chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Vaccine brand other: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 13Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 as dose 4 (booster), single (Lot number: 088D21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: Jul2022; LOSARTAN, start date: Jul2022; ATORVASTATIN, start date: Jul2022, stop date: 11Aug2022; ALOPURINOL, start date: Jul2022; LEVOTHYROXINE, start date: Jul2022; ASPIRIN (E.C.), start date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Rebound covid"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Vaccine brand other: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (21Aug2022) Positive, notes: Rebound case of COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Additional information: Patient had received other vaccine. Yes, for Other medications in two weeks. Patient had Paxlovid for covid 19 as an treatment on 12Aug2022 and stopped on 17Aug2022.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: sick for 2-3 weeks after getting each vaccine; chills; fever; cant do anything; has low white cell count "lower end of the normal"; suppressed autoimmune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 84 years, 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: 1, Lot number: EN6206, Vaccination Anatomical site: Left arm), for COVID-19 Immunization, reaction(s): "chills", "Tiredness", "just did not feel her self", "headache", "she stated she has gotten sick for 2-3 weeks after getting each vaccine"; Bnt162b2 (Dose number: 2, Lot number: EN6205, Vaccination Anatomical site: Left arm), for COVID-19 Immunization, reaction(s): "chills", "sick for 2-3 weeks after getting each vaccine", "suppressed autoimmune system", "cant do anything", "Fever", "low white cell count "lower end of the normal". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick for 2-3 weeks after getting each vaccine"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "cant do anything"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "has low white cell count "lower end of the normal""; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "suppressed autoimmune system". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had two Pfizer vaccine and the 2 booster (COVID-19 Vaccine) and last booster was on 07May2022. she stated she has gotten sick for 2-3 weeks after getting each vaccine; chills fever, cant do anything, no ER visits. She did call Pfizer after the first vaccine and reported it. She has low white cell count "lower end of the normal", suppressed autoimmune system after each doses and it took her longer to recover when she gets sick. Reporter wanted to know can she get her next booster dose before 6 months. Reporter wanted to know how much immunity she had after being sick with each vaccination. Patient reported a day after she was okay and after she was sick chills for 3 weeks. After the second booster patient was without a problem but then was sick again 2 weeks after. Emergency care told her just drinking water. She had been waiting for next booster. She did not go to the buildings she was very restricted life she wear mask all the time she was feeling good. But she wanted to know how to build up immunity how it is possible. Reported as non- Serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 09:00 as dose 1, single (Lot number: En6202), in left arm, on 22Mar2021 at 09:00 as dose 2, single (Lot number: Ep7534), in left arm, on 08Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30155ba), in left arm and on 15Apr2022 at 17:00 as dose 4 (booster), single (Lot number: Fm9992) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Rebound COVID- symptoms of sore throat after finishing Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), on 08Mar2021 as dose 2, single (Lot number: EN6208) and on 21Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "HLD" (unspecified if ongoing), notes: HLD; "White coat HTN" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing), notes: Known allergies: Nuts. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2022, outcome "unknown", described as "Rebound COVID- symptoms of sore throat after finishing Paxlovid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: It was reported that rebound COVID- symptoms of sore throat after finishing Paxlovid. Was still having symptoms of COVID on day 5 of Paxlovid. The patient had previously received a COVID-19 Vaccine.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported COVID-19 positive and disease recurrence after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for COVID; Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: E19261, Expiration Date: 31May2021), on 12Feb2021 as dose 2, single (Lot number: EL9267, Expiration Date: 31May2021) and on 02Dec2021 as dose 3 (booster), single (Lot number: FF2590, Expiration Date: 31Mar2022) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2021, outcome "unknown" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical Course: It was reported that the patient was sick but not really sick. Had fever for a couple of days and was really tired and that was basically it. He was asking when he could receive the second booster. Finished Paxlovid one day last week. When indication for Paxlovid queried caller provided He was positive for Covid and diabetic. All three previous doses of Covid19 Vaccine were manufactured by Pfizer. NDC: 59267100001 (Dose 1), 59267100001 (Dose 2) and 59267100002 (Dose 3).; 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Diabetes mellitus
