chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Fatigue, Feeling abnormal, Headache
Clinical narrative: Immediately following both shots, my throat started to tighten, but never got to a point where I could not breath.; now have to pee every hour; I developed mild vertigo; I have pressure in the front of my head above my eyes and headaches daily; I am now always tired; I have not been able to think straight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 10:00 (Lot number: ER8732) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "Immediately following both shots, my throat started to tighten, but never got to a point where I could not breath."; POLLAKIURIA (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "now have to pee every hour"; VERTIGO (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I developed mild vertigo"; HEADACHE (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I have pressure in the front of my head above my eyes and headaches daily"; FATIGUE (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I am now always tired"; FEELING ABNORMAL (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I have not been able to think straight". The events "immediately following both shots, my throat started to tighten, but never got to a point where i could not breath.", "now have to pee every hour", "i developed mild vertigo", "i have pressure in the front of my head above my eyes and headaches daily", "i am now always tired" and "i have not been able to think straight" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; covid-19: negative. Therapeutic measures were taken as a result of throat tightness, pollakiuria, vertigo, headache, fatigue, feeling abnormal.  Clinical course: All of these symptoms developed immediately after the first shot and got worse when I got the second. I was a healthy person before the vaccines which is why I am filing this report. Happy to assist in providing any tests to try to resolve these issues. patient did not have COVID prior to vaccination. the patient tested COVID after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101803748 similar report from same reporter
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Throat tightness, Vertigo
Clinical narrative: Immediately following both shots, my throat started to tighten, but never got to a point where I could not breath.; now have to pee every hour; I developed mild vertigo; I have pressure in the front of my head above my eyes and headaches daily; I am now always tired; I have not been able to think straight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 10:00 (Lot number: ER8732) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "Immediately following both shots, my throat started to tighten, but never got to a point where I could not breath."; POLLAKIURIA (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "now have to pee every hour"; VERTIGO (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I developed mild vertigo"; HEADACHE (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I have pressure in the front of my head above my eyes and headaches daily"; FATIGUE (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I am now always tired"; FEELING ABNORMAL (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I have not been able to think straight". The events "immediately following both shots, my throat started to tighten, but never got to a point where i could not breath.", "now have to pee every hour", "i developed mild vertigo", "i have pressure in the front of my head above my eyes and headaches daily", "i am now always tired" and "i have not been able to think straight" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; covid-19: negative. Therapeutic measures were taken as a result of throat tightness, pollakiuria, vertigo, headache, fatigue, feeling abnormal.  Clinical course: All of these symptoms developed immediately after the first shot and got worse when I got the second. I was a healthy person before the vaccines which is why I am filing this report. Happy to assist in providing any tests to try to resolve these issues. patient did not have COVID prior to vaccination. the patient tested COVID after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101803748 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 23 year-old 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Eye movement disorder, Illness, Nausea
Clinical narrative: heart just felt like it was fluttering so fast; Heart was racing; throwing up; weak; Shaking; eyes were rolling back into patient''s head; sick; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jun2021 15:00 (Lot number: EW0217) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Time the Vaccination Was Given: First dose: Around 1100 or 1200, lot: EW0178, Route of administration: left arm), administration date: 28May2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 27Jun2021, outcome "not recovered", described as "heart just felt like it was fluttering so fast"; PALPITATIONS (medically significant) with onset 27Jun2021, outcome "not recovered", described as "Heart was racing"; VOMITING (non-serious) with onset 27Jun2021, outcome "recovered" (2021), described as "throwing up"; ASTHENIA (non-serious) with onset 27Jun2021, outcome "recovered" (2021), described as "weak"; TREMOR (non-serious) with onset 27Jun2021, outcome "recovered" (28Jun2021), described as "Shaking"; EYE MOVEMENT DISORDER (non-serious) with onset 27Jun2021, outcome "recovered" (27Jun2021), described as "eyes were rolling back into patient''s head"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea". The events "heart just felt like it was fluttering so fast", "heart was racing" and "sick" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of palpitations, vomiting, nausea.  Clinical course: The patient was rushed past other gurneys and hooked up to immediately in the emergency room. The patient received an IV to give medication to get the patient's heart rate down. patient stayed in the emergency room for several hours until stabilized, the patient was not admitted and was kept in the emergency room just to make sure the medicine was working and such before being discharged from the emergency room.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor, Vomiting
