chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: WM3144) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Then I went into rebound Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medications in two weeks. Anti viral treatment for COVID 19 with Paxlovid (Lot Number: 6D5273) from 18Aug2022 to 23Aug2022. After the first day of Paxlovid patient said that it had helped and was improving. However, a few days after the last dose that seemed to reverse. Then patient went into rebound Covid. Patient think that would not be happened if she had a day or two more of medicine. Patient still have some lung congestion and fatigue. Patient had allergies and other medical history many.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Paxlovid indication : COVID 19 Treatment; Paxlovid indication : COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 at 15:00 as dose 2, single (Lot number: ER8733), in left arm and on 27Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Keflax allergy" (unspecified if ongoing), notes: Known allergies: Keflax. Concomitant medication(s) included: METOPROLOL, start date: 20Dec2019; ELDERBERRY [SAMBUCUS NIGRA FRUIT]; CALCIUM; MAGNESIUM; ZINC; COQ10 [TOCOPHERYL ACETATE;UBIDECARENONE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Paxlovid indication : COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Test positive again approximately 4 days after last negative test; Positive, notes: With round one of covid I tested positive until day 8; Negative, notes: Tested negative day 9 & 10; Negative, notes: Tested negative day 9 & 10. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had taken Paxlovid from 24Aug2022 to 29Aug2022 for the treatment of Covid-19.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Disease recurrence; COVID-19; COVID-19; . This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4275392-00 (Agency).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Thyroid problem" (unspecified if ongoing); "cholesterol problem" (unspecified if ongoing); "seasonal allergies manifested by tiredness" (unspecified if ongoing), notes: seasonal allergies manifested by tiredness; "seasonal allergies manifested by tiredness" (unspecified if ongoing), notes: seasonal allergies manifested by tiredness; "non tobacco user" (unspecified if ongoing); "non-alcohol user" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset Oct2021, outcome "recovering", COVID-19 (medically significant) with onset Oct2021, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (hospitalization, medically significant) with onset Jan2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2021) Positive; (Jan2022) Positive.  The reporter's assessment of the causal relationship of "covid-19" and "disease recurrence" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, covid-19, disease recurrence and the use of suspect product cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Paxlovid :Treatment of COVID-19; Paxlovid :Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 12Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9792), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing), notes: Other medical history: Sleep apnea. Concomitant medication(s) included: ESTRADIOL, start date: 01Mar2020; PROGESTERONE, start date: 01Mar2020. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin, Bactrim DS; Bactrim ds, reaction(s): "Known allergies: Bactrim DS", notes: Known allergies: Amoxicillin, Bactrim DS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid :Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (03Sep2022) Positive, notes: Positive rapid antibody test again day 10; (06Sep2022) Positive, notes: Positive antibody test continue today, day number 13; SARS-CoV-2 test: (Aug2022) Negative, notes: Negative rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had other medication in 2weeks. The patient started Paxlovid (Lot not: 1919255A) treatment from 25Aug2022 to 06Sep2022 for covid-19. The patient had rebound COVID symptoms. Completed 5 day course of Paxlovid started in day 1 after symptoms started. Symptoms were sore throat, body aches, congestion. Negative rapid antigen test and symptoms resolving day number 5 and 6. Developed cough on day 10. Positive rapid antibody test again day 10. Cough, headache, body aches with positive antibody test continue today, day number 13.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Covid vaccine issue/major panic attacks started two weeks after her first vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4527037-00 (AbbVie).  A 51-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "pregnant" (unspecified if ongoing), notes: Other relevant history: Pregnant; "Melanoma" (unspecified if ongoing), notes: She had Melanoma; "miscarriages" (unspecified if ongoing), notes: In past she had miscarriages. The patient's concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious) with onset 17Feb2021, outcome "unknown", described as "major panic attacks started two weeks after her first vaccine".   Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that the event panic attacks was possibly related to Pfizer Biontech COVID-19 vaccine. AbbVie's opinion was that there was no reasonable possibility that the event Covid vaccine issue/ Panic attacks was related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Movement disorder, Neurological symptom
