chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech dose 3 / Treatment of COVID-19; Pfizer / BioNTech dose 3 / Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 21 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "autism" (unspecified if ongoing); "adhd" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "vocal cord dysfunction" (unspecified if ongoing); "known allergies: Almonds" (unspecified if ongoing), notes: known allergies: Almonds; "Allergy" (unspecified if ongoing); "Birth control pill" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity, start date: 22Aug2014. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "recovered" and all described as "Pfizer / BioNTech dose 3 / Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received other medication in 2weeks. The patient received COVID 19 Treatment, (Paxlovid) from 03Jun2022 to 07Jun2022 for treatment of COVID-19. Adverse event I am experiencing rebound symptoms. I am day 12 of my covid illness and was symptom free since day 6. I tested negative day 10, but test positive day 12 after having new onset of symptoms (runny nose, sneezing, congestion, headache, fatigue, SOB). I likely exposed 4 different people today.  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 event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ornithine transcarbamoylase deficiency" (unspecified if ongoing); "known allergies: Shrimp" (unspecified if on-going), notes: known allergies: Shrimp. Concomitant medication(s) included: ACETAMINOPHEN EXTRA STRENGTH; TYLENOL; VITAMIN D3; ZINC received in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: [product COVID 19 Treatment, brand Paxlovid], treatment start date: 13Jun2022, indication: Treatment of COVID-19. Adverse event: Wicked bad taste in mouth, similar to the taste when Tylenol or vitamins get caught in the throat mid-swallow. No treatment received for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: ew0172) and as dose 3 (booster), single (Lot number: en6200) at the age of 33 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 and 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: Tested positive; Negative, notes: negative test on the day previously. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient did not received any other medication in 2weeks. The patient received COVID 19 Treatment, (Paxlovid) from 06Jun2022 to 11Jun2022 for the treatment of COVID-19. Patient tested positive and symptoms returned after a negative test on the day previously.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2 weeks. The patient was treated with paxlovid from 12Jun2022 for the events. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 69 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: "seasonal allergies" (unspecified if ongoing); "Allergy to sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "known allergies: mussels" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy"; Cefazolin sodium, reaction(s): "Allergy"; Bee venom, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received vaccine. The patient had not received other medication in two weeks:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, SARS-CoV-2 test, Vertigo
Clinical narrative: Dizziness; Vertigo; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Trout and barley" (unspecified if ongoing); "Depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "I always have low blood pressure" (unspecified if ongoing); "known allergies: Trout and barley" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Anatomical location: Left arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot Number: UNKNOWN; Anatomical location: Right arm), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Jun2022, outcome "unknown"; VERTIGO (non-serious) with onset Jun2022, outcome "unknown"; HYPERTENSION (non-serious) with onset Jun2022, outcome "unknown", described as "high blood pressure". The events "dizziness", "vertigo" and "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient experienced the events and ended up going to doctor. The dizziness started after she received shot. The patient did not receive any other vaccine in four weeks. It was reported that the patient received (unspecified) other medications in two weeks. The patient did not have COVID prior to vaccination. The patient underwent COVID test post vaccination.  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, COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "scleroderma" (unspecified if ongoing); "myasthenia gravis" (unspecified if ongoing); "Immune compromised" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergy: most pain meds" (unspecified if ongoing); "Immune suppression" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; MESTINON; AZATHIOPRINE taken for immunosuppression, stop date: 04Jun2022; DYAZIDE, stop date: 04Jun2022; DILTIAZEM, stop date: 04Jun2022; PANTOPRAZOLE. 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: Oxygen saturation: (unspecified date) Low, notes: low O2; SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (10Jun2022) Negative, notes: By day 7 I was testing negative until day 9; (13Jun2022) Positive, notes: tested weak positive Day 10; (14Jun2022) Positive, notes: tested weak positive Day 10 and 11 (today) strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Felt better 6 hours after the first dose of Paxlovid. By day 7 she was testing negative until day 9 when she started with all the symptoms again and tested weak positive Day 10 and 11 (today) strong positive and feeling as bad as day 1. Paxlovid rebound for sure. Difficulty breathing and low O2. Trying to manage at home with inhalers and steroids but instructed to go to the hospital if it gets worse. Other medication received in 2weeks product received was Steroid, Immune suppression, Water pill and in 2weeks stopped on 04Jun2022. Paxlovid treatment started on 04Jun2022 and stopped on 08Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FJY989) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose 3 (booster), single (Lot number: 033h21a) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Dairy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Gluten, reaction(s): "Known allergies: Gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "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; (13Jun2022) negative. Therapeutic measures were taken as a result of suspected covid-19 included Paxlovid.  