chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: 330308D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "TTP" (unspecified if ongoing), notes: Other medical history: TTP. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid, treatment start date: 07May2022, treatment stop date: 11May2022.  Clinical course: No reaction to Booster. Took Paxlovid after testing postive for Covid. I tested negative after 4th day and then 6 days after that experienced symptoms and tested positive again.  No follow-up attempts are needed. No further information is expected
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive; positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. There were no Known allergies. There were no other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14May2022, outcome "unknown", COVID-19 (medically significant) with onset 14May2022, outcome "not recovered" and all described as "positive". Patient stated, Initial Covid symptoms were mild and after 5 days I felt good and tested negative. 4 days later I woke up congested so tested again and was positive. The symptoms have been much more severe with with congestion, headache, and cough that was much worse. One night the congestion and headache were bad enough I could not sleep. After 4 days of having Covid a second time I am better but slowly recovering and still testing Positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) positive, notes: After 4 days of having Covid a second time I am better but slowly recovering and still testing Positive; (11May2022) negative, notes: after 5 days I felt good and tested negative; (15May2022) positive, notes: 4 days later I woke up congested so tested again and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details: product: COVID 19 Treatment, brand: paxlovid, treatment start date: 06May2022, treatment stop date: 11May2022, lot number: FX8133.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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) (Pharmacist) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 2, single (Lot number: EN6201) at the age of 34 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; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "assorted fruits" (unspecified if ongoing), notes: Allergy to assorted fruits.; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative; (18May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product: COVID 19 Treatment (PAXLOVID) on start date:10May2022 and stop date:13May2022. Indication is used for treatment of COVID-19. Other medication in 2weeks product: Allegra180 mg, Levothyroxine 25 mcg. Other medical history: None. The patient experienced adverse event, Side effect: dyspepsia within hours of taking Paxlovid. Resolution of symptoms on 13May and negative test: stopped taking Paxlovid (day 4 - did not finish course) rebound symptoms of coughing and congestion on 17May. Retested and came back positive 18May.  Adverse event experienced on: 17May2022. If patient is recovered. the patient did not receive treatment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events drug ineffective and covid19 cannot be totally excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Immunisation reaction, SARS-CoV-1 test
Clinical narrative: Increased Crohn's flare; Horrible reaction with second covid vaccination; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4393868-00 (Abbvie).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 38 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer: Pfizer), for Covid-19 Immunization. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Increased Crohn's flare"; IMMUNISATION REACTION (non-serious), outcome "not recovered", described as "Horrible reaction with second covid vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Unknown result.  The reporter's assessment of the causal relationship of "increased crohn's flare" and "horrible reaction with second covid vaccination" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Felt Covid-19 Positive; Felt Covid-19 Positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4393868-00.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular 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; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Felt Covid-19 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "felt covid-19 positive" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of the reported events cannot be totally excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2022 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for COVID-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "History of thyroid issues, none currently" (unspecified if ongoing), notes: Other medical History: History of thyroid issues, none currently; "Interchange of vaccine products" (unspecified if ongoing), notes: Pfizer/BioNTech Dose number:1 and Johnson & Johsnon Dose Number:1. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events drug ineffective and covid19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, COVID-19, Chest X-ray, Drug ineffective
