chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy in her right side afterwards; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient in her 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Bell's Palsy in her right side afterwards".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Migraine, Off label use
Clinical narrative: recurrent migraines; 1st dose:Pfizer;2nd dose:JANSSEN; 1st dose:Pfizer;2nd dose:JANSSEN; This is a spontaneous report received from contactable reporter (Consumer). Other Case identifier(s): 20211238271(1) (Janssen).  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single then received JANSSEN covid-19 vaccine (JANSSEN COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single both given for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient experienced recurrent migraines (dose number in series 1) when treated with PFIZER BIONTECH COVID-19 VACCINE. Event was considered as serious (medically significant). Then, the patient received the JANSSEN covid-19 vaccine as dose 2 (off label and interchange of vaccine products). The patient then had hypertrophic cardiomyopathy and partial loss of sight-also considered as serious (medically significant). Outcome of recurrent migraine was unknown.   Causality as per reporter for JANSSEN covid-19 vaccine and events of hypertrophic cardiomyopathy and partial loss of sight was Possible.   Sender comment: heart warming hypertrophic cardiomyopathy. This event(s) is considered unassessable. The events has a compatible/ suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: patient received third (booster) dose of bnt162b2; had a breakthrough positive C19 infection; had a breakthrough positive C19 infection; This is a spontaneous report received from contactable reporter (Consumer) from a sales representative. The reporter is the patient. A 40 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "patient received third (booster) dose of bnt162b2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "had a breakthrough positive C19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: breakthrough positive C19 infection. Patient received first 2 vaccines on the set timelines, then the booster on 21Nov2021 and had a breakthrough positive C19 infection. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after previously receiving two doses of the Pfizer vaccine.; Tested positive for COVID-19 after previously receiving two doses of the Pfizer vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 44 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022 07:00, outcome "recovering" and all described as "Tested positive for COVID-19 after previously receiving two doses of the Pfizer vaccine.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not 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: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) at the age of 15 years as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single 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 05Jan2022, outcome "recovering" and all described as "Tested positive for COVID". The seriousness criteria not caused results in death, life threatening, prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test, Swelling
Clinical narrative: highly exposed to covid; got the second dose there was still some swelling from the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, First Dose: hands and feet had severe swelling), administration date: 28Dec2020, for COVID-19 immunization, reaction(s): "First Dose: hands and feet had severe swelling"; Bnt162b2 (1st Dose, First Dose: hands and feet had severe swelling), administration date: 28Dec2020, for Covid-19 Immunization, reaction(s): "irst Dose: hands and feet had severe swelling". The following information was reported: EXPOSURE TO SARS-COV-2 (medically significant), outcome "unknown", described as "highly exposed to covid"; SWELLING (non-serious), outcome "unknown", described as "got the second dose there was still some swelling from the first dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of exposure to sars-cov-2. The patient was 67 when she received her vaccines. The patient was part of the first group that got the vaccine. The patient received her first dose on 28Dec2020 the second one was weeks later in Jan2021. In Aug the patient received the Regeneron IV treatment because she was highly exposed to covid and was given that IV prophylactically. The patient had that protection since Aug2021. As there were increased cases of Covid, 2 residents and 2 employees in the patient's nursing home had tested positive. The patient refused to have the booster as the patient needed some sort of concrete information if it was safe to get the booster dose- the third dose, with that kind of reaction initially. The patient had health issues and takes lots of medications.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; received the booster he developed Omicron after a Christmas Party; received the booster he developed Omicron after a Christmas Party; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: unknown, Dose number: Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received the booster he developed Omicron after a Christmas Party". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive for omicron.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: Lymphoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1st), for COVID-19 immunization. The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "Lymphoma". The patient with Lymphoma mentioned that she went through the vaccination and did not develop any antibodies, she was asking how she can get the Paxlovid in case she develops Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest discomfort, Cough, SARS-CoV-2 test positive
Clinical narrative: Patient is fully vaccinated. COVID + on 12/4/2021. ED visit on 12/4/2021. Patient presents to the ED secondary to cough. States he was diagnosed with COVID-19 in October. Reports continued coughing. Reports dry nonproductive cough. Positive for chest tightness and weakness. Denies any fevers or chills. No nausea or vomiting. No abdominal pain. Denies any shortness of breath. Patient states he is only here for cough relief. Patient has attempted antibiotics and steroids from PCP. Reports chest discomfort during coughing episodes. No improvement of symptoms, thus causing presentation to the ER for evaluation. BP 141/97 | Pulse 84 | Temp 98.3 °F (36.8 °C) | Resp. 18 | HT 180.3 cm (5' 11") | Wt. 79.4 kg (175 lbs.) | SpO2 96% | BMI 24.41 kg/m² Remains hemodynamically stable. Otherwise stable for discharge. Given medication for symptom relief. We'll follow up on an outpatient basis. Continue monitoring oxygen at home a home pulse oximeter. Stable for discharge. Patient instructed to come back to ED if symptoms worsen or situation changes.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: body aches, fever, vomiting, nausea
