chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for a week almost 10 days now; positive for a week almost 10 days now; 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 57-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN 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 "positive for a week almost 10 days now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: i am positive for a week almost 10 days now. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was on paxlovid.  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, COVID19
Symptoms: Anxiety, COVID-19, SARS-CoV-2 test
Clinical narrative: positive for a week almost 10 days now; positive for a week almost 10 days now; 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 57-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN 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 "positive for a week almost 10 days now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: i am positive for a week almost 10 days now. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was on paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: strong positive. Therapeutic measures were taken as a result of covid-19. The patient received Paxlovid for covid-19 from 05Aug2022 to 10Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
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 non-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 22Mar2021 as dose 1, single (Lot number: EN6207), on 12Apr2021 as dose 2, single (Lot number: ER8734) and on 16Dec2021 as dose 3 (booster), 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: "asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Known allergies: Pennicillan" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ASTELIN [AZELASTINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]; MONTELUKAST; QVAR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11Aug2022) Negative; (15Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 04Aug2022 to 09Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6201), in right arm, on 28Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Aspergelosis" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 01Sep2009. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 30Jul2022 to 04Aug2022.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), 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 "not recovered" and all described as "Treatment of 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. Anti-viral treatment included nirmatrelvir/ritonavir (PLAXOVID) from 07Aug2022 to 11Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Hyperaesthesia, Vomiting
Clinical narrative: He had severe diarrhea and also vomiting and also he was taken to the hospital; He had severe diarrhea and also vomiting and also he was taken to the hospital; Abdominal pain; Severe skin sensitivity; loss some weight; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7138, Expiration Date: Dec2022) at the age of 62 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: COVID -19 vaccine (dose 1, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 2, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 3, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (hospitalization), DIARRHOEA (hospitalization), outcome "unknown" and all described as "He had severe diarrhea and also vomiting and also he was taken to the hospital"; ABDOMINAL PAIN (non-serious), outcome "unknown"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "Severe skin sensitivity"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss some weight"; CHILLS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course details: Patient had severe diarrhea and vomiting so he was taken to the hospital. Patient stated he stayed 5 days of the week in intensive care. Patient was told that those were the side effects until he started to have abdominal pain, severe skin sensitivity, chills and everything. Patient was trying to get back to normal. He was drinking dairy then similar products. He was trying to eat very less and Wednesday morning (date unspecified) when his nephew found out and took him to hospital. Patient had 4 vaccines. Patient stated he may have loss some weight in the hospital.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: He had severe diarrhea and also vomiting and also he was taken to the hospital; He had severe diarrhea and also vomiting and also he was taken to the hospital; Abdominal pain; Severe skin sensitivity; loss some weight; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7138, Expiration Date: Dec2022) at the age of 62 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: COVID -19 vaccine (dose 1, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 2, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 3, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (hospitalization), DIARRHOEA (hospitalization), outcome "unknown" and all described as "He had severe diarrhea and also vomiting and also he was taken to the hospital"; ABDOMINAL PAIN (non-serious), outcome "unknown"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "Severe skin sensitivity"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss some weight"; CHILLS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course details: Patient had severe diarrhea and vomiting so he was taken to the hospital. Patient stated he stayed 5 days of the week in intensive care. Patient was told that those were the side effects until he started to have abdominal pain, severe skin sensitivity, chills and everything. Patient was trying to get back to normal. He was drinking dairy then similar products. He was trying to eat very less and Wednesday morning (date unspecified) when his nephew found out and took him to hospital. Patient had 4 vaccines. Patient stated he may have loss some weight in the hospital.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood sodium decreased, Confusional state, Diarrhoea, Dizziness
Clinical narrative: He had severe diarrhea and also vomiting and also he was taken to the hospital; He had severe diarrhea and also vomiting and also he was taken to the hospital; Abdominal pain; Severe skin sensitivity; loss some weight; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7138, Expiration Date: Dec2022) at the age of 62 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: COVID -19 vaccine (dose 1, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 2, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 3, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (hospitalization), DIARRHOEA (hospitalization), outcome "unknown" and all described as "He had severe diarrhea and also vomiting and also he was taken to the hospital"; ABDOMINAL PAIN (non-serious), outcome "unknown"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "Severe skin sensitivity"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss some weight"; CHILLS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course details: Patient had severe diarrhea and vomiting so he was taken to the hospital. Patient stated he stayed 5 days of the week in intensive care. Patient was told that those were the side effects until he started to have abdominal pain, severe skin sensitivity, chills and everything. Patient was trying to get back to normal. He was drinking dairy then similar products. He was trying to eat very less and Wednesday morning (date unspecified) when his nephew found out and took him to hospital. Patient had 4 vaccines. Patient stated he may have loss some weight in the hospital.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Immunisation reaction, Intensive care, Muscle spasms
