chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: that he tested positive for the Covid virus; that he tested positive for the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "that he tested positive for the Covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound COVID/COVID-19 treatment; rebound COVID/COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0150), in right arm and on 23Apr2021 as dose 2, single (Lot number: EW0171) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Dec2021 as dose 3 (booster), single (Lot number: 051F21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other medication in 2weeks. No known allergies reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "rebound COVID/COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product- COVID 19 Treatment; Brand: Paxlovid; Treatment start date- 04May2022; Treatment start date- 09May2022; Indication: Treatment of Covid-19. Adverse event start date: 13May2022.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of covid-19.  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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events COVID-19 & Drug ineffective which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 18:30 as dose 1, single (Lot number: EN6201), in left arm, on 02Mar2021 at 18:30 as dose 2, single (Lot number: EN6198), in left arm, on 08Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 04Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHELATED MAGNESIUM [MAGNESIUM CHELATE]; CALCIUM; VITAMIN D3. The patient received other medication in 2weeks.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Negative, notes: Tested negative on 08May and 10May; (10May2022) Negative, notes: Tested negative on 08May and 10May; (13May2022) Positive, notes: I tested positive again 13May. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 02May2022, Treatment stop date: 07May2022 and Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling abnormal, Injection site swelling
Clinical narrative: Swelling at injection site; felt like skin on fire; tired; dizzy; muscle pain from shoulder to wrist; brain fog; no appetite; 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), on 14May2022 at 11:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; TARTRATE DE PENTOLONIUM; ESTRADIOL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Left), administration date: 15Nov2021, when the patient was 69-year-old, for Covid-19 immunization. The following information was reported: INJECTION SITE SWELLING (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "Swelling at injection site"; FEELING ABNORMAL (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "brain fog"; DIZZINESS (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "dizzy"; SKIN WARM (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "felt like skin on fire"; MYALGIA (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "muscle pain from shoulder to wrist"; DECREASED APPETITE (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "no appetite"; FATIGUE (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of injection site swelling, skin warm, fatigue, dizziness, myalgia, feeling abnormal, decreased appetite.  Additional information: Age group: Adult (18-64 Years). Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other vaccine in two weeks were metoprolol, tartrate, estradiol. Adverse event: Swelling at injection site, about 3" in diameter, bright red in color, hot to touch pain in all joints, felt like skin on fire, tired, dizzy, brain fog, muscle pain from shoulder to wrist, no appetite. No covid prior vaccination. Covid was not tested post vaccination. No known allergies.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Skin warm
Clinical narrative: Swelling at injection site; felt like skin on fire; tired; dizzy; muscle pain from shoulder to wrist; brain fog; no appetite; 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), on 14May2022 at 11:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; TARTRATE DE PENTOLONIUM; ESTRADIOL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Left), administration date: 15Nov2021, when the patient was 69-year-old, for Covid-19 immunization. The following information was reported: INJECTION SITE SWELLING (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "Swelling at injection site"; FEELING ABNORMAL (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "brain fog"; DIZZINESS (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "dizzy"; SKIN WARM (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "felt like skin on fire"; MYALGIA (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "muscle pain from shoulder to wrist"; DECREASED APPETITE (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "no appetite"; FATIGUE (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of injection site swelling, skin warm, fatigue, dizziness, myalgia, feeling abnormal, decreased appetite.  Additional information: Age group: Adult (18-64 Years). Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other vaccine in two weeks were metoprolol, tartrate, estradiol. Adverse event: Swelling at injection site, about 3" in diameter, bright red in color, hot to touch pain in all joints, felt like skin on fire, tired, dizzy, brain fog, muscle pain from shoulder to wrist, no appetite. No covid prior vaccination. Covid was not tested post vaccination. No known allergies.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Oct2021 as dose 2, single (Lot number: Ep7533) at the age of 33 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 had no relevant medical history. Concomitant medication(s) included: ENSKYCE, start date: 08May2022, stop date: 14May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive test for SARS-Cov2; Positive test for SARS-Cov2; This is a spontaneous report received from a contactable reporter(s). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 14Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "elevate cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN (ongoing); ENALAPRIL (ongoing); HCTZ (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Positive test for SARS-Cov2"; NASAL CONGESTION (non-serious), outcome "unknown", described as "mild to moderate congestion"; PRODUCTIVE COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive; (16Apr2022) Positive, notes: ACE RAT; (17Apr2022) Negative, notes: ACE RAT; (18Apr2022) Negative, notes: ACE RAT; (21Apr2022) Positive; (28Apr2022) Negative, notes: covid test (RAT). Therapeutic measures were taken as a result of drug ineffective, covid-19, nasal congestion, productive cough.  Additional information: Paxlovid (PF-07321332/Ritonavir. administration of Paxlovid (PF-07321332/Ritonavir) on 13Apr2022-18Apr2022, batch number is unknown.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 13Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Type 2 DM" (unspecified if ongoing); "Recent cervical surgery 02Mar2022.", start date: 02Mar2022 (unspecified if ongoing), notes: Recent cervical surgery 02Mar2022. Concomitant medication(s) included: ATORVASTATIN, stop date: 10May2022. Past drug history included: Oxycodone, reaction(s): "known allergies: Oxycodone". 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 COVID-19.  Clinical course: Paxlovid was taken by the patient for which start date was 10May2022 and stop date was 15May2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Laboratory test, Suspected COVID-19
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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's relevant medical history included: "Type2 diabeties" (unspecified if ongoing), notes: I am a Type2 diabetic on Metformin, Trulicity and Insulin. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; TRULICITY taken for diabetes mellitus; INSULIN taken for diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had Covid". It was reported that patient recently had Covid after a trip to (Place name withheld). Prior to this experience, patient received vaccines and both boosters. Patient's doctors at (Care name) prescribed the 5 day Paxlovid. Patient's symptoms were fatigue and a cough, no fever. The medication worked great. Patient was a Type2 diabetic on Metformin, Trulicity and Insulin. Prior to Covid patient daily numbers were 140 and above. After taking Paxlovid patient numbers are 95 to 110. A big difference observed and patient wanted to report the positive effect. The patient underwent the following laboratory tests and procedures: daily numbers: 140, notes: I am a Type2 diabetic on Metformin, Trulicity and Insulin. Prior to Covid my daily numbers were 140 and above; 95 to 110, notes: After taking Paxlovid my numbers are 95 to 110. Therapeutic measures were taken as a result of suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hay Fever" (unspecified if ongoing), notes: Childhood hay fever (remission); "Prostate cancer" (unspecified if ongoing), notes: prostate cancer (remission). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 7 months 6 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), 7 months 6 days after the suspect product(s) administration, 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; (06May2022) Negative, notes: Tested negative on 06May on an antigen test; (11May2022) Positive, notes: Tested positive on 11May on an antigen test. Therapeutic measures were taken as a result of covid-19. Clinical course: Paxlovid treatment given for covid-19 from 01May2022 to 05May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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) (Physician) from product quality group. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose 4 (booster), single (Lot number: FF8839) at the age of 34 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, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing). Date of last menstrual period: 22Feb2022. The patient's concomitant medications were not reported. Last menstrual date: 22Feb2022.  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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: Test was negative two and three days after completing treatment and was asymptomatic at that time; (17May2022) Positive, notes: experienced rebound symptoms and a positive COVID test 5 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results on 19May2022 for BNT162b2:  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF8839 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF8839, fill lot FF8833, and the formulated drug product lot FA9148. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 1st diagnosed with covid/ COVID 19 Treatment; 1st diagnosed with covid/ 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 13:00 as dose 1, single (Lot number: en6206), in right arm, on 26Mar2021 at 13:00 as dose 2, single (Lot number: er8730), in right arm and on 12Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30145ba) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Apr2018. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "1st diagnosed with Covid/ COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Serious: No, Seriousness Criteria-Results in death: No, Seriousness Criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. Reaction(s)/Event(s): Reaction/event as reported by primary source: 12 days after being diagnosed, I started having sore throat, congestion, headache, fever, same symptoms as when I was 1st diagnosed with COVID. Date of start of reaction/event: 17May2022. Outcome of reaction/event at the time of last observation: Recovering/Resolving, Hospitalization Prolonged: No Treatment Received: No. Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: COVID-19 Treatment Date of last administration: 13May2022, adverse event start time: 12:00 AM Active Substance Information: Active Drug substance names: COVID 19 Treatment.     No follow-up attempts are needed. No further information is expected.
