chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: realized in between my 2nd dose and booster I had a spot appear in my vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2021 at 15:00 as dose 2, single (Lot number: Ew0173) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0185, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 18May2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious), 1 day after the suspect product(s) administration, outcome "unknown", described as "realized in between my 2nd dose and booster I had a spot appear in my vision".  Additional information: Within a couple days of my booster I realized my vision was blurry. I couldn't see my tv and driving became extremely difficult. I also then realized in between my 2nd dose and booster I had a spot appear in my vision that remained for 2 weeks. My vision since my booster has not returned to normal and is still constantly blurry. The patient not had Covid tested prior vaccination and had Covid tested post vaccination.  No follow-up attempts possible. No further information expected.
Age: 38.0
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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), on 12Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Negative; (08Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was treated for COVID-19 with Paxlovid from 26May2022 to 30May2022. Tested negative 02Jun2022 but started testing positive again today 08Jun2022. Some mild nasal congestion, but no fever. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: face burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE.), for COVID-19 Immunization, reaction(s): "He had this big knot that came up under his arm", "He ran a temperature". The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "face burning". The event "face burning" required physician office visit. Therapeutic measures were taken as a result of burning sensation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EL0140), in left arm, on 11Jan2021 as dose 2, single (Lot number: EL0140), in left arm and on 26Aug2021 as dose 3 (booster), single (Lot number: FC3182), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 07Apr2022 as dose 4 (booster), single (Lot number: 04812/A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: She'll fish" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: nickel" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: mild asthma; "arthritis" (unspecified if ongoing); "Vaccine brand other=Moderna, Dose: 4/Vaccine brand=Pfizer / BioNTech, Dose3, 2 and 1" (unspecified if ongoing), notes: Vaccine brand other=Moderna, Dose: 4/Vaccine brand=Pfizer / BioNTech, Dose3, 2 and 1. Concomitant medication(s) included: METFORMIN. Past drug history included: Known allergies: hctz, reaction(s): "Known allergies: HCTZ". 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". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: she had a sore arm after her Covid vaccines for a day or so at the injection site; she had a sore arm after her Covid vaccines for a day or so at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, 0.3 ml single (Lot number: ER8727) at the age of 64 years, in right arm, on 17Apr2021 as dose 2, 0.3 ml single (Lot number: EW0161), in left arm and on 25Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: 32030DB), 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: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "she had a sore arm after her Covid vaccines for a day or so at the injection site".  Additional information: Caller said that she had a sore arm after her Covid vaccines for a day or so at the injection site. No significant side effects from the Covid vaccines. She got both Moderna and Pfizer. The patient received Moderna Covid-19 Vaccine (lot number: 066K21A) as dose 4 (booster) on 31Mar2022 in the left arm.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: get COVID despite being vaccinated; get COVID despite being vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: had COVID the first of the year.t was, it was in Dec. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "get COVID despite being vaccinated".  Clinical information: Age of patient was between 80-84. Patient infected with COVID, despite being vaccinated. Physician asked the patient what was the last time that he had took the COVID vaccine. Patient answered that he had took first, second and booster dose and didn't get second booster. Doctor asked whether it was more than four or five months of his last dose. Patient replied yes and said that he has not taken second booster because of COVID infection in December. Causality: Not reported.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid 19 with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 23Feb2021 as dose 2, single (Lot number: EL9266), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. Concomitant medication(s) included: LIALDA; PREMPRO; PREMARIN; TYLENOL; TURMERIC [CURCUMA LONGA]; CALCIUM; CENTRUM MULTIGUMMIES; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; FISH OIL; MESALAMINE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), 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 vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks included collagen. COVID 19 treatment included, paxlovid for 5 days from 30May2022 to 04Jun2022.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Renal disorder
Clinical narrative: Flu like symptoms after second dose; 6 Months after develop Minimal Change Disease - rare kidney disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2021 at 11:00 as dose 2, single (Lot number: EW0185) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. Vaccination history included: BNT162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, lot number=EW0167,lot unknown=False, administration date=02May2021, administration time11:00 AM, vaccine location=Left arm), administration date: 02May2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: RENAL DISORDER (disability) with onset 12Dec2021, outcome "not recovered", described as "6 Months after develop Minimal Change Disease - rare kidney disease"; INFLUENZA LIKE ILLNESS (disability) with onset 12Dec2021, outcome "not recovered", described as "Flu like symptoms after second dose". The events "flu like symptoms after second dose" and "6 months after develop minimal change disease - rare kidney disease" required physician office visit. It was unknown if therapeutic measures were taken as a result of influenza like illness, renal disorder.  Clinical information: Flu like symptoms after second dose. 6 Months after develop Minimal Change Disease - rare kidney disease. Never have had any kidney disease or anything related at all, and none in family.