chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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 "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jul2022) Positive, notes: tested strongly positive this morning 31Jul2022 with a home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: Patient received no other medication in 2weeks. Patient received paxlovid for COVID 19 treatment. Treatment start date was 22Jul2022. treatment stop date was 27Jul2022. Adverse event: Patient completed a full course of paxlovid (last dose 27Jul2022 AM) with a good initial symptom response. He started to develop a sore throat on Saturday 30Jul2022 and tested strongly positive this morning 31Jul2022 with a home rapid test. He had moderate covid symptoms (sore throat congestion and cough) so appear to had experienced a paxlovid rebound infection.
Age: 53.0
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 12:00 as dose 1, single (Lot number: EP6955), in left arm, on 13Apr2021 at 12:00 as dose 2, single (Lot number: ER8731), in left arm and on 04Nov2021 at 18:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergies: shellfish" (unspecified if ongoing); "Allergies: melon" (unspecified if ongoing); "known allergies NSAIDs" (unspecified if ongoing), notes: known allergies NSAIDs. Concomitant medication(s) included: ADVAIR; SPIRIVA; AMLODIPINE; TRIAMTERENE HCTZ. Past drug history included: Aspirin, reaction(s): "known allergies aspirin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive; (31Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (from 14Jul2022 to 19Jul2022).  No follow-up attempts are required. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID rebound after taking Paxlovid; COVID rebound after taking Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: 027H21B) at the age of 47 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). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID rebound after taking Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Paxlovid taken as COVID 19 Treatment from 18Jul2022 to 29Jul2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: en9581), on 26Feb2021 as dose 2, single (Lot number: en6205) and on 25Oct2021 as dose 3 (booster), single (Lot number: fc3184) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROPANOLOL [PROPRANOLOL], start date: 01May2021; TADALAFIL, start date: 01Mar2021; ZINC, start date: 03Jan2022; OMEPRAZOLE, start date: 01Jul2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment for covid-19 with Paxlovid from 20Jul2022 to 24Jul2022. The patient had no known allergies.
Age: 50.0
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 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 05Feb2021 as dose 1, single (Lot number: EM9809), in right arm, on 26Feb2021 as dose 2, single (Lot number: EN6203), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301308BA) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Jun2022 at 16:00 as dose 4 (booster), single (Lot number: 059M21), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: days after I completed my Paxlovid treatment; Positive, notes: 5 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Other medication in 2weeks was no. The patient received Anti-viral COVID 19 treatment from 19Jul2022 to 23Jul2022. The patient had no known allergies.
Age: 52.0
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 53-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 09:00 as dose 1, single (Lot number: EN6206), in left arm and on 08Apr2021 at 12:00 as dose 2, single (Lot number: EP7533) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 23Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 011F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "pre diabeted throid issues" (unspecified if ongoing); "afib" (unspecified if ongoing). Concomitant medication(s) included: UNITHROID, start date: 01Oct2021, stop date: 30Jul2022; METFORMIN, start date: 17Sep2020, stop date: 30Jul2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) negative, notes: tested negative for 2 days; (Apr2022) positive; (Apr2022) negative, notes: Tested negative 4th day in; (Apr2022) negative, notes: tested negative 5th day; (Apr2022) negative, notes: tested negative 6th day; (Apr2022) negative, notes: tested negative 7th day; (Apr2022) negative, notes: tested negative 8th day; (Apr2022) positive, notes: tested positive 9th day; (Apr2022) positive, notes: tested positive 10th day; (Apr2022) positive, notes: tested positive 10th day thru 14th day; (Apr2022) positive, notes: tested positive 10th day thru 14th day; (Apr2022) positive, notes: tested positive 10th day thru 14th day; (Apr2022) positive, notes: tested positive 10th day thru 14th day; (Apr2022) negative, notes: then negative no symptoms the whole time. Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient had no known allergies. Patient stated he was exposed and tested negative for 2 days then positive and went right on paxlovid for 5 days.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 male patient received BNT162b2 (BNT162B2), on 15Nov2021 at 13:00 as dose 2 (booster), single (Lot number: EW0185-H) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 03Mar2021 at 13:00 as dose 1, single (Lot number: 041A21A), in left arm 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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient not received other medication in 2weeks. The patient had no known allergies. While taking Paxlovid patient immediately got the bitter taste in his mouth. Since he stopped taking it, the taste in his mouth had gone away. However, patient now had an extreme overreaction to any food or drink that was bitter, making it wholly inedible. Patient thought it was maybe from the Paxlovid still in my system. Yet now a week later patient still had the same reaction.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse food reaction, COVID-19, Dysgeusia
