chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 years, in left arm for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 27Feb2021 as dose 2, single (Lot number: 023M20A), in left arm and on 16Sep2021 as dose 3 (booster), single (Lot number: 026C21A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Interchange of Vaccine Products" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "known allergies: clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medi-cally significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treat-ment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive; (Jun2022) Positive. Therapeutic measures were taken as a re-sult of drug ineffective, covid-19. Patient had received anti-viral medication (Paxlovid) for COVID-19 Treatment which was started on14Jun2022 and stop date was 19Jun2022.
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 71 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: "known allergies Penicillin" (unspecified if ongoing), notes: Verbatim:known allergies Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Start date of treatment for COVID-19 was 20Jun2022. Stop date of treatment for COVID-19 was 25Jun2022. The patient previously received a COVID-19 Vaccine. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 64.0
Sex: M
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 66-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 at 14:00 as dose 1, single (Lot number: ER8729), in right arm, on 01May2021 at 13:00 as dose 2, single (Lot number: EW0170), in right arm and on 04Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FG3527) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 065k21a) for covid-19 immunisation. The patient's relevant medical history included: "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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She has had 4 Pfizer shots and boosters./ she finished her doses last night; She has had 4 Pfizer shots and boosters./ she finished her doses last night; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: ELU142), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL3247), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: EW0198), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "She has an autoimmune disease and was high risk" (unspecified if ongoing). Concomitant medication included: HYDROXYCHLOROQUINE oral taken for rheumatoid arthritis, she initially was taking 2 tablets and she felt funny and switched it to 1 tablet, the product is in a pharmacy vial, she did not take it within 4 hours of taking the Paxlovid though. She has been on the medication for about a year. Patient has had 4 Pfizer shots and boosters. She had COVID after receiving 4 doses of the Pfizer COVID-19 vaccine. She had their grandchildren and they all had COVID and between last Saturday night to Sunday morning (25Jun2022-26Jun2022) she tested positive with symptoms. She was dispensed Paxlovid 5-day treatment regimen and finished her doses of Paxlovid last night (30Jun2022) and today (01Jul2022) she woke up and was very dizzy and nauseated today (AER# 202200920594). Outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: Narcotic pain medication" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral product for COVID 19 Treatment was Pfizer brand Paxlovid from 15Jun2022 to 20Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 16Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: bees" (unspecified if ongoing); "known allergies: Cranberries" (unspecified if ongoing); "known allergies: Coconut" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ambien, reaction(s): "known allergies: Ambien"; Codeine, reaction(s): "known allergies: Codeine"; Vancomycin, reaction(s): "known allergies: Vancomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The lot number was unknown since unable to get. The patient received Paxlovid for COVID 19 treatment. The patient had known allergies Ambien, Codeine, Clarinex,Vancomycin, Coconut, Cranberries, bees.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "FMD"(Foot and mouth disease) (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. COVID rebound. Positive test after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid to treat drug ineffective, covid-19. Treatment start date: 22Jun2022, treatment stop date: 26Jun2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EK4176), in right arm, on 29Jan2021 as dose 2, single (Lot number: EL9262), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure-mild" (unspecified if ongoing), notes: high blood pressure-mild; "significant childhood asthma" (unspecified if ongoing), notes: significant childhood asthma; "kidney stones" (unspecified if ongoing), notes: kidney stones; "Elevated BMI" (unspecified if ongoing), notes: elevated BMI. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROTONIX [OMEPRAZOLE]; LEVOTHYROXINE; QNASL nasal. 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, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information expected.
