chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "recovering" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received no other medication within 2 weeks of vaccination and had no known allergies. She was suffering from minor COVID symptoms like sore throat and headache.  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: Blood disorder, Blood product transfusion dependent, Platelet count, Platelet disorder, Red blood cell count
Clinical narrative: blood transfusion approx every 30 days; Four days after receiving the COVID vaccination my mother was diagnosed with a rare blood disorder; Her white blood cells, red cells, and platelets are were all messed up; Her white blood cells, red cells, and platelets are were all messed up; Her white blood cells, red cells, and platelets are were all messed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRODUCT TRANSFUSION DEPENDENT (hospitalization), outcome "unknown", described as "blood transfusion approx every 30 days"; BLOOD DISORDER (medically significant), outcome "unknown", described as "Four days after receiving the COVID vaccination my mother was diagnosed with a rare blood disorder"; WHITE BLOOD CELL COUNT ABNORMAL (non-serious), RED BLOOD CELL COUNT ABNORMAL (non-serious), PLATELET DISORDER (non-serious), outcome "unknown" and all described as "Her white blood cells, red cells, and platelets are were all messed up". The patient underwent the following laboratory tests and procedures: Platelet count: all messed up; Red blood cell count: all messed up; White blood cell count: all messed up. Therapeutic measures were taken as a result of blood product transfusion dependent, blood disorder, white blood cell count abnormal, red blood cell count abnormal, platelet disorder.  Additional Information: Four days after receiving the COVID vaccination mother was diagnosed with a rare blood disorder. Her white blood cells, red cells, and platelets were all messed up. It had been a year and a half, and she received a blood transfusion approx every 30 days, in addition to now Promacta. The Promacta prescribed was 150mg daily. That was a retail value of very expensive a month. Prior to 2022 she was receiving a shot in her stomach once a week and billed lots of money per shot.   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: Red blood cell count abnormal, White blood cell count, White blood cell count abnormal
Clinical narrative: blood transfusion approx every 30 days; Four days after receiving the COVID vaccination my mother was diagnosed with a rare blood disorder; Her white blood cells, red cells, and platelets are were all messed up; Her white blood cells, red cells, and platelets are were all messed up; Her white blood cells, red cells, and platelets are were all messed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRODUCT TRANSFUSION DEPENDENT (hospitalization), outcome "unknown", described as "blood transfusion approx every 30 days"; BLOOD DISORDER (medically significant), outcome "unknown", described as "Four days after receiving the COVID vaccination my mother was diagnosed with a rare blood disorder"; WHITE BLOOD CELL COUNT ABNORMAL (non-serious), RED BLOOD CELL COUNT ABNORMAL (non-serious), PLATELET DISORDER (non-serious), outcome "unknown" and all described as "Her white blood cells, red cells, and platelets are were all messed up". The patient underwent the following laboratory tests and procedures: Platelet count: all messed up; Red blood cell count: all messed up; White blood cell count: all messed up. Therapeutic measures were taken as a result of blood product transfusion dependent, blood disorder, white blood cell count abnormal, red blood cell count abnormal, platelet disorder.  Additional Information: Four days after receiving the COVID vaccination mother was diagnosed with a rare blood disorder. Her white blood cells, red cells, and platelets were all messed up. It had been a year and a half, and she received a blood transfusion approx every 30 days, in addition to now Promacta. The Promacta prescribed was 150mg daily. That was a retail value of very expensive a month. Prior to 2022 she was receiving a shot in her stomach once a week and billed lots of money per shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DYMISTA, stop date: 13May2022. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (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: (25May2022) Positive. Therapeutic measures were taken as a result of covid-19. Patient received "Paxlovid" to treat covid-19. Treatment start date: 13May2022, treatment stop date: 18May2022.
