chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
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 71-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm 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: "Hypertension" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "Glaucoma" (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient had received Anti-viral medication (Paxloid) as COVID 19 treatment and the treatment was started on 23Jun2022 and stopped on 28Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02May2021 as dose 1, single (Lot number: 012A21A), in right arm, on 31May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 013F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Possible Sjögren's" (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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Treatment of COVID-19; (28Jun2022) Positive, notes: Retested Positive on 3rd day after treatment symptoms worsened. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The case was considered non -Serious. The patient received COVID treatment. Other medication in 2 weeks: Unknown. Anti-viral details: product for COVID 19 Treatment, Brand was Pfizer, treatment start date: 21Jun2022, treatment stop date: 25Jun2022, Indication: Treatment of COVID-19. Reported Event: Took 5 days dose of Paxlovid beginning 21Jun2022. Felt better for 2/3 days. Retested Positive on 3rd day after treatment symptoms worsened. The patient now at 4Jul2022, still sick and symptomatic. Adverse events start date 19Jun2022. Ae resulted in [None of the above]. The patient was Recovering. Treatment ae: Yes. AE treatment Prednisone 20mg, Amoxicillin 125mg, OTC meds.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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 had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid. Clinical course: Paxlovid rebound infection. Tested negative on rapid home test day 5 (same day completed paxlovid). On day 10/11 started feeling symptomatic again - congestion, cough, headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
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.  A 71-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 08Jan2021 as dose 1, single (Lot number: EL 3246), in left arm, on 29Jan2021 as dose 2, single (Lot number: EL 8982), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neopsporin, reaction: "Allergy"; Bicitracin, reaction: "allergy"; Polysporin, reaction: "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphoedema, Nausea
Clinical narrative: Chills; Headache; Nausea; I have Lymphedema that's acting up and it's never acted for like 20 years; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lymphedema" (ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 2022, outcome "unknown"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; LYMPHOEDEMA (non-serious) with onset 2022, outcome "unknown", described as "I have Lymphedema that's acting up and it's never acted for like 20 years"; NAUSEA (non-serious) with onset 2022, outcome "unknown".  Additional information: The patient reported of having the 2nd booster about, on the 26th, which was like 9 days ago and my body is feeling like, I have chills and headache and nausea and also, I have Lymphedema that's acting up and it's never acted for like 20 years. So are those possible things to that might happen when I have this vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, 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 62-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8732), in right arm, on 30Apr2021 as dose 2, single (Lot number: EW0171), in right arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DVT" (unspecified if ongoing); "PE" (unspecified if ongoing); "moderate high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ROBAXIN, start date: 27Jun2022; TYLENOL, start date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Anti-viral details, product COVID 19 treatment, Paxlovid, treatment start date 25Jun2022, treatment stop date (29Jun2022), lot number (GC0529), indication treatment of COVID-19, off (metallic) taste mild sore throat and runny nose symptoms resumed on Mon, 04Jul, If patient not recovered, if treatment ae: no, known allergies: none.
Age: 38.0
Sex: M
Vaccine: 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 39-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.   Clinical course: Patient received other medications within 2 weeks of vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Nausea, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; slight nausea; sick; hives covering back neck and forehead; 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 01Jul2022 at 17:00 as dose 3 (booster), single (Lot number: J4991) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Thyroid" (unspecified if ongoing), notes: Thyroid; "HRT" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: yes. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: BNT162b2 (Dose Number: 2 , Batch/Lot No: EW0170 , Location of injection: Arm Left), administration date: 08May2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "lips and outer mouth area were very numb", "lips and outer mouth area were very numb"; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0170 , Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "lips and outer mouth area were very numb", "lips and outer mouth area were very numb". The following information was reported: PAIN (non-serious) with onset 01Jul2022, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 01Jul2022, outcome "recovering"; PYREXIA (non-serious) with onset 01Jul2022, outcome "recovering", described as "fever"; URTICARIA (non-serious) with onset 01Jul2022, outcome "recovering", described as "hives covering back neck and forehead"; ILLNESS (non-serious) with onset 01Jul2022, outcome "recovering", described as "sick"; NAUSEA (non-serious) with onset 01Jul2022, outcome "recovering", described as "slight nausea". Therapeutic measures were taken as a result of pyrexia, chills, pain, nausea, illness, urticaria.  