chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: Prediabetes; "Gout" (unspecified if ongoing); "hypercholesteremia" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: tested positive again 7 days after completion of Paxlovid. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2 weeks was reported as yes. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug infective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course of the events: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: No. The patient previously received a COVID-19 Vaccine. Reported Event: Covid symptoms reoccurred  about 5 days after the paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fibrin D dimer, SARS-CoV-2 test, Troponin
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: Ew 0172) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: other medical history: migraines. Concomitant medication(s) included: INDAPAMIDE; TRAZODONE; JOLESSA. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Fibrin D dimer: (30May2022) Negative; SARS-CoV-2 test: (May2022) Negative, notes: after testing negative a few days prior; (30May2022) Positive; Troponin: (30May2022) Negative; X-ray: (30May2022) Normal. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: Ew 0172) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: other medical history: migraines. Concomitant medication(s) included: INDAPAMIDE; TRAZODONE; JOLESSA. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Fibrin D dimer: (30May2022) Negative; SARS-CoV-2 test: (May2022) Negative, notes: after testing negative a few days prior; (30May2022) Positive; Troponin: (30May2022) Negative; X-ray: (30May2022) Normal. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: bananas" (unspecified if ongoing), notes: known allergies: bananas. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ADVIL [IBUPROFEN]. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies: Codeine; Zythromax, reaction(s): "Allergy: zythromax", notes: known allergies: zythromax. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (01Jun2022) Positive, notes: Tested positive after testing negative the last 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid, treatment start date: 24May2022, treatment stop date: 29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Respiratory symptom, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test with respiratory symptoms; Positive COVID test with respiratory symptoms; respiratory symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247) at the age of 38 years, in left arm, on 22Feb2021 as dose 2, single (Lot number: EL3247) at the age of 38 years and on 17Nov2021 as dose 3 (booster), single (Lot number: FF8841) the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RESPIRATORY SYMPTOM (non-serious) with onset 29May2022, outcome "not recovered", described as "respiratory symptoms"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "not recovered" and all described as "Positive COVID test with respiratory symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Negative, notes: Nasal Swab; (29May2022) Negative, notes: Nasal Swab; (01Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, respiratory symptom.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: F85682), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Cholesterol" (unspecified if ongoing), notes: Cholesterol. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol; AMLODIPINE taken for blood pressure measurement. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Coughing". Therapeutic measures were taken as a result of cough.  Additional Information: Reporter stated he took the shot about a week and half ago of Pfizer and ever since then he is been coughing. Report it, like it could become one of the side effects because they are studying in so that could be one of the side effects also. Reporter was informed about the role of Pfizer Drug Safety. When probed for gender: Reporter stated that I am reporting for my husband. Vaccination facility details was In Health Center. Reporter stated, All he has been taking is, I went to a pharmacy and I told them, she wanted him to take Zyrtec. So once he start taking the Zyrtec he start coughing more so he stopped taking the Zyrtec. He kind of like take Benadryl so he can sleep and he has taken couple of cough drops. He stopped taking the Zyrtec.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: Er8734), in left arm, on 23Apr2021 as dose 2, single (Lot number: Er8735), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 3lo308d) at the age of 46 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (Jun2022) 102, notes: 102 fever began on Day 11 of covid onset or 4 days after last paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Oropharyngeal pain, Pyrexia, Suspected COVID-19
Clinical narrative: contracted covid 19; contracted covid 19; sore throat; fever; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient in his Late 60's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had severe response to initial Covid vaccine. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "contracted covid 19"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown". Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Bedridden, Respiratory syncytial virus infection
