chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 at 14:00 as dose 1, single (Lot number: EL9269), in left arm, on 04Mar2021 at 14:00 as dose 2, single (Lot number: EL6199), in left arm and on 24Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12May2022 at 14:00 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "gerd" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LIPITOR; DESCOVY; BENADRYL; PANTOPRAZOLE; SINGULAIR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (unspecified date) negative, notes: Had been negative each of prior 4 days; (31May2022) Positive, notes: Last positive antigen test was Tuesday 31May; (05Jun2022) Positive, notes: Positive rapid antigen test today (05Jun). Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 27May2022 to 31May2022.  Clinical course: Paxlovid/Covid rebound on 4th day after completing 5-day Paxlovid prescription. Symptoms returned on 04Jun2022. Positive rapid antigen test on 05Jun2022. Had been negative each of prior 4 days. Last positive antigen test was Tuesday 31May2022. Symptoms had resolved on 29May2022.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever the morning after receiving the third dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 at 14:15 as dose 3 (booster), single (Lot number: FL8095) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 2, single , lot number FK5618, Anatomical location: Left arm), administration date: 28Nov2021, when the patient was 9-year-old, for Covid-19 Immunization; BNT162b2 (dose 1, single, lot number FK5127), administration date: 05Nov2021, when the patient was 9-year-old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 04Jun2022, outcome "recovering", described as "Fever the morning after receiving the third dose.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Patient underwent lab tests and procedures which included on 04Jun2022 Sars-Cov-2-test: negative (nasal swab). Patient did not have known allergies. Patient did not receive other medication within 2 weeks. Patient did not receive other vaccine in four weeks. Prior to vaccination patient was not diagnosed with Covid-19. Patient was tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 06Aug2021 at 12:00 as dose 1, single (Lot number: FA7485), in left arm and on 28Aug2021 at 12:00 as dose 2, single (Lot number: FF2588) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "recovered" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Addition information: Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none. Other vaccine in four weeks was none. Other medications in two weeks was none.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical significance: Covid rebound. Tested poistive, and took 5 days of paxlovid BID, tested negative following return of symptoms and tested positive on day 11.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: FLUVOXAMINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative, notes: Tested neg on covid antigen test day 6; (03Jun2022) Positive, notes: Tested positive covid on home antigen test day 10; (31May2022) Negative, notes: Tested neg on pcr day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Felt 100% back to normal by day 3 of taking paxlovid for covid. Completed the 5 day course. Tested neg on covid antigen test day 6. Tested neg on pcr day 7. Day 10 started having fevers, sore throat, aches, runny nose. Tested positive covid on home antigen test day 10 Known Allergies: No. Other medical history: Depression. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 03Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies were reported. There were no concomitant medications. No other medication was received within 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 18May2022 to 22May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she has got COVID right now, she is vaccinated; she has got COVID right now, she is vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she has got COVID right now, she is vaccinated". The event "she has got covid right now, she is vaccinated" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Reporter stated, So I am calling on behalf of my sister, she has got COVID right now, she is vaccinated and her vaccine, the second vaccine (Confirmed as Pfizer covid-19 vaccine) was like 7 months ago. So, anyways right now she has got COVID on day 5 so yesterday was day 4 and she called like her health insurance and they did a virtual exam with a doctor, they set an appointment with the doctor. The doctor prescribed the pill that came out for COVID, the Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jan2022 as dose 4 (booster), single (Lot number: F51614) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Day 10 negative test; Positive, notes: Day 11 positive test. Therapeutic measures were taken as a result of covid-19.  Clinical course: No other medication in 2 weeks. Patient received Anti-viral treatment for COVID-19 with Paxlovid from 28May2022 to 02Jun2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Cough, Nasal congestion, Rhinorrhoea, Staphylococcal infection
Clinical narrative: symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; staph infection; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete, Pfizer vaccine and booster), for COVID-19 immunization.  The following information was reported: SUSPECTED COVID-19 (hospitalization) with onset 31May2022, outcome "unknown", described as "contracted COVID"; STAPHYLOCOCCAL INFECTION (hospitalization) with onset 31May2022, outcome "unknown", described as "staph infection"; COUGH (hospitalization), RHINORRHOEA (hospitalization), NASAL CONGESTION (hospitalization), ARTHRITIS (hospitalization), SWELLING (hospitalization) all with onset 31May2022, outcome "unknown" and all described as "symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling". Clinical course includes Reporter writing to report that his husband, (Name withheld), contracted COVID after receiving the Pfizer vaccine and booster. She does not have the dates available at this moment of the vaccinations. He was diagnosed 31May. Symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling. She did not report within 24 hours as an oversight due to his hospitalization at the same time with a staph infection that distracted me. She confirmed the date of awareness as 31May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Swelling