Clinical narrative: Positive for COVID; Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: E19261, Expiration Date: 31May2021), on 12Feb2021 as dose 2, single (Lot number: EL9267, Expiration Date: 31May2021) and on 02Dec2021 as dose 3 (booster), single (Lot number: FF2590, Expiration Date: 31Mar2022) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2021, outcome "unknown" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical Course: It was reported that the patient was sick but not really sick. Had fever for a couple of days and was really tired and that was basically it. He was asking when he could receive the second booster. Finished Paxlovid one day last week. When indication for Paxlovid queried caller provided He was positive for Covid and diabetic. All three previous doses of Covid19 Vaccine were manufactured by Pfizer. NDC: 59267100001 (Dose 1), 59267100001 (Dose 2) and 59267100002 (Dose 3).; 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: did a survey and found out he was diabetic; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FF2590, Expiration Date: 31Mar2022) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (first dose:, LOT: E19261, NDC: 59267100001, EXP: 31May2021), administration date: 22Jan2021, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (second dose: , LOT: EL9267, NDC: 59267100001, EXP: 31May2021), administration date: 12Feb2021, for Covid-19 immunization, reaction(s): "COVID-19". The following information was reported: DIABETES MELLITUS (medically significant), outcome "not recovered", described as "did a survey and found out he was diabetic". The patient underwent the following laboratory tests and procedures: Blood test: diabetic positive, notes: patient was positive for COVID and diabetic. Clinical course: Caller had someone call in asking to be vaccinated and had just completed Paxlovid. Caller didn't give the second booster to patient because that was what calling about. The patient was asking when he could receive the second booster. Caller was not sure. The patient went through the drive thru for testing and when he was positive they contacted him and did a survey and found out he was diabetic. They called in prescription for him to pick up Paxlovid. Finished Paxlovid one day last week. When indication for Paxlovid queried caller provided patient was positive for COVID and diabetic.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Diabetes mellitus
Clinical narrative: did a survey and found out he was diabetic; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FF2590, Expiration Date: 31Mar2022) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (first dose:, LOT: E19261, NDC: 59267100001, EXP: 31May2021), administration date: 22Jan2021, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (second dose: , LOT: EL9267, NDC: 59267100001, EXP: 31May2021), administration date: 12Feb2021, for Covid-19 immunization, reaction(s): "COVID-19". The following information was reported: DIABETES MELLITUS (medically significant), outcome "not recovered", described as "did a survey and found out he was diabetic". The patient underwent the following laboratory tests and procedures: Blood test: diabetic positive, notes: patient was positive for COVID and diabetic. Clinical course: Caller had someone call in asking to be vaccinated and had just completed Paxlovid. Caller didn't give the second booster to patient because that was what calling about. The patient was asking when he could receive the second booster. Caller was not sure. The patient went through the drive thru for testing and when he was positive they contacted him and did a survey and found out he was diabetic. They called in prescription for him to pick up Paxlovid. Finished Paxlovid one day last week. When indication for Paxlovid queried caller provided patient was positive for COVID and diabetic.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 57.0
Sex: M
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 HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 10Jun2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 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); "hx PE" (unspecified if ongoing); "DVT" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive Covid test 6 days after testing negative, 9 days after completing 5 days of Paxlovid; Negative, notes: Positive. Covid test 6 days after testing negative, 9 days after completing 5 days of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not have known allergies. Patient received Paxlovid from 12Aug2022 to 16Aug2022 for treatment of COVID-19. Patient experienced congestion, Cough, Body Aches. Positive Covid test 6 days after testing negative, 9days after completing 5 days of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2020 as dose 1, single (Lot number: EK5730), on 09Jan2021 as dose 2, single (Lot number: EL1284) and on 05Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "HLD" (unspecified if ongoing), notes: HLD; "depression" (unspecified if ongoing); "ADHD" (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 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took anti viral product paxlovid for covid 19. The patient previously receive a COVID-19 Vaccine. No known allergies.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: Feb2022, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "Moderate breathing issues"; MYALGIA (non-serious) with onset 2022, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "Significant fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Temperature was 102 degrees Fahrenheit.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient Had the 2nd booster shot about 3.5 weeks ago. Had a total of 4 doses of the Pfizer COVID-19 vaccine. The 1st dose caller received was in Mar2021, then got the 2nd dose caller thought 6 months later, then had the 1st booster, then had the 2nd booster 3.5 weeks ago. Problem was patient had no reactions to any of the 3 other doses of the vaccine, but with the 2nd booster had an adverse reaction. Patient had a temperature, chills, muscle aches, significant fatigue, and moderate breathing issues which have not gone away and have been going on for 3.5 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: Feb2022, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "Moderate breathing issues"; MYALGIA (non-serious) with onset 2022, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "Significant fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Temperature was 102 degrees Fahrenheit.