chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Antiviral treatment of Paxlovid for COVID 19 were started from 14May2022 to 19May2022. Adverse event: Terrible taste in mouth after eating or drinking that lasted hour.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sx of cold stuffy nose mild ST and cough and then 17May positive rapid Ag; sx of cold stuffy nose mild ST and cough and then 17May positive rapid Ag; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 26-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient has been diagnosed with COVID-19 prior to vaccination or not and has been tested since the vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022 at 14:00, outcome "unknown" and all described as "sx of cold stuffy nose mild ST and cough and then 17May positive rapid Ag". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Nasal Swab; (17May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Received COVID 19 Treatment; Received 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 12Apr2021 as dose 2, single (Lot number: EV-158) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 19Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 002F), in right arm and on 06Mar2022 at 12:00 as dose 4 (booster), single (Lot number: R19CP2R7), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Dysphagia" (unspecified if ongoing), notes: other medical history: Mild Dysphagia; "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Received COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: Still not feeling well, aches, headache, cough and congestion worse and testing positive - finished doses 2 days ago. No fever.  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: he tested postiive 18May2022; he tested postiive 18May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 58 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 18May2022, outcome "unknown" and all described as "he tested postive 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: COVID-test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course information: The patient had mild allergy on 15May2022 and on 16May2022 his daughter exposed at school and tested positive 17May2022 and he tested positive on 18May2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptoms 18May then positive AG 19May; Symptoms 18May then positive AG 19May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 46 years 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), VACCINATION FAILURE (medically significant) all with onset 19May2022, outcome "unknown" and all described as "Symptoms 18May then positive AG 19May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: Test type: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical Course: The patient was administered with the most recent COVID-19 vaccine at (Facility) Workplace clinic. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments:  Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: daughter sick first tested positive 15May2022 / AG positive 16May2022; daughter sick first tested positive 15May2022 / AG positive 16May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 39-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 17Dec2021 as dose 3 (booster), single (Lot number: FF2589) 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 15May2022, outcome "unknown" and all described as "daughter sick first tested positive 15May2022 / AG positive 16May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive; (16May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Reporter stating events as non serious. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test post vaccination: covid test date=16May2022, covid test result=Positive; covid_test_post_vaccination: covid_test_date=16May2022, covid_test_result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 31-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years 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) with onset 16May2022, outcome "unknown", described as "Covid test post vaccination: covid test date=16May2022, covid test result=Positive"; VACCINATION FAILURE (medically significant) with onset 16May2022, outcome "unknown", described as "covid_test_post_vaccination: covid_test_date=16May2022, covid_test_result=Positive". The patient underwent the following laboratory tests and procedures: Body temperature: (16May2022) 102, notes: High; SARS-CoV-2 test: (16May2022) Positive, notes: COVID test post vaccination COVID  test type post vaccination=Nasal Swab,. It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested Ag positivie am 18May2022; tested Ag positivie am 18May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 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 18May2022, outcome "unknown" and all described as "tested Ag positivie am 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Covid-19 prior vaccination was unknown. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for Covid.; Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for Covid.; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL9261), on 16Mar2021 as dose 2, single (Lot number: EPE955) and on 20Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (ongoing), notes: Asthmatic, Diagnosed too long ago, caller was in her teens. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Continued testing positive for Covid; (19May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (100mg).  Description of Product Complaint: Description of complaint: Additional PC discovered on additional product while completing report. Pfizer COVID-19 vaccine: Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for COVID. NDC numbers, expiration dates for 3 doses: Unknown. Paxlovid: Didn't work for caller and she got the rebound COVID, has tested positive all along.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Vaccination failure and Covid 19 cannot be completely excluded.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19/positive covid test; Treatment of COVID-19/positive covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 3, single (Batch/Lot number: unknown) at the age of 49 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19/positive covid test". The patient underwent the following laboratory tests and procedures: COVID TEST: (May2022) Positive; (May2022) Positive, notes: DAY 7; SARS-CoV-2 antibody test: (May2022) Negative; (May2022) Negative, notes: DAY 10; (May2022) Positive, notes: DAY 12 Tested highly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Reported event, rebound covid day 11. Started Paxlovid on day 2 of the positive covid test. Rapid response to Paxlovid by end of day 1 of starting treatment, completed full 5 days and tested negative the following day (RAT), day 7 of the initial positive test. remained negative on RAT tests thru day 10, day 11 developed symptoms (mild, sore throat, congestion, slight headache) and day 12 tested highly (like instantly) positive on RAT.  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: Drug ineffective, Suspected COVID-19