Additional Information: Dose #1 and 2: My lips and outer mouth area were very numb for about an hour after receiving the vaccine. Dose #3: That evening I had a fever chills body aches slight nausea. Was sick for about 24 hours. Then began hives covering back neck and forehead. Took Benadryl and Tylenol for relief. Patient received other medication in 2weeks. no any other vaccine in four weeks: other medications in two weeks for HRT and Thyroid Medications. No any treatment ae. Patient was not tested COVID post vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: fever; chills; body aches; slight nausea; sick; hives covering back neck and forehead; 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 01Jul2022 at 17:00 as dose 3 (booster), single (Lot number: J4991) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Thyroid" (unspecified if ongoing), notes: Thyroid; "HRT" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: yes. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: BNT162b2 (Dose Number: 2 , Batch/Lot No: EW0170 , Location of injection: Arm Left), administration date: 08May2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "lips and outer mouth area were very numb", "lips and outer mouth area were very numb"; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0170 , Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "lips and outer mouth area were very numb", "lips and outer mouth area were very numb". The following information was reported: PAIN (non-serious) with onset 01Jul2022, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 01Jul2022, outcome "recovering"; PYREXIA (non-serious) with onset 01Jul2022, outcome "recovering", described as "fever"; URTICARIA (non-serious) with onset 01Jul2022, outcome "recovering", described as "hives covering back neck and forehead"; ILLNESS (non-serious) with onset 01Jul2022, outcome "recovering", described as "sick"; NAUSEA (non-serious) with onset 01Jul2022, outcome "recovering", described as "slight nausea". Therapeutic measures were taken as a result of pyrexia, chills, pain, nausea, illness, urticaria.  Additional Information: Dose #1 and 2: My lips and outer mouth area were very numb for about an hour after receiving the vaccine. Dose #3: That evening I had a fever chills body aches slight nausea. Was sick for about 24 hours. Then began hives covering back neck and forehead. Took Benadryl and Tylenol for relief. Patient received other medication in 2weeks. no any other vaccine in four weeks: other medications in two weeks for HRT and Thyroid Medications. No any treatment ae. Patient was not tested COVID post vaccination.
Age: 44.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 29Apr2021 as dose 2, single (Lot number: EW1075), in right arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Severe sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE PROPIONATE. 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: (2022) Negative, notes: Tested negative on days 6,7,8; (2022) Positive, notes: Tested positive on days 9, 10. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 66.0
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) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 66 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: "hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details includes on 22Jun2022, the patient received COVID 19 treatment with Paxlovid via oral route of administration till 27Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 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: "thalessemia minor" (unspecified if ongoing), notes: thalessemia minor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative 4 days when done then tested positive; (May2022) Positive, notes: Tested negative 4 days when done then tested 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-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 included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks: Yes. Anti viral details: [product=COVID 19 Treatment, brand=Pfizer, treatment start date=23Jun2022, treatment stop date=27Jun2022, indication=Treatment of COVID-19]. Patient was tested negative at conclusion of antiviral. 4 days later symptoms returned and began testing positive again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FD7218) at the age of 58 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: "Low thyroid" (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: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Therapeutic measures were taken as a result of events with Paxlovid.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Treatment product Paxlovid, for indication treatment of COVID-19. Clinical information: The patient was previously received a COVID-19 Vaccine. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: Yes. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6208), on 09Apr2021 as dose 2, single (Lot number: EP7533), on 27Nov2021 as dose 3 (booster), single (Lot number: FJ1620) and on 23May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN; PROGESTERONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Positive, notes: tested positive for Covid (rapid test). Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information expected.