Clinical narrative: symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; staph infection; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete, Pfizer vaccine and booster), for COVID-19 immunization.  The following information was reported: SUSPECTED COVID-19 (hospitalization) with onset 31May2022, outcome "unknown", described as "contracted COVID"; STAPHYLOCOCCAL INFECTION (hospitalization) with onset 31May2022, outcome "unknown", described as "staph infection"; COUGH (hospitalization), RHINORRHOEA (hospitalization), NASAL CONGESTION (hospitalization), ARTHRITIS (hospitalization), SWELLING (hospitalization) all with onset 31May2022, outcome "unknown" and all described as "symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling". Clinical course includes Reporter writing to report that his husband, (Name withheld), contracted COVID after receiving the Pfizer vaccine and booster. She does not have the dates available at this moment of the vaccinations. He was diagnosed 31May. Symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling. She did not report within 24 hours as an oversight due to his hospitalization at the same time with a staph infection that distracted me. She confirmed the date of awareness as 31May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; staph infection; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete, Pfizer vaccine and booster), for COVID-19 immunization.  The following information was reported: SUSPECTED COVID-19 (hospitalization) with onset 31May2022, outcome "unknown", described as "contracted COVID"; STAPHYLOCOCCAL INFECTION (hospitalization) with onset 31May2022, outcome "unknown", described as "staph infection"; COUGH (hospitalization), RHINORRHOEA (hospitalization), NASAL CONGESTION (hospitalization), ARTHRITIS (hospitalization), SWELLING (hospitalization) all with onset 31May2022, outcome "unknown" and all described as "symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling". Clinical course includes Reporter writing to report that his husband, (Name withheld), contracted COVID after receiving the Pfizer vaccine and booster. She does not have the dates available at this moment of the vaccinations. He was diagnosed 31May. Symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling. She did not report within 24 hours as an oversight due to his hospitalization at the same time with a staph infection that distracted me. She confirmed the date of awareness as 31May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had a positive PCR test; I had a positive PCR test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 at 12:00 as dose 1, single (Lot number: Er8737), on 26Apr2021 at 12:00 as dose 2, single (Lot number: Er970) and on 15Apr2022 at 19:00 as dose 4 (booster), single (Lot number: Fk9893) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 27Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 017f21a) for covid-19 immunisation. The patient had no relevant medical history. Patient did not receive other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "recovered" (2022) and all described as "I had a positive PCR test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: I had a positive PCR test and was prescribed Paxlovid; (2022) positive, notes: After starting Paxlovid my symptoms went away. However, I continued to test positive throughout the treatment and have continued to test positive now for 8 more days so far. I never tested negative during or after the treatment; (2022) positive, notes: I tested at day 3 of treatment (positive) and everyday since completing the pills. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started Paxlovid on 26May2022 and stopped on 30May2022 for the treatment of COVID-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: en6200), on 22Mar2021 as dose 2, single (Lot number: er8727), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Iodine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Negative, notes: Negative test after completing 5 day course of Paxlovid; (01Jun2022) Positive, notes: positive antigen test 7 days after the negative test; (05Jun2022) Positive, notes: a positive antigen test 11 days after the negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Negative test was performed after completing 5 day course of nirmatrelvir; ritonavir (PAXLOVID) followed by a positive antigen test 7 days after the negative test. and a positive antigen test 11 days after the negative test. Initial symptoms were mild while taking Paxlovid. There were no COVID symptoms when testing positive 7 through 11 days after the negative test and completion of the course of nirmatrelvir; ritonavir.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID breakthrough; COVID breakthrough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER2613), in Apr2021 as dose 2, single (Lot number: ER2613) and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01May2022, outcome "recovered", SUSPECTED COVID-19 (medically significant) with onset 01May2022, outcome "recovered" (2022) and all described as "COVID breakthrough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Clinical Course: The patient did have other vaccine in four weeks prior covid vaccine. The patient did not have covid prior vaccination.The patient tested for covid post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Incorrect route of product administration, Vaccination site haemorrhage
Clinical narrative: Vaccine injected into blood vessel with bleeding occurring; Vaccine injected into blood vessel with bleeding occurring; I felt dizzy and lightheaded during waiting period; I felt dizzy and lightheaded during waiting period; 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 64-year-old female patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), DIZZINESS (non-serious) all with onset 03Jun2022, outcome "unknown" and all described as "I felt dizzy and lightheaded during waiting period"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), VACCINATION SITE HAEMORRHAGE (non-serious) all with onset 03Jun2022, outcome "unknown" and all described as "Vaccine injected into blood vessel with bleeding occurring".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram, Renal disorder, Renal function test
Clinical narrative: kidney issue left side; 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 79-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 3), for COVID-19 immunisation. The following information was reported: RENAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "kidney issue left side". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood test, COVID-19, Drug ineffective, Globulin
Clinical narrative: kidney issue left side; 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 79-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 3), for COVID-19 immunisation. The following information was reported: RENAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "kidney issue left side". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Iron binding capacity total, Magnetic resonance imaging, Metabolic function test, Positron emission tomogram, Protein total
Clinical narrative: kidney issue left side; 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 79-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 3), for COVID-19 immunisation. The following information was reported: RENAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "kidney issue left side". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 test, Transferrin saturation