Clinical narrative: Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), ASTHENIA (non-serious), MOVEMENT DISORDER (non-serious), outcome "not recovered" and all described as "Get weak as well as other neurological symptoms and lack of mobility".  Additional information: The reporter was reporting about the possible side effects on his mother (the patient) that have continued for 1.5 years. The patient continues to get weak as well as other neurological symptoms and lack of mobility. The reporters brother in law has identical symptoms as his mother as well as 4 other people in the area. It was not just not the reporters mother but it was brought to his attention that his brother in law and 2 other friends have identical symptoms too. They are young and they forgot how to walk, literally. They report severe headaches all the time, they are just confused, can't keep thoughts in their heads.  The reporter does not know their names only their children. The reporter was doing a job and a customer told him about their mother. she had Alzheimer's prior and after she got the vaccine she got the identical symptoms. They thought it was due to the Alzheimer's and everyone has the same symptoms. The reporter does not know which vaccine they received it was just ironic they are having that too. A total of 4 patients that experienced identical symptoms which he had reported. The first patient is his mother (70 year-old female), the second is his brother-in-law (69 year-old male) and the 3rd and 4th are 2 female patients (both elderly, both over the age of 70, exact ages unknown). Reporter reported that he does not have any other patient information to provide on any of the patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201134938 Same reporter/drug, different patients/event;PFIZER INC-202201135619 Same reporter/drug, different patients/event; PFIZER INC-202201139437 Same reporter/drug/event, different patient;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: stiffness in arm; he had pfizer vaccine and had soreness at site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4210732-00.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "Shoulder soreness/ soreness in shoulder", "covid vaccination site soreness", "stiffness in arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "he had pfizer vaccine and had soreness at site"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "stiffness in arm".  Additional Information: The reaction onset date was in 2021. The patient did not have pain in hands and wrists. The patient's Psoriatic arthritis had improved since skyrizi and had sore muscles from over use.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 27Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 18Aug2021 as dose 3 (booster), single (Lot number: EA6780) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Feb2022 as dose 4 (booster), single (Lot number: 026L21B) for covid-19 immunisation. The patient's relevant medical history included: "Selective IgA Deficiency" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Mod to Severe Asthma" (unspecified if ongoing); "Sjogrens Syndrome" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: ZEGRID, start date: Jan2014, stop date: Sep2022; MONTELUKAST, start date: Jan2016, stop date: 28Aug2022; ESTRADIOL, start date: Jan2020 (ongoing). Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins", notes: known allergies: Cephalosporins; Codeine for known allergies: Codeine, notes: known allergies: Codeine. 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: Positive, notes: Finished Paxlovid on Sept 3 am dose. Reoccurrence of headache and stuffy nose started on Sept 6 pm evening; Positive, notes: Prior negative covid test on Sept 5 pm, current covid positive test as of Sept 7 am; Negative, notes: Prior negative covid test on Sept 5 pm, current covid positive test as of Sept 7 am. Therapeutic measures were taken as a result of vaccination failure.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 12Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 27Sep2021 at 15:45 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 11Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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: (28Aug2022) Positive, notes: first testing positive on anti-gen test 28Aug2022; (03Sep2022) Negative, notes: after testing negative starting 03Sep2022; (07Sep2022) Positive, notes: Tested positive again or Covid-19 via antigen test on 07Sep2022; (unspecified date) Positive, notes: COVID 19 Treatment.  Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Paxlovid rebound. Headache, Blocked and runny nose, sneezing, coughing with mild phlegm. No fever yet. Tested positive again for Covid-19 via antigen test on 07Sep2022 after testing negative starting 03Sep2022 following completion Paxlovid course after first testing positive on anti-gen test 28Aug2022.  No Follow-up attempts are possible No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893) 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), 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: "COPD" (unspecified if ongoing); "heart disease" (unspecified if ongoing). The patient had no known allergies. Concomitant medications included: BREZTRI AEROSPHERE, start date: 25Jan2022; LEXAPRO, start date: 29Jul2020; ZETIA, start date: 04Jun2020; POTASSIUM CHLORIDE, start date: 27Apr2020; PROAIR HFA resp inhalation, start date: 31Mar2020; LIPITOR, start date: 31Mar2020; VIBRAMYCIN [DOXYCYCLINE HYCLATE], start date: 30Mar2020; K-DUR, start date: 27Apr2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, which included anti viral COVID 19 treatment with Paxlovid from 18Aug2022 to 22Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 with Paxlovid. 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Myalgia, SARS-CoV-2 test
