chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Investigation, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.; Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EK9231), in left deltoid and on 27Jan2021 as dose 2, single (Lot number: EL3247), in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension just above borderline= 140/90; "Is the patient a smoker/former smoker? : No" (unspecified if ongoing), notes: Is the patient a smoker/former smoker: No. Concomitant medication(s) included: METHYLPHENIDATE; BUPROPION; ALBUTEROL [SALBUTAMOL]; MONTELUKAST; HYZAAR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Oct2021, outcome "recovered" and all described as "Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 140/90, notes: just above borderline; Evidence of hypoxemia, hypercapnia (PaCO2) or acidosis (pH): (unspecified date) Unknown results, notes: Evidence of hypoxemia (e.g. PaO2/FiO2 [P/F ratio], SpO2/FiO2 [S/F ratio]), hypercapnia (PaCO2) or acidosis (pH): Checked; Oxygen saturation: (unspecified date) 92 %, notes: pulse ox brief; SARS-CoV-2 test: (03Oct2021) Positive, notes: Prior occurrence; (25Jul2022) Positive, notes: Reoccurrence RT-PCR; (24Jul2022) Positive.  Clinical course: The patient received multivitamins.  No follow-up attempts are possible. 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 vaccination failure and covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.; Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EK9231), in left deltoid and on 27Jan2021 as dose 2, single (Lot number: EL3247), in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension just above borderline= 140/90; "Is the patient a smoker/former smoker? : No" (unspecified if ongoing), notes: Is the patient a smoker/former smoker: No. Concomitant medication(s) included: METHYLPHENIDATE; BUPROPION; ALBUTEROL [SALBUTAMOL]; MONTELUKAST; HYZAAR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Oct2021, outcome "recovered" and all described as "Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 140/90, notes: just above borderline; Evidence of hypoxemia, hypercapnia (PaCO2) or acidosis (pH): (unspecified date) Unknown results, notes: Evidence of hypoxemia (e.g. PaO2/FiO2 [P/F ratio], SpO2/FiO2 [S/F ratio]), hypercapnia (PaCO2) or acidosis (pH): Checked; Oxygen saturation: (unspecified date) 92 %, notes: pulse ox brief; SARS-CoV-2 test: (03Oct2021) Positive, notes: Prior occurrence; (25Jul2022) Positive, notes: Reoccurrence RT-PCR; (24Jul2022) Positive.  Clinical course: The patient received multivitamins.  No follow-up attempts are possible. 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 vaccination failure and covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ex-31 week preemies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive.  Clinical course: The reporter was physician and vaccinated their family as soon as was available. They developed COVID for first time on 15Aug2022 and now twins tested positive on 17Aug2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200046249 same reporter/vaccine/AE, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ex-31 week preemies" (unspecified if ongoing), notes: ex-31 week preemies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 17Aug2022, outcome "unknown", described as "COVID"; DRUG INEFFECTIVE (medically significant) with onset 17Aug2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) positive. Clinical information: Physician stated that as she has 10-year-old twin boys who are ex-31 week preemies. They have vaccinated their family as soon as  vaccine was available. They developed COVID for first time on 15Aug2022 and now twins tested positive on 17Aug2022.  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202200046249 same reporter/vaccine/AE, different patient;
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PFO closure with Gore Cardioform 30mm" (unspecified if ongoing), notes: PFO closure with Gore Cardioform 30mm. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information- Patient received antiviral drug Paxlovid on 07Aug2022 till 13Aug2022 for Covid-19 treatment. No other medication patient took in 2 weeks. Patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: At home tests(Nasal Swab): Positive; At home tests(Nasal Swab): Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2021 at 10:30 as dose 1, single (Lot number: Er8733), in left arm and on 11Jun2021 at 10:30 as dose 2, single (Lot number: Ew0167) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: ZYRTEC-D. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "At home tests(Nasal Swab): Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: COVID-test type post vaccination: Nasal Swab.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine: List of other medications the patient received within 2 weeks of vaccination:Multi vitamin, birth control and Zrytec D. Patient had permanent hearing loss in my left ear, along with Titinus and vertigo and balance issues. 1 hour after receiving the booster this all started along with muscle weakness, numbness in face, hands received treatment with antibiotics, prednisone and meclizine ae resulted in: [Disability or permanent damage]. Prior to vaccination, the patient was diagnosed with COVID-19 and Since the vaccination, the patient been was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8727), in arm, on 10Apr2021 as dose 2, single (Lot number: EW0162), in arm and on 15Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: FD0810) at the age of 58 years, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; 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-163-4505546-00 (Company).  A 37-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164364) at unk, citrate free, subcutaneous. 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 10Aug2022, outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of COVID with Humira (adalimumab) was a reasonable possibility.  Drug: Humira (solution for injection in pre-filled pen) (adalimumab): Causality: COVID-19 (COVID-19): Action(s) taken with drug : Unknown; Causality as per reporter (Drug/Vaccine): Probable.  Drug: Pfizer Biontech COVID-19 vaccine (tozinameran): COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine): Possible.  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 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 events Drug Ineffective and Suspected Covid-19 and the suspect drug cannot be excluded and Related to the suspected drug. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 at 09:00 as dose 1, single (Lot number: En6207), in left arm, on 09Apr2021 at 09:00 as dose 2, single (Lot number: Ew0158), in left arm, on 03Dec2021 at 09:00 as dose 3 (booster), single (Lot number: Fj8762), in left arm and on 05May2022 at 09:00 as dose 4 (booster), single (Lot number: Fj4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was treated with Anti viral Paxlovid from 08Aug2022 to 12Aug2022 for the treatment of COVID-19. The patient did not received any other medication in 2 weeks.
