chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia, Tremor
Clinical narrative: Chills; slight fever; swollen lymph node; body aches; joint pain; shakes; headache; nasal congestion; clogged ears; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 at 09:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 24 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers-Danlos Syndrome" (unspecified if ongoing); "Mild cerebral palsy" (unspecified if ongoing), notes: Mild cerebral palsy; "Gastroparesis" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medication(s) included: LEXAPRO; BIOTIN; CETIRIZINE; TYLENOL; MOTRIN [IBUPROFEN]. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone", notes: Known allergies: Prednisone. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FE3590, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 21Nov2021, when the patient was 23-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 08Mar2021, when the patient was 22-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; PAIN (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "body aches"; EAR DISCOMFORT (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "clogged ears"; HEADACHE (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "joint pain"; NASAL CONGESTION (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; TREMOR (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "shakes"; PYREXIA (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "slight fever"; LYMPHADENOPATHY (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "swollen lymph node". Therapeutic measures were taken as a result of chills, pyrexia, lymphadenopathy, pain, arthralgia, tremor, headache, nasal congestion, ear discomfort. No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Investigation, Laboratory test, Pyrexia
Clinical narrative: He is just getting worse and getting weaker; He is just getting worse and getting weaker; still getting high fevers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2022 as dose 3 (booste), single (Lot number: FK9896) at the age of 15 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "problems with his stomach" (unspecified if ongoing), notes: problems with his stomach. Concomitant medication(s) included: CYPROHEPTADIN taken for abdominal discomfort. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot num FA6780; Anatomical location: left arm ,  Time around 1-2 pm), administration date: 25Jul2021, when the patient was 15-year-old, for Covid-19 immunization, reaction(s): "dizziness", "weakness", "lack of energy", "high fevers", "extreme fatigue"; BNT162b2 (DOSE 2, SINGLE; Lot num FC3181; Anatomical location: left arm ,  Time around 1-2 pm), administration date: 22Aug2021, when the patient was 15-year-old, for Covid-19 immunization, reaction(s): "dizziness", "weakness", "lack of energy", "high fevers", "extreme fatigue". The following information was reported: CONDITION AGGRAVATED (non-serious), ASTHENIA (non-serious), outcome "not recovered" and all described as "He is just getting worse and getting weaker"; PYREXIA (non-serious), outcome "not recovered", described as "still getting high fevers". The events "he is just getting worse and getting weaker" and "still getting high fevers" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter called because she had some problem with sons health, he had been through a lot of test with his doctors and they found nothing wrong with him. She had been taking him to his doctor and explaining how he was feeling, they have checked for diabetes, they checked his organs and they say everything was okay but he was getting worse. And he was still getting high fevers as well, and she took him to the ER, but they found nothing. The patient did not receive any other products and had no relevant medical history. Also reported as Adverse event: started by Oct2021. He did start a medication for problems with his stomach and was Cyproheptad 4mg. Additional vaccines administered on same date of the Pfizer suspect was no. Prior vaccinations (within 4 weeks) was no.
Age: 66.0
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) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9269), on 02Mar2021 as dose 2, single (Lot number: EN6205), on 03Oct2021 as dose 3 (booster), single (Lot number: CWO187) and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (08Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 26Jun2022 to 30Jun2022 as treatment of COVID-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2021 as dose 1, single (Lot number: EW0186), in left arm, on 23Jun2021 as dose 2, single (Lot number: EW0191), in right arm and on 06Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Coconut" (unspecified if ongoing), notes: Known allergies: Coconut. The patient took concomitant medications. Past drug history included: Levaquin, reaction(s): "Known Allergies: Levaquin", notes: Known Allergies: Levaquin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient took other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported events noted rebound of covid symptoms including severe cough, head congestion, chest congestion and fatigue. Device date was noted as 08Jul2022.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 10:00 as dose 3 (booster), single (Lot number: EW0187) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Pollen allergies" (unspecified if ongoing), notes: Pollen allergies; "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient had other medication in 2 weeks since vaccination. Paxlovid was given as treatment from 21Jun2022 to 25Jun2022, lot number GC2897. Return of COVID symptoms after completing treatment with Paxlovid prescribed 5 days treatment was insufficient, resulted in rebound infection, illness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
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 65-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient had no known allergies or other medical history. The patient's relavant past drug history was reported as allergy (as reported). From 23Jun2022 to 27Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Latex" (unspecified if ongoing), notes: known allergies Latex. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing); "High BMI" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2004, stop date: 28Jun2022. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 48-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022 at 13:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID rebound after Paxlovid treatment, from 26Jun2022 to 01Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 at 07:30 as dose 1, single (Lot number: EK5730), in left arm, on 06Jan2021 at 10:00 as dose 2, single (Lot number: EL3246), in right arm and on 20Sep2021 at 16:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Treatment of COVID-19 included Paxlovid from 22Jun2022 and 27Jun2022.; Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that the events are  related to  BNT162b2 cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 09Jan2021 as dose 2, single (Lot number: EL0142), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies allergic to penicillin" (unspecified if ongoing); "known allergies allergic to sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "known allergies vicodin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The causal association between the events and suspect vaccine cannot be excluded based on known safety profile. Case will be reassessed on receipt of more information.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, 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 Regulatory Authority.. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ep7534), in left arm, on 10Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 31 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Test: (2022) unknown result, notes: went to a "Test to Treat" site at a "withheld''; SARS-CoV-2 test: (29Jun2022) Positive; (04Jul2022) Positive, notes: Faint positive; (05Jul2022) Negative; (06Jul2022) Negative; (08Jul2022) Positive; (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received antiviral treatment with Paxlovid from 29Jun2022 to 03Jul2022. Patient did not received any other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
