chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasal abscess
Clinical narrative: This patient tested positive for Covid-19 via home test on 23May2022; This patient tested positive for Covid-19 via home test on 23May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: 5318), in left arm, on 20Apr2021 as dose 2, single (Lot number: 5318), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: 2589) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "recovered" and all described as "This patient tested positive for Covid-19 via home test on 23May2022". The patient underwent the following laboratory tests and procedures: Nasal abscess: (23May2022) Positive, notes: Covid 19 via home test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Weight
Clinical narrative: thought this was a rash like her second one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 86 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine, Lot number: EL9262 or GL9265), administration date: 25Jan2021, when the patient was 86-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "thought this was a rash like her second one". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2nd dose Pfizer COVID-19 Vaccine: Lot Number / Expiry Date: EN5318 or GN5318/ unknown.  Synthroid: She has been taking Synthroid for years and thinks 10 years. she states she has only ever taken one medication. She states she has never taken a flu shot or the any other shots that are offered at her yearly physical. prior vaccinations within 4 weeks of  first administration date of the suspect vaccine. Caller states she has never had a vaccination before except as a child whatever vaccinations were required but has received none since. No family medical history relevant to AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200789445 similar report from same reporter
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: i got a covid 19 infection; i got a covid 19 infection; 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 (BNT162B2), on 15Apr2021 at 12:00 as dose 1, single (Lot number: ew0164), in left arm, on 06May2021 at 12:00 as dose 2, single (Lot number: ew0167), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: paa173696) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; SERTRALINE.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 20May2022 at 12:00, outcome "unknown", COVID-19 (medically significant) with onset 20May2022 at 12:00, outcome "recovered" and all described as "i got a covid 19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The COVID-19 vaccine was administered at Doctor's office/urgent care. 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 has been tested for COVID-19. The AE did not result in emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection/positive COVID-19 PCR; COVID infection/positive COVID-19 PCR; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm, all intramuscular 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) all with onset 26Apr2022, outcome "recovered with sequelae" and all described as "COVID infection/positive COVID-19 PCR". The patient underwent the following laboratory tests and procedures: PCR: (27Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, COVID-19 with Robitussin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on 07May2022. Started Plaxlovid the same day. Negative after 3 days. Took all 5 days of Plaxlovid. Tested negative for 3 consecutive days beginning 10May2022. No symptoms.Tested positive; Tested positive on 07May2022. Started Plaxlovid the same day. Negative after 3 days. Took all 5 days of Plaxlovid. Tested negative for 3 consecutive days beginning 10May2022. No symptoms.Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "mycosis fungouties" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 09Oct2017, stop date: 02Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "recovered" and all described as "Tested positive on 07May2022. Started Plaxlovid the same day. Negative after 3 days. Took all 5 days of Plaxlovid. Tested negative for 3 consecutive days beginning 10May2022. No symptoms.Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: Tested positive on 07May2022; (09May2022) Negative, notes: Started Plaxlovid the same day. Negative after 3 days; (10May2022) Negative, notes: Tested negative for 3 consecutive days beginning 10May2022; (11May2022) Negative, notes: Tested negative for 3 consecutive days beginning 10May2022; (12May2022) Negative, notes: Tested negative for 3 consecutive days beginning 10May2022; (19May2022) Positive, notes: Tested positive again on 19May2022; (27May2022) Negative, notes: Tested negative on 27May2022. 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: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Poor quality sleep, Pyrexia