Clinical narrative: very rapid heart beat that lasted about 2 days/increased heart rate; ongoing chronic sweats; muscle aches; 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), on 23Nov2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mitro valve prolapse" (unspecified if ongoing); "heart murmer" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; AZELASTINE HCL. Past drug history included: Epinephrine, reaction(s): "allergy", notes: anything with epinephrine or phine ending; Epinephrine, reaction(s): "makes my heart race", notes: anything with epinephrine or phine ending; Neosporin, reaction(s): "allergy"; Metronidazole, reaction(s): "allergy", notes: topical. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP7533, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8735, Vaccine location: Left arm), administration date: 21Apr2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 24Nov2021, outcome "recovered" (Nov2021), described as "muscle aches"; HYPERHIDROSIS (non-serious) with onset 24Nov2021, outcome "recovered" (Dec2021), described as "ongoing chronic sweats"; HEART RATE INCREASED (non-serious) with onset 24Nov2021, outcome "recovered" (Nov2021), described as "very rapid heart beat that lasted about 2 days/increased heart rate". The events "very rapid heart beat that lasted about 2 days/increased heart rate", "ongoing chronic sweats" and "muscle aches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient experienced very rapid heart beat that lasted about 2 days. She also had ongoing chronic sweats and muscle aches. The increased heart rate and muscle aches subsided in 2-3 days. The ongoing sweats decreased each week until at week 4, she didn't have them anymore. The patient never had sweats before or after the vaccine. The patient did not receive any other vaccines in four weeks. The patient called the cardiologist who asked her to monitor.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: chronic tinnitus; This is a spontaneous report received from a contactable reporter consumer or other non HCP. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2021 as dose 2, single (Lot number: FF2588) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies", notes: known allergies: docxycycline. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: fa7485), administration date: 06Aug2021, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "chronic tinnitus". The event "chronic tinnitus" required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: No other vaccine in four weeks and No other medications in two weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101144990 same reporter/patient/product, different dose/AEs;
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Antiviral details Product: Paxlovid, COVID 19 Treatment: Treatment start date: 05Sep2022 Indication: Treatment of COVID-19. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 17:30 as dose 1, single (Lot number: EC9201), in left arm, on 18Feb2021 at 17:15 as dose 2, single (Lot number: EN6201), in left arm, on 30Sep2021 at 13:30 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 22Jun2022 at 11:30 as dose 4 (booster), single (Lot number: FN2908) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: NSAIDs" (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: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: Rebound positive 8 days after negative. Treated with Paxlovid; (07Sep2022) Positive, notes: Rebound positive 8 days after negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was unknown if the patient received other medication in 2weeks. Patient received Paxlovid for treatment of COVID-19 from 24Aug2022 to 29Aug2022. On 07Sep2022, at11:30 AM patient had Rebound positive 8 days after negative. Treated with Paxlovid.
Age: 41.0
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 04May2021 as dose 2, single (Lot number: EW0172), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2583), in left arm and on 22Feb2022 as dose 4 (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: "Seizures" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Over active bladder" (unspecified if ongoing); "Known allergies: Sulfas" (unspecified if ongoing), notes: Known allergies: Sulfas, Penacillin, Octopus, Squid, Casein, Whey, Chickpea; "Known allergies: Penacillin" (unspecified if ongoing); "Known allergies: Octopus" (unspecified if ongoing); "Known allergies: Squid" (unspecified if ongoing); "Known allergies: Casein" (unspecified if ongoing); "Known allergies: Whey" (unspecified if ongoing); "Known allergies: Chickpea" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; MARIJUANA; PEPCIDAC; TROKENDI XR; OXYBUTIN; NALTREXONE. The following information was reported: VACCINATION FAILURE (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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:The patient had taken Other medication in 2 weeks.Patient taken Paxlovid treatment for Covid-19 started on 05Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Adenoid Cystic Carcinoma." (unspecified if ongoing); "Mango allergy" (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: (07Sep2022) Positive, notes: Retested today (07Sep) due to sinus drainage. Positive at home test received(BinaxNow); (unspecified date) Positive, notes: COVID 19 Treatment; (04Sep2022) Negative, notes: Tested negative on 04Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti-viral COVID-19 treatment with Paxlovid from 29Aug2022 to 04Sep2022. Other medication in 2 weeks were unknown. Rebound positive after Paxlovid treatment. Tested negative on 04Sep2022. Retested today (07Sep) due to sinus drainage. Positive at home test received (BinaxNow).  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 04:30 as dose 4 (booster), single (Lot number: EL3247) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in two weeks. On 06Sep2022 patient received treatment of Paxlovid for Covid-19.
