chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: AE details for lack of efficacy of Covid vaccine as AE was realized after call; AE details for lack of efficacy of Covid vaccine as AE was realized after call; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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 "AE details for lack of efficacy of Covid vaccine as AE was realized after call". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter was a pharmacist from an infusion company who was calling on behalf of one of her patients. Reporter states that her patient has taken Paxlovid within the last month and was asking how long should patient wait to get their Pfizer Covid19 booster vaccine after taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster/ tested positive with COVID; She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster/ tested positive with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EW6202/EN6202), on 31Mar2021 as dose 2, single (Lot number: EP6955) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 71 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METAMUCIL [PLANTAGO OVATA]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "not recovered" and all described as "She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster/ tested positive with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: all tests were negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller was calling in regards to Paxlovid. She came down with COVID and tested positive Saturday and started Saturday night on Paxlovid.  She did not take last night's dose. She was not at high risk for hospitalization and was told her lungs and blood pressure was good and had no fever. She would like to discontinue the Paxlovid and wants to know the risks of stopping Paxlovid.  She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster and had no problems. She took the Advil but took none on Saturday and did not start the Advil before the Paxlovid. Caller confirms she was taking no medications while taking Paxlovid and was taking no medications in the 2 weeks prior to starting the Paxlovid. Caller states no medical conditions or test results but had a viral infection several weeks ago and was tested for COVID, Strep, and the Flu but all tests were negative. She states her daughter caught COVID and she was staying with her daughter right now.  AE(s) did not require a visit to emergency room visit or physician office. She went to the minute clinic to get Paxlovid. Prior Vaccinations (within 4 weeks) there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations was none. She didn't get sick with the COVID-19 Vaccines.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), 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".  Clinical course: It was reported that patient and his family developed COVID-19. Uncertain of their vaccination status.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, 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). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EH9899), in right arm, as dose 2, single (Lot number: EJ1686), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17May2022 as dose 4 (booster), single (Lot number: 038A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DMII" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN oral, start date: Jan2018; VALSARTAN+HYDROCHLOROTHIAZIDE oral, start date: Jan2018; TADALAFIL oral, start date: Jan2018; AMLODIPINE oral, start date: Jan2018.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 30, notes: Obesity BMI 30; SARS-CoV-2 test: Positive, notes: Rebound COVID symptoms with positive antigen test 10 days after finishing Paxlovid; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 24May2022 to 28May2022 via oral route for treatment of COVID-19. Rebound COVID symptoms with positive antigen test 10 days after finishing Paxlovid. Patient not had any known allergies. ; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID though vaccinated; Tested positive for COVID though vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old male patient received BNT162b2 (BNT162B2), on 12May2021 as dose 1, single (Lot number: EW0179), in left arm, on 05Jun2021 as dose 2, single (Lot number: EW0185), in left arm and on 20Jan2022 as dose 3 (booster), single (Lot number: F71611) at the age of 13 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known Allergies: Peanuts" (unspecified if ongoing), notes: Known Allergies: Peanuts. Concomitant medication(s) included: QVAR; FOCALIN XR ER. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022 at 20:00, outcome "not recovered" and all described as "Tested positive for COVID though vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Tested positive for COVID though the patient was vaccinated. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. Device timestamp: 07Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
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) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. It was reported that the patient has no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 22May2022, outcome "unknown", COVID-19 (medically significant) with onset 22May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: First tested positive 22May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received treatment of Paxlovid treatment for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
