chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy". 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 results. Therapeutic measures were taken as a result of covid-19. Patient started Paxlovid on 27May2022 and stopped on 31May2022 for the treatment of COVID-19. Other medication in 2weeks were not taken by patient. Vaccine lot no was not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Very painful golf ball sized swelling in armpit the day after treatment.; Very painful golf ball sized swelling in armpit the day after treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 13:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing). Concomitant medication(s) included: BIOTIN; TURMERIC [CURCUMA LONGA]; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; PROBIOTICS. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 03Jun2022 at 07:00, outcome "not recovered", described as "Very painful golf ball sized swelling in armpit the day after treatment"; SWELLING (non-serious) with onset 03Jun2022 at 07:00, outcome "not recovered", described as "Very painful golf ball sized swelling in armpit the day after treatment.". Therapeutic measures were not taken as a result of swelling, axillary pain. Additional information: Patient did not had other vaccine in four weeks. Patient did not have prior vaccination. Patient did not have covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
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 a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 13:00 as dose 1, single (Lot number: EL9266), in right arm, on 05Mar2021 at 12:15 as dose 2, single (Lot number: EN6204), in right arm, on 25Sep2021 at 10:30 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 30Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 71 years, in right arm for covid-19 immunisation. The patient relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment for covid-19. Treatment started on 20May2022 and stop on 24May2022. Patient did not receive other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody 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 47-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EP7533), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: BUPROPION; CHLORTHALIDONE. The patient did not received any other medication in two weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 04Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (31May2022) Negative; (01Jun2022) Negative; (04Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that after testing negative on 31May2022 and 01Jun2022 using at home rapid tests, patient tested positive on 04Jun2022 using at home rapid tests.
Age: 39.0
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). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: Ep6955), in left arm, on 12Apr2021 as dose 2, single (Lot number: Ew0150), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 320308p) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Left kidney removed due to cancer/left testicle removed due to cancer" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; SYMBICORT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SIMVASTATIN, stop date: 24May2022. 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: (unspecified date) Unknown results, notes: COVID 19 Treatment; (02Jun2022) Positive, notes: Quick tested 02Jun2022. Test had a faint positive line; (04Jun2022) Positive, notes: Quick tested 04Jun2022 and test had obvious positive line. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid (Lot number: Ga1519) from 24May2022 to 29May2022 for COVID-19 treatment. Symptoms were going away after 10 days. Quick tested was performed on 02Jun2022. Test had a faint positive line. The patient woke up with running nose and sneezing. Quick tested was performed on04Jun2022 and test had obvious positive line. Test used was on/go brand.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022; COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 10:00 as dose 1, single (Lot number: EL9266), in left arm, on 06Mar2021 at 10:00 as dose 2, single (Lot number: EN6199), in left arm and on 01Oct2021 at 08:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02May2022 at 09:00 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2018; TRIAMTERENE/HCTZ, start date: Jan2009; MYRBETRIQ, start date: Jun2014. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jun2022, outcome "not recovered" and all described as "COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (29May2022) Negative, notes: after testing negative on 01Jun2022 and completing Paxlovid on 29May2022; (01Jun2022) Negative, notes: after testing negative on 01Jun2022; (05Jun2022) Positive, notes: COVID-19 Rebound after taking Paxlovid as characterized by positive viral 05Jun2022. Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid, received from 24May2022 to 29May2022, lot number:GA1519, as COVID-19 treatment. No known allergies were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) 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 (Dose:1, Manufactured: Unknown), for Covid 19 immunization; Covid-19 vaccine (Dose:2, Manufactured: Unknown), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever of 101F approximately 20 hours". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on 05Jun; Tested positive on 05Jun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN [ROSUVASTATIN CALCIUM], start date: 15Dec2020; AMLODIPIN BESYLATE AND BENAZEPRIL HYDROCHLORI, start date: 21Dec2021. Past drug history included: Morphine, reaction(s): "Known allergies: morphine", notes: Known allergies: morphine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive on 05Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative, notes: Tested negative on 30May; (05Jun2022) Positive, notes: Tested positive on 05June. 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: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: High fever for approximately 24 hrs after second injection and coughing for a week after; High fever for approximately 24 hrs after second injection and coughing for a week after; dose administration date=14Dec2021, dose administration time=12:00 PM, dose number=1/administration date=29Mar2022, administration time=12:00 PM, dose number=2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 9-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 at 12:00 as dose 2, single (Lot number: FL8094) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose product= COVID-19, dose brand= Pfizer, dose brand unknown= False, dose lot number= FK5127, dose lot unknown= False, dose administration time= 12:00 PM, dose number= 1, vaccine location: Left arm), administration date: 14Dec2021, when the patient was 9-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Mar2022, outcome "unknown", described as "dose administration date=14Dec2021, dose administration time=12:00 PM, dose number=1/administration date=29Mar2022, administration time=12:00 PM, dose number=2"; PYREXIA (non-serious), COUGH (non-serious) all with onset 31Mar2022 at 07:00, outcome "recovered" (2022) and all described as "High fever for approximately 24 hrs after second injection and coughing for a week after". It was unknown if therapeutic measures were taken as a result of pyrexia, cough. Additional information If other vaccine in four weeks was no. If Covid prior vaccination was no. If Covid tested post vaccination was unknown. The patient did not have known allergies. High fever for approximately 24 hrs after second injection and coughing for a week after   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Lot number: 3020308D) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: other medical history Heart condition. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Rebound with covid 4 days after taking my final dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received other medication in 2 weeks is reported as no. The patient received COVID 19 Treatment Paxlovid from 24May2022 to 28May2022 (GA8204) for the treatment of COVID-19. Adverse event: Rebound with covid 4 days after taking my final dose of paxlovid.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), 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: MYOCARDITIS (hospitalization, medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, SARS-CoV-2 test
Clinical narrative: Developed psoriasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: ER6207) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Lamisil, reaction(s): "known allergies Lamisil", notes: known allergies Lamisil. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER6207, Location of injection: Arm Left), administration date: 21Mar2021, when the patient was 50-year-old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Developed psoriasis". The event "developed psoriasis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of psoriasis.  Addition information: Other vaccine in four weeks was none. Other vaccine in two weeks was none. Covid prior vaccination was none. AE treatment was received included Tropical Medicine. The patietn recieved the first dose of BNT162B2 (Lot Number: ER8734 as reported) on 21Mar2021 on the left arm for COVID-19 immunization.
Age: 47.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 10:15 as dose 4 (booster), single (Lot number: FD0809) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19 which included paxlovid from 02Jun2022 to 05Jun2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).   An elderly male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), ASTHENIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Two days of dizziness, weakness, and a sore arm.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4990), in left arm for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering"; PAIN (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering"; RASH (non-serious) with onset 04Jun2022 at 01:00, outcome "recovering", described as "rash on upper body and arms". Therapeutic measures were not taken as a result of chills, headache, pain, rash. Addition information: Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none. Other medications in two weeks included: blood pressure, cholesterol and thyroid. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 at 14:00 as dose 1, single (Lot number: EL3248), in right arm, on 08Mar2021 at 14:00 as dose 2, single (Lot number: EL3248), in right arm and on 17Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 48 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022 at 11:00, outcome "recovered with sequelae" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had not had COVID prior to vaccination.