Clinical narrative: 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 number unknown (booster), single (Lot number: FL3197, Expiration Date: 30Jun2022) for covid-19 immunization. The patient's relevant medical history included: "elevated blood pressure" (unspecified if ongoing), notes: elevated blood pressure. Concomitant medication(s) included: LISINOPRIL AND HYDROCHLORTIAZIDE taken for blood pressure increased. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 Immunization; Covid-19 vaccine (Dose number unknown first Booster, unknown manufacturer.), for COVID-19 Immunization. The following information was reported: POOR QUALITY SLEEP (non-serious), outcome "recovering", described as "A very restless night of sleep was experienced"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "developed soreness at the injection site"; CHILLS (non-serious), outcome "recovering"; NAUSEA (non-serious), outcome "recovering", described as "very nauseous/bit of nausea"; VOMITING (non-serious), outcome "unknown", described as "became very nauseous, which led to vomiting"; PYREXIA (non-serious), outcome "recovering", described as "fever"; HEADACHE (non-serious), outcome "recovering", described as "a persistent headache". Additional information: Several hours after receiving the 2nd booster of Comirnaty, patient developed soreness at the injection site. 12 hours after the dose, patient experienced chills. 14 hours after dose, patient developed a fever and became very nauseous, which led to vomiting. A very restless night of sleep was experienced. He awoke to a bit of nausea and a persistent headache. Symptoms at the 25 hour point (post dose) are improving substantially. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: 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 number unknown (booster), single (Lot number: FL3197, Expiration Date: 30Jun2022) for covid-19 immunization. The patient's relevant medical history included: "elevated blood pressure" (unspecified if ongoing), notes: elevated blood pressure. Concomitant medication(s) included: LISINOPRIL AND HYDROCHLORTIAZIDE taken for blood pressure increased. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 Immunization; Covid-19 vaccine (Dose number unknown first Booster, unknown manufacturer.), for COVID-19 Immunization. The following information was reported: POOR QUALITY SLEEP (non-serious), outcome "recovering", described as "A very restless night of sleep was experienced"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "developed soreness at the injection site"; CHILLS (non-serious), outcome "recovering"; NAUSEA (non-serious), outcome "recovering", described as "very nauseous/bit of nausea"; VOMITING (non-serious), outcome "unknown", described as "became very nauseous, which led to vomiting"; PYREXIA (non-serious), outcome "recovering", described as "fever"; HEADACHE (non-serious), outcome "recovering", described as "a persistent headache". Additional information: Several hours after receiving the 2nd booster of Comirnaty, patient developed soreness at the injection site. 12 hours after the dose, patient experienced chills. 14 hours after dose, patient developed a fever and became very nauseous, which led to vomiting. A very restless night of sleep was experienced. He awoke to a bit of nausea and a persistent headache. Symptoms at the 25 hour point (post dose) are improving substantially. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: minor aches; Slight soreness at injection site; Sudden onsite of moderate chills; 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 01Jun2022 at 09:15 as dose 4 (booster), single (Lot number: FL3197) at the age of 44 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete(First, second and third dose), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Jun2022 at 23:00, outcome "recovering", described as "Slight soreness at injection site"; CHILLS (non-serious) with onset 01Jun2022 at 23:00, outcome "recovering", described as "Sudden onsite of moderate chills"; PAIN (non-serious) with onset 02Jun2022, outcome "recovering", described as "minor aches". Therapeutic measures were not taken as a result of vaccination site pain, chills, pain. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated he had slight soreness at injection site, sudden onsite of moderate chills at approx. 14hrs with minor aches at approx. 24hrs. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31May2022, outcome "unknown", COVID-19 (medically significant) with onset 31May2022, outcome "recovering" and all described as "tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive; (01Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: dose received: More than 3.product: COVID 19,brand name unknown:COVID19 Vaccine,lot unknown reason:Not available/provided to reporter at the time of report completion,dose number:4.Facility where the most recent COVID-19 vaccine was administered: Unknown.Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown.List of any other medications the patient received within 2 weeks of vaccination: multiple. Reported Event: My Mother and Father tested positive for COVID-19.Other medical history: multiple.Prior to vaccination, was the patient diagnosed with COVID-19. No. Since the vaccination, has the patient been tested for COVID-19. Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200794255 same reporter/product/event, different patient
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Vomiting; Fever; Chills; Headache; Body aches; did not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder, low thyroid" (unspecified if ongoing), notes: Thyroid disorder, low thyroid; "low thyroid" (unspecified if ongoing), notes: low thyroid. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose 3, early 2022), administration date: 2022, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "Body aches"; CHILLS (non-serious) with onset Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Jun2022, outcome "unknown"; VOMITING (non-serious) with onset Jun2022, outcome "unknown"; MALAISE (non-serious) with onset Jun2022, outcome "unknown", described as "did not feel good".  Additional information: Chamomile tea was used as a treatment, as the patient did not feel good so they did not want to take anything strong.  patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. two Pfizer doses in 2021 and a booster early 2022 and now having the second booster yesterday.