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 non-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 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 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 and concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical information: Treatment drug included Paxlovid from 06Jul2022. Seriousness criteria were reported yes "no".    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 13:30 as dose 1, single (Lot number: ER2613), in left arm, on 16Apr2021 at 13:30 as dose 2, single (Lot number: EW0150), in left arm and on 01Dec2021 at 13:30 as dose 3 (booster), single (Lot number: FG3527) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: for 5 days; (Jul2022) positive, notes: (different brand); (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: After finishing the 5-day course of Paxlovid, the patient was tested negative for 5 days. 8 days after completing Paxlovid, the patient began to feel congestion in my head again, same as he did when he first contracted COVID. The patient originally thought it was allergies but the congestion worsened over the next 36 hours so out of caution, The patient took a rapid test that came back positive. The patient took another rapid test (different brand) to be sure, and that came back positive as well. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), on 01Apr2021 as dose 2, single (Lot number: ER8737), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593) and on 21May2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: levoquin, reaction(s): "Known allergies: levoquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: negative on day 8; (2022) positivity, notes: Started paxlovid on 1st day positivity; (08Jul2022) Positive, notes: Then tested positive again on day 10 after. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 18Jun2022 to 23Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 07May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 027A21A), in right arm, on 01Apr2021 as dose 2, single (Lot number: 02821A), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: 033A21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE(GSMs), start date: Apr2011; PROPRANOLOL(GSMs), start date: 14Jan2022; ESCITALOPRAM(GSMs), start date: Jan2014; ATORVASTATIN(GSMs), start date: Jan2014. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid from 30Jun2022 to 04Jul2022. Clinical courses is as follows: 5 days after completion of Paxlovid regimen, patient experienced rebound symptoms-mild body aches, scratchy throat and mild fatigue. Abbott BinaxNOW antigen self-test Positive at 4:40PM / 09Jul2022.
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 non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: known allergies: Ibuprofen; Naproxen, reaction(s): "known allergies: Naproxen", notes: known allergies: Naproxen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not received any other medications/products within 2 weeks of starting COVID-19 treatment. Patient received treatment drug as Paxlovid (lot number=GC8124) from 27Jun2022 to 02Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 71.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 04Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FJ9943) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 11Feb2021 as dose 2, single (Lot number: EL9267), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "kidney stones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Anti viral details included COVID 19 Treatment, (brand was Paxlovid), started on 28Jun2022 to 03Jul2022. Other medication in 2 weeks product was Amlodipine, valsartan, atorvastatin. The patient previously received a COVID-19 Vaccine. It was reported as Covid recurred, positive test. No known allergies were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Feb2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 16Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: FLECAINIDE, start date: 04Nov2020, stop date: 30Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient's other medication in 2weeks product is Flecainide. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient Reported Event: Atrial fibrillation began about 10:00 am, 04Jul and has not stopped. I resumed flecainide 24 hours after stopping Paxlovid. The patient was Not recovered and treatment received for the reported AE: Flecainide restarted 07Jul. The patient did not have any known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
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) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 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 was not reported. The patient took concomitant medications. Past drug history included: Flagyl, reaction(s): "known allergies:Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (01Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient was taking Prozac within 2 weeks of starting COVID-19 treatment also patient had previously received COVID-19 Vaccine. Rebound Covid. Positive test on July 1st after testing negative after treatment on 18Jun, adverse event start date 01Jul2022 and stop date 07Jul2022 with outcome 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 current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Age: 53.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 18Jan2021 as dose 2, single (Lot number: EL3248), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial septal aneurysm" (unspecified if ongoing), notes: Atrial septal aneurysm; "intermittent atrial fibrillation" (unspecified if ongoing), notes: intermittent atrial fibrillation; "premalignant ovarian tumor" (unspecified if ongoing), notes: premalignant ovarian tumor. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 30Jun2022 to 05Jul2022.  Clinical course: The patient had no known allergies. The 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 plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 29.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: EW0171), in left arm and on 11May2021 as dose 2, single (Lot number: EW0183) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), 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 Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Panic disorder" (unspecified if ongoing); "obesity" (unspecified if ongoing); "ptsd" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received Paxlovid from 30Jun2022 to 04Jul2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: patient received COVID 19 Treatment (Paxlovid) from 30Jun2022 to 04Jul2022 for Treatment of COVID-19.  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; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 94-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Anti-viral product Paxlovid (Lot number: FX8140) from 06Jul2022 to 10Jul2022 for COVID 19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Lot number: el0142), at the age of 57 years, on 21Jan2021 as dose 2, single (Lot number: el3302) at the age of 57 years, and on 14Oct2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Post gastric bypass surgery", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; CELEXA [CELECOXIB]; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022 at 05:00, 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. Therapeutic measures were taken as a result of vaccination failure, covid-19 from 29Jun2022 to 03Jul2022. Clinical course: return of COVID symptoms, after taking Paxlovid. Mild cold symptoms after resolution. The patient did have a minor cough with sputum production, but on 10Jul22 significant nasal symptoms, sore throat again. No fever, but she never did have fever. Her antigen test remains positive as of reporting dat is the 14th day since original onset and 16 days from assumed exposure.; Sender's Comments: Based on data provided and temporal association, the reported events are assessed as possibly related to BNT162b2.
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) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FJ8762), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical courses: Anti-viral COVID-19 treatment started from 29Jun2022 to 03Jul2022. Tested positive for COVID (on 09Jul2022) 5 days after testing negative. No treatment was received. No Other medication in 2 weeks.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 23Aug2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient experienced Recurrence of COVID symptoms.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 52.0
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) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Positive, notes: I had rebound tested positive again after 5 day course of plaxovid treatment; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Plaxovid from 24Jun2022 to 29Jun2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.