chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Severe Pain in left neck and left arm; Severe Pain in left neck and left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "neck diagnosis issue" (unspecified if ongoing), notes: past neck diagnosis issue from over, 10 years ago. Concomitant medication(s) included: NASONEX; SUDAFED 12 HOUR. Vaccination history included: BNT162b2 (Dose 2, single, Lot: Er8734, administration time 02:00 PM, vaccine location: Left arm), administration date: 03Apr2021, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, single, Lot: En6199, administration time 03:00 PM, vaccine location: Left arm), administration date: 13Mar2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (medically significant), NECK PAIN (medically significant) all with onset 02May2022 at 15:00, outcome "not recovered" and all described as "Severe Pain in left neck and left arm". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive. Therapeutic measures were taken as a result of pain in extremity, neck pain.  Clinical course: Facility type vaccine: Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Nasonnex and Sudafed. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no reported allergies. Severe Pain in left neck and left arm. 3 male employees at a office of 24 are experiencing the same symptoms. The only thing we all have in common is the Phizer shots. We are of different ethnicity's and age. We each have a past neck diagnosis issue from over 10 years ago. None of us have had any issues with our necks or arms up to this year from Previous issue. Seems like to much of a coincidence that it's not either a side effect of the vaccine or a side effect of Covid. Each of us had a Covid infection with light to no symptoms. The symptoms are ongoing with health care being administered with PT. Since the vaccination, the patient had been tested for COVID-19 (covid test type post vaccination Nasal Swab, Covid test name post vaccination=Bionax, covid test date=31Jan2022, covid test result=Positive).  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828047 same reporter/product/event, different patient;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Severe Pain in left neck and left arm; Severe Pain in left neck and left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "neck diagnosis issue" (unspecified if ongoing), notes: past neck diagnosis issue from over, 10 years ago. Concomitant medication(s) included: NASONEX; SUDAFED 12 HOUR. Vaccination history included: BNT162b2 (Dose 2, single, Lot: Er8734, administration time 02:00 PM, vaccine location: Left arm), administration date: 03Apr2021, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, single, Lot: En6199, administration time 03:00 PM, vaccine location: Left arm), administration date: 13Mar2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (medically significant), NECK PAIN (medically significant) all with onset 02May2022 at 15:00, outcome "not recovered" and all described as "Severe Pain in left neck and left arm". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive. Therapeutic measures were taken as a result of pain in extremity, neck pain.  Clinical course: Facility type vaccine: Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Nasonnex and Sudafed. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no reported allergies. Severe Pain in left neck and left arm. 3 male employees at a office of 24 are experiencing the same symptoms. The only thing we all have in common is the Phizer shots. We are of different ethnicity's and age. We each have a past neck diagnosis issue from over 10 years ago. None of us have had any issues with our necks or arms up to this year from Previous issue. Seems like to much of a coincidence that it's not either a side effect of the vaccine or a side effect of Covid. Each of us had a Covid infection with light to no symptoms. The symptoms are ongoing with health care being administered with PT. Since the vaccination, the patient had been tested for COVID-19 (covid test type post vaccination Nasal Swab, Covid test name post vaccination=Bionax, covid test date=31Jan2022, covid test result=Positive).  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828047 same reporter/product/event, different patient;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Severe Pain in left neck and left arm; Severe Pain in left neck and left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "neck diagnosis issue" (unspecified if ongoing), notes: past neck diagnosis issue from over, 10 years ago. Concomitant medication(s) included: NASONEX; SUDAFED 12 HOUR. Vaccination history included: BNT162b2 (Dose 2, single, Lot: Er8734, administration time 02:00 PM, vaccine location: Left arm), administration date: 03Apr2021, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, single, Lot: En6199, administration time 03:00 PM, vaccine location: Left arm), administration date: 13Mar2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (medically significant), NECK PAIN (medically significant) all with onset 02May2022 at 15:00, outcome "not recovered" and all described as "Severe Pain in left neck and left arm". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive. Therapeutic measures were taken as a result of pain in extremity, neck pain.  Clinical course: Facility type vaccine: Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Nasonnex and Sudafed. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no reported allergies. Severe Pain in left neck and left arm. 3 male employees at a office of 24 are experiencing the same symptoms. The only thing we all have in common is the Phizer shots. We are of different ethnicity's and age. We each have a past neck diagnosis issue from over 10 years ago. None of us have had any issues with our necks or arms up to this year from Previous issue. Seems like to much of a coincidence that it's not either a side effect of the vaccine or a side effect of Covid. Each of us had a Covid infection with light to no symptoms. The symptoms are ongoing with health care being administered with PT. Since the vaccination, the patient had been tested for COVID-19 (covid test type post vaccination Nasal Swab, Covid test name post vaccination=Bionax, covid test date=31Jan2022, covid test result=Positive).  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828047 same reporter/product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Eye operation, Neoplasm malignant
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for Covid-19 immunization; Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: EYE OPERATION (medically significant), outcome "unknown", described as "eye surgery"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". Clinical course: Caller is a consumer who's asking about the Pfizer Covid-19 vaccine, and whose past medical history was significant for cancer. She also notes that she is bedbound, and would like to know "how I can get somebody to come to my home and give my first booster"? She also notes, "her husband had cancer and had eye surgery recently, he needs his 2nd booster". Possible AE noted after call, both patients mentioned have cancer and have had the Pfizer 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, FLUX
Symptoms: Illness
Clinical narrative: got so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "dementia problems" (unspecified if ongoing), notes: dementia problems. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "got so sick".  Additional information; Warm transfer from name with Pfizer Medical Information, GRACE: INT-#. Caller was told by the CDC to contact Pfizer. She had her first Pfizer BioNTech COVID-19 Vaccine at the end of Aug and 10 days later she had the second dose administered. Her sister gets the flu vaccine but got so sick one year. She looked at her age and if anything happens and looked in the newspaper and television and people were dying like flies. She got the vaccine because of family. She states her sister got the basic vaccine and her and her husband got the vaccine and was really sick for 3 days. Her sister went religiously right after she remembers her getting very sick. She told her sister the flu shots are brought around and she read in the paper the flu shots wasn't effective. Her sister and her brother in law are both 90 years old and have dementia problems. Her sister is the only one she has left of 7. She can't understand what you are saying anymore and her husband is in the same boat. She states this is a very sad way to live this long only for your brain to go.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cytokine storm, Dyspnoea, Nasal congestion, Productive cough
Clinical narrative: hit by cytokine storm worse than initial event; productive cough; Labored breathing; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2), for Covid-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 07Jun2022, outcome "unknown", described as "Labored breathing"; NASAL CONGESTION (non-serious) with onset 07Jun2022, outcome "unknown", described as "congestion"; CYTOKINE STORM (non-serious), outcome "unknown", described as "hit by cytokine storm worse than initial event"; PRODUCTIVE COUGH (non-serious), outcome "unknown".  Clinical course: 2-vaccines. 1-booster, no COVID until 03Jun2022. Labored breathing, congestion clearing thru 07Jun, productive cough. Exposed to cordyceps dust (insecticide) on 07Jun & hit by cytokine storm worse than initial event. This fad supplement may lead to morbidity as it appears to be an immediate vaccine antagonist. Cetrizine suppresses cytokine cascade.  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: Drug ineffective, Gait inability, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. 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: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "COVID"; GAIT INABILITY (hospitalization), outcome "unknown", described as "he can't walk". Additional information: Patient's daughter withheld called for assistance with colestipol. She stated my mom has C diff and she's taking colestipol hydrochloride but at this point my dad is in the living room in a hospital bed because he can't walk since COVID even though he got all 3 of your vaccines and than she yeah he's a whole another ball game but meanwhile my mom has C diff and colestipol the only thing stopping it and we can't afford to buy it anymore. 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: Abnormal dreams, Mobility decreased, Muscular weakness, Tension headache