Clinical information: No other medication in 2weeks. Adverse event description: Experienced Covid-19 rebound 3 days after finishing 5 day regiment of Paxlovid. Testing negative 13Jun2022, however feeling extremely fatigued, brain fog. My wife contracted Covid-19 4 days after my infection. She too took Paxlovid, experienced rebound similar to myself and was still fighting virus. Anti-viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: 19May2022, treatment stop date: 23May2022, indication: treatment of COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 22May2021 as dose 2 , single (Lot number: EN6199), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 14May2022 at 10:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies; Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 15Jun2017, stop date: 10Jun2022; PRAVASTATIN SODIUM, start date: 15Jun2017, stop date: 10Jun2022; ESTRADIOL, start date: 15Jun2017, stop date: 10Jun2022; NORTRIPTYLINE HCL, start date: 15Jun2017, stop date: 10Jun2022; ACTONEL, start date: 15Jun2017, stop date: 10Jun2022.  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: home test still positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported a patient had rebound of symptoms (runny nose, congestion, cough).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: extreme vertigo beginning the following day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies adhesives" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; VITAMIN D NOS. Vaccination history included: Bnt162b2 (Dose 1, unknown manufacturer), for Covid-19 immunization; Bnt162b2 (Dose 2, unknown manufacturer), for Covid-19 immunization; Bnt162b2 (Dose 3, unknown manufacturer), for Covid-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 12Jun2022 at 08:00, outcome "recovered", described as "extreme vertigo beginning the following day". Therapeutic measures were not taken as a result of vertigo.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller asking the efficacy of the second Pfizer COVID 19 Booster during the time a patient actively has covid?; Caller asking the efficacy of the second Pfizer COVID 19 Booster during the time a patient actively has covid?; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. 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), outcome "unknown" and all described as "Caller asking the efficacy of the second Pfizer COVID 19 Booster during the time a patient actively has covid?".  Additional information: Reporter voiced the vaccine was 95% effective throughout year. Now it's ran down with the first and second boosters. Reporter also voiced that she has encountered several people who have tested positive with covid even after the boosters.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Inflammation
Clinical narrative: This is a spontaneous report received from noncontactable consumer or other non-HCP. A male patient received the 4th dose (second booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st, 2nd and 3rd (first booster) of the COVID-19 vaccine (manufacturer unknown), for immunization. The patient experienced inflammation (inflammatory issues), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: The caller stated their father got the 4th dose of Pfizer COVID-19 vaccine. He and his doctors suspect the vaccine may have caused some sort of autoimmune issue in his body. He is concerned about his increased blood cell counts. He is seeing a hematologist now doing tests for leukemia. The caller stated they called to report his side effects of vaccination, and to ask if Pfizer has any specialist/doctor to refer the patient for the treatment of inflammatory issues. Caller referred back to their father's PCP or hematologist, as Pfizer is unable to make any specific treatment recommendations for individual patients. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: bottom ofhis feet started hurting and continue to hurt; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "bottom ofhis feet started hurting and continue to hurt". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: This report was about COVID Vaccine. Patient did receive the vaccine. Lot number was unknown because not available/provided to reporter at the time of report completion. It was unknown whether the patient received other vaccine in four weeks. It was unknown about covid prior vaccination. It was unknown whether covid tested post vaccination  No Follow-up attempts are possible. Information about lot/batch cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE, start date: 01Jun2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 42 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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(s) (Pharmacist).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "paroxysmal atrial fibrillation" (unspecified if ongoing); "non-Hodgkins lymphoma", start date: 1980 (unspecified if ongoing), notes: (diagnosed and treated in 1980). The patient took concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (10Jun2022) Negative; (12Jun2022) Negative; (14Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : On 04Jun2022 patient received Anti viral Paxlovid as covid treatment. treatment stop date is 09Jun2022. patient received other medication as Metoprolol succinate via oral route. start date of Metoprolol succinate was 01oct2019. Adverse event: After completing 5 day course of Paxlovid therapy on 09Jun22, patient had 2 negative rapid antigen tests (10Jun22 and 12Jun22) and had been afebrile since 06Jun22). On 14Jun22, symptoms of nasal congestion and fatigue returned and rapid antigen test was positive. Patient advised to isolate for 5 days and wear a mask until day 10. Other medical history: paroxysmal atrial fibrillation, history of non-Hodgkin's lymphoma (diagnosed and treated in 1980)  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 information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2020 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Jan2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NUVARING, start date: 01Jun2022; FLUOXETINE, start date: 01Jul2021. 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: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had treatment of Paxlovid on 13Jun2022 for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: "Rebound" covid infection; "Rebound" covid infection; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 01May2021 as dose 2, single (Lot number: EW0171) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 03Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FEROSUL; VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as ""Rebound" covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (06Jun2022) Negative, notes: PCR; (12Jun2022) Positive, notes: PCR; (13Jun2022) Positive, notes: rapid; (04Jun2022) Negative, notes: rapid; (05Jun2022) Negative, notes: rapid; (11Jun2022) Positive, notes: rapid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No known allergies.  "Rebound" covid infection. After initial infection and during/after her course of Paxlovid from 31May2022 to 05Jun2022 as treatment of COVID-19, she tested negative for covid on 04Jun (rapid), 05Jun (rapid), and 06Jun (PCR). She began feeling sick again approximately 10Jun2022 and tested positive for covid on 11Jun2022 (rapid), 12Jun2022 (PCR), and 13Jun2022 (rapid). Still symptomatic as of 14Jun2022. No treatment received. Patient has not recovered.
