chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 3 (booster), single (Lot number: FI9893) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Jan2021 as dose 1, single (Lot number: 012L20A), in left arm and on 22Oct2021 as dose 2, single (Lot number: 046C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obese" (unspecified if ongoing); "pulmonary embolism" (unspecified if ongoing); "infarction" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN & HCTZ, start date: 01Jan2020. Past drug history included: Vicodin, reaction(s): "known allergies;  Vicodin". 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: Rebound starting the day after stopping Paxlovid; Positive, notes: Still testing positive 20 days after initial positive test with continuing cold type symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that COVID 19 Treatment with Paxlovid , treatment start date: 11Jul2022, treatment stop date: 15Jul2022.It was also reported that  rebound starting the day after stopping Paxlovid. Still testing positive 20 days after initial positive test with continuing cold type symptoms.
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Continued symptoms 3 days after last dose; Continued symptoms 3 days after last dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 94-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 93 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: "Diabetes" (unspecified if ongoing), notes: heart disease; "heart disease" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications within 2 weeks after vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "Continued symptoms 3 days after last dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Covid-19 from 07Jul2022 to 12Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: 01Jan2013; REMICADE, start date: 01Jul2017; METOPROLOL, start date: 01Jul2020; ROSUVASTATIN, start date: 01Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: tested positive for Covid. 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: 32.0
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 11Apr2021 as dose 2, single (Lot number: ER8729) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 20Dec2021 as dose 3 (booster), single (Lot number: 032H214), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: I got test positive on day 1 and start Paxlovid on day 1; (18Jul2022) Negative, notes: I got a negative test on day 6; (21Jul2022) Positive, notes: positive test on day 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient got test positive on day 1 and start Paxlovid on day 1. She finishes the 5 day Paxlovid does to treat Covid. She got a negative test on day 6 but got a positive test on day 9 and start to have symptoms again on day 9. Antiviral details: Product was Paxlovid and started on 13Jul2022 and stopped on 17Jul2022. Indication was treatment of covid-19.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2020 at 10:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 64 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. Concomitant medication(s) included: VALSARTAN. Past drug history included: Known alergies: amantadine, reaction(s): "Known alergies: amantadine". 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: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Reported Treatment of COVID-19 with drug Paxlovid with start date 10Jul2022 and stop date 14Jul2022.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: EN6207) at the age of 78 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: tested negative after completing Paxlovid; (23Jul2022) positive, notes: He presents today and has tested positive for COVID. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 09Jul2022 to 14Jul2022.  Clinical course: The patient had no known allergies. The patient did not receive other medication in 2weeks before COVID 19 Treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all  the reported events Drug ineffective, COVID-19  cannot be completely excluded based on temporal association and known drug safety profile
Age: 61.0
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 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 right arm and on 17May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, 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 "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; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was not Pregnant.The patient has no other medication in 2weeks. The patient had no Known allergies. Paxlovid seemed to work initially - They have tested negative after 7 days of getting virus. On Day 10, felt just as bad as onset. On Day 11, tested positive. They were out of town when they believe they got infected. They tested positive when They got home.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 13Jul2022. 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: (unspecified date) Positive, notes: Treatment of COVID-19; (Jul2022) Negative, notes: testing negative for CV-19; (Jul2022) Positive, notes: After testing negative for CV-19, I had a return of symptoms, although mild, and I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had other medication in 2 weeks. On 14Jul2022, patient received paxlovid (anti viral) (Lot number: GC4762)  for the treatment of covid 19  and treatment stop on 18Jul2022. Other medication details in 2 weeks product was Lisinopril started on 13Jul2022. It was reported that, After testing negative for Covid-19, she had a return of symptoms, although mild, and she tested positive again.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Computerised tomogram, Pneumonia, SARS-CoV-2 test
