chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
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 57-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6204), in right arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in right arm, on 09Sep2021 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; MONTELUKAST; CETIRIZINE; FLUTICASONE; VITAMIN D 3; FISH OIL; MELATONIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive; (May2022) Negative, notes: Tuesday tested negative using rapid antigen test. Completed Paxlovid regiment on Thursday. Friday tested negative using rapid antigen test; (25May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medications also in 2 weeks of vaccination. Other medication in 2weeks product also included Vitamin D3. The patient had no known allergy and other medical history. Symptoms started 14May2022 at 1am for COVID and tested positive using rapid antigen test. Started Paxlovid on Saturday 14May2022 at 3pm. Treatment start date was 14May2022 and treatment stop date was 19May2022. No symptoms Monday. Tuesday tested negative using rapid antigen test. Completed Paxlovid regiment on Thursday. Friday tested negative using rapid antigen test. 25May, tested positive using rapid antigen test and mild cough (no other symptoms, no fever).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 49-year-old patient received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 including Paxlovid from 20May2022 to 25May2022 and experiencing sore body and bad taste in mouth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma/restrictive airway" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medications in two weeks (ClaridinD, Proair, Symbicort, Flonase allergy) from 30Apr2022 to 25May2022 and had no known allergies. Patient was treated with Paxlovid from 10May20222 to 15May2022 for treatment of Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive antigen test; positive antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), on 25Mar2021 as dose 2, single (Lot number: EP6955) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Postural Orthostatic Tachycardia Syndrome" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "IgA deficiency" (unspecified if ongoing). Concomitant medication(s) included: DEXMETHYLPHENIDATE; ONDANSETRON; ESCITALOPRAM; L METHYLFOLATE; PANTOPRAZOLE; VITAMIN D NOS. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16May2022, outcome "unknown", COVID-19 (medically significant) with onset 16May2022, outcome "not recovered" and all described as "positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive; (22May2022) Negative; (25May2022) Positive; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient received vaccine. The patient received other medication in 2weeks. Anti-viral details: product COVID 19 Treatment, brand Paxlovid, treatment start date 16May2022, treatment stop date 20May2022, indication was treatment of COVID-19. Other medication details: Other medication in 2weeks product also included Adult multivitamin. Adverse event: Rebound of COVID-19 after Paxlovid treatment. Day 0 (15May) start of symptoms (headache, body pain, trouble breathing, chest pain, cough, sneezing, congestion, nausea). Day 1 (16May) positive antigen test; positive PCR test; start of Paxlovid treatment. Day 6 (21May) end of symptoms. Day 7 (22May) negative antigen test. Day 10 (25May) recurrence of symptoms (sneezing, coughing); positive antigen test. Adverse event start date 25May2022. The patient was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown, Vaccine lot unknown reason: Unable to locate or read the details) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Known allergies: no. There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". Anti viral details:  Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 14May2022, Treatment stop date: 19May2022. Adverse event: Symptoms resolved and I tested negative last week. I am now testing positive and am experiencing different symptoms. Adverse event start date: 24May2022. If patient recovered: Not recovered. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (May2022) negative, notes: Symptoms resolved and I tested negative last week; (May2022) Positive, notes: I am now testing positive and am experiencing different symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Treatment: COVID 19 Treatment, treatment start date on 24May2022, indication was treatment of COVID-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
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) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 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: "Emphysema" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "lung cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metronidazole, reaction(s): "Known allergies: Metronidazole". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; Negative, notes: symptoms 5 days after testing negative; Positive, notes: Rebound positive Covid testing. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2weeks Paxlovid for treatment of Covid 19 treatment and Zpak from 12May2022 to 17May2022. Rebound positive Covid testing and symptoms 5 days after testing negative and feeling symptom free.   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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound Covid at day 9 18May, stopped 23May; Rebound Covid at day 9 18May, stopped 23May; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient had no relevant medical history. Patient other medical history and known allergies were reported as none. There were no concomitant medications. Patient received the vaccine. Patient did not receive any other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18May2022, outcome "unknown", COVID-19 (medically significant) with onset 18May2022, outcome "recovered" (23May2022) and all described as "Rebound Covid at day 9 18May, stopped 23May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid at day 9 on 18May2022, stopped 23May2022. Therapeutic measures were taken as a result of covid-19. Adverse event was reported as rebound COVID-19 at day 9 on 18May2022 and stopped on 23May2022. Patient received the treatment for COVID-19 which included Paxlovid which started from 10May2022 and ended on 14May2022 via oral route of administration with indication as treatment of COVID-19. Adverse events resulted in none of the above.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 to product and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 09:00 as dose 1, single (Lot number: 012a21a), in left arm, on 28Mar2021 at 09:00 as dose 2, single (Lot number: 028a21a), in left arm, on 24Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 026d21a), in left arm and on 01Apr2022 at 09:00 as dose 4 (booster), single (Lot number: fic4894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown whether the patient received medication with in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown result. Therapeutic measures were taken as a result of suspected covid-19
