chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pain in extremity
Clinical narrative: Bones ache; Feet were really bad muscles ache; The pain was in legs; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bones ache), MYALGIA (Feet were really bad muscles ache) and PAIN IN EXTREMITY (The pain was in legs) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 prophylaxis.     Acute illness at the time of vaccination and up to one month before: None.  The patient's past medical history included Blood cholesterol abnormal (Cholesterol). Concurrent medical conditions included Lower extremities discomfort (Legs, feet and ankles and from  start date: 02-May-2021 having the same status) since 30-Mar-2021, Temper tantrum (Temper), Heart disorder and Heartburn. Concomitant products included ATORVASTATIN from 20-Jan-2021 to an unknown date for Blood cholesterol abnormal, LISINOPRIL from 17-Feb-2019 to an unknown date for Heart disorder, OMEPRAZOLE from 15-Jan-2017 to an unknown date for Heartburn, ARIPIPRAZOLE from 02-Mar-2020 to an unknown date and DULOXETINE from 07-Feb-2019 to an unknown date for Temper tantrum.    On 30-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Bones ache), MYALGIA (Feet were really bad muscles ache) and PAIN IN EXTREMITY (The pain was in legs). At the time of the report, BONE PAIN (Bones ache), MYALGIA (Feet were really bad muscles ache) and PAIN IN EXTREMITY (The pain was in legs) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported by the patient that this had been ongoing and was very painful. The patient legs had not got any better, was bad and all this had started after first Moderna Shot. The treatment information included that the patient hafted to walk with boots on up to the knees.  No treatment medications were reported.   This case was linked to MOD-2021-273083 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter has not yet contacted patients for follow up.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first) in a 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2022, the patient experienced IMMUNISATION REACTION (My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first). At the time of the report, IMMUNISATION REACTION (My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: Big knot first sized after injection and bruised; Big knot first sized after injection and bruised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (Big knot first sized after injection and bruised) and INJECTION SITE BRUISING (Big knot first sized after injection and bruised) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INJECTION SITE NODULE (Big knot first sized after injection and bruised) and INJECTION SITE BRUISING (Big knot first sized after injection and bruised). At the time of the report, INJECTION SITE NODULE (Big knot first sized after injection and bruised) and INJECTION SITE BRUISING (Big knot first sized after injection and bruised) had not resolved.            No concomitant information was reported. Reporter causality for the events Injection site nodule and Injection site bruising with Humira was reported as probable. No treatment information was reported. It was unknown if the patient was enrolled in a Covid -9 vaccine trail.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: Em9809), on 05Mar2021 as dose 2, single (Lot number: Eme199) and on 29Oct2021 as dose 3 (booster), single (Lot number: Ff2587) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing), notes: Other medical history: Pre-diabetic. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I came up positive for Covid 19 around 21May or 22May2022; Negative, notes: I showed negative after the 5 days and then went back to work; Positive, notes: About 4-6 days later I took a home test/ The test was again positive with Covid; Positive, notes: I have been quarantined for 10 days since and now I am still showing positive for Covid via home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 with antiviral treatment drug Paxlovid, starting from 23May2022, till 28May2022.  Clinical course: Patient came up positive for Covid 19 around 21May2022 or 22May2022. He began taking PAXLOVID on approximately 23May2022 and took the 5 day course. He showed negative after the 5 days and then went back to work. About 4-6 days later he took a home test after feeling dizzy and having a headache, low grade fever (same type of symptoms as when he had Covid). The test was again positive with Covid. Patient have been quarantined for 10 days since and now he is still showing positive for Covid via home test.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FF2587, EM9809 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2587, EM9809 fill lot FF2556, EM9807 and the formulated drug product lot FE5315, EM9805. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 again five days after stopping Paxlovid.; Tested positive for COVID-19 again five 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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 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 included: "High blood pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Hibiscus" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: levoquin, reaction(s): "Known allergies: Levoquin"; Known allergies: mucinex, reaction(s): "Known allergies: Mucinex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "Tested positive for COVID-19 again five days after stopping Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: Tested positive for COVID-19 again five days after stopping Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral details: Product: COVID 19 treatment Brand: Paxlovid. Treatment start date: 31May2022. Treatment stop date: 04Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Taste disorder
Clinical narrative: COVID-19; COVID-19; Horrible taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 at 16:15 as dose 4 (booster), single (Lot number: FM7553) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TASTE DISORDER (non-serious) with onset 12Jun2022 at 14:00, outcome "unknown", described as "Horrible taste in mouth"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. Patient had covid-19 treatment with Paxlovid with start date 11Jun2022 and stop date as 12Jun2022. Patient has horrible taste in mouth- it immediacy came back after brushing teeth, rinsing mouth or swallowing food.  Conclusion of Previously Completed Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM7553. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: 30155819) at the age of 68 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. There were no concomitant medications. No Other medication in 2 weeks. The patient had no known allergies. OTC drugs were administered to address symptom. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (11Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30May2022 to 03Jun2022.  Amendment: This follow-up report is being submitted to amend previous information: Recoded suspect product to BNT162b2 and amend case as per vaccine convention (Events recoded to drug ineffective and covid-19 (medically significant), LOE classification added, first 2 doses are captured under "Covid-19 Vaccine" as manufacturer not provided).
