chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Paxlovid start date: 10Aug2022; Pfizer / BioNTech / Paxlovid start date: 10Aug2022; Symptoms returned on 19Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Batch/Lot number: unknown), on 30Jan2021 as dose 2, single (Batch/Lot number: unknown), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies Yes - Sulfa" (unspecified if ongoing), notes: known allergies Yes - sulfa. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies Yes - Aspirin", notes: known allergies Yes - Aspirin. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 19Aug2022 at 15:00, outcome "unknown", described as "Symptoms returned on 19Aug2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech / Paxlovid start date: 10Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: product=COVID 19 Treatment, brand=Paxlovid; (20Aug2022) Positive, notes: Tested Positive 20Aug2022 and 25Aug2022; (25Aug2022) Positive, notes: Tested Positive 20Aug2022 and 25Aug2022. 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: Anti viral Paxlovid was given from 10Aug2022 to 14Aug2022. Symptoms returned on 19Aug2022 at 15:00. No treatment was given. Tested Positive 20Aug2022 and 25Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body mass index, COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jul2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "32 bmi" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE, start date: 01Dec2020, stop date: 25Aug2022. Past drug history included: Iodine, reaction(s): "Known allergies: Iodine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 22Aug2022 at 15:00, outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 32; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if therapeutic measures were taken as a result of disease recurrence. Clinical course: Paxlovid start date: 11Aug2022, stop date: 16Aug2022. The patient was fully vaccinated and double boosted. J&J, then Moderna booster then Pfizer booster. She took Paxlovid and 6 days later she became ill again with cough, runny nose, shortness of breath with difficulty breathing, fever and lethargy. She was on day 16 since first symptoms and felt like she was getting worse.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 17Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment included PAXLOVID from 26Jul2022 to 30Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Reporting for self as a Pfizer employee-Tested positive for COVID-19 on 25Aug2022; Reporting for self as a Pfizer employee-Tested positive for COVID-19 on 25Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8734), in left arm, on 24Apr2021 as dose 2, single (Lot number: ER8735), in left arm, on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 21Jul2022 as dose 4 (booster), single (Lot number: FJ4992) at the age of 48 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: covid prior vaccination: yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Aug2022, outcome "recovering" and all described as "Reporting for self as a Pfizer employee-Tested positive for COVID-19 on 25Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2022) Positive, notes: BiNax Now. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Facility type vaccine Pharmacy or Drug Store. Patient did not receive any other vaccines in four weeks. The reported adverse events did not result in any other seriousness criteria.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
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) (Nurse) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6207), in right arm and on 02Apr2021 as dose 2, single (Lot number: ER8734) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: known allergies: Amoxicillin erythromycin; Erythromycin, reaction(s): "Allergy", notes: known allergies: Amoxicillin erythromycin. 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. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received paxlovid as COVID 19 Treatment.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, vaccination failure and the administration of the vaccine cannot be excluded.
Age: 73.0
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 contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "BPH" (unspecified if ongoing); "PVCs" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; ATORVASTATIN; FLOMAX [MORNIFLUMATE]; MULTAQ. 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: Positive, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient had no known allergies. Anti-viral COVID 19 treatment with Paxlovid.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported events and suspect BNT162B2 cannot be excluded .The case will be reviewed further with FU information. 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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: being positive for covid; being positive for covid; 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.  A male patient 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "being positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative for COVID twice; (01Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. After getting the first booster shot he and his wife got COVID and that is why they needed to take the Paxlovid. He wanted to know if he can take the second booster shot or not.    Clinical course: Caller wanted to know how long after taking Paxlovid and being positive for COVID does he had to wait before he could get a 2nd booster dose of the Pfizer Covid 19 vaccine. The caller tested positive for COVID along with his wife on 01Aug2022. Both he and his wife took Paxlovid and afterwards they both tested negative for COVID twice. He wants to know if they are now able to get the fourth shot of the vaccine, clarified to second booster of COVID 19 Vaccine.