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no Known allergies. There were no concomitant medications/No other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive, notes: still testing positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event: Covid symptoms came back a couple days after completing the paxlovid medication and still testing positive for Covid.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 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: "Coronary artery disease" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. Patient did not received any other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history was not reported. Concomitant medication(s) included: CETIRIZINE, start date: 13May2022; FLONASE [FLUTICASONE PROPIONATE], start date: 13May2022. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin"; Cipro, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) positive, notes: 11 days after initial positive test; (27May2022) positive, notes: Rebound Covid infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: My COVID symptoms have returned after I completed my first dose; My COVID symptoms have returned after I completed my first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "My COVID symptoms have returned after I completed my first dose".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Eye disorder, Facial paralysis, Lacrimation increased
Clinical narrative: Facial paralysis right side of face; soreness behind right ear; watery eye; difficulty closing right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF259U) and as dose 4 (booster), single (Lot number: FM7553) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergie: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "Facial paralysis right side of face"; EYE DISORDER (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "difficulty closing right eye"; EAR PAIN (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "soreness behind right ear"; LACRIMATION INCREASED (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "watery eye". Therapeutic measures were not taken as a result of facial paralysis, ear pain, lacrimation increased, eye disorder.  Clinical course: Most recent dose details: product=COVID 19, Brand: Pfizer, Vaccine, lot Number=FM7553, Administration date=23May2022,Administration Time: 09:30 AM, Dose number=4,vaccine location=Right arm. Other vaccine same date details: lot number=FF259U,same date vaccine date=23May2022,Same date dose number=3,Facility type vaccine: Public Health Clinic/Military Administration facility. If other vaccine in four weeks: No. If covid prior vaccination: No. if covid tested post vaccination: No.  No follow up attempts are needed. No Further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid test after negative Covid test (rebound); Positive Covid test after negative Covid test (rebound); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "not recovered" and all described as "Positive Covid test after negative Covid test (rebound)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Positive COVID test after negative, COVID test (rebound); (May2022) Negative, notes: Positive COVID test after negative, COVID test (rebound). Therapeutic measures were taken as a result of covid-19.  Clinical course: Anti viral details, product: COVID 19 Treatment, treatment start date: 20May2022, treatment stop date: 25May2022, indication: Treatment of COVID-19 (as reported). Adverse event: Positive Covid test after negative Covid test (rebound), adverse event start date: 30May2022, if patient recovered: Not recovered, if treatment ae: No (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Apr2021 at 12:00 as dose 4 (booster), single (Lot number: fj9943) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "High blood pressure, controlled" (unspecified if ongoing), notes: High blood pressure, controlled; "arthritis" (unspecified if ongoing); "High blood pressure, controlled" (unspecified if ongoing), notes: High blood pressure, controlled. The patient's concomitant medications were not reported. Past drug history included: Thiomersal, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer remission" (unspecified if ongoing), notes: Prostate cancer remission; "heart valve replacement" (unspecified if ongoing); "aorta repair" (unspecified if ongoing), notes: aorta repair; "Vaccine dose number=3, 2,1 Pfizer, Vaccine dose number=4 Moderna" (unspecified if ongoing), notes: Vaccine dose number=3, 2,1 Pfizer, Vaccine dose number=4 Moderna. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 11Apr2022 at 13:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 11Apr2022 at 13:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive antigen test/Treatment of COVID-19; positive antigen test/Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "positive antigen test/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Negative antigen for day then on day 10 running nose and positive antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: The only thing I have done differently is taken 3 Covid vaccines from Pfizer. I think the vaccine stopped the itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "I have suffered severe itching with every bite" (unspecified if ongoing), notes: I live in (State withheld) where mosquitoes are terrible and I have suffered severe itching with every bite; "I have suffered severe itching with every bite" (unspecified if ongoing), notes: I live in (State withheld) where mosquitoes are terrible and I have suffered severe itching with every bite. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The only thing I have done differently is taken 3 Covid vaccines from Pfizer. I think the vaccine stopped the itching".  Additional information: It was reported that the patient has something strange that has happened to me for the first time in my life! My mosquito bites do not itch anymore. I live in (State withheld) where mosquitoes are terrible and I have suffered severe itching with every bite. I! am 65 years old and my bites do not itch The only thing I have done differently is taken 3 Covid vaccines from Pfizer. I think the vaccine stopped the itching!  No Follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Jan2020, stop date: 17May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Recurrence of symptoms of sore throat and dry cough. Paxlovid was used as treatment for covid 19. The Hospitalization was not Prolonged. The patient did not received treatment. AE resulted in None of the above. The patient had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Positive; COVID-19 Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), on 18Mar2021 as dose 2, single (Lot number: EN6204) and on 25Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 as dose 4 (booster), single (Lot number: 48L21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ; SINGULAIR; ATORVASTATIN; ESTRADIOL AND NORETHINDRONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID-19 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid treatment received from 17May2022 to 22May2022 for the treatment of covid-19.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Booster; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: El9264), in left arm, on 29Jul2021 as dose 2, single (Lot number: EL9269), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 18Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Cipro allergy" (unspecified if ongoing), notes: Known allergies: Cipro; "Cod allergy" (unspecified if ongoing), notes: Known allergies: Cod; "String Beans allergy" (unspecified if ongoing), notes: Known allergies: String Beans; "Animal Dander allergy" (unspecified if ongoing), notes: Known allergies: Animal Dander. Concomitant medication(s) included: LIOTHYRONINE SOD.; LISINOPRIL; CALCIUM; FISH OIL; VITAMIN D3; VIT B12; L-THYROXINE [LEVOTHYROXINE]. The following information was reported: IMMUNISATION (medically significant) with onset 18Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 18Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: tested positive again two days later; (May2022) Positive, notes: testing positive since with increasingly severe symptoms. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical Course previously Paxlovid was taken for covid-19 and  recovered after taking Paxlovid, then tested positive again two days later and have been testing positive since with increasingly severe symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Took a COVID PCR test and was positive; Took a COVID PCR test and was positive; Chills; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 58-year-old female patient received BNT162b2 (COMIRNATY), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Took a COVID PCR test and was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Positive. Clinical information: I will see if I can obtain lot number and expiration date within the next few days. In Dec2021 the patient experienced chills and then took a COVID PCR test and was positive.  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, a possible contributory role of the suspect drug BNT162b2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Jan2021 as dose 1, single (Batch/Lot number: unknown), on 02Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery for bicuspid aortic valve replacement" (unspecified if ongoing); "hypertrophic cardiomyopathy" (unspecified if ongoing); "pacemaker/difibrillator" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN. The following information was reported: DRUG INEFFECTIVE (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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 04May2021 as dose 2, single (Lot number: EW0169), in left arm and on 15Jan2022 as dose 3 [booster], single (Lot number: FJ8757) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Rebound COVID starting 2 days after completion of Paxlovid, with different symptoms (sore throat and fever originally and nasal congestion on the rebound case).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications (reported as patient received other medications in two weeks of starting COVID-19 treatment). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 19May2022 and stopped on 24May2022. Clinical course was reported as, Covid symptoms rebound 5 days from last paxlovid dose on 28May2022. No treatment received for symptoms and patient was recovering from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), on 23Mar2021 as dose 2, single (Lot number: EN6206) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient did not receive any other medications in 2 weeks. Adverse event: Flu-like symptoms. Cough, sneezing and headache. There was no treatment for AE.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EP7533), in left arm and on 04May2021 as dose 2, single (Lot number: EN6198) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 03Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; PHENTERMINE; ALLEGRA. Patient received the vaccine. Patient received the other medication in 2weeks included duloxetine, phentermine and allegra. No known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (23May2022) Negative, notes: tested negative on day 5 after taking paxlovid; (27May2022) positive, notes: Tested positive for covid on day 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event Covid Rebound after Paxlovid. Tested negative on day 5 after taking Paxlovid. Tested positive for covid on day 9 with symptoms including Congestion, sore throat and sinus pain. Anti-viral details: COVID 19 Treatment, Paxlovid, treatment start date was 18May2022 and treatment stop date was 22May2022.