chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GH9702) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (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 Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Feb2023) Negative; (03Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies.
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 healthcare professional. The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 04Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "PE" (not 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) all with onset Feb2023, outcome "recovered with sequelae" (26Feb2023) and all described as "COVID-19". As therapeutic measures to the events, the patient started nirmatrelvir/ ritonavir (PAXLOVID) on 18Feb2023 and finished on 22Feb2023, tested negative on 26Feb2023. The patient had 3 vaccines and 2 boosters (unspecified). This was the patient's first time getting COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
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 67-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 11:00 as dose 1, single (Lot number: EM9809), in left arm, on 27Feb2021 at 11:00 as dose 2, single (Lot number: EN6203), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 15Jul2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid from 21Feb2023 to 25Feb2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Moderna dose 1, 2, booster/ Pfizer bivalent; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: GH9693) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2021 as dose 1, single (Lot number: 041B21A), on 11May2021 as dose 2, single (Lot number: 023C21A) and on 27Nov2021 as dose 3 (booster), single (Lot number: 939903) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2022, outcome "unknown", described as "Moderna dose 1, 2, booster/ Pfizer bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Negative, notes: negative for the prior 3 consecutive days; (01Mar2023) Negative, notes: negative for the prior 3 consecutive days; (02Mar2023) Negative, notes: negative for the prior 3 consecutive days; (2023) Positive, notes: Rapid antigen positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Feb2023 to 26Feb2023. The patient experienced COVID rebound; symptoms returned the evening of 03Mar2023 after most symptoms except for the fatigue having disappeared and negative for the prior 3 consecutive days (28Feb, 01Mar, 02Mar) via home rapid antigen test. Sore throat returned and upon re-test, rapid antigen was positive.   No follow-up attempts are possible. No further information is expected.
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 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 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 included: "High cholesterol" (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 02Mar2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: 4th day after last dose of Paxlovid and a negative Covid home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: 4th day after last dose of Paxlovid and a negative Covid home test, the patient started experiencing symptoms again. First day of symptoms included congestion, second day included congestion, chills, body aches, and fatigue. There were no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 64-year-old female patient received BNT162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Hypothyroidism" (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 Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: tested negative twice; (2023) Negative, notes: tested negative twice; (2023) Positive, notes: tested and was positive. Therapeutic measures were taken as a result of covid-19, drug ineffective which included paxlovid on 21Feb2023 to 26Feb2023. Clinical course: symptoms were just as bad as the patient's initial bout with COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 86-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 85 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 at 13:00 as dose 1, single (Lot number: EL3247), in left arm, on 10Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in left arm, on 28Sep2021 at 13:00 as dose 3 (booster), single (Lot number: EW0185), in left arm and on 01Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9729), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thrombocytopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metformin for High blood sugar, notes: High blood sugar, controlled with Metformin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Feb2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included COVID 19 Treatment (Pfizer) from 20Feb2023 to 26Feb2023.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jun2022 at 13:00 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 included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: vicodin, reaction(s): "Known allergies: Vicodin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Oct2022 at 15:00, outcome "not recovered", described as "Vaccine brand other: Moderna"; 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, notes: 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.
Age: 45.0
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 (Other HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 45 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 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: COVID-19 test: Positive, notes: 6 days after recovery from initial infection; Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 21Feb2023 to 26Feb2023.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19  and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 48.0
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 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound and tested positive again. 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: 64.0
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) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Lot number: G73277) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: DF10F), in left arm and on 07Jun2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: Still testing positive on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: the patient was treated with PAXLOVID.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 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: "High BP" (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 Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Negative; (04Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 21Feb2023 to 26Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in right 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: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 16:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient'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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 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 (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Idiopathic Hypersomnia" (unspecified if ongoing); "POTS" (unspecified if ongoing); "known allergies: Fragrances only" (unspecified if ongoing). Concomitant medication included: DEXTROAMPHETAMINE [DEXAMFETAMINE]. 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: Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Treatment of COVID-19 included Paxlovid from 22Feb2023 to 27Feb2023.  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, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 23Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (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 "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir from 22Feb2023 to 26Feb2023.  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
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 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 at 14:30 as dose 1, single (Lot number: EN6021), in left arm, on 10Mar2021 at 15:45 as dose 2, single (Lot number: EN6199), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (Lot number 6F7861) from 24Feb2023 to 28Feb2023.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol"; "blood pressure". Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID).