Clinical narrative: 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 elderly female patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FL3197) 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); "IVP DYE" (unspecified if ongoing). 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 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 220/110; Blood test: Normal; Chest X-ray: Normal; Electrocardiogram: Normal; Urine analysis: Normal. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: On the completion of day 2 of Paxlovid, 4 doses totally B/P went up to 220/110. Consumer went to the ED and it was felt it was due to the Paxlovid, all her tests were normal-EKG, chest films and blood work and urinalysis. Anti-viral details included Paxlovid for COVID-19 Treatment, started on 16May2022 and ended on 18May2022. Anti-viral details included Paxlovid for COVID-19 Treatment, started on 16May2022 and ended on 18May2022.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Urine analysis
Clinical narrative: 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 elderly female patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FL3197) 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); "IVP DYE" (unspecified if ongoing). 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 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 220/110; Blood test: Normal; Chest X-ray: Normal; Electrocardiogram: Normal; Urine analysis: Normal. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: On the completion of day 2 of Paxlovid, 4 doses totally B/P went up to 220/110. Consumer went to the ED and it was felt it was due to the Paxlovid, all her tests were normal-EKG, chest films and blood work and urinalysis. Anti-viral details included Paxlovid for COVID-19 Treatment, started on 16May2022 and ended on 18May2022. Anti-viral details included Paxlovid for COVID-19 Treatment, started on 16May2022 and ended on 18May2022.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: EW0202) at the age of 47 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 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 10May2022, outcome "recovered" (May2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) positive, notes: confirmed that day by a PCR; (09May2022) negative, notes: I tested negative on a rapid test; (10May2022) positive, notes: I took a second rapid test and was positive; (16May2022) faint line, notes: I took a rapid test and saw only a faint line; (18May2022) bold second line, notes: rapid test had a very bold second line. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10May2022 to 14May2022 and advil, as needed for covid symptoms. Clinical course: The Covid Symptoms (congestion) started on a Monday (09May2022) night and patient tested negative on a rapid test. On Tuesday morning (10May2022), he took a second rapid test and was positive, confirmed that day by a PCR. Started paxlovid immediately, with two doses that day. By Saturday (14May2022), symptoms were gone and Paxlovid regimen complete. On the next Monday (16May2022) morning, he took a rapid test and saw only a faint line. But that night had high fever again out of nowhere. By Wednesday (18May2022) morning symptoms gone again but rapid test had a very bold second line. Seems to be "paxlovid rebound". No Known allergies.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Additional Information: Patient reported that she received Anti-viral Paxlovid From 09May2022 to 14May2022 for Treatment of COVID-19, Adverse event: Rebound COVID symptoms began about 24 hours after finishing last dose of Paxlovid. Increased congestion in nose & throat, headaches, fatigue, sore throat, ear ache, and leg/ankle edema. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Burning sensation, Investigation, Oropharyngeal pain, Swelling
Clinical narrative: Angina; Burning swollen pain in tonsils 1 minute after injection; Burning swollen pain in tonsils 1 minute after injection; cystic-like sore near tonsil; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 12:00 as dose 2, single (Lot number: FJ6369) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: fruits" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "Recent diagnoses on HTN" (unspecified if ongoing), notes: Recent diagnoses on HTN. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: BNT162b2 (previous dose details , previous dose product: COVID 19, previous dose brand: Pfizer, previous dose brand unknown: False, previous dose lot number: FJ6369, previous dose lot unknown: False, previous dose administration date: 28Jan2022, previous dose administration time: 08:00AM, previous dose dose number: 1, previous dose vaccine location: Left arm), administration date: 28Jan2022, when the patient was 33-year-old, for COVID-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 16May2022 at 12:00, outcome "not recovered", described as "Angina"; BURNING SENSATION (non-serious), SWELLING (non-serious) all with onset 16May2022 at 12:00, outcome "not recovered" and all described as "Burning swollen pain in tonsils 1 minute after injection"; OROPHARYNGEAL PAIN (non-serious) with onset 16May2022 at 12:00, outcome "not recovered", described as "cystic-like sore near tonsil". The patient underwent the following laboratory tests and procedures: HTN: Unknown results, notes: Recent diagnoses on HTN. Therapeutic measures were not taken as a result of angina pectoris, burning sensation, swelling, oropharyngeal pain.  Additional information: report about covid vaccine was yes. If other vaccine in four weeks reported as No. other medications in two weeks reported as amlodipine 2.5 mg once a day. If covid prior vaccination reported as No. If covid tested post vaccination reported as No. Adverse event reported Burning swollen pain in tonsils 1 minute after injection, followed by cystic-like sore near tonsil. Angina.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Polymerase chain reaction
