chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax, Electromyogram
Clinical narrative: Lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body; Severe cramping happens sporadically, primarily in my hands, feet and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 16Jun2021 at 14:00 as dose 2, single (Lot number: EW0178) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 22May2021, when the patient was 44-year-old, for Covid-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The following information was reported: SENSORY LOSS (disability) with onset 02Jul2021, outcome "not recovered", described as "Lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body"; MUSCLE SPASMS (disability) with onset 02Jul2021, outcome "not recovered", described as "Severe cramping happens sporadically, primarily in my hands, feet and legs". The events "lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body" and "severe cramping happens sporadically, primarily in my hands, feet and legs" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: Okay; Computerised tomogram abdomen: Unremarkable; Computerised tomogram pelvis: Unremarkable; Computerised tomogram thorax: Unremarkable; Electromyogram: Unremarkable; Fat Aspirate Procedure: Unknown results; Lumbar puncture: Unremarkable; Magnetic resonance imaging head: Unknown results; Good; Magnetic resonance imaging neck: Good; Oxygen saturation: Unknown results; Reflex test: Unknown results; Sweat test: Unknown results; Ultrasound testes: Unknown results. Therapeutic measures were not taken as a result of sensory loss, muscle spasms. Clinical course: A few weeks after receiving the 2nd dose, patient started to lose sensation in his fingers and toes. Since then, the lack of sensation had spread throughout his entire body. In addition, severe cramping happens sporadically, primarily in his hands, feet and legs. Patient have seen a Neurologist, Autoimmune Specialist and a Urologist.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging neck, Muscle spasms
Clinical narrative: Lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body; Severe cramping happens sporadically, primarily in my hands, feet and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 16Jun2021 at 14:00 as dose 2, single (Lot number: EW0178) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 22May2021, when the patient was 44-year-old, for Covid-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The following information was reported: SENSORY LOSS (disability) with onset 02Jul2021, outcome "not recovered", described as "Lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body"; MUSCLE SPASMS (disability) with onset 02Jul2021, outcome "not recovered", described as "Severe cramping happens sporadically, primarily in my hands, feet and legs". The events "lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body" and "severe cramping happens sporadically, primarily in my hands, feet and legs" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: Okay; Computerised tomogram abdomen: Unremarkable; Computerised tomogram pelvis: Unremarkable; Computerised tomogram thorax: Unremarkable; Electromyogram: Unremarkable; Fat Aspirate Procedure: Unknown results; Lumbar puncture: Unremarkable; Magnetic resonance imaging head: Unknown results; Good; Magnetic resonance imaging neck: Good; Oxygen saturation: Unknown results; Reflex test: Unknown results; Sweat test: Unknown results; Ultrasound testes: Unknown results. Therapeutic measures were not taken as a result of sensory loss, muscle spasms. Clinical course: A few weeks after receiving the 2nd dose, patient started to lose sensation in his fingers and toes. Since then, the lack of sensation had spread throughout his entire body. In addition, severe cramping happens sporadically, primarily in his hands, feet and legs. Patient have seen a Neurologist, Autoimmune Specialist and a Urologist.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Reflex test, Sensory loss, Sweat test, Ultrasound testes
Clinical narrative: Lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body; Severe cramping happens sporadically, primarily in my hands, feet and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 16Jun2021 at 14:00 as dose 2, single (Lot number: EW0178) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 22May2021, when the patient was 44-year-old, for Covid-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The following information was reported: SENSORY LOSS (disability) with onset 02Jul2021, outcome "not recovered", described as "Lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body"; MUSCLE SPASMS (disability) with onset 02Jul2021, outcome "not recovered", described as "Severe cramping happens sporadically, primarily in my hands, feet and legs". The events "lose sensation in my fingers and toes/ lack of sensation has spread throughout my entire body" and "severe cramping happens sporadically, primarily in my hands, feet and legs" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: Okay; Computerised tomogram abdomen: Unremarkable; Computerised tomogram