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer which was successfully treated." (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "not recovered" and all described as "I did not feel well, and took a Covid home rapid test 21May2022 that came out Positive/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) positive, notes: home rapid test 21May2022 that came out Positive; (28May2022) negative, notes: took a rapid home test 28May2022 that came out Negative; (30May2022) positive, notes: Two days later, took another rapid home test that came out Positive; (30May2022) positive, notes: today when I tested Positive again. Therapeutic measures were taken as a result of Covid-19 included Paxlovid from 21May2022 to 26May2022. Clinical course: The patient did not receive any other vaccines in 2 weeks or other medication in 2 weeks. Patient had no known allergies. The patient did not feel well, and took a Covid home rapid test 21May2022 that came out Positive. Doctor had prescribed Paxlovid that was delivered to patient within 3 hours. Took first dose (3 pills) at 5:00 pm that day. Continued taking Paxlovid for the 5 days. Final dose was 8:30 am 26May2022. Felt better, patient took a rapid home test 28May2022 that came out Negative. Two days later, took another rapid home test that came out Positive. That day (today) patient was not feeling well. None of the symptoms were extreme or severe even on the first day when patient began the Paxlovid treatment or today when patient tested Positive again. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 69-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 09May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Took Paxlovid beginning the day after testing positive; (23May2022) Positive, notes: Tested again on Days 11, 12, 13; all were positive; (24May2022) Positive, notes: Tested again on Days 11, 12, 13; all were positive; (25May2022) Positive, notes: Tested again on Days 11, 12, 13; all were positive; (28May2022) Positive, notes: On Day 15, symptoms returned with a lot of nasal congestion, cough, muscle aches and fatigue No fever as with initial diagnosis, but felt badly. Test on Day 16-positive result, strong like initial diagnosis. Therapeutic measures were taken as a result of covid-19.  Clinical course: Took Paxlovid beginning the day after testing positive. Symptoms improved beginning with the second day and continued to improve. Tested again on Days 11, 12, 13; all were positive, but second line was faint as opposed to dark on the initial testing. Doctor advised that I could test positive for a while, and to stop testing and said I was not considered contagious. On Day 15, symptoms returned with a lot of nasal congestion, cough, muscle aches and fatigue. No fever as with initial diagnosis, but felt badly. Test on Day 16-positive result, strong like initial diagnosis. Contacted doctor and spoke with triage nurse. She thought this was most likely a continuation of the initial infection and not a new infection, and that according to CDC guidelines, I was not considered contagious. But that I should mask and avoid being around others considered vulnerable. My wife and I decided I should isolate again. I am on Day 4 of that and beginning to feel some relief of the symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200779934 Same reporter/patient, different drug/events
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. Concomitant medication(s) included: ATORVASTATIN; LOSARTAN; LORAZEPAM; TRULICITY; ASPIRIN [ACETYLSALICYLIC ACID]; JARDIANCE and also reported as, other medications/products within 2 weeks.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 from 21May2022 to 23May2022.   Clinical course was reported as, The patient had to discontinue Paxlovid after dose five (day three, first dose) because severe severe nausea, vomiting on 23May2022. It worked very well up to then-COVID symptoms decreased greatly-but rebounded a bit after discontinuation, mainly as congestion at that point. Vaccine lot was not available/provided to reporter at the time of report completion. Patient was recovered from symptoms on 24May2022 and no treatment received for symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, 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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FE8839) at the age of 58 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: "myotonic muscular dystrophy" (unspecified if ongoing), notes: other medical history: myotonic muscular dystrophy; "myotonic muscular dystrophy" (unspecified if ongoing), notes: other medical history: myotonic muscular dystrophy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 18May2022 and stop date: 23May2022, indication is used for treatment of COVID-19, Administrator route: Oral. The patient did not receive other medication in 2 weeks. The patient had Known allergies to NKDA. Adverse event experienced on 24May2022 and stop date on 27May2022. Rebound positive age test after testing negative after she took the course of Paxlovid. Mild s/s mainly a "raspy" voice. The patient did not receive treatment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.