chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: small blood clots all over lungs; D-Dimmer elevated; Tenderness and pain in left calf muscle; pain in left calf muscle; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Back surgery" (unspecified if ongoing), notes: had last year and nothing showed up on lab work at that time regarding blood clots or any issues. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, (Confirmed just received two doses)), for COVID-19 Immunization. The patient stated he never had issue blood clots whatsoever. Then, on 24Mar2023, the patient stated he had symptoms that seemed to be related to a DVT. He went to urgent care and was referred to the Emergency Room. They did a lot of test. Thought was almost came done, but then blood work came back. The marker D-dimmer, showed indicative of blood clots. Due to this elevated marker in blood results and this was the only thing elevated also had CT Scan. The CT Scan was done which showed small blood all over lungs.  Also, had genetic testing to see if pre-disposed to blood clots and none came back positive. He does not have any genetic component to it.  The patient had to do follow-up with primary care for more blood work. This was when they did the genetic testing component to see if it was positive and it was not. The patient later clarified the DVT symptoms experienced to be tenderness and pain in left calf muscle which started on 19Mar2023.  This feeling then subsided, but then they reemerged and by 24Mar2023 thought needed to go to urgent care. This tenderness and pain has gone away. It went away 28Mar2023. The events AE required visit to: Urgent Care, then referred to Emergency Room; had to have follow-up at Physician Office. The outcome of the events Tenderness and pain in left calf muscle was recovered in 28Mar2023; the outcome of the other events was unknown. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (24Mar2023) Unknown results, notes: Result: small blood clots all over lungs;  Unit: Not Provided; Fibrin D dimer: (24Mar2023) Elevated, notes: Unit: Not Provided. Therapeutic measures were taken as a result of pulmonary thrombosis which includes blood thinner, Xarelto 15mg for the next 21 days twice daily then dosage is escalated to 20mg after that, then assuming this will be the dose on for the remainder of the 3-6 months course.  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: Illness
Clinical narrative: sickly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "unknown", described as "sickly".  Additional Information: Reporter questioned regarding howfast the mRNA or spike protein is dissolved in the body and if the spike protein goes through the brain barrier. The responses provided regarding mechanism of action (as reported-MOA)  and no further specific information found. Reporter asked how long would it take to dissolve the vessel that carries the protein. Reporter was unsatisfied with "no information" responses. The reporter asked why was Pfizer COVID vaccine being recommend while people are dying. Her relatives were dying. Her husband became sickly since they got the vaccine and so why did she need to take it. Also reported that It was really suspicious and they were not giving her any information that was out there. She was not very happy with their  answers right now(as reported) and stated that it was killing people and said some kind of resistance had to be done. The reporter also asked about the contents of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 17:30 as dose 5 (booster), single (Lot number: GJ3274) at the age of 49 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EM9810), as dose 2, single (Lot number: EN6204), as dose 3 (booster), single (Lot number: FC3181) and on 08Jul2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Migraines" (unspecified if ongoing), notes: Migraines; "Epilepsy" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Tegretol, reaction(s): "Allergy_Tegretol"; Cephalasporin, reaction(s): "Allergy_Cephalasporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: relative died; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "relative died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter mentioned her 2 relatives died when they took the vaccine and her husband became sickly when he took the vaccine too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300061028 same reporter/vaccine/event, different patient;; Reported Cause(s) of Death: relative died
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sickly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A male patient received BNT162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "unknown", described as "sickly".  Additional Information: Reporter questioned why was Pfizer COVID-19 vaccine  being recommended while people are dying and what was the content of the vaccine and her husband became sickly when he took the vaccine too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300141645 same reporter, different patient/ event.;US-PFIZER INC-PV202300061028 same reporter, different patient/ event.;
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain, Rash erythematous
Clinical narrative: broke out with reaction under her eye / each day it was getting redder and redder / because of the rash the doctor prescribed a cream; and got cream under her eye; the whole white of that eye was bloody red; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "on BP medication" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "broke out with reaction under her eye / each day it was getting redder and redder / because of the rash the doctor prescribed a cream; and got cream under her eye"; OCULAR HYPERAEMIA (non-serious), outcome "recovered", described as "the whole white of that eye was bloody red"; PAIN (non-serious), outcome "unknown". The events "broke out with reaction under her eye / each day it was getting redder and redder / because of the rash the doctor prescribed a cream; and got cream under her eye" and "the whole white of that eye was bloody red" required physician office visit. Therapeutic measures were taken as a result of rash erythematous, ocular hyperaemia, pain. Additional information: Reporter stated her sister (patient) got Pfizer Covid booster and shots and broke out with reaction under her eye and the whole white of that eye was bloody red. Her sister did not go to the doctor and got 2-3 more boosters. Caller stated she found that out 2 days prior to her getting her vaccines which was why she chose not to get Pfizer product (for the reporter herself). Caller stated patient told her she got maybe 3-4 since this all came out; she thought more like 3. Reporter just found this out because reporter was going for a shot from another company. Reporter had a reaction and wanted to make note but she won't give her name. The very first Pfizer Covid vaccine the patient ever got, that was when it all started (as reported). Within a couple days, patient broke out under her eye and each day it was getting redder and redder. Her husband was really concerned. It's gone now. Reporter doesn't know how long it took to go away. Patient doesn't take as many concomitant medications, she's on BP medication and vitamin supplements she has always taken; has been on before vaccines. No testing. Because of the rash, the doctor prescribed a cream and patient went to the ophthalmologist and got cream under her eye for the same eye, guessed it was just one eye, not both and got steroid eye drops. Reporter thought it was the left eye but was not sure. It was also reported that the previous nurse was going to connect the patient with pain patches that Pfizer doesn't make anymore, Flector pain patches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 2 relatives died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer ).