chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 17:15 as dose 5 (booster), single (Lot number: GI3277) at the age of 59 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment with Paxlovid from 03Jan2023 to 07Jan2023 and patient was not received other medication in 2 weeks.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "drug ineffective", "COVID-19".
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 09:15 as dose 1, single (Lot number: EP7533), in left arm and on 24Apr2021 at 09:15 as dose 2, single (Lot number: EW0170) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with paxlovid from 26Dec2022 to 28Dec2022. Patient took other medication in 2weeks. Patient did not had allergies.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9703) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Lot number: O31L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: O31L20A), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: O17F21A), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: O59w12A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2022 at 13:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti-viral Product (Paxlovid) from 01Jan2023 for COVID-19 Treatment. Rebound five days after ending Paxlovid treatment, from 07Jan2023 09:00 AM, received no treatment and was not recovered at the time of this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Previous cancer history" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: E19263), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: EWO187), in left arm and on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Known allergies: Crustacean shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 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), as dose 3 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: an earlier negative test; Positive, notes: Positive COVID-19 test after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information:  Positive COVID-19 test after completing Paxlovid treatment and an earlier negative test.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fluorescence angiogram, Retinal artery occlusion, Retinal vasculitis, Susac's syndrome
Clinical narrative: had suffered branch retinal arterial occlusions (BRAO) in both eyes; under treatment for retinal vasculitis and possible Susac's syndrome; under treatment for retinal vasculitis and possible Susac's syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Lot number: ER8729) at the age of 41 years, in left arm for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TESTOSTERONE CYPIONATE; HCG. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 41-year-old, for COVID-19 immunization. The following information was reported: RETINAL VASCULITIS (medically significant), SUSAC'S SYNDROME (medically significant) all with onset 2021, outcome "not recovered" and all described as "under treatment for retinal vasculitis and possible Susac's syndrome"; RETINAL ARTERY OCCLUSION (medically significant) with onset 04Sep2021 at 09:00, outcome "not recovered", described as "had suffered branch retinal arterial occlusions (BRAO) in both eyes". The patient underwent the following laboratory tests and procedures: Fluorescence angiogram: confirmed another BRAO. Therapeutic measures were taken as a result of retinal vasculitis, retinal artery occlusion, Susac's syndrome.  Clinical course: The patient had no other vaccine in four weeks, had no COVID prior to vaccination, and had no known allergies. Other medication in two weeks also included multivitamins. On 04Sep2021, the patient noticed a blind spot in his right eye. After seeking treatment, he was told that he had suffered branch retinal arterial occlusions (BRAO) in both eyes, but his right eye was the most affected, with a noticeable scotoma (blind spot). He had since been under treatment for retinal vasculitis and possible Susac's syndrome. On 05Nov2022, he noticed another scotoma to his right eye. A flourescien angiogram confirmed another BRAO. The patient was currently undergoing aggressive immunosuppressive treatments and has been hospitalized three times since his first episode.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300008410 Same patient, different vaccine dose, different events;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 14Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 10Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 10May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Oct2022 as dose 5 (booster), single (Lot number: AS7165B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Oct2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID).  No follow-up attempts are possible. No further information is expected.
