chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; Vaccination failure; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "overweight" (unspecified if ongoing); "Overactive bladder" (unspecified if ongoing); "Penicillin and related antibiotics" (unspecified if ongoing); "Penicillin and related antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered"; VACCINATION FAILURE (medically significant), outcome "unknown". Therapeutic measures were taken as a result of covid-19. Clinical course I developed a runny nose and swollen throat today and did an antigen test and was positive, after being negative and feeling fine for 4 days.  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 events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: experienced Covid rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition ifnoamtion: Other medication in 2weeks was unknown. Treatment start date was 22May2022. Treatment stop date was27May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech/ COVID 19 Treatment 22/May/2022; Pfizer / BioNTech/ COVID 19 Treatment 22/May/2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose number unknown, single (Batch/Lot number: unknown), on 25Mar2021 as dose number unknown, single (Batch/Lot number: unknown) and on 19Oct2021 at 15:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ELAVIL [ALLOPURINOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "Pfizer / BioNTech/ COVID 19 Treatment 22/May/2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (03Jun2022) positive, notes: keep testing positive on day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks. Patient had Chest congested and keep testing positive on day 13 (adverse event start date: 31May2022). Patient received treatment for Covid-19 with Paxlovid from 22May2022 to 26May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Rebound infection; Rebound infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 3 (booster), single (Lot number: EL9729) 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: "Asthma" (unspecified if ongoing). Patient did not have any known allergies.Concomitant medication(s) included: TRUVADA.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "Rebound infection". Therapeutic measures were not taken as a result of suspected covid-19, drug ineffective. Patient received Truvada medication in 2 weeks.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old male patient received BNT162b2 (BNT162B2), on 22May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history and no known allergies. There were no concomitant medications or other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech 22May2021 / Treatment of COVID-19 23May2022". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19 which included Paxlovid from 23May2022 to 27May2022. The patient had diarrhea and metallic taste in mouth during treatment. Symptoms reduced on second day, gone by day three of 5 day treatment. Three days after completion, fever, congestion, cough all returned. Unsure if adverse reaction to medications or COVID bounce back. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8737), in left arm and on 26Apr2021 as dose 2, single (Lot number: EW0169) at the age of 32 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". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had not received any other medication in 2 weeks of vaccination. Patient had no Known allergies. Patient received Anti-viral Paxlovid treatment for COVID-19 starting from 23May2022 to 27May2022.
Age: 51.0
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) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 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: "Crohn's" (unspecified if ongoing), notes: Other medical history: Crohn's. There were no concomitant medications. Past drug history included: Diclofenac, reaction(s): "Known allergies: Diclofenac". 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; Negative, notes: Full return on symptoms after having tested negative for 6 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound infection beginning on 01Jun. Full return on symptoms after having tested negative for 6 days. Patient was treated with Anti-viral from 21May2022 to 25May2022 for Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: my hair started to fall out at an alarming rate/lost 50% of my hair mass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 immunization.  The following information was reported: ALOPECIA (non-serious) with onset Apr2021, outcome "unknown", described as "my hair started to fall out at an alarming rate/lost 50% of my hair mass".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant patient" (unspecified if ongoing), notes: Kidney transplant patient; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CYCLOSPORINE; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; PREDNISONE; LABETALOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: neg test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19 23May2022; Pfizer / BioNTech / Treatment of COVID-19 23May2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 31Aug2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Topamax, reaction(s): "Known allergies: Topamax", notes: known allergies Topamax. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19 23May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive; (26May2022) Negative, notes: asymptomatic and testing negative. Tested negative for 7 days; (02Jun2022) Negative, notes: antigen test was initially negative this morning but after hours faint line; (02Jun2022) Positive, notes: evening immediately positive on antigen testing. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No other medication in 2weeks. Antiviral details: Product: Covid 19 treatment, Brand: Pfizert, treatment start date: 23May2022, treatment stop date: 27May2022, indication: treatment of covid-19, administrator route: oral. Adverse event: tested positive for Covid early Monday 23May. 2 risk factors and immediately started paxlovid by Thursday 26May was asymptomatic and testing negative. Strictly isolated for 5 days at the time. Tested negative for 7 days, 02Jun mildly symptomatic again (tested metal like the medicine in morning, post-nasal drip) antigen test was initially negative this morning but after hours faint line, 02Jun evening immediately positive on antigen testing.