Clinical narrative: heart just felt like it was fluttering so fast; Heart was racing; throwing up; weak; Shaking; eyes were rolling back into patient''s head; sick; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jun2021 15:00 (Lot number: EW0217) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Time the Vaccination Was Given: First dose: Around 1100 or 1200, lot: EW0178, Route of administration: left arm), administration date: 28May2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 27Jun2021, outcome "not recovered", described as "heart just felt like it was fluttering so fast"; PALPITATIONS (medically significant) with onset 27Jun2021, outcome "not recovered", described as "Heart was racing"; VOMITING (non-serious) with onset 27Jun2021, outcome "recovered" (2021), described as "throwing up"; ASTHENIA (non-serious) with onset 27Jun2021, outcome "recovered" (2021), described as "weak"; TREMOR (non-serious) with onset 27Jun2021, outcome "recovered" (28Jun2021), described as "Shaking"; EYE MOVEMENT DISORDER (non-serious) with onset 27Jun2021, outcome "recovered" (27Jun2021), described as "eyes were rolling back into patient''s head"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea". The events "heart just felt like it was fluttering so fast", "heart was racing" and "sick" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of palpitations, vomiting, nausea.  Clinical course: The patient was rushed past other gurneys and hooked up to immediately in the emergency room. The patient received an IV to give medication to get the patient's heart rate down. patient stayed in the emergency room for several hours until stabilized, the patient was not admitted and was kept in the emergency room just to make sure the medicine was working and such before being discharged from the emergency room.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she had the Pfizer vaccine and she still got COVID; she had the Pfizer vaccine and she still got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (169752). The reporter is the patient.  A female 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she had the Pfizer vaccine and she still got COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female 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: SYSTEMIC LUPUS ERYTHEMATOSUS (non-serious), outcome "unknown", described as "Lupus".  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: Boosted 45 year old; Breakthrough Covid; Breakthrough Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2) (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 (Unknown manufacturer, Dose unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Boosted 45 year old"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The event took place after use of product. Patient was having mild symptoms.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with bells palsy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Nov2021 16:00 (Lot number: FH 8030) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 29Oct2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 07Dec2021, outcome "recovering", described as "Diagnosed with bells palsy.". The event "diagnosed with bells palsy." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of bell's palsy (Steriod and antiviral). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram thorax, Haemoglobin, Neutrophil count, Platelet count
Clinical narrative: Nasal swab PCR positive for SARSCoV2; Nasal swab PCR positive for SARSCoV2; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 24 year-old male patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20Mar2021 (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 (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "Nasal swab PCR positive for SARSCoV2"; COVID-19 PNEUMONIA (hospitalization, medically significant) with onset 17Dec2021, outcome "unknown", described as The events "nasal swab pcr positive for sarscov2", "nasal swab pcr positive for sarscov2", "covid19 lung infection", "fever" and "dry cough" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: (17Dec2021) groundglass opacities, notes: Groundglass opacities consistent with COVID19 lung infection; haemoglobin: (17Dec2021) 13.2; neutrophil count: (17Dec2021) 5.41; platelet count: (17Dec2021) 93; pyrexia: (17Dec2021) 101.8 Fahrenheit; sars-cov-2 test: (17Dec2021) positive; white blood cell count: (17Dec2021) 6.0. Therapeutic measures were taken as a result of covid-19 pneumonia, pyrexia, cough. The patient presented to ER on 17Dec2021 with complaint of fever (Tmax=101.8F) associated with dry cough. Nasal swab PCR positive for SARSCoV2.Chest CT in ER showed ground glass opacities consistent with COVID19 lung infection. Patient admitted and started empirically on IV cefepime and linezolid. Patient was vaccinated against SARSCoV2 bust has not received booster (inoculations administered 20Mar2021 and 10Apr2021). The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure  (LOE) cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure, White blood cell count