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Fever; Chills; Headache; Body aches; did not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder, low thyroid" (unspecified if ongoing), notes: Thyroid disorder, low thyroid; "low thyroid" (unspecified if ongoing), notes: low thyroid. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose 3, early 2022), administration date: 2022, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "Body aches"; CHILLS (non-serious) with onset Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Jun2022, outcome "unknown"; VOMITING (non-serious) with onset Jun2022, outcome "unknown"; MALAISE (non-serious) with onset Jun2022, outcome "unknown", described as "did not feel good".  Additional information: Chamomile tea was used as a treatment, as the patient did not feel good so they did not want to take anything strong.  patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. two Pfizer doses in 2021 and a booster early 2022 and now having the second booster yesterday.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Somnolence, Vaccination site pain
Clinical narrative: Tenderness and aches of arm where injection was given; Tenderness and aches of arm where injection was given; Headache; Drowsiness; Light headedness; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 at 11:45 as dose 4 (booster), single (Lot number: FH8028) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Whey from milk" (unspecified if ongoing), notes: Known allergies: Whey from milk; "Known allergies: Unknown fragrance" (unspecified if ongoing), notes: Known allergies: Unknown fragrance. The patient took concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: FF8839, Prev dose dose number: 3,, Prev dose vaccine location: Left arm), administration date: 20Oct2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: EL3247,, Prev dose dose number: 2,, Prev dose vaccine location: Left arm), administration date: 08Feb2021, when the patient was 49-year-old, for COVID-19 Immunization; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer,, Prev dose lot number: EL3247, Prev dose dose number: 1), administration date: 20Jan2021, when the patient was 49-year-old, for COVID-19 Immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 01Jun2022 at 01:00, outcome "recovering", described as "Drowsiness"; HEADACHE (non-serious) with onset 01Jun2022 at 01:00, outcome "recovering"; DIZZINESS (non-serious) with onset 01Jun2022 at 01:00, outcome "recovering", described as "Light headedness"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 01Jun2022 at 01:00, outcome "recovering" and all described as "Tenderness and aches of arm where injection was given". Therapeutic measures were taken as a result of vaccination site pain, vaccination site pain, headache, somnolence, dizziness. Additional information: Patient had not received other vaccine in four weeks. Patient had received other medications in two weeks. Patient had not COVID prior vaccination. Patient had not COVID tested post vaccination. Patient had took acetaminophen treatment for AE.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An elderly female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered"; DIARRHEA (non-serious), outcome "recovered", described as "diarrhea".  Additional information: Reporter Reported that elderly mother in law had nausea, vomiting, and diarrhea for 48 hours following Pfizer COVID vaccine. Awareness Date 01Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: Nasal Swab, Result: positive; Test: Nasal Swab, Result: positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), on 24Mar2021 as dose 2, single (Lot number: EL3248) and on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa Drugs" (unspecified if ongoing), notes: known allergies: Sulfa Drugs. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 14Oct2021 as dose number unknown, single. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin, Sulfa Drugs", notes: known allergies: Augmentin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Test: Nasal Swab, Result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive. Clinical course: Other vaccine 4weeks details: other vaccine 4weeks product: Flu Vaccine. Other vaccine 4 weeks vaccine date: 14Oct2021. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Device Date : 02Jun2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient is expected to deliver a baby(s) on 29Nov2021. 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 01Jun2022, outcome "recovering" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: covid test type post vaccination= Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive other vaccine in four weeks and not had covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Nasal congestion
Clinical narrative: Contracted COVID; contracted COVID; fatigue; nasal congestion; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 02Jun2022, outcome "recovering", described as "Contracted COVID"; DRUG INEFFECTIVE (medically significant) with onset 02Jun2022, outcome "recovering", described as "contracted COVID"; COUGH (non-serious) with onset 02Jun2022, outcome "recovering"; FATIGUE (non-serious) with onset 02Jun2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 02Jun2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, fatigue, nasal congestion, cough. The patient has no Seriousness criteria for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Mild symptoms were reported. The patient did not diagnose with COVID-19 prior to vaccination. The patient has been tested for COVID-19 from the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Contracted COVID; contracted COVID; fatigue; nasal congestion; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 02Jun2022, outcome "recovering", described as "Contracted COVID"; DRUG INEFFECTIVE (medically significant) with onset 02Jun2022, outcome "recovering", described as "contracted COVID"; COUGH (non-serious) with onset 02Jun2022, outcome "recovering"; FATIGUE (non-serious) with onset 02Jun2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 02Jun2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, fatigue, nasal congestion, cough. The patient has no Seriousness criteria for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Mild symptoms were reported. The patient did not diagnose with COVID-19 prior to vaccination. The patient has been tested for COVID-19 from the vaccination.  