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 45-year-old male patient received bnt162b2 (BNT162B2) on 02Jun2022 as dose 3 (booster), single (Lot number: FJ5683), in left arm, for COVID-19 immunization. The patient's relevant medical history was not reported. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3247; Anatomical site: Left arm), administration date: 04Mar2021, when the patient was 44 years old, for COVID-19 immunization and Bnt162b2 (DOSE 2, SINGLE; Lot number: HEP6955; Anatomical site: Left arm), administration date: 25Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 02Jun2022, outcome "not recovered", described as "Fever 102.5"; PAIN IN EXTREMITY (non-serious) with onset 02Jun2022, outcome "not recovered", described as "Left arm pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia and pain in extremity. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment included ADVIL and TYLENOL for PYREXIA and PAIN IN EXTREMITY. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fatigue, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: AFIB; Fever; headache; muscle cramping/fingers cramped; heavy fatigue; sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concurrent conditions were not reported. The patient had NKA (no known allergies). Concomitant medication(s) included: SYNTHROID; MAGNESIUM, received within 2 weeks of vaccination. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to the covid vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient has not been tested for covid-19 since the vaccination. Device Date : 03Jun2022. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "AFIB"; PYREXIA (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "Fever"; HEADACHE (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022); FATIGUE (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "heavy fatigue"; MUSCLE SPASMS (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "muscle cramping/fingers cramped"; HYPERHIDROSIS (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "sweats". The events "afib", "fever", "headache", "muscle cramping/fingers cramped", "heavy fatigue" and "sweats" resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of atrial fibrillation, pyrexia, headache, muscle spasms, fatigue, hyperhidrosis. The reporter assessed the case as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: AFIB; Fever; headache; muscle cramping/fingers cramped; heavy fatigue; sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concurrent conditions were not reported. The patient had NKA (no known allergies). Concomitant medication(s) included: SYNTHROID; MAGNESIUM, received within 2 weeks of vaccination. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to the covid vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient has not been tested for covid-19 since the vaccination. Device Date : 03Jun2022. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "AFIB"; PYREXIA (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "Fever"; HEADACHE (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022); FATIGUE (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "heavy fatigue"; MUSCLE SPASMS (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "muscle cramping/fingers cramped"; HYPERHIDROSIS (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "sweats". The events "afib", "fever", "headache", "muscle cramping/fingers cramped", "heavy fatigue" and "sweats" resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of atrial fibrillation, pyrexia, headache, muscle spasms, fatigue, hyperhidrosis. The reporter assessed the case as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Electrocardiogram, Herpes zoster, Hypertension
Clinical narrative: tested positive for Covid-19 in 2021; tested positive for Covid-19 in 2021; increased hypertension; shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: medical history of lupus; "hypertension" (unspecified if ongoing); "COVID-19", start date: 2020 (unspecified if ongoing), notes: she was diagnosed with Covid-19 back in 2020. The patient's concomitant medications were not reported.  The following information was reported: HYPERTENSION (hospitalization) with onset 2021, outcome "unknown", described as "increased hypertension"; HERPES ZOSTER (hospitalization) with onset 2021, outcome "unknown", described as "shingles"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for Covid-19 in 2021". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (2021) irregular; Hypertension: (2021) increased; SARS-CoV-2 antibody test: (2021) antibodies for Covid-19, notes: she has antibodies for Covid-19; SARS-CoV-2 test: (2021) Positive; (2021) Negative; (2021) false positive, notes: her HCP told her that she had a false positive test for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 in 2021; tested positive for Covid-19 in 2021; increased hypertension; shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: medical history of lupus; "hypertension" (unspecified if ongoing); "COVID-19", start date: 2020 (unspecified if ongoing), notes: she was diagnosed with Covid-19 back in 2020. The patient's concomitant medications were not reported.  The following information was reported: HYPERTENSION (hospitalization) with onset 2021, outcome "unknown", described as "increased hypertension"; HERPES ZOSTER (hospitalization) with onset 2021, outcome "unknown", described as "shingles"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for Covid-19 in 2021". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (2021) irregular; Hypertension: (2021) increased; SARS-CoV-2 antibody test: (2021) antibodies for Covid-19, notes: she has antibodies for Covid-19; SARS-CoV-2 test: (2021) Positive; (2021) Negative; (2021) false positive, notes: her HCP told her that she had a false positive test for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