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Flu like symptoms after second dose; 6 Months after develop Minimal Change Disease - rare kidney disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2021 at 11:00 as dose 2, single (Lot number: EW0185) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. Vaccination history included: BNT162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, lot number=EW0167,lot unknown=False, administration date=02May2021, administration time11:00 AM, vaccine location=Left arm), administration date: 02May2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: RENAL DISORDER (disability) with onset 12Dec2021, outcome "not recovered", described as "6 Months after develop Minimal Change Disease - rare kidney disease"; INFLUENZA LIKE ILLNESS (disability) with onset 12Dec2021, outcome "not recovered", described as "Flu like symptoms after second dose". The events "flu like symptoms after second dose" and "6 months after develop minimal change disease - rare kidney disease" required physician office visit. It was unknown if therapeutic measures were taken as a result of influenza like illness, renal disorder.  Clinical information: Flu like symptoms after second dose. 6 Months after develop Minimal Change Disease - rare kidney disease. Never have had any kidney disease or anything related at all, and none in family.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Product: COVID 19 Treatment, brand: Paxlovid/vaccine brand: Pfizer/BioNTech.; Product: COVID 19 Treatment, brand: Paxlovid/vaccine brand: Pfizer/BioNTech.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 33030BP) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Other medical history: High cholesterol, kidney stones; "kidney stones" (unspecified if ongoing), notes: Other medical history: High cholesterol, kidney stones. Concomitant medication(s) included: CRESTOR, start date: 01Jun2017, stop date: 24May2022; FISH OIL; VITAMIN D [COLECALCIFEROL]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "not recovered" and all described as "Product: COVID 19 Treatment, brand: Paxlovid/vaccine brand: Pfizer/BioNTech.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative; (08Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had known allergies: No.Other medical history: High cholesterol, kidney stones. Adverse event: Tested positive again on 8Jun after testing Negative on 30May. Started experiencing mild symptoms of cough, sneezing, fatigue, body aches, brain fog. Patient had other medication in 2weeks: Yes. The patient received treatment for Antiviral drug, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 24May2022, Treatment stop date: 29May2022, Indication: Treatment of COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 08Jun2022 at 09:30, outcome "recovering", described as "Fainting". Therapeutic measures were taken as a result of syncope.  clinical course: Fainting outcome: She's better now, she is not diabetic and does not have low blood sugar but she drank some orange juice and that helped, she has not eaten breakfast. She verified there has been no relevant testing, treatment or medical interventions to report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore ankle since last summer; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EN6207) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's", start date: 2008 (unspecified if ongoing), notes: Parkinson's disease Diagnosed 14 years ago. . The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Pfizer Covid-19 Vaccine:, Dose 1: , Date: 21Feb2021, Lot: EL9266), administration date: 21Feb2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Sore ankle since last summer".  Additional information: The patient reported Parkinson's disease Diagnosed 14 years ago. Never really had pain with it before. Just a little bit her or there. Never had this kind of joint pain with it. The patient reported she had sore ankle since last summer, but lately in the last two weeks, its been severe. Went to the ER, but hasn't gotten in to see the rheumatoglost yet. She has Parkinson's. Doctors were concerned with one of her labs they did, but she doesn't remember what it was. Maybe it was autoimmune, maybe its cause the by the vaccine, they don't know. She was never asked the question if she was vaccinated or not when she went to the hospital. The joint pain has gotten worse. Doesn't know if its connected dot the vaccine or not. Had an x-ray that was negative in the emergency department and they sent her home. Went to an orthopedic  doctor and the CAT scan was negative there. But, pain hasn't gone away. Today was one of the worst days. The patients stated prior vaccinations of flu shot was not close to the Covid 19 booster. She gets her flu shot in September.  No statement required. F/U will be conducted.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EN5318), in left arm and on 11Feb2021 as dose 2, single (Lot number: EK9231) at the age of 66 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 050F21A), in left arm and on 24May2022 at 17:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TOLTERODINE; VENLAFAXINE HCL; FAMOTIDINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine". The patient was not pregnant at time of vaccination. Other vaccine in 2 weeks was reported as yes. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, 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 result; (31May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details: Product: covid 19 treatment.  Clinical course: It was reported that, the patient got 4th booster on 24May2022, began with symptoms of COVID-19 on 25May2022. Stated that, contacted her healthcare provider on 26May2022 and started Paxlovid that evening. Stated that, the patient took full 5 day course. Felt better but still lethargic and tested negative on 31May2022. On 02Jun or 03Jun2022 began to feel exhausted and had headaches. On 05Jun, felt more exhausted and had headaches. On 07Jun2022, nasal congestion, exhaustion, headache, coughing, sneezing. Worse on 08Jun2022. Dyspneic with speech. No fever. Diarrhea throughout past 2 weeks. Called PCP who ordered Paxlovid again.  No follow-up attempts are possible. 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 serious events vaccination failure and COVID-19 cannot be totally excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 at 12:00 as dose 3 (booster), single (Lot number: Fk9894) at the age of 30 years, in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (COVID 19, manufacturer unknown, lot number: Ew0173, administration time: 03:00 pm, dose number: 2, vaccination location: right arm), administration date: 09Jun2021, when the patient was 29-year-old, for COVID-19 immunization; COVID-19 vaccine (COVID 19, manufacturer unknown, lot number: Ew0185, administration time: 02:00 pm, dose number: 1, vaccination location: right arm), administration date: 18May2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 30Mar2022, outcome "unknown", described as "my vision was blurry". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vision blurred. Additional information: Age group: Adult (18-64 Years), patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. I could not see my tv and driving became extremely difficult. I also then realized in between my 2nd dose and booster I had a spot appear in my vision that remained for 2 weeks. My vision since my booster has not returned to normal and is still constantly blurry. Follow-up attempts are completed. No further information is expected.