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Immune system disorder, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: sick for 2-3 weeks after getting each vaccine; chills; fever; cant do anything; 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 83-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: EN6205), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6206, Vaccination Anatomical site: Left arm), administration date: 2021, for COVID-19 Immunization, reaction(s): "Chills", "Tiredness", "just did not feel her self", "Headache". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "cant do anything"; CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "low white cell count "lower end of the normal""; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick for 2-3 weeks after getting each vaccine"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "suppressed autoimmune system". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller received 2 primary series of Pfizer COVID vaccine and 2 boosters shot, last one on 07May2022. She stated she has gotten sick for 2-3 weeks after getting each vaccine; chills, fever, can't 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 and it takes her longer to recover when she gets sick. Caller wanted to know can she get her next booster dose before 6 months. Patient have the low white blood count cell and suppressed immune system after each dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: sick for 2-3 weeks after getting each vaccine; chills; fever; cant do anything; 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 83-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: EN6205), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6206, Vaccination Anatomical site: Left arm), administration date: 2021, for COVID-19 Immunization, reaction(s): "Chills", "Tiredness", "just did not feel her self", "Headache". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "cant do anything"; CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "low white cell count "lower end of the normal""; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick for 2-3 weeks after getting each vaccine"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "suppressed autoimmune system". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller received 2 primary series of Pfizer COVID vaccine and 2 boosters shot, last one on 07May2022. She stated she has gotten sick for 2-3 weeks after getting each vaccine; chills, fever, can't 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 and it takes her longer to recover when she gets sick. Caller wanted to know can she get her next booster dose before 6 months. Patient have the low white blood count cell and suppressed immune system after each dose.  No follow-up attempts are possible. No further information is expected.
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: el9262), in left arm, on 12Feb2021 as dose 2, single (Lot number: en6200), in right arm, in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: May2007. Past drug history included: Welbutrin, reaction(s): "known allergies: Welbutrin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment included PAXLOVID from 12Aug2022 to 17Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: After 2nd shot, got sick for a day; felt crummy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 2, single (Lot number: ER8731) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 2000 (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Tendon on right wrist", start date: 2020 (unspecified if ongoing); "Fall", start date: 2020 (unspecified if ongoing), notes: Two falls in 2020; "Tore knee", start date: 2020 (unspecified if ongoing); "Tore muscles on upper right side", start date: 2020 (unspecified if ongoing). The patient's family history included: "Pre-diabetic", start date: 2019 (unspecified if ongoing), notes: Mother's family has sugar diabetes and she was 91 and did not have it. Concomitant medication(s) included: IRON taken for anaemia. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8735; Expiration date: Unknown; Vaccination time:13:45; Anatomical location: left upper arm near shoulder), administration date: 03Apr2021, when the patient was 60-year-old, for Covid-19 immunization; Shingrex shot, for immunisation; Flu shots, for immunisation, reaction(s): "Soreness in arm". The following information was reported: ILLNESS (non-serious) with onset 24Apr2021, outcome "recovered" (25Apr2021), described as "After 2nd shot, got sick for a day"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt crummy". Therapeutic measures were not taken as a result of illness, malaise.  Additional information: The patient was also taking vitamins for anaemia. The patient had confirmed that she had anemia and was overweight, prior to getting Pfizer COVID vaccines. The patient received Shingrix shot and could not remember if it was before or after the first between the first and 2nd. Her mother got Shingles, so reporter got a Shingrix shot. There was no any other vaccine was administered on same date of Pfizer Suspect vaccine. The events did not result in emergency room or physician office visit. The patient might have received Shingrex within four weeks prior to the first administration date of the suspect vaccine. The patient had two falls and fell about 10 months ago on the same side. She was not hospitalized. She went to various doctors, but did not have to go to the hospital to stay. The patient did not have any relevant tests. The patient family history included: the patients dad died at 65 of heart attack. Mom had a rare lung disease, that she won't get because it was for skinny weight women and she won't be in that category.