chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: er8737), in left arm, on 23Apr2021 as dose 2, single (Lot number: ew0161), in right arm and on 27Dec2021 as dose 3 (booster), single (Lot number: 33130ba) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol"; Topamax, reaction(s): "Known allergies: Topamax". The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 19Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Negative, notes: I started feeling unwell the last couple of days after testing negative on 14Aug22 and 15Aug22; (15Aug2022) Negative, notes: I started feeling unwell the last couple of days after testing negative on 14Aug22 and 15Aug22; (19Aug2022) Positive, notes: I just took another home test today 19Aug22 and it is positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information:  Patient did not receive any other medications in 2 weeks. Patient had COVID rebound. She started feeling unwell the last couple of days after testing negative on 14Aug22 and 15Aug22. She just took another home test today 19Aug22 and it was positive.  No follow-up attempts are possible. No further information is expected.  Follow-up (23Aug2022): Follow-up attempts are completed. No further information is expected.
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 at 12:15 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 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) 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: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Patient received treatment with anti viral drug paxlovid for covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive antigen test 9Aug2022. Went to Urgent Care 10Aug2022 positive PCR; Positive antigen test 9Aug2022. Went to Urgent Care 10Aug2022 positive PCR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 2, single (Lot number: EN6206) at the age of 44 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: "Asthma" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Smoker" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "not recovered" and all described as "Positive antigen test 9Aug2022. Went to Urgent Care 10Aug2022 positive PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) Positive, notes: Positive antigen test 09Aug2022; (15Aug2022) Negative, notes: Took antigen test 15Aug2022 at 07:15hrs result negative; (20Aug2022) Positive, notes: Tested at home antigen kit 20Aug2022 at 09:30hrs with positive result; (10Aug2022) Positive, notes: Went to Urgent Care 10Aug2022 positive PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Aug2022 to 15Aug2022. The patient had no other medication in 2 weeks.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 50 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: "Known allergies: Kiwi" (unspecified if ongoing); "Intermittent asthma" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Dilated cardiomyopathy" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL, start date: 01Jan2020. 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 antibody test: Positive, notes: COVID 19 Treatment; Positive, notes: home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: symptoms again (body aches, fatigue, runny nose, sore throat) and next morning positive home antigen test. The patient received ADVIL (ibuprofen) on 10Aug2022.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oxygen saturation, 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) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EP7533), on 10May2021 as dose 2, single (Lot number: EW0176) and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: other medical history: Obesity; "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 105 degree; Oxygen saturation: (unspecified date) 93 %; SARS-CoV-2 test: (09Aug2022) Positive, notes: had a positive antigen test on 09Aug2022; (14Aug2022) Negative, notes: my COVID symptoms had resolved by 14Aug2022, and that day I tested negative on an antigen test; (16Aug2022) Negative, notes: and tested negative on antigen tests taken 16Aug2022 and 18Aug2022; (18Aug2022) Negative, notes: and tested negative on antigen tests taken 16Aug2022 and 18Aug2022; (19Aug2022) Positive, notes: I took another antigen test on the evening of 19Aug2022 and this time it was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 09Aug2022 to 14Aug2022.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; SINGULAIR; CALCIUM; VITAMIN D [VITAMIN D NOS]; TRIPHALA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Negative, notes: Negative COVID test one day after taking last dose of paxlovid; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took other medication in 2 weeks. The patient did not have any known allergies. The patient received treatment of COVID 19 with Paxlovid from 09Aug2022 to 19Aug2022. Negative covid test one day after talking last dose of Paxlovid. Mild symptoms resolved 2 days after negative test. 4 days after negative test home test reveals positive results.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Feb2021, stop date: 20Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details: The patient received Paxlovid for COVID 19 treatment from 10Aug2022 to 14Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