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 49-year-old female patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FH8021) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Topical class B steriods" (unspecified if ongoing), notes: Known allergies: topical class B steriods. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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 drug ineffective, suspected covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 22Mar2021 as dose 2, single (Lot number: Er8727), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE, start date: Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course included: The patient received Paxlovid (Lot number: Gc0466) from 17May2022 to 19May2022 for the treatment of COVID-19. No known allergies. The patient was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Lactose intolerance" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; DEPLIN [CALCIUM LEVOMEFOLATE]; LOSARTAN HYDROCHLOROTHIAZIDE; METHYLPHENIDATE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Antiviral treatment of Paxlovid for COVID 19 were started from 09May2022 to 14May2022. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 at 13:30 as dose 3 (booster), single (Lot number: 330303D) at the age of 16 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". 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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: covid; covid; 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 patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (08May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received other medication in 2 weeks, product was Albuteral inhaler. Rapid test was negative on Sunday 08May2022. Started to have Covid symptoms again on 16May2022. Took another rapid test and showed positive. Sinus issues. Patient believe was contagious with second flair up because now the patients sister tested positive on 19May2022. No Known allergies. Other medical history include asthma. Treatment drug included Paxlovid from 02May2022 to 06May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies and was taking no other medication in 2 weeks. She was on treatment for COVID-19 from 02May2022 to 06May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 76 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), all with latency 10 days 18 hrs. after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical course: Vaccine received and no other medications with in 2 weeks. Adverse event: Symptoms were completely gone on 13May, but came back worse than they originally were on 15May. No known allergies. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: experienced a hole in her arm at the injection site after her first COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: INJECTION SITE REACTION (medically significant), outcome "unknown", described as "experienced a hole in her arm at the injection site after her first COVID vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site reaction cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid; Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11May2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies; "epilepsy" (unspecified if ongoing); "hormonal joint condition" (unspecified if ongoing), notes: hormonal joint condition. Concomitant medication(s) included: VENTOLIN [SALBUTAMOL SULFATE]; MONTELUKAST; DUPIXENT. Past drug history included: Dilantin, reaction(s): "Known allergies: Dilantin", notes: known allergies Dilantin, keppra; Keppra, reaction(s): "Known allergies: keppra", notes: known allergies Dilantin, keppra. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid. Anti-viral details: product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-06May2022, Treatment stop date-11May2022, Indication: Treatment of COVID-19. Ae treatment: Steroid inhaler, acupuncture, nasal rinse etc  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Visual impairment, Vitreous floaters
Clinical narrative: experienced 40+ floaters in my left eye that hurt my vision; experienced 40+ floaters in my left eye that hurt my vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 19-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer : Unknown, Dose number: Unknown), for COVID-19 immunization. The following information was reported: VITREOUS FLOATERS (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "experienced 40+ floaters in my left eye that hurt my vision". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Request Name: REQ-795287. Question: Hello, my name is (name-withheld). I am a 19 year old student and in late Jan i suddenly experienced 40+ floaters in my left eye that hurt my vision, and was tested for many serious things including different cancers and diseases. A few weeks prior to this happening, I had COVID and also received the pfizer booster shot around the exact same time. I am searching for answers related to what could be wrong with me, and I wanted to contact you to see if you know anything at all. Thank you. Agent: E-transmit only. Non-phone case, unable to gather additional demographics. Outbound call back placed 20May2022, at 2:47PM . Left VM with MI phone, hours of operation, and INT.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On day 12, very strong positive antigen test; On day 12, very strong positive antigen test; This is a spontaneous report received from a 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 08Apr2021 as dose 1, single (Lot number: EW0153), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0173), in right arm and on 08Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN, start date: 09May2022, stop date: 11May2022; ADVIL [IBUPROFEN], start date: 09May2022, stop date: 11May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "On day 12, very strong positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19.  Anti-viral details: The patient had no known allergies. The patient had other medical history: Bo, [{product=COVID 19 Treatment, brand=Paxlovid, treatment start date=09May2022, treatment stop date=13May2022, indication=Treatment of COVID-19}]. Adverse event is experienced on 16May2022 at 07:00 AM. The patient took Paxlovid on day 1 of positive antigen test. Symptoms were mild at the time with sore throat, fever, body aches. Symptoms disappeared by end of 5 days of taking Paxlovid. On day 8, developed cough, which got worse. On day 12, very strong positive antigen test. The outcome of events was recovering without treatment.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm and on 16Mar2021 as dose 2, single (Lot number: EP6955) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS (Polycystic Ovary Syndrome)" (unspecified if ongoing); "RSD (Reflex Sympathetic Dystrophy)" (unspecified if ongoing); "CRPS (Complex Regional Pain Syndrome)" (unspecified if ongoing); "Chronic, Non-Healing; Wound from recent surgery" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Raynauds Disease" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "ADHESIVES" (unspecified if ongoing); "Known allergies: CILANTRO" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine for allergies MORPHINE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Cinical course information: It was reported that the patient was not taking any other medications in 2 weeks.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia, Thrombosis