Clinical narrative: The second one gave him tightness in the back of the head behind his right ear.; It has affected his mobility with his knees and right hand feeling weak and his legs buckling; It has affected his mobility with his knees and right hand feeling weak and his legs buckling; lewd dreams, weird dreams; 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 38-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization, reaction(s): "seizure". The following information was reported: TENSION HEADACHE (non-serious), outcome "unknown", described as "The second one gave him tightness in the back of the head behind his right ear."; MOBILITY DECREASED (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "It has affected his mobility with his knees and right hand feeling weak and his legs buckling"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "lewd dreams, weird dreams".  Additional information: A 38 years old male patient called and reported that he was hesitant to take the Pfizer BioNTech COVID 19 vaccine but after the first one he experienced diminished health.  He caught a seizure and he suffers from seizures. The second one gave him tightness in the back of the head behind his right ear. It had affected his mobility with his knees and right hand feeling weak and his legs buckling. He also had been having lewd dreams, weird dreams. He had to go to court with his family, he lost his job, he's lost friends since the vaccine. He knows people are recording him. He was assaulted two days ago. There were cameras in the street and watching him when he goes to the bathroom. He sees things in his peripherals and sees them recording from his eyes. He asked if Comirnaty (also known as Pfizer-BioNTech COVID-19 Vaccine) contain a microchip to allow tracking of individuals who received vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: 1st booster about 6 months ago, one month later (around December) they got Covid; 1st booster about 6 months ago, one month later (around December) they got Covid; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "1st booster about 6 months ago, one month later (around December) they got Covid". Same patient received 2nd booster about a month ago, got covid again about a month after and it was their worst case of covid. They were sicker than they were the first time, hit harder than before. They were still ill, still having mild congestion issues.  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: Anaphylactic reaction
Clinical narrative: An allergic reaction/ an anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "An allergic reaction/ an anaphylactic reaction". The event "an allergic reaction/ an anaphylactic reaction" required emergency room visit.  Clinical course: Doctor said she personally experienced an allergic reaction to Pfizer's COVID vaccine that led her to visit a local hospital ER. She believed it to be an anaphylactic reaction. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Peripheral swelling
Clinical narrative: Left arm swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Lot number: EW0180) at the age of 90 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "high eye pressure/glaucoma" (unspecified if ongoing), notes: high eye pressure; "breast cancer" (unspecified if ongoing), notes: history of breast cancer removal of left breast and lymph nodes left side 20 years ago. The patient's family history included: "sick" (unspecified if ongoing), notes: Her sister gets the flu vaccine but got so sick one year. Concomitant medication(s) included: AMLODIPINE BESYLATE taken for hypertension, start date: 2010; HYDROCHLOROTHIAZIDE; LATANOPROST taken for glaucoma, start date: 2005. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Aug2021, outcome "unknown", described as "Left arm swelled up". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not received other medications in two weeks. Anti-viral details: product=COVID 19 Treatment, Brand: Pfizer, treatment start date: 31May2022, treatment stop date: 04Jun2022, Indication: treatment of Covid-19. There were no known allergies and other medical history.  No follow-up attempts are possible; information about lot/batch can not be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered with sequelae", described as "stroke".  Clinical information: The patient had a stroke within 2 weeks of receiving 2nd dose. It was told by physician that due to vaccine. Recovered with lasting effects  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID on 27May; tested positive for COVID on 27May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "tested positive for COVID on 27May ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive; (06Jun2022) Negative; (09Jun2022) Positive. Therapeutic measures, Paxlovid from 27May2022 until 01Jun2022, were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested positive for COVID on 27May2022 and started Paxlovid that same day. Patient tested negative on 06Jun and then tested positive again on 09Jun.  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: Biopsy kidney, Blood albumin, Glomerulonephritis minimal lesion, Microscopy, Urine protein/creatinine ratio