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "2 relatives died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: The reporter asked why Pfizer COVID-19 vaccine was being recommended while people were dying and what was the content of the vaccine. The reporter then mentioned that her 2 relatives died when they took the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300141693 same reporter, drug, and event; different patient;; Reported Cause(s) of Death: 2 relatives died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 2 relatives died; This is a spontaneous report received from a non-contactable reporter (consumer).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "2 relatives died". The date and cause of death for the patient were unknown. It was unknown if an autopsy was performed. Clinical course: The reporter asked why Pfizer COVID-19 vaccine was being recommended while people were dying and what was the content of the vaccine. The reporter then mentioned that her 2 relatives died when they took the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300141692 same reporter, drug, and event; different patient;; Reported Cause(s) of Death: 2 relatives died
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Secondary immunodeficiency
Clinical narrative: tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines.; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (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: 01), for COVID-19 immunization; Bnt162b2 (Dose: 02), for COVID-19 immunization. The following information was reported: SECONDARY IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines.". The patient underwent the following laboratory tests and procedures: secondary immune deficiencies/secondary immune: Positive, notes: 3 patients have tested positive for secondary immune deficiencies. Therapeutic measures were taken as a result of secondary immunodeficiency.  Additional information: 3 patients have tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines. All have been diagnosed and started on IVIG. Patients were not treated with any biologics prior to testing positive for secondary immune deficiency.  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 limited information provided, the Company (Pfizer) cannot completely excluded that the suspect medication may have contributed to the reported event secondary immune deficiencies  in this patient. Additional information regarding onset dates of drug administration/ events, relevant medical history, underlying conditions, concomitant medications will aid in the comprehensive assessment of the case. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300061072 same reporter/drug/event, diff patients;US-PFIZER INC-202300141698 same reporter/drug/event, diff patients;
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 3; Moderna Dose Number: 2, Moderna Dose Number: 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 54 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Apr2021 as dose 2, single (Lot number: 001C21A) for covid-19 immunisation. The patient's relevant medical history included: "A fib" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Nov2021, outcome "unknown", described as "Pfizer / BioNTech: Dose Number: 3; Moderna Dose Number: 2, Moderna Dose Number: 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid (COVID 19 Treatment) from 20Mar2023 to 24Mar2023.
Age: 32.0
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 non-contactable reporter (Consumer). The reporter is the patient. A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: gh9702) at the age of 32 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood cancer" (unspecified if ongoing), notes: blood cancer age 11; "Chemo" (unspecified if ongoing), notes: Chemo; "Radiation to chest" (unspecified if ongoing), notes: Radiation to chest; "Thyroidectomy" (unspecified if ongoing), notes: at age 24; "Papillary carcinoma" (unspecified if ongoing), notes: papillary carcinoma age 24.  The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive.  Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8734), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 31Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test Saturday. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 64.0
Sex: F
Vaccine: 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 (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 64 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208), on 08Apr2021 as dose 2, single (Lot number: ER8737), on 03Nov2021 as dose 3 (booster), single (Lot number: FH8028) and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9894) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 22Mar2023 to 26Mar2023.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 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: "Multiple Sclerosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 15Mar2023 to 19Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand other: Janssen, vaccine dose number: 1; vaccine brand: Pfizer / BioNTech; 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 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 12:30 as dose 3 (booster), single (Lot number: GJ5342) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 16Dec2021 at 11:00 as dose 2 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 at 15:00 as dose 1, single (Lot number: 042A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "known allergies: walnuts/hazelnuts" (unspecified if ongoing); "known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin"; Lidocaine, reaction(s): "known allergies: possible allergy to lidocaine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other: Janssen, vaccine dose number: 1; vaccine brand: Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID..