Age: 37.0
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) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: ej1686) and on 15Jan2021 as dose 2, single (Lot number: el3248) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Dec2021 as dose 3 (booster), single (Lot number: 030h21b) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. 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: (unspecified date) Unknown result; (30Jun2022) positive, notes: covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other medications within 2 weeks of vaccination. The patient has no reported allergies. Reportedly rebound COVID. Felt fine on day 5 of Paxlovid (Day 6 of illness). Mild symptoms started day 10, more severe day 11.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had positive home test for COVID on 24Jun2022; had positive home test for COVID on 24Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 16Apr2021 as dose 2, single (Lot number: FW0151), in left arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 18Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus II" (unspecified if ongoing), notes: diabetes mellitus II; "Hypothyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. The patient's concomitant medications were not reported. Past drug history included: Metformin, reaction(s): "Known allergies: Metformin", notes: Known allergies: Metformin; Januvia, reaction(s): "Known allergies: Januvia", notes: Known allergies: Januvia; Lipitor, reaction(s): "Known allergies: Januvia", notes: Known allergies: lipitor. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "had positive home test for COVID on 24Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (29Jun2022) with no symptoms, notes: tested clear on June 29Jun2022 with no symptoms (home test.); (30Jun2022) with no symptoms, notes: tested clear on 30Jun20222 with no symptoms (home test); (03Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had positive home test for COVID on 24Jun2022. started paxlovid on 24Jun2022 (two doses on start date). Finished Course on 28Jun2022. tested clear on 29Jun2022 with no symptoms (home test.) tested clear on 30Jun2022 with no symptoms (home test). woke ups Sunday 03Jul2022 with stuffy/runny nose and scratchy throat. feeling woozily in the head. took home test. Positive for COVID. Patient received other medications within two weeks of vaccination were reported as Levothyroxine 0.125 mg, started on 01Jun2022; losartan 100mg, started on 01Jun2022; metoprolol succinate 50 mg, started on 01Jun2022; hydrochlorothiazide 25 mg, started on 01Jun2022; Allerfex, started on 01Jun2022 with lot number: 1kr0449; Meloxicam, started on 01Jun2022; Tylenol 500 xrta strength started on 01Jun2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (treated with Paxlovid from 29Jun2022 to 30Jun2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 symptoms started 28Jun2022-29Jun2022/Tested positive for COVID on 30Jun2022; COVID-19 symptoms started 28Jun2022-29Jun2022/Tested positive for COVID on 30Jun2022; This is a spontaneous report received from contactable reporter (Physician). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 18Dec2020 as dose 1, single (Lot number: Eh9899), in left arm, on 15Jan2021 as dose 2, single (Lot number: El1284), in left arm and on 19Aug2021 as dose 3 (booster), single (Lot number: Fd8448) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Persistent asthma" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Infertility" (unspecified if ongoing); "Rosacea" (unspecified if ongoing). No known allergies. Concomitant medications included: ADDERALL; METFORMIN; AZELAIC ACID; IBUPROFEN; ALKA-SELTZER PLUS COLD & FLU MEDICINE; OMEPRAZOLE; FLOVENT; ALBUTEROL [SALBUTAMOL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Patient received vaccine in four weeks and other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "COVID-19 symptoms started 28Jun2022-29Jun2022/Tested positive for COVID on 30Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid. Clinical course: COVID-19 symptoms started 28Jun2022-29Jun2022. Tested positive for COVID on 30Jun2022. Started Paxlovid on 01Jul2022. Within a few hours of starting Paxlovid noted a terrible taste in the mouth and stinging sensation on anterior 1/3 of the tongue. Neither had been present before and worsened with each dose. When taking the fourth dose she noted the anterior 1/3 of her tongue was red and blistered. She was unsure if this had been present since the taste/stinging started as she had not looked in the mirror before the 4th dose.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 13:00 as dose 1, single (Lot number: EN6208), in right arm, on 02Apr2021 at 13:00 as dose 2, single (Lot number: ER8733), in right arm, on 07Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FG3527), in right arm and on 29Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "known allergies: Ciprofloxacin"; Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Naproxen, reaction(s): "known allergies: Naproxen". The following information was reported: VACCINATION FAILURE (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: I never completely tested negative after my last dose. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information expected.
