chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 2 (booster), single (Lot number: FE3690) at the age of 44 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Highly susceptible to nausea and motion sickness" (unspecified if ongoing), notes: Highly susceptible to nausea and motion sickness; "Highly susceptible to nausea and motion sickness" (unspecified if ongoing), notes: Highly susceptible to nausea and motion sickness. Concomitant medication(s) included: PRISTIQ; GABAPENTIN. Past drug history included: Sumatriptan, reaction(s): "Known allergies: Sumatriptan". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; MELOXICAM; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]. 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: (03Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 17Jun2022 to 22Jun2022. Clinical course: Concomitant medication also included Multi vitamin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2020 at 07:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Jan2022 at 08:00 as dose 3, single (Batch/Lot number: unknown), in left arm and on 06Apr2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 "vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with paxlovid from 22Jun2022 to 26Jun2022.  Clinical course: It was reported that the patient did not take any other medications within 2 weeks.  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: 34.0
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 34-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 26Apr2022 as dose 2, single (Lot number: EW0164) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxycillin and probably other -cillins", notes: Known allergies: Amoxycillin and probably other -cillins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: Day 0, Sun.19Jun being the first day I tested positive; (2022) Mildly Positive, notes: I tested mildly positive on an at-home antigen test; (30Jun2022) Strongly positive, notes: On Thursday. 30Jun and Monday 04Jul (Days 11 and 15), I tested strongly positive; (04Jul2022) Strongly positive, notes: On Thursday. 30Jun and Monday 04Jul (Days 11 and 15), I tested strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had COVID treatment from 20Jun2022 to 25Jun2022.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EE0169), on May 4, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0162), on Apr 13, 2021, for COVID-19 immunization, reaction: "I completely lost my sense of taste and smell." The patient experienced ageusia and anosmia; onset 2021, with outcome of not recovered. Patient described: "My sense of smell and taste has never returned in any normal or consistent capacity." Sender's comments: Linked report: US-PFIZER INC-202200926529 (same reporter/patient, different drug, similar event); US-PFIZER INC-PV202200016058 (same reporter/patient, different drug, similar event).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 46 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: "Natural Killer Cell Deficiency" (unspecified if ongoing), notes: Natural Killer Cell Deficiency; "numerous environmental and food allergies" (unspecified if ongoing), notes: numerous environmental and food allergies; "numerous environmental and food allergies" (unspecified if ongoing), notes: numerous environmental and food allergies; "PCOS" (unspecified if ongoing), notes: PCOS; "chronic fatigue syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "known allergies: gluten" (unspecified if ongoing), notes: known allergies: gluten; "known allergies: soy" (unspecified if ongoing), notes: known allergies: soy; "known allergies: egg" (unspecified if ongoing), notes: known allergies: egg; "immunocompromised" (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 information: Patient started anti viral treatment of Paxlovid for covid 19 treatment on 13Jun2022 and stopped on 17Jun2022. Patient's physician would not prescribe another round of Paxlovid due to FDA not recommending it. Although in an article that Withheld and other people were able to be prescribed a second round. Patient was extremely ill and developed secondary infections. Patient was completely stuck. Because doctor gave Paxlovid, they said patient was not eligible for any of the other treatments because was made to quarantine for 10 days even though symptoms came back and tried to get help. It's a terrible system and high risk people like need to be allowed to have a second round of Paxlovid when they rebound because was almost hospitalized when  rebounded. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. 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 the suspect drug BNT162B2.
Age: 72.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 72 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: "Meds for bp" (unspecified if ongoing), notes: Meds for bp and cholesterol; "cholesterol" (unspecified if ongoing), notes: Meds for bp and cholesterol; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin, sulfa drugs; "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: penicillin, sulfa drugs. Concomitant medication(s) included: TRINTELLIX, start date: May2022; L METHYLFOLATE, start date: Jan2017; ATORVASTATIN, start date: Jan2018; LISINOPRIL, start date: Jan2014; DYAZIDE, start date: Jan2014. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Reporter stated that, report was about covid treatment. age group was Elderly (65+ Years). Received Other medication in 2weeks. Anti viral details was reported, Product-COVID 19 Treatment, Brand-Paxlovid. Treatment started on 23un2022 and stop date was 28Jun2022. Covid vaccine details was reported as Pfizer / BioNTech. Other medication details was reported as, Other medication in 2weeks product was Trintellix, start date=May2022. Product=L-methyl folate, brand=Deplin, start date=Jan2017. product=atorvastatin, start date=Jan2018. product=lisinopril, start date=Jan2014. product=dyazide, start date=Jan2014. Adverse event details was reported as, Rebound of Covid symptoms 5 days after completing Paxlovid. Adverse event start date was 03Jul2022. patient was Not recovered. No treatment ae was reported. Other medical history was Meds for bp and cholesterol.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 23Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 23Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 24Jun2022- 28Jun2022 and after treatment tested negative; (23Jun2022) Positive, notes: Tested + for covid on 23Jun2022; (05Jul2022) Positive, notes: On 05Jul2022 tested positive for covid (rebound). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Known allergies was none. No other medication in 2weeks.Paxlovid was taken as treatment for Covid-19.Treatment start date was 24Jun2022 stop date was 28Jun2022.Tested +ve for covid on 23Jun2022; took Paxlovid for 5 days (24Jun2022- 28Jun2022 and after treatment tested negative.   No follow-up attempts are possible.  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 the suspect drug BNT162B2.