Sex: M
Vaccine: COVID19
Symptoms: Glomerulonephritis, Nephropathy, Vasculitis
Clinical narrative: the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022CCX00281 (ChemoCentryx).  A 68-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): "The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021", "The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021", "The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021". The following information was reported: GLOMERULONEPHRITIS (medically significant), NEPHROPATHY (non-serious), VASCULITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021".  Clinical course: On 08Aug2022, it was reported that a patient started treatment on an unspecified date with the Covid vaccine and boosters (Mfr. Pfizer) at unreported doses and frequencies of administration for vaccination. It was reported the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021 (it had previously been diagnosed in 2013, then went into remission). They (not further clarified) thought the Covid vaccine and boosters caused the flare up and that it really messed with his immune system. No further follow-up is anticipated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 04May2010; CELEXA [CELECOXIB], start date: 04May2010; AMLODIPINE, start date: 04May2010; VICTOZA, start date: 04May2010; ISOSORBIDE MONONITRATE, start date: 04May2010. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril"; Morphine, reaction(s): "Known allergies: morphine"; Fentanyl, reaction(s): "Known allergies: fentanyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect BNT162B2 cannot be excluded.
Age: 37.0
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) (Pharmacist). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (18Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID given from 08Aug2022 to 13Aug2022.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 07:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 at 07:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Oct2021 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: After 3 days, I tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was nauseous and headachy. When she first started feeling sick, she was experiencing only a bronchitis-like cough. After 3 days, she tested positive for Covid, so she asked her doctor to prescribe Paxlovid. Patient was not having Known allergies and Other medical history. Patient didn't took other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: U
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) from product quality group. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: ER8733), in left arm, on 14Apr2021 at 12:00 as dose 2, single (Lot number: ER8735), in left arm and on 14Dec2021 as dose 3 (booster), single (Lot number: Foo809) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "mild emphysema" (unspecified if ongoing); "pelvic neuritis" (unspecified if ongoing); "Known allergies : Shellfish" (unspecified if ongoing); "Known allergies : Bee sting" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies : Aspirin"; Iodine, reaction(s): "known allergies : Iodine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: COVID 19 Treatment; (15Aug2022) Negative, notes: Tested negative; (18Aug2022) Negative, notes: Tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given COVID 19 Treatment (brand: Pfizer, lot number: GD8771) from 07Aug2022 to 12Aug2022; symptoms resolved by end of treatment, tested negative on 15Aug. 16Aug nasal congestion and cough started to return. Cough worsened on 17Aug. Still testing negative on 18Aug. Primary care doc prescribed prednisone for 10 days as cough and wheezing worsened.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: 005M21A) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had no known allergies. Patient was treated with anti-viral Paxlovid for COVID-19 treatment from 09Aug2022 to 14Aug2022.; Sender's Comments: Reported events of drug ineffective and COVID-19 are considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Break through bleeding from 2 days after the vaccine until today (3 weeks plus); 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 23Jul2022 as dose 3 (booster), single (Lot number: P40173) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]. Past drug history included: Ibuprofen, reaction(s): "Known allergies : Ibuprofen", notes: Known allergies : Ibuprofen. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3182, Location of injection: Arm Left), administration date: 24Sep2021, when the patient was 31-year-old, reaction(s): "Covid-19 immunization"; BNT162b2 (Dose Number: 1, Batch/Lot No: FC3182, Location of injection: Arm Left), administration date: 03Sep2021, when the patient was 31-year-old, reaction(s): "Covid-19 immunization". The following information was reported: HAEMORRHAGE (medically significant) with onset 25Jul2022, outcome "not recovered", described as "Break through bleeding from 2 days after the vaccine until today (3 weeks plus)". Therapeutic measures were not taken as a result of haemorrhage.  Clinical information: Other vaccine in two week was Prenatal and probiotic.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing), notes: OSA on CPAP; "CPAP" (unspecified if ongoing), notes: OSA on CPAP; "obesity" (unspecified if ongoing); "hypersomnia" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ESCITALOPRAM. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 08Aug2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive, notes: Symptoms of COVID started 08Aug2022; (19Aug2022) Positive, notes: Patient tested positive again on 19Aug2022. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 09Aug2022 to 13Aug2022.  Additional information: The patient was treated with Paxlovid (Treatment start date: 09Aug2022; Treatment stop date: 13Aug2022; lot number unknown) orally for Indication: Treatment of COVID-19. Symptoms of COVID started 08Aug2022. Paxlovid initiated 09Aug2022. Completed 5 day course on 13Aug2022 with improvement in symptoms. Symptoms returned 15Aug2022. Patient tested positive again on 19Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 22Jan2021 as dose 2, single (Lot number: EL3249), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 02Jun2021, stop date: 06Aug2022; LOSARTAN, start date: 01Jun1996. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had no known allergies. Patient was treated with anti-viral COVID 19 Treatment Paxlovid from 07Aug2022 to 12Aug2022.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162b2 vaccine,  cannot be excluded for the vaccination failure and covid-19.  There is limited information provided in this report.  This case will be reassessed once additional information is available. 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: U
Vaccine: COVID19
Symptoms: Lymphoma, Pain
