chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29May2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 49 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 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20Jul2022) Positive, notes: After treatment was complete I rebounded with Covid 4 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: It was unknown whether patient received any other medications in 2 weeks.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test positive Wednesday morn; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN8705), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FU4989) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Known allergies: Statins" (unspecified if ongoing); "Known allergies: Yellow dye" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; OMEPRAZOLE; WELLBUTRIN; EZETIMIBE; BIOTIN; CALTRATE VITAMIN D3; ELDERBERRY [SAMBUCUS NIGRA]; ZINC. 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"; DISEASE RECURRENCE (medically significant) with onset 20Jul2022, outcome "not recovered", described as "COVID test positive Wednesday morn". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: Paxlovid taken Sunday 10Jul2022 evening thru Friday 15Jul2022 morning. Bit breathless Saturday Sunday prednisone and nebulizer added Monday 18Jul2022. Improved until Wednesday late afternoon (20Jul2022). COVID test positive Wednesday morning (after nearly disappearing Sunday 17Jul2022) Dyspnea, headache, malaise Thurs 21Jul2022. Dyspnea, headache, loss of taste and smell Friday 22Jul2022. AE treatment: Prednisone (Medrol pack) and nebulizing Albuterol.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: ch9899), in left arm, on 06Jan2021 as dose 2, single (Lot number: ek9231), in left arm and on 23Aug2021 as dose 3 (booster), singl (Lot number: fd8448) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 26Jan2022 as dose 4 (booster), single (Lot number: 022j21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 03Jan2022, stop date: 11Jul2022; WEGOVY, start date: 19Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received paxlovid on 11Jul2022 to 15Jul2022 for Covid 19 treatment. The patient received other medication in past 2 weeks. The patient had no allergy.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Running nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 09:00 as dose 1, single (Lot number: EN), in left arm, on 27Feb2021 at 09:00 as dose 2, single (Lot number: EN6201), in left arm and on 29Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 3203080) at the age of 66 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 15Jul2022, outcome "unknown", described as "Running nose"; VACCINATION FAILURE (medically significant) with onset 15Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 15Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (15Jul2022) 102, notes: 15Jul2022 6:30 pm fever 102; (16Jul2022) 101, notes: 15Jul2022 6:15 pm fever 101; (23Jul2022) 100.1, notes: 23Jul2022 temperature 100.1 after shower; (23Jul2022) 98.7, notes: 23Jul2022 temperature 100.1 after shower. Reduce to 98.7 after one hour; SARS-CoV-2 test: (14Jul2022) Negative, notes: 14Jul2022 tired, test negative; (15Jul2022) Positive, notes: 15Jul2022 early morning, running nose, tested positive; (21Jul2022) Negative, notes: 21Jul tested negative, tired and sleep much more than normal. Eyes blurry; (22Jul2022) Negative, notes: 22Jul2022 tested negative; (23Jul2022) Positive, notes: 23Jul2022 tired in the morning. Blurry eyes. Running nose from noontime. Tested positive around 6:30 pm. Therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea.  Clinical course: Other medication in 2 weeks was yes. Treatment AE was No. Known allergies was No. Other medical history was No. 14Jul2022 tired, test negative 15Jul2022 early morning, running nose, tested positive. 15Jul2022 2:00 pm took first dose of Paxlovid. 15Jul2022 6:30 pm fever 102, took Tylenol, sweat and fever reduced.
Age: 30.0
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 31-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result; Negative, notes: Paxlovid rebound 3 days after first negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid from 13Jul2022 to 18Jul2022.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 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: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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) negative; (23Jul2022) positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: After testing negative patient started feeling sick again. Worse then original. Tested positive. Proprietary medicinal product name: Pavloxid, Indication for use in the case: Treatment of COVID-19, Date of start of drug: 15Jul2022, Date of last administration: 19Jul2022, The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 13:00 as dose 1, single (Lot number: EW0178), in right arm, on 08Apr2021 at 13:00 as dose 2, single (Lot number: EW0178), in left arm and on 11Oct2021 at 15:00 as dose 3 (booster), single (Lot number: EW0178) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiac disease" (unspecified if ongoing); "stents" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 14Jul2022 to 18Jul2022 with lot no. GD3258.  No known allergies were reported and no fever (temperature normal)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 33-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication was taken in 2 weeks. Patient received Paxlovid for Treatment of COVID-19 from 26Jun2022 till 01Jul2022. Patient experienced COVID-19 rebound on 22Jul2022.  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 .