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). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8737), in left arm and on 26Apr2021 as dose 2, single (Lot number: ER8735) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Lot number: 069F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: LEXAPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. 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: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative, notes: receiving a negative test; (30May2022) Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter (Nurse). A 66-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 23Mar2021 as dose 1, single (Lot number: ER2613) and on 13Apr2021 as dose 2, single (Lot number: ER8730) at the age of 64 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), on 01Oct2021 as dose 3 (booster), single (Lot number: 30145BA) for Covid-19 immunisation. The patient's relevant medical history included: "Follicular lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy"; Thimerosal, reaction(s): "Allergy"; Lanolin, reaction(s): "Allergy". 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: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, Covid-19. The patient received Paxlovid to treated vaccination failure, Covid-19. Treatment start date: 25May2022, treatment stop date: 29May2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 29Aug2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 47 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: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Scopolamine, reaction(s): "Known allergies: scopolamine"; Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: No, Product: COVID 19 treatment, Brand: Paxlovid, Treatment start date: 02Jun2022 Treatment stop date: 03Jun2022, Lot number: GC0470, Indication=Treatment of COVID-19. Adverse Event: Nausea after taking each dose of paxlovid. Adverse event start date: 02Jun2022, Recovering, If treatment ae: No.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 32.0
Sex: M
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 33-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL, start date: 24May2022, stop date: 02Jun2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: The product Paxlovid for  COVID 19 treatment its treatment start date was 02Jun2022 and treatment stop date was 03Jun2022 . other medication in 2weeks product: DayQuil/NyQuil throat losenges start date from 24May2022 and stop date was 02Jun2022
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID with mild symptoms and low fever; tested positive for COVID with mild symptoms and low fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 11-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 10Nov2021 as dose 1, single (Lot number: FK5127), in right arm and on 01Dec2021 as dose 2, single (Lot number: FK5618) at the age of 11 years, in right 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) all with onset 09Jan2022, outcome "recovered" and all described as "tested positive for COVID with mild symptoms and low fever". The patient underwent the following laboratory tests and procedures: Body temperature: (09Jan2022) low; SARS-CoV-2 test: (11Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epiglottic oedema, Laryngeal oedema
Clinical narrative: swelling in her epiglottis; swelling in the larynx; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPIGLOTTIC OEDEMA (medically significant), outcome "unknown", described as "swelling in her epiglottis"; LARYNGEAL OEDEMA (medically significant), outcome "unknown", described as "swelling in the larynx". The events "swelling in her epiglottis" and "swelling in the larynx" required physician office visit.  Additional information reported that patient's parent wondering if there were any reported side effects from the COVID vaccine regarding swelling in the larynx, specifically the epiglottis. Patient who is 15-year-old, received 2 doses of the Pfizer COVID vaccine and then developed swelling in her epiglottis. She is currently seeing a doctor for this condition but they have not been able to give her a diagnosis as to what caused it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pericardial effusion
Clinical narrative: Pericardial effusion; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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: PERICARDIAL EFFUSION (medically significant), outcome "unknown".  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 event  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose fluctuation, Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "bee stings" (unspecified if ongoing); "Known allergies: fragrances" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Septra, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number=EN6205,, lot unknown=False,, vaccine location=Left arm), administration date: 01Mar2021, when the patient was 71-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, prev dose lot number=EW0188,, prev dose lot unknown=False, prev dose vaccine location=Left arm), administration date: 12Oct2021, when the patient was 72-year-old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 24May2022, outcome "recovering", described as "elevate blood pressure"; BLOOD GLUCOSE FLUCTUATION (non-serious) with onset 24May2022, outcome "recovering", described as "fluctuations in blood sugar"; HEADACHE (non-serious) with onset 24May2022, outcome "recovering", described as "severe headache for 10days". The events "severe headache for 10days", "elevate blood pressure" and "fluctuations in blood sugar" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure increased. Additional information: If other vaccine in four weeks: No. Other medications in two weeks: 25 mg Losartan bid. Ae treatment: increased strength of bp medication. If covid prior vaccination: No. If covid tested post vaccination: no.