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 contactable reporter(s) (Physician).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gerd" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies: Cipro", notes: known allergies: cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive; (01Jun2022) Negative; (03Jun2022) Negative; (06Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 27May2022, rapid test was positive, the patient started paxlovid as a treatment for Covid-19 and 01Jun2022 and 03Jun2022, the negative rapid tests after completion of medicine. On 06Jun2022, the symptoms recurred/ rapid test was positive twice. No other medication received in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 drug ineffective and Covid-19 cannot be ruled out.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, SARS-CoV-2 test, Systemic lupus erythematosus
Clinical narrative: I have recently been diagnosed with MS; Lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FM0689) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. No other vaccine in four weeks and other medication in two weeks. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Right), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Right), administration date: 23Apr2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FF2593, Location of injection: Arm Right), administration date: 23Oct2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant) with onset Apr2022, outcome "not recovered", described as "I have recently been diagnosed with MS"; SYSTEMIC LUPUS ERYTHEMATOSUS (disability, medically significant) with onset Apr2022, outcome "not recovered", described as "Lupus". The events "i have recently been diagnosed with ms" and "lupus" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2021) Negative, notes: Nasal Swab; (Jun2022) Negative, notes: Nasal Swab; (Oct2021) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of multiple sclerosis, systemic lupus erythematosus.  Clinical course: Patient had recently been diagnosed with MS and also possibly Lupus. Stated that why would these two autoimmune diseases suddenly come on her at that stage of her life. Patient wished she had never gotten vaccinated. Her life, as she knew it, was over. No covid prior vaccination. Patient was covid tested post vaccination. No other vaccine in four weeks.  No other medication in two weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Sinus congestion, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Sinus congestion; 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-163-4421537-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 27Apr2022 to 12May2022 at unk, (citrate free), subcutaneous for psoriasis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "recovering" and all described as "COVID-19"; SINUS CONGESTION (non-serious) with onset 2022, outcome "unknown". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" 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 reporter considered "covid-19" and "sinus congestion" related to BNT162b2.  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 event 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 product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Immunisation reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Vaccination adverse reaction; 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-163-4421253-00 (Agency).  A 56-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "COVID-19"; IMMUNISATION REACTION (non-serious) with onset 01Jun2022, outcome "recovering", described as "Vaccination adverse reaction". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: diagnosed with covid-19 with humira. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: On an unknown date, the patient experienced reaction to COVID shots. 01Jun2022, the patient experienced diagnosed with COVID-19. Pfizer BioNTech COVID-19 vaccine (Tozinameran) and Moderna COVID-19 vaccine (Elasomeran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporters causality for the event of reaction to both COVID shots and diagnosed with COVID-19 was not provided. Patient had no known allergies.  The reporter's assessment of the causal relationship of "covid-19" 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 reporter considered "vaccination adverse reaction" probable to BNT162b2.  Causality of Humira: Causality as per reporter for events COVID-19 and Vaccination adverse reaction was not reported.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, vaccination failure,  Vaccination adverse reaction and the administration of the vaccine cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Movement disorder, Pain in extremity, Peripheral nerve injury
Clinical narrative: L arm neuro changes; Left arm severe pain; Weakness; Unable to move; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3302) at the age of 68 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "RA" (ongoing), notes: Route: Per Oral; "Lymphoma", start date: 1994, stop date: Jun1995, notes: Chemo + Radiation.; "Chemo" (unspecified if ongoing), notes: Chemo + Radiation.; "Radiation" (unspecified if ongoing), notes: Chemo + Radiation.; "Weakened immune system" (unspecified if ongoing), notes: Weakened immune system; "immune compromise" (unspecified if ongoing), notes: immune compromise. Concomitant medication(s) included: METHOTREXATE oral taken for rheumatoid arthritis (ongoing). The following information was reported: PERIPHERAL NERVE INJURY (medically significant), outcome "recovered", described as "L arm neuro changes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm severe pain"; ASTHENIA (non-serious), outcome "recovering", described as "Weakness"; MOVEMENT DISORDER (non-serious), outcome "recovering", described as "Unable to move". Therapeutic measures were not taken as a result of peripheral nerve injury.  Clinical course: Left arm with severe pain for 2-4 weeks p 1st injection into L deltoid. Weakness, unable to move X 2wks improved by 1 month later.  Vaccination Facility Type: Hospital. Vaccine Administered at Facility? No. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Family Medical History Relevant To AE(s): None. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia: None; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pulmonary endarterectomy