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: he has got hives all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 14-year-old male patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose 2, single (Lot number: FM0173) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Jun2022, outcome "unknown", described as "he has got hives all over his body". Therapeutic measures were taken as a result of urticaria. Additional information Reporter stated, my son got, he is 14, he got a second dose of the Covid vaccination on Friday and Saturday he has got hives all over his body. If wants to report or have any question: Reporter stated, I want to report. I was told to report it. My doctor told me to report it to you. Reporter stated, No I am the mother of my child. Medical conditions or Concomitant medications: Reporter stated, "Nothing (Further not appropriately clarified, hence tab left uncheckered). Treatment: Reporter stated, "Just Claritin like a you know, (voice overlapped).  No follow-up attempts are needed. No further information is expected.
Age: 70.0
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) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 11:00 as dose 1, single (Lot number: EN6201), in left arm, on 12Mar2021 at 16:30 as dose 2, single (Lot number: EN6207), in left arm, on 04Oct2021 at 16:45 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 31Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs - minor allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, 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) Positive, notes: Treatment of COVID-19; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: No other medication in 2 weeks. She was concerned that after ending the 5 day course of Paxlovid which started on 08Jun2022 and stopped on 12Jun2022 at 8:00PM, she was still tested positive for COVID 19 on 13Jun2022. The symptoms was very mild, just a drippy nose.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN620s), in left arm, on 30Mar2022 as dose 3 (booster), single (Lot number: EP7533), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 55 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 2, single (Lot number: 027c21a), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: known allergies no, other medical history no. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive; (04Jun2022) Negative, notes: tested negative with a home kit on 04Jun2022; (13Jun2022) Positive, notes: PCR and home test; (08Jun2022) Negative, notes: tested negative with a home kit on 04Jun2022 and on PCR test on 08Jun2022; (13Jun2022) Positive, notes: PCR and home test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bilateral Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  MANUFACTURER UNKNOWN.), for Covid-19 immunisation; Covid-19 vaccine (Dose 3 (booster); MANUFACTURER UNKNOWN.), for Covid-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 24May2022, outcome "unknown", described as "Bilateral Tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: other medical history: HTN. There were no concomitant medications. 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. Brand: Paxlovid. Treatment start date: 03Jun2022. Treatment stop date: 07Jun2022.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 at 11:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "4 autoimmune diseases" (unspecified if ongoing), notes: 4 autoimmune diseases; "Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (30May2022) Positive, notes: Rebound Covid. First positive, 30May2022; (05Jun2022) Negative, notes: Tested negative twice (5 & 9 June); (09Jun2022) Negative, notes: Tested negative twice (5 & 9 June); (14Jun2022) Positive, notes: Symptoms reoccurred and tested positive 14Jun2022. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient does not have any known allergies. Concomitant medication(s) included: ZYRTEC ALLERGY; MONTELUKAST. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody 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 68-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 at 11:30 as dose 2, single (Lot number: ER8732), in left arm and on 14Dec2021 at 19:00 as dose 3 (booster), single (Lot number: Fj8757) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29May2022) Positive, notes: very positive; (04Jun2022) Positive, notes: still slightly positive; (06Jun2022) Negative; (08Jun2022) Positive; (12Jun2022) Positive, notes: still slightly positive; (14Jun2022) Negative; (29May2022) Positive, notes: very positive; (02Jun2022) Positive; (06Jun2022) Negative.  Clinical course: Adverse event: No Known allergies were reported. 29May2022: Mild Symptoms Binax both very positive. 02Jun2022: test still positive. 04Jun2022: Binaxnow still slightly positive. 06Jun2022 Binaxnow Negative. Felt great. 08Jun2022: Stuffy nose Binaxnow positive again. 12Jun2022: still slightly positive. 14Jun2022 Negative. Feel great. Reporting Today 15Jun2022. Something wrong with an app. Patient cannot enter the correct adverse correct event stop date. Third week in June was inaccessible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200842391 Same patient, different product and event;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Radical prostectomy" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 04Jun2022, stop date: 06Jun2022; CODEINE, start date: 06Jun2022, stop date: 07Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks includes Advil (start date= 04Jun2022, stop date=06Jun2022), Codeine cough syrup (Start date= 06Jun2022, stop date- 07Jun2022). I had recovered from the original COVID infection. Four days after completing the Paxlovid series, my COVID symptoms returned. Adverse event start date: 13Jun2021, start time: 02:00 PM, Outcome: Recovering, treatment AE: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 73.0
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) from product quality. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 at 13:00 as dose 1, single (Lot number: EL8982), in left arm, on 08Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 30146BA), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: 9729) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive, notes: antigen tests Abbot BinaxNOW very strong positive result; (12Jun2022) Positive, notes: very weak positive antigen test; (15Jun2022) Positive, notes: strong positive antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.No known allergies and other medical history reported for the patient.   Clinical course: Drug Fluticasone started on 23May2022 and stopped on 6Jun2022. Lot number (ab4318a).  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: Asthenia, Fatigue