Clinical narrative: He had severe diarrhea and also vomiting and also he was taken to the hospital; He had severe diarrhea and also vomiting and also he was taken to the hospital; Abdominal pain; Severe skin sensitivity; loss some weight; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7138, Expiration Date: Dec2022) at the age of 62 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: COVID -19 vaccine (dose 1, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 2, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 3, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (hospitalization), DIARRHOEA (hospitalization), outcome "unknown" and all described as "He had severe diarrhea and also vomiting and also he was taken to the hospital"; ABDOMINAL PAIN (non-serious), outcome "unknown"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "Severe skin sensitivity"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss some weight"; CHILLS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course details: Patient had severe diarrhea and vomiting so he was taken to the hospital. Patient stated he stayed 5 days of the week in intensive care. Patient was told that those were the side effects until he started to have abdominal pain, severe skin sensitivity, chills and everything. Patient was trying to get back to normal. He was drinking dairy then similar products. He was trying to eat very less and Wednesday morning (date unspecified) when his nephew found out and took him to hospital. Patient had 4 vaccines. Patient stated he may have loss some weight in the hospital.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Perfume sensitivity, Restlessness, Sensitive skin, Sleep disorder
Clinical narrative: He had severe diarrhea and also vomiting and also he was taken to the hospital; He had severe diarrhea and also vomiting and also he was taken to the hospital; Abdominal pain; Severe skin sensitivity; loss some weight; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7138, Expiration Date: Dec2022) at the age of 62 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: COVID -19 vaccine (dose 1, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 2, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 3, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (hospitalization), DIARRHOEA (hospitalization), outcome "unknown" and all described as "He had severe diarrhea and also vomiting and also he was taken to the hospital"; ABDOMINAL PAIN (non-serious), outcome "unknown"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "Severe skin sensitivity"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss some weight"; CHILLS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course details: Patient had severe diarrhea and vomiting so he was taken to the hospital. Patient stated he stayed 5 days of the week in intensive care. Patient was told that those were the side effects until he started to have abdominal pain, severe skin sensitivity, chills and everything. Patient was trying to get back to normal. He was drinking dairy then similar products. He was trying to eat very less and Wednesday morning (date unspecified) when his nephew found out and took him to hospital. Patient had 4 vaccines. Patient stated he may have loss some weight in the hospital.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Vomiting
Clinical narrative: He had severe diarrhea and also vomiting and also he was taken to the hospital; He had severe diarrhea and also vomiting and also he was taken to the hospital; Abdominal pain; Severe skin sensitivity; loss some weight; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7138, Expiration Date: Dec2022) at the age of 62 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: COVID -19 vaccine (dose 1, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 2, single, Manufacturer unknown), for COVID-19 immunization; COVID -19 vaccine (dose 3, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (hospitalization), DIARRHOEA (hospitalization), outcome "unknown" and all described as "He had severe diarrhea and also vomiting and also he was taken to the hospital"; ABDOMINAL PAIN (non-serious), outcome "unknown"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "Severe skin sensitivity"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss some weight"; CHILLS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Weight: loss. Clinical course details: Patient had severe diarrhea and vomiting so he was taken to the hospital. Patient stated he stayed 5 days of the week in intensive care. Patient was told that those were the side effects until he started to have abdominal pain, severe skin sensitivity, chills and everything. Patient was trying to get back to normal. He was drinking dairy then similar products. He was trying to eat very less and Wednesday morning (date unspecified) when his nephew found out and took him to hospital. Patient had 4 vaccines. Patient stated he may have loss some weight in the hospital.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female 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 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 "tested positive for COVID". 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. Treatment included nirmatrelvir/ritonavir (PAXLOVID). Clinical course: She already got the first and second dose of the Pfizer COVID-19 Vaccines and also had the booster dose; after 8 months she tested positive for COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 25Jul2022; DESVENLAFAXINE, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Aug2022) Positive, notes: Tested positive again on 15Aug2022. 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8735), in left arm, on 06May2021 as dose 2, single (Lot number: EW0173), in left arm and on 24Nov2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15Aug2022) Positive. Therapeutic measure included Paxlovid which was taken from 07Aug2022 to 11Aug2022, as a result of vaccination failure, covid-19.