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201094682 same reporter/patient/product, different dose/AEs;US-PFIZER INC-202201094977 same reporter/patient/product, different dose/AEs;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / 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 65-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 at 19:30 as dose number unknown, single (Lot number: Ep6955) at the age of 63 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 2022, outcome "unknown" and all described as "Pfizer / BioNTech / Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not received any other medication in two weeks. Patient received treatment of Paxlovid for covid 19 from 15Aug2022 to 17Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female 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 "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Female patient (soon-to-be 71y/o) who is a retired ICU nurse called for her and her husband (soon-to-be 73y/o) who were prescribed PAXLOVID. Reporter stated that she had side effects and provide feedback about PAXLOVID. Also stated that she was not going to recommend other people to take it. Completed her 5-day course but her husband stopped after 3 doses, because it was too nasty. Stated that they would not do it gain. Mentioned that they also had the Pfizer vaccines.  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 available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201095022 Same product and event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Eye swelling, Facial pain, Osteitis
Clinical narrative: inflammation of my eye suckers and cheekbones; eyes were swollen shut; severe facial pain; inflammation of my eye suckers and cheekbones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0158), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Patient had COVID-19 prior vaccination. There were no concomitant medications. Past drug history included: Cephlex, reaction(s): "Known allergies: Cephlex", notes: Known allergies: Cephlex. The following information was reported: EYE INFLAMMATION (non-serious), OSTEITIS (non-serious), outcome "recovered" and all described as "inflammation of my eye suckers and cheekbones"; EYE SWELLING (non-serious), outcome "recovered", described as "eyes were swollen shut"; FACIAL PAIN (non-serious), outcome "recovered", described as "severe facial pain".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient after 1st vaccine had events that lasted 2 weeks. Patient had not tested for COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201094320 Same patient/drug, different event sep in time;
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) (Nurse) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Female patient (soon-to-be 71y/o) who is a retired ICU nurse called for her and her husband (soon-to-be 73y/o) who were prescribed PAXLOVID. Reporter stated that she had side effects and provide feedback about PAXLOVID. Also stated that she was not going to recommend other people to take it. Completed her 5-day course but her husband stopped after 3 doses, because it was too nasty. Stated that they would not do it gain. Mentioned that they also had the Pfizer vaccines.  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 available information and possible temporal association the causal relationship between the reported events and suspect cannot be excluded .BNT162B2.The case will be reviewed further with FU information., Linked Report(s) : US-PFIZER INC-202201095005 Same product and event, different patient;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 at 03:30 as dose 1, single (Lot number: EN9264), in right arm, on 25Feb2021 at 10:00 as dose 2, single (Lot number: EN6202), in left arm and on 02Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 26Sep2016, stop date: 15Aug2022. The following information was reported: VACCINATION FAILURE (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: Positive, notes: Treatment of COVID-19; Positive, notes: COVID tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medications were received in 2 weeks. The antiviral drug (COVID 19 Treatment) received from 16Aug2022 to 20Aug2022 for treatment of COVID-19. The event COVID tested positive with symptoms sneezing and coughing from 24Aug2022 at 3 PM (outcome: not recovered).
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Body temperature, COVID-19, Drug ineffective, Electrocardiogram
Clinical narrative: She tested positive for SARS-CoV-2; She tested positive for SARS-CoV-2; This is a literature report for the following literature source(s): Pediatric Nephrology, 2022; pgs:1-2, DOI:10.1007/s00467-022-05712-0.  A 14-year-old female patient 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 included: "kidney failure secondary to Henoch-Shonlein Purpura nephritis" (unspecified if ongoing); "living related kidney transplantation at 12 years of age" (unspecified if ongoing); "kidney failure secondary to Henoch-Shonlein Purpura nephritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE oral taken for immunosuppression; TACROLIMUS oral taken for immunosuppression. The following information was reported: DRUG INEFFECTIVE (medically significant), 6 months after the suspect product(s) administration, outcome "recovered", COVID-19 (medically significant), outcome "recovered" and all described as "She tested positive for SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Blood creatinine: 0.9 mg/dl; 1.1 mg/dl; 0.9 mg/dl, notes: back at her baseline; Body temperature: 102.3 Fahrenheit; Electrocardiogram: QTc prolongation; Epstein-Barr virus test: 520, notes: copies/ml; tacrolimus: 4.8 ng/ml; 54 ng/ml, notes: supratherapeutic; 49 ng/ml, notes: A repeat tacrolimus level 1 and  3 days later showed a decline  (54 h following last tacrolimus dose); 13 ng/ml, notes: (103 h following last tacrolimus dose); 9.5 ng/ml, notes: upon re-check 3 days later; 6.1 ng/ml, notes: 4 days following the dose change; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; 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: Epstein-Barr virus test, Laboratory test, SARS-CoV-2 test
