chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; vaccine brand other=MODERNA/vaccine dose number=4,3,2,1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 at 08:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing); "Significient multilevel lumbar spondylosis" (unspecified if ongoing), notes: Significient multilevel lumbar spondylosis; "Obesity" (unspecified if ongoing); "known allergies :Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2010, stop date: 01Jan2023; AMLODIPINE BESYLATE, start date: Jan2010, stop date: 01Jan2023; METOPROLOL SUCCINATE, start date: Jan2010, stop date: 01Jan2023; TOLTERODINE TARTRATE, start date: Jan2016, stop date: 01Jan2023; FINASTERIDE, start date: Jan2016, stop date: 01Jan2023; MEMBERS MARK WOMEN 50+ MULTIVITAMIN, start date: Jan2021, stop date: 01Jan2023; ZINC COLD THERAPY, start date: 21Dec2022, stop date: 01Jan2023; MUCINEX DM; DAYQUIL SEVERE COLD & FLU. Past drug history included: Known allergies: zocor, reaction(s): "Known allergies: ZOCOR"; Known allergies: flowmax, reaction(s): "Known allergies: Flowmax"; Known allergies: cozaar, reaction(s): "Known allergies: Cozaar"; Known allergies: niaspan, reaction(s): "Known allergies: Niaspan"; Known allergies: sulindac, reaction(s): "Known allergies: Sulindac". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2022 at 08:45, outcome "unknown", described as "vaccine brand other=MODERNA/vaccine dose number=4,3,2,1"; DRUG INEFFECTIVE (medically significant) with onset 22Dec2022, outcome "not recovered", COVID-19 (medically significant) with onset 22Dec2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive. Therapeutic measures were taken as a result of covid-19 which include paxlovid from 22Dec2022 to 27Dec2022.  Clinical course: The patient received other medications within 2 weeks include Omega-3 Krill Oil 500MG and Vicks.  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: Linked Report(s) : US-PFIZER INC-202300000114 Same patient, different product and event;
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Proteinuria, SARS-CoV-2 test, Weight, Weight decreased
Clinical narrative: 37lb unintentional weight loss over 6 weeks; Gross hematuria; proteinurea; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2, single (Lot number: 330268D) at the age of 32 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FF2593, Route of Administration: Intramuscular), administration date: 18Oct2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: WEIGHT DECREASED (medically significant) with onset 16Jan2022, outcome "unknown", described as "37lb unintentional weight loss over 6 weeks"; HAEMATURIA (medically significant) with onset 16Jan2022, outcome "unknown", described as "Gross hematuria"; PROTEINURIA (medically significant) with onset 16Jan2022, outcome "unknown", described as "proteinurea". The events "37lb unintentional weight loss over 6 weeks", "gross hematuria" and "proteinurea" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab; Weight: 37 lbs, notes: 37lb unintentional weight loss over 6 weeks. Therapeutic measures were taken as a result of weight decreased, haematuria, proteinuria. Clinical course: The patient experienced Gross hematuria, proteinurea & 37lb unintentional weight loss over 6 weeks and received treatment of surgery - stent placement. The patient had not experienced COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the events of weight decreased, haematuria and proteinuria and the suspect product cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
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) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 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: "Htn" (unspecified if ongoing), notes: Other medical history: Htn, pre DM, asthma; "asthma" (unspecified if ongoing), notes: Other medical history: Htn, pre DM, asthma; "pre DM" (unspecified if ongoing). Concomitant medication(s) included: CALCITRATE, start date: 06Jun2009. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine. The following information was reported: DRUG INEFFECTIVE (medically significant), 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. 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: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 13:00 as dose number unknown (booster), single (Lot number: GH9703) at the age of 65 years, in left arm 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 was not reported. Concomitant medication(s) included: METFORMIN; ATORVASTATIN [ATORVASTATIN CALCIUM]; LOSARTAN; VITAMIN D [COLECALCIFEROL]. 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; (unspecified date) Negative; (29Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks were Metformin, Atorvastatin, Losartan and Vitamin D. Patient had no known allergies. Patient received Paxlovid from 20Dec2022 to 25Dec2022 for COVID-19 treatment. Covid came back after testing negative for 3 days.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Wrong product administered