Age: 51.0
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 from a contactable consumer. The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single and as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "smoker"; "high blood pressure"; "known allergies: penicillin". Concomitant medication included: LOSARTAN. 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: COVID-19 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: PAXLOVID from 06Aug2022 to 10Aug022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Muscle twitching, SARS-CoV-2 test
Clinical narrative: Severe bell's palsy; twitch on affected side of face when stressed; This is a spontaneous report received from a contactable reporter) (Consumer). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: ER8737) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety/depression" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "dust allergy" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; CONCERTA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL; IBUPROFEN. The following information was reported: BELL'S PALSY (hospitalization, medically significant) with onset 17Apr2021 at 10:00, outcome "recovered with sequelae", described as "Severe bell's palsy"; MUSCLE TWITCHING (hospitalization) with onset 17Apr2021 at 10:00, outcome "recovered with sequelae", described as "twitch on affected side of face when stressed". The patient was hospitalized for bell's palsy, muscle twitching (hospitalization duration: 1 day(s)). The events "severe bell's palsy" and "twitch on affected side of face when stressed" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: covid tested post vaccination. Therapeutic measures were taken as a result of bell's palsy, muscle twitching. Clinical course: Patient had no known allergies; no other vaccine in four weeks. It was unknown if patient experienced covid prior vaccination. Patient experienced severe bell's palsy was 9 months before recovering with lasting twitch on affected side of face when stressed. Treatment included steroids, antiviral medication. Patient recovered with lasting effects. Patient also received dose 2 (Lot number: EW0175) on 06May2021 in right arm.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech Dose Number: 2 / Treatment of COVID-19 5-AUG-2022; Pfizer / BioNTech Dose Number: 2 / Treatment of COVID-19 5-AUG-2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), as dose 2, 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) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE, taken in 2 weeks, start date: 05Aug2022, stop date: 12Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech Dose Number: 2 / Treatment of COVID-19 5-AUG-2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive, notes: Rebound symptoms 6 days after ending treatment. Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included treatment with Paxlovid from 05Aug2022 to 09Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
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 (Consumer or other non-HCP).  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: FL3209) at the age of 33 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (31Jul2022) Negative; (05Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PF-07321332, ritonavir (PAXLOVID) with treatment start date: 26Jul2022, treatment stop date: 31Jul2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Shortness of breath; cough; low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 14Aug2022, outcome "recovering", described as "Shortness of breath"; COUGH (non-serious) with onset 14Aug2022, outcome "recovering"; ASTHENIA (non-serious) with onset 14Aug2022, outcome "recovering", described as "low energy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, cough, asthenia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201063839 Same patient and product, different AEs;
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 3 (booster), single (Lot number: HFF8841) at the age of 55 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: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ZYLOPRIM oral, start date: Jan2018; ACIPHEX oral. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PF-07321332, ritonavir (PAXLOVID) with treatment start date: 11Aug2022, treatment stop date: 16Aug2022.
