chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 16Apr2021 as dose 2, single (Lot number: EL9261), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: FA6780), in right arm and on 19Apr2022 as dose 4 (booster), single (Lot number: 9729) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "Sjogren's Syndrome" (unspecified if ongoing); "Inflammatory Arthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: 04Jan2011, stop date: 17Jun2022; LEVOTHYROXINE, start date: 06Oct2016, stop date: 17Jun2022; FLUOXETINE, start date: 10Feb1997, stop date: 17Jun2022.  The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19  Clinical course: The patient received Anti-viral Product for COVID 19 Treatment, Brand: Paxlovid, treatment Start Date: 07Jun2022, treatment Stop Date: 11Jun2022, Lot number: GA9630.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 as dose 2, single (Lot number: Ew0158), in left arm and on 19Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "tree pollen allergy" (unspecified if ongoing), notes: tree pollen allergy; "dogs allergy" (unspecified if ongoing), notes: dogs allergy; "dust mites allergy" (unspecified if ongoing), notes: dust mites allergy. Concomitant medication(s) included: WELLBUTRIN XL, start date: 01Jun2010; ALBUTEROL [SALBUTAMOL], start date: 12Mar2019; SYMBICORT. Past drug history included: Morphine, reaction(s): "Known Allergies: Morphine", notes: Known Allergies: Morphine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: prior negative tests; (15Jun2022) Positive, notes: Tested positive again. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details: product=COVID 19 Treatment, Paxlovid, treatment start date=07Jun2022, treatment stop date=12Jun2022, indication=Treatment of COVID-19. Patient couldn't sleep first two nights, awful taste in mouth all 5 days, but reported COVID rebound 4 days after last paxlovid pill and after prior negative tests. Tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.   Clinical course: The patient did not have any known allergies. Relevant past drug history: Name of Drug as Reported was no, Reaction: Allergy. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Anti-viral details: product-COVID 19 Treatment, brand-Paxlovid, treatment start date-02Jun2022, treatment stop date-06Jun2022, indication-Treatment of COVID-19. Reported Event: The original COVID Symptoms came back. Since Monday I had the headache, sore throat and a couple of days later, my waist and hips started hurting (they feel stiff and achy). These were all COVID symptoms I had before taking Paxlovid. All the symptoms were gone when I finished the antiviral medication but came back days later. Also, one of the side effects of Paxlovid that I wasn't aware of is that it kept me awake. It gave me enough energy to keep me awake during the day and at night. I could not sleep throughout those 5 days that I took Paxlovid. Date of start of reaction/event: 12Jun2022. Outcome of reaction/event at the time of last observation: Not recovered/Not resolved. Hospitalization Prolonged: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZITHROMYCIN, start date: 13Jun2022, stop date: 17Jun2022; Z-PAK, start date: 17Jun2022, stop date: 18Jun2022; ALBUTEROL [SALBUTAMOL], start date: 16Jun2022. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 63.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2021 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 63 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: "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 covid-19. Clinical course: The patient previously received COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
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) (Nurse).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "hyperlipidaemia" (unspecified if ongoing); "extrinsic asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril", notes: Known allergies: Lisinopril; Hctz, reaction(s): "Known allergies: HCTZ", notes: Known allergies: HCTZ; Spironloactone, reaction(s): "Known allergies: Spironoloactone", notes: Known allergies: Spironoloactone. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: (10Jun2022) negative; (17Jun2022) positive, notes: developed symptoms 16Jun2022, retested 17Jun2022 and positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid; Treatment start date: 03Jun2022, Treatment stop date: 08Jun2022; Indication: Treatment of COVID-19; Administrator route: Oral. It was unknown if the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Event: Retested for COVID 10Jun2022 negative, and developed symptoms 16Jun2022, retested 17Jun2022 and positive. Adverse event start date: 15Jun2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 62.0
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) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: eh9899), in right arm, on 12Jan2021 as dose 2, single (Lot number: ekl9899), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: ff2588) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Lot number: 259M2117), in left arm for covid-19 immunisation. The patient's relevant medical history included: "SP Prostate Cancer" (unspecified if ongoing); "currently throat cancer" (unspecified if ongoing); "MGUS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: On 16Jun2022, rebound post Paxlovid treatment. Home test strong positive 5 days post treatment. At 2 days post treatment, home test a reliable negative. Noticeable symptoms started on day 4 post treatment. COVID 19 Treatment: Paxlovid. Treatment start date: 08Jun2022 and stop date: 12Jun2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date : 18Jun2022.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high bp" (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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient received vaccine and Other medication in 2weeks. The patient had no known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 16Dec2021 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.