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Vaccine brand other=Mixed Moderna/Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other=Mixed Moderna/Pfizer". Vaccine brand was reported as Mixed Moderna/Pfizer, Vaccine dose number was 5. Therapeutic measures were taken as a result of COVID 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "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.
Age: 37.0
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 contactable reporter (Consumer). The reporter is the patient. A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 19:00 as dose 4 (booster), single (Lot number: CUS9602) at the age of 37 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 was not reported. Concomitant medication included: SERTRALINE, start date: 09Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; positive, notes: Took a Covid test Friday night and the positive mark showed up and was at about 50% opacity compared to a full blown positive test.   Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Other/Vaccine brand other=Moderna/Vaccine administration date=29Oct2021/Vaccine dose number=3; This is a spontaneous report received from 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 13Mar2021 as dose 1, single (Lot number: EP7534), in left arm and on 03Apr2021 as dose 2, single (Lot number: EW0150) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 as dose 3 (booster), single (Lot number: 051F21A), in left arm and on 13Jul2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Oct2021, outcome "unknown", described as "Vaccine brand=Other/Vaccine brand other=Moderna/Vaccine administration date=29Oct2021/Vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: after five days of being symptom free and testing negative; (30Mar2023) Positive, notes: Testing positive four days in a row (so far); (31Mar2023) Positive, notes: Testing positive four days in a row (so far); (01Apr2023) Positive, notes: Testing positive four days in a row (so far); (02Apr2023) Positive, notes: Testing positive four days in a row (so far). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Mar2023 to 25Mar2023. The patient had no known allergies.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right 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: "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Mar2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99 degree; SARS-CoV-2 test: (28Mar2023) Negative; (30Mar2023) Positive; (01Apr2023) Positive, notes: Today is April 1, and I  am still positive (very dark line). Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
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), on 11Feb2021 as dose number unknown, single (Lot number: EN6021) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing); "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
Age: 64.0
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) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 64 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 22Mar2023. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 1-4: MODERNA; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown), on 12Nov2021 as dose 3 (booster), single (Lot number: 066F21A) and on 12Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "HI CHOLESTEROL" (unspecified if ongoing); "Gerd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Dose Number: 1-4: MODERNA"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (31Mar2023) Negative, notes: Tested negative on 31Mar2023; (01Apr2023) Positive, notes: 0n 01Apr2023 had Headache and Rhinorrhea and tested Positive. Therapeutic measures, Paxlovid was taken from 23Mar2023 to 27Mar2023, were taken as a result of drug ineffective, covid-19.
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 non-contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "breast cancer in remission" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Mar2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 22Mar2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Age: 34.0
Sex: M
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 (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 34 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: "GERD" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test: (unspecified date) Positive; (2023) Negative, notes: feeling fine after finishing Paxlovid; (2023) Positive, notes: positive again. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 24Mar2023 to 28Mar2023.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 at 13:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Asthma" (unspecified if ongoing); "pcos" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "adhd" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Mangos, kiwi, aguacate" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: 12Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Mar2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 at 10:00 as dose 1, single (Lot number: EL9261), in left arm and on 16Feb2021 at 10:00 as dose 2, single (Lot number: EN6201), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: other medical history: hypothyroidism. Concomitant medication(s) included: LEVOTHYROXIN. The following information was reported: VACCINATION FAILURE (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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. 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; 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 32-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 22Mar2023 to 27Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 01:15 as dose 5 (booster), single (Lot number: GJ5342) at the age of 79 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 at 14:30 as dose 1, single (Lot number: EL2963), in right arm, on 23Feb2021 at 14:30 as dose 2, single (Lot number: EN6201), in right arm, on 31Oct2021 at 13:15 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 31May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 19Mar2023 to 24Mar2023.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Hot flush, Pyrexia, Seasonal allergy, Vaccination site haemorrhage
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Feb2023 as dose number unknown (booster), single (Lot number: GJ6743) 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 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 "I have COVID".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Feb2023 as dose number unknown (booster), single (Lot number: GJ6743) 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 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 "I have COVID".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Feb2023 as dose number unknown (booster), single (Lot number: GJ6743) 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 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 "I have COVID".  No follow-up attempts are possible. No further information is expected.