Clinical narrative: had to get a central line in hospital because of blood clots in both arms; severe anemia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 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: THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "had to get a central line in hospital because of blood clots in both arms"; ANAEMIA (medically significant) with onset 2021, outcome "unknown", described as "severe anemia". Therapeutic measures were taken as a result of thrombosis with blood thinners. Clinical course: Patient received the vaccine in Oct2021 and since receiving have blood clots in both arms and have never had a blood clot in patient life and no one in family has ever had a blood clot so there's no history. Now patient blood recently came back resulting in being prone to blood clots with no medical history of this until now. Patient was currently on blood thinners with severe anemia and terrified and had to get a central line in hospital because of blood clots in both arms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 at 05:00 as dose 1, single (Lot number: EJ1685), in right arm, on 09Jan2021 at 08:45 as dose 2, single (Lot number: EL3248), in right arm and on 29Sep2021 at 15:00 as dose 3 (booster), single (Lot number: EW0191) at the age of 49 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Low HDL" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of Covid-19. No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "elevated bp" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, stop date: 07May2022; OLMESARTAN; ASPIRIN 81. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquinn". 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. 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.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: my husband had a widow maker heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 Immunization; Bnt162b2 (Dose:2), for Covid-19 Immunization; Bnt162b2 (Dose:3), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 08Feb2021, outcome "unknown", described as "my husband had a widow maker heart attack".  Clinical Course: The reporter stated that her husband had a widow maker heart attack on 08Feb2021 after his second booster was given, he had been out of work for quite some time after that do you have a investigator working on any cases that has been reported. She needed some assistance on what to do, she was the only one working and she couldn't afford to make all his bills and herself and the gov would not approve disability please look in to this matter, she can send the vaccination card and all of his medical records.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Computerised tomogram, Malaise, Myalgia, Pyrexia
Clinical narrative: muscle aches; fever; malaise; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; MORPHINE SULPHATE. The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "muscle aches"; PYREXIA (non-serious), outcome "recovered", described as "fever"; MALAISE (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Addition information: Other vaccine in four weeks was none. Adverse event: Patient describes receiving the COVID-19 vaccine and developing approximately 1 weeks of fever, muscle aches and malaise. Subsequently, she developed periodic fever, muscle aches, chills and malaise. Her inflammatory markers were checked and she has an elevated ESR and CRP to moderate to high level.  Due to her cyclical symptoms of fever a CT chest abdomen and pelvis was ordered to rule out underlying malignancy such as lymphoma. Incidentally this picked up inflammatory changes within her lung parenchyma consistent with organizing pneumonia. Initiation of steroid therapy improved her symptoms but with weaning of the dose her symptoms have recurred now out to approximately 16 months. Covid prior vaccination was none. Covid tested post vaccination (Nasal Swab). Known allergies was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200742763 Same reporter, patient, drug, different event
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: muscle aches; fever; malaise; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; MORPHINE SULPHATE. The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "muscle aches"; PYREXIA (non-serious), outcome "recovered", described as "fever"; MALAISE (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Addition information: Other vaccine in four weeks was none. Adverse event: Patient describes receiving the COVID-19 vaccine and developing approximately 1 weeks of fever, muscle aches and malaise. Subsequently, she developed periodic fever, muscle aches, chills and malaise. Her inflammatory markers were checked and she has an elevated ESR and CRP to moderate to high level.  Due to her cyclical symptoms of fever a CT chest abdomen and pelvis was ordered to rule out underlying malignancy such as lymphoma. Incidentally this picked up inflammatory changes within her lung parenchyma consistent with organizing pneumonia. Initiation of steroid therapy improved her symptoms but with weaning of the dose her symptoms have recurred now out to approximately 16 months. Covid prior vaccination was none. Covid tested post vaccination (Nasal Swab). Known allergies was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200742763 Same reporter, patient, drug, different event
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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). The patient's relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 16Mar1998, stop date: 20May2022. The following information was reported: COVID-19 (medically significant), outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: By end of paxlovid, no symptoms and negative, antigen test. Therapeutic measures were taken as a result of covid-19.  Clinical course: Adverse event: Adverse event from paxlovid, not related to vaccine. Paxlovid recurrence with worse covid19 symptoms than original illness. Original illness was mild to very moderate congestion, sore throat, fatigue, very mild cough. By end of paxlovid, no symptoms and negative antigen test. Then 4 days after end of paxlovid, symptoms returned and worsened to include serious cough, shortness if breath, loss of taste, severe congestion, malaise, fatigue. I felt much worse 2nd time around. Cough and shortness of breath continue. This is unrelated to pfizer vaccine, which for me included original 2 doses then 2 booster when permitted. Known allergies: Penicillin. Other medical history: Hashimotos thyroiditis. IBS. Asthma.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.