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2021 at 16:00 as dose 2, single (Lot number: EW0168), in left arm and on 09Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "menopause" (unspecified if ongoing), notes: Other medical history: Only menopause for past 7 years - hot flashes; "hot flashes" (unspecified if ongoing), notes: Other medical history: Only menopause for past 7 years - hot flashes. Other medical history included only menopause for past 7 years with hot flashes and patient known allergies included allergy to Tamiflu, bactrim and fluconazole. The patient's concomitant medications were not reported. Past drug history included: Tamiflu, reaction(s): "Known allergies: Tamiflu", notes: Known allergies: Tamiflu, bactrim and fluconazole; Bactrim, reaction(s): "Known allergies: bactrim", notes: Known allergies: Tamiflu, bactrim and fluconazole; Fluconazole, reaction(s): "Known allergies: fluconazole", notes: Known allergies: Tamiflu, bactrim and fluconazole. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Positive, notes: Tested positive on rapid test 16Jul2022; (21Jul2022) Negative, notes: Tested negative 21Jul2022/22Jul2022; (22Jul2022) Negative, notes: Tested negative 21Jul2022/22Jul2022; (23Jul2022) Negative, notes: 23Jul2022 and tested negative; (24Jul2022) Positive, notes: tested positive on 2 separate rapid tests; (24Jul2022) Positive, notes: tested positive on 2 separate rapid tests. Patient received the vaccine. Patient received Paxlovid from 16Jul2022 to 20Jul2022 for treatment of COVID-19. Covid symptoms started 15Jul2022. Tested positive on rapid test 16Jul2022 and immediately started Paxlovid. Finished treatment on 20Jul2022. Tested negative on 21Jul2022/22Jul2022. Symptoms returned on 23Jul2022 and tested negative. Symptoms worsened on 24Jul2022 and tested positive on 2 separate rapid tests. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Disease recurrence; 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 13Jun2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) positive; (10Jun2022) Negative; (13Jun2022) Positive; (Jun2022) Negative, notes: I had tested negative, was feeling fine; (Jun2022) Positive, notes: had symptoms again and tested positive a few days after having tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Reporter stated that, No Other medication in 2weeks. Anti viral details product was mentioned as COVID 19 Treatment, treatment started on 03Jun2022 and stopped date=08Jun2022, indication was Treatment of COVID-19. vaccine lot unknown reason was mentioned as Unable to locate or read the details. Patient was tested positive for COVID on 03Jun2022.  Patient took Paxlovid (53-years-old and have asthma). tested negative on 10Jun and symptoms had disappeared by then. However, three days later on 13Jun, developed pink eye, had a bad headache and felt tired. Patient  did another COVID test and tested positive on 13Jun. Patient had symptoms this second round for about 4 days. This is not an adverse effect but more a prolonged COVID case. Patient had tested negative, was feeling fine and then had symptoms again and tested positive a few days after having tested negative. her husband tested positive at the same time and recovered much quickly than she did. her symptoms were different in the first infection than in the second phase. patient only had pink eye and headache the second time she tested positive. Adverse event start date was 13Jun2022, Patient was recovered. Adverse event stop date was reported as 7Jun2022. No treatment Ae.. No Known allergies. Device timestamp: 23Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 07May2021 as dose 2, single (Lot number: EN6208), in right arm and on 14Oct2021 as dose 3 (booster), single (Lot number: EFE3590) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR, start date: 08Apr2022, stop date: 12Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (24Jul2022) Positive, notes: I used a Siemens's antigen test. It was positive on 24Jul (7 days after my last). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medications in two weeks of vaccination. Treatment started on 12Jul2022. Treatment stopped on 17Jul2022. Six days after of last dose of Paxlovid, patient started experiencing cold like symptoms: congestion, some sneezing, sinus pressure. Initially thinking it could be seasonal allergies or potential for sinus infection. After reading so many journals and articles on "rebound" with Paxlovid, patient used a Siemens's antigen test. It was positive on 24Jul (7 days after her last dose). Known allergies and other medical history were reported as No.