Age: 41.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL1284), in right arm, on 19Jan2021 as dose 2, single (Lot number: EL3302), in right arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: Unknown results, notes: Indication: Covid-19 treatment; negative; positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Rebound COVID occurred at 4 days following completion of Paxlovid treatment and was confirmed through home antigen test. Previous negative home antigen and negative PCR tests were received 4 days following initial infection on the date Paxlovid treatment was completed (6/26). Current symptoms include headache, sore throat, body aches, running nose, congestion and fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable Physician. A 41-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) 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: "Chronic Hep B" (unspecified if ongoing). There were no concomitant medications.Patient did not have other medication in 2weeks. Patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Patient received Paxlovid as covid treatment from 23Jun2022 to 28Jun2022.   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: 45.0
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 a contactable reporter (Consumer or other non- HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 05Apr2021 as dose 2, single (Lot number: ER8734), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 45 years (as of dose 1 and dose 2), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medications included: MONTELUKAST; ALBUTEROL HFA; MOMETASONE; CLINDAMYCIN. The following information was reported: COVID-19 (medically significant) with onset 20Jun2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive; (21Jun2022) Positive; (24Jun2022) Positive; (26Jun2022) Positive; (27Jun2022) Negative; (29Jun2022) Negative; (30Jun2022) Positive; (01Jul2022) Positive; (02Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included: nirmatrelvir; ritonavir (PAXLOVID). Clinical course: tested positive on 20Jun2022. Took nirmatrelvir; ritonavir from 21Jun2022 to 25Jun2022. Significant symptoms initially that improved and then resolved with nirmatrelvir; ritonavir. Tested positive on 21Jun2022, 24Jun2022, and 26Jun2022. Tested negative and symptom-free 27Jun2022 and 29Jun2022. Symptoms returned late in the day on 29Jun2022. Tested positive 30Jun2022, 01Jul2022, and 02Jul2022. Mild symptoms so far in second round.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: first testing positive for Covid (severe symptoms: fever is 103 every day/ bad headache/ pain/ sick); first testing positive for Covid (severe symptoms: fever is 103 every day/ bad headache/ pain/ sick); This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 at 20:30 as dose 1, single (Lot number: EL3246), in right arm, on 05Feb2021 as dose 2, single (Lot number: FM981D), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 06May2022 at 16:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "bladder cancer" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "allergies", notes: Known allergies: Fentanyl and other narcotics. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "first testing positive for Covid (severe symptoms: fever is 103 every day/ bad headache/ pain/ sick)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: after taking Paxlovid for five days; (Jun2022) Positive, notes: first testing positive; (20Jun2022) Positive, notes: tested positive again 11 days from first testing positive for Covid; Body temperature: (unspecified date) 103. Therapeutic measures were taken as a result of vaccination failure, covid-19. The clinical course was reported as follows: After taking Paxlovid for five days, the entire course, and testing negative, 11 days from first testing positive for Covid, I tested positive again, and had more severe symptoms. My fever is 103 every day, even taking Tylenol. I have a bad headache. I did not need to take any other medication for pain or fever while taking Paxlovid. But then when I became sick the second time, it was more severe symptoms. I need to use an inhaler because of restricted breathing.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22May2021 as dose 2, single (Batch/Lot number: unknown), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Jan2010, stop date: Jul2022; ATORVASTATIN, start date: Jan2010, stop date: Jul2022; LOSARTAN, start date: Jan2010, stop date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (30Jun2022) Negative, notes: tested negative for Covid 3 days after completing treatment; (02Jul2022) Positive, notes: tested positive for Covid 5 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient had no known allergies. Patient experienced Covid rebound 5 days after completing treatment. Tested negative for Covid 3 days after completing treatment and then tested positive for Covid 5 days after completing treatment. Anti viral for COVID 19 Treatment included Paxlovid, from 23Jun2022 to 27Jun2022, lot number=GA5109. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3249), in right arm, on 03Mar2021 as dose 2, single (Lot number: EM9810), in right arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received covid treatment from 20Jun2022 to 26Jun2022.