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 non-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 17Jan2021 as dose 1, single (Lot number: fc3184), on 07Feb2021 as dose 2, single (Lot number: e19269) and on 16Sep2021 as dose 3 (booster), single (Lot number: e18982) for covid-19 immunisation. The patient's relevant medical history included: "pollen allergies" (unspecified if ongoing); "frequent sinus infections unless diligent with care" (unspecified if ongoing), notes: Other medical history: frequent sinus infections unless diligent with care. Concomitant medication(s) included: LEXAPRO; ESCITALOPRAM; ASPIRIN 81; COQ10 [UBIDECARENONE]; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Began Paxlovid day first tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment reported as Yes. If vaccine received and Other medication in 2weeks reported as Yes. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 08Jun2022, Treatment stop date: 13Jun2022, Indication: Treatment of COVID-19. Known allergies reported as No. Adverse event reported as Began Paxlovid day first tested positive. Fever resolved within a few days and feeling better each day. Today is day 10 and fever and tiredness has returned. Cough has been consistent however has gotten better over time.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID after the COVID-19 Vaccines; got COVID after the COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 82-year-old male patient received BNT162b2 (BNT162B2), on 31Oct2021 as dose 1, single (Lot number: 301558A), in left arm, on 01Nov2021 as dose 2, single (Batch/Lot number: unknown) and on 31May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "prostate" (unspecified if ongoing), notes: prostate. Concomitant medication(s) included: CRESTOR taken for blood cholesterol; FLOMAX RELIEF taken for prostate cancer; MUCINEX DM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "got COVID after the COVID-19 Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: She is a registered nurse that does hospital audits for car accident cases. She thinks her father had rebound COVID too but he was never tested so she can't be sure. Her father was also told not to take his Crestor.  Paxlovid: She states her father had the same dose she was taking. NDC, lot number, and expiration date: unknown as her father threw the box out.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 78.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: el9265), on 16Feb2021 as dose 2, single (Lot number: en6200), on 03Oct2021 as dose 3 (booster), single (Lot number: 30b5b4) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years 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) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2 weeks. Treatment start date was reported as 03Jun2022 and treatment stop date was 07Jun2022. It was reported that 5 days after completing treatment, all cold symptoms reappeared. Adverse event start date was reported as 11Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "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: The patient did not receive other medications or products within 2 weeks of starting COVID-19 treatment and the patient previously receive a COVID-19 Vaccine.  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: 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthmatic" (unspecified if ongoing); "Known allergies: sesame" (unspecified if ongoing), notes: Known allergies: sesame; "Known allergies:  nuts" (unspecified if ongoing), notes: Known allergies:  nuts. 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.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2weeks was reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 at 16:00 as dose 1, single (Lot number: EL3249), in right arm, on 04Feb2021 at 12:00 as dose 2, single (Lot number: EL9264), in left arm and on 04Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Fibromyalgia" (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 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: patient taking  other medications/products within 2 weeks of starting COVID-19 treatment. brand-Paxlovid, treatment start date-08Jun2022 stop date-13Jun2022, product-Acetaminophen 500 mg, start date-08Jun2022 stop date-16Jun2022, Product-Ibuprofen 200 mg start date-08Jun2022 stop date-16Jun2022.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 62-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: positive test after multiple negative tests post-Paxlovid; (2022) Negative, notes: positive test after multiple negative tests post-Paxlovid. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Covid 19 treatment involved brand Paxlovid, treatment start date was 27May2022 and treatment stop date was 31May2022, administrator route was oral. Vaccine lot was unknown as not available provided to reporter at the time of report completion, patient was taking other medications products within 2 weeks of starting Covid-19 treatment. Patient previously received a Covid-19 vaccine. Reported event was rebound symptoms and positive test after multiple negative tests post Paxlovid. Adverse event start date was 08Jun2022. Patient was recovering. Device date was given as 17jun2022. 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 possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 02Mar2021 as dose 2, single (Lot number: En6502), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 61 years, in left 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: VACCINATION FAILURE (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 vaccination failure, covid-19.  Clinical Course: Known allergies: None known. It was reported that the patient received Paxlovid (Lot Number: GA6765) from 13Jun2022 to 17Jun2022 as treatment of COVID-19. With paxlovid the patient experienced a bad, metallic taste and a couple of diarrhea instances.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