Age: 41.0
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "hsv2" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Known allergies: Nuts and eggs" (unspecified if ongoing); "Known allergies: Nuts and eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Negative; (04Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received nirmatrelvir, ritonavir (PAXLOVID) from 21Feb2023 to 25Feb2023 as treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 13:00 as dose 4 (booster), single (Lot number: 057F22A) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Dysautonomia" (unspecified if ongoing), notes: Other medical history: Dysautonomia. The patient's concomitant medications were not reported. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy"; Known allergies: epinephrine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (received Paxlovid as COVID-19 treatment on 20Feb2023).; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2 NOS), on 21Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 25Feb2023 to 01Mar2023.  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: 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 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "Raynaud's" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allerigies: Erythromycin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 14:30 as dose 1, single (Lot number: EL1283), in right arm, on 10Feb2021 at 10:30 as dose 2, single (Lot number: PFIZER), in right arm, on 26Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 06Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Breast Cancer Stage 3 in 2012", start date: 2012 (unspecified if ongoing), notes: Other Medical History: Breast Cancer Stage 3 in 2012. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Mar2023) Negative, notes: I tested negative in the morning; (05Mar2023) Positive, notes: I tested positive day 5 in the morning. Therapeutic measures were taken as a result of vaccination failure, COVID-19 with Paxlovid from 24Feb2023 to 28Feb2023. Additional information: The patient has no known allergies.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "CHF" (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 "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, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 12:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 65 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Additional information: The patient has no known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (received Paxlovid for COVID 19 treatment on 24Feb2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Recovering from legionnaires pneumonia" (unspecified if ongoing); "Known allergies: Sulfa" (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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300096844 same patient/product, different event;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia legionella
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Recovering from legionnaires pneumonia" (unspecified if ongoing); "Known allergies: Sulfa" (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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300096844 same patient/product, different event;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: legionnaires pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA LEGIONELLA (medically significant), outcome "recovering", described as "legionnaires pneumonia".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300096843 same patient/product, different dose/event;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia legionella
Clinical narrative: legionnaires pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA LEGIONELLA (medically significant), outcome "recovering", described as "legionnaires pneumonia".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300096843 same patient/product, different dose/event;
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: 9H9694) at the age of 77 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TESTOSTERONE CYPIONATE, start date: 01Jan2008. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 97.0, notes: Normal temperature; (06Mar2023) 100.4; SARS-CoV-2 test: (06Mar2023) Positive, notes: Strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After completing Paxlovid on a Thursdayand feeling fairly healthy, he went about his life masked, and was OK until Sunday night. He noticed some nasal congestion but by evening it was complete. His nose was blocked. Today he took antihistamine and flonase, and was able to breathe through his nose, but began to feel ill, and by afternoon had a fever of 100.4 (his normal temperature is 97.0). He felt considerable fatigue as temperature was 97.0). He felt considerable fatigue as well. He took a home COVID test and the result was a strong positive. Other medications in 2 weeks were testosterone cypionate (start date: 01Jan2008), esomeprazole, Tylenol and Zyrtec.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, Weight
Clinical narrative: she was really sick in Dec2022 and tested negative for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group, Program ID: The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2008 (unspecified if ongoing), notes: After hysterectomy; "hysterectomy" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 2 diabetes mellitus (ongoing). Vaccination history included: BNT162b2 (dose 3, single), administration date: 06Nov2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single, LOT: ER8733 EXP: unknown, Anatomical location: either right or left arm), administration date: 24Mar2021, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (dose 1, single, LOT: EN6203, EXP: unknown , Anatomical location: either right or left arm), administration date: 03Feb2021, when the patient was 59-year-old, for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset Dec2022, outcome "unknown", described as "she was really sick in Dec2022 and tested negative for Covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was really sick in Dec2022 and tested negative for Covid. She got sick the first week in December and took 4 Covid test and they were negative. Her husband was sick in Dec2022, but it was influenza A. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300094230 same reporter, product, different dose, events;US-PFIZER INC-202300094238 same reporter, product, different dose, events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for COVID 05Mar2023; Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for Covid 05Mar2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mixed Connective Tissue Disorder" (unspecified if ongoing), notes: History of Mixed Connective Tissue Disorder.; "Immunosuppressived" (unspecified if ongoing), notes: Immunosuppressived. Concomitant medication(s) included: MYCOPHENOLATE; PREDNISONE; PANTOPRAZOLE; ATORVASTATIN; NIFEDIPINE XL; CETIRIZINE; CALCIUM. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Mar2023, outcome "unknown", described as "Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for COVID 05Mar2023"; COVID-19 (medically significant) with onset 04Mar2023, outcome "unknown", described as "Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for Covid 05Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2023) Positive, notes: Tested positive for COVID 05Mar2023. Clinical course: The patient experienced body aches, mild fever, sneezing and coughing started 04Mar2023. Tested positive for COVID 05Mar2023. The patient was taking Multivitamin and Calcium 500mg. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.