Age: 64.0
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 65-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. 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: (16Aug2022) Positive, notes: Rebound. Tested positive for Covid on 16Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Pfizer covid-19 treatment from 05Aug2022 to 10Aug2022. Clinical course: There were no other medication in 2weeks.   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; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-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: "Mitro valve prolapse" (unspecified if ongoing), notes: Mitro valve prolapse; "Super Ventricular tachycardia" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid (Lot: GD8744) from 12Aug2022 to 16Aug2022 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.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Tinnitus
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), 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: TINNITUS (non-serious), outcome "unknown"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell". Additional information: Patient stated that he developed tinnitus and loss of taste and smell after two doses of Pfizer Covid vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-PV202200042943 Same patient/drug/AE, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, Cytomegalovirus test, Epstein-Barr virus test, Physical examination, Vulval ulceration
Clinical narrative: Post COVID-19 Vaccination vulvar aphthous ulcers; Post COVID-19 Vaccination vulvar aphthous ulcers; This is a literature report.  An adolescent patient received BNT162b2 (BNT162B2), in 2021 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 1, Single), for COVID-19 immunisation, reaction(s): "Without complications". The following information was reported: VULVAL ULCERATION (medically significant), APHTHOUS ULCER (medically significant) all with onset 2021, latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "Post COVID-19 Vaccination vulvar aphthous ulcers". The event "post covid-19 vaccination vulvar aphthous ulcers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: negative; Epstein-Barr virus test: negative; Physical exam: was consistent with a dianosis, notes: of vulvar aphthous ulcers with no exceptional characteristics.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202201056246 Same article/drug/event and different patient:;US-PFIZER INC-202201056247 Same article/drug/event and different patient:;
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Tinnitus
Clinical narrative: tinnitus; Loss of taste; Loss of smell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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 1, SINGLE), for COVID-19 immunisation, reaction(s): "Loss of taste", "Loss of smell", "tinnitus". The following information was reported: TINNITUS (non-serious), outcome "unknown"; AGEUSIA (non-serious), outcome "unknown", described as "Loss of taste"; ANOSMIA (non-serious), outcome "unknown", described as "Loss of smell".  Additional information: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201065129 Same patient/drug/AE, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Peripheral swelling
Clinical narrative: legs swollen 24 hr after; severe leg pain in my calf muscle; I sick of the pain; 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 patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "legs swollen 24 hr after"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "severe leg pain in my calf muscle"; ILLNESS (non-serious), outcome "unknown", described as "I sick of the pain".  Additional information: Patient reported that I got your Covid shot at a my legs swollen 24 hr after along with severe leg pain in my calf muscle , I called a company and your site had no warnings about this when I seen a video from 2021 you Company knew about it. What is causing it, I need to know what to ask my physician to look for. I'm a CNA this affects me 24hr a day nothing helps. I sick of the pain I'm 37 what is causing it so I can have my physician look.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: After trying so so hard not not catch covid, fell victim to an innocent close contact; After trying so so hard not not catch covid, fell victim to an innocent close contact; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After trying so so hard not not catch covid, fell victim to an innocent close contact". The patient was home with an annoying "cold" and not in a hospital, and not dead.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200043443 same drug/reporter/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Nasopharyngitis, Suspected COVID-19
Clinical narrative: After trying so so hard not not catch covid, fell victim to an innocent close contact / Thank you for saving my life, and my husband's, as yes we did not manage to not share.; After trying so so hard not not catch covid, fell victim to an innocent close contact / Thank you for saving my life, and my husband's, as yes we did not manage to not share.; I'm home with an annoying cold/ Thank you for saving my life, and my husband's as yes we did not manage to not share; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After trying so so hard not not catch covid, fell victim to an innocent close contact / Thank you for saving my life, and my husband's, as yes we did not manage to not share."; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I'm home with an annoying cold/ Thank you for saving my life, and my husband's as yes we did not manage to not share". After trying so so hard not not catch covid , fell victim to an innocent close contact. But thanks to having my vaccine, and two boosters, I'm home with an annoying ''cold'' and not in a hospital, and not dead.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200043442 same drug/reporter/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Three vaccines and I still get Covid; Three vaccines and I still get Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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 and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Aug2022, outcome "unknown" and all described as "Three vaccines and I still get Covid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: "congestive heart failure" (unspecified if ongoing); "Crohn's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2022, outcome "not recovered" and all described as "tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Positive; (13Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received 2 Pfizer vaccinations as well as a booster. Patient was tested positive for Covid on 03Aug2022 after returning from a trip. Because had congestive heart failure and Crohn's Disease the Dr put him/her on Paxlovid. Symptoms abated until today when began sneezing, sinus pressure and slight chills so purchased and took a drug store Covid test which showed positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.