Age: 28.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 01Jan2023 to 05Jan2023.  Clinical information : It was reported that, Vaccine lot unknown reason was Misplaced/discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 15Mar2021 at 10:00 as dose 2, single (Lot number: EN6207), in left arm, on 28Sep2021 at 09:30 as dose 3 (booster), single (Lot number: EW0168), in left arm and on 18May2022 at 10:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: 01May2019; BYSTOLIC, start date: 14Jan2022. No known allergies reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative, notes: home test on day 7; Positive, notes: positive on day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 23Sep2022 to 27Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 68 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; desvenlafaxine succinate monohydrate (PRISTIQ), (Batch/Lot number: unknown); fexofenadine hydrochloride (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), (Batch/Lot number: unknown); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), (Batch/Lot number: unknown); buspirone (BUSPIRONE), (Batch/Lot number: unknown); naproxen (NAPROXEN), (Batch/Lot number: unknown). The patient's relevant medical history included: "Cardiac arrhythmia" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "Depression with anxiety" (unspecified if ongoing); "Depression with anxiety" (unspecified if ongoing); "perennial allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. She received Paxlovid for COVID-19 treatment, started from 25Dec2022 to 29Dec2022.; Sender's Comments: As per the available information the causality of the events drug ineffective, covid-19 with the suspect can not be ruled out completely.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Aug2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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: "htn" (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), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the lot was not available/ provided to reporter at the time of report completion. Patient has received other medication guaifenesin in 2 weeks and patient had no known drug allergy. Patient received anti-viral as COVID 19 treatment from 08Jan2023 via oral route.  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 known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: NEBIVOLOL, start date: 01Jan2016; LISINOPRIL, start date: 01Jan2017; MELATONIN, start date: 01Dec2021. Past drug history included: Tamiflu, reaction(s): "cardiac arrhythmia due to Tamiflu"; Tamiflu, reaction(s): "known allergies: Tamiflu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 27Dec2022 to 31Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 25Dec2020 at 11:00 as dose 1, single (Lot number: EL0140), in left arm, on 19Jan2021 at 16:00 as dose 2, single (Lot number: FJ1686), in left arm and on 31Jan2022 at 16:00 as dose 3 (booster), single (Lot number: 059H21A) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Aug2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) negative, notes: Tested negative; (07Jan2023) positive, notes: Tested positive immediately with 2 covid tests; (07Jan2023) positive, notes: Tested positive immediately with 2 covid tests; (29Dec2022) positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks: Yes. The patient received Antiviral drug Paxlovid from 29Dec2022 to 02Jan2023 for the treatment of COVID-19. Other medical history: Pacemaker implanted 03Jun2022. Not on medication.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 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 had no relevant medical history. The patient's 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Negative; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment from 30Dec2022 to 04Jan2023. Patient felt better during treatment and tested negative two days after completing 5 day regimen. Patient then tested positive for COVID 4 days after last dose and has symptoms of infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: GH9703), in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "elevated kidney numbers" (unspecified if ongoing), notes: other medical history: elevated kidney numbers; "atrial fibrillation" (unspecified if ongoing), notes: other medical history: atrial fibrillation. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive; (01Jan2023) Negative; (07Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies reported. Other medication in 2weeks product was expectorant and cough suppressant from 25Dec2022 to 27Dec2022. Adverse event: experienced mild covid symptoms on 25Dec. Tested positive 27Dec. Began Paxlovid (renal dose) on 27Dec. Covid symptoms completely gone 30Dec. Tested negative 01Jan2023. Mild symptoms returned 04Jan2023. Tested positive for covid 07Jan2023.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 at 13:30 as dose 1, single (Lot number: EL1284), in right arm, on 27Jan2021 at 13:30 as dose 2, single (Lot number: EL0742), in right arm and on 13Oct2021 at 13:30 as dose 3 (booster), single (Lot number: FF2590) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "elevated lipid panel" (unspecified if ongoing), notes: elevated lipid panel. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment included Anti-viral details from 11Oct2022 to 16Oct2022 for covid 19. No nown allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 43 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Lot number: 034F21A) 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 had no relevant medical history. No Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Covid rebound, tested positive 3 days after a negative test and 6 days after completing Paxlovid; Negative, notes: Covid rebound, tested positive 3 days after a negative test and 6 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included with Paxlovid from 27Dec2022 to 01Jan2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: GH9693) at the age of 52 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: "gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 26Dec2022 to 30Dec2022 for the treatment of COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 26 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), as dose 3 (booster) single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken such as Paxlovid as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 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 covid-19 with the suspect drugs BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Age: 75.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Yes, vaccine was received and other medication in 2 weeks. Atorvastatin was given as other medication in 2 weeks. No, known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: QJ3277), in right arm for COVID-19 immunization; 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 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Negative, notes: antigen test negative on 02Jan2022. On 07Jan runny nose; positive antigen test; (07Jan2023) Positive, notes: antigen test negative on 02Jan2022. On 07Jan runny nose; positive antigen test; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient did not receive other medication in 2weeks. Patient received Anti-viral medication Paxlovid as treatment of COVID-19; treatment start date 27Dec2022 and stop date was 31Dec2022. Original symptoms were resolved and antigen test negative on 02Jan2022. On 07Jan runny nose; positive antigen test.