Clinical narrative: Nasal swab PCR positive for SARSCoV2; Nasal swab PCR positive for SARSCoV2; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 24 year-old male patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20Mar2021 (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 (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "Nasal swab PCR positive for SARSCoV2"; COVID-19 PNEUMONIA (hospitalization, medically significant) with onset 17Dec2021, outcome "unknown", described as The events "nasal swab pcr positive for sarscov2", "nasal swab pcr positive for sarscov2", "covid19 lung infection", "fever" and "dry cough" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: (17Dec2021) groundglass opacities, notes: Groundglass opacities consistent with COVID19 lung infection; haemoglobin: (17Dec2021) 13.2; neutrophil count: (17Dec2021) 5.41; platelet count: (17Dec2021) 93; pyrexia: (17Dec2021) 101.8 Fahrenheit; sars-cov-2 test: (17Dec2021) positive; white blood cell count: (17Dec2021) 6.0. Therapeutic measures were taken as a result of covid-19 pneumonia, pyrexia, cough. The patient presented to ER on 17Dec2021 with complaint of fever (Tmax=101.8F) associated with dry cough. Nasal swab PCR positive for SARSCoV2.Chest CT in ER showed ground glass opacities consistent with COVID19 lung infection. Patient admitted and started empirically on IV cefepime and linezolid. Patient was vaccinated against SARSCoV2 bust has not received booster (inoculations administered 20Mar2021 and 10Apr2021). The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure  (LOE) cannot be ruled out.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Oropharyngeal pain
Clinical narrative: Positive COVID Test; Positive COVID Test; mild cough; sore throat; lost of taste and smell; lost of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EL3247) at the age of 25 years as dose 2, single and administration date 19Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Not received any other vaccine in four weeks. Patient had no Covid prior vaccination. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021, outcome "recovering" and all described as "Positive COVID Test"; COUGH (non-serious) with onset 16Dec2021, outcome "recovering", described as "mild cough"; OROPHARYNGEAL PAIN (non-serious) with onset 16Dec2021, outcome "recovering", described as "sore throat"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 16Dec2021, outcome "recovering" and all described as "lost of taste and smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Dec2021) negative, notes: Nasal Swab; (17Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, cough, oropharyngeal pain, ageusia, anosmia.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID Test; Positive COVID Test; mild cough; sore throat; lost of taste and smell; lost of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EL3247) at the age of 25 years as dose 2, single and administration date 19Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Not received any other vaccine in four weeks. Patient had no Covid prior vaccination. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021, outcome "recovering" and all described as "Positive COVID Test"; COUGH (non-serious) with onset 16Dec2021, outcome "recovering", described as "mild cough"; OROPHARYNGEAL PAIN (non-serious) with onset 16Dec2021, outcome "recovering", described as "sore throat"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 16Dec2021, outcome "recovering" and all described as "lost of taste and smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Dec2021) negative, notes: Nasal Swab; (17Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, cough, oropharyngeal pain, ageusia, anosmia.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I came down with COVID; I came down with COVID-asymptomatic; Dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: 30145BA) at the age of 56 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "generalized anxiety disorder" (unspecified if ongoing); "sulfa eye drops" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Reynaud's" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percoset, reaction(s): "Known allergies: percocet". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 07Mar2021, when the patient was 55 years old, for COVID-19 immunization; Flu. The following information was reported: IMMUNISATION (medically significant) with onset 02Oct2021, outcome "unknown", described as "Dose received 3"; VACCINATION FAILURE (medically significant) with onset 10Dec2021, outcome "recovering", described as "I came down with COVID"; COVID-19 (medically significant) with onset 10Dec2021, outcome "recovering", described as "I came down with COVID-asymptomatic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical course: Patient did not tested covid prior vaccination. Patient tested positive for Covid post vaccination. It was reported that other vaccine received in 4 weeks was Flu.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID test; positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: EW0171) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW051), administration date: 14Apr2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: Mar2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "recovering" and all described as "positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: positive COVID test; positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: EW0171) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW051), administration date: 14Apr2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: Mar2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "recovering" and all described as "positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Scab
Clinical narrative: Really bad scabs; to what extent he has pain to; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (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: SCAB (hospitalization) with onset Dec2021, outcome "unknown", described as "Really bad scabs"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "to what extent he has pain to". Caller on the line calling about the Pfizer Covid Vaccine. She was calling about her husband who had a reaction. He was experienced really bad scabs. She was on the way to meet her husband as he was on the way to the hospital. She indicated she would tell her husband to call us as she does not know all the details and to what extent he had pain   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, Respiratory tract infection bacterial, SARS-CoV-2 test