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: L PRED; SERTRALINE; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: The patient received other medication in 2 weeks. Anti-viral details: COVID 19 treatment with Paxlovid from 15May2022 to 19May2022. The patient experienced rebound infection 25May2022 and no treatment was received for the event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FT1620) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Patient do not have any known allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any medications within 2 weeks. From 15May2022 to 19May2022 patient took Covid-19 treatment of Paxlovid. Patient stated that there were no adverse effects but Covid symptoms returned after 5 days from completing the therapy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events drug ineffective, covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose number unknown, single (Lot number: EL0185) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma (exercise induced)" (unspecified if ongoing), notes: Asthma (exercise induced). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergic to: Aspirin", notes: known allergies Allergic to: Aspirin, pepcid; Pepcid, reaction(s): "Allergic to: pepcid", notes: known allergies Allergic to: Aspirin, pepcid. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "hx MV regurgitation" (unspecified if ongoing). Known allergies: NKDA Concomitant medication(s) included: ALFUZOSIN also other medication in 2weeks product. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Apr2022) Negative, notes: Patient's rapid antigen test turned negative in hospital; (30Apr2022) Positive, notes: his rapid antigen test turned positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid, treatment start date: 20Apr2022, treatment stop date: 24Apr2022. 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 currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Immunohistochemistry, Investigation, Magnetic resonance imaging head, Neurological examination
Clinical narrative: Internal tremor with paresthesia in all limbs, stabbing pain ininterscapular area, blood pressure fluctuation; This is a literature report for the following literature source(s).  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "Systemic lupus erythematosus" (unspecified if ongoing), notes: autoimmune diseases. The patient's concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "Internal tremor with paresthesia in all limbs, stabbing pain ininterscapular area, blood pressure fluctuation". The patient underwent the following laboratory tests and procedures: Heart rate: Unknown results; Immunohistochemistry: Unknown results; anti-C1q: Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Magnetic resonance imaging head: Normal brain and lumbar spinal cord; Neurological examination: Normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/ drug and different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: Internal tremor with paresthesia in all limbs, stabbing pain ininterscapular area, blood pressure fluctuation; This is a literature report for the following literature source(s).  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "Systemic lupus erythematosus" (unspecified if ongoing), notes: autoimmune diseases. The patient's concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "Internal tremor with paresthesia in all limbs, stabbing pain ininterscapular area, blood pressure fluctuation". The patient underwent the following laboratory tests and procedures: Heart rate: Unknown results; Immunohistochemistry: Unknown results; anti-C1q: Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Unknown results; Magnetic resonance imaging head: Normal brain and lumbar spinal cord; Neurological examination: Normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/ drug and different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electromyogram, Heart rate, Investigation, Magnetic resonance imaging neck
Clinical narrative: Severe paresthesia and heaviness in lower limbs; This is a literature report. A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fever" (unspecified if ongoing); "fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "Severe paresthesia and heaviness in lower limbs". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results; Electromyogram: Normal; Heart rate: Unknown results; anti AchR: Unknown results; Unknown results; Unknown results; Unknown results; Magnetic resonance imaging neck: Normal; Neurological examination: Normal; Respiratory rate: Unknown results; Tilt table test: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient and different drug/event.
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Neuropathy peripheral, Respiratory rate, Tilt table test
Clinical narrative: Severe paresthesia and heaviness in lower limbs; This is a literature report. A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fever" (unspecified if ongoing); "fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "Severe paresthesia and heaviness in lower limbs". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results; Electromyogram: Normal; Heart rate: Unknown results; anti AchR: Unknown results; Unknown results; Unknown results; Unknown results; Magnetic resonance imaging neck: Normal; Neurological examination: Normal; Respiratory rate: Unknown results; Tilt table test: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient and different drug/event.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Heart rate, Investigation, Neurological examination
Clinical narrative: This is a literature report for the following literature source(s): "Neuropathic symptoms with SARS-CoV-2 vaccination", 2022. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Sudden onset of cold sensation in legs and formication" (unspecified if ongoing); "Sudden onset of cold sensation in legs and formication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), PARAESTHESIA (non-serious), BURNING SENSATION (non-serious), all with latency 3 hrs. after the suspect product(s) administration, outcome "unknown" and all described as "Lower limbs paresthesia and burning sensation". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results; Heart rate: Unknown results; anti AChR: Unknown results; Unknown results; Unknown results; Unknown results; Neurological examination: Normal; Respiratory rate: Unknown results; Tilt table test: Unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202200764439 Same article/patient different drug/event.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Respiratory rate, Tilt table test