Age: 27.0
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). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRUVADA, start date: Sep2019, stop date: 05Jun2022; BENICAR HCT taken for blood pressure abnormal, start date: 01Aug2012, stop date: 05Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (03Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical courses: The patient had no known allergies.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022; received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022 at 7:51 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Mar-2022 at 7:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 17-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Patient had received first booster dose. Reporter provided doses of moderna COVID 19 vaccine after the beyond use date as reporter did not know that the vials should not be used past 30 days from thawing the vials. Date vials were initially stored was reported as 31-Jan-2022. Thaw expiration date was reported as 2-Mar-2022. Total twenty doses were given. Total fifteen vials were used. Vial did not undergo any temperature excursion. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) continuously testing positive for COVID-19 even after 14th day since 1st symptoms.         No concomitant medication was reported. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. From 21-May-2022 to 24-May-2022, other medication Tylenol was administered. Patient was continuously testing positive for COVID-19 even after 14th day since 1st symptoms  Device Date was reported as 05-Jun-2022  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 5 days and had rebound, continuously testing positive for COVID even after 14th day since 1st symptoms. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 5 days and had rebound, continuously testing positive for COVID even after 14th day since 1st symptoms. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Erythema
Clinical narrative: Red marks under arm; Had trouble with some of joints / had pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red marks under arm) and ARTHRALGIA (Had trouble with some of joints / had pain in joints) 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) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, 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) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient experienced ERYTHEMA (Red marks under arm) and ARTHRALGIA (Had trouble with some of joints / had pain in joints). At the time of the report, ERYTHEMA (Red marks under arm) and ARTHRALGIA (Had trouble with some of joints / had pain in joints) had not resolved.            No concomitant medications were reported.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: NEVIBOLOL DCI, start date: 01May2022, stop date: 28May2022. The patient experienced Covid-19 on an unspecified date. The patient received PAXLOVID orally from 17May2022 to 21May2022 as Covid-19 treatment. The patient underwent the following laboratory tests and procedures: Covid-19 test: Unknown results. The outcome of the event was unknown. Product Quality Group provided investigational results on 02Jun2022 for BNT162B2: the complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9895. 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. PGS (site withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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 currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200771991 same reporter/pt, different drug/event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: FJ1620) 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: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED 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 antibody test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Antiviral details: COVID 19 Treatment: Paxlovid, Treatment start date: 12May2022 to 16May2022, Indication: Treatment of COVID-19. No known allergies reported.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
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) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCN" (unspecified if ongoing); "Sulfa" (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 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
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 65-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (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: Negative, notes: 3 days after completion of 5 day anti-viral medication regimen. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medications was received within two weeks. Patient developed what I though was a bad cold (no other symptoms) 4 days after completing medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Nov2021 at 19:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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 "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative, notes: tested negative for 3 days strait after Paxlovid on day 4 or 5 of beginning the pills; Positive, notes: I am now testing positive with rebound symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. The patient had no other medication in 2 weeks. The patient had anti-viral Pfizer product for treatment of Covid-19 from 24May2022 to 29May2022. The patient now tested positive with rebound symptoms of running nose, sneezing and occasional cough. Voice is raspy from congestion. Prior to this rebound, he tested negative for 3 days stright after Paxlovid on day 4 or 5 of beginning the pills.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: prescribed Paxlovid after vaccination; prescribed Paxlovid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 01:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Apr2021 at 01:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Nov2021 at 02:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rynatan, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prescribed Paxlovid after vaccination". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti viral Product for COVID 19 Treatment, Brand: Paxlovid, treatment start date 26May2022, treatment stop date 30May2022, Lot number: paa186372. Terrible aftertaste and rebounded after 5 days off medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 16:00 as dose 1, single (Lot number: EN5318), in left arm, on 12Feb2021 at 16:45 as dose 2, single (Lot number: EL9266), in left arm, on 23Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 301301A), in left arm and on 30Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Low thyroid" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Chronic nerve pain" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Oct1999; CRESTOR, start date: 01May2022, stop date: 25May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: I tested positive for Covid; (31May2022) Negative; (01Jun2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid (Lot number: GA3581) for 5 days from 25May2022 to 31May2022 for the treatment of COVID-19.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Heart rate, Heart rate increased, Limb discomfort
Clinical narrative: COVID test result: Positive; COVID test result: Positive; heaviness in left arm and left leg; Chest pain; rapid heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2021 at 11:30 as dose 1, single (Lot number: FJ5682), in left arm, on 03Jun2021 at 09:45 as dose 2, single (Lot number: EW0183), in left arm and on 07Jan2022 at 11:30 as dose 3 (booster), single (Lot number: FJ5682) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: CHEST PAIN (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered", described as "rapid heart rate"; LIMB DISCOMFORT (non-serious) with onset 26Jan2022, outcome "not recovered", described as "heaviness in left arm and left leg"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "unknown" and all described as "COVID test result: Positive". The events "chest pain", "rapid heart rate" and "heaviness in left arm and left leg" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (10Jan2022) Rapid; SARS-CoV-2 test: (21May2022) Positive, notes: Nasal Swab; (08Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of chest pain included Ibuprofen.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.