Age: 69.0
Sex: U
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 70-year-old patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EJ1686), in left arm, on 07Feb2021 as dose 2, single (Lot number: EL9261), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 69 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: 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: (unspecified date) Positive; (13Jul2022) Positive, notes: Rebound after 4 days after paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies. Patient did not receive any medications within two weeks
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Nov2021 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral Paxlovid COVID 19 Treatment which start date was 13Jul2022 and stop date was 17Jul2022.The patient was taking any other medications products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Sinus infection 5 days after completion of Paxlovid. adverse event start date was 22Jul2022. It was unknown if patient was recovered. No treatment received for AE  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Anemia" (unspecified if ongoing), notes: occasional anemia. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures (Treatment with Paxlovid started on 09Jul2022 and stop date on 14Jul2022) were taken as a result of covid-19, drug ineffective.  Clinical course: I am testing positive again for Covid via two different rapid tests. Mild symptoms include fatigue and general feelings of being run down. Some mild congestion and coughing. Other medication in 2weeks product Generic for Lexapro taken daily. Known allergies No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
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 41-year-old male patient received BNT162b2 (BNT162B2), on 11Sep2021 as dose 3 (booster), single (Lot number: F3183) at the age of 41 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 was not reported. Concomitant medication(s) included: METOPROLOL; LEXAPRO; CLARITIN [LORATADINE]; FENOFIBRATE; FLONASE [MOMETASONE FUROATE]. 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: (2022) Negative, notes: Positive COVID test 6 days after testing negative; (2022) Positive, notes: Positive COVID test 6 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details product: COVID-19 Treatment, brand: Plaxovid, treatment start date: 10Jul2022, treatment stop date: 14Jul2022, indication: Treatment of COVID-19. Positive COVID test 6 days after testing negative, patient recovered, No Known allergies, Device timestamp: 22Jul2022.
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) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 17May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "have only 1 kidney" (unspecified if ongoing), notes: have only 1 kidney. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive; (19Jul2022) Negative; (23Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information :The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.The patient previously received a COVID-19 Vaccine. Patient tested positive on 13Jul2022 and took 5 day course of Paxlovid. Patient tested negative on 19Jul2022. Patient started feeling poorly (chills and headache) and tested positive again on 23Jul.2022 .patients exposure was in different country, but tested positive in another.  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 available information , there is reasonable possibility of causal association between the events Vaccination failure and COVID 19  and the suspect drug BNT162b2 .
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0162), in left arm and on 28May2021 as dose 2, single (Lot number: EW0167) at the age of 36 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receives a COVID-19 Vaccine. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 12Jul2022, treatment stop date: 16Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 13:15 as dose 1, single (Lot number: EL3246), in left arm, on 12Feb2021 at 12:30 as dose 2, single (Lot number: EL3246), in left arm, on 13Oct2021 at 10:15 as dose 3 (booster), single (Lot number: FP2589), in left arm and on 13Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ5683) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) positive, notes: Symptoms returned 5 days after completion of Paxlovid treatment. Have continued to test positivity since onset of first positive test on 12Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine. No known allergies reported. No drug as reported and reaction: Allergy. No hospitalization prolonged.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vaccination failure,covid-19.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 15May2021 at 09:00 as dose 1, single (Lot number: EW0167), in left arm, on 07Jun2021 at 09:00 as dose 2, single (Lot number: EW0187), in left arm and on 07Jan2022 at 09:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing); "Known allergy: Blue cheese" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergy: Erythromycin". The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown results; (2022) Negative, notes: testing negative; (21Jul2022) Positive, notes: Covid 19 symptoms reoccurred with a positive test 3 days after finishing PAXLOVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient stated that Anti-viral details for COVID 19 Treatment, Paxlovid, Treatment start date: 13Jul2022, Treatment stop date: 18Jul2022, Covid 19 symptoms reoccurred with a positive test 3 days after finishing PAXLOVID and testing negative.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "Kidney disease" (unspecified if ongoing), notes: Kidney disease. Concomitant medication(s) included: WELLBUTRIN; SERTRALINE; DEXTROAMPHETAMINE [DEXAMFETAMINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 75-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "High Colesterol" (unspecified if ongoing), notes: High Colesterol; "spinach caused loose bowels" (unspecified if ongoing), notes: spinach caused loose bowels. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient took anti-viral paxlovid as part of covid-19 treatment (treatment start date:13Jul2022, treatment stop date:17Jul2022) and other antibiotics (11Jul2022 to 15Jul2022). The reason for lot unknown was unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 10:00 as dose 1, single (Lot number: EN5318), in left arm, on 24Feb2021 at 10:00 as dose 2, single (Lot number: EN6203), in left arm, on 24Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 11May2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 66 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction(s): "known allergies: Celebrex", notes: known allergies: Celebrex; Morphine, reaction(s): "known allergies: morphine", notes: known allergies: morphine; Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The patient was not pregnant at the time of vaccination. Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as no. Did the patient previously received a COVID-19 Vaccine was reported as yes. 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: (Jul2022) Positive, notes: original positive test. Therapeutic measures were taken as a result of covid-19. It was reported that, rebound of COVID-19 with symptoms slightly worse than the original symptoms. Rebound was 8 days after original positive test. The device date was on 23Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6199), on 08Apr2021 as dose 2, single (Lot number: ER8730) and on 30Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure but blood pressure has been under control for several months. Concomitant medication(s) included: LISINOPRIL; METFORMIN; ATORVASTATIN. Past drug history included: Sulfa antibiotics, reaction(s): "known allergies: Sulfa antibiotics". The following information was reported: VACCINATION FAILURE (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: Unknown Results; Negative; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 07Jul2022 to 12Jul2022, Lot number: GC4035.  Clinical course: Adverse event: Even though starting testing negative for COVID 5 days after initial start of symptoms and continued to test negative up to around day 15 following onset of symptoms, symptoms have lingered. Symptoms began to worsen 17 days following initial symptom onset and when tested, test was positive. Other medical history: type 2 diabetes, high blood pressure but blood pressure has been under control for several months.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 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: "cervical spondylosis" (unspecified if ongoing); "HLD" (unspecified if ongoing), notes: HLD; "hypothyroidism" (unspecified if ongoing); "ischemic colitis" (unspecified if ongoing); "ischemic heart disease" (unspecified if ongoing); "macrocytosis" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  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: SARS-CoV-2 test: (23Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=11Jul2022, treatment stop date=16Jul2022, Indication=Treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I had shots before I got the stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, single), administration date: 2021, for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I had shots before I got the stroke".  Clinical course: Patient got 2 shots for COVID a year ago. Patient had not gotten the booster. First of all 6 months ago patient had a stroke that well patient was stuck and the result that patient didn't get the booster and later on patient found that there has not been any kind of study on people at patient age, patient was 80 So, patient wanted to know why was not there any studies on patient's age regarding the vaccine and regarding the booster. So, patient had not taken the booster. Patient doctor did not know either.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 at 08:30 as dose 3 (booster), single (Lot number: EP6955) at the age of 41 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), notes: Other medical history: Obesity. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Covid-19 therapeutic measure included paxlovid with start date on 13Jul2022 and stop date on 17Jul2022. No other medications were taken within 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
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) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 12:00 as dose 1, single (Lot number: PAA156051), in right arm, on 20Jun2021 at 12:00 as dose 2, single (Lot number: EL9261), in left arm and on 06Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer", start date: 2012 (unspecified if ongoing); "thyroidectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Known Allergies: Sulfur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative; (05Jul2022) Positive; (17Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She was taking any other medications/products within 2 weeks of starting COVID-19 treatment-Yes. She previously receive a COVID-19 Vaccine- Yes. She tested positive with PCR test 05Jul2022. she started Paxlovid 08Jul2022, finished med. Wed 13Jul2022. she took another PCR test 17Jul2022 the test results came back positive, the antigen test she took that day was negative. Still not feeling 100%, tired with dry cough.  No follow up attempt are possible no further information 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, 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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Arthritic Spine" (unspecified if ongoing), notes: Arthritic Spine; "Minor Bone Spurs In Upper Middle Spine" (unspecified if ongoing), notes: Minor Bone Spurs In Upper Middle Spine; "Gender Dysphoria" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient previously receive a COVID-19 Vaccine. Reported event was breaking out in an allergic reaction to paxlovid. Similar to chickenpox. It's painful to scratch. My tongue is also red, swollen and has sores. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.