Age: 26.0
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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Got tonsillectomy+adenoidectomy", start date: 2004 (unspecified if ongoing), notes: Got tonsillectomy+adenoidectomy in 2004; "ad/hd" (unspecified if ongoing), notes: ad/hd. Concomitant medication(s) included: BUPROPION, start date: 01Nov2014; VENLAFAXINE, start date: 01Jan2017; ADDERALL, start date: 01May2021, stop date: 03May2022; VITAMIN D [COLECALCIFEROL], start date: 01Jun2014; CETIRIZINE, start date: 01Jun2019. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: At-home Antigen test for COVID was negative. Therapeutic measures were taken as a result of covid-19.anti viral details product COVID 19 Treatment, brand: Pfizer, treatment start date:03May2022, treatment stop date:08May2022, indication:Treatment of COVID-19.Adverse event: Symptoms returned on May 18: coughing, sore throat, sore lymph nodes, fatigue/tiredness, congestion. At-home Antigen test for COVID was negative.Adverse event start date and Time :18May2022;03:30 AM.Device timestamp: 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: indication=Treatment of COVID-19; indication=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 37-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in May2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and in Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunization. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "sleep apnea" (unspecified if ongoing); "hypogonadism" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), suspected COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Covid-19 treatment included Paxlovid from 17May2022 of lot number GA6765 for the indication of treatment of Covid-19.  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: Angiogram, Blood creatine phosphokinase, Blood creatinine, Blood pressure measurement, Body temperature
Clinical narrative: Covid-19 Booster-Induced Thromboembolism; falling; revealed left hip fracture; This is a literature report.  A 90-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Cerebrovascular accident" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "Covid-19 Booster-Induced Thromboembolism"; FALL (medically significant), outcome "unknown", described as "falling"; HIP FRACTURE (medically significant), outcome "unknown", described as "revealed left hip fracture". The patient underwent the following laboratory tests and procedures: Angiogram: demonstated concern for PE; Blood creatine phosphokinase: 1514; Blood creatinine: 2.18, notes: baseline-1.7; Blood pressure measurement: 126/61; Body temperature: 36.8 Centigrade; Computerised tomogram thorax: large central pulmonary emboli extending into ever, notes: large central pulmonary emboli extending into every lobi bilaterally and right heart strain; Heart rate: 87; Oxygen saturation: 87 %; 91 %, notes: improvement; physical examination: unremarkable; Respiratory rate: 24; Troponin: 1990; X-ray: revealed left hip fracture. Therapeutic measures were taken as a result of embolism.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Embolism, Fall, Heart rate, Hip fracture
Clinical narrative: Covid-19 Booster-Induced Thromboembolism; falling; revealed left hip fracture; This is a literature report.  A 90-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Cerebrovascular accident" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "Covid-19 Booster-Induced Thromboembolism"; FALL (medically significant), outcome "unknown", described as "falling"; HIP FRACTURE (medically significant), outcome "unknown", described as "revealed left hip fracture". The patient underwent the following laboratory tests and procedures: Angiogram: demonstated concern for PE; Blood creatine phosphokinase: 1514; Blood creatinine: 2.18, notes: baseline-1.7; Blood pressure measurement: 126/61; Body temperature: 36.8 Centigrade; Computerised tomogram thorax: large central pulmonary emboli extending into ever, notes: large central pulmonary emboli extending into every lobi bilaterally and right heart strain; Heart rate: 87; Oxygen saturation: 87 %; 91 %, notes: improvement; physical examination: unremarkable; Respiratory rate: 24; Troponin: 1990; X-ray: revealed left hip fracture. Therapeutic measures were taken as a result of embolism.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Physical examination, Respiratory rate, Troponin, X-ray
Clinical narrative: Covid-19 Booster-Induced Thromboembolism; falling; revealed left hip fracture; This is a literature report.  A 90-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Cerebrovascular accident" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "Covid-19 Booster-Induced Thromboembolism"; FALL (medically significant), outcome "unknown", described as "falling"; HIP FRACTURE (medically significant), outcome "unknown", described as "revealed left hip fracture". The patient underwent the following laboratory tests and procedures: Angiogram: demonstated concern for PE; Blood creatine phosphokinase: 1514; Blood creatinine: 2.18, notes: baseline-1.7; Blood pressure measurement: 126/61; Body temperature: 36.8 Centigrade; Computerised tomogram thorax: large central pulmonary emboli extending into ever, notes: large central pulmonary emboli extending into every lobi bilaterally and right heart strain; Heart rate: 87; Oxygen saturation: 87 %; 91 %, notes: improvement; physical examination: unremarkable; Respiratory rate: 24; Troponin: 1990; X-ray: revealed left hip fracture. Therapeutic measures were taken as a result of embolism.