Clinical narrative: 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 male patient received BNT162b2 (BNT162B2), on 15Nov2021 at 13:00 as dose 2 (booster), single (Lot number: EW0185-H) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 03Mar2021 at 13:00 as dose 1, single (Lot number: 041A21A), in left arm 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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient not received other medication in 2weeks. The patient had no known allergies. While taking Paxlovid patient immediately got the bitter taste in his mouth. Since he stopped taking it, the taste in his mouth had gone away. However, patient now had an extreme overreaction to any food or drink that was bitter, making it wholly inedible. Patient thought it was maybe from the Paxlovid still in my system. Yet now a week later patient still had the same reaction.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN, start date: 01Jan2014. Past drug history included: Bactrim, reaction(s): "Known allergy: Bactrim". 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. Patient took other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 1, single (Lot number: El3247), in left arm, on 11Feb2021 at 12:00 as dose 2, single (Lot number: Em9808), in right arm and on 25Sep2021 at 12:00 as dose 3 (booster), single (Lot number: Fc3184) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "compete hysterectomy for uterine carcinoma" (unspecified if ongoing), notes: Other medical history: compete hysterectomy for uterine carcinoma; "compete hysterectomy for uterine carcinoma" (unspecified if ongoing), notes: Other medical history: compete hysterectomy for uterine carcinoma. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (31Jul2022) 99, notes: positive test, 99 temp on 31Jul2022; SARS-CoV-2 test: (Jul2022) Positive, notes: COVID 19 Treatment; (31Jul2022) Positive, notes: positive test, 99 temp on 31Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid treatment for COVID-19, Treatment start date:19Jul2022, Treatment stop date:23Jul2022. The patient had no known allergies. The patient had no other medication in 2weeks.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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 had no relevant medical history. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: I also re-tested and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks was Lexapro (generic). Patient had no known allergies. Patient received Paxlovid (anti-viral) from 22Jul2022 to 26Jul2022 for COVID-19 treatment. Patient was prescribed Paxlovid for the treatment of Covid and symptoms started to resolve after about 3 days. However, at day 5 or 6 they returned and were worse than before with cough, sore throat, body aches, fatigue and headache (all had resolved previously) patient also re-tested and tested positive again.  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, the causal association between the reported events Drug ineffective, Covid-19 and suspect drug Comirnaty cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Covid 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 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: "Osteoarthritis" (unspecified if ongoing), notes: Other medical history: Osteoarthritis, coronary artery calcium; "coronary artery calcium" (unspecified if ongoing), notes: Other medical history: Osteoarthritis, coronary artery calcium. Concomitant medication(s) included: LOSARTAN, start date: 01Apr2022; CRESTOR, start date: 02Jun2021, stop date: 21Jul2022; DUPIXENT, start date: 05Nov2021. Past drug history included: Cipro, reaction(s): "known allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Rebound 4 days after completing Paxlovid; (29Jul2022) Positive, notes: Rebound 4 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : Anti viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 21Jul2022, Treatment stop date: 25Jul2022, indication=Treatment of COVID-19. Other medication received in 2 weeks. Known allergies: Cipro. Other medical history: Osteoarthritis, coronary artery calcium.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
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 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), 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: (23Jul2022) Negative, notes: Tested negative on day 5 of Paxlovid treatment; (28Jul2022) Positive, notes: Tested positive 5 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 19Jul2022 till 23Jul2022. Clinical course: No known allergies. Patient received paxlovid for Treatment of COVID-19. Patient tested negative on day 5 of Paxlovid treatment and tested positive 5 days later. Patient did not had any other medication in 2 weeks. Patient was on day 3 of rebound case experiencing very mild symptoms: some sinus pressure and runny nose.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 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) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I am still testing positive no symptoms; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, patient received anti-viral drug paxlovid from 21Jul2022 to 26Jul2022 as COVID 19 Treatment. Adverse event: she was still testing positive no symptoms and she feel fine and adverse event start date on 30Jul2022 and no treatment for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. Concomitant medication(s) included: PREDNISONE, start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (22Jul2022) Negative, notes: Tested neg on day six and 7; (23Jul2022) Negative, notes: Tested neg on day six and 7; (25Jul2022) Positive, notes: On day 9 tested positive and had symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Jul2022 to 21Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative, notes: I tested negative after the 5 day course of Paxlovid; (30Jul2022) Positive, notes: 6 days after finishing the treatment, I tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested negative after the 5 days course of Paxlovid. Was feeling good. Minimal symptoms. 4 days later, I became very stuffy/congested. 6 days after finishing the treatment, I tested positive for Covid again. No known allergies. Covid-19 was treated with Paxlovid (Treatment start date= 20Jul2022, Treatment stop date= 24Jul2022).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Lot Gc2897) treatment start date was 20Jul2022 and stop date was 25Jul2022.  Clinical course: From 29Jul2022 at 09 AM the patient began to experience sore throat, runny nose, swollen glands last night and upper respiratory congestion with outcome not recovered. Patient received vaccine and no any other medication in 2weeks.No any Known allergies.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Apr2022 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothroidism" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; SIMVASTATIN. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (03Jul2022) Positive, notes: Sunday, July 3 (5th day of Paxlovid): Positive rapid antigen test around 8:10 am; (06Jul2022) Negative, notes: Wednesday, 6Jul: I feel pretty darn good Negative rapid antigen test taken about 9:40 AM; (12Jul2022) Positive, notes: Tuesday, 12Jul: Positive rapid antigen test at 10 am. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Continued mild symptoms- scratchy (and occasionally sore) throat. It was still hard to fall asleep last night. Patient feel like she had a mild cold. Her head was stuffy. That was her only symptom. She really thought she was going to test negative because she attributes the cold to two consecutive nights of abysmal sleep.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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 had no relevant medical history. Concomitant medication(s) included: AUROVELA 1.5/30. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, 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; (25Jul2022) Negative, notes: tested negative for Covid-19; (31Jul2022) Positive, notes: tested positive for Covid-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was given paxlovid from 20Jul2022 through 25Jul2022 as a treatment for covid 19. Patient took other medication in 2 weeks. Patient does not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 95.0