Age: 69.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 at 11:00 as dose 1, single (Lot number: EV9267), in right arm, on 15Mar2021 at 11:00 as dose 2, single (Lot number: EN6205), in right arm, on 24Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 09May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer-mastectomy", start date: Feb2021 (unspecified if ongoing); "Breast cancer-mastectomy", start date: Feb2021 (unspecified if ongoing); "Knee replacement", start date: Apr2022 (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: RALOXIFENE, start date: 15Jun2022; THYROID T3, start date: 08Jan2001; THYROXINE, start date: 08Jan2001. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022 at 15:00, outcome "recovered" (Sep2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive; (03Sep2022) Negative; (04Sep2022) Negative; (05Sep2022) Negative; (06Sep2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid for 5 days. Tested negative for 4 days after completion.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 test positive; COVID-19 test positive; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 21Aug2022, outcome "recovered" and all described as "COVID-19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive, notes: he counts the first day as 21Aug2022; (22Aug2022) Positive, notes: COVID back on probably the 1st day was 22Aug2022 and took Paxlovid immediately that day. Therapeutic measures were taken as a result of COVID-19.  Clinical course details: The patient was fully vaccinated and boosted and came down with COVID back on probably the 1st day was 22Aug2022 and took Paxlovid immediately that day and took a five day full course and finished on 26Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Age: 44.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: EW0172) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: my antigen tests still showed positive, but they were very faint lines and getting progressively fainter; (Sep2022) Positive, notes: antigen test result began showing a brighter positive line. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient experienced cough with phlegm in Aug2022 and is subsumed as Symptom under COVID-19. Patient did not had any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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) all with onset Aug2022, 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: Paxlovid used for treatment of COVID-19  from 27Aug2022 to 01Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 13:15 as dose 1, single (Lot number: el9263), in left arm, on 11Feb2021 at 14:30 as dose 2, single (Lot number: em9809), in left arm, on 30Sep2021 at 12:15 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 04Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillium allergy" (unspecified if ongoing), notes: Penicillium allergy. Concomitant medication(s) included: RALOXIFENE, start date: 01Aug2014; SOLIFENACIN, start date: 01Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: two negative tests; Negative, notes: two negative tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment start date:23Aug2022, Treatment stop date: 27Aug2022, Indication: Treatment of COVID-19.
Age: 62.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER8737), in right arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinusitis" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) (Other medication in 2weeks) included: THYROXIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from Aug2022 to Aug2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: rebound of Covid/had a positive test; rebound of Covid/had a positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EN6207), in left arm and on 23Apr2021 as dose 2, single (Lot number: EL9262) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Nov2021 as dose 3 (booster), single (Lot number: 052E21A), in left arm and on 04Jun2022 at 10:00 as dose 4 (booster), single (Lot number: 058A22-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "other than menstrual migraine" (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 "rebound of Covid/had a positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive, notes: I received faintly positive tests on 31Aug2022and 01Sep2022; (01Sep2022) Positive, notes: I received faintly positive tests on 31Aug2022and 01Sep2022; (02Sep2022) Negative, notes: followed by a negative test on 02Sep2022; (03Sep2022) Positive, notes: Then I had a positive test on 03Sep2022, followed by onset of symptoms; (07Sep2022) Positive, notes: I am still positive as of today, 07Sep2022, and still experiencing symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: I experienced a rebound of Covid symptoms after recovering from all symptoms and having a negative test. I received faintly positive tests on 31Aug2022 and 01Sep2022, followed by a negative test on 02Sep2022. Then I had a positive test on 03Sep2022, followed by onset of symptoms. I am still positive as of today, 07Sep2022, and still experiencing symptoms.Paxlovid (start date: 26Aug2022, stop date: 31Aug2022)
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) in 2 weeks included: ZOLOFT, start date: 01May2022; ORTHO MICRONOR, start date: 01Apr2022. The patient was not pregnant at the time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 27Aug2022 and treatment stopped on 01Sep2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.