chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of the events  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 product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech  dose 1-4, Treatment of COVID-19 start date: 13Jun2022; Pfizer / BioNTech  dose 1-4, Treatment of COVID-19 start date: 13Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), on 07Mar2021 as dose 2, single (Lot number: EN6207), on 30Aug2021 as dose 3, (booster) single (Lot number: FC3184) and on 07Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE; LOSARTAN; SIMVASTATIN; LYRICA; AMLODIPINE; CALCIUM; VITAMIN D NOS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech dose 1-4, Treatment of COVID-19 start date: 13Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jun2022) Positive, notes: did not test for Covid until Sunday the 26Jun2022 and tested positive for Covid; (01Jul2022) Positive, notes: and patient still testing positive on 01Jul2022 though any symptoms were gone. Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid on 13Jun2022 to 18Jun2022. it was reported that on Friday 24Jun2022 patient started having lots of sinus drainage that settled in his chest quickly, but he thought it was a sinus infection and did not test for Covid until Sunday the 26Jun2022 and tested positive for Covid. Patient isolated again and was still testing positive on 01July2022 though any symptoms were gone.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included high cholesterol addressed with vitamins, diet and lifestyle. There were no concomitant medications. The patient experienced Covid 19 on an unspecified date. The patient received PAXLOVID for Covid 19 treatment from 23May2022 to 18Jun2022. The patient tested negative for Covid 19 after finishing his PAXLOVID treatment. The outcome of Covid 19 was recovered on an unspecified date in 2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE PROPIONATE, start date: Jun2022, stop date: 21Jun2022; SALMETEROL, start date: Jun2022, stop date: 21Jun2022. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Oxycontin, reaction(s): "Known allergies: oxycontin". 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: Unknown results; Negative, notes: a rebound case of Covid 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient received Paxlovid from 21Jun2022 to 26Jun2022 for the treatment of COVID-19. Patient had first severe metallic taste in back of mouth when as soon as she took dose of Paxlovid. A rebound case of Covid 2 days after testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EKS730), on 08Jan2021 as dose 2, single (Lot number: ELIZ84) and on 24Sep2021 as dose 3 (booster), single (Lot number: FF2580) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 at 14:30 as dose 4 (booster), single (Lot number: 046L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma; "hypertension" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "hyperlidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Proton pump inhibitors, reaction(s): "Known allergies: Proton pump inhibitors", notes: Known allergies: Proton pump inhibitors; Biaxin, reaction(s): "Known allergies: Biaxin", notes: Known allergies: Biaxin. Patient received treatment with Paxlovid from 17Jun2022 to 22Jun2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination failure and "covid-19"  and the suspect drug BNT162b2.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Lot number: fk9729) at the age of 62 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: "Sjogren's syndrome" (unspecified if ongoing); "mgus" (unspecified if ongoing); "Contrast Dye" (unspecified if ongoing), notes: Verbatim:Contrast Dye. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment, brand=Paxlovid
Age: 53.0
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 53-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2022 as dose 4 (booster), single (Lot number: FJ1614) at the age of 53 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 was not reported. Concomitant medication(s) included: EMTRICITABINE, start date: 01Jan2022, stop date: 03Jul2022; TENOFOVIR, start date: 01Jan2022, stop date: 03Jul2022. 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: (30Jun2022) negative, notes: I tested negative on antigen tests multiple times as of 30Jun2022; (03Jul2022) positive, notes: tested positive on two antigen tests on 03Jul2022; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: fatigue, scratchy throat, head congestion, night sweats. Symptoms resolved, and I tested negative on antigen tests multiple times as of 30Jun2022, but rebounded and tested positive on two antigen tests on 03Jul2022.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 1, single (Lot number: Fd0809), in right arm, on 22Dec2021 as dose 2, single (Lot number: Ej1685), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: El1284) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: O46L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies:Sufa" (unspecified if ongoing), notes: Known allergies:Sufa. Concomitant medication(s) included: ALLEGRA, start date: 01Apr2022, stop date: 01Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for Covid-19 from 19Jun2022 to 23Jun2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 19Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: 3302680) at the age of 52 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Negative, notes: Tested negative on day 9; (22Jun2022) Negative, notes: Tested negative on day 10; (25Jun2022) Positive, notes: Tested positive asymptomatic; (02Jul2022) Positive, notes: positive and symptoms remain. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Mar2021 as dose 1, single (Lot number: En6208), in right arm, on 02Apr2021 as dose 2, single (Lot number: Er8732), in right arm and on 04Nov2021 as dose 3 (booster), single (Lot number: Fg3527) at the age of 28 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: clindamycin, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid to treat vaccination failure, covid-19. Treatment start date: 22Jun2022, stop date: 26Jun2022.