pelvis: Unremarkable; Computerised tomogram thorax: Unremarkable; Electromyogram: Unremarkable; Fat Aspirate Procedure: Unknown results; Lumbar puncture: Unremarkable; Magnetic resonance imaging head: Unknown results; Good; Magnetic resonance imaging neck: Good; Oxygen saturation: Unknown results; Reflex test: Unknown results; Sweat test: Unknown results; Ultrasound testes: Unknown results. Therapeutic measures were not taken as a result of sensory loss, muscle spasms. Clinical course: A few weeks after receiving the 2nd dose, patient started to lose sensation in his fingers and toes. Since then, the lack of sensation had spread throughout his entire body. In addition, severe cramping happens sporadically, primarily in his hands, feet and legs. Patient have seen a Neurologist, Autoimmune Specialist and a Urologist.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Started to get a rash on her both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 03May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (First booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 09May2022, outcome "unknown", described as "Started to get a rash on her both legs".  Additional information: The reporter was reported raised. The patient was subtype reporter. The report his wife received the 2nd booster shot of the Pfizer-BioNTech COVID 19 Vaccine last Tuesday and 7 days later. She started to get a rash on her both legs. The reporter wants to know if this a common side effect due to the vaccine. The other products not provided. The regards to the COVID vaccine. His wife had the vaccine last week on Tuesday, 03May2022. It was the second booster shot. On Monday. 09May2022, seven days later, a rash appeared on both of her legs.   Follow-up (11May2022): This is a follow-up spontaneous report received from a same contactable consumer. This consumer (Patient's Spouse) reported for a female patient that: Updated Information: Reporter's address updated, Event onset date updated. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Eating disorder, Fatigue, Hiccups
Clinical narrative: Hiccups has gotten worse; Intractable hiccoughs; Tired and Exhausted; No energy; Losing weight; Cannot eat; Hiccoughs; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: EATING DISORDER (non-serious) with onset Jan2021, outcome "unknown", described as "Cannot eat"; HICCUPS (non-serious) with onset Jan2021, outcome "not recovered", described as "Hiccoughs"; HICCUPS (non-serious) with onset Jan2021, outcome "not recovered", described as "Intractable hiccoughs"; WEIGHT DECREASED (non-serious) with onset Jan2021, outcome "unknown", described as "Losing weight"; ASTHENIA (non-serious) with onset Jan2021, outcome "unknown", described as "No energy"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Tired and Exhausted"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Hiccups has gotten worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hiccups, condition aggravated, hiccups.  Clinical course: Thorazine three times a day, after about a week it does not work for the hiccups and he received Lyrica twice a day, after about a week the Lyrica does not work for the hiccups.  Additional information: The patient received Second Dose of the Pfizer Covid Vaccine on 29Jan2021; Lot Number: EN5318; NDC and Expiry Date: Unknown. The patient received Third and Fourth Doses of the Pfizer Covid Vaccine on an unspecified date, Lot Number, Expiry Date: Unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Weight, Weight decreased
Clinical narrative: Hiccups has gotten worse; Intractable hiccoughs; Tired and Exhausted; No energy; Losing weight; Cannot eat; Hiccoughs; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: EATING DISORDER (non-serious) with onset Jan2021, outcome "unknown", described as "Cannot eat"; HICCUPS (non-serious) with onset Jan2021, outcome "not recovered", described as "Hiccoughs"; HICCUPS (non-serious) with onset Jan2021, outcome "not recovered", described as "Intractable hiccoughs"; WEIGHT DECREASED (non-serious) with onset Jan2021, outcome "unknown", described as "Losing weight"; ASTHENIA (non-serious) with onset Jan2021, outcome "unknown", described as "No energy"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Tired and Exhausted"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Hiccups has gotten worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hiccups, condition aggravated, hiccups.  Clinical course: Thorazine three times a day, after about a week it does not work for the hiccups and he received Lyrica twice a day, after about a week the Lyrica does not work for the hiccups.  Additional information: The patient received Second Dose of the Pfizer Covid Vaccine on 29Jan2021; Lot Number: EN5318; NDC and Expiry Date: Unknown. The patient received Third and Fourth Doses of the Pfizer Covid Vaccine on an unspecified date, Lot Number, Expiry Date: Unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "shellfish/ citrus allergy" (unspecified if ongoing), notes: shellfish/ citrus allergy; "shellfish/ citrus allergy" (unspecified if ongoing), notes: shellfish/ citrus allergy. 