separated in time;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling of the fingertips; some numbness today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose number unknown (second booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1 Booster , MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer"), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset Jul2022, outcome "unknown", described as "some numbness today"; PARAESTHESIA (non-serious) with onset 20Jul2022, outcome "not recovered", described as "tingling of the fingertips".  Additional information: Consumer calling in about the Pfizer COVID 19 vaccine. She received the second booster shot Tuesday 19Jul, and started to feel tingling of the fingertips/some numbness today. She wants to know if this is a side effect of the vaccine.She doesn't know if this is from booster or not. She got booster shot this past Tuesday, 19Jul2022, and is noticing tingling in finger tips yesterday and today. Could that be the result of the vaccine. During call, caller stated she has to clear throat. She did not have email for primary care. She did not have date of 1st dose or others and stated she did not have vaccine card with her.  Caller decided she did not have all of the information needed to complete report and requested to be transferred to have her question answered. No further details provided.  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications/The patient had no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received the Anti-viral COVID 19 Treatment, Paxlovid, of started on 11Jul2022 and stop on 15Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
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 64-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 21Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 19Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 as dose 4 (booster) , single (Lot number: 048L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "None." (unspecified if ongoing). Concomitant medication(s) included: GLUCOSAMINE SULFATE, start date: Jan2012, stop date: 21Jul2022; VITAMIN D3 1000, start date: Jan2021, stop date: 21Jul2022. The following information was reported: VACCINATION FAILURE (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: (19Jul2022) Negative; (20Jul2022) Positive; (21Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 28Jun2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (20Jul2022) Positive, notes: Rebound COVID 20Jul22. 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: Linked Report(s) : US-PFIZER INC-202200996400 same reporter, same patient, same product, different event;
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA 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: "Heart disease" (unspecified if ongoing), notes: Other medical history: Heart disease - high blood pressure -high cholesterol; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Heart disease - high blood pressure -high cholesterol; "high cholesterol" (unspecified if ongoing), notes: Other medical history: Heart disease - high blood pressure -high cholesterol. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Unknown results, notes: COVID 19 Treatment; (20Jul2022) Positive, notes: Tested positive 4 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Product: COVID 19 Treatment, Brand: Paxlovid. Treatment start date: 11Jul2022; Treatment stop date: 16Jul2022. Indication: Treatment of COVID-19. The patient had no known allergies. Tested positive 4 days after completing treatment.  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
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 16:00 as dose 1, single (Lot number: EN6208), on 02Apr2021 at 16:00 as dose 2, single (Lot number: ER8734), on 05Nov2021 at 17:00 as dose 3 (booster), single (Lot number: FH8027) and on 27May2022 at 16:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION, start date: 06Jul2018; ATORVASTATIN, start date: 03Aug2018, stop date: 07Jul2022; VITAMIN C ACID; VITAMIN D NOS; ZINC; CBD OIL. Past drug history included: Codeine, reaction(s): "Known allergies: codeine", notes: Known allergies: codeine. The following information was reported: VACCINATION FAILURE (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; Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The Patient took PAXLOVID from 08Jul2022 to 12Jul2022 for the COVID-19 treatment and 8 days after finishing PAXLOVID symptoms returned and tested positive again on 20Jul2022 at 06:00 PM. No treatment was received.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 21May2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti viral details: Product COVID 19 Treatment Paxlovid with lot number 1917015A, treatment start date was 13Jul2022, treatment stop date was 18Jul2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 05Jul2022 to 09Jul2022 via oral for treatment of COVID-19. Clinical Course: No other medication in 2 weeks and no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event vaccination failure and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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: "Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other Medication in 2 weeks. Patient had known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SANDOZ-ESTRADIOL, start date: Oct2021; PROGESTERONE, start date: Mar2020. Past drug history included: Lovenox, reaction(s): "known allergies: Lovenox". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. 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.