Clinical narrative: numbness to bilateral lower extremities; dysphagia; bivalent formulation as a primary series; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 1, single (Lot number: GJ3277) at the age of 73 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Carpal Tunnel" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Sep2022, outcome "unknown", described as "bivalent formulation as a primary series"; DYSPHAGIA (caused and prolonged hospitalization, disability, life threatening) with onset 20Sep2022, outcome "not recovered"; HYPOAESTHESIA (caused and prolonged hospitalization, disability, life threatening) with onset 20Sep2022, outcome "not recovered", described as "numbness to bilateral lower extremities". The patient was hospitalized and prolonged hospitalization for hypoaesthesia, dysphagia (hospitalization duration: 20 day(s)). The events "numbness to bilateral lower extremities" and "dysphagia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of hypoaesthesia, dysphagia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, 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).  A 61-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), 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: "Elevated BP" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient did not have any known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Elevated; SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000098 Same patient, different product and event;
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 /Sore throat, Weakness; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Dec2022 at 17:00 as dose 4 (booster), single (Lot number: GJ3274) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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: COVID-19 (non-serious) with onset 29Dec2022, outcome "unknown", described as "COVID 19 /Sore throat, Weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient had no known allergies. Patient started COVID symptoms on 29Dec2022 late night with very bad sore throat. The next day on 30Dec2022 patient started feeling weak and tested positive for COVID on 31Dec2022 morning. Patient started taking paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 2: Moderna; Dose 1: Janssen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 49 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 2 (booster), single (Lot number: O12F21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 11Apr2021 as dose 1, single (Lot number: 207A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE; VITAMIN D3. Past drug history included: Vagisil, reaction(s): "Known allergies: vagisil", notes: Known allergies: vagisil. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Dose 2: Moderna; Dose 1: Janssen"; 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: The patient received other medications in 2weeks.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: 1433), 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) 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); "high cholesterol" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; SIMVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000099 Same patient, different product and event;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER3612), in left arm, on 09Apr2021 as dose 2, single (Lot number: EC00162), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: 33025BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies:Banana, avocado" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (23Dec2022) Negative, notes: felt great and tested negative. Therapeutic measures, Paxlovid from 17Dec2022 to 21Dec2022, were taken as a result of drug ineffective, covid-19.
Age: 68.0
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 contactable reporter(s). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ2524) 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) 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); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Apr2020; METAFORT, start date: Aug2020. Past drug history included: Emycin, reaction(s): "known allergies: Emycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, latency 10 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events DRUG INEFFECTIVE and COVID-19 be ruled out.,Linked Report(s) : US-PFIZER INC-202300002128 Same patient, different product and event;
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer) from product quality group. The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years for COVID-19 immunization; BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FE3590), in right arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Chronic neck pain" (unspecified if ongoing); "Chronic lower back pain" (unspecified if ongoing); "cervical disc replacement" (unspecified if ongoing); "overactive bladder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone"; Cymbalta, reaction(s): "Known allergies: CYMBALTA"; Wellbutrin, reaction(s): "Known allergies: Wellbutrin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Dec2022) Negative; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical information: It was reported that the patient had COVID-19 in 2022. The patient started PAXLOVID as COVID-19 treatment from 19Dec2022 until 23Dec2022. It was stated that the patient tested negative 2x on rapid tests following completed PAXLOVID course.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Dose 1-3: BNT162B2, Dose 4: Moderna, Dose 5: BNT162B2; 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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: gh9693) at the age of 48 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: er8732), in left arm, on 16Apr2021 as dose 2, single (Lot number: ew0161), in left arm and on 17Oct2021 as dose 3 (booster), single (Lot number: fe3590), in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 059m21a), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Pre-hypertension" (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 2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1-3: BNT162B2, Dose 4: Moderna, Dose 5: BNT162B2". Therapeutic measures were taken (PAXLOVID from 24Dec2022 to 29Dec2022) as a result of vaccination failure, COVID-19.