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". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 at 02:00 as dose 3 [booster], single (Batch/Lot number: unknown) at the age of 65 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy", notes: Known allergies: no. Vaccination history included: Covid-19 vaccination (Primary immunization series complete., Manufacturer unknown), for COVID-19 immunization. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Apr2022 at 06:00, outcome "recovered" and all described as "COVID-19 Treatment". Therapeutic measures were not taken as a result of suspected Covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: testing positive for COVID; testing positive for COVID; 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 27Oct2021 as dose 3 (booster), single (Lot number: EW0175) at the age of 69 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: "emphysema" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; LISINOPRIL; HYDROCHLOROTHIAZIDE; ATORVASTATIN; XHANCE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "testing positive for COVID". The patient underwent the following laboratory tests and procedures: COVID-19: (Apr2022) Positive; (11May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 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: "Depression" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX, start date: Oct2018; LOESTRIN FE, start date: Jan2021. Clinical course included other medication details: other medication in 2weeks product: Trintellix, Loestrin FE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.   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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sx ST congertion cough mild 06May  then Ag positive 09May; Sx ST congertion cough mild 06May  then Ag positive 09May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 1, single (Lot number: FF2589) at the age of 22 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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) all with onset 09May2022, outcome "unknown" and all described as "Sx ST congertion cough mild 06May  then Ag positive 09May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: COVID-test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: Irregular EKG on 09May, sent for Echocardiogram on 11May; 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 06May2022 at 15:00 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 was not reported. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose 3, Batch/Lot No: 30130BA, Location of injection: Arm Left), administration date: 25Sep2021, when the patient was 70-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 23Mar2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 69-year-old, for Covid-19 immunization. The following information was reported: ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 09May2022, outcome "unknown", described as "Irregular EKG on 09May, sent for Echocardiogram on 11May". The event "irregular ekg on 09may, sent for echocardiogram on 11may" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of electrocardiogram abnormal.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (the patient). An 82-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0185), Aug 2021, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9269), Feb 2, 2021, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 108982), on Jan 14, 2021; both single dose, for COVID-19 immunization. Medical history not reported. Concomitant medication included Actemra taken for rheumatoid arthritis. The patient experienced COVID-19/positive for COVID-19 virus (medically significant) and vaccination failure (medically significant), onset May 9, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May 9, 2022) positive; (May 11, 2022) positive; (May, 2022) positive. No follow-up attempts possible. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Jan2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies:  Penicillin; "MS" (unspecified if ongoing); "Ankylosing spondylitis" (unspecified if ongoing); "anemia" (unspecified if ongoing). Concomitant medication(s) included: TYSABRI, start date: Jan2011, stop date: 31Mar2022; TOPAMAX, start date: Jun2015; SULFASALAZINE, start date: Dec2021, stop date: 02Apr2022; COSENTYX, start date: 14Apr2022, stop date: 21Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "not recovered", COVID-19 (medically significant) with onset 07May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Negative, notes: tested negative 03May (6 days after original pos test); (07May2022) positive, notes: test positive on 07May. I'm still sick and positive on 11May; (11May2022) positive, notes: test positive on 07May. I'm still sick and positive on 11May. Therapeutic measures were not taken as a result of drug ineffective, covid-19. clinical course : Antiviral treatment of Paxlovid for COVID-19 were started from 26Apr2022 to 30Apr2022. Patient had recovered from COVID and tested negative 03May (6 days after original pos test) Then I felt sick again 3 days later and test positive on 07May. I'm still sick and positive on 11May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 antibody test, Sneezing, Vaccination failure
Clinical narrative: + AG 5/10 with sneezing and tested pior to travel some rhinorrhea; + AG 5/10 with sneezing and tested pior to travel some rhinorrhea; + AG 5/10 with sneezing and tested pior to travel some rhinorrhea; + AG 5/10 with sneezing and tested pior to travel some rhinorrhea; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 12Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), RHINORRHOEA (non-serious), SNEEZING (non-serious) all with onset 11May2022, outcome "unknown" and all described as "+ AG 5/10 with sneezing and tested pior to travel some rhinorrhea". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) +5/10; (11May2022) Positive; (11May2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, sneezing.  Clinical Course: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Device Date 11May2022  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: EH9899), on 14Jan2021 as dose 2, single (Lot number: EK9231) and on 01Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I know one person who died after the 2nd Pfizer COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A 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: Covid-19 vaccine (Dose: 1 MANUFACTURER UNKNOWN), for COVID-19 Immunization.The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "I know one person who died after the 2nd Pfizer COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.Clinical information: Reporter know one person who died after the 2nd Pfizer Covid vaccine and another who will be on anti-seizure medicine for the rest of their lives after taking the 2nd vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: I know one person who died after the 2nd Pfizer COVID vaccine
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 56-year-old male patient received BNT162b2 (BNT162B2), on 21Nov2021 as dose 2 (initial pfizer dose), single (Lot number: FH8030) at the age of 55 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Apr2021 as dose 1, single (Lot number: 043A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "gallbladder removed" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing); "Hypertensive disorder" (unspecified if ongoing), notes: Hypertensive disorder; "diabetes" (unspecified if ongoing); "Jansen: 11Apr2021/ Pfizer: 21Nov2021" (unspecified if ongoing), notes: Jansen: 11Apr2021/ Pfizer: 21Nov2021; "Blood thinner" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for anticoagulant therapy, start date: Jan2018, stop date: 09May2022; AMLODIPINE taken for blood pressure measurement, start date: Jan2020, stop date: 09May2022; OMEPRAZOLE; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course included: COVID-19 was treated with Paxlovid (Lot number FY7031) from 10May2022. On 11May2022 the patient experienced Taste change/bitterness in mouth.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A patient (no qualifiers provided) 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: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant), outcome "not recovered", described as "another who will be on anti-seizure medicine for the rest of their lives after taking the 2nd vaccine". Therapeutic measures were taken as a result of seizure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 64 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) with onset 11May2022, outcome "unknown", COVID-19 (medically significant) with onset 11May2022 at 13:00, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (07May2022) Negative; (11May2022) Positive. Therapeutic measures were taken as a result of covid-19. c clinical Course : Antiviral treatment of Paxlovid for COVID were started from 29Apr2022 to 03MAy2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral ischaemia, Prostate cancer
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 79-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 at 14:35 as dose 1, single (Lot number: EL3246), in left deltoid and on 19Feb2021 at 15:29 as dose 2, single (Lot number: EL9261) at the age of 78 years, in right deltoid, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "Left leg Ischemia" (ongoing), notes: Left leg ischemia; "Prostate" (unspecified if ongoing), notes: Prostate; "Congestive heart failure" (ongoing); "Prostate cancer", start date: Mar2011 (ongoing); "Left leg Ischemia", start date: 09Aug2021, stop date: 11Aug2021, notes: Left leg ischemia. Concomitant medication(s) included: PLAVIX oral taken for peripheral ischaemia, start date: 07Sep2021 (ongoing); LIPITOR oral taken for peripheral ischaemia, start date: 07Sep2021 (ongoing); ELIQUIS oral taken for peripheral ischaemia, start date: 07Sep2021 (ongoing); HYTRIN oral taken for prostate cancer. Vaccination history included: fluval quad (Name: FLUVAL QUAD (2021-2022), Manufacturer: ID Biomedical, Batch/ Lo: 33D9, Route: Intramuscular, Anatomical site of injection: Left arm), administration date: 07Oct2021. The