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: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25May2022, 1 day after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, Thrombosis
Clinical narrative: bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee; bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee; bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2021 at 09:30 as dose 2, single (Lot number: Fa7484) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: Fc3183, Administration time: 09:00 AM, Anatomical location: Left arm), administration date: 21Jul2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant, life threatening), DEEP VEIN THROMBOSIS (hospitalization, medically significant, life threatening), THROMBOSIS (hospitalization, medically significant, life threatening) all with onset 31Dec2021 at 12:00, outcome "recovered" and all described as "bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee". The patient was hospitalized for pulmonary embolism, deep vein thrombosis, thrombosis (hospitalization duration: 3 day(s)). The event "bilateral pulmonary embolism due to clots coming from a large dvt in my right thigh, above the knee" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, deep vein thrombosis, thrombosis.  Clinical course: Facility type of vaccine was pharmacy or drug store. The patient did not receive other vaccines in four weeks. In Mar2022 the patient developed bilateral pulmonary embolism due to clots coming from a large DVT in right thigh, above the knee. There was no known cause, injury or otherwise, to e plane the formation of the DVT and initial symptoms could be traced back to as early as Dec2021. Patient was treated with Heparin, followed by continued daily dose of Xarel. No covid prior to vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 12:00 as dose 1, single (Lot number: EN6202), in left arm and on 23Mar2021 at 12:00 as dose 2, single (Lot number: ER2613), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 030h21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "known allergies: airborne allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (27May2022) Negative; (30May2022) positive, notes: Had Covid rebound. Tested positive again 3 days after testing negative and started having symptoms again. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid tests; Positive Covid tests; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EWO217) and as dose 2, single (Lot number: EWO198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive Covid tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The clinical course was reported as follows: "My family and I had positive COVID tests, congestion, cough, fatigue. Some had headaches. Awareness Date : 07Feb2022." No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 41-year-old female patient (not pregnant) received BNT162b2 (Pfizer), on 22Feb2021 at 09:30AM as dose 1, single (Lot number: EL3247), in right arm, on 15Mar2021 at 09:30AM as dose 2, single (Lot number: EL3247), in right arm and on 05Nov2021 at 11:45AM as dose 3 (booster), single (Lot number: FH8030) at the age of 40 years, in right arm, all intramuscular for COVID-19 immunization. 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) all with onset 18Apr2022, outcome "recovered" (2022) and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: Nasal Swab: (19Feb2021) Negative; (15Mar2021) Negative; (29Dec2021) Negative; (19Apr2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had no Covid prior vaccination. The patient had Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted symptomatic Covid-19 on 17May2022; Contracted symptomatic Covid-19 on 17May2022; 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 adult female received COVID-19 immunization at a workplace clinic with the first dose of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot EN5318 and expiry information not provided) as a single dose on 27Jan2021 (at 50-years-old); a second dose of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot EN5318 and expiry information not provided) as a single dose on 17Feb2021 (at 50-years-old); and a third (booster) dose of intramuscular  BNT162B2 (COMIRNATY, solution for injection; Lot ED6955 and expiry information not provided) as a single dose in the right arm on 30Sep2021 (at 51-years-old). The patient had no medical history, denied any known allergies and also denied receiving any other medications within two weeks of the vaccinations. The patient also denied receiving any other vaccination within four weeks of these vaccinations. The patient reported that she contracted symptomatic COVID-19 on 17May2022 confirmed with a positive nasal swab test on 18May2022. Treatment details included PAXLOVID. The outcome of the event Contracted symptomatic Covid-19 was recovered on an unspecified date in 2022.