Clinical narrative: bacterial respiratory infection; positive for COVID; positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 14Nov2021 (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 20Dec2021, outcome "unknown" and all described as "positive for COVID"; RESPIRATORY TRACT INFECTION BACTERIAL (non-serious), outcome "unknown", described as "bacterial respiratory infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Dec2021) negative; (20Dec2021) positive. Therapeutic measures were taken as a result of respiratory tract infection bacterial on 10Dec2021. It was reported that, he was otherwise healthy and tested again for COVID since family members tested positive on 17Dec2020.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed as positive for COVID on 19Dec2021 after having been adminsitered 2 doses of Pfizer-BioNTech Covid Vaccine on 08Feb2021 and 01Mar2021; COVID; high point of her fever was 101 degrees Fahrenheit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Feb2021 15:00 (Lot number: EL3247) as dose 1, single and administered in arm right, administration date 01Mar2021 14:30 (Lot number: EL3247) as dose 2, single for immunisation. Relevant medical history included: "Felt a little fatigued", start date: Dec2021 (unspecified if ongoing), notes: Verbatim: Felt a little fatigued; "Obesity" (ongoing), notes: About 10 years ago. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: Apr2021, stop date: Apr2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Dec2021, outcome "unknown", described as "diagnosed as positive for COVID on 19Dec2021 after having been adminsitered 2 doses of Pfizer-BioNTech Covid Vaccine on 08Feb2021 and 01Mar2021"; COVID-19 (medically significant) with onset 19Dec2021, outcome "recovering", described as "COVID"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "high point of her fever was 101 degrees Fahrenheit". The event "covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (2021) 101 degrees; sars-cov-2 test: (19Dec2021) positive for covid.  Additional information: The patient did not have any other vaccinations within four weeks prior to vaccination. There was a Product Complaint. Description of Product Complaint: The patient was diagnosed as positive for COVID on 19Dec2021 after having been adminsitered 2 doses of Pfizer-BioNTech Covid Vaccine on 08Feb2021 and 01Mar2021.  there are  predisposing factors (e.g. immunosuppression, contact with other infected persons) Not that patient was aware of, but there was a gentleman that came over to visit on Monday 13Dec2021 and he was notified by his phone that he may have been exposed to COVID 12 days prior, but he had no symptoms.   No follow-up information is possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR confirmed positive for COVID; PCR confirmed positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 13 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 06Jun2021 (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), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "PCR confirmed positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive.  Additional information: She was asymptomatic but tested because other family members had just tested positive and they were supposed to travel. Patient had 2nd Pfizer vaccine on 06Jun2021 and had breakthrough confirmed COVID 19 via PCR.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Immunisation, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; very mild symptoms of slight sore throat; tired; dose 3 (booster); 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 female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Nov2021 (Lot number: EW0217) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 23Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 14Oct2021; FASENRA; MONTELUKAST; OMEPRAZOLE; DULERA. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021, outcome "unknown", described as "dose 3 (booster)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "recovered" and all described as "Tested positive for COVID"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021, outcome "recovered", described as "very mild symptoms of slight sore throat"; FATIGUE (non-serious) with onset 14Dec2021, outcome "recovered", described as "tired". The patient underwent the following laboratory tests and procedures: Covid-19: (20Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, oropharyngeal pain, fatigue. AE resulted in: None of the above.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; very mild symptoms of slight sore throat; tired; dose 3 (booster); 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 female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Nov2021 (Lot number: EW0217) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 23Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 14Oct2021; FASENRA; MONTELUKAST; OMEPRAZOLE; DULERA. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021, outcome "unknown", described as "dose 3 (booster)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "recovered" and all described as "Tested positive for COVID"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021, outcome "recovered", described as "very mild symptoms of slight sore throat"; FATIGUE (non-serious) with onset 14Dec2021, outcome "recovered", described as "tired". The patient underwent the following laboratory tests and procedures: Covid-19: (20Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, oropharyngeal pain, fatigue. AE resulted in: None of the above.