Clinical narrative: Pulmonary endarterectomy; Flu like symptoms; 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-163-4421646-00.  A 62-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY ENDARTERECTOMY (medically significant) with onset Feb2021, outcome "unknown"; INFLUENZA LIKE ILLNESS (medically significant) with onset 2021, outcome "unknown", described as "Flu like symptoms". The action taken for adalimumab was unknown.  The reporter considered "flu like symptoms" related to BNT162b2. The reporter's assessment of the causal relationship of "pulmonary endarterectomy" 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 reporter causality for the co suspect HUMIRA (ADALIMUMAB) for events Pulmonary thromboendarterectomy and flu like symptoms was not provided. Agency opinion is that there is no reasonable possibility that the event of Pulmonary thromboendarterectomy and flu like symptoms are related to  HUMIRA (ADALIMUMAB).  Clinical course: In Feb2021, the patient had Pulmonary thromboendarterectomy. He had covid vaccine issue which showed flu like symptoms. It was unknown if he was enrolled in a covid 19 vaccine trial.   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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events, influenza like illness and pulmonary endarterectomy cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: developed full on symptoms of COVID-19; developed full on symptoms of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12-year-old male patient received BNT162b2 (COMIRNATY), 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), outcome "unknown" and all described as "developed full on symptoms of COVID-19". Clinical course: . He received COVID-19 vaccine prior to the infection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Myalgia, Pyrexia
Clinical narrative: myalgias 31May2022; fevers 01Jun; cough; Rhinorrhea; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False, prev dose administration date: 17Mar2021 prev dose dose number: 2), administration date: 17Mar2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False, prev dose administration date: 23Feb2021 prev dose dose number: 1), administration date: 23Feb2021, when the patient was 59-year-old, for Covid-19 immunization; Covid-19 vaccine (prev dose product: COVID 19, prev dose brand unknown: True, prev dose brand name unknown: COVID19 Vaccine, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose dose number: 3), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 31May2022, outcome "unknown", described as "HA"; RHINORRHOEA (non-serious) with onset 31May2022, outcome "unknown", described as "Rhinorrhea"; COUGH (non-serious) with onset 31May2022, outcome "unknown"; PYREXIA (non-serious) with onset 31May2022, outcome "unknown", described as "fevers 01Jun"; MYALGIA (non-serious) with onset 31May2022, outcome "unknown", described as "myalgias 31May2022". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, pyrexia, cough, rhinorrhoea, headache.  Additional information: Patient took Paxlovid  for the adverse events of myalgia, pyrexia, cough, rhinorrhoea, headache. Patient did not have covid prior vaccination. Patient had a positive nasal swab covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: myalgias 31May2022; fevers 01Jun; cough; Rhinorrhea; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False, prev dose administration date: 17Mar2021 prev dose dose number: 2), administration date: 17Mar2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False, prev dose administration date: 23Feb2021 prev dose dose number: 1), administration date: 23Feb2021, when the patient was 59-year-old, for Covid-19 immunization; Covid-19 vaccine (prev dose product: COVID 19, prev dose brand unknown: True, prev dose brand name unknown: COVID19 Vaccine, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose dose number: 3), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 31May2022, outcome "unknown", described as "HA"; RHINORRHOEA (non-serious) with onset 31May2022, outcome "unknown", described as "Rhinorrhea"; COUGH (non-serious) with onset 31May2022, outcome "unknown"; PYREXIA (non-serious) with onset 31May2022, outcome "unknown", described as "fevers 01Jun"; MYALGIA (non-serious) with onset 31May2022, outcome "unknown", described as "myalgias 31May2022". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, pyrexia, cough, rhinorrhoea, headache.  Additional information: Patient took Paxlovid  for the adverse events of myalgia, pyrexia, cough, rhinorrhoea, headache. Patient did not have covid prior vaccination. Patient had a positive nasal swab covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Fatigue