Clinical narrative: In May 2022, the patient experienced PNEUMONIA.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4400131-00.  An 80-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1(single), Route of Administration: Intramuscular, Event onset Date/Year: 2021., Outcome of Event: Unknown), administration date: 2021, for COVID-19 immunization, reaction(s): "Pulmonary thrombosis"; Bnt162b2 (DOSE 1(single), Route of Administration: Intramuscular, Event onset Date/Year: 2021., Outcome of Event: Not recovered/not resolved), administration date: 2021, for COVID-19 immunization, reaction(s): "Persistent cough"; Bnt162b2 (DOSE 1(single), Route of Administration: Intramuscular, Event onset Date/Year: 2021., Outcome of Event: Recovered/ Resolved, Start Date : 2021), administration date: 2021, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19". The following information was reported: PNEUMONIA (medically significant) with onset May2022, outcome "recovered" (2022), described as "In May 2022, the patient experienced PNEUMONIA.". The event "in May 2022, the patient experienced pneumonia." required emergency room visit. The patient underwent the following laboratory tests and procedures: Bone densitometry: Unknown results; Computerised tomogram: Unknown results; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of pneumonia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Tinnitus after the Second vaccine; Dose administration date: 31Jul2021/dose number: 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jul2021 as dose 2, single (Lot number: Er8731) at the age of 57 years, in left arm for covid-19 immunisation. The patient relevant medical history included: "COPD" (unspecified if ongoing), "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. The patient was not received other vaccine in four weeks. Vaccination history included: BNT162b2 (Dose 1, lot number: Er8730, vaccine location: Left arm), administration date: 23Mar2021, when the patient was 57-year-old, for COVID-19 Immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown", described as "Dose administration date: 31Jul2021/dose number: 2", TINNITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "Tinnitus after the Second vaccine". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Patient received vaccine Facility in Doctor's office/urgent care.
Age: 51.0
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FDO809), in left arm and on 02Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 51 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: "high cholesterol" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "ascending aortic aneurysm" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA, start date: Aug2010, stop date: Aug2010; HYDROCHLOROTHIAZIDE; ATORVASTATIN, start date: Jul2021, stop date: 10Jul2022; SPIRONOLACTONE; ASPIRIN (E.C.). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested positive again on 23Jul22 after at least 1 negative test; (23Jul2022) Positive, notes: tested positive again on 23Jul22 after at least 1 negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19   Clinical Course: Patient had no known allergies. Patient received other medications in 2 weeks. COVID rebound-symptomatic and tested positive again on 23Jul2022 after at least 1 negative test.Anti viral details, product: COVID 19 Treatment, brand: Pfizer, treatment start date and stop date: 11Jul2022 and  16Jul2022.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies were 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: 7 days free of symptoms and negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Other medication in 2 weeks was reported as No. The patient received Anti-viral COVID 19 treatment Paxlovid from 08Jul2022 to 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4473268-00.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course included: Other medical history noted as not reported. Concomitant drugs was not reported. On an unknown date, the patient experienced COVID. The patient had covid and was in the hospital. She did not agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Causality as per reporter (Drug/Vaccine) was noted as possible.  The reporter considered "covid-19" related to BNT162b2.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "controlled blood pressure" (unspecified if ongoing); "chronic sinus & allergy issues" (unspecified if ongoing); "allergy issues" (unspecified if ongoing). Concomitant medication(s) included: CETRIZINE; VITAMIN C [ASCORBIC ACID], start date: 17Jun2022; VITAMIN D [VITAMIN D NOS], start date: 17Jun2022; MUCUS RELIEF DM; FLONASE [FLUTICASONE PROPIONATE], start date: 25May2022. Past drug history included: Lisinopril, start date: 12Dec2018, notes: Other medication details:, Other medication in 2weeks brand=Lisinopril,, Other medication in 2weeks start date=12Dec2018. The following information was reported: VACCINATION FAILURE (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: (25May2022) Positive, notes: Flu-like sxs & tested positive on 25May2022; (06Jun2022) Positive, notes: then felt sick again w/ head cold-like sxs & tested positive on 06Jun2022- rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 25May2022 to 29May2022 for treatment of COVID-19. Flu-like sxs & tested positive on 25May2022, took paxlovid as prescribed, then felt sick again w/ head cold-like sxs & tested positive on 06Jun2022- rebound. Infection never fully resolved w/ paxlovid tx. The treatment included Flonase & Zyrtec at Night.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: M
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 38-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 at 14:00 as dose 1, single (Lot number: en6202), in right arm, on 21Mar2021 as dose 2, single (Lot number: en6206), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 37 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient had no known allergies The following information was reported: VACCINATION FAILURE (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: (23Jul2022) Positive, notes: I took two at home tests, both of which came back positive; (23Jul2022) Positive, notes: I took two at home tests, both of which came back positive; (17Jul2022) Negative, notes: first negative COVID test was on Sunday. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 13Jul2022 to 18Jul2022. It was reported that the first negative COVID test was on Sunday, 17Jul2022. Today (Saturday, 23Jul2022) patient began to feel allergy-like symptoms (stuffiness, runny nose). Out of an abundance of caution, patient took two at-home tests, both of which came back positive. Patient had also been more tired than normal, which he attributed to heat and physical exertion but now suspect could be connected.