Clinical narrative: Dose Number1: 02Feb2021, dose2: 25Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 at 11:00 as dose 2, single (Lot number: EP6955) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 (DOSE 1, SINGLE at 17:00, Anatomical Location: Arm right), administration date: 02Feb2021, for COVID-19 Immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (hospitalization) with onset 25Mar2021 at 11:00, described as "Dose Number1: 02Feb2021, dose2: 25Mar2021". The patient was hospitalized for inappropriate schedule of product administration (hospitalization duration: 4 day(s)). The patient did not have covid prior to the vaccination. The patient was tested for covid post vaccination. The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (03May2022) Negative, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200733254 Same patient and drug, different event separated in time
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EW0217), in left arm, on 18Apr2021 as dose 2, single (Lot number: EW0196), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: EW027) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetics" (unspecified if ongoing), notes: Other medical history: Diabetics, hypertension; "hypertension" (unspecified if ongoing), notes: Other medical history: Diabetics, hypertension. Concomitant medication(s) included: LAMOTRIGINE, start date: 06Sep2021; METFORMIN, start date: 05Oct2020; TOPIRAMATE, start date: 06Sep2021; PRAZOSIN, start date: 06Sep2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "covid-19". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: If vaccine received: Yes; Other medication in 2weeks: Yes. Known allergies: No.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: After each dose of the vaccine I experienced atrial fibrillation for a number of days,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 at 08:00 as dose 2, single (Lot number: FW0150), in left arm, on 12Nov2021 at 08:00 as dose 3 (booster), single (Lot number: FE3690), in left arm and on 17May2022 at 17:30 as dose 4 (booster), single (Lot number: FM9998) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: ajovy (Other vaccine 4weeks dose number=2, Other vaccine 4weeks vaccine location=Left leg), administration date: 16May2022, when the patient was 52-year-old, for Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 18May2022 at 22:00, outcome "recovering", described as "I have a pre-existing condition, atrial fibrillation, controlled by Metoprolol with no symptoms. After each dose of the vaccine I experienced atrial fibrillation for a number of days, until it eventually subsides". Therapeutic measures were not taken as a result of atrial fibrillation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Ovarian cyst" (unspecified if ongoing); "known allergies: dust" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing). Concomitant medication(s) included: LITHIUM CARBONATE; ABILIFY; LAMOTRIGINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: Post-paxlovid series I tested negative on an antigen test on 07May; (unspecified date) Positive, notes: Treatment of COVID-19; (10May2022) Negative, notes: and then negative on a PCR on 10May; (18May2022) Positive, notes: On 18May I tested positive on 2 rapid tests; (18May2022) Positive, notes: On 18May I tested positive on 2 rapid tests; (19May2022) Positive, notes: and then positive again on 19May on a rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: ER8731) and on 14Nov2021 as dose 2, single (Lot number: FH8030) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: antigen test positive on day 5 and 6; (14May2022) Positive, notes: antigen test positive on day 5 and 6; (15May2022) Negative, notes: negative on day 7 and 8; (16May2022) Negative, notes: negative on day 7 and 8; (18May2022) Positive, notes: positive on day 10 and 11; (19May2022) Positive, notes: positive on day 10 and 11; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course :Adverse event: After finishing 5 day Paxlovid, antigen test positive on day 5 and 6, negative on day 7 and 8. No test on day 9. Positive on day 10 and 11.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EK4176), in left arm, as dose 2, single (Lot number: EL9262), in right arm and as dose 3 (booster), single (Lot number: FF2589), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL COLD AND FLU DAYTIME, start date: 07May2022, stop date: 16May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 14:30, outcome "not recovered" and all described as "Diagnosed with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: Tested Covid positive 07May2022, began Paxlovid treatment with first evening dose; (12May2022) Negative, notes: Tested Covid negative 12May2022 and negative 14May2022; (14May2022) Negative, notes: Tested Covid negative 12May2022 and negative 14May2022; (19May2022) Positive, notes: Tested Covid positive 19May2022. Therapeutic measures were taken as a result of covid-19.  Clinical information: No known allergies. The patient was diagnosed with Covid, began Paxlovid treatment with first evening dose. Finished Paxlovid 12May2022 with last dose (morning). Symptoms worsened on 16May2022. COVID 19 Treatment was started on 07May2022 and stopped on 12May2022.
