chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), 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 included: "known allergies: tree nuts" (unspecified if ongoing), notes: known allergies: tree nuts; "known allergies: shellfish" (unspecified if ongoing), notes: known allergies: shellfish. The patient took concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical Information: Patient had paxlovid mouth left a bad taste in mouth that was strongest closing to dosing but remained for hours following dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she contracted Covid last Mar2022; she contracted Covid last Mar2022; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 87-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lung disease" (unspecified if ongoing), notes: She mentioned that her mother is 87 years old and has history of lung disease so she is in the high risk category. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "she contracted Covid last Mar2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) she contracted Covid, notes: she contracted Covid last Mar2022. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) 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 included: "Hypertension" (unspecified if ongoing); "Known allergies" (unspecified if ongoing), notes: Known allergies: yes. 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 "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After recovering from symptoms and testing negative; Positive, notes: I again tested positive; Positive, notes: COVID 19 Treatment. I again tested positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
Age: 50.0
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 non-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 25Feb2021 at 11:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 at 11:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Jun2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reflux" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "asthma" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "allergies" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "anxiety" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline; Doxycycline, reaction(s): "Known allergies: doxycycline", notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (11Jun2022) Positive, notes: positive test 11Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 28May2022 to 02Jun2022 for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Limited information precludes a comprehensive causality of event , based on temporal association the causal role of suspect cannot be excluded.Case will be reviewed on receipt of FU information.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
Symptoms: Leg amputation, Neoplasm malignant
Clinical narrative: got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated; got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: NEOPLASM MALIGNANT (medically significant), LEG AMPUTATION (medically significant), outcome "unknown" and all described as "got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated". Clinical information: The reporter mentioned that a young girl from (withheld), (withheld) got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated (she mentioned she does not know which vaccines were administered to her). She stated she got really scared about this because this young girl was very athletic. The reporter was concerned after hearing this.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive initially on 15Jun2022; testing positive initially on 15Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "not recovered" and all described as "testing positive initially on 15Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive; (29Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Other medication in two weeks was no, anti-viral details product=COVID 19 Treatment, if treatment adverse event no.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Pfizer / BioNTech(30Sep2021); Treatment of COVID-19/Pfizer / BioNTech(30Sep2021); 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), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19/Pfizer / BioNTech(30Sep2021)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Adverse event: Recurrence of COVID symptoms on day 10 that lasted for an additional 8 days. New symptoms developed that I did not experience during the initial cycle of Paxlovid, including severe sinus congestion, eye watering and swelling, and loss of taste and smell. If vaccine received: Yes, Other medication in 2weeks: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun.; Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 15Jun2022, outcome "recovering" and all described as "Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Positive, notes: Tested positive 17Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks product reported synthroid, birth control. Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun. Started Paxlovid 17Jun in the evening. Took the 5 day dose. Felt better then had a sore throat come back 27Jun-29Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound Covid; Rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing); "hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]; ASA; LIPITOR; HYDROCHLOROTHIAZIDE; REVATIO.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (23Jun2022) Negative; (26Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical Course:Rebound Covid at 2 weeks, initially tested negative after 4 days post paxlovid. Then symptoms started again on day 7 later and then tested positive again.  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 limited information in the case , a possible causal association between   the reported  events Drug ineffective , covid 19 and the suspect drug cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 029L20A), in right arm, on 28Feb2021 as dose 2, single (Lot number: 010A21A), in right arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 939905), in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer", start date: 2010 (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin; Gentamycin, reaction(s): "known allergies: gentamycin", notes: known allergies: gentamycin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive test after taking Paxlovid; Negative, notes: testing negative; unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Patient had Known allergies of amoxicillin, gentamycin.