Clinical narrative: RSV Virus with a booster; her back is broken; she cannot get out of the bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "RSV Virus with a booster"; BACK INJURY (non-serious), outcome "unknown", described as "her back is broken"; BEDRIDDEN (non-serious), outcome "unknown", described as "she cannot get out of the bed".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Infection; COVID-19 Infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 9-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 8 years, in left arm 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) with onset Mar2022, outcome "unknown", COVID-19 (medically significant) with onset Mar2022, outcome "recovered" and all described as "COVID-19 Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) Positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: No vaccine in 4 weeks and no other medication in 2 weeks. No covid prior vaccination. patient was tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Exposed to covid over the weekend then allergy sx (symptoms) started 24May2022 then + 27May2022 Ag test; Exposed to covid over the weekend then allergy sx (symptoms) started 24May2022 then + 27May2022 Ag test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 36-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "Exposed to covid over the weekend then allergy sx (symptoms) started 24May2022 then + 27May2022 Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course: Facility type vaccine was Workplace clinic. It was unknown: If other vaccine in four weeks and If COVID prior vaccination. COVID tested post vaccination: Yes.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was diagnose with COVID. I had exhaustion, runny nose, fever and painful skin.; I was diagnose with COVID. I had exhaustion, runny nose, fever and painful skin.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years, in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in left arm and on 31Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "known allergy to berries" (unspecified if ongoing). There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient has no history of COVID-19 prior vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "recovered" (Apr2022) and all described as "I was diagnose with COVID. I had exhaustion, runny nose, fever and painful skin.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Dermatitis atopic, Inappropriate schedule of product administration
Clinical narrative: stated they started getting atopic dermatitus after vaccine; Drug Start date: May2021/ Date of start of drug: Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing), notes: anxiety and other. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Manufacturer unknown), administration date: May2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Aug2021, outcome "unknown", described as "Drug Start date: May2021/ Date of start of drug: Aug2021"; DERMATITIS ATOPIC (non-serious) with onset Sep2021, outcome "recovered with sequelae", described as "stated they started getting atopic dermatitus after vaccine". The event "stated they started getting atopic dermatitus after vaccine" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dermatitis atopic.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medication within 2 weeks of vaccination. Adverse event result in multiple visits to dermatologist, biopsy and patient was on dupixent treatment. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination.  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
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Soreness in arm was achy and tired; Soreness in arm was achy and tired; Soreness in arm was achy and tired; 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), on 01Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS; ATORVASTATIN; DILTIAZEM. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 01Jun2022 at 20:00, outcome "recovered" (Jun2022) and all described as "Soreness in arm was achy and tired". Therapeutic measures were not taken as a result of arthralgia, pain, fatigue.  Additional information: It was reported that the patient had received no other vaccines within 4 weeks prior to covid vaccine. The patient had not diagnosed with covid prior vaccination and the patient had not tested to covid post vaccination. The patient had no known allergies.
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) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), 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) positive, notes: COVID diagnosed by rapid antigen test; (30May2022) Negative, notes: Negative rapid antigen test on day 10 of therapy; (01Jun2022) Positive, notes: rapid antigen test on 01Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nasal congestion, Pain
Clinical narrative: cough; congestion; sinus pressure; fatigue; headache; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Unable to locate or read the details,, prev dose dose number=2}]), for Covid-19 immunization; Bnt162b2 ({prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Unable to locate or read the details,, prev dose dose number=1}]), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 21May2022, outcome "recovered", described as "body ache"; NASAL CONGESTION (non-serious) with onset 21May2022, outcome "recovered", described as "congestion"; COUGH (non-serious) with onset 21May2022, outcome "recovered"; FATIGUE (non-serious) with onset 21May2022, outcome "recovered"; HEADACHE (non-serious) with onset 21May2022, outcome "recovered"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 21May2022, outcome "recovered", described as "sinus pressure". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cough, nasal congestion, paranasal sinus discomfort, fatigue, headache, pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200792447 Same patient and drug, different event separated in time.