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 55-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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: "RA" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "GI" (unspecified if ongoing); "IBS" (unspecified if ongoing); "SIBO" (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 Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment of Paxlovid started on 29JUN2022 and stopped on 04JUL2022 and had event of awful bitter taste in mouth all day long (bitter grapefruit and soap).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: I can't always taste salt, sometimes I can smell the food but can't taste what I smell. Coffee is a toss up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Feb2022 as dose 3 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, EW0162), administration date: 13Apr2021, for Covid-19 Immunization, reaction(s): "lost my sense of taste and smell"; BNT162b2 (Dose 2, EE0169), administration date: 04May2021, for Covid-19 Immunization, reaction(s): "sense of smell and taste has never returned". The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "I can't always taste salt, sometimes I can smell the food but can't taste what I smell. Coffee is a toss up".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200926528 same reporter/patient, different dose, similar event;US-PFIZER INC-PV202200016058 same reporter/patient, different dose, similar event;
Age: 34.0
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) (Pharmacist). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 3203080) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "depression" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR, start date: 01Sep2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Patient received other medication in 2 weeks. Patient received Paxlovid from 23Jun2022 to 27Jun2022 for treatment of COVID-19. Adverse event 4 days after completion of 5 day Paxlovid course, patient experienced a positive rapid test, 101.2 fever, cough, congestion, runny nose, and fatigue all over again (experienced this from 22Jun-24Jun as well when patient was initially positive for COVID 19).; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 61-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil", notes: Known allergies: Cefzil; Percoset, reaction(s): "Known allergies: percoset". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Anti-viral details: Product COVID-19 Treatment, brand Paxlovid, on 23Jun2022 treatment started, treatment stop date was 27Jun2022. Rebound of symptoms 3 days after negative test.  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, 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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2022 at 13:00 as dose 3 (booster), single (Lot number: 33036BD) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, 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. Clinical Information:Patient took Paxlovid for COVID 19 treatment from 21Jun2022 to 26Jun2022. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Previously patient had received a COVID-19 Vaccine. COVID rebound 3 days after final dose of Paxlovid. Cough, congestion, severe headache, fatigue. Relatedness of drug to reaction(s)/event(s): COVID-19, SARS-CoV-2 PCR test positive: Source of assessment: RA Result of Assessment: D. Unclassifiable.
Age: 47.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "4 torn arteries - carotid and vertebral", start date: 2015 (unspecified if ongoing), notes: 4 torn arteries - carotid and vertebral in 2015. Stroke in recovery after stent inserted in 2015.; "Stroke in recovery after stent inserted", start date: 2015 (unspecified if ongoing), notes: 4 torn arteries - carotid and vertebral in 2015. Stroke in recovery after stent inserted in 2015.; "Known allergies: Sulphur meds" (unspecified if ongoing), notes: Known allergies: Sulphur meds. Concomitant medication(s) included: PLAVIX, start date: 01Nov2015; EMGALITY [GALCANEZUMAB], start date: 01Jul2020.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Took Paxlovid for 5 days and after 5 days tested negative; (2022) positive, notes: 11 days after finishing Plaxlovid I tested positive; (2022) positive, notes: Next day tested positive with home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Took Paxlovid for 5 days and after 5 days tested negative. Travelled to withheld and day the patient returned the patient started to feel sick - very tired headache sore throat and high temp. Next day tested positive with home test. 11 days after finishing Paxlovid the patient tested positive. The patient's husband also had COVID first time and took paxlovid but has not tested positive with the patient the second time. The husband did not travel with the patient to withheld. The patient have severe chest pain and burning and very tired with sore throat and high temp. The patient don't have a cough that time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
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 76-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jun2022, 7 days 8 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 26Jun2022 to 30Jun2022. Clinical course: Other medication in 2 weeks included nasal spray for allergy in Jun2022. The case was reported as non-serious.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Apr2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Nov2021 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 15Nov2010; TRUVADA, start date: 15Aug2009; FOCUS FACTOR, start date: 15Sep2018; FLONASE [FLUTICASONE PROPIONATE], start date: 15Jun2006. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) negative; (30Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: The patient taking other medications/products within 2 weeks of starting COVID-19 treatment and  the patient previously received a COVID-19 Vaccine. Reported Event: Patient reported "I felt better after 2 days. I completed treatment on 24Jun Saturday and tested negative on Sunday 25Jun. After feeling good all week I got grad cold symptoms on Thursday 30Jun and tested Positive again. I still have cold symptoms but getting less by the day (04Jul now).  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: 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 male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunization; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 01Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given as anti-viral treatment for covid-19 from 22Jun22 to 27Jun22. Other medication given in 2 weeks: Wellbutrin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
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 67-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6205), in right arm, on 20Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 66 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: Amlodipine Besilate, start date: 01Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 antigen test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19 with PAXLOVID.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 60-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8731), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Apr2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive other medications in 2 weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for Covid-19 immunisation; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 17Mar2020 at 12:00 as dose 1, single (Lot number: 042A21A), in left arm for Covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 02Apr2022 at 12:00 as dose 2, single (Lot number: 048L21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: Wellbutrin; Zoloft; Synthroid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with anti-viral Brand: Paxlovid. Treatment start date with 21Jun2022 and stopped on 25Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.