Clinical narrative: felt "run down"; diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  An 85-year-old male patient received tofacitinib citrate (XELJANZ XR), at 11 mg; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Covid-19 vaccine for COVID-19 immunization, notes: Primary series of immunization completed manufacturer: Unknown. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt "run down""; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". The action taken for tofacitinib citrate was unknown.  Additional Information: It was reported that, on 06Jun2022 [Xeljanz D/C Call] completed. Spoke with patient's wife. Reports getting COVID 4th dose 2 weeks ago, and patient felt "run down" for about a week after and experienced some diarrhea. Did not stop Xeljanz for that dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: + Ag test 01Jun2022; + Ag test 01Jun2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 17Mar2021 as dose 2, single (Lot number: EL3247) and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "+ Ag test 01Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Nausea, Vomiting, Walking aid user
Clinical narrative: feeling weak; Brain fog; Nauseous; Vomiting; she needs the assistance of cane to walk because she is so week; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 18May2022, outcome "unknown", described as "Brain fog"; NAUSEA (non-serious) with onset 18May2022, outcome "unknown", described as "Nauseous"; VOMITING (non-serious) with onset 18May2022, outcome "unknown"; ASTHENIA (non-serious) with onset 18May2022, outcome "unknown", described as "feeling weak"; WALKING AID USER (non-serious) with onset 18May2022, outcome "not recovered", described as "she needs the assistance of cane to walk because she is so week". Additional information: The reporter stated that, 30 minutes after the vaccine patient started feeling weak, brain fog. She was nauseous and vomiting. She actually now use a cane to walk around. No, she needs the assistance of cane to walk because she was so week.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : 202200810438 Same reporter, different product/patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: tested positive in at home test, went to Emergency out clinic; tested positive in at home test, went to Emergency out clinic; tired; sore throat; headache; runny nose; 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL3246), in right arm, on 21Jan2021 as dose 2, single (Lot number: EL9261), on 17Aug2021 as dose 3 (booster), single (Lot number: EW0171), in right arm and on 10May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no Known allergies. Patient had not received other medication in 2 weeks. The following information was reported: HEADACHE (non-serious) with onset 23May2022, outcome "not recovered"; RHINORRHOEA (non-serious) with onset 23May2022, outcome "not recovered", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 23May2022, outcome "not recovered", de-scribed as "sore throat"; VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant), outcome "not recovered" and all described as "tested positive in at home test, went to Emergency out clinic"; FATIGUE (non-serious), outcome "unknown", described as "tired". The events "tested positive in at home test, went to emergency out clinic", "sore throat", "headache" and "runny nose" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (23May2022) positive; (25May2022) positive; (04Jun2022) positive; (05Jun2022) positive; (06Jun2022) positive; (07Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, sars-cov-2 test positive, oropharyngeal pain, headache, rhinorrhoea, fatigue. On 23May started with sore throat, headache, runny nose, tested positive in at home test, went to Emergency out clinic on 25May and tested positive there. Pre-scribed Paxlovid for 5 days. Felt great after 2 days, continued taking all med, tested negative for 4 days, then tested positive again on Jun 4,5,6,7. I feel fine except very tired. Patient had not received treatment for ae.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: tested positive in at home test, went to Emergency out clinic; tested positive in at home test, went to Emergency out clinic; tired; sore throat; headache; runny nose; 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL3246), in right arm, on 21Jan2021 as dose 2, single (Lot number: EL9261), on 17Aug2021 as dose 3 (booster), single (Lot number: EW0171), in right arm and on 10May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no Known allergies. Patient had not received other medication in 2 weeks. The following information was reported: HEADACHE (non-serious) with onset 23May2022, outcome "not recovered"; RHINORRHOEA (non-serious) with onset 23May2022, outcome "not recovered", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 23May2022, outcome "not recovered", de-scribed as "sore throat"; VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant), outcome "not recovered" and all described as "tested positive in at home test, went to Emergency out clinic"; FATIGUE (non-serious), outcome "unknown", described as "tired". The events "tested positive in at home test, went to emergency out clinic", "sore throat", "headache" and "runny nose" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (23May2022) positive; (25May2022) positive; (04Jun2022) positive; (05Jun2022) positive; (06Jun2022) positive; (07Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, sars-cov-2 test positive, oropharyngeal pain, headache, rhinorrhoea, fatigue. On 23May started with sore throat, headache, runny nose, tested positive in at home test, went to Emergency out clinic on 25May and tested positive there. Pre-scribed Paxlovid for 5 days. Felt great after 2 days, continued taking all med, tested negative for 4 days, then tested positive again on Jun 4,5,6,7. I feel fine except very tired. Patient had not received treatment for ae.