Clinical narrative: weakness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "weakness"; FATIGUE (non-serious), outcome "unknown". The action taken for cilgavimab, tixagevimab was unknown.  Additional information: Pharmacist mentioned that they had a patient who experienced fatigue and weakness for 2 weeks after the vaccination. Caller clarified that the patient received Pfizer Covid-19 Vaccine, Gray cap formulation on the same date that he received AstraZeneca product Evusheld. The patient experienced fatigue and weakness for 2 weeks after they received the Pfizer Covid-19 Vaccine, Gray cap formulation and Evusheld. She tried to reach out to AstraZeneca about how long the systemic side effects like the fatigue and weakness are expected to last, but their medical affairs department is going to take at least 24 hours to get back to her; so she wanted to ask Pfizer how long the systemic side effects like the fatigue and weakness are expected to last. She does not know that it is because of the products that the patient experienced these events. She has already reported this information to AstraZeneca and declined to complete this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9263), in right arm, on 13Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: Ff2588), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Negative; (08Jun2022) Negative, notes: After the 2nd dose symptoms began to rapidly improve and by day 6 all that remained was fatigue. Antigen test was negative; (Jun2022) Positive, notes: 5 days later I woke up in the middle of the night with a fever, cold symptoms and headache. Antigen test was positive in 15 seconds; (02Jun2022) Positive, notes: started on 02Jun and were confirmed with a PCR test on 02Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 03Jun2022 to 08Jun2022. Paxlovid Rebound patient's Covid symptoms (scratchy throat, cough, headache, muscle aches, fatigue) started on 02Jun and were confirmed with a PCR test on 02Jun. Antigen tests were negative, physician prescribed Paxlovid on 03Jun and she took the first dose that day. After the 2nd dose symptoms began to rapidly improve and by day 6 all that remained was fatigue. Antigen test was negative. 5 days later she woke up in the middle of the night with a fever, cold symptoms and headache. Antigen test was positive in 15 seconds. The patients was now on day 3 and symptoms were the same.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 63 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative; Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: RN6201), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 60 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Over weight" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "under active thyroid" (unspecified if ongoing), notes: under active thyroid; "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies were reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (06Jun2022) Negative, notes: After completing the 5 day series of Paxlovid on 06Jun she went back to medical provider and tested NEGATIVE; (14Jun2022) Positive, notes: tested POSITIvE using a home test on 14Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 08Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: 33025BD) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes, sulfa based antibiotics give me a rash" (unspecified if ongoing); "known allergies: Yes, sulfa based antibiotics give me a rash" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had not other medication in 2 weeks. The patient had received covid 19 treatment, paxlovid, from 01Jun2022 (Lot number: FY4445) to 04Jun2022 for COVID-19 treatment.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Psoriasis
Clinical narrative: Pregnancy Due Date: 30Oct2022; Psoriasis flair up all over body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Lot number: FJ11989) at the age of 31 years, in right arm for covid-19 immunisation. Date of last menstrual period: 23Jan2022. The patient was 17 weeks pregnant at the time of exposure to BNT162b2. The patient was 19 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Oct2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PSORIASIS (non-serious) with onset 25May2022, outcome "recovered" (2022), described as "Psoriasis flair up all over body"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Pregnancy Due Date: 30Oct2022".  Additional information: The patient had no known allergies to medications, food, or other products. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: My right arm at injection site is in severe pain and a lot of discomfort which mild swelling; My right arm at injection site is in severe pain and a lot of discomfort which mild swelling; My right arm at injection site is in severe pain and a lot of discomfort which mild swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jun2022 at 15:00 as dose 1, single (Lot number: FJ4989) at the age of 36 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious), INJECTION SITE DISCOMFORT (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 08Jun2022 at 15:00, outcome "not recovered" and all described as "My right arm at injection site is in severe pain and a lot of discomfort which mild swelling". The events "my right arm at injection site is in severe pain and a lot of discomfort which mild swelling" required physician office visit. Therapeutic measures were not taken as a result of injection site pain, injection site discomfort, injection site swelling.  Additional Information: The patient was not tested for COVID-19 since vaccination. Prior to vaccination, the patient was not diagnosed for COVID-19. The patient didn't receive any other vaccination within 4 weeks of COVID-19 vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient received anti-viral treatment for Covid 19 started on 15Jun2022 for one day (Lot number: 6A7394). The patient had rampant diarrhea. Only second dose of paxlovid. No other medication in 2 weeks. If Vaccine received: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
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) (Physician) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2589) 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from start date 25May2022 to end date=29May2022.  Clinical Information: The patient did not received other medication in 2 weeks. The patient received COVID 19 Treatment (Paxlovid) from 25May2022 to 29May2022 for the Treatment of COVID-19.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.