Age: 71.0
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 71-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 14Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 14Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Mar2022 as dose 4 (booster), single (Lot number: EY0584) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (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 "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. The patient received treatment of Paxlovid for COVID-19 from 11Jul2022 to 15Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: M
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) (Physician).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 10:00 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 at 11:00 as dose 2, single (Lot number: EN6201), in left arm, on 23Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 19May2022 at 14:00 as dose 4 (booster), single (Lot number: FM992) at the age of 84 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: Positive, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: If vaccine received reported as Yes. Other medication in 2weeks reported as No. Patient received anti-viral treatment started from 11Jul2022 to stop date 16Jul2022 for Treatment of COVID-19 via oral Administrator route.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: As there is limited information in the case provided, the causal association between the events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 64.0
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 17:00 as dose 1, single (Lot number: EP7534), in left arm, on 21Apr2021 at 17:00 as dose 2, single (Lot number: ER8729), in left arm, on 02Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FJ1611), in left arm and on 16Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis C" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]; FISH OIL; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]; POTASSIUM [POTASSIUM CHLORIDE]; SIMVASTATIN; SERTRALINE; VITAMIN C [ASCORBIC ACID]. Past drug history included: Interferon, stop date: 1999, for hepatitis c, notes: I did have hepatitis c but was treated for it with interferon and riboviron for 11 months completing treatment in 1999.; Riboviron, stop date: 1999, for hepatitis c, notes: I did have hepatitis c but was treated for it with interferon and riboviron for 11 months completing treatment in 1999. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient receive Paxlovid treatment (Lot- GA6765) from 20Jul2022 for COVID-19. The patient stated that, constant bad taste in mouth. Patient had only taken 3 doses. The patient had no known allergies.