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Drug ineffective, Investigation, Karyotype analysis, SARS-CoV-2 antibody test
Clinical narrative: After the third vaccine dose, 1 patient (P-53) had documented breakthrough SARS-CoV-2 infection resulting in hospitalization and recovered fully; After the third vaccine dose, 1 patient (P-53) had documented breakthrough SARS-CoV-2 infection resulting in hospitalization and recovered fully; This is a literature report for the following literature source(s):  A 65-year-old 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 immunisation. The patient's relevant medical history included: "MDS" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Seasonal influenza vaccination, for immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", BREAKTHROUGH COVID-19 (hospitalization, medically significant), outcome "recovered" and all described as "After the third vaccine dose, 1 patient (P-53) had documented breakthrough SARS-CoV-2 infection resulting in hospitalization and recovered fully". The patient underwent the following laboratory tests and procedures: IPSS-R/ELN/DIPSS: 8, notes: Very high; Unknown results; Karyotype analysis: 46, XY, del(7) (q22q36); SARS-CoV-2 antibody test: Unknown results. Therapeutic measures were taken as a result of breakthrough covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202200803661 same article/product/event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Aug2021 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 miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Primary Mediastinal B Cell Lymphoma", start date: 12Mar2020 (unspecified if ongoing), notes: Primary Mediastinal B Cell Lymphoma diagnosed treatment completed 30 Mar2021; "remission" (unspecified if ongoing), notes: have remained in remission. Concomitant medication(s) included: Celexa [Celecoxib]; Wellbutrin; Pepcid [Famotidine]; Vitamin C [Ascorbic Acid]; Afrin [Oxymetazoline]; Fluticasone Propionate; Tylenol; Ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of Covid-19. The patient had no known allergies. The information on the batch/lot number for [BNT162B2] was not provided and will be requested during follow up. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: nausea; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 27-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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9262), on 25Feb2021 as dose 2, single (Lot number: EM9809) and on 27Sep2021 as dose 3 (booster), single (Lot number: 30135BA) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; FIBERCON; CANAGLIFLOZIN; FAMOTIDINE; FINASTERIDE; GABAPENTIN; GLIPIZIDE; LEVOTHYROXINE; MELOXICAM; QUINAPRIL; SPIRONOLACTONE; TAMSULOSIN. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 11Apr2022 at 01:45 as dose 4 (booster), single (Lot number: FK9729) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "eye drops allergy" (unspecified if ongoing), notes: known allergies: eye drops allergy; "bandages allergy" (unspecified if ongoing), notes: known allergies: bandages allergy. There were no concomitant medications. No other medication in 2 weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details for event COVID 19 Treatment included Paxlovid, treatment start date: 17May2022 and treatment stop date: 22May2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.