Age: 56.0
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 a contactable reporter (consumer). The reporter is the patient. A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (lot number unknown) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 01May2022 as dose 4 (booster), single (lot number unknown), in right arm for covid-19 immunisation; covid-19 vaccine as dose 1, single (lot number unknown), as dose 2, single (lot number unknown) and as dose 3 (booster), single (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) and COVID-19 (medically significant) both with onset Dec2022, outcome "unknown" and described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid taken from 23Dec2022 to 28Dec2022.  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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Within 5 days she had Covid; Within 5 days she had Covid; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. An 88-year-old female patient received BNT162b2 (BNT162B2), 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: "Covid" (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 "Within 5 days she had Covid". The event "within 5 days she had covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: they prescribed Paxlovid for her. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient went upstate for the holidays with her family and within 5 days she had Covid. She had Covid before and she have had the two booster shots. She had the Immuno as treatment that is very effective for Covid (Monoclonal Antibody) when she got the virus for the first time. She absolutely had no side effects and she wouldn't have known she had it, if she had the test. She mentioned that she had began coughing so she went to a clinic (urgent care clinic) and prescribed her with Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 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 was not reported. There were no concomitant medications. Past drug history included: Duracef, reaction(s): "Known allergies: duracef medication". 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: (30Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid Treatment start date: 23Dec2022 until 27Dec2022. On 01Jan2023 i started feeling bad again after making what I thought was a full recovery - i was previously symptom free and I had gotten a negative COVID result on 30Dec2022  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: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 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: "Caposy Sarcoma" (unspecified if ongoing). There were no concomitant medications. 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: new positive home test results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The treatment received for COVID-19 was with Paxlovid from 21Dec2022 to 27Dec2022.  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: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 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: "High blood pressure" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxin, reaction(s): "Known allergies: naproxin". 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Dec2022 to 21Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 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: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "overweight" (unspecified if ongoing), notes: other medical history: overweight. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. 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 Paxlovid from 21Dec2022 to26Dec2022 for the treatment of 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2021 as dose 1, single (Lot number: EW0175), in left arm, on 05Aug2021 as dose 2, single (Lot number: EW0177), in left arm and on 13Jun2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE AND LIOTHYRONINE [LEVOTHYROXINE;LIOTHYRONINE], start date: 01Apr2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), 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 received paxlovid for COVID 19 treatment from 22Dec2022 till 26Dec2022.