Clinical narrative: This is a literature report for the following literature source(s): "Neuropathic symptoms with SARS-CoV-2 vaccination", 2022. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Sudden onset of cold sensation in legs and formication" (unspecified if ongoing); "Sudden onset of cold sensation in legs and formication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), PARAESTHESIA (non-serious), BURNING SENSATION (non-serious), all with latency 3 hrs. after the suspect product(s) administration, outcome "unknown" and all described as "Lower limbs paresthesia and burning sensation". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results; Heart rate: Unknown results; anti AChR: Unknown results; Unknown results; Unknown results; Unknown results; Neurological examination: Normal; Respiratory rate: Unknown results; Tilt table test: Unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202200764439 Same article/patient different drug/event.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Electromyogram, Investigation, Magnetic resonance imaging head, Neurological examination
Clinical narrative: Bilateral paresthesia in lower limbs; bilateral calf pain; This is a literature report for the following literature source(s): DOI:10.1101/2022.05.16.22274439.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "Bilateral paresthesia in lower limbs"; PAIN IN EXTREMITY (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "bilateral calf pain". The patient underwent the following laboratory tests and procedures: Biopsy skin: Borderline low normal small fiber density; Electromyogram: Normal; Skin fiber density distal leg: 6.3; Normal; Magnetic resonance imaging head: Normal; Neurological examination: Normal; Rheumatological examination: Negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient different drug/event.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Rheumatological examination
Clinical narrative: Bilateral paresthesia in lower limbs; bilateral calf pain; This is a literature report for the following literature source(s): DOI:10.1101/2022.05.16.22274439.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "Bilateral paresthesia in lower limbs"; PAIN IN EXTREMITY (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "bilateral calf pain". The patient underwent the following laboratory tests and procedures: Biopsy skin: Borderline low normal small fiber density; Electromyogram: Normal; Skin fiber density distal leg: 6.3; Normal; Magnetic resonance imaging head: Normal; Neurological examination: Normal; Rheumatological examination: Negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient different drug/event.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood immunoglobulin M, Heart rate, Immunohistochemistry, Investigation
Clinical narrative: Paresthesia and burning sensation followed by fasciculations in thighs and forearms; This is a literature report.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), 5 hrs after the suspect product(s) administration, outcome "unknown", described as "Paresthesia and burning sensation followed by fasciculations in thighs and forearms". The patient underwent the following laboratory tests and procedures: Biopsy skin: Low small fiber density in distal leg; Blood immunoglobulin M: Unknown Results; Heart rate: Unknown Results; Immunohistochemistry: Unknown Results; anti-C1q: Unknown Results; Unknown Results; Unknown Results; Unknown Results; Not done; Normal; Normal; Negative, notes: Rheumatologic w/u; 4; Normal; Normal; Unknown Results; Unknown Results; Magnetic resonance imaging: Not done; Neurological examination: Normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/drug and different event and patient.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neurological examination, Neurological symptom
Clinical narrative: Paresthesia and burning sensation followed by fasciculations in thighs and forearms; This is a literature report.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), 5 hrs after the suspect product(s) administration, outcome "unknown", described as "Paresthesia and burning sensation followed by fasciculations in thighs and forearms". The patient underwent the following laboratory tests and procedures: Biopsy skin: Low small fiber density in distal leg; Blood immunoglobulin M: Unknown Results; Heart rate: Unknown Results; Immunohistochemistry: Unknown Results; anti-C1q: Unknown Results; Unknown Results; Unknown Results; Unknown Results; Not done; Normal; Normal; Negative, notes: Rheumatologic w/u; 4; Normal; Normal; Unknown Results; Unknown Results; Magnetic resonance imaging: Not done; Neurological examination: Normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/drug and different event and patient.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Biopsy skin, Electromyogram, Investigation, Neurological examination
Clinical narrative: Paresthesia and burning sensation in limbs and face, fatigue, exercise intolerance, calf pain, internal tremor, dizziness; This is a literature report.   An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), 7 days after the suspect product(s) administration, outcome "unknown", described as "Paresthesia and burning sensation in limbs and face, fatigue, exercise intolerance, calf pain, internal tremor, dizziness". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Mildly positive; Biopsy skin: Low small fiber density in distal leg; 1.2; Electromyogram: Mild left Ulnar neuropathy and, notes: mild Rt median neuropathy; Autonomic testing: Normal; Neurological examination: Mild decreased vibration sense in toes bilaterally; Rheumatological examination: negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient different drug/event
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Rheumatological examination
Clinical narrative: Paresthesia and burning sensation in limbs and face, fatigue, exercise intolerance, calf pain, internal tremor, dizziness; This is a literature report.   An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), 7 days after the suspect product(s) administration, outcome "unknown", described as "Paresthesia and burning sensation in limbs and face, fatigue, exercise intolerance, calf pain, internal tremor, dizziness". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Mildly positive; Biopsy skin: Low small fiber density in distal leg; 1.2; Electromyogram: Mild left Ulnar neuropathy and, notes: mild Rt median neuropathy; Autonomic testing: Normal; Neurological examination: Mild decreased vibration sense in toes bilaterally; Rheumatological examination: negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient different drug/event