Sex: M
Vaccine: COVID19
Symptoms: Generalised oedema, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; body parts swelled up; 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-163-4423017-00.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered with sequelae", described as "Rheumatoid arthritis flare up"; GENERALISED OEDEMA (non-serious), outcome "unknown", described as "body parts swelled up".  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "body parts swelled up" 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.  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 rheumatoid arthritis flare up" and "body parts swelled up". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Lot number: ew0170), in left arm and on 13May2021 as dose 2, single (Lot number: ew0182) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 03Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 069f21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022 at 02:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Negative; (01Jun2022) Negative; (05Jun2022) Negative; (06Jun2022) Positive, notes: evening; (unspecified date) Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient did not receive any medication in 2 weeks. Patient had no known allergies. Adverse event: negative antigen test 22May. Negative antigen test 01Jun. Negative antigen test 05Jun. Positive antigen test 06Jun evening. Took evening test because patient felt achy similar to how felt with covid. So 15 days covid negative then positive. The patient received Paxlovid as a treatment for COVID-19 from 19May2022 to 23Jun2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FJ1620), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "recovering" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive to Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was treated with anti-viral drug of Paxlovid from 19May2022 to 24May2022 for COVID-19. The treatment medication included albuterol nebulizer treatments.  No follow-up attempts possible. No further information expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-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: "Cardiac arrhythmia" (unspecified if ongoing). The patient's family history included: "Covid-19" (unspecified if ongoing), notes: My family all had covid 19 at the same time, and three other family members. Concomitant medication(s) included: PROPRANOLOL; DILTIAZEM. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27May2022, outcome "unknown", COVID-19 (medically significant) with onset 27May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative, and then a day later, covid symptoms returned rapidly and in full force; (unspecified date) Positive, notes: I am now testing positive for Covid-19 again after testing negative; (27May2022) Positive; (01Jun2022) Negative; (05Jun2022) Positive; (06Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient reported that she suffering from moderate Covid-19 rebound symptoms after completing a 5 day course of Paxlovid. She was fully vaccinated/boosted, and believe Paxlovid extended and worsened my covid-19 illness instead of making it better. Her family all had covid 19 at the same time, and three other family members who did not take Paxlovid are back to normal routine, testing negative. she took Paxlovid for 5 days. Felt better. Tested negative, and then a day later, covid symptoms returned rapidly and in full force, and are actually WORSE than before she took the Paxlovid. She was now testing positive for Covid-19 again after testing negative. Tested positive for Covid-19 on 27May Started Paxlovid 27May Symptoms resolved 29May Completed Paxlovid 01Jun Tested negative for Covid 19 04Jun Symptoms returned on 05Jun and positive Covid test on 05Jun and 06Jun. Symptoms more severe on 06Jun - 07Jun than they were on 27May before taking Paxlovid. Paxlovid lengthened my illness and also caused worse symptoms with the rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.