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) (Other HCP) from product quality group.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 12:00 as dose 1, single (Lot number: ew0153), in left arm, on 29Apr2021 at 11:00 as dose 2, single (Lot number: ew0172), in left arm, on 24Nov2021 at 12:00 as dose 3 (booster), single (Lot number: fh8128), in left arm and on 01Jun2022 at 18:00 as dose 4 (booster), single (Lot number: fm9992) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC R; B12 1000 SR; MOTEGRITY; PRILOSEC [OMEPRAZOLE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Adverse event: Covid rebound. After testing negative 7 and 8 days after day zero patient began showing symptoms a few days later (1 week after paxlovid was finished). The patient again tested a strong positive and was sick with fever and cold symptoms, lethargy etc.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from 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 11Feb2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Aug2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Mar2022 at 12:00 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). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies Keflex". 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 09Aug2022 to 14Aug2022, for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Cancer history with chemo treatments 5 years ago" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Other medication in 2weeks: Concomitant medication(s) included: THYROXINE; ATENOLOL; ASPIRIN [ACETYLSALICYLIC ACID]; ACETAMINOPHEN; IBUPROFEN. 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: Negative, notes: Rebound 2 days after testing negative; Positive, notes: And tested positive again; Unknown results, notes: Rebound 2 days after testing negative.Paxlovid were started on10Aug2022 and stopped on 15Aug2022 for covid-19 treatment. Adverse event: Rebound 2 days after testing negative, (9 days after starting paxlovid). Mild Symptoms can back, fever, runny  nose, sore throat, body aches, fatigue. And tested positive again. 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: 52.0
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EW0151), in left arm and on 28Apr2021 as dose 2, single (Lot number: ER8736) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in right arm and on 04Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (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 Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid on 15Aug2022, lot number: 2815213 and stop date was on 19Aug2022. Reported Event: Paxlovid rebound. Two negative rapid tests and no symptoms followed by return of symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231), on 20Jan2021 as dose 2, single (Lot number: EL3246), on 14Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 20Apr2022 as dose 4 (booster), single (Lot number: Pk9894) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: lemongrass" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "overweight" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Gabapentin, reaction(s): "Known allergies: gabapentin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, latency 3 months 30 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks. The patient received antiviral treatment for Covid-19 from 09Aug2022 to 14Aug2022. Rebound Covid infection on 19Aug2022 with new symptoms started 5 days after completion of treatment.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information in the case the reported events Vaccination failure, Covid 19 are assessed as related to suspect drug .
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) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunization. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "crohns" (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 Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective received Paxlovid .  Clinical course: Patient had not known allergies. Patient anti-viral medication included Paxlovid (oral) for COVID-19 Treatment. Treatment started on 08Aug2022 and stopped on 13Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Drug ineffective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Concomitant medication(s) included: VALSARTAN; LEXIPRON. The following information was reported: COVID-19 (medically significant), outcome "not recovered", described as "Covid 19"; DRUG INEFFECTIVE (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; (Aug2022) Positive, notes: Still testing positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid from 08Aug2022 to 13Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) (Physician).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Hypertension" (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 Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was treated with Anti-viral Paxlovid via oral from 08Aug2022 to 13Aug2022 for the treatment of COVID-19. The patient did not received any other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