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 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 included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received vaccine. The patient took other medication in 2weeks Unknown. The patient took Paxlovid for COVID 19 Treatment. The treatment start date was reported as 20Jun2022. The stop date was 24Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 50-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 02Jul2022, 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: Rebound. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical courses: No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV Positive" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "COVID 19 rebound". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Other medication in 2 weeks was unknown. Start date of Treatment for COVID-19 was 20Jun2022. Stop date of Treatment for COVID-19 was 25Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 20 years, in left arm and on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 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: "Moderate asthma" (unspecified if ongoing); "POTs"(Postural orthostatic tachycardia syndrome) (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid to treat drug ineffective, covid-19. Treatment start date 22Jun2022, treatment stop date 26Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 14:15 as dose number unknown, single (Lot number: EH9009), in left arm, on 03Mar2021 at 14:15 as dose number unknown, single (Lot number: EN6205), in left arm and on 26Apr2022 at 11:00 as dose number unknown, single (Lot number: FU989U) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Nov2021 at 10:00 as dose number unknown, single (Lot number: 037F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Goiter" (unspecified if ongoing); "Uterine Cancer" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Lympmhedema" (unspecified if ongoing); "known allergies Sulfa" (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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid (Start date: 20Jun2022, Stop date: 25Jun2022).
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 08:00 as dose 1, single (Lot number: EL3246) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "shellfish" (unspecified if ongoing), notes: known allergies shellfish. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Paxlovid rebound after 3 days of testing negative; Positive, notes: Paxlovid rebound after 3 days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 16:45 as dose 1, single (Lot number: EJ1685), in left arm, on 11Jan2021 at 12:00 as dose 2, single (Lot number: EL0142), in left arm and on 22Jul2021 at 16:45 as dose 3 (booster), single (Lot number: EW0175) at the age of 64 years, in left 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 Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: The patient previously received a COVID-19 Vaccine. The patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive on 19Jun2022/Treatment of COVID-19; Tested positive on 19Jun2022/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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: E19261), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Mar2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Fresh pineapple" (unspecified if ongoing), notes: Possibly fresh pineapple in large quantities. Concomitant medication(s) included: VALSARTAN/HCT, start date: Dec2002, stop date: 30Jun2022; FENOFIBRATE, start date: Dec2009, stop date: 30Jun2022; MONTELUKAST SODIUM, start date: Dec2011, stop date: 30Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "recovering" and all described as "Tested positive on 19Jun2022/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (Jun2022) Increased, notes: mostly increased temperature that went up and down; SARS-CoV-2 test: (19Jun2022) Positive; (27Jun2022) Unknown; (01Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 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: "Overweight" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19/Worse COVID symptoms: Nasal congestion runny eyes cough slight fever fluctuating pulse OX, some chest pain". Therapeutic measures were taken as a result of drug ineffective, Covid-19, Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 20Mar2021 at 11:00 as dose 1, single (Lot number: ER2613) at the age of 36 years, in right arm, on 14Apr2021 at 12:30 as dose 2, single (Lot number: EW0614) at the age of 36 years, in left arm and on 21Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 1FF8841) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "severe seasonal allergies" (unspecified if ongoing), notes: severe seasonal allergies; "herpies" (unspecified if ongoing), notes: herpies; "GERD" (unspecified if ongoing); "known allergies: Sulfa based meds" (unspecified if ongoing), notes: known allergies: Sulfa based meds. Concomitant medication(s) included: ROSUVASTATIN CALCIUM, start date: 01Apr2021, stop date: 27Jun2022; ESTRADIOL, start date: 01Sep2021; OMEPRAZOLE, start date: 01Mar2010; VALACYCLOVIR HCL, start date: 01Jul2016; SERTRALINE HCL, start date: 01Oct2016; LORATADINE, start date: 01Apr2013. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid to treat vaccination failure, covid-19, treatment start date: 28Jun2022, treatment stop date: 02Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 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: "History of cancer" (unspecified if ongoing), notes: Other medical history: History of cancer; "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts; "Known allergies: Peanuts and tree nuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts. Concomitant medication(s) included: LEVOTHYROXINE, start date: 05May2014; LIOTHYRONINE, start date: 15Oct2014. 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: testing positive again on day 9; Negative, notes: negative tests days 5-8. 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.