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL0142), in left arm, on 02Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FX9883) at the age of 76 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "Osteo arthritis" (unspecified if ongoing). There were no known Allergies. Concomitant medication(s) included: Zyrtec [Cetirizine Hydrochloride]; Fluticasone; Buspirone; Nabumetone; Losartan; Myrbetriq; Rosuvastatin; Celebrex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication=Treatment of COVID-19; (26Jun2022) positive, notes: eight days after last Paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, Covid-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had two of your vaccines and one of your booster; I tested positive for COVID; had two of your vaccines and one of your booster; I tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "had two of your vaccines and one of your booster; I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional Context: Consumer stated, I am 67-years-old and I have had two of your vaccines and one of your booster and then I tested positive for COVID this past Saturday. My symptoms were very much improved but my doctor, the Internist recommended that I take the Paxlovid (Suspect captured conservatively) and I am reading all this information and now I have only had one dose. I am really getting a bit nervous with it (Event captured conservatively as per verbatim) specially the information about the vaccinated people. Can you share any information, can it be discontinued after just one dose of it or is there a risk with that? Consumer stated, I do not have time right now but I will be happy to call back tomorrow, I want to get hold of them. Consumer was informed about the timings of Pfizer Drug Safety as 24 7.  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
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 15:00 as dose 1, single (Lot number: EL1283), on 04Feb2021 at 10:00 as dose 2, single (Lot number: EL9265) and on 25Oct2021 at 14:00 as dose 3 (booster), single (Lot number: EW0186) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 20May2022 at 11:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; DYAZIDE; VITAMIN D3; IMMUNITY WITH BETA GLUCAN; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Negative, notes: Tested negative on Binax now home test on 27Jun; (29Jun2022) Positive, notes: 29Jun started feeling symptoms returning. Took another Binax test, positive; (30Jun2022) Positive, notes: 30Jun positive Binax test with full symptoms again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details: COVID 19 Treatment with Brand Pfizer Paxlovid, treatment start date from 19Jun2022 till treatment stop date 23Jun2022 with Lot number: 300691085301.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 18Jan2021 as dose 1, single (Lot number: 071856), on 10Feb2021 as dose 2, single (Lot number: 004M20A) and on 20Sep2021 as dose 3 (booster), single (Lot number: 048F2A) for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN, start date: 31Dec2019, stop date: 19Jun2022; PREMPRO, start date: 01Aug2021, stop date: 19Jun2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive home test day 10; Negative, notes: Negative home test on day 7.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Irritability, Somnolence
Clinical narrative: 36 hours post administration, had irritability, drowsiness and diarrhea; 36 hours post administration, had irritability, drowsiness and diarrhea; 36 hours post administration, had irritability, drowsiness and diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9-month-old male patient received BNT162b2 (BNT162B2), on 26Jun2022 at 15:45 as dose 1, single (Lot number: FT9142) at the age of 9 months intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious), IRRITABILITY (non-serious), SOMNOLENCE (non-serious) all with onset 28Jun2022 at 09:30, outcome "recovering" and all described as "36 hours post administration, had irritability, drowsiness and diarrhea". Therapeutic measures were not taken as a result of diarrhoea, irritability, somnolence.  Additional information: No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination, no covid tested post vaccination, no known allergies and no other medical history.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostrate cancer" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 31Dec2014; CENTRUM [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHLORINE;CHROMIUM;COPPER;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRI, start date: 31Dec2009; LUPRON, start date: 18Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 at 09:30 as dose 1 , single (Batch/Lot number: unknown), in left arm, on 17Feb2021 at 09:30 as dose 2, single (Lot number: EN6200), in left arm and on 14Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20May2022 at 14:00 as dose 4 (booster), single (Lot number: 059M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Enlarged prostate" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Lung infection", start date: Apr2022 (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: 27Sep2021; ASPRIN; MAGNESIUM OXIDE, start date: May2018; NIACIN, start date: Dec2018; B12 [CYANOCOBALAMIN], start date: Dec2018; DOXYCYCLINE HYCLATE, start date: 26Apr2022, stop date: 01May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: (22Jun2022) Negative; (23Jun2022) Negative; (25Jun2022) Positive; (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient reported a rebound after completion of Paxlovid treatment. He finished the Paxlovid course on the morning of 20Jun2022 and had negative rapid antigen tests on 22Jun2022 and 23Jun2022. Symptoms (sore throat and night-sweating) returned on 25Jun2022, and he had positive rapid antigen tests on 25Jun2022 an 29Jun2022. He suspended taking Tamsulosin on 15Jun2022 per instructions from his urologist and resumed on 23Jun2022. The patient received other medications such as N-Acetyl Cysteine with Selenium & Molybdenum,  start date - May2020, lot number- 3225302 and Multivitamin, brand -, start date - Dec1979, lot number - 16934701.