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 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 25Feb2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 at 13:00 as dose 2, single (Lot number: ER8730), in left arm, on 04Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 18Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "low thyroid" (unspecified if ongoing), notes: low thyroid. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive, notes: new positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment with Paxlovid, from 10Aug2022 to 15Aug2022 for Covid-19. Patient had no known allergies, serious criteria Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect reported was No and patient not received any other medications/products within 2 weeks of starting COVID-19 treatment  The information on the batch/lot number for BNT162b2 has been requested and will be submitted when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Originally tested antigen positive on 08Aug, symptoms began on 06Aug; Originally tested antigen positive on 08Aug, symptoms began on 06Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Originally tested antigen positive on 08Aug, symptoms began on 06Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive, notes: Originally tested antigen positive on 8Aug; (13Aug2022) Negative, notes: tested Negative on both August 13 and 15; (15Aug2022) Negative, notes: tested Negative on both August 13 and 15; (16Aug2022) Positive, notes: Tested positive again via antigen test on 16Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Anti-viral details reported as Product (Paxlovid) for Covid-19 treatment from 08Aug2022 to 12Aug2022.Tested positive again via antigen test on 16Aug2022. Initially tested Negative on both 13Aug and 15 after 5 day dose of Paxlovid. Originally tested antigen positive on 8Aug, symptoms began on 6Aug. Took Paxlovid from 8-12Aug as directed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hx stemi and stent", start date: 2014 (unspecified if ongoing), notes: Hx stemi and stent; "Hx stemi and stent", start date: 2014 (unspecified if ongoing), notes: Hx stemi and stent; "prediabetes" (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 Aug2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 05Aug2022 to 10Aug2022 for COVID-19 treatment. Reported Event: Rebound of COVID symptoms and Positive ag test 8 days after completion. The patient had no know allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: 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), as dose 3 (booster), single (Lot number: FP7137), in right deltoid for covid-19 immunisation; influenza vaccine (FLU), as dose number unknown, single (Batch/Lot number: unknown), in right deltoid. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer.), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "he arm is so painful and it is very uncomfortable". Additional information: The received Booster (reported as yesterday) and also Flu shot (unspecified Flu shot) in my right deltoid and the have been up all night, the arm was so painful and it was very uncomfortable. Additional Context: Concern, consumer stated, "This was not an emergency by any means but the patient received the Booster yesterday evening about 6 O'clock in (State withheld) at (name withheld) and the patient was also given the Flu shot (unspecified Flu shot). They were given in my right deltoid and the patient have been up all night. The patient was just, the arm was so painful, the just want to know if the patient can take some sort of (treatment) to relieve some of that.". Consumer stated, "It is just very uncomfortable. I just wanted to know if I could take like a Motrin or something to get some relief from that." In response consumer stated, "Well that won't help me." Response was provided, consumer was informed to visit to nearest Emergency room in case of emergency. In response consumer stated, "Well they are not going to because it is Sunday and nobody is going to tell me until tomorrow morning. Thank you anyway." In response consumer stated, "Well they are not going to because it is Sunday and nobody is going to tell me until tomorrow morning. Thank you anyway." No follow-up attempts are possible. No further information is expected. Sender's Comments:
Age: 47.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, vaccine lot unknown, vaccine dose number unknown: True, vaccine lot unknown reason: misplaced/discarded, vaccine dose number unknown reason: unknown), on 05Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). known allergies: No. Concomitant medication(s) included in 2 weeks: GLIPIZIDE. 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) Negative, notes: Took paxlovid tested; (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 12Aug2022, treatment stop date: 15Aug2022, indication: Treatment of COVID-19. Adverse event: took Paxlovid tested negative and have a rebound case. Adverse event start date: 20Aug2022. if patient recovered: not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Depressed mood, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sporanox, reaction(s): "Known allergies: Sporanox". Vaccination history included: Covid-19 vaccine (Primary immunization complete;, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (FIRST BOOSTER DOSE;, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Jun2022, outcome "not recovered", described as "in pain for 9 week"; DEPRESSED MOOD (non-serious) with onset 13Jun2022, outcome "not recovered", described as "scared/depressed"; LYMPHADENOPATHY (non-serious) with onset 13Jun2022, outcome "not recovered", described as "swollen lymph nodes under both of my arms and in my neck and on my subclaviclular areas on both sides". The events "swollen lymph nodes under both of my arms and in my neck and on my subclaviclular areas on both sides", "in pain for 9 week" and "scared/depressed" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient stated that on 13Jun she got swollen lymph nodes under both of her arms and in her neck and on her subclaviclular areas on both sides. She stated that she had been in pain for 9 weeks now. She stated that she had many blood tests, MRI, ultrasounds, CT scans, x-rays to rule out ultrasounds, CT scans, x-rays to rule out cancer. She stated that she had been very scared and depressed thinking that she had something awful. No follow-up attempts are possible. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Ultrasound scan, X-ray