Sex: M
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) (Physician).  A 95-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 95 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Feb2021 at 14:00 as dose 1, single (Lot number: 032L20A), in left arm and on 03Mar2021 at 13:30 as dose 2, single (Lot number: 032L20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "PVD" (unspecified if ongoing); "BPH" (unspecified if ongoing); "DM" (unspecified if ongoing); "Parkinsonism" (unspecified if ongoing); "MI" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN oral, start date: 23Jun2022; METOPROLOL TARTRATE oral; METFORMIN oral; MELATONIN oral; LEVOTHYROXINE [LEVOTHYROXINE SODIUM] oral; GABAPENTIN oral; PROSCAR oral; FERROUS GLUCONATE oral; LIPITOR oral, start date: 23Jun2022; ACETAMINOPHEN oral; ASPIRIN (E.C.) oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) positive; (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid Treatment received (from 23Jun2022 to 27Jun2022) 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 available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 at 12:15 as dose 4 (booster), single (Lot number: FJ4989) 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: "CAD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: Four days later began feeling ill again, then re-tested positive; Negative, notes: Tested negative two days after completing the full doses of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested negative two days after completing the full doses of Paxlovid. Four days later began feeling ill again, then re-tested positive. No Known allergies. No other medication in 2weeks.
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 26Mar2021 as dose 2, single (Lot number: ER8727), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Negative; (27Jul2022) Positive; (29Jul2022) Negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid, start on 19Jul2022 and stop on 24Jul2022.  Clinical information: The patient had received vaccine and also had administered another medication (which are captured in linked case 202201022902) within 2 weeks of vaccine administration.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLONASE ALLERGY RELIEF; ZYRTEC ALLERGY. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (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) Positive, notes: COVID 19 Treatment; (21Jul2022) Positive, notes: days after first dose of Paxlovid, felt better and tested barely positive; (23Jul2022) Positive, notes: 11 days after first dose, started having symptoms and tested very positive; (30Jul2022) Positive, notes: 18 days after first dose of Paxlovid, still symptomatic and testing very positive. Therapeutic measures were taken as a result of drug ineffective, sars-cov-2 test positive.   Clinical course: The patient took other medication in 2 weeks which included Flonase, one a day vitamin, Zyrtec and saline nose spray. The patient received Paxlovid, start date:12Jul2022; stop date:17Jul2022 as treatment for adverse events. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vicodin allergy, reaction(s): "known allergies: Vicodin allergy", notes: known allergies: Vicodin allergy. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medication vitamins with iron in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 12:00 as dose 1, single (Lot number: EP6955), in right arm and on 08Apr2021 at 12:00 as dose 2, single (Lot number: ER8720) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 20May2022 at 18:00 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Primary Immune Deficiency" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: The patient started COVID 19 treatment from 15Jul2022 till 19Jul2022, lot number 2815213.
Age: 40.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 40 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: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE & HCTZ, start date: 11Oct2017; SERTRALINE, start date: 03Sep2019.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient had received Other medication in 2weeks. Rebound Covid infection. Symptoms began on Tuesday 26Jul2022. Anti viral details: product: COVID 19 Treatment, brand: Pfizer, treatment start date:17Jul2022, treatment stop date: 22Jul2022, lot number: 1910752A, indication: Treatment of COVID-19. Adverse event start date: 26Jul2022 adverse event start time: 12:00 PM, Ae resulted in: [None of the above], If patient recovered: Recovering, If treatment ae: Unknown. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 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: "TA aneurysm" (unspecified if ongoing), notes: Other medical history: TA aneurysm; "controlled Afib" (unspecified if ongoing), notes: Other medical history: controlled Afib; "known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "known allergies finned fish" (unspecified if ongoing), notes: known allergies finned fish; "Prosthetic Aortic valve" (unspecified if ongoing), notes: Other medical history: Prosthetic Aortic valve (near end of replacement duration). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Jul2022) Negative, notes: Tested negative after finishing Paxlovid 5 day course. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 18Jul2022 to 22Jul2022 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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Psoriatic arthritis" (unspecified if ongoing), notes: Other medical history: Psoriatic arthritis; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: METHOTREXATE, start date: 10Jul2022, stop date: 24Jul2022. Past drug history included: Guaifenesin for known allergies: guafenesin, notes: Known allergies: Guaifenesin. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: Positive, notes: Strong positive antigen test result. 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.