Clinical narrative: had a serious lymphoma type reaction. It is very painful; had a serious lymphoma type reaction. It is very painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown (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 completed; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (first BOOSTER dose; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: LYMPHOMA (medically significant), PAIN (non-serious) all with onset 2022, outcome "unknown" and all described as "had a serious lymphoma type reaction. It is very painful".  Clinical information: On Apr2022 patient received the Pfizer Booster (second) Covid vaccination and patient have had a serious lymphoma type reaction. It was very painful, and patient do not know what to do about it. Patient thought this need to be informed, because there seems to be some opinions that this was not happening. Patient wanted to know it was happening, and at least it should be some of the information given at the time the Covid booster vaccinations are given.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; 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-163-4504739-00 (Abbvie).  A 28-year-old 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), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter considered "covid-19" 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: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Suspected Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; 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-163-4506591-00.  A 22-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164825) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), Suspected COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Suspected Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Suspected covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive getting Covid near the end of the cruise; Tested positive getting Covid near the end of the cruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in Jul2022 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 included: "Covid" (unspecified if ongoing), notes: I have had Covid before plus fully vaccinated. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "Tested positive getting Covid near the end of the cruise". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive. The patient received a booster 3.5 weeks before, just before a cruise. She has had Covid before, plus fully vaccinated. On 17Aug2022, she tested positive getting Covid near the end of the cruise. Most likely from an excursion. She was quarantined, but the booster appears to have minimal affect on reducing transmission. The patient was negative and self-quarantining. Boosters may have helped in surviving the first infection. She was stable now.  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: Death, SARS-CoV-2 test
Clinical narrative: Starting the day after his 2nd shot, my husband was in the hospital many times for different things over the next ten months, eventually passing on November 19Nov2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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. The following information was reported: DEATH (death, medically significant) with onset 19Nov2021, outcome "fatal", described as "Starting the day after his 2nd shot, my husband was in the hospital many times for different things over the next ten months, eventually passing on November 19Nov2021.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. The patient date of death was 19Nov2021. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Additional information: Starting the day after his 2nd shot, the patient was in the hospital many times for different things over the next ten months, eventually passing on 19Nov2021. The patient was in the reporter's health plan. The patient was in relatively good health before the shots. He was tested for Covid every time he was admitted, and the test was always negative. The reporter gave permission to examine all of the patient's medical records. The reporter mentioned that if there are statistics on 'death after shots' the reporter would be interested. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Starting the day after his 2nd shot, my husband, was in the hospital, many times for different things over the next ten months, eventually passing on 19Nov2021
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered a dose of MENACTRA, today, from an expired MENACTRA vial with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 16 years old male patient who was administered a dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra], today, from an expired menactra vial with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Aug-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D conj) vaccine (formulation and strength not reported; lot U6877BC, expiry date: 28-Feb-2022) via intramuscular route in the left deltoid for immunization.  On 12-Aug-2022, the patient was administered a dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra], today, from an expired menactra vial with no reported adverse event (expired product administered) (latency : same day).  It was reported, "stated a 16 year old male patient was administered a dose of MENACTRA, today, from an expired MENACTRA vial. Caller asked, about the efficacy the dose that was administered from an expired MENACTRA vial that was administered to the patient".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient is overdue for Tdap/adacel vaccine with no reported adverse event; Initial information received on 13-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics and it was reported that the patient is overdue for tdap/adacel vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergic to thimerosal (Allergy to chemicals).   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site for Immunization.Lot number was requested.  On an unknown date the patient was overdue for tdap/adacel vaccine with no reported adverse event (product dose omission issue) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.The physician with whom the patient work with wanted to know if there were components of thimerosal in Adacel as the patient was possibly allergic to thimerosal.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient is overdue for Tdap/adacel vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 years and 8 months old was given quadracel with no reported adverse event; Initial information received on 15-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years and 8 months old female patient who was given quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 12-Aug-2022, the patient received a fifth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot C5970AA, expiration date: 02-Feb-2024, via intramuscular route in the left thigh as Immunization.  On 12-AUG-2022 the patient who was 7 years and 8 months old was given quadracel with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  corrective treatment-None   At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.