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sporanox, reaction(s): "Known allergies: Sporanox". Vaccination history included: Covid-19 vaccine (Primary immunization complete;, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (FIRST BOOSTER DOSE;, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Jun2022, outcome "not recovered", described as "in pain for 9 week"; DEPRESSED MOOD (non-serious) with onset 13Jun2022, outcome "not recovered", described as "scared/depressed"; LYMPHADENOPATHY (non-serious) with onset 13Jun2022, outcome "not recovered", described as "swollen lymph nodes under both of my arms and in my neck and on my subclaviclular areas on both sides". The events "swollen lymph nodes under both of my arms and in my neck and on my subclaviclular areas on both sides", "in pain for 9 week" and "scared/depressed" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient stated that on 13Jun she got swollen lymph nodes under both of her arms and in her neck and on her subclaviclular areas on both sides. She stated that she had been in pain for 9 weeks now. She stated that she had many blood tests, MRI, ultrasounds, CT scans, x-rays to rule out ultrasounds, CT scans, x-rays to rule out cancer. She stated that she had been very scared and depressed thinking that she had something awful. No follow-up attempts are possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Lot number: EW4109), in left arm, on 23Jun2021 as dose 2, single (Lot number: FC9001), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FK9708) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Contracted Covid in March 2020", start date: Mar2020 (unspecified if ongoing), notes: Contracted Covid in Mar2020. 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 "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Positive, notes: product=COVID 19 Treatment; (18Aug2022) Positive, notes: positive test result after taking Paxlovid for five days. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 09Aug2022 to 14Aug2022. Clinical course: Rebound symptoms, such as a runny nose, congestion and upper back pain, and a positive test result after taking Paxlovid for five days. No follow-up attempts are possible. No further information is expected.
Age: 54.0
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sesame seeds" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing); "Known allergies: seasonal allergy to pollen" (unspecified if ongoing). Concomitant medication(s) included: METRONIDAZOLE; NASACORT, stop date: Jul2022; OLOPATADINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Other medication in 2weeks included Multivitamin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) positive; (13Aug2022) Negative; (16Aug2022) positive; (20Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 08Aug2022 to 12Aug2022.  Clinical course: Patient received dose 3 vaccine on Nov2021 at 02:15 PM and dose 4 on Apr2022 at 12:00 PM. Tested positive to Covid 19 with rapid test on 08Aug2022 and began treatment with Paxlovid the same day. Mild symptoms or runny nose/sore throat. Tested Negative on rapid test on 13Aug. recurrence of symptoms runny nose/sore throat on 16Aug and tested positive that same day. symptoms became worse and as of today, 20Aug still testing positive for Covid on rapid test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: tetracycline, reaction(s): "Allergy". 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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was Unknown. Treatment of COVID-19 with Paxlovid start date: 08Aug2022, stop date: 13Aug2022. Vaccine lot unknown reason 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.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9262), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: PF2589), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If vaccine received: Yes, other medication in 2weeks: Yes. Patient received paxlovid on 10Aug2022 and stopped on 14Aug2022 for covid 19 treatment. Rebound symptoms 6 days after finishing a 5-day course of Paxlovid.  No follow-up attempts are possible. No further information is expected.
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 32-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications in 2 weeks. 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; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Anti viral details: Product: COVID 19 Treatment, Brand: Pfizer paxlovid, Treatment start date: 12Aug2022, Treatment stop date: 16Aug2022 and Indication: Treatment of COVID-19. Adverse event: Tested negative, then tested positive. Four days after treatment ended began experiencing covid symptoms, namely congestion and small fever while testing positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.