Age: 64.0
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) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6201), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: EW0185), in left arm and on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", stop date: 2008, notes: Breast cancer (cancer free since 2008), acoustic neuroma surgery (2014).; "acoustic neuroma surgery" (unspecified if ongoing), notes: Breast cancer (cancer free since 2008), acoustic neuroma surgery (2014).; "known allergies: Shrimp" (unspecified if ongoing), notes: known allergies: Shrimp; "known allergies: contrast dye" (unspecified if ongoing), notes: known allergies: contrast dye. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19. Anti-viral details reported as COVID 19 Treatment, treatment start date was 04Jun2022, treatment stop date was 08Jun2022 and indication was treatment of COVID-19. Other medication in 2weeks reported as no. No chronic health conditions.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 29Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: other medical history: thyroid; "diabetes" (unspecified if ongoing), notes: other medical history: diabetes; "7 stent" (unspecified if ongoing), notes: other medical history: 7 stent; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: ASPIRIN 81; CENTRUM FOR WOMEN; FUROSEMIDE; IRON; JARDIANCE; LEVOTHYROXINE; LOSARTAN POTASSIUM; METFORMIN HCL; METOPROLOL TARTRATE; VITAMIN C 1000 PLUS ZINC & BIOFLAVONOIDS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "adhd" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing). Concomitant medication(s) included: TRIAZOLAM, start date: 01Mar2013, stop date: 27May2022; METHYLPHENIDATE, start date: 01Mar2022; CONCERTA, start date: 01Jan2022; PRISTIQ, start date: 11May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive again; (02Jun2022) Negative, notes: I tested negative 02Jun; (06Jun2022) Positive, notes: Then 06Jun tested positive again; (14Jun2022) Positive, notes: Now 14Jun still testing positive. 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.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Hypogonadism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 13Jun2022, outcome "recovering" 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 drug ineffective, covid-19.  Clinical course: Patient tested positive and felt sick on 13Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: RAT testing positive; RAT testing positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 16May2021 as dose 1, single (Batch/Lot number: unknown) and on 25Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "RAT testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (07Jun2022) Negative; (13Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient symptoms resolved with paxlovid tested negative RAT on 07Jun, symptoms returned 13Jun and RAT testing positive. COVID 19 Treatment with Paxlovid. Treatment start date from 02Jun2022 to treatment stop date 07Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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: (unspecified date) Unknown results; (Jun2022) Positive; (Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. No other medication in 2 weeks. Return of covid symptoms and a positive test exactly one week after finishing treatment (5 day supply). Patient previously tested negative for covid 19 after finishing course of treatment last week. Paxlovid given from 02Jun2022 till 06Jun2022 for the 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: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive after taking the Pfizer Covid 19 vaccine; She tested positive after taking the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old 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 included: "I have the hearing problem" (unspecified if ongoing), notes: Consumer stated, I have the hearing problem. I can't really hear you. I have put on hearing aid; "hearing aid" (unspecified if ongoing), notes: Consumer stated, I have the hearing problem. I can't really hear you. I have put on hearing aid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "she tested positive after taking the Pfizer Covid 19 vaccine"; COVID-19 (medically significant), outcome "unknown", described as "She tested positive after taking the Pfizer Covid 19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The caller is she tested positive after taking the Pfizer Covid 19 vaccine and also she was prescribed to take Paxlovid since she tested positive for Covid so, she already took the dose. So, she started taking the Paxlovid around 2:30 the afternoon so, she also have the question about the product." I had three vaccines full doses and I had one booster and I stayed home 2 years and only now I went out little bit and so, I am shocked that I have covid and because I am 74 year old and I was authorized to take this drug and I received it just now and I decided there is time limit when you take it. I took it this afternoon at 2:30. I was not going to wait till tomorrow morning. It is a simple question as I don't want to double up and it's for 5 days it means I continue taking this weird hours but I want to know when should I take my next dose should I wait till morning or should I wake up 2:30 in the morning or what.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 14Jun positive with new symptoms; 14Jun positive with new symptoms; 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200), on 11Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FF8871) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "14Jun positive with new symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive; (08Jun2022) Negative but symptomatic; (14Jun2022) Positive with new symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Morbid obesity" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient received paxlovid as treatment for covid-19. Treatment start date was 07Jun2022 and stop date was 12Jun2022. 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 information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (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 "unknown" and all described as "COVID 19 Treatment". 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 information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.