Age: 48.0
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) (Nurse).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8734) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) 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) Unknown Results, notes: Indication Treatment of COVID-19; (20Jul2022) Negative, notes: Had a negative home test on 20Jul2022; (21Jul2022) Positive, notes: Did another home test and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: COVID 19 Treatment with Pfizer brand from 12Jul2022 to 16Jul2022 for the treatment of COVID-19, Oral route of administration. The patient did not receive no other medication in two weeks. No Known allergies. Other medical history: none. No other medication received in 2weeks.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid after having 4 doses of the Pfizer COVID-19 vaccine; Tested positive for Covid after having 4 doses of the Pfizer COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6199), on 09Apr2021 as dose 2, single (Lot number: EN6204), on 23Nov2021 as dose 3 (booster), single (Lot number: FJ1611) and on 30Jun2022 at 17:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid Reflux" (unspecified if ongoing), notes: Has been taking medication Omeprazole for a couple of years now. Concomitant medication(s) included: OMEPRAZOLE oral taken for gastrooesophageal reflux disease. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "Tested positive for Covid after having 4 doses of the Pfizer COVID-19 vaccine". The event "tested positive for covid after having 4 doses of the pfizer covid-19 vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Negative, notes: tested negative at home, 15Jul2022/ tested negative on Friday; (17Jul2022) Positive, notes: Then tested positive Sunday 17Jul2022. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was also reported that patient went to a emergency care facility to get a test. She first tested at home and then wanted to get test from facility to make sure home test was accurate  No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894), 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 relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: Initial covid symptoms began 7/8, tested positive on iHealth antigen; (13Jul2022) Negative, notes: Tested negative 7/13, symptoms absent by 7/15, (19Jul2022) weakly positive, notes: Then "Paxlovid rebound" On 7/19 mild symptoms recurred, tested weakly positive, (20Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (21Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (22Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (23Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (24Jul2022) weakly positive, notes: weakly positive 7/24. Paxlovid was taken as therapeutic measures were taken as a result of drug ineffective, covid-19 from 10Jul2022 to 15Jul2022.  Clinical course: Initial covid symptoms began 08Jul, tested positive on iHealth antigen tests same day. 5 day course of Paxlovid started on 10Jul2022. Tested negative on 13Jul, symptoms absent by 15Jul. Apparently "cured." Then "Paxlovid rebound" On 19Jul mild symptoms recurred, tested weakly positive. Tested strongly positive on 20Jul-23Jul, weakly positive 24Jul. Symptoms essentially absent on 24Jul.
Age: 41.0
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if the patient had received any other medication in 2weeks. Patient had received unspecified medication as a treatment of COVID-19 from 11Jul2022 to 15Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Feb2022 at 10:00 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: "Elevated lipids" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "Bipolar Disorder" (unspecified if ongoing); "brain subarachnoid hemorrhage" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL, start date: 01Jan2006; LAMOTRIGINE, start date: 07Jan2006; LIPITOR, start date: 03Dec2018, stop date: 28Jun2022; LORAZEPAM, start date: 02Jan2006; WELLBUTRIN, start date: 01Jan2006. 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; Took an antigen test and it was positive again.; 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 male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 19Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V" (unspecified if ongoing); "protein C deficiency" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "DVT" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 15Jul2022, outcome "unknown", described as "Took an antigen test and it was positive again."; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. It was reported patient receive Paxlovid for covid-19 treatment. Three days following Paxlovid course patient had recurring symptoms of aching eyes, severe sinus symptoms. Took an antigen test and it was positive again.
Age: 65.0
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Jun2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE. 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". 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 Information: No known allergies. The patient took anti-viral product Paxlovid on 11Jul2022 for COVID 19 Treatment and ended on 15Jul2022. She  had a rebound beginning 21Jul2022. No treatment received. The event was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 38-year-old male patient received BNT162b2 (BNT162B2), in Sep2020 as dose 3 (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 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient did not receive any other medications in two weeks. The patient received treatment with Paxlovid from 17Jul2022 to 21Jul2022 for COVID-19. COVID rebound after negative test result the days after completing 5 day course of Paxlovid. positive test came on day 4 after completion of 5 day course of Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "bee stings" (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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I had tested negative the day before; Positive, notes: I started taking Paxlovid on Day 1 after testing positive for Covid; Negative, notes: Tested negative on day 7; Positive, notes: However on Day 9 I developed symptoms and felt sick again and tested positive. I continued to be sick and test positive for a full week. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient started taking Paxlovid on Day 1 after testing positive for Covid. She had tested negative the day before, but was experiencing a sore throat, cough, and runny nose. After starting Paxlovid, she started feeling better by day 2 or 3. She completed the 5 days treatment and tested negative on day 7. However, on Day 9 she developed symptoms and felt sick again and tested positive. She called my doctor for a second round of paxlovid and he said it was not necessary. She continued to be sick and test positive for a full week. She believed the 5 days treatment was not sufficient to fully rid the virus from her body. If she had to do it again, she would not take paxlovid unless she was offered a 10 days dose.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.