Clinical narrative: This is a literature report for the following literature source(s): "Report of three cases of minimal change disease following the second dose of mRNA SARS-CoV-2 COVID-19 vaccine", Kidney International Reports, 2021. A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "steroid-sensitive MCD" (unspecified if ongoing), notes: at age 4 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 immunisation. The following information was reported: GLOMERULONEPHRITIS MINIMAL LESION (medically significant), outcome "unknown", described as "minimal change disease". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed features consistent with MCD, notes: Figure 1c, f; Blood albumin: 2.8 g/dl, notes: hypoalbuminemia; Microscopy: Unknown result; Unknown result; Urine protein/creatinine ratio: 12.9, notes: Unit: g/g nephrotic-range proteinuria. No follow-up attempts are needed. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: 'Glomerulonephritis minimal lesion" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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. Linked Report(s): US-PFIZER INC-202101654930 Same article/ drug and different event/patient.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), on 21Dec2021 at 14:00 as dose 1, single (lot number: 33030BD) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) with onset 27May2022, outcome "not recovered" and described as "covid-19". The patient underwent the following laboratory tests and procedures: covid-19 test: (27May2022) positive (first day of covid); (01Jun2022) negative; (06Jun2022) positive (woke up with symptoms, tested positive again). Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid. Clinical course: The patient started Paxlovid on first day of covid 27May2022. Took for 5 days. Tested negative on 01Jun2022. Woke up with symptoms on 06Jun2022 and tested positive again. No fever; head cold, cough and fatigue as of 09Jun2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "asthma" (unspecified if ongoing); "known allergies Latex" (unspecified if ongoing), notes: known allergies Latex. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; ZOLOFT; MINOCYCLINE. Past drug history included: Morphine, reaction(s): "known allergies morphine", notes: known allergies morphine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Adverse event start date was 01Jun2022. Right arm and leg tremors days 1-5 and then today 09Jun (day 10 from first dose of antivirals) I am sick again and testing positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) positive, notes: testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral Paxlovid was given as treatment for covid-19, start date 31May2022 and stop date 05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing), notes: POTS. The patient's 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: Unknown result, notes: Paxlovid for COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: Anti-viral details: Paxlovid was started from 08Jun2022 for COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast and vulvar cancer" (unspecified if ongoing); "vulvar cancer" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient's 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : The patient received Paxlovid as a covid treatment is on 26May2022 and stop date of drug is 30May2022. The patient received Letrazole is as Other medication on 01Feb2022. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Arthralgia, Arthropathy, COVID-19, Drug ineffective, Joint swelling
Clinical narrative: COVID-19; COVID-19; Knee swelling; Arthropathy aggravated; Knee pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4385646-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis, psoriasis; cortisone (CORTISONE), since 02May2022 (Batch/Lot number: unknown). The patient had no relevant medical history. Patient had no allergies. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. The following information was reported: ARTHROPATHY (non-serious) with onset May2022, outcome "recovering", described as "Arthropathy aggravated"; ARTHRALGIA (non-serious) with onset May2022, outcome "unknown", described as "Knee pain"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; JOINT SWELLING (non-serious), outcome "unknown", described as "Knee swelling". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was dosage not changed; for cortisone was unknown. Clinical course are as follows: Solicited report from the (country) by a consumer of a 69 year old female  with events of non-serious bad flare up/flare up with right knee, knee pain, knee swelling and covid with Humira (Adalimumab).On unknown dates, the patient experienced knee swelling and covid. In May2022, the patient experienced bad flare up/flare up with right knee and knee pain. Cortisone and pfizer biontech covid-19 vaccine (tozinameran) were also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of covid was not reported while for other events was no reasonable possibility with humira adalimumab).The reporter's causality for the event of Arthropathy aggravated was probable while for other events was not reported with cortisone.  The reporter's assessment of the causal relationship of "covid-19", "arthropathy aggravated", "knee pain" and "knee swelling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Knee swelling; Arthropathy aggravated; Knee pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4385646-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis, psoriasis; cortisone (CORTISONE), since 02May2022 (Batch/Lot number: unknown). The patient had no relevant medical history. Patient had no allergies. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. The following information was reported: ARTHROPATHY (non-serious) with onset May2022, outcome "recovering", described as "Arthropathy aggravated"; ARTHRALGIA (non-serious) with onset May2022, outcome "unknown", described as "Knee pain"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; JOINT SWELLING (non-serious), outcome "unknown", described as "Knee swelling". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was dosage not changed; for cortisone was unknown. Clinical course are as follows: Solicited report from the (country) by a consumer of a 69 year old female  with events of non-serious bad flare up/flare up with right knee, knee pain, knee swelling and covid with Humira (Adalimumab).On unknown dates, the patient experienced knee swelling and covid. In May2022, the patient experienced bad flare up/flare up with right knee and knee pain. Cortisone and pfizer biontech covid-19 vaccine (tozinameran) were also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of covid was not reported while for other events was no reasonable possibility with humira adalimumab).The reporter's causality for the event of Arthropathy aggravated was probable while for other events was not reported with cortisone.  The reporter's assessment of the causal relationship of "covid-19", "arthropathy aggravated", "knee pain" and "knee swelling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Tested positive yesterday; Tested positive yesterday; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 77-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "TIAs" (unspecified if ongoing), notes: Transient ischaemic attack. The patient's concomitant medications were not reported. Patient had no Covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "not recovered" and all described as "Tested positive yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (08Jun2022) Positive, notes: Nasal Swab (reported as, covid tested post vaccination). It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as, Patient attended graduation, returned home and started not feeling well. Tested positive yesterday. Very lethargic and minor cough.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: took home test and tested positive; took home test and tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 75-year-old female patient (not pregnant) 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: "Asthma" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 08Jun2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "took home test and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (08Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Attended graduation over the weekend, returned home, was not feeling well, took home test and tested positive. Lethargic and cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 67.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm, on 05Nov2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged Prostrate" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Patient had no known allergies and other medical history included Enlarged Prostrate, Diverticulitis, Asthma. Concomitant medication(s) included: TAMSULOSIN; FINASTERIDE; MONTELUKAST; OXYBUTYNIN. Other medication in 2 weeks included Tamsulosin, Finasteride, Montelukast, Oxybutynin.  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: After patient had tested positive for COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. This report was about COVID-19 treatment. Patient received the vaccine. Patient received treatment for COVID-19 which included Paxlovid which started on 06Jun2022 and stopped on an unspecified date in Jun2022 with Lot number- GA3594. Patient had tested positive for COVID-19. Patient started taking Paxlovid on 05Jun2022. Patient mentioned it was better to dying from COVID-19.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL1284), in right arm, on 29Jan2021 as dose 2, single (Lot number: FL3302), in left arm, on 26Jul2021 as dose 3 (booster), single (Lot number: FF0894), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Positive test 26May2022 treated with Paxlovid; (09Jun2022) Positive, notes: antigen testing 09Jun2022 positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid from 27May2022 to 31May2022, orally for COVID 19 treatment. Other medication in 2weeks taken was reported as concomitant drug. Adverse event reported as Positive test 26May2022 treated with Paxlovid x 5 days antigen testing 09Jun2022 positive. Patient had no Known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: chronic hives; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "autoimmune disease and inflammatory disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA CHRONIC (non-serious), outcome "not recovered", described as "chronic hives". Therapeutic measures were taken as a result of urticaria chronic.  Additional information: HCP reported to colleague that patient after receiving second dose of Pfizer vaccine now has chronic hives. Pfizer vaccine two Dose no booster. Six months after second vaccination patient experienced on going chronic hives. Patient now is on medication plus food restriction to avoid breakouts. HCP suggested family history of autoimmune disease and inflammatory disease within patient's family. Understands that six months is long duration after Vaccine but still feels correlation. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.