Clinical narrative: She tested positive for SARS-CoV-2; She tested positive for SARS-CoV-2; This is a literature report for the following literature source(s): Pediatric Nephrology, 2022; pgs:1-2, DOI:10.1007/s00467-022-05712-0.  A 14-year-old female patient 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 included: "kidney failure secondary to Henoch-Shonlein Purpura nephritis" (unspecified if ongoing); "living related kidney transplantation at 12 years of age" (unspecified if ongoing); "kidney failure secondary to Henoch-Shonlein Purpura nephritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE oral taken for immunosuppression; TACROLIMUS oral taken for immunosuppression. The following information was reported: DRUG INEFFECTIVE (medically significant), 6 months after the suspect product(s) administration, outcome "recovered", COVID-19 (medically significant), outcome "recovered" and all described as "She tested positive for SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Blood creatinine: 0.9 mg/dl; 1.1 mg/dl; 0.9 mg/dl, notes: back at her baseline; Body temperature: 102.3 Fahrenheit; Electrocardiogram: QTc prolongation; Epstein-Barr virus test: 520, notes: copies/ml; tacrolimus: 4.8 ng/ml; 54 ng/ml, notes: supratherapeutic; 49 ng/ml, notes: A repeat tacrolimus level 1 and  3 days later showed a decline  (54 h following last tacrolimus dose); 13 ng/ml, notes: (103 h following last tacrolimus dose); 9.5 ng/ml, notes: upon re-check 3 days later; 6.1 ng/ml, notes: 4 days following the dose change; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; 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: Limb injury, Magnetic resonance imaging, Periarthritis, Plantar fasciitis
Clinical narrative: her plantar fasciitis flared for several hours; Patient had fallen on her shoulder,The shoulder then "froze"; adhesive capsulitis, brought on by the vaccination; 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), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: PLANTAR FASCIITIS (non-serious), outcome "recovered", described as "her plantar fasciitis flared for several hours"; LIMB INJURY (non-serious), outcome "unknown", described as "Patient had fallen on her shoulder,The shoulder then "froze""; PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis, brought on by the vaccination". The events "her plantar fasciitis flared for several hours", "patient had fallen on her shoulder,the shoulder then "froze"" and "adhesive capsulitis, brought on by the vaccination" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of plantar fasciitis, limb injury, periarthritis.  Additional information: It was reported that 6 months post 3rd Pfizer-Biontech COVID-19 vaccine, the patient received a 4th vaccination. Events occurred after the 4th vaccination. 3 hours after receiving the 4th vaccination, her plantar fasciitis flared for several hours then resolved. Patient had fallen on her shoulder 6 weeks prior to receiving the 4th vaccination. The vaccination was given in the shoulder on which she had fallen. The shoulder then froze. Diagnosis from her physician, post MRI, was adhesive capsulitis, brought on by the vaccination. The physician was not concerned and said he had been seeing reactions to the vaccine that are focused on the shoulder and back of patients. This patient was treated with a cortisone shot. The patient did not received any other vaccine in four weeks. No other medication in two weeks. No COVID prior vaccination and not tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Incoherent, Influenza like illness, Lymphadenopathy
Clinical narrative: she was sick for 2.5 - 3 days; felt like she had the flu she was quite sick; She had a 103 fever and was sort of like out of it; she was incoherent; Swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2021 at 16:30 as dose 3 (booster), single (Lot number: EW0186) at the age of 75 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE, Lot number: EL3249, Expiry: unknown, NDC: unknown), administration date: 21Jan2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "Fever"; BNT162b2 (DOSE 2, SINGLE, Lot number: EL9267, Expiry: unknown, NDC: unknown), administration date: 11Feb2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "She had a 103 fever and was sort of like out of it"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "Swollen lymph nodes"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "felt like she had the flu she was quite sick"; INCOHERENT (non-serious) with onset Oct2021, outcome "unknown", described as "she was incoherent"; ILLNESS (non-serious) with onset 20Oct2021, outcome "recovered" (Oct2021), described as "she was sick for 2.5 - 3 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Caller was reported for his wife that she had a 103 Fever with each one. The patient did get a fever the one time and she was incoherent. The patient had a 103 fever and was sort of like out of it. Caller then handed the phone over to his wife and wife then completed the rest of the report on herself. The patient said she was sick for 2.5 - 3 days. The patient reports having a fever after each dose, felt like she had the flu she was quite sick. Caller then stated she could not have her mammogram because of swollen lymph nodes from the covid Shot. She had to reschedule it for 8 weeks later. The first one she got the vaccine at 100:00am and 12 that night it started. The second time it was 12 hours or 13 hours later and then same thing booster, got it at 4:30pm and work up sick the next day as far as she can remember. Vaccination facility type it was at a Satellite office or doctor's office. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had no family medical history. No additional vaccines administered on same date.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she was sick for 2.5 - 3 days; felt like she had the flu she was quite sick; She had a 103 fever and was sort of like out of it; she was incoherent; Swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2021 at 16:30 as dose 3 (booster), single (Lot number: EW0186) at the age of 75 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE, Lot number: EL3249, Expiry: unknown, NDC: unknown), administration date: 21Jan2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "Fever"; BNT162b2 (DOSE 2, SINGLE, Lot number: EL9267, Expiry: unknown, NDC: unknown), administration date: 11Feb2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "She had a 103 fever and was sort of like out of it"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "Swollen lymph nodes"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "felt like she had the flu she was quite sick"; INCOHERENT (non-serious) with onset Oct2021, outcome "unknown", described as "she was incoherent"; ILLNESS (non-serious) with onset 20Oct2021, outcome "recovered" (Oct2021), described as "she was sick for 2.5 - 3 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Caller was reported for his wife that she had a 103 Fever with each one. The patient did get a fever the one time and she was incoherent. The patient had a 103 fever and was sort of like out of it. Caller then handed the phone over to his wife and wife then completed the rest of the report on herself. The patient said she was sick for 2.5 - 3 days. The patient reports having a fever after each dose, felt like she had the flu she was quite sick. Caller then stated she could not have her mammogram because of swollen lymph nodes from the covid Shot. She had to reschedule it for 8 weeks later. The first one she got the vaccine at 100:00am and 12 that night it started. The second time it was 12 hours or 13 hours later and then same thing booster, got it at 4:30pm and work up sick the next day as far as she can remember. Vaccination facility type it was at a Satellite office or doctor's office. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had no family medical history. No additional vaccines administered on same date.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid rebound after 3 day of completion of Paxlovid course; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 65 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: Shell fish" (unspecified if ongoing). There were no concomitant medications. Patient did not take other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 19Aug2022, outcome "recovering", described as "Covid rebound after 3 day of completion of Paxlovid course". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 12Aug2022 to 16Aug2022.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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 (treated)" (unspecified if ongoing), notes: Hypertension (treated). Concomitant medication(s) included: LOSARTAN/HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Weak positive on at-home antigen test; (Aug2022) Positive, notes: Strong positive result; (Aug2022) Positive, notes: Still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No Known allergies were reported. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Device date was 25Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose #1: Pfizer , Date: 21Jan2021 , Lot: EL3249, Expiry: unknown , NDC: unknown), administration date: 21Jan2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose #2: Pfizer , Date: 11Feb2021 , Lot: EL9267, Expiry: unknown , NDC: unknown), administration date: 11Feb2021, when the patient was 76-year-old, for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Oct2021, outcome "not recovered", described as "arm pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Agent has a patient on the other line reporting arm pain after getting booster shot, he got the shot on Oct2021 and has been experience arm pain the past 6 months. Caller confirms above information and adds him, and his wife got the 2 shots plus the booster last Oct2021. Confirms this is the Covid-19 Vaccine. Caller states he got it and had a sore arm for a day or two and after that nothing really happened in his life and the last 6 months, he has had pains in both of his arms, states he doesn't do any athletic stuff, but his arm has been killing him since getting this drug. Arm Pain: it started the next day just a little put his hand up and feel like if you play baseball or something like that. Then the same day it was running rampid and with this pain it is worse at night and better in the morning. Adverse event not resulted in Emergency Room or Physician Office visit. No . Prior Vaccinations within 4 weeks.