Age: 55.0
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) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 55 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 had no relevant medical history. 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: original positive Covid test; Positive, notes: home Covid test had faint positive line; Positive, notes: On Day 10, bright pink positive line after only 3 min. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies. Rebound on Day 10 from original positive Covid test. Nasal congestion, runny nose. On Day 8, home Covid test had faint positive line. On Day 10, bright pink Positive line after only 3 min.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events DRUG INEFFECTIVE and COVID-19 cannot be ruled out.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: 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 (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2022 at 12:15 as dose 3 (booster), single (Lot number: 33025BD), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2021 at 10:30 as dose 1, single (Lot number: 036021A), in left arm and on 07May2021 at 14:30 as dose 2, single (Lot number: 025C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Borderline HBP" (unspecified if ongoing); "Grave's Disease", start date: 2012 (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL, start date: 01Feb2019, stop date: 01Jan2023; SYNTHROID, start date: 11Jul2012, stop date: 01Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Jan2022 at 12:15, 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: Negative, notes: tested negative for COVID 2 days after completing the 5 day treatment of Paxlovid; Positive, notes: 4 days after completing the Paxlovid, I am testing COVID positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Treatment start date was 23Dec2022 and stop date was 27Dec2022  Clinical course: After having a moderately bad COVID infection (my first one) Patient took Paxlovid for 5 days, tested negative for COVID 2 days after completing the 5-day treatment of Paxlovid, and now 4 days after completing the Paxlovid, Patient testing COVID positive again with minor symptoms. Patient had no risk factors, Patient had daily runner, never smoked and had no significant medical history and Patient not immuno-compromised in anyway. Patient had COVID, took Paxlovid, felt better each day, tested COVID negative after completing the 5 days of Paxlovid.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose number unknown, single (Lot number: FJ4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: other medical history: HBP. Concomitant medication(s) included: AMLODIPINE; ATENOLOL; OMEPRAZOLE; POTASSIUM; SPIRONOLACTONE. 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: Positive, notes: Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 23Dec2022 to 27Dec2022, patient received treatment with Paxlovid for COVID-19 Treatment. The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Primary series + dose 3 booster: Moderna/ Dose 4 booster: Pfizer; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster, initial Pfizer dose), single (Batch/Lot number: unknown) for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 038A21A), on 09Nov2021 as dose 2, single (Lot number: 039F21A) and on 18Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Low thyroid functioning" (unspecified if ongoing). Concomitant medications included: LEVOXYL, start date: 11Nov2021; MELATONIN; OLMESARTAN MEDOXOMIL, start date: 09Mar2022; PRAVASTATIN, start date: 18Mar2021, stop date: 16Dec2022; VIT B12; VIT D [VITAMIN D NOS]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Primary series + dose 3 booster: Moderna/ Dose 4 booster: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2022) Positive; (25Dec2022) faintest of faint pink line; (26Dec2022) Positive; (31Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient tested positive for COVID on 16Dec2022 using a rapid at-home test. The patient was treated with Paxlovid from 16Dec2022 to 21Dec2022. On 25Dec2022, the COVID rapid test had the faintest of faint pink line. The patient much better than she had in days. On 26De2022, the patient woke up with harsh symptoms (congestion, sore throat, coughing, etc). She took another at-home COVID test and it turned positive almost immediately. She felt bad for about 6 days and then began to feel a little better. The patient last tested on 31Dec2022 and it was still very positive. She hadn't tested since. Additional information: The patient was taking melatonin with CBD 10 mg.  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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-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: GJ5342) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6204), in left arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FH4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild stroke", start date: 11Mar2021 (unspecified if ongoing), notes: Mild stroke 11Mar2021; "high blood pressure" (unspecified if ongoing), notes: high blood pressure and cholesterol- take Praluent injections 75 mg; "cholesterol" (unspecified if ongoing), notes: high blood pressure and cholesterol- take Praluent injections 75 mg; "known allergies Penicillin" (unspecified if ongoing); "known allergies aloe vera" (unspecified if ongoing); "known allergies Azulfidine, Demerol, Erythromycin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 05Apr2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. From 21Dec2022 to 26Dec2022, patient received Paxlovid for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
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 57-year-old male patient received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DLBCL" (unspecified if ongoing); "papillary thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 15Apr2022. Past drug history included: Penicillin, reaction(s): "Known allergies". 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: Negative, notes: Positive Covid test 3 days after negative test following completion of Paxlovid; Positive, notes: Positive Covid test 3 days after negative test following completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks Levothyroxine. Patient received Anti-viral details: product=COVID 19 Treatment, indication=Treatment of COVID-19. Rebound (Positive Covid test 3 days after negative test following completion of Paxlovid Tx) started on 30Dec2022, received no treatment and was recovering at the time of this report. Dose 2 vaccine lot unknown reason stated as unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000100 Same patient, different product and event;
Age: 43.0
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 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, 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) 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes. Patient had not known allergies. Patient had received Paxlovid as treatment for ae(Treatment start date: 19Dec2022, stop date: 24Dec2022).  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.