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 49-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 at 14:00 as dose 3 (booster), single (Lot number: D3527) at the age of 48 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 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) 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. Additional information: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Reaction/event as reported by primary source was COVID rebound, Date of start of reaction/event was 16Jun2022, Outcome of reaction/event at the time of last observation Not Recovered/Not Resolved, no hospitalization Prolonged. Patient administered Paxlovid for treatment of COVID-19, drug start date was 06Jun2022 and Date of last administration was 11Jun2022, Patient not administered any other medications/products within 2 weeks of starting COVID-19 treatment, patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: allergic reaction; Broke out into a rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4434297-00 .  A 62-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 2, Route of administration: Intramuscular), administration date: 11May2021, when the patient was 61-year-old, for COVID-19 vaccination, reaction(s): "Eczema aggravated", "Psoriasis", "Stress"; BNT162b2 (Dose number: 1, Route of administration: Intramuscular), administration date: 11Apr2021, when the patient was 61-year-old, for COVID-19 vaccination, reaction(s): "Eczema aggravated", "Psoriasis", "stress". The following information was reported: RASH (non-serious) with onset 2022, outcome "unknown", described as "Broke out into a rash"; HYPERSENSITIVITY (non-serious) with onset 2022, outcome "recovered" (2022), described as "allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2 (BNT162B2), 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 was not reported. The patient took concomitant medications. 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: SARS-CoV-2 test: (15Jun2022) Positive, notes: Symptoms have returned, positive antigen test; (unspecified date) Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19.- Clinical course: Other medication in two weeks: Yes. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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); "ulcerative colitis" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing), notes: Seasonal 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: (10Jun2022) negative, notes: day 8; (11Jun2022) negative, notes: day 9; (12Jun2022) negative, notes: day 10; (Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, in left leg 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: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receives a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FL31017) at the age of 21 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical History: Lupus; "IBS" (unspecified if ongoing), notes: Other medical History: IBS; "Sjögren's Syndrome" (unspecified if ongoing), notes: Other medical History: Sjogren's Syndrome. Concomitant medication(s) included: PLAQUENIL, start date: 31Oct2019; SPIRONOLACTONE, start date: 31Oct2021. Past drug history included: Amoxicillin, reaction(s): "Allergy:Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; ZOLOFT; VITAMIN D3; VIT E [TOCOPHEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Negative; (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was reported about adverse events and other medications received in 2 weeks. The anti viral details product COVID 19 treatment. The treatment start date 29May2022 and Stop date 03Jun2022 and lot number threw out. The indication treatment of COVID-19 reported. The vaccine location right arm was administered. The other medication details other medication in 2 weeks product Crestor other medication in 2weeks and brand Unsure, Zoloft, Vitamin D3 and Vit E. The adverse event Rebound COVID. Negative test and better 06Jun. Symptoms back and positive again 10Jun. The adverse event start date 10Jun2022. The patient recovered Recovering and treatment for adverse event was reported as No and patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 53.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 at 12:00 as dose 4 (booster), single (Lot number: rn2908) at the age of 53 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: "covid infection", start date: 15Jan2019 (unspecified if ongoing), notes: Other medical History: Possible previous covid infection on 15Jan2019. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment was Verapamil start date 30Apr2022. the patient was previously received a COVID-19 Vaccine. Reported Event 6 days after taking a full course of Paxlovid and testing negative with a home antigen test mild symptoms returned and patient tested positive with another antigen test. Adverse event start date 15Jun2022. Anti viral details product COVID 19 Treatment, brand Paxlovid, Treatment start date 05Jun2022, Treatment stop date 09Jun2022, Indication for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 2 (initial pfizer dose), single (Lot number: EL9262) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Nov2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vaccine brand other=Moderna, vaccine dose number=1; vaccine brand=Pfizer / BioNTech, vaccine dose number=2" (unspecified if ongoing), notes: Moderna dose number: 1, Pfizer dose number: 2. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid for the treatment of COVID-19 (treatment start date: 06Jun2022 and treatment stop date:11Jun2022). Other medication details: other medication in 2weeks: product: Dicloxicillin, other medication in 2weeks start date: 05Jun2022, other medication in 2weeks stop date: 15Jun2022), (other medication in 2weeks product: Zyrtec. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event: Rebound COVID- runny nose, congestion, sore throat, sinus pressure, adverse event start date: 15Jun2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective cannot be ruled out.