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient Had the 2nd booster shot about 3.5 weeks ago. Had a total of 4 doses of the Pfizer COVID-19 vaccine. The 1st dose caller received was in Mar2021, then got the 2nd dose caller thought 6 months later, then had the 1st booster, then had the 2nd booster 3.5 weeks ago. Problem was patient had no reactions to any of the 3 other doses of the vaccine, but with the 2nd booster had an adverse reaction. Patient had a temperature, chills, muscle aches, significant fatigue, and moderate breathing issues which have not gone away and have been going on for 3.5 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: Fn6205), in left arm, on 25Mar2021 at 10:30 as dose 2, single (Lot number: Er8727), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: Ff2589), in left arm and on 31Mar2022 at 15:00 as dose 4 (booster), single (Lot number: Fk9894) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild-moderate asthma" (unspecified if ongoing), notes: Mild-moderate asthma; "known allergies: Penicillin" (unspecified if ongoing), notes: related antibiotics. Concomitant medication(s) included: DESLORATADIN, start date: 24Jul2022; MONTELUKAST, start date: 24Jul2022; DULERA oral, start date: 07Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Negative; (16Aug2022) Positive; (25Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: After completing full paxlovid course on 11Aug2022, I tested negative on 14Aug2022 and had no symptoms on that date. On 16Aug2022 I tested positive and began experiences mild symptoms including low-grade fever. As of today 25Aug2022, I continue to test positive although I have been symptom free since 21Aug2022. Patient had other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: pcn" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Pencillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test after recovery; Negative, notes: two negative tests; Negative, notes: two negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Patient received Paxlovid treatment for Covid-19 from 14Aug2022 to 18Aug2022. The patient did not receive other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Tested COVID positive on 10Aug. Started Paxlovid on 11Aug. Tested negative on 20Aug. Now tested COVID positive again on 25Aug; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 18:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LUPIN, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Tested COVID positive on 10Aug. Started Paxlovid on 11Aug. Tested negative on 20Aug. Now tested COVID positive again on 25Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Aug2022) Positive, notes: Tested COVID positive on 10Aug; (20Aug2022) Negative, notes: Started Paxlovid on 11Aug. Tested negative on 20Aug; (25Aug2022) Positive, notes: Now tested COVID positive again on 25Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. The patient was treated with Paxlovid from 11Aug2022 to 15Aug2022 for the events. Clinical course: The patient has been isolating during this time.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 15:00 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 at 15:00 as dose 2, single (Lot number: ER2613), in right arm and on 21Dec2021 at 12:00 as dose 3 (booster),single (Lot number: FJ8762) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Jan2022; BUPROPION, start date: Jan2022. Past drug history included: Nickel, reaction(s): "known allergies"; Thimerasol, reaction(s): "known allergies". 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.Additional details include: Patient received antiviral (Pfizer brand)for COVID 19 Treatment From 12Aug2022 to 16Aug2022, Adverse event- Rebound - Foul taste in mouth despite regular oral hygiene. Chewing mint gum helped alleviate.Clinical course: Other medication in 2weeks product includedEscitalopram Tablets (brand- SOLCO Healthcare), Bupropion Extended-Release Tablets (brand- lupin pharmaceuticals). Patient was given anti-viral Paxlovid 12Aug2022 to 16Aug2022 for treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Chronic right hand infection" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; ALBUTEROL [SALBUTAMOL]; HYDROXYCHLOROQUINE; ALEVE; DICLOFENAC; FOLIC ACID. Past drug history included: Cefazolin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Missed 2 weeks of xeljanz xr  because of covid.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, SARS-CoV-2 test
Clinical narrative: I have had now several cardiac events of heart racing to greater than 180bpm with little to no exertion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, prev dose vaccine location=Right arm), for COVID-19 Immunization. The following information was reported: PALPITATIONS (medically significant) with onset 24Jun2022, outcome "not recovered", described as "I have had now several cardiac events of heart racing to greater than 180bpm with little to no exertion". The event "i have had now several cardiac events of heart racing to greater than 180bpm with little to no exertion" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (24Jun2022) heart racing to greater than 180bpm, notes: heart racing to greater than 180bpm; SARS-CoV-2 test: (28Jun2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of palpitations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Rebound Covid 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 11:30 as dose 1, single (Lot number: EL9266) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM type 2" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "recovered", described as "Rebound Covid 19"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Known allergies was reported as none. Follow-up attempts are possible. no further information expected; Sender's Comments: Based on the information in the case, an association between the reported events Drug ineffective and covid 19 and the suspect product BNT162B2cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, Ocular discomfort, SARS-CoV-2 test
Clinical narrative: This is the third time of covid that he got; he has shots and everything; This is the third time of covid that he got; he has shots and everything; pressure in his eyes; he can barely see right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 29-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "This is the third time of covid that he got; he has shots and everything"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "pressure in his eyes"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "he can barely see right". The patient underwent the following laboratory tests and procedures: chest work: Unknown results, notes: he has chest work so, he knows he has it; SARS-CoV-2 test: Positive, notes: This is the third time of Covid that he got. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: he prescribed that Paxlovid. Reporter stated My son called last night, he is 29 years old and this is the third time of Covid that he got and he has chest work so, he knows he has it. He has shots (Later clarified as Pfizer covid29 vaccine) and everything, so I really don't understand but anyhow this time he just got this great pressure in his eyes, he can barely see right. I didn't know that was, I mean Is that a sign. Reporter stated, Yes, is eye pressure a sign of Covid. I have never heard that before. Yes. Reporter further stated, "Okay but this time he had a virtual which I don't understand, I am too old to understand that's virtual doctor appointment and he prescribed that Paxlovid (Further clarification unknown, hence, suspect captured conservatively) and that's your right, Pfizer's. Okay, would you prescribed that for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: This is the third time of covid that he got; he has shots and everything; This is the third time of covid that he got; he has shots and everything; pressure in his eyes; he can barely see right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 29-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "This is the third time of covid that he got; he has shots and everything"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "pressure in his eyes"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "he can barely see right". The patient underwent the following laboratory tests and procedures: chest work: Unknown results, notes: he has chest work so, he knows he has it; SARS-CoV-2 test: Positive, notes: This is the third time of Covid that he got. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: he prescribed that Paxlovid. Reporter stated My son called last night, he is 29 years old and this is the third time of Covid that he got and he has chest work so, he knows he has it. He has shots (Later clarified as Pfizer covid29 vaccine) and everything, so I really don't understand but anyhow this time he just got this great pressure in his eyes, he can barely see right. I didn't know that was, I mean Is that a sign. Reporter stated, Yes, is eye pressure a sign of Covid. I have never heard that before. Yes. Reporter further stated, "Okay but this time he had a virtual which I don't understand, I am too old to understand that's virtual doctor appointment and he prescribed that Paxlovid (Further clarification unknown, hence, suspect captured conservatively) and that's your right, Pfizer's. Okay, would you prescribed that for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if the patient took other medications in 2weeks. The patient took Anti-viral medication Paxlovid from 21Aug2022 to 25Aug2022 via oral route for the treatment of COVID-19. It was reported that from 21Aug2022, there was metallic taste in mouth when patient was taking meds. Initially felt sicker with meds than before taken. Later started feeling better and by end of regimen, was feeling great on 25Aug2022 without any treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pavloxid Rebound. Came back 2 days after testing negative.; 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 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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 blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; FLOMAX [MORNIFLUMATE]. Past drug history included: Statin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Pavloxid Rebound. Came back 2 days after testing negative.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Pavloxid Rebound Came back 2 days after testing negative; Positive, notes: Pavloxid Rebound Came back 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound Covid. Positive13Aug (1st Positive test 14Aug). Neg on 20Aug and symptom resolved by 21Aug. Recurrence and positive test 25Aug2022; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), on 14Jan2021 as dose 2, single (Lot number: EL3246) and on 30Sep2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "not recovered", described as "Rebound Covid. Positive13Aug (1st Positive test 14Aug). Neg on 20Aug and symptom resolved by 21Aug. Recurrence and positive test 25Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive, notes: first positive antigen test 14Aug; (20Aug2022) Negative, notes: negative antigen test 20Aug; (25Aug2022) Positive, notes: recurrence of symptoms and positive antigen test 25Aug2022; (13Aug2022) Positive, notes: positive PCR 13Aug known exposure 10Aug and onset of symptoms 13Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Rebound COVID. Positive PCR 13Aug2022 (known exposure 10Aug2022 and onset of symptoms 13Aug2022), first positive antigen test 14Aug2022. Patient was given anti-viral Paxlovid from14Aug2022 to 18Aug2022 for treatment of COVID-19. Negative antigen test 20Aug2022 and resolution of symptoms by 21Aug2022. Recurrence of symptoms and positive antigen test 25Aug2022.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19, vaccination failure , disease recurrence cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19, vaccination failure, disease recurrence  is : expected. The case will be reassessed further upon receipt of additional information.