following information was reported: PERIPHERAL ISCHAEMIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "left leg ischemia"; PROSTATE CANCER (medically significant), outcome "not recovered". Clinical Course: Pertinent details: 3 stents implanted in left leg arteries, Congestive heart failure was ongoing. No follow-up attempts are possible. No further information was 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 event Prostate cancer which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, 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 60-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6199) and on 09Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 59 years for COVID-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Chronic coughing" (unspecified if ongoing), notes: History of chronic coughing but all three chest X-rays performed in 2020 were negative. Concomitant medication(s) included: AMLODIPINE BENAZEPRIL, start date: 01Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Cough: (2020) Negative; (2020) Negative; (2020) Negative; SARS-CoV-2 test: (11May2021) Positive, notes: clearly positive again after 1 week from last dose. Therapeutic measures were taken as a result of COVID-19; Anti-viral (Paxlovid) treatment start date=29Apr2022, treatment stop date=04May2022.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete , unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 Booster, unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches".  Additional information: Event took place after use of product. 180 5'10  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 12:00 as dose 1, single (Lot number: EN5318), in left arm, on 17Feb2021 at 13:00 as dose 2, single (Lot number: EL9266), in left arm and on 27Oct2021 at 12:00 as dose 3 (booster), single (Lot number: EW0181) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "congestive heart failure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Afib" (unspecified if ongoing); "PVC" (unspecified if ongoing), notes: other medical history:PVC; "Grass allergy" (unspecified if ongoing); "mountain cedar allergy" (unspecified if ongoing), notes: known allergies:mountain cedar. Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE], start date: Mar2000; LISINOPRIL, start date: Oct2020; METOPROLOL, start date: Mar2010. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid .; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events Drug ineffective , suspected covid-19 cannot be completely excluded based on temporal association.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: Em9809), in left arm, on 01Mar2021 as dose 2, single (Lot number: En6203), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: Fh8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Cholesterol" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, start date: Jan2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2 weeks was reported as yes. No Known allergies.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Jan2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left leg and on 15Aug2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Jan2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "LBP" (unspecified if ongoing), notes: LBP; "Interchange of Vaccine" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: Jan2016; SINGULAIR, start date: Jan2016; GABAPENTIN, start date: Jan2020. Past drug history included: Keflex and vicryl sutures, reaction(s): "Allergy", notes: known allergies: Keflex and Vicryl sutures. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included: COVID-19 was treated with Pfizer drug (lot number:  FY5656) from 2MAy2022 to 6May2022. Day 1-4 post Paxlovid treatment She tested negative on home antigen test. Day 5 woke up with symptoms (headache, sore throat, dry cough, chest tightness, arthralgias). Tested positive on home antigen test. Rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she started to get a rash on her both legs above the ankles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (3rd dose (1st booster dose), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 11May2022, outcome "unknown", described as "she started to get a rash on her both legs above the ankles".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: 30145ba) at the age of 71 years, in right 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: "Hypothyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CRESTOR. Vaccination history included: Covid-19 vaccine (Dose manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes, antiviral details [product=COVID 19 Treatment, brand paxlovid, treatment start date 09May2022, treatment stop date 10May2022, lot number 6A1513, indication Treatment of COVID-19. Adverse event: Strong metallic taste in mouth, nausea, diarrhea, Adverse event start date 09May2022, Adverse event start time 06:00 PM, If patient recovered : Recovered, Adverse event stop date :10May2022, If treatment AE :No and Device timestamp: 11May2022.  No follow-up attempts are possible. No further information was expected.