Clinical narrative: kidney issue left side; 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 79-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 3), for COVID-19 immunisation. The following information was reported: RENAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "kidney issue left side". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: all tested positive for Covid last week.  No hospitalizations resulted.; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 30May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 30May2022, outcome "unknown", described as "all tested positive for Covid last week.  No hospitalizations resulted.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: The first positive case was on 30May2022 for the oldest son.  Clinical course: Reporter reported that, his wife and all three of the children who were all fully vaccinated with Pfizer Covid vaccine all tested positive for Covid last week. No hospitalizations resulted. His wife was 46 years old and has had other medical issues. She was prescribed Paxlovid and reports a foul taste in her mouth after starting the initial does on 02Jun2022. The children are 11, 8 and 7 years old and had only received the initial two doses. The first positive case was on 30May2022 for the oldest son. The 8 year old tested positive on 01Jun2022. His wife tested positive on 01Jun. The seven year old tested positive on 04Jun  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication was received in 2 weeks. Covid rebound symptoms 4 days after completing treatment AND testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "AV Heart Block" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive; (Jun2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chills, Hypotension, Pain
Clinical narrative: Low blood pressure; difficulty, generalized weakness for several days; chills; body aches; 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 76-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "Low blood pressure"; ASTHENIA (non-serious), outcome "unknown", described as "difficulty, generalized weakness for several days"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 01Apr2021 as dose 2, single (Lot number: EN6208), in left arm and on 14Aug2021 as dose 3 (booster), single (Lot number: FA7485), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing); "shoulder surgery" (unspecified if ongoing), notes: Patient is recovering from rotator cuff bicep left shoulder surgery. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I did my treatment and I tested negative; Positive, notes: After they day treatment then had symptoms return after 8 days having treatment. And am positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient's age was reported as 65+ years. Patient received other medication in 2 weeks. Anti viral details for COVID-19 treatment included treatment start date was on 23May2022, treatment stop date was on 27May2022, lot number of product: 196905. Patient did treatment and tested negative after they day treatment then had symptoms return after 8 days having treatment, and patient is positive again.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL2247), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 17Aug2021 as dose 3 (booster), single (Lot number: EW0181) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2022 as dose 4 (booster), single (Lot number: 068H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; ROSUVASTATIN; TADALAFIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Unknown results, notes: Paxlovid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient had no known allergies. The patient received other medications in 2 weeks. On 23May2022, the patient received Paxlovid for treatment of COVID-19 and stopped on 28May2022.; 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 lack of efficacy  cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Nodule
Clinical narrative: bleeding; a new nude appeared on her husband's neck and clavicle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: her husband is a cancer patient. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization completed but manufacture unknown), for COVID-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding"; NODULE (non-serious), outcome "not recovered", described as "a new nude appeared on her husband's neck and clavicle". Therapeutic measures were taken as a result of nodule.  Clinical course: Reporter stated that her husband was a cancer patient. He got a booster shot last November. She stated that she saw on the news that the booster shot had some side effects on people with cancer, specifically around the neck and experiencing numbness. After that, she noticed that a new nude appeared on her husband's neck and clavicle. For this reason, he received aggressive chemotherapy for 3 weeks, and the nodes were reduced by half. But a few weeks later they noticed that it grew back with some bleeding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Information: Adverse event: Tired. Fever. Congestion. Positive COVID test. Anti viral details: product: COVID 19 Treatment  (Paxlovid), start date: 23May2022 and  stop date: 29May2022, indication was treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: test positive 25May2022; test positive 25May2022; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL;IPRATROPIUM other, start date: 14Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "test positive 25May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: home antigen test; (25May2022) Positive; (03Jun2022) Negative, notes: test at home. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies were reported. Other medication received in 2 weeks was Albuterol/Ipratropium via inhalation route. COVID symptom start date: 25May2022 test positive 25May2022 Paxlovid 25May2022 completed 5 days negative test at home 03Jun2022 recurrent symptoms 05Jun2022 with a positive home antigen test 05Jun2022. Treatment included Paxlovid via oral route from 25May2022 to 31May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 25Apr2021 as dose 2, single (Lot number: 045B12A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Symptom onset 20May2022. Treated with Paxlovid 23May-27. No symptoms on completion of treatment with negative antigen test 29May. Symptoms returned 02Jun with negative test daily until 06Jun. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Negative; (02Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (03Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (04Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (05Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (06Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid for treatment of COVID-19. Treatment start date: 23May2022. Treatment stop date: 27May2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.