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: cough; congestion; sinus pressure; fatigue; headache; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Unable to locate or read the details,, prev dose dose number=2}]), for Covid-19 immunization; Bnt162b2 ({prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Unable to locate or read the details,, prev dose dose number=1}]), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 21May2022, outcome "recovered", described as "body ache"; NASAL CONGESTION (non-serious) with onset 21May2022, outcome "recovered", described as "congestion"; COUGH (non-serious) with onset 21May2022, outcome "recovered"; FATIGUE (non-serious) with onset 21May2022, outcome "recovered"; HEADACHE (non-serious) with onset 21May2022, outcome "recovered"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 21May2022, outcome "recovered", described as "sinus pressure". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cough, nasal congestion, paranasal sinus discomfort, fatigue, headache, pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200792447 Same patient and drug, different event separated in time.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Covid-19 infection; 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 22Mar2021 at 10:45 as dose 1, single (Lot number: EP6955), in left arm, on 12Apr2021 at 10:30 as dose 2, single (Lot number: EP6955), in left arm and on 22Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 35 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 25May2022 at 13:00, outcome "recovering", described as "Covid-19 infection"; VACCINATION FAILURE (medically significant) with onset 25May2022 at 13:00, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2021) Negative, notes: Nasal Swab weekly Mar-Sep2021; (25May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of covid-19.  Clinical course: Hospitalization Prolonged was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Dayquil treatment was received for the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and tested for COVID-19 since the vaccination. No known allergies were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptoms of COVID 19 on 20May2022; Positive COVID test 24May2022; Symptoms of COVID 19 on 20May2022; Positive COVID test 24May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP7534), on 21Apr2021 as dose 2, single (Lot number: EP7534) and on 20Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 21 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "Mild cerebral palsy" (unspecified if ongoing), notes: Mild cerebral palsy. Concomitant medication(s) included: QUETIAPINE FUMARATE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20May2022, outcome "unknown", COVID-19 (medically significant) with onset 20May2022, outcome "recovered" (28May2022) and all described as "Symptoms of COVID 19 on 20May2022; Positive COVID test 24May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: COVID-test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course included patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Symptoms of COVID 19 on 20May2022; Positive Covid test 24May2022. Symptoms lasted through 28May2022. No prolonged hospitalization, No known allergies reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination,  patient not tested for COVID-19.
Age: 38.0
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 38-year-old male patient received BNT162b2 (BNT162B2), on 03May2022 at 10:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 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: "High cholesterol" (unspecified if ongoing). 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive, notes: symptoms returned and a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Adverse event: COVID rebound. I am only reporting to let you know I had a round on day seven after finishing medication. The medicine was incredible at treating my COVID symptoms. My rebound so far (now on day three since symptoms returned and a positive test) has been extremely mild and more like allergies. Congested nose feeling, occasional runny nose, feeling tired. So far easily treated with over the counter DayQuil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested and the result showed positive; tested and the result showed positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: EL3247) intramuscular, in left arm, on 12Apr2021 at 13:00 as dose 2, single (Lot number: EL3247) intramuscular, in right arm, as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FH8027) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "recovered" and all described as "tested and the result showed positive". The events "tested and the result showed positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received 2 Pfizer Covid vaccines plus 2 Pfizer Covid boosters. The last booster was on 05Apr2022. About a month after that, she was with a friend who later tested positive for Covid, so when she started to feel symptoms, she tested herself, and the result showed that she too, was positive and categorize symptoms as being mild. The patient went to emergency room/department or urgent care. Treatment reported as IV fluids and Advil. Covid test type post vaccination was a Nasal Swab on 21May2022 (positive).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Palpitations, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested and the result showed positive; tested and the result showed positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: EL3247) intramuscular, in left arm, on 12Apr2021 at 13:00 as dose 2, single (Lot number: EL3247) intramuscular, in right arm, as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FH8027) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "recovered" and all described as "tested and the result showed positive". The events "tested and the result showed positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received 2 Pfizer Covid vaccines plus 2 Pfizer Covid boosters. The last booster was on 05Apr2022. About a month after that, she was with a friend who later tested positive for Covid, so when she started to feel symptoms, she tested herself, and the result showed that she too, was positive and categorize symptoms as being mild. The patient went to emergency room/department or urgent care. Treatment reported as IV fluids and Advil. Covid test type post vaccination was a Nasal Swab on 21May2022 (positive).