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19 pneumonia, Hypoxia, Pulmonary contusion, Road traffic accident
Clinical narrative: Patient is fully vaccinate and booted on 11/17/2021.  COVID + on 12/6/2021.  Hospitalized for 3 days starting 12/6/2021.  Patient presented to hospital S/P MVC, found to be COVID positive. All imaging workup was negative, including neurological. Cleared by trauma. Covid is asymptomatic.  He did have Hypoxemia requiring supplemental oxygen. Right pulmonary contusion. Right pulmonary contusion. Pneumonia due to COVID-19 virus.  IV decadron, Breo inhaler.      Stable
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Scan normal
Clinical narrative: Patient is fully vaccinate and booted on 11/17/2021.  COVID + on 12/6/2021.  Hospitalized for 3 days starting 12/6/2021.  Patient presented to hospital S/P MVC, found to be COVID positive. All imaging workup was negative, including neurological. Cleared by trauma. Covid is asymptomatic.  He did have Hypoxemia requiring supplemental oxygen. Right pulmonary contusion. Right pulmonary contusion. Pneumonia due to COVID-19 virus.  IV decadron, Breo inhaler.      Stable
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Patient is fully vaccinated.  Presented to the ED on 12/6/2021.  Vaccinated patient started having fever, cough, congestion and body aches beginning last 12/1/2021.  She was diagnosed with Covid last 12/2/2021.  She presents today with worsening dyspnea and fatigue and her oxygen level dropped down to 89% and her heart rte went up to the 130's with her home pulse oximeter with ambulation. Positive for chest pain, cough, diaphoresis, fever and headaches. Hypoxemia requiring supplemental oxygen Pneumonia due to COVID-19 virus: established and improving. Labs:  D-dimer 633, troponin normal, She will be discharged and go directly to the infusion center.She is instructed to return to the ED if her condition deteriorates in any way.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Headache, Heart rate increased, Hyperhidrosis, Hypoxia
Clinical narrative: Patient is fully vaccinated.  Presented to the ED on 12/6/2021.  Vaccinated patient started having fever, cough, congestion and body aches beginning last 12/1/2021.  She was diagnosed with Covid last 12/2/2021.  She presents today with worsening dyspnea and fatigue and her oxygen level dropped down to 89% and her heart rte went up to the 130's with her home pulse oximeter with ambulation. Positive for chest pain, cough, diaphoresis, fever and headaches. Hypoxemia requiring supplemental oxygen Pneumonia due to COVID-19 virus: established and improving. Labs:  D-dimer 633, troponin normal, She will be discharged and go directly to the infusion center.She is instructed to return to the ED if her condition deteriorates in any way.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen therapy, Pain, Pneumonia, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient is fully vaccinated.  Presented to the ED on 12/6/2021.  Vaccinated patient started having fever, cough, congestion and body aches beginning last 12/1/2021.  She was diagnosed with Covid last 12/2/2021.  She presents today with worsening dyspnea and fatigue and her oxygen level dropped down to 89% and her heart rte went up to the 130's with her home pulse oximeter with ambulation. Positive for chest pain, cough, diaphoresis, fever and headaches. Hypoxemia requiring supplemental oxygen Pneumonia due to COVID-19 virus: established and improving. Labs:  D-dimer 633, troponin normal, She will be discharged and go directly to the infusion center.She is instructed to return to the ED if her condition deteriorates in any way.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Patient is fully vaccinated.  Presented to the ED on 12/6/2021.  Vaccinated patient started having fever, cough, congestion and body aches beginning last 12/1/2021.  She was diagnosed with Covid last 12/2/2021.  She presents today with worsening dyspnea and fatigue and her oxygen level dropped down to 89% and her heart rte went up to the 130's with her home pulse oximeter with ambulation. Positive for chest pain, cough, diaphoresis, fever and headaches. Hypoxemia requiring supplemental oxygen Pneumonia due to COVID-19 virus: established and improving. Labs:  D-dimer 633, troponin normal, She will be discharged and go directly to the infusion center.She is instructed to return to the ED if her condition deteriorates in any way.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Dermatographia, hives. Starts in hands and scalp, spreads to entire rest of body. No closing of throat or shortness of breath, only intense itching and can draw on skin.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchial disorder, Chest pain, Cough, Dyspnoea, Ear, nose and throat examination
Clinical narrative: Short of breath chest pain on going coughing bronchial issues.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary function test
Clinical narrative: Short of breath chest pain on going coughing bronchial issues.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Face injury, Fall, SARS-CoV-2 test positive
Clinical narrative: Patient is fully vaccinated.  COVID + on 12/6202179-year-old female presents the ED after a fall. Patient reportedly dizzy when moving from chair to bed. Patient landing onto her right side and hitting her face. Patient is not on a blood thinner and did not lose consciousness. Patient denies any chest pain, shortness of breath. Reports pain with palpation over right-sided chest. and presented to ED. Patient's daughter called and said she recently tested positive for COVID 19. Daughter lives with patient. BP 180/79  | Pulse 68  | Temp 98 °F (36.7 °C) (Oral)  | Resp 18  | Ht 160 cm (5' 3")  | Wt 76.7 kg (169 lb)  | LMP  (LMP Unknown)  | SpO2 97%  | BMI 29.94 kg/m² Patient ordered a pulse oximeter with discharge. Patient's information sent to monoclonal antibiody clinic for possible outpatient treatment.Patient in stable condition with stable vitals for discharge and outpatient follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer) for a  program (159558). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single, and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single 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), outcome unknown, COVID-19 (medically significant) with onset 13Dec2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test (13Dec2021) positive.  The reporter stated that she is calling on behalf of her son (16 years old), he mentioned that her son got the 2 doses of the Pfizer vaccine last Jun2021, she mentioned that her son got an appointment for the booster shot last 15Dec2021 however her son tested positive last 13Dec2021 with covid-19 virus. She wants to ask if her son is eligible to get the booster shot after all.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Immunisation, Nasopharyngitis