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Could not properly sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Apr2021 (Lot number: EP6955) at the age of 32 years as dose 2, single and intramuscular, administered in arm right, administration date 08Mar2021 (Lot number: EL3247) 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) with onset 21Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "not recovered" and all described as "Tested positive for COVID-19"; PYREXIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Chills/Shivering"; FATIGUE (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Fatigue"; INSOMNIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Could not properly sleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: Covidt test type post vaccination Nasal Swab, covid test name post vaccination COVID-19 Antigen, covid test date=22Dec2021, covid Test result=Positive]. Therapeutic measures were taken as a result of covid-19, pyrexia, chills, fatigue, insomnia.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Advil treatment for the adverse events. Prior to vaccination patient was not diagnosed with COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Psychotic disorder
Clinical narrative: Psychosis; Pfizer vaccines affected his autoimmune system; Psychosis";; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Schizophrenia" (unspecified if ongoing). Concomitant medication(s) included: CLOZAPINE taken for schizophrenia; LITHIUM taken for schizophrenia. The following information was reported: PSYCHOTIC DISORDER (hospitalization, medically significant), outcome "unknown", described as "Psychosis"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Pfizer vaccines affected his autoimmune system"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "Psychosis";". The events "psychosis" and "pfizer vaccines affected his autoimmune system" were evaluated at the physician office visit. Clinical comment: The patient received Clozapine and Lithium for over 7 years and lives a normal life without any psychotic episode for the last 7 years. After administration of the first dose of the Pfizer covid vaccine, he went into psychosis 2 weeks later.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Nervousness
Clinical narrative: she experienced burning throughout her body from head to toe; felt weak; shaky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6206) at the age of 65 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 (First Dose, Lot: EN9809), administration date: 12Feb2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "she got burning in left arm/she had burning sensation in her arm where she received her injection on the left side", "It went up to her ear on left side/she had burning sensation in her arm where she received her injection on the left side and went up to her ear". The following information was reported: BURNING SENSATION (hospitalization) with onset Mar2021, outcome "recovered" (Mar2021), described as "she experienced burning throughout her body from head to toe"; ASTHENIA (hospitalization) with onset Mar2021, outcome "recovered" (Mar2021), described as "felt weak"; NERVOUSNESS (hospitalization) with onset Mar2021, outcome "recovered" (Mar2021), described as "shaky".   Additional Information: After the second dose, she experienced burning throughout her body from head to toe, felt weak and shaky. Those effects lasted 20 minutes. Caller wants to know if it's going to be worse with the booster dose. Now, she is real concerned about getting the booster. She heard that whatever you  experience with the first two, the third will be worse. She stated that she almost went to the hospital with the second one.  It was reported that, if patient received a Booster Shot so far, reactions reported after getting a booster shot were similar to those after the two-dose or single-dose primary series. Fever, headache, fatigue and pain at the injection site were the most commonly reported side effects, and overall, most side effects were mild to moderate. However, as with the two-dose or single-dose primary series, serious side effects are rare, but may occur.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Reactions - a "mini tour" of covid; Reactions - a "mini tour" of covid; Exhausted for a couple of weeks afterward each shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 16:00 (Lot number: Er2613) at the age of 49 years as dose 2, single and administered in arm left, administration date 18Mar2021 21:00 (Lot number: Er2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Reactions - a "mini tour" of covid"; FATIGUE (non-serious), outcome "unknown", described as "Exhausted for a couple of weeks afterward each shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101777539 same reporter/ patient/ drug, different event/ dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Malaise, Night sweats
Clinical narrative: The patient had COVID last March; The patient had COVID last March; Chills; Malaise; Night sweats; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 17Feb2021 (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), with onset of Mar2021, outcome "unknown" and all described as "The patient had COVID last March"; CHILLS (non-serious) with onset 17Feb2021, outcome "unknown", described as "Chills"; MALAISE (non-serious) with onset 17Feb2021, outcome "unknown", described as "Malaise"; NIGHT SWEATS (non-serious) with onset 17Feb2021, outcome "unknown", described as "Night sweats". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (unspecified date) positive, notes: May; sars-cov-2 test: (Mar2021) positive. She just has a question. She was glad she got the Pfizer shot instead of other brands. Last March she had COVID. She tested positive for antibodies in May. She didn't have shortness of breath, but she had other symptoms. She got the first shot 17Feb2021. She got chills, malaise, and night sweats. The night sweats were like when you are getting over COVID, but not as bad as when she had COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.