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EJ1686), in left arm, as dose 2, single (Batch/Lot number: unknown), in right arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9484) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mango allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "osteoarthritis of the spine" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "depression" (unspecified if ongoing); "cervical stenosis" (unspecified if ongoing); "Meralgia paraesthetica" (unspecified if ongoing); "bilateral hip replacements" (unspecified if ongoing); "cervical ACDF" (unspecified if ongoing); "Thoracic outlet syndrome" (unspecified if ongoing); "leg weakness" (unspecified if ongoing); "migraines" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "back pain" (unspecified if ongoing); "muscle spasms" (unspecified if ongoing); "CRPS of hand" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM, start date: 14Dec2020, stop date: 13Jun2022; PREGABALIN, start date: 14Dec2020; TRAZODONE, start date: 30Nov2018; CYCLOBENZAPRINE, start date: 31Dec2018; ALBUTEROL [SALBUTAMOL], start date: 31Dec2015. Past drug history included: Metaxalone for Drug allergy. 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: Negative, notes: Tested negative; Positive, notes: Tested positive this morning. Have all of the COVID symptoms now. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment (Paxlovid), from 14Jun2022 to 19Jun2022. Took for five days. Tested negative. General allergies acting up. Got worse yesterday. Tested positive this morning. Have all of the COVID symptoms now. Almost feel worse than originally. Also, face was numb and immobile on one side for a day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing), notes: Other medical history: High bp; "diagnosed with diabetes (no meds)" (unspecified if ongoing), notes: Other medical history: diagnosed with diabetes (no meds). Concomitant medication(s) included: AMLODIPINE; OXYCODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive; Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Brand-Paxlovid Treatment start date- 14Jun2022, Treatment stop date- 20Jun2022  Clinical course: After onset, seemed to recover, tested negative on a Thursday. The following Tuesday felt bad, tested positive. Bad cold like symptoms, getting chills on wed. Cannot work. Adverse event start date: 27Jun2022 Adverse event start time: 08:00 AM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Epilepsy, Seizure
Clinical narrative: trigger seizures or epilepsy; trigger seizures or epilepsy; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID: (159558).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: SEIZURE (medically significant), EPILEPSY (medically significant), outcome "unknown" and all described as "trigger seizures or epilepsy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Seizure and Epilepsy and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Jan2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Paxlovid rebound - Sunday Jun 19-27. On the 27th I tested negative. I had low fever, fatigue, upper respiratory cough and thick throat, taste off. The metallic taste in my mouth that started with the pills is still here on 30Jun. If treatment ae was no. No Other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
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 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), on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took 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: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative; (27Jun2022) Positive, notes: Covid rebound, positive test. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9264), in right arm, on 18Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 17Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa and Lipitor. There were no concomitant medications. Past drug history included: Known allergies: lipitor, reaction(s): "Known allergies: lipitor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: Tested positive 5 days after competing Paxlovid and negative test; (29Jun2022) Positive, notes: Tested positive 5 days after competing Paxlovid and negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 73.0
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 2, single (Lot number: EN62002) at the age of 73 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: "giant cell arteritis in remission" (unspecified if ongoing), notes: Other medical history: giant cell arteritis in remission; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], start date: 31May2022, stop date: 06Jun2022 and Northstar. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Additional information: Patient received other medication in 2weeks. Anti-viral details Product: COVID 19 Treatment, Brand: Plaxovid, Treatment start date: 15Jun2022, Treatment stop date: 20Jun2022, Indication: Treatment of COVID-19. Return of symptoms (runny nose, dry coughing spasms) four days after completing Paxlovid regimen.
Age: 71.0
Sex: M
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 71-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19May2021 at 17:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Jan2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for Covid-19 immunization. The patient's relevant medical history included: "Asthma (controlled)" (unspecified if ongoing), notes: Other medical history: Asthma (controlled); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. There were no concomitant medications. Other medication in 2 weeks reported as no. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of Covid-19. It was reported that, rebound effect of symptoms after 10 days. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment was started on 18Jun2022 and stopped on 23Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Initial COVID symptoms on 16Jun2022, so I started PAXLOVID; Initial COVID symptoms on 16Jun2022, so I started PAXLOVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 025L20A), on 04Feb2021 as dose 2, single (Lot number: 043L20A) and on 14Aug2021 as dose 3 (booster), single (Lot number: 002F21A) for covid-19 immunisation. The patient's relevant medical history included: "zero negative rheumatoid arthritis" (unspecified if ongoing), notes: Other medical history: zero negative rheumatoid arthritis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "Initial COVID symptoms on 16Jun2022, so I started PAXLOVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 61.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "high cholestoral" (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: (unspecified date) unknown results, notes: Treatment of COVID-19; (26Jun2022) Negative; (27Jun2022) Positive, notes: COVID Rebound - tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient stated that no known allergies he knew of. The patient took COVID 19 treatment with Paxlovid (treatment start date: 20Jun2022, treatment stop date: 24Jun2022, lot number: FW4118, indication: Treatment of COVID-19). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.