Clinical narrative: booster; cold symptoms; weakness; diagnosed positive for covid; diagnosed positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172086).  A 83 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 83 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Cancer" (unspecified if ongoing), notes: he is a two time cancer survivor. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "diagnosed positive for covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Consumer was calling on behalf of her 83 year old father, withheld. He was diagnosed positive for covid today. He had a lot of pre existing health issues like diabetes and he was a two time cancer survivor. He was fully vaccinated and boosted. He was experiencing cold symptoms and weakness. Is it safe for him to take the Paxlovid pill?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: booster; cold symptoms; weakness; diagnosed positive for covid; diagnosed positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172086).  A 83 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 83 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Cancer" (unspecified if ongoing), notes: he is a two time cancer survivor. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "diagnosed positive for covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Consumer was calling on behalf of her 83 year old father, withheld. He was diagnosed positive for covid today. He had a lot of pre existing health issues like diabetes and he was a two time cancer survivor. He was fully vaccinated and boosted. He was experiencing cold symptoms and weakness. Is it safe for him to take the Paxlovid pill?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Nasal congestion
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Dry cough; Nasal congestion; Body aches; Fatigue; Some sneezing; Symptoms described as "like a bad cold".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 19Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 2021, outcome "unknown" and all described as "Tested positive for COVID"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "Dry cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "Nasal congestion"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; SNEEZING (non-serious) with onset 2021, outcome "unknown", described as "Some sneezing"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Symptoms described as "like a bad cold".". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  Clinical information: 17-year-old female tested positive for COVID. Patient had two Pfizer COVID vaccines administered with the 2nd vaccination 19Jun2021. Symptoms were dry cough, nasal congestion, body aches, fatigue and some sneezing. Symptoms described as "like a bad cold".  The lot number for bnt162b2 was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, SARS-CoV-2 test, Sneezing
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Dry cough; Nasal congestion; Body aches; Fatigue; Some sneezing; Symptoms described as "like a bad cold".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 19Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 2021, outcome "unknown" and all described as "Tested positive for COVID"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "Dry cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "Nasal congestion"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; SNEEZING (non-serious) with onset 2021, outcome "unknown", described as "Some sneezing"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Symptoms described as "like a bad cold".". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  Clinical information: 17-year-old female tested positive for COVID. Patient had two Pfizer COVID vaccines administered with the 2nd vaccination 19Jun2021. Symptoms were dry cough, nasal congestion, body aches, fatigue and some sneezing. Symptoms described as "like a bad cold".  The lot number for bnt162b2 was not provided and will be requested during follow up
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Booster; Tested positive for Covid on 04Jan2022; Tested positive for Covid on 04Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Tested positive for Covid on 04Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Clinical course: adverse event: (withheld) said that someone they saw at # tested positive for Covid on 04Jan2022. withheld got tested on 05Jan2022 and is awaiting results. They are fully vaccinated and boosted, and they have noticed no symptoms 5 days from potential exposure. They believe they have avoided contracting Covid but the test will confirm. (withheld) is of #. I do not know what vaccine they have gotten (Moderna vs Pfizer). I reported info for (withheld) in this submission, but I really wanted to submit this information because the person they were hanging out with may have also been vaccinated - unsure as I do not know who it was.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (NVSC2021US301047_NS). A male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a skin disorder/was clear but now forming some patches every since he got the COVID-19 vaccine (medically significant), with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: sx of mild stuffy nose 30Dec am then AG post at home 02Jan2022; sx of mild stuffy nose 30Dec am then AG post at home 02Jan2022; received moderna dose 1 and 2/Pfizer dose 3, booster dose; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: FF2589) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown whether the patient was diagnosed with Covid-19, prior to vaccination.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "received moderna dose 1 and 2/Pfizer dose 3, booster dose"; IMMUNISATION (medically significant) with onset 10Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "sx of mild stuffy nose 30Dec am then AG post at home 02Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: AG post at home. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pain assessment