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Temperature of 102 degrees; Racing heart; could not fall back to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FH8027) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 57-year-old, for covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset May2022, outcome "recovering", described as "Racing heart"; PYREXIA (non-serious) with onset May2022, outcome "recovering", described as "Temperature of 102 degrees"; INSOMNIA (non-serious) with onset May2022, outcome "recovering", described as "could not fall back to sleep". The events "temperature of 102 degrees", "racing heart" and "could not fall back to sleep" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, palpitations, insomnia.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not on any other medications within 2 weeks of vaccination. Patient received 2 Pfizer Covid vaccines plus 2 Pfizer Covid boosters. On the day of her last booster, 05Apr2022, she also had a dentist appointment. She told to dentist at the start of visit that she had just received a Covid booster. He said that he was only going to give her no vacaine, so it would not be an issue. She went to sleep early that evening and woke up at 3am with a racing heart. She could not fall back to sleep. At around 7am her heart had been racing for hours, so she went to the emergency room. They confirmed that heart was racing and that she had a temperature of 102 degrees. They gave to patient IV fluids and lots of tests and sent to home after several hours. Treatment received for the adverse event with IV fluids, Advil. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200793055 similar report from same reporter
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Palpitations, Pyrexia, SARS-CoV-2 test
Clinical narrative: Temperature of 102 degrees; Racing heart; could not fall back to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FH8027) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 57-year-old, for covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset May2022, outcome "recovering", described as "Racing heart"; PYREXIA (non-serious) with onset May2022, outcome "recovering", described as "Temperature of 102 degrees"; INSOMNIA (non-serious) with onset May2022, outcome "recovering", described as "could not fall back to sleep". The events "temperature of 102 degrees", "racing heart" and "could not fall back to sleep" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, palpitations, insomnia.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not on any other medications within 2 weeks of vaccination. Patient received 2 Pfizer Covid vaccines plus 2 Pfizer Covid boosters. On the day of her last booster, 05Apr2022, she also had a dentist appointment. She told to dentist at the start of visit that she had just received a Covid booster. He said that he was only going to give her no vacaine, so it would not be an issue. She went to sleep early that evening and woke up at 3am with a racing heart. She could not fall back to sleep. At around 7am her heart had been racing for hours, so she went to the emergency room. They confirmed that heart was racing and that she had a temperature of 102 degrees. They gave to patient IV fluids and lots of tests and sent to home after several hours. Treatment received for the adverse event with IV fluids, Advil. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200793055 similar report from same reporter
Age: 44.0
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) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ER8731), in left arm, on 08May2021 as dose 2, single (Lot number: EW0176), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes II," (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: Jan2020; METFORMIN HCL, start date: Jan2020; BIOTIN, start date: Jan2020, stop date: May2022; FISH OIL, start date: Jan2018, stop date: May2022; TURMERIC [CURCUMA LONGA], start date: Oct2021, stop date: May2022. Sentry Womens Multivitamin and multimineral, start date: Jan2020, stop date: May2020, also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (Treatment start date- 26May2022, treatment stop date- 26May2022 and Lot number-FY6826). Clinical course was reported as, the patient was tested positive for COVID 19 on 24May2022. Doctor prescribed Paxlovid late in the day on 25May. The patient received it from the pharmacy on 26May.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on 02Jun2022; tested positive on 02Jun2022; This is a spontaneous report received from 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 29Dec2021 as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Aspirin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "not recovered" and all described as "tested positive on 02Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative, notes: Tested negative with antigen test on 30May2022; (unspecified date) Unknown results; (02Jun2022) Positive, notes: Then some symptoms returned and tested positive on 02Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment for COVID-19 was initiated from 19May2022 to 24May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.