Age: 51.0
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 51-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin"; Citrus, reaction(s): "known allergies: citrus", notes: known allergies: citrus. 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; (07Jun2022) positive, notes: tested instantly positive on Tuesday 07Jun; (08Jun2022) Positive, notes: tested instantly positive on Tuesday 07Jun and Tuesday 08Jun. Therapeutic measures were taken as a result of drug ineffective, Covid-19.The patient was treated with Paxlovid from 30May2022 to 03Jun2022 for the treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities
Clinical narrative: incapacitated for 3 weeks from the 2nd vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer ), for COVID-19 immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "incapacitated for 3 weeks from the 2nd vaccine". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Malaise, Pain, SARS-CoV-2 test
Clinical narrative: malaise; body ache; positive home test on the first day i felt sick; positive home test on the first day i felt sick; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03May2022, outcome "unknown", COVID-19 (medically significant) with onset 03May2022, outcome "recovered" and all described as "positive home test on the first day i felt sick"; ILLNESS (non-serious) with onset 03May2022, outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body ache". The events "positive home test on the first day i felt sick", "sick", "malaise" and "body ache" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) positive, notes: I had a positive home test on the first day/felt sick, 03May; (13May2022) Negative, notes: I has a negative home test on 13May; (16May2022) Positive, notes: On 15May I woke up very sick and on 16May I tested positive; (19May2022) positive, notes: I stayed very sick through 19May when I tested positive again; (24May2022) Negative, notes: I tested negative on 24May. Therapeutic measures were taken as a result of covid-19, illness, malaise, pain.  Clinical course: Patient was exposed to Covid by a family member and became sick 3 days later with malaise, body aches, sore throat, runny nose and diarrhea. Patient had a positive home test on the first day/felt sick, 03May2022. Reported issues occur after use of a Pfizer product. Patient received treatment for Covid-19 illness and positive test with Ritonavir (Paxlovid) from 03May2022 to 08May2022 (5 days of 2-3 pill dose per day).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: malaise; body ache; positive home test on the first day i felt sick; positive home test on the first day i felt sick; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03May2022, outcome "unknown", COVID-19 (medically significant) with onset 03May2022, outcome "recovered" and all described as "positive home test on the first day i felt sick"; ILLNESS (non-serious) with onset 03May2022, outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body ache". The events "positive home test on the first day i felt sick", "sick", "malaise" and "body ache" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) positive, notes: I had a positive home test on the first day/felt sick, 03May; (13May2022) Negative, notes: I has a negative home test on 13May; (16May2022) Positive, notes: On 15May I woke up very sick and on 16May I tested positive; (19May2022) positive, notes: I stayed very sick through 19May when I tested positive again; (24May2022) Negative, notes: I tested negative on 24May. Therapeutic measures were taken as a result of covid-19, illness, malaise, pain.  Clinical course: Patient was exposed to Covid by a family member and became sick 3 days later with malaise, body aches, sore throat, runny nose and diarrhea. Patient had a positive home test on the first day/felt sick, 03May2022. Reported issues occur after use of a Pfizer product. Patient received treatment for Covid-19 illness and positive test with Ritonavir (Paxlovid) from 03May2022 to 08May2022 (5 days of 2-3 pill dose per day).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: Reporter stated patient might have COVID despite being vaccinated. The patient's whole family got COVID right after (DEIDENTIFIED). Everybody got it. Causality was not reported  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, 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.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MUCINEX FAST MAX COLD & FLU; LEXAPRO; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient received covid-19 treatment (Pfizer brand) from 21May2022 to 25May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3248), on 11Feb2021 as dose 2, single (Lot number: EL9264), on 12Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 11Apr2022 as dose 4 (booster), single (Lot number: FH4989) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure", start date: 2000 (unspecified if ongoing); "Vertigo" (unspecified if ongoing); "Migraine w/aura" (unspecified if ongoing), notes: Migraine w/aura; "Known allergies: Iodinated Diagnostic X-Ray Materials; Contrast Media" (unspecified if ongoing), notes: Iodinated Diagnostic X-Ray Materials; Contrast Media. Concomitant medication(s) included: TRILEPTAL, start date: 29Feb2000; TOPAMAX, start date: 29Feb2000; LEXAPRO, start date: 01Aug2000; ADVIL [IBUPROFEN]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" 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; (08Jun2022) Positive, notes: tested positive again on 08Jun22. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid (Lot number=GA1529) from 29May2022 to 02Jun2022 for Covid-19. Additionally, tested positive again on 08Jun2022 - 5 days after completing Paxlovid.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), on 10Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: LISINOPRIL; CRESTOR, also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: COVID 19 Treatment; (Jun2022) negative, notes: tested negative; (Jun2022) Positive, notes: positive covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started from 27May2022 to 01Jun2022. Clinical Course was reported as, the patient completed paxlovid, tested negative, recurring symptoms 5 days later on 08Jun2022 to include a positive covid test. Patient not received treatment for symptoms and was recovering from symptoms.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.   A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EH9899), on 08Jan2021 as dose 2, single (Lot number: EK9231), on 27Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Medullary Thyroid Cancer" (unspecified if ongoing); "history of Mitral Valve Repair" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; METOPROLOL; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 08Apr2022, 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; (03Jun2022) negative, notes: tested negative 03Jun; (05Jun2022) Positive, notes: Tested positive Sunday the 05Jun; (08Jun2022) Positive, notes: still positive Wednesday the 08Jun. Therapeutic measures were taken as a result of covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and covid -19 with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Age: 32.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: Ew0172), in right arm, on 06Apr2021 as dose 2, single (Lot number: Er8737), in right arm and on 17Mar2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 32 years, in right arm for covid-19 immunisation; diclofenac sodium (DICLOFENAC SODIUM), since 01Jan2022 (Batch/Lot number: unknown). The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, latency 2 months 21 days after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical significance: Patient after taking the Paxlovid and recovering from COVID, he was now experiencing symptoms again and tested positive again. he was currently 6 days post the final dose of the Paxlovid. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.  Follow-Up (10Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: I was unable to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Gout prone or had some other inflammatory issues" (ongoing); "Gout prone or had some other inflammatory issues" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer.), for COVID-19 immunization; Bnt162b2 (Dose: 2, was incapacitated for 3 weeks from the 2nd vaccine), for COVID-19 immunization, reaction(s): "incapacitated for 3 weeks from the 2nd vaccine". The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I was unable to walk". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
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 58-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), on 29Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2010, stop date: Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on antigen test; Positive, notes: I also tested positive on antigen test; Positive, notes: continue to test positive on antigen test; Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks. The patient had no known allergies and other medical history. After stopping Paxlovid after 5 day treatment, the patient had no symptoms and tested negative on antigen test. Two days later, he had congestion, sore throat and headache. He also tested positive on antigen test. Symptoms continue for 6 more days and continue to test positive on antigen test.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 73 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: "RA" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "microadenoma on pituitary" (unspecified if ongoing); "claudication in legs" (unspecified if ongoing); "pre diabetes" (unspecified if ongoing); "raynauds" (unspecified if ongoing); "dry eye" (unspecified if ongoing). Concomitant medication(s) included: BROMOCRIPTINE; METHOTREXATE; LISINOPRIL; SOLIFENACIN SUCCINATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No allergies.  Anti viral details: Product: COVID 19 Treatment,Treatment start date: 28May2022,Treatment stop date: 01Jun2022,Indication: Treatment of COVID-19  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "shellfish" (unspecified if ongoing). Concomitant medication(s) included: REMICADE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (03May2022) Negative; (07Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received Paxlovid for COVID-19 from 26May2022 to 30May2022. Took a COVID test on 03May2022 which was negative. Started having a sore throat on 06Jun222, Sore throat and congestion on 07Jun2022 and had positive rapid and PCR test.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and Covid 19 cannot be ruled out.