Age: 42.0
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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: "Crossover Psoriatic Arthritis" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Past drug history included: Rybelsus (same reaction), reaction(s): "known allergies"; Azithromycin, reaction(s): "pin prick rash"; Codeine, reaction(s): "severe heartburn". 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Anti-viral details, Product: COVID-19 Treatment, Brand: Paxlovid, Treatment start date: 18May2022, Treatment stop date: 19May2022, Lot number: GA1189, Indication: Treatment of COVID-19. It was reported that patient received other medication within 2weeks. Additional information: After the first dose- Severe dysgeusia after 1 hour of the first dose. The taste was so bad that it was difficult to sleep. After the second dose- small very itchy bumps appeared on chest, near belly button, left leg, left arm, side and head. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I'm fully vaccinated. I took 2 doses and 2 boosters, the last one was one month ago. On 04May2022 I tested positive for COVID-19; I'm fully vaccinated. I took 2 doses and 2 boosters, the last one was one month ago. On 04May2022 I tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (003110). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (COMIRNATY), on 12Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6205), on 29Oct2021 as dose 3 (booster), single (Lot number: FG3527) and on 19Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "unknown" and all described as "I'm fully vaccinated. I took 2 doses and 2 boosters, the last one was one month ago. On 04May2022 I tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: She tested positive for COVID 0May2022; (May2022) unknown result, notes: It was sometime the week of 10May2022 -12May2022; (19May2022) Positive, notes: However today I again tested positive after feeling pretty lousy. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid. Clinical course: The patient first tested positive on 04May2022, patient did not took paxlovid immediately and the following week she was not feeling well again so she tested herself again. She doesn't know which day. It was sometime the week of 10May2022- 12May2022. After that, was when she took Paxlovid. Her son recommended it, and sent her a box of it. She took the doses of it at home. Since, then she took the doses as recommended, and she came back to withheld where they stay for the spring, summer and fall. She doesn't have any of the Paxlovid left over. She took it 5 days. Then, later caller said she thinks the treatment was three days and seemed to recover after a relatively mild case. Three days ago, she was not feeling good. They still had test kits so she took one, and tested positive today (19May2022) after feeling pretty lousy. Her husband tested negative. He has medical issues, and he was high risk so she has stayed away from him. This has been the last 3 days. How long will she test positive for? The patient wanted to know does Paxlovid provide any extended immunity? Or can patient expect a continuing repeat of this? Was this the same infection or a reinfection? She hope it's not a false positive.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: covid test result Positive; covid test result Positive; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: EL3248) at the age of 30 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), CHILLS (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 19May2022, outcome "unknown" and all described as "Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, pain, chills, oropharyngeal pain.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: EL3248) at the age of 30 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), CHILLS (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 19May2022, outcome "unknown" and all described as "Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, pain, chills, oropharyngeal pain.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive antigen test; positive antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 at 10:00 as dose 2, single (Lot number: ER8732), in left arm and on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: EW0183) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine dose brand: MODERNA, Dose Number: 4. Concomitant medication(s) included: LOSARTAN HCTZ; ATORVASTATIN.  The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown" and all described as "positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive; (19May2022) Positive; (09May2022) Negative, notes: Consecutive negative tests from 9May to 15May; (10May2022) Negative; (11May2022) Negative; (12May2022) Negative; (13May2022) Negative; (14May2022) Negative; (15May2022) Negative; (15May2022) Negative, notes: negative molecule test ('detect hub'). Therapeutic measures were taken as a result of covid-19.  Clinical Course: Seriousness criteria-Results in death was not reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes. No Known Allergies.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: positive antigen test; positive antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 at 10:00 as dose 2, single (Lot number: ER8732), in left arm and on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: EW0183) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine dose brand: MODERNA, Dose Number: 4. Concomitant medication(s) included: LOSARTAN HCTZ; ATORVASTATIN.  The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown" and all described as "positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive; (19May2022) Positive; (09May2022) Negative, notes: Consecutive negative tests from 9May to 15May; (10May2022) Negative; (11May2022) Negative; (12May2022) Negative; (13May2022) Negative; (14May2022) Negative; (15May2022) Negative; (15May2022) Negative, notes: negative molecule test ('detect hub'). Therapeutic measures were taken as a result of covid-19.  Clinical Course: Seriousness criteria-Results in death was not reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes. No Known Allergies.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Taken COVID-19 Treatment; Taken 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2022 at 14:00 as dose 4 (booster), single (Lot number: fj4989) at the age of 60 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 blood pressure" (unspecified if ongoing), notes: neuropathy, overweight.; "neuropathy" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Taken COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Negative; (17May2022) Negative; (18May2022) Negative; (19May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient received Paxlovid for the treatment of COVID-19 from 10May2022 to 15May2022. No known allergies. On 19May2022 some minor symptoms were back. Headache, congestion, but very minor compared to horrible sore throat, etc. while during initial symptom phase.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/testing  positive with symptoms; Treatment of COVID-19/testing  positive with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 17:00 as dose 1, single (Lot number: El3246), in left arm, on 16Feb2021 at 12:00 as dose 2, single (Lot number: En6201), in left arm and on 03Nov2021 at 14:00 as dose 3 (booster), single (Lot number: Ff2593) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jan2022, stop date: 21Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19/testing  positive with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Apr2022) positive; (29Apr2022) negative; (09May2022) positive, notes: tested positive home test and also at urgent care rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course included the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. First day of testing  positive with symptoms 21Apr2022. Finished 5 day of PAXLOVID on Tuesday morning 26Apr2022 and tested negative on 29Apr2022 and 20. on 09May2022 same symptoms returned and tested positive home test and also at urgent care rapid test.