Clinical narrative: afib; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (ongoing). Concomitant medication(s) included: XELJANZ XR taken for rheumatoid arthritis, start date: 01Dec2021 (ongoing). Past drug history included: Humira, reaction(s): "bruising all over her body", notes: second injection of humira she woke up with bruising all over her body and md immediately discontinued medication.; Humira, notes: First injection. Vaccination history included: Covid-19 vaccine (Dose:01), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "not recovered", described as "afib". The patient underwent the following laboratory tests and procedures: pain assessment: 6, notes: i have pain all over but it has only been two weeks. my pain level is a 6.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: after getting vaccinated he got the Covid-19 virus; after getting vaccinated he got the Covid-19 virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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 "after getting vaccinated he got the Covid-19 virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: booster; covid over the break even with booster; covid over the break even with booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid over the break even with booster". Clinical course: Other suspect are Genotropin pen 12/12mg cartridge/0.4mg daily.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient contracted COVID, positive PCR on 06Jan2021; patient contracted COVID, positive PCR on 06Jan2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 16:00 (Lot number: FF2590) at the age of 12 years as dose 2, single and administered in arm left, administration date 30Sep2021 16:00 (Lot number: 30155BA) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "recovering" and all described as "patient contracted COVID, positive PCR on 06Jan2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   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.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain
Clinical narrative: got COVID after vaccination; got COVID after vaccination; had a bad sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 13Jun2021 (Lot number: EW0180) at the age of 56 years as dose 2, single and administration date 23May2021 (Lot number: EW0182) as dose 1, single 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 2021, outcome "unknown" and all described as "got COVID after vaccination"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "had a bad sore throat".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: vaccinated with booster; Fully vaccinated with booster and was a confirmed positive for COVID on 05Jan2022; Fully vaccinated with booster and was a confirmed positive for COVID on 05Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Fully vaccinated with booster and was a confirmed positive for COVID on 05Jan2022"; IMMUNISATION (non-serious), outcome "unknown", described as "vaccinated with booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: received 3 Pfizer inoculations; 3 Pfizer inoculations / daughter-in-law becoming infected with Omicron; 3 Pfizer inoculations / daughter-in-law becoming infected with Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 3 Pfizer inoculations"; DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "3 Pfizer inoculations / daughter-in-law becoming infected with Omicron". Clinical course: The reporter's daughter-in-law (patient) became infected with Omicron despite having the vaccine. She had moderate infection but was fortunate to have gotten a PAXLOVID prescription before the pharmacy sold out. The patient was reported to had received 3 Pfizer inoculations. She was recovering.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid on 09Jan2022; tested positive for covid on 09Jan2022; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from regulatory authority. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Nov2021 13:00 (Lot number: EW0217) at the age of 44 years as dose 3 (booster), single, intramuscular, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 04Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE]; PRILOSEC [OMEPRAZOLE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021 13:00, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "not recovered" and all described as "tested positive for covid on 09Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive; (18Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is to report a breakthrough Covid infection.; This is to report a breakthrough Covid infection.; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Lot number: EW0187) at the age of 55 years as dose 3 (booster), single, administered in arm left, administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 22Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation.  The patient had no relevant medical history. There were no concomitant medications: no other medications in two-weeks. No other vaccine in four-weeks. The following information was reported: IMMUNISATION (medically significant) with onset 08Nov2021, outcome "unknown", described as "dose number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "This is to report a breakthrough Covid infection.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group.  A male patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown" and all described as "Tested positive for COVID". While reporting for herself, patient indicated that she wanted to have her husband call in and complete report for himself. He also has never been sick and only once in the entire time in 12 years she has known him, has he ever called out from work. He got COVID too and got his shots on the same dates. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Tested positive for COVID.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036150 same reporter/drug/event, different patient
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Break through covid infection, positive test 07Jan2022; Break through covid infection, positive test 07Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Lot number: EL3247) at the age of 44 years as dose 2, single and administered in arm left, administration date 26Jan2021 (Lot number: EL3247) as dose 1, single 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), outcome "unknown", COVID-19 (medically significant) with onset 07Jan2022, outcome "unknown" and all described as "Break through covid infection, positive test 07Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19.