Age: 58.0
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 58-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 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: "HBP" (unspecified if ongoing), notes: HBP. Concomitant medication(s) included: MACLEODS DONEPEZIL, start date: Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had no known allergies.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 16:00 as dose number unknown, single (Lot number: Er8733) at the age of 59 years, 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: Topical lidocaine, reaction(s): "Known allergies: Topical Lidocaine", notes: Known allergies: Topical Lidocaine. 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: (2022) Negative, notes: COVID symptoms returned and tested positive after testing negative and had no symptoms; (2022) Positive, notes: COVID symptoms returned and tested positive after testing negative and had no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect reported as No. Other medication in 2weeks reported as Yes. Anti viral details: product: COVID 19 Treatment, brand: Pavlovid, treatment start date: 20Jun2022, treatment stop date: 25Jun2022. Adverse event reported as COVID symptoms returned and tested positive after testing negative and had no symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Other medication in 2 weeks includes Lisinopril, rovastatin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, Patient received Paxlovid treatment for COVID-19, treatment start date at 17Jun2022, and treatment stop date at 18Jun2022. Known allergies: None. Device Date: 01Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 at 15:00 as dose 1, single (Lot number: EL9269), in left arm, on 02Mar2021 at 13:00 as dose 2, single (Lot number: EL9269), in right arm and on 09Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 30130BA) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre Diabetic" (unspecified if ongoing), notes: Pre Diabetic. Concomitant medication(s) included: METFORMIN, start date: 14Oct2021, stop date: 30Jun2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) 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: (2022) negative, notes: Rebound after negative results; (2022) Positive, notes: Positive again 4 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9269), in right arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 67 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID, start date: Jan2021; METHENAMINE, start date: 23Jun2022, stop date: 27Jun2022. 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: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks stop date: 27Jun2022, Adverse event: Within an hour of the first dose, I had a horrible taste in my mouth that wouldn't go away no matter how many times I rinsed my mouth, brushed my teeth, or ate or drank something. Hard to describe - metallic, bitter - totally disgusting. Since my symptoms were mild it wasn't worth continuing to take the medication. Discontinued after 1 1/2 days.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
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 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "bipolar" (unspecified if ongoing), notes: bipolar; "Known allergies: Shellfish" (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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Negative; (27Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received vaccine and other medication in 2 weeks. The patient took Paxlovid for COVID-19 Treatment. The treatment start date was reported as 17Jun2022 and stop date was 22Jun2022. The patient took Famotidine, Lamotrigine, Hydroxyzine, Spironolactone and Prazosin as other medication in 2weeks product. The patient received other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
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 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 17Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 01Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of lung collapse" (unspecified if ongoing), notes: History of lung collapse; "lung blebs removed", start date: 2020 (unspecified if ongoing), notes: lung blebs removed in 2020; "Endometriosis (thoracic, pelvic, and intestinal)" (unspecified if ongoing), notes: Endometriosis (thoracic, pelvic, and intestinal); "Endometriosis (thoracic, pelvic, and intestinal)" (unspecified if ongoing), notes: Endometriosis (thoracic, pelvic, and intestinal); "Endometriosis (thoracic, pelvic, and intestinal)" (unspecified if ongoing), notes: Endometriosis (thoracic, pelvic, and intestinal); "known allergies: Pineapple, apple, apricot" (unspecified if ongoing), notes: known allergies: Pineapple, apple, apricot; "known allergies: Beef" (unspecified if ongoing), notes: known allergies: Beef; "Ulcerative colitis" (unspecified if ongoing), notes: Ulcerative colitis. Concomitant medication(s) included: NORETHINDRONE [NORETHISTERONE ACETATE], start date: 01Aug2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: tested negative from day 7-12; (Jun2022) Positive, notes: symptoms return on day 13 and was sick again for 5 day. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: I got better after day 7. Felt fine and tested negative from day 7-12. I tested positive and had symptoms return on day 13 and was sick again for 5 day. When symptoms returned I had extreme chest pain, trouble breathing, congestion, and fever. It was just as bad as the first 5 days, with the exception of intestinal issues. The first 5 days intestinal issues were the worst for me, and only nausea returned with my rebound.Anti-Viral details: product=COVID 19 Treatment, brand=Pfizer Paxlovid, treatment start date=14Jun2022, treatment stop date=19Jun2022, indication=Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207), in right arm and on 13Apr2021 as dose 2, single (Lot number: EW0153), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 068H21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative; Positive, notes: Positive COVID test one week after finishing medication. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Reinfection. Positive COVID test one week after finishing medication and testing negative. Subsequent development of headache, fatigue, low grade fever, etc. No known allergies reported.