Age: 61.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL0142), in right arm, on 27Jan2021 as dose 2, single (Lot number: EL9265), in right arm and on 14Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 61 years, in right 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 02Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient experienced recurrent COVID symptoms and positive test after Paxlovid. Anti viral products included COVID 19 Treatment (brand: Pfizer) from 22Jun2022 to 27Jun2022. Patient had no known allergies.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 21Jun2022 to 26Jun2022. Additional information: the patient had rebound and spread to other family members without knowledge when rebounded since 30Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID test after almost negative test; Positive COVID test after almost negative test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022 at 12:00, outcome "not recovered" and all described as "Positive COVID test after almost negative test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Positive COVID test after almost negative test; (03Jul2022) Positive, notes: 12:00: Positive COVID test after almost negative test. 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: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), on 17Apr2021 at 09:00 as dose 2, single (Lot number: EW0151) at the age of 25 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (manufacturer unknown), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "recovering" and all described as "tested positive for COVID". The patient first tested positive for COVID on 18Jun2022 and started Paxlovid the same day. He fully completed 5-day course of Paxlovid and the symptoms had improve greatly on this day. On 25Jun2022, 7 days after testing positive, the patient tested negative. Then on 02Jul2022, 7 days after first testing negative, he tested positive again and had symptoms of fatigue and nasal congestion. The patient was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH3080) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing). No Known allergies. Concomitant medication(s) in 2 weeks product included: LOSARTAN; CITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Experiencing mild cold like symptoms and a positive covid test after taking Paxlovid and previously testing negative. The patient received COVID 19 Treatment: Paxlovid from 21Jun2022 to 26Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received the first and second dose of the Covid-19 vaccine as well as the booster dose. Unfortunately, she tested positive with covid; Received the first and second dose of the Covid-19 vaccine as well as the booster dose. Unfortunately, she tested positive with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Received the first and second dose of the Covid-19 vaccine as well as the booster dose. Unfortunately, she tested positive with covid". The patient had both of her Pfizer shots and she had both of her booster shots and went Tuesday and she tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Malaise, Oropharyngeal pain, SARS-CoV-2 antibody test
Clinical narrative: Self Test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes; Self Test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes; I felt ill, super fatigued with a sore throat.; I felt ill, super fatigued with a sore throat.; I felt ill, super fatigued with a sore throat.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EL3247), on 30Mar2021 as dose 2, single (Lot number: EpG955) and on 11Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious), FATIGUE (non-serious), MALAISE (non-serious) all with onset 20Jun2022, outcome "recovering" and all described as "I felt ill, super fatigued with a sore throat."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "unknown" and all described as "Self Test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of oropharyngeal pain, fatigue, malaise. No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Self Test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes; Self Test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes; I felt ill, super fatigued with a sore throat.; I felt ill, super fatigued with a sore throat.; I felt ill, super fatigued with a sore throat.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EL3247), on 30Mar2021 as dose 2, single (Lot number: EpG955) and on 11Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious), FATIGUE (non-serious), MALAISE (non-serious) all with onset 20Jun2022, outcome "recovering" and all described as "I felt ill, super fatigued with a sore throat."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "unknown" and all described as "Self Test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of oropharyngeal pain, fatigue, malaise. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 61-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Lot number: EL9262), on 06Mar2021 as dose 2, single (Lot number: EN6199) and on 25Aug2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 4 (booster), single (Lot number: 041J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) in 2weeks included: HUMIRA, start date: 25Jan2017; METHOTREXATE (brand: Accord Healthcare), start date: 25Jan2017; DOXYCYCLINE (brand: Heritage), start date: 01Feb2021; LOSARTAN (brand: Zydus), start date: 06May2015; TYLENOL (brand: abbvie), start date: 25Jan2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient received Paxlovid as COVID 19 treatment from 21Jun2022 to 26Jun2022. First symptoms were scratchy throat, then body aches and fatigue. Rebound effects: cough and body aches. Events did not result in emergency room visit or physician office visit. Patient did not have known allergies.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), 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 included: "Lupus" (unspecified if ongoing); "sjodgrens" (unspecified if ongoing); "autoimmune neutropenia" (unspecified if ongoing); "Inflammatory arthritis" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 19Jun2022 to 24Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.