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment adminitered; COVID 19 Treatment adminitered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment adminitered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. No Known alleries.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course : Antiviral treatment details product COVID 19 Treatment, brand Paxlovid for COVID 19 were started from 12May2022 to 16May2022, lot number fy7031 Patient received COVID-19 Vaccine. Reported Event: Metallic taste in mouth about an hour after taking the pills for about 3-4 hours. Then it goes away. Also, had symptoms return two days after treatment ended. Fever returned.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 25Aug2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Ceclor, reaction(s): "Known allergies: ceclor". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) negative; (18May2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
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) (Consumer or other non HCP).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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), 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19. Patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heavy menstrual bleeding
Clinical narrative: It made the bleeding worse even more; It made the bleeding worse even more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. An 18-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL3209), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE: 1, Date: 16May2021, Time: 3:30 PM, Anatomical site of injection: Right Arm, Batch/Lot number: Pfizer 6W0182), administration date: 16May2021, for Covid-19 immunization, BNT162b2 (DOSE: 2, Date: 06Jun2021, Time: 4:30 PM, Anatomical site of injection: Right Arm, Batch/Lot number: Pfizer 6W0181), administration date: 06Jun2021 for Covid-19 immunization, reaction(s): "Everytime I got up, I would bleed everywhere, legs to floor", "My periods were always bad but never this heavy". The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "It made the bleeding worse even more".  Clinical course: Patient stated her periods were always bad but never this heavy, it all started when she was out in the (state name withheld), where she got her 2nd dose. Every time she got up, she would bleed everywhere, legs to floor and it's so much so fast, the pool cannot hold. When she got my booster, it made the bleeding worse even more. There were no prior vaccinations, Relevant Tests and Specific relevant test for Thromboembolic events with Thrombocytopenia reported.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Elevated liver enzymes; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4396536-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), since 10Feb2022 (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (Dose 1, Daily dose: First dose (1 in 1 once), route of admin: Intramuscular), for Covid-19 immunization; Bnt162b2 (Dose 2, Daily dose: Second dose (1 in 1 once), route of admin: Intramuscular), for Covid-19 immunization. The following information was reported: HEPATIC ENZYME INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Elevated liver enzymes"; RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "recovering", described as "Rheumatoid arthritis flare up". The patient underwent the following laboratory tests and procedures: Hepatic enzyme: (2022) Elevated. The action taken for adalimumab was temporarily withdrawn. It was unknown If patient was enrolled in a COVID-19 Vaccine Trial. Reported that, Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's assessment of the causal relationship of "elevated liver enzymes" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "elevated liver enzymes" with the suspect product adalimumab (HUMIRA) was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Initial Covid on 04May; Initial Covid on 04May; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 12:00 as dose 1, single (Lot number: EN6206), in right arm, on 04Apr2021 at 12:00 as dose 2, single (Lot number: EW0151), in right arm, on 11Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 14Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04May2022, outcome "unknown", COVID-19 (medically significant) with onset 04May2022, outcome "not recovered" and all described as "Initial Covid on 04May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive; (04May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid rebound: Initial Covid + on 04May2022 and began Pax regiment same day; no symptoms by 07May2022 Rebound symptoms begin 14May2022  all cold like symptoms but stronger than original symptoms on 03May, 04May, 05May home test still + on 16May Symptoms still exist as of this writing report on 18May.  No follow-up attempts are possible. No further information is expected