Age: 54.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications in two weeks were reported as no. The patient received covid-19 treatment of Paxlovid, from 29Dec2022 to 03Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Migraine
Clinical narrative: migraine; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 at 07:45 as dose 4 (booster), single (Lot number: GL0446) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 07Jan2023 at 07:30, outcome "unknown", described as "headaches"; MIGRAINE (non-serious) with onset 07Jan2023 at 07:30, outcome "unknown". Therapeutic measures were not taken as a result of migraine, headache. Additional information: The patient has no covid prior vaccination, no covid tested post vaccination, no known allergies, and no other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect dose administered
Clinical narrative: got all 3 boosters / had COVID twice; got all 3 boosters / had COVID twice; Inappropriate dose of Vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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: "Patient stated she has stage 3 kidney failure" (unspecified if ongoing), notes: Patient stated she has stage 3 kidney failure; "She had a flare up" (unspecified if ongoing), notes: She had a flare up; "is always sick" (unspecified if ongoing), notes: is always sick; "had 2 back surgery" (unspecified if ongoing), notes: had 2 back surgery. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got all 3 boosters / had COVID twice"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of Vaccine administered".  Additional Information: Inbound call: Patient due for a refill: Patient stated she has stage 3 kidney failure. She had a flare up, is always sick, got all 3 boosters, takes about 3 antibiotics, had COVID twice, and had 2 back surgery. Patient was prescribed Xeljanz 5mg tablets.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: She suffered a minor heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient husband  A female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, 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: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset Feb2021, outcome "unknown", described as "She suffered a minor heart attack". Therapeutic measures were taken as a result of myocardial infarction.  Additional information: My wife (hysterically) woke me up at 5:30 a.m. in early Feb2021, complaining of chest discomfort and shooting pain down her left arm. I sat her down right away and dialed 911 to request an ambulance from emergency services. She suffered a minor heart attack, which was treated at a nearby hospital.   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: Idiopathic urticaria
Clinical narrative: idiopathic urticaria; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adolescent male patient received COVID-19 Vaccine - Manufacturer Unknown, 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: IDIOPATHIC URTICARIA (non-serious), outcome "unknown".  Additional information: Teen had idiopathic urticaria. Patient had a COVID vaccine a few months prior. Not sure if related. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: majority those tested have receive all four Pfizer testing positive including himself or herself; majority those tested have receive all four Pfizer testing positive including himself or herself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 "unknown" and all described as "majority those tested have receive all four Pfizer testing positive including himself or herself". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: receive all four Pfizer testing positive including himself or herself.  Additional information: The organization an avid supporter of constituency receiving Pfizer regular and booster shot. Himself or herself and majority organization receive both regular and two boosters. The administration during random COVID testing, test administered majority those tested have receive all four Pfizer testing positive including himself or herself. This having attack credibility in supporting Pfizer testing.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia, White blood cell count, White blood cell count decreased
Clinical narrative: someone who has been diagnosed with CLL and in stage 1; a reduction of my white blood cell count/my white blood cell count dropped from approximately 120k to 99k; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2 (Dose 4 (Booster)), for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), outcome "unknown", described as "someone who has been diagnosed with CLL and in stage 1"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "a reduction of my white blood cell count/my white blood cell count dropped from approximately 120k to 99k". The patient underwent the following laboratory tests and procedures: White blood cell count: Dropped 120k to 99k, notes: My lab results shortly after the vaccine resulted in a reduction of my white blood cell count. In my most recent lab results my white blood cell count dropped from approximately 120k to 99k; reduction of my white blood cell count, notes: noted that my lab results shortly after the vaccine resulted in a reduction of my white blood cell count.  Additional information: I am writing to inform you that I have been vaccinated 5 times with the Pfizer/biontech COVID vaccine including boosters and as someone who has been diagnosed with CLL (Chronic lymphocytic leukaemia) and in stage 1, I noted that my lab results shortly after the vaccine resulted in a reduction of my white blood cell count. In my most recent lab results my white blood cell count dropped from approximately 120k to 99k. Needless to say, I don't know why the decrease happened, but I thought that information may be helpful in guiding your cancer research scientists to examine a link between your COVID vaccine and CLL to a potential pathway that would result in either slowing the trajectory of the disease or hopefully finding a cure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  SUSPECT PRODUCT is under agreement with BIONTECH SE.