Age: 44.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose number unknown, single (Lot number: EW0180) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Aspirine, reaction(s): "Known allergies: Aspirine"; Iodine, reaction(s): "Known allergies: Iodine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: It was reported that no other vaccines were given within 4 weeks. Anti-viral details: product=COVID 19, treatment, brand=Paxlovid, treatment start date: 27Jun2022, treatment stop date=01Jul2022, indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested negative after Paxlovid treatment on 29Jun22 then tested positive again on 03Jul22; Tested negative after Paxlovid treatment on 29Jun22 then tested positive again on 03Jul22; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), on 27May2021 as dose 2, single (Lot number: ER8730) and on 05Oct2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 47 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: COVID-19 (medically significant) with onset 03Jul2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 03Jul2022, outcome "not recovered" and all described as "Tested negative after Paxlovid treatment on 29Jun22 then tested positive again on 03Jul22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Negative; (03Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient tested negative after Paxlovid treatment on 29Jun2022 then tested positive again on 03Jul2022 after starting to feel unwell. Patient received Paxlovid from 22Jun2022 to 26Jun2022, as treatment of COVID-19. Other medication in 2 weeks: Unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200930857 same patient/vaccine, different dose/events;
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 at 16:45 as dose 4 (booster), single (Lot number: fk9896) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "heart attack", start date: 19Dec2019 (unspecified if ongoing), notes: Other medical history: heart attack 19Dec2019; "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: relapse of symptoms and a positive test 5 days after ending paxlovid; (Jul2022) Negative, notes: 3 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course of the events: It was reported that relapse of symptoms and a positive test 5 days after ending paxlovid and 3 days of negative tests. Other medication in 2 weeks was Unknown. No Known allergies.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Hypertension, Oxygen saturation, Oxygen saturation abnormal
Clinical narrative: I have rheumatoid arthritis which is in remission; high blood pressure; my BP & O2 level bottomed out on me; my BP & O2 level bottomed out on me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "I have rheumatoid arthritis which is in remission"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; BLOOD PRESSURE ABNORMAL (non-serious), OXYGEN SATURATION ABNORMAL (non-serious), outcome "unknown" and all described as "my BP & O2 level bottomed out on me". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high; Unknown results, notes: My BP and O2 level bottomed on me; Oxygen saturation: Unknown results, notes: My BP and O2 level bottomed on me.  Clinical course: The reporter reported that, patient will be 70 in November. Patient just got over the covid. Patient was fully vaccinated & continued to wear my mask & etc. The patient was very thankful for the vaccines & the antiviral made by Pfizer and doing fine now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: I have rheumatoid arthritis which is in remission; high blood pressure; my BP & O2 level bottomed out on me; my BP & O2 level bottomed out on me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "I have rheumatoid arthritis which is in remission"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; BLOOD PRESSURE ABNORMAL (non-serious), OXYGEN SATURATION ABNORMAL (non-serious), outcome "unknown" and all described as "my BP & O2 level bottomed out on me". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high; Unknown results, notes: My BP and O2 level bottomed on me; Oxygen saturation: Unknown results, notes: My BP and O2 level bottomed on me.  Clinical course: The reporter reported that, patient will be 70 in November. Patient just got over the covid. Patient was fully vaccinated & continued to wear my mask & etc. The patient was very thankful for the vaccines & the antiviral made by Pfizer and doing fine now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Drug ineffective, Oxygen saturation, Suspected COVID-19
Clinical narrative: I have rheumatoid arthritis which is in remission; high blood pressure; my BP & O2 level bottomed out on me; my BP & O2 level bottomed out on me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "I have rheumatoid arthritis which is in remission"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; BLOOD PRESSURE ABNORMAL (non-serious), OXYGEN SATURATION ABNORMAL (non-serious), outcome "unknown" and all described as "my BP & O2 level bottomed out on me". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high; Unknown results, notes: My BP and O2 level bottomed on me; Oxygen saturation: Unknown results, notes: My BP and O2 level bottomed on me.  Clinical course: The reporter reported that, patient will be 70 in November. Patient just got over the covid. Patient was fully vaccinated & continued to wear my mask & etc. The patient was very thankful for the vaccines & the antiviral made by Pfizer and doing fine now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: FJ1620), 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: "hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "known allergies: lisinopril". 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 included antiviral COVID-19 treatment of Paxlovid from 01Jul2022 to 03Jul2022, orally.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (the patient). Case identifier: 22K-163-4446716-00). An 85-year-old female patient received the 3rd dose (first booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), intramuscularly, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (intramuscular), for COVID-19 immunization, reactions: dry cough, dry throat, falling, broken hip, interstitial lung disease and postnasal drainage; and the 2nd dose of BNT162B2 (intramuscular), for COVID-19 immunization, reactions: dry cough, dry throat, falling, broken hip, interstitial lung disease and post nasal drainage. The patient experienced arthralgia/joint pain and nausea, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 72.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 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: "High blood pressure (controlled)" (unspecified if ongoing), notes: High blood pressure (controlled). 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: The anti viral details included, product=COVID 19 Treatment, brand=Pfizer, treatment start date=22Jun2022, treatment stop date=27Jun2022, indication=Treatment of COVID-19. BNT162B2 vaccine lot unknown reason: other (Not provided to reporter). The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine and the patient experienced fever and sinus congestion on 30Jun2022 at 08:00 PM. The outcome of fever and sinus congestion was recovering. No treatment was given for fever and sinus congestion. No known allergies were reported.    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
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 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 14:00 as dose 1, single (Lot number: EL3247), in right arm, on 15Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in right arm and on 10Nov2021 at 16:00 as dose 3 (booster), single (Lot number: ff2593) at the age of 76 , in right arm for covid-19 immunisation. The patient's relevant medical history included: "Small fiber sensory neuropathy", start date: Nov2021 (unspecified if ongoing), notes: Small fiber sensory neuropathy; "Known allergies: Microbic" (unspecified if ongoing), notes: Known allergies: Microbic. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], start date: Jul2004; CALTRATE [CALCIUM CARBONATE], start date: Jan2000. Past drug history included: Septa, reaction(s): "Known allergies: Septa", notes: Known allergies: Septa; Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) COVID Rebound, notes: COVID Rebound after Paxlovid Treatment"; (04Jul2022) positive, notes: I was positive until 04Jul and continued to have nasal congestion; (05Jul2022) Negative, notes: I tested negative again this morning ,05Jul; (21Jun2022) Negative, notes: I tested negative with home antigen 21Jun and 22Jun; (22Jun2022) Negative, notes: I tested negative with home antigen 21Jun and 22Jun; (26Jun2022) positive, notes: On 25Jun my symptoms returned and I tested positive on 26Jun with home antigen; (15Jun2022) positive, notes: I started Paxlovid after testing positive (PCR) 15Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Started Paxlovid after testing positive (PCR) 15Jun2022 and completed 5 days 20Jun2022. My symptoms of nasal congestion were mild and I tested negative with home antigen 21Jun and 22Jun. On 25Jun my symptoms returned and I tested positive on 26Jun with home antigen. My symptoms of nasal congestion and mild cough were worse than original onset. I was positive until 04Jul and continued to have nasal congestion. I tested negative again this morning ,05Jul. I found the CDC Health Advisory distributed 24May2022 on line describing COVID Rebound after Paxlovid Treatment. I believe this is what happened to me. I notified my PCP when I tested positive on 26Jun and started the isolation period over .
Age: 49.0
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) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown), on 07Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 21Jun2022, stop date: 23Jun2022,as other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (28Jun2022) Negative; (29Jun2022) Negative; (30Jun2022) Negative; (01Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19.  Clinical course: Paxlovid was started in 22Jun2022 till 27Jun2022 for the treatment of COVID-19. Starting 04Jul2022 at 04:00 PM. 7 days after completing Paxlovid, the patient started having symptoms of fatigue. On 05Jul2022, the patient had sore throat, body aches. The patient did 2 home COVID tests, both were positive. Before this, the patient had 4 negative Covid tests starting on 28Jun2022 after the patient completed taking Paxlovid. The patient was Not recovered.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 49.0
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm and on 13Apr2021 as dose 2, single (Lot number: ER8731) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Lot number: 035C2114), 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: It was reported to be non serious, Seriousness criteria-Resulted in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. Reported about COVID treatment: Yes, No other medication were received in 2 weeks anti viral details: product=COVID 19 Treatment, It was reported that patient had Covid rebound 3 days after finishing Paxlovid. No treatment for adverse event recieved. Had no known allergies. Had no other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) 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: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment - Anti-viral details: Paxlovid, Treatment start date 26Jun2022 and Treatment Stop date 30Jun2022, Indication included Treatment of COVID-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 00:15 as dose 1, single (Lot number: EM9810), in right arm, on 27Feb2021 at 01:00 as dose 2, single (Lot number: EN6205), in right arm and on 29Sep2021 at 13:00 as dose 3 (booster), single (Lot number: EW0179) at the age of 67 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: LOSARTAN; AMLODIPINE; CARVEDILOL; ASPIRIN [ACETYLSALICYLIC ACID]; DUTASTERIDE; ATORVASTATIN; VYVANSE. Past drug history included: Spironolactone, reaction(s): "Allergy:Spironolactone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive, notes: 23Jun: Initial POS test and commence Paxlovid; (30Jun2022) Negative, notes: 30Jun: Symptoms minimal & NEG test; (02Jul2022) Positive, notes: 02Jul: Symptoms returned; (03Jul2022) Positive, notes: 03Jul: Strong POS test; (05Jul2022) Positive, notes: 03Jul: Symptoms remain & strong POS test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 Treatment was received. Treatment start date 23Jun2022 & treatment stop date 27Jun2022.lot number=Paxlovid. Patient received other medication in 2weeks Losartan 50mg, Amlodipine 2.5mg, Carvedilol 12mg. Aspirin 81mg, Dutasteride 0.5mg, Atorvastatin 20mg and Vyvanse 50mg. Known allergies: Spironolactone. Other medical history: High blood pressure. Relapse after Paxlovid treatment. 23Jun: Initial POS test and commence Paxlovid. 30Jun: Symptoms minimal & NEG test. 02Jul: Symptoms returned. 03Jul: Strong POS test. 05Jul: Symptoms remain & strong POS test.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive in-home antigen (Name withheld) 16Jun2022; Positive in-home antigen (Name withheld) 16Jun2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 2, single (Lot number: EL0140) at the age of 40 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; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Oct2021 at 11:00 as dose 3 (booster), single (Lot number: 012F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. There were no known allergies reported. Patient took Paxlovid for COVID 19, treatment was started on 16Jun2022 and Stopped on was 20Jun2022, Lot number as 1916517A. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "Positive in-home antigen (Name withheld) 16Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative, notes: Negative test 23Jun2022; (16Jun2022) Positive, notes: Positive in-home antigen (name withheld). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not take other medication in 2 weeks. Reporter stated that Possible rebound after Paxlovid. Original symptoms started evening of 14Jun2022. Positive in-home antigen test (Name withheld) on 16Jun2022. Paxlovid Started in the evening of 16Jun2022. Negative test on 23Jun2022. On 29Jun2022, deeper cough/phlegm was started, Heavy congestion, Complete loss of taste/smell on 05Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1 , single (Batch/Lot number: unknown), as dose 2 , single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 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 Jun2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) positive, notes: through a home kit in February. Reporter stated that her daughter tested positive for COVID through a home kit in Feb. Reporter stated that her doctors were against her staying with her daughter. It was reported that reporter got the shot in the doctors office, when she came home she didn't feel bad, the next day she even took her bandage off on 30Jun2022, and asked her daughter if she saw anything because her daughters usually gets red, hard, and hot but her daughter told her she saw nothing on the reporter arm. Reporter stated that her daughter and grandson they do had their card, she does know they had Pfizer for 2 shots, and a booster was what they had, but they did not had the last one, reporter states that she doesn't know if it's by age. When reporter was probed what was meant by Pfizer vaccine, reporter states that she doesn't know what the Pfizer vaccines were for and she does not know the names or had Lot numbers of her daughter and grandsons vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bipolar 2" (unspecified if ongoing); "allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; OXCARBAZEPINE; MONTELUKAST; LORATADINE; BUPROPION; BUDESONIDE; FLUTICASONE. Past drug history included: Aspirin, reaction(s): "Known allergies: aspirin", notes: Known allergies: aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19 which included Paxlovid started on 23Jun2022 and stopped on 27Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications. No other medication in 2weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: COVID 19 Treatment; (03Jul2022) Positive, notes: positive test 5 days after completion of 5 day Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reoccurrence of covid symptoms and positive test 5 days after completion of 5-day Paxlovid course. Anti-viral product Paxlovid, treatment start date was 23Jun2022 and treatment stop date was 28Jun2022.  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
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications Oral Contraceptive. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received anti viral COVID 19 Treatment Paxlovid from 05Jul2022 to 06Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202200934096 Same patient, different product and event;