Age: 36.0
Sex: F
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 37-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of hodgkins lymphoma" (unspecified if ongoing). Concomitant medication(s) included: VIT D [COLECALCIFEROL], start date: 04Nov2019; VIT C; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; NEXIUM [ESOMEPRAZOLE SODIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: use of vaccines after being involved in temperature excursion with no reported adverse event; vaccine out of range since 08DEC2021 with the temperature range of 0.61 degrees C up to 12 degrees C; temperature excursion with no reported adverse event; Initial information received regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA180455(CLUSTER).  This case involves an unknown age and unknown gender patients who administered vaccine which was out of range since 08dec2021 with the temperature range of 0.61 degrees c up to 12 degrees c; temperature excursion with no reported adverse event and use of vaccines after being involved in temperature excursion with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Dec-2021, the patient received a  dose of suspect influenza quadrival a-b vaccine (formulation, strength, route, lot number, expiry date : unknown) unknown administration site for prophylactic vaccination.  Vaccine was out of range since 08-Dec-2021 with the temperature range of 0.61 degrees c up to 12 degrees c; temperature excursion with no reported adverse event (product temperature excursion issue) and on an unknown date the patient had use of vaccines after being involved in temperature excursion with no reported adverse event (poor quality product administered) (unknown latency). Clinic staff as unaware that there was a recommended temperature the products must be kept in.   Action taken: Not applicable for both the events  Outcome: Unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01098962:
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Echocardiogram, Myocarditis, Troponin
Clinical narrative: MYOCARDITIS; This 44-year-old, male subject (US0070016) was participating in a study.  The subject's medical history, as provided by the investigator, included hypertension, migraines, and anxiety. Concomitant medications reported included paracetamol, benazepril hydrochloride, mirtazapine, and buspirone.   Prior to event onset, the subject received intramuscular mRNA-1273.211 (Dose 1) for SARS-CoV-2 vaccination on 28 May 2021, approximately 11 months and 10 days before onset of the event.  On 07 May 2022, the subject noted chest pain lasting for 30 minutes.   Through week of 08 May 2022, he noted exertional chest pain.   On 13 May 2022, his chest pain returned, and its increased severity prompted medical evaluation in the emergency room and was admitted due to the event.  Laboratory test results indicated that his serial troponin was elevated, while his echocardiogram and cardiac catheterization were with no findings. The subject was given a diagnosis of myocarditis. Treatment for the event included oral colchicine and oral metoprolol tartrate.  On 15 May 2022, the subject was discharged from the hospital.    The subject received the scheduled dose of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.  The event, myocarditis, was reported as not resolved.  The investigator assessed the event, myocarditis, as not related to study drug and not related to study procedure.  Company comment: This case concerns a 44-year-old with male subject whit medical history of hypertension,migraines and anxiety who experienced the serious adverse event of special interest of myocarditis. Prior to event onset, the subject received intramuscular mRNA-1273.211  for SARS-CoV-2 vaccination on 28 May 2021, approximately 11 months and 10 days before onset of the event. The event was considered as not  solved ; as per the SD, the subject noted exertional chest pain which increased severity in the following days. The event was assessed as related to IP in agreement with  the Investigator.; Reporter's Comments: Company comment: This case concerns a 44-year-old with male subject whit medical history of hypertension,migraines and anxiety who experienced the serious adverse event of special interest of myocarditis. Prior to event onset, the subject received intramuscular mRNA-1273.211  for SARS-CoV-2 vaccination on 28 May 2021, approximately 11 months and 10 days before onset of the event. The event was considered as not  solved ; as per the SD, the subject noted exertional chest pain which increased severity in the following days. The event was assessed as related to IP in agreement with  the Investigator.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; administration of improperly stored vaccines to patient; This spontaneous report was received from a vaccine coordinator  (Office Manager) and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in 2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (dose: 1 (unit not reported),  lot #U017138, expiration date: 28-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of minus 14 degree Celsius for a time frame of 7 hours (occurred on 20-JAN-2022). There were no previous temperature excursions reported. No additional adverse event (AE) information was provided.   This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2205USA005084: US-009507513-2205USA005067: US-009507513-2205USA004997: