chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pain
Clinical narrative: Headache; chills; body aches; nausea; dizziness; I don't feel good; tiredness; cough; chest heaviness; SOB; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 10:30 as dose 4 (booster), single (Lot number: Gh9693) at the age of 45 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Environmental" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: Ff2587), administration date: 30Sep2021, when the patient was 44-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; MALAISE (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "I don't feel good"; DYSPNOEA (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "SOB"; PAIN (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "body aches"; CHEST DISCOMFORT (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "chest heaviness"; CHILLS (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; COUGH (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; DIZZINESS (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; NAUSEA (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; FATIGUE (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "tiredness". Therapeutic measures were not taken as a result of headache, chills, pain, nausea, dizziness, malaise, fatigue, cough, chest discomfort, dyspnoea.  Additional information: No other vaccine in four weeks. If covid prior vaccination: Yes. If covid tested post vaccination: No.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
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 58-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 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: "Diabetes mellitus" (unspecified if ongoing), notes: Other medical history Diabetes; "PCN" (unspecified if ongoing), notes: Known allergies PCN. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received covid treatment. Other medication in 2weeks were Unknown. Anti-viral details, brand Pfizer with treatment start date from 28Sep2022 till 02Oct2022 for COVID-19. Known allergies included PCN and other medical history included Diabetes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested covid positive on 19Sep2022; Tested covid positive on 19Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 11:30 as dose 1, single (Lot number: EN6201), in right arm, on 12Mar2021 at 14:00 as dose 2, single (Lot number: EN6202), in right arm, on 28Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FE8841), in right arm and on 07Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seasonal allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022 at 15:00, outcome "recovered" (2022) and all described as "Tested covid positive on 19Sep2022". The event "tested covid positive on 19sep2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Facility type vaccine was Pharmacy or Drug Store. Other medications in two weeks included multi vitamins. No other vaccine in four weeks and no COVID prior vaccination. Adverse event treatment included PAXLOVID.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure disorder" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Severe chills fever within 3 hours.; Severe chills fever within 3 hours.; extreme fatigue; muscle ache all over; severe headaches; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:15 as dose 1, single (Lot number: GH9694) at the age of 69 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: FATIGUE (non-serious) with onset 05Oct2022, outcome "unknown", described as "extreme fatigue"; MYALGIA (non-serious) with onset 05Oct2022, outcome "unknown", described as "muscle ache all over"; HEADACHE (non-serious) with onset 05Oct2022, outcome "unknown", described as "severe headaches"; CHILLS (non-serious) with onset 05Oct2022 at 17:15, outcome "not recovered", PYREXIA (non-serious) with onset 05Oct2022 at 17:15, outcome "unknown" and all described as "Severe chills fever within 3 hours.". Therapeutic measures were not taken as a result of chills, pyrexia, fatigue, myalgia, headache.  Additional information: The patient did not have any other vaccine in four weeks. Four days later still have chills. The patient did not have COVID prior vaccination and was not COVID tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "Hypoferritinemia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29May2022, outcome "unknown", described as "Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was unknown if the patient took any other medications/products within 2 weeks of starting COVID-19 treatment. The reporter considered event to be non-serious.  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 possible temporal association the causal association of suspect drug  BNT162b2 and for reported events -drug ineffective ,COVID-19,Interchange of vaccine products cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 12Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 06Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: OBF21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; LISINOPRIL; TYLENOL; OMEGA 3 FISH OIL [FISH OIL]. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin; Septra, reaction(s): "Known allergies: septrac", notes: Known allergies: septrac. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive; (Oct2022) Negative, notes: I had 2 negative tests that were taken 48 hours apart; (Oct2022) Negative, notes: I had 2 negative tests that were taken 48 hours apart. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient has received Paxlovid for the treatment of Covid-19 from 28Sep2022 to 03Oct2022. 4 days after completing Paxlovid, and 24 hours after she had 2 negative tests that were taken 48 hours apart, her COVID symptoms returned and she had a positive test on 07Oct2022, it was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 09:00 as dose 5 (bivalent; booster), single (Lot number: GJ6739) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; SIMVASTATIN; DESVENLAFAXINE; LOSARTAN POTASSIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Oct2022.  Clinical course: other medication within 2 weeks were tamsulosin, simvistatin, desvenlafaxine and losartan potassium
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". Therapeutic measures were taken as a result of neoplasm malignant.  Clinical course: Reported stated they have both had the Pfizer-BioNTech COVID-19 Vaccine primary series and the patient (her husband) has also had the Pfizer BioNTech COVID-19 Vaccine booster dose. She still needs to get her booster dose but was currently being treated for cancer. They spoke to her husband's doctor and they suggested he take acidophilus, which he has been taking along with Imodium DM, which was not helping the symptoms. He has one more dose and he may not take it.  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: Her Husband Started taking Paxlovid for Covid-19 treatment; Her Husband Started taking Paxlovid for Covid-19 treatment; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 Oct2022, outcome "unknown" and all described as "Her Husband Started taking Paxlovid for Covid-19 treatment". The event "her husband started taking paxlovid for covid-19 treatment" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient's wife reported her husband (patient) started taking Paxlovid on Monday, 03Oct2022, at 4pm. He has been having nausea, extreme diarrhea and vomiting. Reporter stated "he almost had to sleep in the bathroom it's been so bad." The reporter stated the patient's symptoms started before he started taking the Paxlovid, was he doing something wrong? Reporter stated they have both had the Pfizer-BioNTech COVID-19 Vaccine primary series and the patient (her husband) has also had the Pfizer-BioNTech COVID-19 Vaccine booster dose. She still needs to get her booster dose but was currently being treated for cancer. They spoke to her husband's doctor and they suggested he take acidophilus, which he has been taken along with Imodium DM, which was not helping the symptoms. "He has one more dose and he may not take it."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
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) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "non alcoholic fatty liver" (unspecified if ongoing), notes: non alcoholic fatty liver; "fibromyalgia" (unspecified if ongoing); "anemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "sclerosis of sacrum in pelvis" (unspecified if ongoing), notes: sclerosis of sacrum in pelvis; "increased brain pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (Oct2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: There were no other medication in 2weeks.Anti viral details included brand paxlovid, with treatment start date 27Sep2022 and stop date 05Oct2022 for COVID 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
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) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 24Jul2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 63 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: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: Jan2010; CALCIUM, start date: Jan2000; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE], start date: Oct2021; COLLAGEN, start date: Nov2017; VITAMIN D [COLECALCIFEROL], start date: Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, 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's concomitant medication also included VitreousHealth.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Treatment of COVID-19 with Paxlovid. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  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, SARS-CoV-2 test
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 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received covid-19 treatment as PAXLOVID from 28Sep2022 to 02Oct2022. Patient did not received any other medication in 2weeks.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: el3247), on 10Feb2021 as dose 2, single (Lot number: en6201), on 03Oct2021 as dose 3 (booster), single (Lot number: ff2589) and on 23May2022 as dose 4 (booster), single (Lot number: fp4554) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "celica disease" (unspecified if ongoing); "hypothyriod" (unspecified if ongoing); "penicllium" (unspecified if ongoing); "metals" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Neomycin, reaction(s): "Known allergies: neomycin". The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive; (06Oct2022) Positive, notes: Covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks was reported as no. Patient received Paxlovid treatment from 27Sep2022 to 02Oct2022 for Covid-19.
Age: 49.0
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) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 08:00 as dose 6 (booster), single (Lot number: GH9694) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NP THYROID; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2022) Positive, notes: COVID; (05Oct2022) Negative; (08Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did received other medication in 2weeks. The patient received the COVID 19 Treatment, brand=paxlovid, treatment start date/stop date- 28Sep2022/03Oct2022 and lot number: 1918530A. Patient tested positive for COVID on 28Sep, started Paxlovid 28Sep, tested negative 05Oct, and now just tested positive again on 08Oct. And not only me, but my husband as well. (Same dates as above for him, except he first tested positive on 27Sep. The Seriousness criteria-results did not result in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
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) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Splenectomy in 1975", start date: 1975 (unspecified if ongoing), notes: Splenectomy in 1975; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Wasp venom" (unspecified if ongoing), notes: Known allergies: Wasp venom. Concomitant medication(s) included: SPIRONOLACTONE; LISINOPRIL; ZETIA; DILTIAZEM; FISH OIL; COENZYME Q10 [UBIDECARENONE]; LIVALO; PEPCID [FAMOTIDINE]. 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: (2022) Positive, notes: Still testing positive on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 30Sep2022 to 04Oct2022.  Clinical course: Event as reported by primary source: Feeling better on day 3-5. Symptoms began to get worse on day 7. Still testing positive on day 11. The patient received other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.; 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 its Lack of efficacy cannot be ruled out.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine dose number=2: vaccine brand other=Moderna/ Vaccine dose number=3: vaccine brand=Pfizer / BioNTech; 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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Oct2021 as dose 2 (booster), single (Lot number: 019F21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 02Apr2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "vaccine dose number=2: vaccine brand other=Moderna/ Vaccine dose number=3: vaccine brand=Pfizer / BioNTech"; 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, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: 077C21B) at the age of 26 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 was not reported. Concomitant medication(s) included: WELLBUTRIN; HYDROXYZINE; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient has received antiviral drug for the treatment of COVID 19 from 27Sep2022 to 02Oct2022. 6 days after treatment ended on 08Oct2022 again tested positive for COVID-19. Runny nose and cough was rebounded breakthrough as a symptoms, patient was not recovered and no treatment received. Patient had no seriousness criteria such as death, disabling/Incapacitating, life threatening, congenital anomaly/birth defect.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Neuropathy peripheral, Paraesthesia
Clinical narrative: Neuropathy; Paraesthesia; Electrical sensations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Heartburn" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for dyspepsia. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 05Oct2022, outcome "unknown", described as "Electrical sensations"; NEUROPATHY PERIPHERAL (medically significant) with onset 05Oct2022, outcome "unknown", described as "Neuropathy"; PARAESTHESIA (non-serious) with onset 05Oct2022, outcome "unknown". The events "neuropathy", "paraesthesia" and "electrical sensations" required emergency room visit. Therapeutic measures were not taken as a result of neuropathy peripheral, paraesthesia, electric shock sensation.  Clinical course: The patient reported that she believed she had an adverse reaction to the Bivalent Vaccine, it was a neurological reaction. The patient stated that paraesthesia, neuropathy and electrical sensations. She ended up in the ER which they did not pay any attention to her. They said that paraesthesia and neuropathy was addressed through the Neurologist.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; severe dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "severe dizziness". Additional information: Reporter had a quick question; reporter had a friend that just about week or so ago have the COVID Pfizer Booster, the new booster was asking for any kind of complaints of vertigo, severe dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:00 as dose 4 (booster), single (Lot number: HRSAGH9694) at the age of 77 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: "Kidney donor" (unspecified if ongoing), notes: Kidney donor, I took the appropriate Paxlovid dosage. Concomitant medication(s) included: DOXYCYCLINE MONOHYDRATE; FINASTERIDE; DIPHENHYDRAMINE; FLAXSEED OIL. 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. 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 received a COVID-19 Vaccine. COVID-19 Treatment brand=Pfizer Treatment start date=25Sep2022 and Treatment stop date=01Oct2022.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 at 07:00 as dose 1, single (Lot number: EW0158), on 03May2021 at 07:00 as dose 2, single (Lot number: EW0173), in right arm and on 21Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; LEXAPRO, stop date: 30Sep2022; BUPROPION, stop date: 30Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2022) Negative; (04Oct2022) Negative; (07Oct2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 54.0
Sex: M
Vaccine: COVID19-2
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 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 08:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day, as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day and as dose 4 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALLOPURINOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Sep2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Sep2022) Positive; (05Oct2022) Negative; (08Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was received as treatment for COVID-19 from 28Sep2022 to 03Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, 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) (Other HCP) from product quality group. The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EL1284), on 09Jan2021 as dose 2, single (Lot number: EL1284) and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Unspecified connective tissue disease" (unspecified if ongoing); "hypermobile ehler danlos" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Penicillins" (unspecified if ongoing), notes: Known allergies: Penicillins. Concomitant medication(s) included: EMGALITY [GALCANEZUMAB]; FISH OIL; MELOXICAM; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; VITAMIN D [ERGOCALCIFEROL]. Past drug history included: Omnicef/cefdinir, reaction(s): "Known allergies: Omnicef/Cefdinir"; Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) Low, notes: history of low antibody titers; SARS-CoV-2 test: (2022) Positive, notes: Testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received Other medication in 2 weeks.   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 available information in the case, the causal association between the event s drug ineffective,Covid-19 and the suspect drug BNT162B2 cannot be excluded
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 30Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have any known allergies. Concomitant medication(s) and other medication in 2 weeks included: GUAIFENESIN; NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 03Oct2022 to 05Oct2022.  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 current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 72-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3249), on 04Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FC3163), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: other medical history: HTN; "BPH" (unspecified if ongoing), notes: other medical history: BPH; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included in 2weeks product: TAMSULOSINA AUROBINDO; LISINOPRIL LUPIN (brand: Pharmacy); HYDROCHLOROTHIAZIDE; DILTIAZEM CD; PREVAGEN [APOAEQUORIN], stop date: 30Sep2022; COQ-10,, stop date: 30Sep2022; VITAMIN D3, stop date: 30Sep2022; CALCIUM CITRATE + D3, stop date: 30Sep2022; ASPIRIN LOW, stop date: 30Sep2022; AIRBORNE, start date: 20Sep2022, stop date: 22Sep2022. Other medication in 2weeks product also included Men's 50+ Formula multivitamin/multimineral/Herbal supplement, Other medication in 2weeks, Other medication in 2weeks stop date: 30Sep2022. Other medication in 2weeks product: Movement Advanced dietary supplement, Other medication in 2weeks, Other medication in 2weeks stop date: 30Sep2022, Other medication in 2weeks lot number: 109796. Past drug history included: Codiene, reaction(s): "Allergy", notes: known allergies: Codeine; Amoxicillin, reaction(s): "Allergy", notes: known allergies: amoxicillin. Anti-viral details: Product-COVID 19 Treatment, Brand-Pfizer Paxlovid, [Treatment start date- 29Sep2022, Treatment stop date- 04Oct2022, Indication-Treatment of COVID-19]. Adverse event: Rebound Covid 19 infection (Onset date 08Oct2022, 05:00 PM). 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: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound Covid 19 infection. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 32 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: "Other medical history: Crohns" (unspecified if ongoing), notes: Other medical history: Crohns Asthma Anxiety; "Other medical history: Asthma" (unspecified if ongoing), notes: Other medical history: Crohns Asthma Anxiety; "Other medical history: Anxiety" (unspecified if ongoing), notes: Other medical history: Crohns Asthma Anxiety; "Known allergies All nuts/peanuts" (unspecified if ongoing), notes: Known allergies All nuts/peanuts; "Known allergies All nuts/peanuts" (unspecified if ongoing), notes: Known allergies All nuts/peanuts. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; FAMOTIDINE; SINGULAIR; DULERA; ALESSE; STELARA; VITAMIN C [ASCORBIC ACID]; TURMERIC [CURCUMA LONGA RHIZOME]; PROBIOTICS. 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: (unspecified date) Positive, notes: Treatment of COVID-19; (05Oct2022) Positive, notes: but 4 days after stopping paxlovid treatment, my symptoms came back and I'm testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was received vaccine. The patient was received other medication in 2weeks.  Follow-up attempts are completed. No further information is expected.